(36 days)
Not Found
No
The device description and performance studies focus on the material properties and biocompatibility of a surgical mesh, with no mention of AI or ML.
No
Explanation: The device is a surgical mesh intended to reinforce soft tissues, which is a structural or supportive function, not a therapeutic one. Therapeutic devices are typically designed to treat or cure a disease or condition.
No
Explanation: The device is described as a "Surgical Mesh intended for implantation to reinforce soft tissues," which is a therapeutic function, not a diagnostic one. It does not mention any diagnostic capabilities or the ability to identify diseases or conditions.
No
The device description clearly states it is a surgical mesh composed of porcine collagen, 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 is "for implantation to reinforce soft tissues." This describes a device used in vivo (within the body) for structural support.
- Device Description: The device is a "surgical mesh composed of porcine collagen" intended for implantation. This is consistent with a surgical implant, not a diagnostic test performed in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely structural reinforcement within the body.
N/A
Intended Use / Indications for Use
The ACell UBM Surgical Mesh is intended for implantation to reinforce soft tissue. The device is intended for one-time use.
Product codes (comma separated list FDA assigned to the subject device)
FTM
Device Description
The ACell UBM Surgical Mesh is composed of porcine collagen and is supplied sterile in single sheet sizes ranging from 16 cm^2 to 360 cm^2 .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues
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)
The ACell UBM Surgical Mesh was subjected to a number of tests to assess the biocompatibility and the performance of the material. It passed the requirements of all tests and was shown to be safe and effective as a surgical mesh for soft tissue reinforcement.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
APR 1 4 2004
Submitter: ACell, Inc.
ACell UBM Surgical Mesh Abbreviated 510(k) Premarket Notification
KO4062
Section 9.0 510(k) SUMMARY—ACell UBM Surgical Mesh
| Submitter Name: | ACell, Incorporated |
|---|---|
| Submitter Address: | 10555 Guilford Road |
| Suite 113 | |
| Jessup, Maryland 20790 | |
| Contact Person: | James R. DeFrancesco |
| Chief Executive Officer | |
| Phone Number: | |
| Fax Number: | 410-715-1700 |
| 410-715-4511 | |
| Date Prepared: | March 9, 2004 |
| Device Trade Name: | ACell UBM Surgical Mesh |
| Device Common | |
| Name: | Surgical mesh |
| Classification Name: | Mesh, Surgical (FTM, 21 CFR 878.3300) |
| Predicate Devices: | K021637, ACell, Inc., ACell UBM Lyophilized Wound Dressing |
| K980431, Cook Biotech, Inc., SurgiS/S® | |
| Device Description: | The ACell UBM Surgical Mesh is composed of porcine collagen and is |
| supplied sterile in single sheet sizes ranging from $16 cm^2$ to $360 cm^2$ . | |
| Intended Use: | The ACell UBM Surgical Mesh is intended for implantation to reinforce |
| soft tissue. The device is intended for one-time use. | |
| Discussion of tests | |
| and test results: | The ACell UBM Surgical Mesh was subjected to a number of tests to |
| assess the biocompatibility and the performance of the material. It | |
| passed the requirements of all tests and was shown to be safe and | |
| effective as a surgical mesh for soft tissue reinforcement. | |
| Conclusion: | This device, with respect to material composition, device characteristics |
| and intended use, is substantially equivalent to the predicate devices. |
:
...
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 2004
ACell, Inc. c/o Ms. Patsy J. Trisler, J.D., RAC 5610 Wisconsin Avenue, #304 Chevy Chase, Maryland 20815
Re: K040621
Trade/Device Name: ACell UBM Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTM Dated: March 9, 2004 Received: March 9, 2004
Dear Ms. Trisler:
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. Patsy J. Trisler, J.D., RAC
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), please contact 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 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.
Sincerely yours,
Mark Milliken
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
Indications for Use
510(k) Number (if known): $04062(
ACell UBM Surgical Mesh Device Name:
Indications for Use:
The ACell UBM Surgical Mesh is intended for implantation to reinforce soft tissues. The device is intended for one-time use.
Prescription Use × Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
(Posted November 13, 2003) 510(k) Number K040621 Page 1 of 1