(63 days)
Not Found
No
The summary describes a physical mesh device with a bioresorbable coating and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as "designed for the reconstruction of soft tissue deficiencies" and "for the repair of hernias," which are therapeutic actions.
No
The device description indicates it is a surgical mesh for tissue repair, not a tool for diagnosing medical conditions.
No
The device description clearly describes a physical mesh made of polypropylene and polyglycolic acid fibers with a bioresorbable coating. This is a hardware device, 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 the "reconstruction of soft tissue deficiencies, such as for the repair of hernias." This describes a surgical implant used directly in the body for structural support and repair.
- Device Description: The description details a physical mesh made of fibers and coatings designed to be implanted. It discusses tissue ingrowth, separation from organs, and resorption of components within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is a surgical implant used inside the body for structural repair.
N/A
Intended Use / Indications for Use
Sepramesh™ IP Bioresorbable Coating - Permanent Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
Product codes (comma separated list FDA assigned to the subject device)
FTM
Device Description
Sepramesh™ IP Bioresorbable Coating - Permanent Mosh (Sepramesh™ IP) is a dualcomponent (absorbable and non-absorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. Sepramesh™ IP is co-knitted using polypropylene and polyglycolic acid (PGA) fibers to result in a two-sided mesh with a polypropylene surface and PGA surface. The mesh is coated on the PGA surface with a bioresorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and a polyethylene glycol (PEG) based hydrogel.
The fascial side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, encouraging tissue ingrowth, similar to polypropylene mesh alone. The visceral side of the mesh provides a hydrophilic bioresorbable layer, separating the mesh from underlying tissue and organ surfaces during the critical wound-healing period resulting in minimal tissue attachment and visceral adhesions to the mesh. Shortly after placement, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days. The absorption of the PGA fibers is essentially complete between 50 and 80 days. The polypropylene mesh is permanent and allows for tissue ingrowth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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.
K994328, KK002684, K810428, K830889
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
510(K) SUMMARY (as required by 21 CFR 807.92) 10.0
Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Genzyme Corporation is providing a summary of the safety and effectiveness information available for Sepramesh™ IP Bioresorbable Coating - Permanent Mesh (Sepramesh™ IP), as well as the substantial equivalence decision making process used for Sepramesh™.
10.1 Sponsor/Applicant Name and Address:
Genzyme Corporation 500 Kendall Street Cambridge, MA 02142
10.2 Sponsor Contact Information:
Michael G. Halpin Director, Regulatory Affairs Phone: 617.591.5836 FAX: 617.761.8414 email: michael.halpin@genzyme.com
10.3 Date of Preparation of 510(k) Summary:
May 25, 2004
10.4 Device Trade or Proprietary Name:
Sepramesh™ IP Bioresorbable Coating -- Permanent Mesh
10.5 Device Common/Usual or Classification Name:
Surgical Mesh
1
| Name of Predicate Device | Name of Manufacturer
(Town, State) | 510(k) Number |
|-----------------------------|---------------------------------------|---------------|
| Sepramesh™ | Genzyme Corporation,
Cambridge, MA | K994328 |
| Bard® Mesh | Davol Inc., Cranston, RI | Pre-amendment |
| Bard® Composix® E/X
Mesh | Davol Inc., Cranston, RI | KK002684 |
| Vicryl™ Knitted Mesh | Ethicon Inc., Somerville, NJ | K810428 |
| Dexon® PGA Mesh | Davis & Geck Inc., Norwalk, CT | K830889 |
Identification of the Legally Marketed Devices to which Equivalence is Being Claimed: 10.6
10.7 Device Description:
Sepramesh™ IP Bioresorbable Coating - Permanent Mosh (Sepramesh™ IP) is a dualcomponent (absorbable and non-absorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. Sepramesh™ IP is co-knitted using polypropylene and polyglycolic acid (PGA) fibers to result in a two-sided mesh with a polypropylene surface and PGA surface. The mesh is coated on the PGA surface with a bioresorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and a polyethylene glycol (PEG) based hydrogel.
The fascial side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, encouraging tissue ingrowth, similar to polypropylene mesh alone. The visceral side of the mesh provides a hydrophilic bioresorbable layer, separating the mesh from underlying tissue and organ surfaces during the critical wound-healing period resulting in minimal tissue attachment and visceral adhesions to the mesh. Shortly after placement, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days. The absorption of the PGA fibers is essentially complete between 50 and 80 days. The polypropylene mesh is permanent and allows for tissue ingrowth.
10.8 Intended Use:
Sepramesh™ IP Bioresorbable Coating- Permanent Mesh is indicated for use in the reconstruction of soft tissue deficiencies such as for the repair of hernias.
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2
10.9 Comparison of Technological Characteristics of Sepramesh™ IP with Legally Marketed Devices:
Table 15 is the Table of Similarities and Differences between Genzyme's Sepramesh™ IP Bioresorbable Coating - Permanent Mesh and the legally marketed devices identified in Section 10.6.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 4 2004
Mr. Michael G. Halpin Director, Regulatory Affairs Genzyme Corporation 500 Kendall Street Cambridge, Massachusetts 02142
Re: K040868
Trade/Device Name: Sepramesh™ IP Bioresorbable Coating - Permanent mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: April 1, 2004 Received: April 5, 2004
Dear Mr. Halpin:
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 for use surfally in the encreated of 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, do hoosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and coometre fore, 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.
4
Page 2 - Mr. Michael G. Halpin
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with and w yourse FDA finding of substantial equivalence of your device to a legally premaired predicated 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 if you desire specific acrepliance 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 other general michhaal 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 yours,
Sincerely yours,
Mark A. Milhousen
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
5
16040868
Indications for Use Form
510(k) Number (if known): K040868
Device Name: Sepramesh™ IP Bioresorbable Coating -- Permanent Mesh
Indications for Use:
Sepramesh™ IP Bioresorbable Coating - Permanent Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Millhurn
Division Sign=Off Division of General, Restorative, and Neurological Devices
Page I of I
1040868 510(k) Number_