(340 days)
The PolyGraft™ BGS is to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. The PolyGraff™ BGS is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. The PolyGraft™ BGS may be combined with autogenous blood products, such as platelet rich plasma, and/or sterile fluids, such as saline or Ringer's solution. The addition of these autogenous products does not alter the performance of the device.
PolyGraft™ BGS is manufactured using a blend of poly(D,L-lactide-coglycolide), calcium sulfate, polyglycolide fibers and surfactant. The PolyGrafi™ BGS will be provided in a variety of shapes and sizes ranging from small, porous granules to preformed cylindrical plugs.
The provided text describes the PolyGraft™ BGS, a resorbable bone void filler, and its 510(k) summary (K040047). However, the document does not contain the specific information required to complete all sections of your request, such as a table of acceptance criteria, detailed device performance metrics, or information about AI/algorithm performance. The device described is a physical medical device, not an AI/algorithm-based diagnostic tool.
Therefore, many of the requested fields related to AI/algorithm performance, ground truth establishment for AI, sample sizes for test/training sets in an AI context, and expert adjudication are not applicable or cannot be extracted from this document.
Here's a breakdown of the information that can be gleaned from the provided text, addressing your questions to the extent possible:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that the PolyGraft™ BGS is "substantially equivalent in design, function and performance to the PolyGraft™ BGS cleared as K030288." This implies that the acceptance criteria are met by demonstrating equivalence to a predicate device.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as per Study) |
|---|---|
| Biocompatibility (materials used) | Demonstrated biocompatibility by independent certified laboratories. |
| Degradation rate in simulated body fluid | Showed degradation rate substantially equivalent to predicate devices. |
| Bone formation (in vivo) | Histologically showed bone formation similar to the predicate device (PolyGraft™ BGS alone) at different endpoints, particularly when combined with autogenous blood products. |
| Performance when combined with autogenous blood products | Demonstrated that the addition of autogenous blood products (like platelet rich plasma) does not alter the performance of the device and supported expanded indications. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions a "rabbit metaphyseal defect study." However, the exact number of rabbits or lesions used in this study is not specified.
- Data Provenance: The study was an "in vivo comparison" using rabbits, which is a prospective animal study. The country of origin of the data is not specified, but the applicant is based in San Antonio, Texas, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document mentions "histologically showed bone formation" but does not specify the number or qualifications of experts who assessed these histological results.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. It notes "histologically showed bone formation similar to the predicate device," implying a comparative assessment, but not a formal adjudication process amongst multiple readers/experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study conducted was an in vivo animal study comparing a device variant to a predicate device. This is not applicable to a physical bone graft substitute.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this device is a physical bone void filler, not an algorithm or AI. Standalone algorithm performance is not applicable.
7. The Type of Ground Truth Used
The ground truth was established through histological analysis of bone formation in a rabbit model.
8. The Sample Size for the Training Set
This product is a physical medical device, not an AI algorithm. Therefore, the concept of a "training set" in the context of machine learning does not apply. The studies were for performance and safety demonstrations.
9. How the Ground Truth for the Training Set was Established
As above, the concept of a "training set" is not applicable for this type of medical device. The "ground truth" for the performance studies was established through histological assessment in the animal model.
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KD40047
DEC 17 2004
510(k) SUMMARY
| Submitter | Contact |
|---|---|
| Image: OBI Logo | Gabriele G. Niederauer, Ph.D. |
| OsteoBiologics, Inc. | Director of Research and Development |
| 12500 Network, Suite 112 | Phone: 210-690-2131 (ext. 228) |
| San Antonio, Texas 78249,USA | Fax: 210-690-2559 |
| E-mail: gabi@obi.com |
| Date of Summary: | January 9, 2004 |
|---|---|
| Revised: | November 16, 2004 |
| Common Name: | Resorbable Bone Void Filler |
| Proprietary Name: | PolyGraft™ BGS |
| Device Classification: | Resorbable calcium salt bone void filler (Product Code 87MQV) is a Class II device, per 21 CFR 888.3045 |
| 510(k) Number: | K040047 |
Description of Device: PolyGraft™ BGS is manufactured using a blend of poly(D,L-lactide-coglycolide), calcium sulfate, polyglycolide fibers and surfactant. The PolyGrafi™ BGS will be provided in a variety of shapes and sizes ranging from small, porous granules to preformed cylindrical plugs.
Intended Use: The PolyGraft™ BGS is to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. The PolyGraft™ BGS is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or os the offects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. The PolyGraft™ RGS may he combined with autogenous blood products, such as platelet rich plasma, and/or sterile fluids, such as saline or Ringer's solution. The addition of these autogenous products does not alter the performance of the device.
Substantial Equivalence: The PolyGraft™ BGS is substantially equivalent in design, function and performance to the PolyGraft™ BGS cleared as K030288 on July 17, 2003.
Testing: Biocompatibility assessment performed by independent certified laboratories demonstrated the biocompatibility of the materials used for this device. Degradation testing performed in a simulated body fluid at 37° C showed that the degradation rate is substantially equivalent to the predicate devices. OsteoBiologics performed a rabbit metaphyseal defect study to compare the bone formation of the PolyGraft™ BGS to the predicate device. The PolyGrafi™ BGS combined with autogenous blood products histologically showed bone formation similar to the predicate device (PolyGraft™ BGS alone) at different endpoints. The result from this sideby-side in vivo comparison demonstrated the expanded indications that PolyGraff™ BGS in combination with autogenous blood products are substantially equivalent to PolyGraft™ BGS alone, therefore supporting the suitability of the PolyGraft™ BGS combined with autogenous blood products for use in a clinical situation.
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Public Health Service
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 2004
Gabriele G. Niederauer, Ph.D. Director of Research and Development Osteobiologics 12500 Network, Suite 112 San Antonio, TX 78249-3308
Re: K040047
Trade Name: PolyGraft BGS Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: November 15, 2004 Received: November 16, 2004
Dear Dr. Niederauer:
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.
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
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Page 2 - Gabriele G. Niederauer, Ph.D.
manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 manufacturing practicable, 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 This letter will anow you to ough inding of substantial equivalence of your device 510(x) prematical 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), If you desire specific at no row pliance at (240) 276-0120. 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 Inter other Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely, yours,
Mark A. Mulkern
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use (Form)
INDICATIONS FOR USE
510(K) Number (if known): K040047
Device Name:
PolyGraft™ BGS (Bone Graft Substitute)
Indications for Use:
The PolyGraft™ BGS is to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. The PolyGraff™ BGS is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. The PolyGraft™ BGS may be combined with autogenous blood products, such as platelet rich plasma, and/or sterile fluids, such as saline or Ringer's solution. The addition of these autogenous products does not alter the performance of the device.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Mark N. Milliken
and Neurologic
510(k) Numbe
510(k) Premarket Notification: PolyGraft™ BGS - Expanded Claims
Confidential
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.