(81 days)
Not Found
No
The description focuses on the material properties, sizes, and surgical procedures for a polypropylene mesh, with no mention of AI or ML capabilities.
No.
The device is a polypropylene mesh intended for surgical repair and reinforcement of tissue, which is a structural and support function, not a direct therapeutic or healing function.
No
The device is described as a polypropylene mesh for tissue reinforcement during surgical repair, not for diagnosis. Its "Intended Use" clearly states its purpose is for repair, and the "Device Description" details its physical characteristics and how it is used surgically, with no mention of diagnostic capabilities.
No
The device is a physical mesh made from polypropylene and polyethylene, intended for surgical implantation. It is clearly a hardware medical device.
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 hernias. This is a surgical implant used directly on the patient's body.
- Device Description: The description details a physical mesh made of polypropylene that is surgically implanted.
- 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) to provide information for diagnosis, monitoring, or treatment.
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 Parietene® Polypropylene Mesh is a polypropylene mesh intended for the reinforcement of tissue during surgical repair. It is indicated for inguinal hernias, parietal reinforcement of tissues and abdominal wall repair.
Product codes
FTL
Device Description
The Parietene® Polypropylene Mesh is used during open (laparounny) procedures The or during laparoscopic (transperitoneal or preperttoneal) procedures. The Parietene® Polypropylene Mesh is offered in several sizes and designs to accommodate the type and approach of the operation as described below:
Parietene® Polypropylene Mesh Models PP 0611, 1510, 1515, 2020, and Parietene® PP 3030 can be used during oven or laparoscopic procedures. Parietence PP 1410, and 1510 are used only during laparoscopic procedures.
All of the models are made from polyethylenc and are available in various sizes.
The Parietene® Polypropylene Mesh are nude from polypropylene sealed monofilament stitches and are offered in square and rectangular shapes with rounded edges. The Parietene® Puly Mesh are fixed to the patient by either staples or sutures.
The Parietene® Polypropylene Mesh Model 1410 contains a thread made from polyvinyl diffuorene. This thread is used to keep the mesh folded during insertion through a trocar during laparoscopic procedures. The thread is removed when the mesh has been unfolded in the trocar.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
inguinal, parietal, 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)
Testing was performed to determine the performance characteristics of the Mesh. The density, thickness, clongation, breaking strength, tear resistance, burst resistance, tensile strength were sil evaluated by ITF de LYON, a test laboratory in France. All of the testing was performed using Atrium and Visilex Mesh predicate devices for comparative purposes and followed ISO standards. The test proults showed that the Sofradim and predicate devices were similar in performance charactcristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Sofradim Parictex® Meshes, Bard-Davol Visilex® Mesh, Atrium Medical Corporation Atrium® Mesh
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
JUL 12 999
510(k) Summary for Parietene® Polypropylene Mesh
SPONSOR 1.
·
Sofradim Production 197 Avenue Theodore Kraun 69400 Villefranche sur Saone France
Patrice Becker Contact: 33 04 74 60 03 27 Telephone: Facsimile: 33 04 74 60 03 66
-
- DEVICE NAME
| Proprietary Name: | Parietene® Polypropylene Mesh |
|---|---|
| Common/Usual Name: | Surgical Mesh |
| Classification Name: | Surgical Mesh |
-
- PREDICATE DEVICES
Bard-Davol Visilex® Mesh Atrium Medical Corporation Atrium® Mesh Sofradim Parictex® Meshes
- PREDICATE DEVICES
DEVICE DESCRIPTION 4.
The Parietene® Polypropylene Mesh is used during open (laparounny) procedures The or during laparoscopic (transperitoneal or preperttoneal) procedures. Parietene® Polypropylene Mesh is offered in several sizes and designs to accommodate the type and approach of the operation as described below:
Parietene® Polypropylene Mesh Models PP 0611, 1510, 1515, 2020, and Parietene® PP 3030 can be used during oven or laparoscopic procedures. Parietence PP 1410, and 1510 are used only during laparoscopic procedures.
All of the models are made from polyethylenc and are available in various sizes.
1
The Parietene® Polypropylene Mesh are nude from polypropylene sealed monofilament stitches and are offered in square and rectangular shapes with rounded edges. The Parietene® Pulypropylene Mesh are fixed to the patient by either staples or sutures.
The Parietene® Polypropylene Mesh Model 1410 contains a thread made from polyvinyl diffuorene. This thread is used to keep the mesh folded during insertion through a trocar during laparoscopic procedures. The thread is removed when the mesh has been unfolded in the trocar.
INTENDED USB 5.
The Parietene® Polypropylene Mesh is a polypropylene mesh intended for the reinforcement of tissue during surgical repair. It is indicated for inguinal hernias, parietal reinforcement of tissues and abdominal wall repair.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE ર્ભ.
The Parietene® Polypropyiene Mesh is substantially equivalent to the Sofradim Parietex® Mesbes, the Bard-Davol Visilex® Mesh, and the Atrium Medical Corporation Atrium® Mesh. The Parietene® Polypropylene Mesh and the predicate devices have the same intended use in that they are all used for reinforcement of tissue during surgical repair. The Parietene®, Parietex® Polypropylene Mesth and the Atrium Mesh are inserted either through open or laparoscopic methous whereas the Bard-Davol Visilex is inserted laparoscopically only.
The Parietene® Polypropylene Mesh. the Bard-Davol Visilex and Atrium Mesh predicate devices are all made from polypropylene scaled monofilament stitches. The Softadim Parietex® mesh is made from polyethylene terephtalate. The proposed and predicate devices all offer various sizes and shapes to accommodate different surgical procedures. The proposed Parietene® Mesh is also offered with a lateral slit for cord for easier insertion during laparoscopic procedures. All of the devices are fixed to the patient by either staples or sutures and are single use devices only.
7. PERFORMANCE TESTING
Testing was performed to determine the performance characteristics of the Mesh. The density, thickness, clongation, breaking strength, tear resistance, burst resistance, tensile strength were sil evaluated by ITF de LYON, a test laboratory in France. All of the testing was performed using Atrium and Visilex Mesh
7/1/99
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predicate devices for comparative purposes and followed ISO standards. The test proults showed that the Sofradim and predicate devices were similar in performance charactcristics.
Sofradim 21000 Sofradim Parietene® Polypropylene Mesh
7/1/99 ·
Page E-3
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1:2 1999
Sofradim Production c/o Ms. Mary McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
Re: K991400
Trade Name: Perietene Polypropylene Mesh Regulatory Class: II Product Code: FTL Dated: April 21, 1999 Received: April 22, 1999
Dear Ms. McNamara:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Ms. Mary McNamara-Cullinane, RAC
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K991400 510(k) Number (if known): _
Sofredim Parietung® Polypropylene Mesh Device Name:_
Indications For Use:
The Parleten® Palypropylene Meslu is a polypropylene mosh intended for the reinforcement of tissue during surgical repair. It is indicated for inguinal hermia», parietal reinforcement of tissues and abdominal wall hernia repair.
(PLEASH IN NOT WRITE BELOW THIS LINE . CONTINUE ON ANOTHER PAGE IP NECESSARY
Concurrentes of CDRH, Office of Device Evaluation (ODF.) Forman Sigh-Off in of General Restorative Devices (COO, 1400 ﻟﻠﺘﻨﺎ 510(k) Number -OR Over-The-Counter I.Jan Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96) Sofradim 7/1/99 510(k) Sofradim Parietene® Polypropylene Mesh Page v