(264 days)
The PolyGraft™ TCP 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™ TCP 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.
PolyGraft™ TCP is manufactured using a blend of poly(D,L-lactide-coglycolide), tricalcium phosphate, polyglycolide fibers and surfactant. The PolyGraff™ TCP will be provided in a variety of shapes and sizes ranging from small, porous granules to preformed cylindrical plugs.
The provided text is a 510(k) summary for the PolyGraft™ TCP device. It describes the device, its intended use, and claims substantial equivalence to a predicate device (PolyGraft™ BGS, K030288).
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific acceptance criteria (e.g., a certain percentage of degradation, specific mechanical strength thresholds). Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Demonstrated biocompatibility of materials by independent certified laboratories. |
| Degradation rate | Degradation testing in simulated body fluid at 37°C showed the degradation rate is substantially equivalent to predicate devices. |
| Design, Function, Intended Use | Substantially equivalent to PolyGraft™ BGS (K030288). |
2. Sample Size and Data Provenance for Test Set
- Sample Size: The document does not specify a distinct "test set" in the context of clinical or performance data for the PolyGraft™ TCP device itself. The evidence presented focuses on in vitro testing for degradation and biocompatibility.
- Data Provenance:
- Country of Origin: Not specified for the in vitro testing.
- Retrospective or Prospective: The in vitro degradation testing is inherently prospective laboratory testing. Biocompatibility assessment would also be laboratory-based.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Number of Experts: Not applicable. The document describes in vitro laboratory tests (biocompatibility, degradation) rather than human-interpreted data requiring expert consensus for ground truth.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This concept is relevant for studies involving human interpretation or clinical endpoints requiring expert review, which is not described here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. An MRMC comparative effectiveness study is not mentioned. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data. The PolyGraft™ TCP is a resorbable bone void filler.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- Standalone Performance Done: Yes, in a sense. The described testing (biocompatibility, degradation rate) is performed directly on the device material itself, without human intervention as part of its function to deliver a diagnostic or interpretive result. The "performance" here is the material's inherent properties and behavior.
7. Type of Ground Truth Used
- Type of Ground Truth: For the in vitro studies, the "ground truth" is established by standard laboratory methods and control conditions.
- Biocompatibility: Established by "independent certified laboratories" according to recognized standards.
- Degradation: Established by in vitro testing in a "simulated body fluid at 37 ℃" with comparison to predicate devices.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This device is not an AI/ML algorithm that requires training data in the conventional sense. The "training" for this type of device involved formulation development and manufacturing processes.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment: Not applicable. No "training set" or "ground truth" in the context of AI/ML algorithms is mentioned for this device. The development process would have involved material science principles and iterative testing to achieve the desired properties, but not in the framework of machine learning.
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AUG 1 6 2004
510(k) SUMMARY
| Submitter | Contact |
|---|---|
| Image: OBI LogoOsteoBiologics, Inc.12500 Network, Suite 112San Antonio, Texas 78249USA | Gabriele G. Niederauer, Ph.D.Director of Research and DevelopmentPhone: 210-690-2131 (ext. 228)Fax: 210-690-2559E-mail: gabi@obi.com |
| Date of Summary: | November 25, 2003 |
|---|---|
| Revised: | August 11, 2004 |
| Common Name: | Resorbable Bone Void Filler |
| Proprietary Name: | PolyGraft™ TCP |
| Device Classification: | Resorbable calcium salt bone void filler (Product Code87MQV) is a Class II device, per 21 CFR 888.3045 |
| 510(k) Number: | K033707 |
Description of Device: PolyGraft™ TCP is manufactured using a blend of poly(D,L-lactide-coglycolide), tricalcium phosphate, polyglycolide fibers and surfactant. The PolyGraff™ TCP will be provided in a variety of shapes and sizes ranging from small, porous granules to preformed cylindrical plugs.
Intended Use: The PolyGraft™ TCP 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™ TCP 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.
Substantial Equivalence: The PolyGraft™ TCP is substantially equivalent in design, function and intended use to the PolyGraft™ BGS cleared as K030288 on July 17, 2003.
Biocompatibility assessment performed by independent certified laboratories Testing: demonstrated the biocompatibility of the materials used for this device. Degradation testing performed in a simulated body fluid at 37 ℃ showed that the degradation rate is substantially equivalent to the predicate devices. The results from this side-by-side in vitro comparison demonstrated that PolyGraft™ TCP are substantially equivalent to the predicate devices, therefore supporting the suitability of the PolyGraft™ TCP for use in a clinical situation.
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Image /page/1/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the border of the circle. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 6 2004
Gabriele G. Niederauer, Ph.D. Director of Research and Development Osteobiologics 12500 Network, Suite 112 San Antonio, TX 78249-3308
Re: K033707
Trade Name: PolyGraft TCP Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MQV Dated: July 22, 2004 Received: July 23, 2004
Dear Dr. Niederauer:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your early and 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 merslate commerce prior to have been reclassified in accordance with the provisions of Amendinens, or to de roses 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 upprovisions of the Act. The general controls provisions of the Act include controls providents of a 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 (1 Writ), it may of our in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal 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 mour that I Dr. Federal statutes and regulations administered by other Federal agencies. or the ret 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 and fisting (21 CFR rath in the quality systems (QS) regulation (21 CFR Part 820); and if
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Page 2 - Gabriele G. Niederauer, Ph.D.
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) This feter will anony of Jo The FDA finding of substantial equivalence of your device to a premiurker notification - I - 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), 11 you don't the Office of Compliance at (301) 594-4659. 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 may obtain of 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 vours.
Mark N Millkerson
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
510(k) Number (if known): K033707
Device Name: PolyGraft™ TCP
Indications for Use:
The PolyGraft™ TCP is to be used to fill bony voids or gaps caused by trauma on surgery that are not intrinsic to the stability of the bony structure. The PolyGraft™ TCP surgery that are not internet to the bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous extremities, spino and pents/eated from traumatic injury to the bone. The product ucinots or occouds and is resorbs and is replaced with bone during the healing process.
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)
l Mark N. Millhuser
. Restorative, and Neurological Devices
) Number K033707
Page 1 of 1
510(k) Nu
§ 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.