(55 days)
No
The device description and performance studies focus on the material properties and physical characteristics of a surgical mesh, with no mention of AI or ML capabilities.
Yes
The device is a surgical mesh intended for the reinforcement of soft tissue, specifically for the repair of hernias, which is a therapeutic intervention.
No
Explanation: The device is a surgical mesh intended for reinforcing soft tissue, not for identifying, monitoring, or predicting medical conditions.
No
The device description clearly states it is a physical mesh made of polyester and collagen, intended for surgical implantation. It is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "reinforcement of soft tissue where a weakness exists such as the repair of the primary abdominal wall and incisional hernias." This is a surgical implant used directly on the patient's body.
- Device Description: The description details a physical mesh made of polyester and collagen, designed to be implanted.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such testing on specimens.
The Symbotex™ Composite Mesh is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Symbotex™ Composite Mesh is intended for the reinforcement of soft tissue where a weakness exists such as the repair of the primary abdominal wall and incisional hernias.
The non-absorbable three-dimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.
Product codes
FTL, OXJ
Device Description
Symbotex™ Composite Mesh is made out of a three-dimensional (3D) monofilament polyester textile, which is covered with an absorbable, continuous and hydrophilic film on one of its sides. This film is made up of collagen from porcine origin and glycerol.
Symbotex™ Composite Mesh will be proposed in 3 configurations:
Symbotex™ Composite Mesh flat sheet (SYM): 3D textile mesh(s) of various sizes with a central green (dye D&C Green No6) marking to help surgeons center and orient the mesh.
Symbotex™ Composite Mesh flat sheet with sutures (SYMF): 3D textile mesh(s) of various sizes with a central green (dye D&C Green No6) marking and pre-placed Dermalon® sutures to help surgeons, place and fixate the mesh.
Symbotex™ Composite Mesh with flap (SYMOS): 3D textile mesh(s) of various sizes with a green (dye D&C Green No6) bi-dimensional (2D) monofilament polyester flap providing a dedicated fixation area.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, primary abdominal wall, incisional hernias
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons
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)
Bench testing has been conducted in accordance with FDA's Guidance for the Preparation of a Premarket Notification for Surgical Mesh issued March 2, 1999 to evaluate the performance characteristics of the proposed Symbotex™ Composite Mesh. The following mesh characteristics were assessed: mesh thickness, pore size, surface density, bursting strength, bursting distension, breaking strength, elongation at break, tear strength, suturing strength, seam strength, suture assembly strength and trocar testing.
An In-vivo pre-clinical test on a representative animal model was conducted in comparison with the predicate PARIETEX™ Optimized Composite Mesh (K110663) to demonstrate the minimizing tissue attachment performance.
The results of the bench and preclinical tests demonstrate that the device is substantially equivalent to the predicates PARIETEX™ Composite Mesh (K040998) and PARIETEX™ Optimized Composite Mesh (K110663 and K110816).
Symbotex™ Composite Mesh is comprised of materials that have been evaluated for biocompatibility in accordance with ISO 10993-1 for a permanent implant, a recognized standard by FDA (#2-156).
Symbotex™ Composite Mesh shelf life has been demonstrated by stability testing on materials and components.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PARIETEX™ Composite Mesh (K040998), PARIETEX™ Optimized Composite Mesh (K110663 and K110816), PARIETEX™ Composite Ventral Patch (K120506), PARIETEX™ Monofilament Polyester Mesh (K090858), PARIETEX™ Composite Mono PM Mesh (K081126)
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
K131969 page 1/3
510(k) Summary
| Submitter Information | |
|---|---|
| Name: | Sofradim Production (subsidiary of Covidien LLC) |
| Address: | 116, avenue du formans |
| 01600 Trevoux, | |
| France | |
| Phone number | +33 (0)4 74 08 90 00 |
| Fax number: | +33 (0) 4 74 08 90 02 |
| Establishment Registration: | 9615742 |
| Name of contact person: | Clare Santulli |
| Manager, Regulatory Affairs | |
| 60 Middletown Avenue | |
| North Haven, CT 06473 | |
| Phone: (203) 492-7635 | |
| Fax: (203) 492-5029 | |
| Date prepared: | August 20th, 2013 |
| Name of device | |
| Trade or proprietary name: | Symbotex™ Composite Mesh |
| Common or usual name: | Surgical Mesh |
| Classification name: | Mesh, Surgical, Polymeric |
| Classification panel: | General and Plastic Surgery (79) |
| Regulation: | 21 CFR 878.3300 |
| Product Code: | FTL |
| Legally marketed devices to | |
| which equivalence is claimed: | PARIETEX™ Composite Mesh (K040998) |
| PARIETEX™ Optimized Composite Mesh (K110663 and K110816) | |
| PARIETEX™ Composite Ventral Patch (K120506) | |
| PARIETEX™ Monofilament Polyester Mesh (K090858) | |
| PARIETEX™ Composite Mono PM Mesh (K081126) | |
| Reason for 510(k) submission: | To obtain market clearance of the Symbotex™ Composite Mesh(s). |
| Device description: | Symbotex™ Composite Mesh is made out of a three-dimensional (3D) |
| monofilament polyester textile, which is covered with an absorbable, | |
| continuous and hydrophilic film on one of its sides. This film is made up of | |
| collagen from porcine origin and glycerol. | |
| Symbotex™ Composite Mesh will be proposed in 3 configurations: |
1
K131969 page 2/3
Symbotex™ Composite Mesh flat sheet (SYM): 3D textile mesh(s) of various sizes with a central green (dye D&C Green No6) marking to help surgeons center and orient the mesh.
Symbotex™ Composite Mesh flat sheet with sutures (SYMF): 3D textile mesh(s) of various sizes with a central green (dye D&C Green No6) marking and pre-placed Dermalon® sutures to help surgeons, place and fixate the mesh.
Symbotex™ Composite Mesh with flap (SYMOS): 3D textile mesh(s) of various sizes with a green (dye D&C Green No6) bi-dimensional (2D) monofilament polyester flap providing a dedicated fixation area.
The Symbotex™ Composite Mesh is intended for the reinforcement of Intended use of the device: soft tissue where a weakness exists.
Indications for use:
Symbotex™ Composite Mesh is indicated for the reinforcement of soft tissue where a weakness exists such as the repair of the primary abdominal wall and incisional hernias.
The non-absorbable three-dimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.
Summary comparing the technological characteristics of the subject and predicate devices:
The proposed Symbotex™ Composite Mesh is equivalent to the predicate devices PARIETEX™ Composite Mesh (K040998). PARIETEX™ Optimized Composite Mesh (K110663 and K110816) in terms of design for the following technological characteristics:
- Indications
- 3D polyester textile performance characteristics
- collagen film performance
- assembly strength
- 2D polyester flap performance characteristics
The raw material of the proposed Symbotex " Composite Mesh is equivalent to the predicate devices:
- PARIETEX™ Composite Ventral Patch (K120506) for the green polyester monofilament (D&C Green n°6) and 2D polyester monofilament textile.
PARIETEX™ Monofilament Polyester Mesh (K090858) . and PARIETEX™ Composite Mono PM Mesh (K081126) for the 3D polyester monofilament textile,
- PARIETEX™ Optimized Composite Mesh (K110663) for the hydrophilic film and Dermalon® suture.
2
KI31969 page 3/3
Performance data:
Bench testing has been conducted in accordance with FDA's Guidance for the Preparation of a Premarket Notification for Surgical Mesh issued March 2, 1999 to evaluate the performance characteristics
of the proposed Symbotex™ Composite Mesh. The following mesh characteristics were assessed: mesh thickness, pore size, surface density, bursting strength, bursting distension, breaking strength, elongation at break, tear strength, suturing strength, seam strength, suture assembly strength and trocar testing.
An In-vivo pre-clinical test on a representative animal model was conducted in comparison with the predicate PARIETEX™ Optimized Composite Mesh (K110663) to demonstrate the minimizing tissue attachment performance.
The results of the bench and preclinical tests demonstrate that the device is substantially equivalent to the predicates PARIETEX™ Composite Mesh (K040998) and PARIETEX™ Optimized Composite Mesh (K110663 and K110816).
Symbotex™ Composite Mesh is comprised of materials that have been evaluated for biocompatibility in accordance with ISO 10993-1 for a permanent implant, a recognized standard by FDA (#2-156).
Symbotex™ Composite Mesh shelf life has been demonstrated by stability testing on materials and components.
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of a staff with two snakes coiled around it, and a pair of wings at the top.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2013
Sofradim Production % Clare Santulli Regulatory Affairs Manager Surgical devices, a global business unit of Covidien 60 Middletown Avenue North Haven, Connecticut 06473
Re: K131969
Trade/Device Name: Symbotex™ Composite Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL, OXJ Dated: June 26, 2013 Received: June 28, 2013
Dear Ms. Santulli:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
4
Page 2 - Clare Santulli
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.
Sincerely yours,
Jiyoung Dang -S
on behalf of Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications For Use
510(k) Number (if known): K131969
Device Name: Symbotex™ Composite Mesh
Indications for Use:
The Symbotex™ Composite Mesh is intended for the reinforcement of soft tissue where a weakness exists such as the repair of the primary abdominal wall and incisional hernias.
The non-absorbable three-dimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.
Prescription Use X (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)
David Krause -S
(Division Sign-Off Division of Surgical Devices 510(k) Number: K131969