(83 days)
PROGENIX™ DBM Putty is intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oralmaxillofacial and dental intraosseous defects including but not limited to:
Ridge augmentation
Filling of cystic defect
Filling of extraction sites
Filling of lesions of periodontal origin
Craniofacial augmentation
Filling of defects of endodontic origin
Mandibular reconstruction
Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture
Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall.
PROGENIX™ DBM Putty contains human demineralized bone matrix (DBM) in a biocompatible carrier. The carrier is a mixture of bovine collagen with a natural polysaccharide (sodium alginate). The components are mixed in phosphate buffered saline to achieve a flowable or moldable consistency. All DBM used in the preparation of PROGENIX™ DBM Putty must induce bone formation when evaluated in a validated athymic nude rat assay. Although, findings from an animal model are not necessarily predictive of human clinical results.
PROGENIX™ DBM Putty is a single use product intended for use in the oralmaxillofacial region. Additionally, this product is not designed to impart any mechanical strength to the surgical site. PROGENIX™ DBM Putty is provided in ready-to-use malleable forms that may be molded or manipulated by the surgeon into various shapes. This product has been shown to be osteoconductive as well as osteoinductive in an athymic rat assay, allowing for bony ingrowth across the graft site while resorbing at a rate consistent with bony healing
The provided text is a 510(k) premarket notification for a medical device called PROGENIX™ DBM Putty. This document focuses on demonstrating substantial equivalence to existing devices rather than presenting a study of the device's performance against specific acceptance criteria in a clinical setting.
Therefore, many of the requested sections about explicit acceptance criteria, detailed study design, and performance metrics are not directly found in the provided text. The submission is a regulatory filing for market clearance, not typically a detailed report on clinical trial outcomes with specific statistical thresholds.
Here's an analysis based on the available information:
Acceptance Criteria and Device Performance
Since this is a 510(k) submission for a bone void filler, the "acceptance criteria" are primarily related to substantial equivalence to predicate devices and demonstrating the device's ability to induce bone formation and be osteoconductive. No specific numerical performance metrics are provided in the context of clinical acceptance criteria.
The key "performance" mentioned is in an animal model:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Osteoinductive Capacity (as per validated assay) | All DBM used in the preparation of PROGENIX™ DBM Putty must induce bone formation when evaluated in a validated athymic nude rat assay. The product has been shown to be osteoinductive in an athymic rat assay. (Note: "Although, findings from an animal model are not necessarily predictive of human clinical results.") |
| Osteoconductive Properties (as per animal model) | The product has been shown to be osteoconductive in an athymic rat assay, allowing for bony ingrowth across the graft site. |
| Resorption Rate (consistent with bony healing, as per animal model) | Resorbing at a rate consistent with bony healing in an athymic rat assay. |
| Biocompatibility (implied for components) | Contains human demineralized bone matrix (DBM) in a biocompatible carrier (mixture of bovine collagen with a natural polysaccharide (sodium alginate)). (Implied acceptance by using generally recognized biocompatible materials, no specific test data provided here). |
| Substantial Equivalence to legally marketed predicate devices | Explicitly claimed and accepted by the FDA. The submission provides documentation demonstrating substantial equivalence to several predicate bone void fillers (e.g., PROGENIX™ DBM Putty (K072265, K060794), DBX Demineralized Bone Matrix Putty and Paste (K040501), Accell Connexus™ DBM Putty (K060306), Intergo® Oral (K070147), and GRAFTON® DBM (K051188)). The FDA's letter (K080462) confirms this determination. |
Study Details (Based on available information)
-
Sample size used for the test set and the data provenance:
- The primary "test set" described for performance is an athymic nude rat assay. The exact number of animals (sample size) is not specified in this document.
- Data Provenance: Animal model data (athymic nude rat assay). The location of the assay or the origin of the facility is not stated, but it's part of the product development for a US company. This would be considered prospective data generation for the purpose of demonstrating device characteristics.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this animal model. The "ground truth" for the animal assay (e.g., presence/absence of bone formation, rate of resorption) would be determined by standard histological and imaging analyses conducted by trained veterinary pathologists or researchers, but specific details about their number or qualifications are not provided as it's a foundational biological assay.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for human clinical assessments or image interpretation where expert agreement is needed to establish a "ground truth" diagnosis. This document references an animal assay where outcomes are generally assessed objectively through histological examination.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a bone void filler product, not an AI-powered diagnostic device, so MRMC studies involving human readers and AI assistance are not relevant.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a bone void filler, not an algorithm. Performance is evaluated on its biological effects (osteoinduction, osteoconduction, resorption) within a biological system.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the animal assay, the ground truth for osteoinduction, osteoconduction, and resorption rate would be established through histopathology (microscopic examination of tissue samples) and potentially imaging techniques appropriate for small animal models.
-
The sample size for the training set:
- Not applicable. This product is a physical bone void filler, not a machine learning model, so there is no "training set" in the context of AI.
-
How the ground truth for the training set was established:
- Not applicable for the reason stated in point 7.
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MAY 13 2008
Medtronic Sofamor Danek PROGENIX™ DBM Putty 510(k) Summary February 2008
l. Company: Medtronic Sofamor Danek USA 1800 Pyramid Place Memphis, TN 38132 Telephone: (901) 396-3133 Fax: (901) 346-9738
Contact: Michelle Obenauer Regulatory Affairs Supervisor
- II. Proposed Proprietary Trade Name: Classification Name: Product Code: Regulation No .:
PROGENIX™ DBM Putty Bone Void Filler NUN 872.3930
III. Product Description/Purpose of Application
PROGENIX™ DBM Putty contains human demineralized bone matrix (DBM) in a biocompatible carrier. The carrier is a mixture of bovine collagen with a natural polysaccharide (sodium alginate). The components are mixed in phosphate buffered saline to achieve a flowable or moldable consistency. All DBM used in the preparation of PROGENIX™ DBM Putty must induce bone formation when evaluated in a validated athymic nude rat assay. Although, findings from an animal model are not necessarily predictive of human clinical results.
PROGENIX™ DBM Putty is a single use product intended for use in the oralmaxillofacial region. Additionally, this product is not designed to impart any mechanical strength to the surgical site. PROGENIX™ DBM Putty is provided in ready-to-use malleable forms that may be molded or manipulated by the surgeon into various shapes. This product has been shown to be osteoconductive as well as osteoinductive in an athymic rat assay, allowing for bony ingrowth across the graft site while resorbing at a rate consistent with bony healing
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The purpose of this 510(k) application is to introduce PROGENIX™ DBM Putty into the market for the oralmaxillofacial applications listed on the Indications for Use Form.
IV. Indications
PROGENIX™ DBM Putty is intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oralmaxillofacial and dental intraosseous defects including but not limited to:
Ridge augmentation Filling of cystic defect Filling of extraction sites Filling of lesions of periodontal origin Craniofacial augmentation Filling of defects of endodontic origin Mandibular reconstruction Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall.
V. Substantial Equivalence
Documentation is provided which demonstrates PROGENIX™ DBM Putty to be substantially equivalent to previously cleared bone void fillers such as PROGENIX™ DBM Putty (Medtronic Sofamor Danek, K072265, SE 1/9/2008), PROGENIX™ DBM Putty (Medtronic Sofamor Danek, K060794, SE 12/18/06), DBX Demineralized Bone Matrix Putty and Paste (Musculoskeletal Transplant Foundation, K040501, SE 04/29/05), Accell Connexus™ DBM Putty (IsoTis, OrthoBiologics, Inc., K060306, SE 03/27/2006), Intergo® Oral (Biomet 3i, K070147, SE 05/14/2007), and GRAFTON® DBM (Osteotech, Inc., K051188, SE 01/03/2006).
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized abstract symbol resembling an eagle or bird in flight. The symbol is composed of thick, curved lines. Encircling the symbol is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 2008
Ms. Michelle Obenauer Regulatory Affairs Supervisor Medtronic Sofamor Danek USA 1800 Pyramid Place Memphis, Tennesse 38132
Re: K080462
Trade/Device Name: PROGENIX™M DBM Putty Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NUN Dated: February 12, 2008 Received: February 20, 2008
Dear Ms. Obenauer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Obenauer
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Clars
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K080462
Device Name: PROGENIX™ DBM Putty
Indications for Use:
PROGENIX™ DBM Putty is intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oralmaxillofacial and dental intraosseous defects including but not limited to:
Ridge augmentation
Filling of cystic defect
Filling of extraction sites
Filling of lesions of periodontal origin
Craniofacial augmentation
Filling of defects of endodontic origin
Mandibular reconstruction
Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture
Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
KOF0442
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.