(62 days)
Intended for use in the treatment of hernias where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support including urethral slings, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, tissue repair, and sacrocolposuspension.
DermMatrix is a sterile, chemically treated, pyrogen free, non-perforated porcine skin that has both the epidermal and subdermal sides removed.
The provided text for K021160, concerning the DermMatrix Surgical Mesh, focuses on establishing substantial equivalence to predicate devices, rather than a de novo study proving the device meets specific acceptance criteria through quantitative performance metrics. The submission is a 510(k) summary, which typically demonstrates equivalence to existing legally marketed devices, not necessarily de novo performance.
Therefore, many of the requested details regarding acceptance criteria, specific performance metrics, and study methodologies for proving those metrics are not present in the provided document.
Here's an attempt to answer based on the available information, noting where data is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated with quantitative targets) | Reported Device Performance (Summary from submission) |
|---|---|---|
| Technological Characteristics | "Identical to the predicate device (DermMatrix)" | Confirmed to be identical to the predicate DermMatrix Surgical Mesh. |
| Material Safety/Biocompatibility | (Not explicitly stated with quantitative targets, implied by predicate equivalence) | "Biocompatibility... have demonstrated that the device is safe and effective for its intended use" |
| Mechanical/Physical Performance | (Not explicitly stated with quantitative targets for tensile strength, elasticity, degradation, etc.) | "Bench testing... have demonstrated that the device is safe and effective for its intended use" |
| Clinical Effectiveness | (Not explicitly stated with quantitative targets for success rates, complication rates in specific procedures) | "Numerous clinical experiences have demonstrated that the device is safe and effective for its intended use" |
| Substantial Equivalence | Demonstrated to be "substantially equivalent to the predicate devices" (Carbon Medical Technologies DermMatrix [K993459], Tissue Science Laboratories Permacol [K992556], Cook Biotech, Inc. Surgisis Sling [K992159]). | FDA concurrence that the device is "substantially equivalent" to legally marketed predicate devices for the stated indications for use. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific "test set" or a new clinical study with a defined sample size for the DermMatrix Surgical Mesh to prove its performance against acceptance criteria. The claim is based on:
- Technological equivalence to an existing predicate DermMatrix device (K993459), suggesting that the earlier data on K993459 would be relevant.
- "Biocompatibility, bench testing and numerous clinical experiences" are cited generally, but without specific study details (sample size, data provenance, retrospective/prospective nature).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the submission. The submission does not detail a study where ground truth was established by experts for a specific test set for the new DermMatrix device.
4. Adjudication Method for the Test Set
This information is not provided as there is no described test set or study requiring expert adjudication for this 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or presented in the provided 510(k) summary. This type of study is more common for diagnostic imaging AI systems comparing human performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the DermMatrix Surgical Mesh is a physical medical device (surgical mesh), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. Type of Ground Truth Used
Given that this is a 510(k) submission for a physical medical device, the "ground truth" for demonstrating safety and effectiveness for substantial equivalence is primarily based on:
- Established performance and safety of predicate devices: The FDA's substantial equivalence determination relies on the predicates' existing record of safety and effectiveness, supported by their indications for use, technological characteristics, and clinical history.
- Bench testing: In vitro laboratory tests confirming material properties and mechanical performance.
- Biocompatibility testing: Standardized tests to ensure the material does not elicit adverse biological responses.
- "Clinical experiences": This vague term likely refers to general medical knowledge, published literature on similar devices, and potentially post-market surveillance data for the predicate devices, rather than a new, specific clinical trial for this particular submission.
8. Sample Size for the Training Set
This information is not applicable. The DermMatrix Surgical Mesh is a physical medical device. The concept of a "training set" is relevant to machine learning algorithms, which are not involved in this device submission.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above (physical medical device, no machine learning algorithm).
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JUN 1 2 2002
Carbon Medical Technologies, Inc.
EXHIBIT 5
510(k) Summary
Submitter's Name, Address, and Date of Submission
Karen E. Peterson Vice President of Regulatory, Clinical, & QA Carbon Medical Technologies, Inc. 1290 Hammond Road St. Paul, MN 55110 651-762-2146 Phone: Phone: Fax: 651-407-1975
Submitted: April 10, 2002
Device Name
Trade Name: Classification Name: Common/Usual Name: DermMatrix Surgical Mesh Surgical Mesh, 21 CFR 878.3300 Surgical Mesh
Predicate Devices
Carbon Medical Technologies DermMatrix Surgical Mesh [K993459] Tissue Science Laboratories Permacol (marketed by Bard as Pelvicol) [K992556] Cook Biotech, Inc. Surgisis Sling [K992159]
Indication for Use
Intended for use in the treatment of hernias where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support including urethral slings, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, tissue repair, and sacrocolposuspension.
Device Description
DermMatrix is a sterile, chemically treated, pyrogen free, non-perforated porcine skin that has both the epidermal and subdermal sides removed.
Technological Characteristics and Performance
The technological characteristics are identical to the predicate device (DermMatrix). Biocompatibility, bench testing and numerous clinical experiences have demonstrated that the device is safe and effective for its intended use, and that its performance is substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
JUN 1 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karen E. Peterson Vice President of Regulatory, Clinical and Quality Affairs Carbon Medical Technologies, Inc. 1290 Hammond Road St. Paul, MN 55110
Re: K021160
Trade/Device Name: DermMatrix Surgical Mesh Regulation Number: 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: April 10, 2002 Received: April 11, 2002
Dear Ms. Peterson:
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 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.
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Page 2 – Ms. Karen E. Peterson
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division 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 A. Millerson
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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EXHIBIT 3
Indications for Use Statement
510(k) Number (if known)
510(k) Number (if known)______________________________________________________________________________________________________________________________________________________
Device Name
DermMatrix Surgical Mesh
Indications for Use
Intended for use in the treatment of hernias where the connective tissue has ruptured or
for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support including urethral slings, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, tissue repair, and sacrocolposuspension.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over the Counter Use ______ |
|---|---|---|---|
| (Per 21 CFR 801.109 |
for Mark n Millberg
(Division Sign-Off) (Optimal Format 1-2-96)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K021160 |
|---|---|
| --------------- | --------- |
§ 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.