(62 days)
Not Found
No
The device description and performance studies focus on the physical properties and substantial equivalence of a polypropylene mesh, with no mention of AI or ML.
Yes
The device is indicated for "tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended," which describes a therapeutic purpose.
No
The device, Parietene™ Duo and Parietene™ Quadra Polypropylene Meshes, is indicated for tissue reinforcement and long-lasting stabilization of fascial structures, acting as mechanical support or bridging material. It is a surgical implant designed to treat an existing condition (prolapse), not to diagnose or detect a disease or condition.
No
The device description clearly states it is a "monofilament polypropylene prolapse repair mesh," which is a physical implantable material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The description and intended use of the Parietene™ Duo and Parietene™ Quadra Polypropylene Meshes clearly indicate they are implantable surgical devices used for tissue reinforcement and stabilization within the body during surgical repair of pelvic floor prolapse. They are not used to test samples or provide diagnostic information.
The information provided confirms it's a surgical mesh intended for implantation, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Parietene™ Duo and Parietene™ Quadra Polypropylene Meshes are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended either as mechanical support or bridging material for the fascial defect.
Product codes
OTP, OTO
Device Description
Parietene™ Duo and Parietene™ Quadra are monofilament polypropylene prolapse repair meshes. The nonabsorbable, polypropylene mesh provides a long-term reinforcement for support structures. Parietene™ Duo Polypropylene Mesh is a pre-shaped mesh for posterior prolapse repair. Parietene™ Quadra Polypropylene Mesh is a pre-shaped mesh for anterior prolapse repair. Parietene™ Duo and Parietene™ Quadra meshes have a soft knit in the central section for compliant organ support and a strong knit in the lateral sides to provide strength for tension-free fixation of the mesh.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor
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 conducted to determine the performance characteristics of the subject meshes. The results demonstrate that the Parietene™ Duo and Parietene™ Quadra Polypropylene Meshes are substantially equivalent to the predicate UGYTEX™ Dual Knit Mesh.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
UGYTEXT™ Dual Knit Mesh (K051503), Parietene™ Polypropylene Mesh (K991400)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.
(a)
Identification. Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).(b)
Classification. Class III (premarket approval).(c)
Date premarket application approval or notice of completion of a product development protocol is required. A premarket application approval or notice of completion of a product development protocol for a device is required to be filed with the Food and Drug Administration on or before July 5, 2018, for any surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 5, 2018, been found substantially equivalent to a surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976. Any other surgical mesh for transvaginal pelvic organ prolapse repair shall have an approved premarket application or declared completed product development protocol in effect before being placed in commercial distribution.
0
510(k) Summary of Safety and Effectiveness
| SUBMITTER: | Sofradim Production
116, avenue du Formans
01600 Trevoux, France
Tel. No.: (33) 04 74 08 90 00 |
| ------------ | --------------------------------------------------------------------------------------------------------- |
|---|
1/2
DEC 1 9 2007
| CONTACT PERSON: | Sharon Alexander
Senior Associate, Regulatory Affairs
Covidien
150 Glover Avenue
Norwalk, CT 06856 USA
Tel. No.: (203) 492-6060 |
| ----------------- | ------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
| DATE PREPARED: | October 17, 2007 |
|---|---|
| ---------------- | ------------------ |
| TRADE/PROPRIETARY NAME: | Parietene™ Duo Polypropylene Mesh
Parietene™ Quadra Polypropylene Mesh |
| ------------------------- | --------------------------------------------------------------------------- |
|---|
| COMMON/USUAL NAME: | Surgical Mesh |
|---|---|
| -------------------- | --------------- |
| CLASSIFICATION NAME: | Mesh, Surgical, Polymeric |
|---|---|
| ---------------------- | --------------------------- |
| PREDICATE DEVICE(S): | UGYTEXT™ Dual Knit Mesh (K051503)
Parietene™ Polypropylene Mesh (K991400) |
| ---------------------- | ------------------------------------------------------------------------------ |
|---|
| DEVICE DESCRIPTION: | Parietene™ Duo and Parietene™ Quadra are monofilament
polypropylene prolapse repair meshes. The nonabsorbable,
polypropylene mesh provides a long-term reinforcement for
support structures. Parietene™ Duo Polypropylene Mesh is a
pre-shaped mesh for posterior prolapse repair. Parietene™
Quadra Polypropylene Mesh is a pre-shaped mesh for anterior
prolapse repair. Parietene™ Duo and Parietene™ Quadra
meshes have a soft knit in the central section for compliant
organ support and a strong knit in the lateral sides to provide
strength for tension-free fixation of the mesh. |
| --------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| INTENDED USE: | Parietene™ Duo and Parietene™ Quadra Polypropylene
Meshes are indicated for tissue reinforcement and long-lasting
stabilization of fascial structures of the pelvic floor in vaginal
wall prolapse where surgical treatment is intended either as
mechanical support or bridging material for the fascial defect. |
| --------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| TECHNOLOGICAL
CHARACTERISTICS: | The technological characteristics, design and materials of the
meshes are substantially equivalent to the predicate
UGYTEX™ Dual Knit Mesh. |
| ----------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| MATERIALS: | Parietene™ Duo and Parietene™ Quadra Polypropylene
Meshes are comprised of materials that have been evaluated
for biocompatibility for their intended patient contact profile
according to ISO 10993-1 and/or USP standards. |
| ------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
1022951
1
PERFORMANCE DATA: Testing was conducted to determine the performance characteristics of the subject meshes. The results demonstrate that the Parietene™ Duo and Parietene™ Quadra Polypropylene Meshes are substantially equivalent to the predicate UGYTEX™ Dual Knit Mesh.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, and it is often used on official documents and websites.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sofradim Production % Ms. Sharon Alexander Senior Associate, Regulatory Affairs Covidien 150 Glover Avenue NORWALK CT 06856
SEP 2 8 2012
Re: K072951
Trade/Device Name: Parietene™ Duo and Parietene™ Quadra Polypropylene Meshes Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP, OTO Dated: November 26, 2007 Received: November 27, 2007
Dear Ms. Alexander:
This letter corrects our substantially equivalent letter of December 19, 2007.
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 (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 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
3
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 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" (21 CFR 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,
Sincerely yours,
Benjamin R. Fuchs
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use
510(k) Number (if known):
Device Name: Parietene™ Duo and Parietene™ Quadra Polypropylene Meshes
Indications for Use:
Parietene™ Duo and Parietene™ Quadra Polypropylene Meshes are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended either as mechanical support or bridging material for the fascial defect.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| 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 of General, Restorative, and Neurological Devices
| 510(k) Num | 16072957 |
|---|---|
| ------------ | ---------- |