(156 days)
No
The summary describes a physical surgical mesh and its materials, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a surgical mesh used for tissue reinforcement, not a therapeutic device designed to cure or prevent specific diseases.
No
Explanation: The device is a surgical mesh used for tissue reinforcement during surgical repair of hernias and abdominal wall defects. It is a therapeutic device, not a diagnostic one.
No
The device description clearly indicates it is a physical mesh made of polyester, collagen, and glycerol, intended for surgical implantation. It is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "reinforcement of tissues during surgical repair" and treatment of hernias and abdominal wall defects. This is a surgical implant, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a surgical mesh made of polyester and collagen, designed to be implanted in the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
Therefore, the PARIETEX™ OPTIMIZED COMPOSITE MESH is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The PARIETEX™ OPTIMIZED COMPOSITE MESH is used for the reinforcement of tissues during surgical repair. It is indicated for the treatment of incisional hernias, abdominal wall repair and parietal (i.e. pertaining to the walls) reinforcement of tissues. 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 (comma separated list FDA assigned to the subject device)
FTL
Device Description
PARIETEX™ Optimized Composite Mesh is available Device description: in rectangular and round shape. This device is made out of a threedimensional multifilament polyester knit for wall reinforcement, 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, and extends 5 mm over the edge of the reinforcement. One or many non-absorbable color monofilaments are tied to the three-dimensional mesh
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)
Bench testing was conducted in accordance with FDA's quidance for the Preparation of a Premarket Notification Application for Surgical Mesh to evaluate the performance characteristics of the proposed PARIETEX™ Optimized Composite Mesh. Bench testing for Surgical Mesh included physical characterization and extensive mechanical performance testing with comparison to the predicate PARIETEX™ Composite Mesh. These tests demonstrated improvement of mechanical properties of proposed device versus predicate.
Confirmation tests on Dermalon® threads were conducted and demonstrated the compliance with the Tensile Strength Suture US Monograph. This tests confirmed Dermalon ability to fill the suture function.
In-vivo performance testing on representative animal model was conducted in comparison with predicate to demonstrate the collagen film minimizes visceral attachment to the mesh. The results demonstrated the performance of the collagen film of PARIETEX™ Optimized Composite Mesh was equivalent to the predicate.
The results of the nonclinical and pre-clinical tests demonstrate that the device performs as well as or better than the legally 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.
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.
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
KII0663
lofz
510(k) Summary of Safety and Effectiveness
. . .
Submitter Information
公
. | ... ... ... ..
:
:
AUG 1 1 2011
:
| Name: | Sofradim Production |
|---|---|
| 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: | James McMahon |
| Manager, Regulatory Affairs | |
| Covidien | |
| 15 Crosby drive | |
| Bedford, MA 01730 USA | |
| Phone: (781) 839 1787 | |
| Date prepared: | March 4, 2011 |
| Name of device | |
| Trade or proprietary name: | PARIETEX™ Optimized 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 (K002699 and K040998) |
| Dermalon® suture (K930586) | |
| BIOMESH® CA.B.S.'Air® (K072962) | |
| Reason for 510(k) submission: | To introduce the PARIETEX™ Optimized Composite mesh which is |
| made from a three-dimensional multifilament polyester knit covered | |
| with an absorbable, continuous and hydrophilic film on one side. | |
| The multifilament polyester material provides long term wall | |
| reinforcement while the hydrophilic film minimizes tissue | |
| attachment to the mesh in case of direct contact with the viscera. | |
| One or many non-absorbable color monofilament threads are pre- | |
| tied to the three-dimensional mesh to facilitate placement and | |
| fixation of the mesh. The proposed PARIETEX™ Optimized | |
| Composite Mesh has been improved compared to the predicate | |
| devices as the knitting textile has been modified to obtain a higher | |
| mechanical resistance of the mesh and the collagen film | |
| formulation has been changed to get a film more resistant to handling. |
1
PARIETEX™ Optimized Composite Mesh is available Device description: in rectangular and round shape. This device is made out of a threedimensional multifilament polyester knit for wall reinforcement, 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, and extends 5 mm over the edge of the reinforcement. One or many non-absorbable color monofilaments are tied to the three-dimensional mesh
The PARIETEX™ Optimized Composite Mesh is used for the Intended use of the device: reinforcement of tissues during surgical repair.
It is indicated for the treatment of incisional hernias, abdominal wall repair and parietal (i.e. pertaining to the walls) reinforcement of tissues. 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:
Indications for use:
ﺔ
The subject PARIETEX™ Optimized Composite Mesh is equivalent to the predicate devices PARIETEX™ Composite Mesh (K002699, K040998) and Dermalon® suture (K981532) in terms of its technological characteristics and material. The three-dimensional multifilament polyester knit and and monofilament sutures are identical to the predicates. No major technological changes are proposed to the currently marketed devices PARIETEX™ Composite Mesh and Dermalon® suture in this submission.
Performance data: Bench testing was conducted in accordance with FDA's quidance for the Preparation of a Premarket Notification Application for Surgical Mesh to evaluate the performance characteristics of the proposed PARIETEX™ Optimized Composite Mesh. Bench testing for Surgical Mesh included physical characterization and extensive mechanical performance testing with comparison to the predicate PARIETEX™ Composite Mesh. These tests demonstrated improvement of mechanical properties of proposed device versus predicate.
Confirmation tests on Dermalon® threads were conducted and demonstrated the compliance with the Tensile Strength Suture US Monograph. This tests confirmed Dermalon ability to fill the suture function.
In-vivo performance testing on representative animal model was conducted in comparison with predicate to demonstrate the collagen film minimizes visceral attachment to the mesh. The results demonstrated the performance of the collagen film of PARIETEX™ Optimized Composite Mesh was equivalent to the predicate.
The results of the nonclinical and pre-clinical tests demonstrate that the device performs as well as or better than the legally marketed predicate devices.
2
Image /page/2/Picture/1 description: The image shows a logo or emblem. On the left side, there is text that reads "DEPARTMENT OF HEALTH & HIG.", arranged in a circular fashion. To the right of the text, there is a stylized graphic that resembles a bird in flight, composed of three curved lines. The overall impression is that of an official seal or symbol, possibly related to a health or government organization.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sofradim Production % Covidien Mr. James McMahon 15 Crosby Drive Bedford, Massachusetts 01730
AUG 11 2011
Re: K110663
Trade/Device Name: PARIETEX™ Optimized Composite Mesh (PCO-FX references) Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: August 3, 2011 Received: August 5, 2011
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 Mcdical 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.
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
3
Page 2 - Mr. James McMahon
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.
fa. Nola Vercia D.N
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
510(k) Number (if known): V110663
PARIETEX™ Optimized Composite Mesh (PCO-FX references) Device Name:
Indications For Use:
The PARIETEX™ OPTIMIZED COMPOSITE MESH is used for the reinforcement of tissues during surgical repair. It is indicated for the treatment of incisional hernias, abdominal wall repair and parietal (i.e. pertaining to the walls) reinforcement of tissues. 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)
Daind Knare ken MXM
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K11663