(101 days)
ProPatch® is indicated for implantation to reinforce soft tissues where weakness exists including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture-line reinforcement, and reconstructive procedures.
ProPatch is indicated for the reinforcement of soft tissues repaired by sutures or by suture anchors during tendon repair surgery including, but not limited to: reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.
Non-Joint Related Repair
ProPatch is indicated for implantation to reinforce soft tissues where weakness exists including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement, and reconstructive procedures.
Joint Related Repair
ProPatch is indicated for the reinforcement of soft tissues repaired by sutures or by suture anchors during tendon repair surgery including, but not limited to: reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.
ProPatch Soft Tissue Repair Matrix (ProPatch) is a surgical mesh manufactured from decellularized bovine pericardium. Decellularized tissues undergo chemical microbial and viral inactivation processes, are inspected for freedom from defects, packaged, and terminally sterilized via gamma radiation.
ProPatch is comprised of a single layer, nominally 0.6 mm thick, and is provided as a sterile and non-pyrogenic product that is fully hydrated and ready for use without the need for rinsing or rehydration prior to implantation.
The provided document describes a 510(k) submission for the "ProPatch® Soft Tissue Repair Matrix" and specifically states that no new studies were performed to prove the device meets acceptance criteria. Instead, this submission is for minor changes to the Instructions for Use and a manufacturing change, and the device's equivalence to a previously cleared predicate device (K061892) is asserted based on identical indicated uses and technological characteristics.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a new study is not applicable to this particular 510(k) submission.
Here's an explanation based on the provided text:
- 1. A table of acceptance criteria and the reported device performance: Not applicable. The document does not describe new performance or acceptance criteria for this 510(k) submission. It relies on the prior clearance of the predicate device.
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No new test set or data are mentioned.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. No new ground truth establishment is described.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No new test set adjudication is described.
- 5. 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 device is a surgical mesh, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical mesh; it is not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this submission. The original predicate device's clearance would have relied on appropriate testing for surgical mesh, likely including mechanical properties, biocompatibility, and potentially animal or clinical data, which would have established its "ground truth" for safety and effectiveness.
- 8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
- 9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device requiring a training set.
Summary based on the document:
This 510(k) submission (K101587) for the ProPatch® Soft Tissue Repair Matrix is a "Special 510(k)" or similar submission for minor changes (Instructions for Use and minor manufacturing change) to an already cleared device. The manufacturer asserts equivalence to the predicate device K061892 based on "identical indicated uses and technological characteristics." Therefore, this document does not contain information about new studies proving the device meets acceptance criteria, as its substantial equivalence is based on the previously cleared device.
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y<:101587
ProPatch® Soft Tissue Repair Matrix Special 510(k) Submission CryoLife, Inc.
510(k) Summary
SEP 1 6 2010
| Submitter: | CryoLife, Inc. |
|---|---|
| Contact: | Bryan BrosseauRegulatory Affairs Specialist |
| Address: | 1655 Roberts Blvd. NWKennesaw, GA 30144 |
| Phone: | 770-419-3355 |
| Fax: | 770-590-3783 |
| Date: | June 4, 2010 |
| Trade Name: | ProPatch® Soft Tissue Repair Matrix |
| Common Name: | Surgical Mesh |
| Classification Name: | Mesh, Surgical (21 CFR 878.3300, Product Code FTM) |
| Predicate Device: | ProPatch® Soft Tissue Repair MatrixK061892 - 11/22/2006CryoLife, Inc.1655 Roberts Blvd. NWKennesaw, GA 30144 |
Intended Use:
ProPatch® is indicated for implantation to reinforce soft tissues where weakness exists including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture-line reinforcement, and reconstructive procedures.
ProPatch is indicated for the reinforcement of soft tissues repaired by sutures or by suture anchors during tendon repair surgery including, but not limited to: reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.
Device Description:
ProPatch Soft Tissue Repair Matrix (ProPatch) is a surgical mesh manufactured from decellularized bovine pericardium. Decellularized tissues undergo chemical microbial
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and viral inactivation processes, are inspected for freedom from defects, packaged, and terminally sterilized via gamma radiation.
ProPatch is comprised of a single layer, nominally 0.6 mm thick, and is provided as a sterile and non-pyrogenic product that is fully hydrated and ready for use without the need for rinsing or rehydration prior to implantation.
Equivalence to Predicate Device:
:
This submission is related to changes to the ProPatch Instructions for Use and a minor manufacturing change. The indicated uses and technological characteristics are identical to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure. The logo is simple and uses a single color.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
CryoLife, Incorporated % Mr. Bryan Brosseau Regulatory Affairs Specialist 1655 Roberts Boulevard Northwest Kennesaw, Georgia 30144
JUN 22 2012
Re: K101587
Trade/Device Name: ProPatch® Soft Tissue Repair Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM, OXK, OXB, OXH, OXE, OWY Dated: August 25, 2010 Received: August 27, 2010
Dear Mr. Brosseau:
This letter corrects our substantially equivalent letter of September 16, 2010.
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 (PMA). You may, therefore, market the device, subject to the general controls 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Bryan Brosseau
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Jo / Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K101587
Device Name: ProPatch Soft Tissue Repair Matrix
Indications for Use:
Non-Joint Related Repair
ProPatch is indicated for implantation to reinforce soft tissues where weakness exists including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement, and reconstructive procedures.
Joint Related Repair
ProPatch is indicated for the reinforcement of soft tissues repaired by sutures or by suture anchors during tendon repair surgery including, but not limited to: reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.
Prescription Use _ (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 OF NEEDED)
Concurrence of CDRH, Qffice of I
Daniel Kane for WPD
(Division Sign-Off)
: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . and Restorative Devices
510(k) Number_K101587
5
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.