(48 days)
Not Found
No
The device description focuses on the material composition and physical properties of a surgical mesh, with no mention of AI or ML technology.
Yes
The device is described as a "dual-component (absorbable and non-absorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies, such as for the repair of hernias," which directly addresses and treats a medical condition.
No
Explanation: The device is a surgical mesh for repairing soft tissue deficiencies, not for diagnosing conditions.
No
The device is a physical mesh made of polypropylene and polyglycolic acid fibers with a bioresorbable coating. It is a hardware medical 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 various materials designed to be implanted. It discusses its physical properties, how it interacts with tissue, and its bioresorbable coating.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such function.
Therefore, the Sepramesh™ IP Bioresorbable Barrier - Permanent Mesh is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Sepramesh™ IP Bioresorbable Barrier - 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, FTL
Device Description
Sepramesh™ IP Bioresorbable Coating/Permanent Mesh (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. Genzyme will offer two versions of the device. The first version, previously cleared through K040868 utilizes violet dyed PGA fibers. The second version described in this submission utilizes natural beige PGA fibers. The mesh is coated on the PGA surface with a bioresorbable barrier of chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and a polyethylene glycol (PEG) based hydrogel.
The uncoated side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, encouraging tissue ingrowth, similar to polypropylene mesh alone. The coated 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)
The biocompatibility and safety tests conducted for Sepramesh™ IP were selected in accordance with the Blue Book Memorandum G95-1, "Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices. Based on the results from these studies, Sepramesh™ IP is considered to be non-toxic, nonmutagenic, non-sensitizing, biocompatible and safe.
The effectiveness of Sepramesh™ IP was compared in vivo in a rabbit hernia repair model to Bard® Composix® E/X Mesh and Bard® Mesh. The overall performance of Sepramesh™ IP, including adhesion formation and tissue ingrowth, was substantially equivalent to these hernia repair products. Cellular response and tissue ingrowth for all three groups was comparable. Sepramesh™ IP performed substantially equivalent or better than Bard® Composix® E/X Mesh and Bard® Mesh in all of the evaluated adhesion reduction categories.
The physical and mechanical characteristics of Sepramesh™ IP, such as mesh thickness, mesh knit characteristics, pore size, mesh mass/area, suture retention strength, tear propagation strength and burst strength, are substantially equivalent to the currently marketed predicate devices.
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.
K040868, K994328, K002684, 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
Ko53066 1/5
genzyme
1
DEC 1 9 2005
Sepramesh™ IP Bioresorbable Coating/Permanent Mesh
PART 2
510(K) SUMMARY AS REQUIRED BY 21 CFR 807.92
Per 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 Barrier - Permanent Mesh (Sepramesh™ IP), as well as the substantial equivalence decision making process used for SeprameshTM.
Sponsor/Applicant Name and Address: 1.1
Genzyme Corporation 500 Kendall Street Cambridge, MA 02142
Sponsor Contact Information: 1.2
Lisa D. Crockett Sr. Regulatory Affairs Associate Phone: 617.591.5548 FAX: 617.761.8414 email: lisa.crockett(@genzyme.com
Date of Preparation of 510(k) Summary: 1.3
October 27, 2005October 26, 2005
Device Trade or Proprietary Name: 1.4
Sepramesh™ IP Bioresorbable Coating/Permanent Mesh
Device Common/Usual or Classification Name: 1.5
Surgical Mesh (21 CFR 878.3300, Product Code FTM)
Identification of the Legally Marketed Devices to which Equivalence 1.6 is Being Claimed:
| Name of Predicate Device | Name of Manufacturer
(Town, State) | 510(k) Number |
|--------------------------|---------------------------------------|---------------|
| Sepramesh™ IP | Genzyme Corporation,
Cambridge, MA | K040868 |
| Sepramesh™ | Genzyme Corporation, | K994328 |
1
K053066 2/5
Image /page/1/Picture/1 description: The image shows the word "genzyme" in a simple, sans-serif font. The letters are all lowercase and evenly spaced. The word appears to be a company or brand name, given its presentation as a single word.
Sepramesh™ IP Bioresorbable Coating/Permanent Mesh
| Cambridge, MA | ||
|---|---|---|
| Bard® Composix® E/X Mesh | Davol Inc., Cranston, RI | K002684 |
| Bard® Mesh | Davol Inc., Cranston, RI | Pre-Amendment |
| Vicryl™ Knitted Mesh | Ethicon Inc., Somerville, NJ | K810428 |
| Dexon® PGA Mesh | Davis & Geck Inc., Norwalk, | |
| CT | K830889 |
Device Description: 1.7
Sepramesh™ IP Bioresorbable Coating/Permanent Mesh (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. Genzyme will offer two versions of the device. The first version, previously cleared through K040868 utilizes violet dyed PGA fibers. The second version described in this submission utilizes natural beige PGA fibers. The mesh is coated on the PGA surface with a bioresorbable barrier of chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and a polyethylene glycol (PEG) based hydrogel.
The uncoated side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, encouraging tissue ingrowth, similar to polypropylene mesh alone. The coated 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.
Intended Use: 1.8
Sepramesh™ IP Bioresorbable Coating/Permanent Mesh is indicated for use in the reconstruction of soft tissue deficiencies such as for the repair of hernias.
2
Comparison of Technological Characteristics of Sepramesh™ IP with 1.9 Legally Marketed Devices:
Table 16 is the Table of Similarities and Differences between Genzyme's Sepramesh™ IP Bioresorbable Coating/Permanent Mesh and the legally marketed devices identified in Section 1.6.
3
| A-4777 | |
|---|---|
| ----- | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| Feature | Proposed
Sepramesh™ IP
Bioresorbable
Coating/Permanent Mesh | Sepramesh™ IP
Bioresorbable
Coating/Permanent Mesh | Sepramesh™
Biosurgical
Composite | Bard®
Composix® E/X
Mesh | Bard® Mesh | Dexon®
PGA Mesh | Comments on
Differences |
|--------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------|
| 510(k) No. | To be determined | K040868 | K994328 | K002684 | Pre-
Amendment | K830889 | Not Applicable |
| Classification | Class II: Polymeric | Class II: Polymeric | Class II: Polymeric
Surgical Mesh | Class II: Polymeric
Surgical Mesh | Class II: Polymeric
Surgical Mesh | Class II: Polymeric
Surgical Mesh | Substantially
Equivalent |
| Indication | Reconstruction of
soft tissue
deficiencies, such
as for the repair of
hernias | Reconstruction of
soft tissue
deficiencies, such
as for the repair of
hernias | Reconstruction of
soft tissue
deficiencies, such
as for the repair
of hernias | Reconstruction of
soft tissue
deficiencies, such
as for the repair
of hernias and
chest wall defects | Reinforce soft
tissue where
weakness
exists, i.e.,
repair of
hernias and
chest wall
defects | External
organ support
and organ
architecture
preservation | Substantially
Equivalent |
| Labeling
Claims | Biopolymer surface
minimizes tissue
and visceral
adhesions to device | Biopolymer surface
minimizes tissue
and visceral
adhesions to device | HA/CMC surface
minimizes tissue
and visceral
adhesions to device | ePTFE minimizes
adhesions to
device | None | None | Substantially
Equivalent |
| Product
Design | Polypropylene/
PGA mesh with
biopolymer coating
on one surface | Polypropylene/
PGA mesh with
biopolymer coating
on one surface | Polypropylene
mesh with
HA/CMC coating
on one surface | Polypropylene
mesh with an
ePTFE layer
stitched on one
surface | Polypropylene
mesh | PGA Mesh | Coated surface
placed facing
viscera. |
able 16: Table of Similarities and Differences/Substantial Equivalence to Predicate Devices
Proprietary and Confidential
Document Info: SEPRAMESH_IP_510K_FINAL WO APPENDICES I.DO
Kossokb
4/5
4
Summary of Nonclinical Data: 1.10
The biocompatibility and safety tests conducted for Sepramesh™ IP were selected in accordance with the Blue Book Memorandum G95-1, "Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices. Based on the results from these studies, Sepramesh™ IP is considered to be non-toxic, nonmutagenic, non-sensitizing, biocompatible and safe.
The effectiveness of Sepramesh™ IP was compared in vivo in a rabbit hernia repair model to Bard® Composix® E/X Mesh and Bard® Mesh. The overall performance of Sepramesh™ IP, including adhesion formation and tissue ingrowth, was substantially equivalent to these hernia repair products. Cellular response and tissue ingrowth for all three groups was comparable. Sepramesh™ IP performed substantially equivalent or better than Bard® Composix® E/X Mesh and Bard® Mesh in all of the evaluated adhesion reduction categories.
The physical and mechanical characteristics of Sepramesh™ IP, such as mesh thickness, mesh knit characteristics, pore size, mesh mass/area, suture retention strength, tear propagation strength and burst strength, are substantially equivalent to the currently marketed predicate devices.
5
Image /page/5/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling an emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines representing the branches of the department. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2005
Ms. Lisa D. Crockett Sr. Regulatory Affairs Associate Genzyme Corporation 55 Cambridge Parkway Cambridge, Massachusetts 02142
Re: K053066
Trade/Device Name: Sparamesh IP Bioresorbable Coating/Permanent Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: October 31, 2005 Received: December 1, 2005
Dear Ms. Crockett:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the 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 or any I 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.
6
Page 2 - Ms. Crockett
This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter witi anow you to oegin maine of substantial equivalence of your device to a legally premarket notification: "The PDF interestion 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 utsire specific advice for your as (240) 276-0115. Also, please note the regulation entitled, Contact on Other of Compitante and ret notification (21CFR Part 807.97). You may obtain Of Small other general informational 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/industry/support/index.html.
Sincerely yours,
Barbara Buehl
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K053066
Device Name: Sepramesh™ IP Bioresorbable Barrier - Permanent Mesh
Indications For Use:
Sepramesh™ IP Bioresorbable Barrier - Permanent Mesh is indicated for use in the Sepramesn'" IP Bloresorbable Barns " Permanent of hernias.
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 801 Subpart C)
.. .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Friedrich for MCM
(Division Division of Ge and Neurological D
Page 1 of 1_
510(k) Number K1053066