(61 days)
Not Found
Not Found
No
The device description focuses on the material properties and construction of a surgical mesh, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for tissue reinforcement and stabilization of fascial structures in vaginal wall prolapse, which are therapeutic interventions.
No
Explanation: The device is a surgical mesh used for tissue reinforcement and stabilization of fascial structures, not for diagnosing conditions.
No
The device description clearly states it is a physical mesh constructed of knitted filaments of extruded polypropylene, intended for surgical implantation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes.
- Device Description and Intended Use: The description and intended use clearly state that GYNEMESH PROLENE Soft Mesh is a surgical implant used for tissue reinforcement and stabilization of the pelvic floor. It is a physical material implanted into the body during surgery.
- Lack of IVD Characteristics: There is no mention of examining specimens from the body, performing tests on biological samples, or providing diagnostic information based on such tests.
Therefore, GYNEMESH PROLENE Soft Mesh is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This mesh is intended for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
This mesh is used for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
GYNEMESH PROLENE Soft (Polypropylene) Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
Product codes (comma separated list FDA assigned to the subject device)
OTO
Device Description
GYNEMESH PROLENE Soft Mesh is constructed of knitted filaments of extruded polypropylene identical in composition to that used in PROLENE* Polypropylene Suture, Nonabsorbable Surgical Sutures, U.S.P. (ETHICON, INC.). The mesh affords excellent strength, durability and surgical adaptability, with sufficient porosity for necessary tissue ingrowth. Blue PROLENE monofilaments have been incorporated to produce contrast striping in the mesh. The mesh is constructed of reduced diameter monofilament fibers, knitted into a unique design that results in a mesh that is approximately 50 percent more flexible than standard PROLENE Mesh. This material, when used as a suture, has been reported to be non-reactive and to retain its strength indefinitely in clinical use.
GYNEMESH PROLENE Soft Mesh is knitted by a process which interlinks each fiber junction and which provides for elasticity in both directions. This construction permits the mesh to be cut into any desired shape or size without unraveling. The bi-directional elastic property allows adaption to various stresses encountered in the body.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor, vaginal 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)
Nonclinical laboratory testing was not performed as there is no change to the clinical intended use as compared to the two predicate devices. Sufficient bench testing was conducted in accordance with the FDA guidance document 'Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh.'
Published clinical data on the use of PROLENE Mesh and MERSILENE mesh was submitted to support the used of these materials as reinforcing or bridging materials in fascial deficiencies of the pelvic wall.
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.
Not Found
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
8 2002 JAN
SECTION 7
SUMMARY OF SAFETY AND EFFECTIVENESS
| 510(k) Summary of
Safety and Effectiveness | Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.
MODIFIED DEVICE NAME: GYNEMESH PROLENE Soft (Polypropylene) Mesh
PREDICATE DEVICE NAME: PROLENE Soft (Polypropylene) Mesh, PROLENE* (Polypropylene) Mesh and MERSILENE* Mesh
510(k) SUMMARY |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | GYNEMESH PROLENE Soft Mesh is constructed of knitted filaments of extruded polypropylene identical in composition to that used in PROLENE* Polypropylene Suture, Nonabsorbable Surgical Sutures, U.S.P. (ETHICON, INC.). The mesh affords excellent strength, durability and surgical adaptability, with sufficient porosity for necessary tissue ingrowth. Blue PROLENE monofilaments have been incorporated to produce contrast striping in the mesh. The mesh is constructed of reduced diameter monofilament fibers, knitted into a unique design that results in a mesh that is approximately 50 percent more flexible than standard PROLENE Mesh. This material, when used as a suture, has been reported to be non-reactive and to retain its strength indefinitely in clinical use. |
| | 510(k) SUMMARY, Continued |
| Description (continued) | GYNEMESH PROLENE Soft Mesh is knitted by a process which
interlinks each fiber junction and which provides for elasticity in
both directions. This construction permits the mesh to be cut into
any desired shape or size without unraveling. The bi-directional
elastic property allows adaption to various stresses encountered in
the body. |
| Intended Use | This mesh is intended for the repair of hernia or other fascial
defects that require the addition of a reinforcing or bridging
material to obtain the desired surgical result. |
| Indications Statement | This mesh is used for the repair of hernia or other fascial defects
that require the addition of a reinforcing or bridging material to
obtain the desired surgical result. |
| Technological
Characteristics | For technological characteristics, the values are the same as
PROLENE Soft Mesh and are less than those of PROLENE Mesh,
but greater than those of MERSILENE Mesh do. GYNEMESH
PROLENE Soft Mesh, PROLENE Soft Mesh and PROLENE Mesh are
constructed of polypropylene fibers. GYNEMESH PROLENE Soft M
and PROLENE Soft Mesh offers a 50% more flexible monofilament
mesh. |
| Performance Data | Nonclinical laboratory testing was not performed as there is no
change to the clinical intended use as compared to the two
predicate devices. Sufficient bench testing was conducted in
accordance with the FDA guidance document 'Guidance for the
Preparation of a Premarket Notification Application for a Surgical
Mesh.' |
| | Published clinical data on the use of PROLENE Mesh and
MERSILENE mesh was submitted to support the used of these
materials as reinforcing or bridging materials in fascial deficiencies
of the pelvic wall. |
| | Continued on next page |
Continued on next page
1
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
2
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
Based on the 510(k) summaries and 510(k) statements (21 CFR Conclusions 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Device under the Federal Food, Drug, and Cosmetic Act. Gregory R. Jones Contact Director, GYNECARE QA/RA ETHICON, Inc. Rt. #22, West Somerville, NJ 08876-0151
Date
November 6, 2001
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circle's perimeter. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Gregory R. Jones Director, GYNECARE RA/QA Ethicon, Inc. P.O. Box 151 SOMERVILLE NJ 08876
SEP 2 8 2012
Re: K013718 Trade/Device Name: GYNEMESH PROLENE Soft Nonabsorbable Synthetic Surgical Mesh for Pelvic Floor Repair Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: November 6, 2001 Received: November 8, 2001
Dear Mr. Jones:
This letter corrects our substantially equivalent letter of January 8, 2002.
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
4
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" (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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sincerely yours,
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
5
INDICATION FOR USE ાળી રેમવ
510(k) Number (if known):
Device Name:
Indications for Use:
GYNEMESH PROLENE Soft (Polypropylene) Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
GYNEMESH PROLENE* Soft (Polypropylene) Mesh
lro for cmw
Division Sign-Off) Division of General, Restorative and Neurological Devices