(26 days)
Not Found
No
The summary describes a surgical mesh and its introducer, with no mention of AI, ML, image processing, or data-driven performance metrics.
No.
The device is a surgical mesh used for tissue reinforcement during hernia repair, which is a structural support function, not a therapeutic intervention in itself.
No
The device is indicated for reinforcement during surgical repair of hernias, which is a treatment, not a diagnostic purpose.
No
The device description explicitly states it is a mesh packaged with an introducer and suture loops, indicating it is a physical 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 the "reinforcement of tissue during surgical repair of inguinal hernias through laparoscopic approach." This describes a surgical implant used directly on the patient's body during a procedure.
- Device Description: The device is a "Polyester Mesh" packaged with an "Introducer." This is a physical medical device used in surgery.
- 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 screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Parietex® Polyester Mesh with Introducer is indicated for use in the reinforcement of tissue during surgical repair of inguinal hernias through laparoscopic approach.
Product codes
FTL
Device Description
The Parietex® Polyester Mesh will be packaged with an Introducer. Suture loops are attached to the meshes and aide in inserting and removing the mesh from the Introducer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
inguinal hernias
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
Bench tests were conducted to demonstrate that the modification to the device did not change the performance when compared to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Parietex® Polyester Mesh (K982532)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 of Safety and Effectiveness
JUL 1 0 2007
| SUBMITTER: | Sofradim Production
116, avenue du Formans
01600 Trevoux- France
Tel. No .: (33) 04 74 08 90 00 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Renee Borgesano
Manager, Regulatory Affairs
(203)492-5325 |
| DATE PREPARED: | June 13, 2007 |
| TRADE/PROPRIETARY NAME: | Parietex® Polyester Mesh |
| COMMON/USUAL NAME: | Surgical Mesh |
| CLASSIFICATION NAME: | Surgical Mesh |
| PREDDICATE DEVICE(S): | Parietex® Polyester Mesh (K982532) |
| DEVICE DESCRIPTION: | The Parietex® Polyester Mesh will be packaged with an
Introducer. Suture loops are attached to the meshes and aide
in inserting and removing the mesh from the Introducer. |
| INTENDED USE: | The Parietex® Polyester Mesh with Introducer is indicated for
use in the reinforcement of tissue during surgical repair of
inguinal hernias through laparoscopic approach. |
| TECHNOLOGICAL CHARACTERISTICS: | The technological characteristics, design and materials of the
meshes are identical to the predicate device. |
| MATERIALS: | All components of the Parietex® Polyester Mesh with Introducer
are comprised of materials that have passed biocompatibility
testing for their intended patient contact profile according to ISO
10993-1 and/or USP standards. |
| PERFORMANCE DATA: | Bench tests were conducted to demonstrate that the
modification to the device did not change the performance when
compared to the predicate device. |
United States Surgical Premarket Notification Page 22
™Tradem rk
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus-like design, with three lines representing the branches of government and three wavy lines below, possibly representing the people served by the department.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sofradim Production % United States Surgical Ms. Renee Borgesano Manager, Regulatory Affairs 150 Glover Avenue Norwalk, Connecticut 06856
JUL 10 2007
Re: K071629
Trade/Device Name: Parietex® Polyester Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: June 13, 2007 Received: June 14, 2007
Dear Ms. Borgesano:
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.
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
2
Page 2 - Ms. Renee Borgesano
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 contact the Office of Compliance at (240) 276-0115. 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Por
ark N. Melkerson
rector
Mark N. Melkerson Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use
510(k) Number (if known):
Ko.71629
Device Name: Parietex® Polyester Mesh
Indications for Use:
The Parietex® Polyester Mesh is indicated for use in the reinforcement of tissue during surgical repair of inguinal hernias through laparoscopic approach.
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)
(Division Sign-Off) (Division Sign of General, Restorative, and Neurological Devices
510(k) Number K071625
United States Surgical Premarket Notification
Page 20 ™ Trademark