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Regulatory Rationale Bone Graft
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Regulatory Rationale Bone Graft

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  • 1. Bone Graft Substitute REGULATORY RATIONALE Project # 102386 Date: November 24, 2010 Revision: 01 Author: Ujwal Parikh______________ ______________ ______________Project Manager Marketing RegulatoryKazim Efendioglu Steve Tanenbaum Ujwal Parikh______________ _______________ ______________Pre-Clinical Clinical QualityAsha Pullikal Shreelesh Gharat Daniel CarrinoRevision Change DateNew Original Document 11/24/2010
  • 2. REGULATORY RATIONALENAME: UJWAL PARIKHDATE : NOVEMBER 24,2010Device Generic Name: StemGroTMDevice Trade Name: StemGroTMApplicants Name Medical Design Device Corp.Address: University Heights Newark NJ 07102Classification Name: Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction MPWRegistered 1284048Establishment Number:Establishment Operations: Manufacturer
  • 3. DescriptionStemGroTM is an orthopedic surgical implant for the treatment of bone damage caused due toan injury or defect. StemGroTM consists of a Polycaprolectone- Hydroxyapatite (HA)/ β-Tricalcium Phosphate (TCP) scaffold coated with allogeneic mesenchymal stem cells (MSC).Once implanted in the body, the device stimulates natural bone healing by differentiating intoosteoblasts. Presence of allogeneic MSCs on a biocompatible scaffold makes it anosteoconductive and osteoinductive bone graft material. Addition of recombinant human bonemorphogenic protein-2 increases bone healing by actively recruiting stem cells fromsurrounding tissue and blood supply, initiating the bone formation cascade.Claims1. No immunological response due to the presence of allogeneic mesenchymal stem cells.2. Enhances bone healing due to osteoinductive and osterconductive property of bone graft.3. Enhanced biomechanical strength due to presence of polymer/ceramic based scaffold4. Scaffold material easily biodegradable.Indications for UseThis device has to be used under supervision of a healthcare professional only.1. Treatment for distal long bone limb fractures with Gustilo-Anderson type I, II, III A or B without joint involvement.2. Can be used in addition to wound management along with an intermedullary nail for fracture stabilization.3. An alternative to auto graft for treatment of open fractures.Contraindications
  • 4. The use of this device should be contraindicated in the following cases:1. In the vicinity of a resected or extant tumor, in patients with any active malignancy, or in patients undergoing treatment for a malignancy2. Patients who are skeletally immature (<18 years of age or no radiographic evidence of epiphyseal closure)3. Pregnant women4. Patients suffering from traumatic instability, metabolic & circumferential bone loss and inadequate neurovascular status.5. Patients having medical history on iliac wing contraindicating bone marrow aspiration.6. Patients with an active infection at the operative site.7. Person with any metal implant or pacemakersGoverning AgencyThe device is governed by Centre for Devices & Radiological Health.The device requires Request for Designation as it is a combination product as per 21 CFR3.2(e)Classification of the Device
  • 5. Class IClass IIClass III XRegulatory PathwaySince it is a Class III Device, Pre-Market Approval (PMA) with Investigational DeviceExemption (IDE) should be submitted to the FDA. The device is a combination product and willrequire Request for Designation. Pre-Clinical and Clinical studies should be carried out tovalidate the claims, to prove substantial equivalence and to prove that the device is safe andeffective. Compliance with the general control provisions of the Federal Food, Drug & CosmeticAct (Act) is necessary.Pre-clinical StudiesThe safety of StemGroTM should be evaluated in accordance with the tests described in ISO10993. Extensive biocompatibility and safety testing should be performed using StemGroTM,including cytotoxicity, sensitization, genotoxicity, carcinogenicity and reproductive toxicity.Additional studies, related to biomechanical testing, biodegradability, radiological observationand histology should be performed using StemGroTM. The results of this extensivebiocompatibility and safety testing performed in a range of in vitro cell based studies and invivo animal studies should be properly documented to evaluate the safety of StemGro TM forbone repair.Clinical Studies
  • 6. Under Investigational Device Exemptions, a randomized, prospective, controlled multicenterstudy should be conducted to evaluate the ability of StemGroTM to safely heal distal long bonelimb fractures with Gustilo-Anderson type I, II, III A or B, without joint involvement. Studyentry should show that each patient failed to heal the conventional treatment. Three groupswill be created. First group will be given the conventional intermedullary rod treatment.Second group will be given StemGroTM as a bone graft material for bone healing. Third groupwill be given a combination of StemGroTM and IM rod. The results of this study will be analyzedto evaluate the use of StemGroTM as a bone grafting material.Registration Requirements (Device Listing)Following devices with their registration number were approved by the FDA. These devicesfunction similarly to our product. Device Device Regis. Description Class # OP-1 Implant by 3 123.5680 OP-1 Implant is an osteoinductive and osteoconductive bone graft material Stryker®. consisting of a combination of 3.3 mg of recombinant human BMP-7 (rhBMP-7) and 1 g of purified Type I bovine collagen, which is used as a carrier. The product is applied in the form of paste reconstituted with 2-3 cc of saline at the site of nonunion. OP-1 Implant is indicated for use as an alternative to auto graft in recalcitrant long bone nonunion where use of auto graft is unfeasible and alternative treatments have failed. INFUSE® Bone 3 342.6574 INFUSE® Bone Graft is recombinant human Bone Morphogenetic Protein-2 Graft by (rhBMP-2) applied to an absorbable collagen sponge (ACS) carrier. The purpose of the protein, which occurs naturally in the body, is to stimulate Medtronic®. bone formation. INFUSE® Bone Graft is indicated for healing of open tibial fracture and as an alternative for auto graft.Patent DeterminationName of the Patent Patent/Application Issue/Filing Date
  • 7. NumberPorous bioceramics for bone scaffoldand method for manufacturing the 10/723,401 Nov. 26, 2003sameRegeneration and augmentation of 09/840,284 June 26, 2002bone using mesenchymal stem cellsCompliance with the ACT • Registration and listing (21CFR Part 807) • Labeling (21 CFR Part 801) • Good Manufacturing Practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) • Electronic product radiation control provisions (Sections 53 1-542 of the Act) 21 CFR 1000-1050ISO STANDARDS
  • 8. • ISO 10993-1:2009: Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process. • ISO 10993-2:2006: Biological evaluation of medical devices -- Part 2: Animal welfare requirements • ISO 10993-3:2003: Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity • ISO 10993-4:2002 provides general requirements for evaluating the interactions of medical devices with blood. • ISO 10993-5:2009 describes test methods to assess the in vitro cytotoxicity of medical devices • ISO 10993-6:2007 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices. • ISO 15142-1:2003 specifies metallic medical devices used for the temporary intramedullary stabilization of long bones by surgical implantation, defining terms and giving requirements for intramedullary nails • ISO/TR 14283 provides fundamental principles for the design and manufacture of active or non-active implants in order to achieve the intended purpose. • ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices. • ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. • ISO 11607-2:2006 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. • ISO 14155-1:2002 defines procedures for the conduct and performance of clinical investigations of medical devices.References
  • 9. • www.fda.gov• www.iso.org• https://www.infusebonegraft.com/• www.stryker.com