(62 days)
Not Found
No
The device description and performance studies focus on the material properties and clinical use of a porcine skin mesh, with no mention of AI or ML.
Yes
The device is intended for the "treatment of hernias" and "implantation to reinforce soft tissues where weakness exists", which are therapeutic actions.
No
Explanation: The "Intended Use / Indications for Use" section clearly states the device is "intended for use in the treatment of hernias" and "for implantation to reinforce soft tissues," which are therapeutic and reconstructive purposes, not diagnostic.
No
The device description clearly states it is a "sterile, chemically treated, pyrogen free, non-perforated porcine skin," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used in the treatment of hernias and for implantation to reinforce soft tissues. This is a therapeutic or surgical application, not a diagnostic one.
- Device Description: The description of DermMatrix as a sterile, chemically treated porcine skin for implantation aligns with a surgical or implantable device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to help diagnose or monitor medical conditions. This device is used directly within the body for structural support and repair.
N/A
Intended Use / 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.
Product codes
FTM
Device Description
DermMatrix is a sterile, chemically treated, pyrogen free, non-perforated porcine skin that has both the epidermal and subdermal sides removed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urological, gynecological and gastroenterological anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
0
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.
1
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.
2
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
3
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 |
|---|---|
| --------------- | --------- |