(113 days)
Not Found
No
The summary describes a physical surgical mesh and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a surgical mesh used for the reinforcement of soft tissues during surgical repair of ventral defects, which is a structural repair rather than a "therapy."
No
Explanation: The device is a surgical mesh used for reinforcement of soft tissues during surgical repair of ventral defects, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details a physical mesh and fixation system made of polyester textile and collagen film, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "reinforcement of soft tissues during surgical repair" and "treatment of ventral defects (primary and incisional hernias)." This describes a device used in vivo (within the body) during surgery.
- Device Description: The description details a surgical mesh designed to be implanted in 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, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly designed for in vivo surgical implantation.
N/A
Intended Use / Indications for Use
The Parietex™ Composite Ventral Patch is used for the reinforcement of soft tissues during surgical repair. It is indicated for the treatment of ventral defects (primary and incisional hernias). The three-dimensional non absorbable monofilament polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.
Product codes (comma separated list FDA assigned to the subject device)
FTL, OXJ
Device Description
Parietex™ Composite Ventral Patch is available as a round shape. It is a dual facing mesh composed of a non-absorbable three-dimensional monofilament polyester textile for abdominal wall reinforcement covered by a bioabsorbable hydrophilic collagen film to minimize visceral attachment. A fixation system composed of four flaps made out of a bidimensional monofilament polyester textile and two removable handles completes the device. This fixation system and the three-dimensional reinforcement textile are assembled with two poly(glycolide-co-L-lactide) (PGLA) expanders. This system facilitates placement and fixation of the mesh.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal wall
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)
Bench testing was conducted in accordance with FDA's guidance for the Preparation of a Premarket Notification Application for Surgical Mesh to evaluate the performance characteristics of the proposed Parietex™ Composite Ventral Patch. Bench testing included : characterizations which demonstrate that the mechanical performance of the textiles are equivalent to the predicate Parietex™ Composite Mesh (K040998), Traction testing to demonstrate the equivalency of the assembly tensile strength of the mesh compared to the predicate Bard Ventralex® Patch (K021736 and K024008). In vivo performance testing on a representative animal model was conducted in comparison with predicate to demonstrate the collagen film minimizes attachment to the mesh. The results demonstrates that the collagen film performance of Parietex™ Composite Ventral Patch is equivalent to the predicate Parietex™ Composite Mesh (K040998). The results of the bench and preclinical tests demonstrate that the device is substantially equivalent to its predicate devices, Parietex™ Composite Mesh (K040998) and the Bard Ventralex® Patch (K021736 and K024008).
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
K120506 page 1/2
510(k) Summary
JUN 1 3 2012
| 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: | |
| (US Agent) | James McMahon |
| Senior Manager, Regulatory Affairs | |
| Covidien | |
| 15 Crosby Drive | |
| Bedford, MA 01730 USA | |
| Phone: (781) 839 1787 | |
| Date prepared: | June 11, 2012 |
| Name of device | |
| Trade or proprietary name: | Parietex™ Composite Ventral Patch |
| 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) |
| Bard Ventralex® Patch (K021736 and K024008) | |
| Reason for 510(k) submission: | To introduce the Parietex™ Composite Ventral Patch which is a |
| dual facing mesh, covered with an absorbable collagen film. | |
| Device description: | Parietex™ Composite Ventral Patch is available as a round shape. |
| It is a dual facing mesh composed of a non-absorbable three- | |
| dimensional monofilament polyester textile for abdominal wall | |
| reinforcement covered by a bioabsorbable hydrophilic collagen film | |
| to minimize visceral attachment. A fixation system composed of | |
| four flaps made out of a bidimensional monofilament polyester | |
| textile and two removable handles completes the device. This | |
| fixation system and the three-dimensional reinforcement textile are | |
| assembled with two poly(glycolide-co-L-lactide) (PGLA) expanders. | |
| This system facilitates placement and fixation of the mesh. |
1
Parietex™ Composite Ventral Patch
Intended use of the device: The Parietex™ Composite Ventral Patch is used for the reinforcement of soft tissues during surgical repair. Indications for use: The Parietex™ Composite Ventral Patch is used for the reinforcement of soft tissues during surgical repair. It is indicated for the treatment of ventral defects (primary and incisional hernias). The three-dimensional non absorbable monofilament polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera. Summary comparing the technological characteristics The Parietex™ of the subiect and predicate: Composite Ventral Patch is substantially equivalent to the predicate devices, Parietex™ Composite Mesh (K040998) and Bard Ventralex® Patch (K021736 and K024008), in terms of its technological characteristics and material. The Parietex™ Composite Ventral Patch is equivalent to the polyester textile and hydrophilic collagen film performance as the predicate Parietex™ Composite Mesh (K040998). In addition, the mechanical performance of the fixation polyester flap is also equivalent to the polyester textile of the predicate Parietex™ Composite Mesh (K040998). The proposed Parietex™ Composite Ventral Patch is substantially equivalent to the predicate Bard Ventralex® Patch (K021736 and K024008) in assembly strength. Performance data: Bench testing was conducted in accordance with FDA's guidance for the Preparation of a Premarket Notification Application for Surgical Mesh to evaluate the performance characteristics of the proposed Parietex™ Composite Ventral Patch. Bench testing included : characterizations which demonstrate that . Textile the mechanical performance of the textiles are equivalent to the predicate Parietex™ Composite Mesh (K040998), Traction testing to demonstrate the equivalency of ম the assembly tensile strength of the mesh compared to the predicate Bard Ventralex® Patch (K021736 and K024008). In vivo performance testing on a representative animal model was conducted in comparison with predicate to demonstrate the collagen film minimizes attachment to the mesh. The results demonstrates that the collagen film performance of Parietex™ Composite Ventral Patch is equivalent to the predicate Parietex™ Composite Mesh (K040998). The results of the bench and preclinical tests demonstrate that the device is substantially equivalent to its predicate devices, Parietex™ Composite Mesh (K040998) and the Bard Ventralex® Patch (K021736 and K024008).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The bird is positioned above a wavy line, which could represent water or a horizon. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 · Silver Spring, MD 20993-0002
JUN 1 3 2012
Sofradim Production % Surgical Devices, A Global Bus of Covidien Mr. James McMahon Senior Manager, Regulatory Affairs 15 Crosby Drive Bedford, Massachusetts 01730
Re: K120506
Trade/Device Name: PARIETEX ™ Composite Ventral Patch Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL, OXJ Dated: May 11, 2012 Received: May 14, 2012
Dear Mr. McMahon:
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. 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.
3
Page 2 - Mr. James McMahon
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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
is h Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
4
Indications For Use
120506 510(k) Number (if known):
Device Name:
PARIETEX™ Composite Ventral Patch
Indications For Use:
The PARIETEX™ composite ventral patch is used for the reinforcement of soft tissues during surgical repair. It is indicated for the treatment of ventral defects (primary and The three-dimensional non-absorbable monofilament polyester incisional hernias). mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.
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)
Danil Keane for MMM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120506