(346 days)
Not Found
No
The 510(k) summary describes a surgical mesh and instrument system for pelvic floor repair. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies. The performance studies focus on material biocompatibility and functional performance testing.
Yes
The device is described as a "Pelvic Floor Repair System" intended for tissue reinforcement and stabilization in vaginal wall prolapse, serving as "mechanical support or bridging material for the fascial defect," which aligns with the definition of a therapeutic device designed to treat a medical condition.
No
The device description clearly states that these are "Pelvic Floor Repair Systems" consisting of mesh implants and instruments for their placement, which are used for "tissue reinforcement and long-lasting stabilization of fascial structures." This indicates a therapeutic or reconstructive purpose rather than a diagnostic one.
No
The device description explicitly states that the systems consist of pre-cut mesh implants and a set of instruments, indicating physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor in vaginal wall prolapse. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device consists of mesh implants and instruments for placement. This is consistent with a surgical implant and delivery system, not a diagnostic kit or instrument used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
The device is clearly intended for surgical repair of pelvic floor prolapse, which falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The GYNECARE PROLIFT* Total, Anterior, and Posterior Pelvic Floor Repair Systems, through the placement of GYNECARE GYNEMESH PS* PROLENE Soft Mesh, 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.
The GYNECARE PROLIFT+M* Total, Anterior, and Posterior Pelvic Floor Repair Systems, through the placement of GYNECARE GYNEMESH M* Partially Absorbable Mesh, 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 (comma separated list FDA assigned to the subject device)
OTP
Device Description
The GYNECARE PROLIFT Total, Anterior, and Posterior Pelvic Floor Repair Systems consist of pre-cut non-absorbable mesh implants and a set of instruments to facilitate mesh implant placement.
The GYNECARE PROLIFT+M Total, Anterior, and Posterior Pelvic Floor Repair Systems consist of pre-cut partially absorbable mesh implants and a set of instruments to facilitate mesh implant placement.
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)
Biological reactivity of the materials has been assessed using methods specified in ISO 10993-1. and the materials were found to be acceptable for their intended uses. Results of functional performance testing (bench and cadaver testing) indicate that the proposed device meets or exceeds all functional requirements, based on FDA's Guidance Document "Guidance for the Preparation of a Premarket Notification Arplication for a Surgical Mesh". Preclinical modelling was used to evaluate procedural performance of the systems.
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.
K013718, K033337, K040537, K040623
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
§ 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
K071512
pg 1 of 2
Summary of Safety and Effectiveness
Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, in respect to safety and effectiveness is summarized below.
Submitted by:
Bryan A. Lisa Regulatory Affairs Project Manager ETHICON, Inc., A Johnson & Johnson Company Route 22 West, PO Box 151 Somerville, NJ 08876
MAY 1 5 2008
Name/Classification of Device:
Class II in 21 CFR § 878.3300, Surgical Mesh (0TP) Class I in 21 CFR § 878.4800, Manual surgical instrument for general use
Trade Name:
GYNECARE PROLIFT Total, Anterior, and Posterior Pelvic Floor Repair Systems GYNECARE PROLIFT+M* Total, Anterior, and Posterior Pelvic Floor Repair Systems
Predicate Devices:
- GYNECARE GYNEMESH PS* PROLENE* Soft Mesh (ETHICON, Inc.) K013718 .
- ULTRAPRO* Mesh (ETHICON, Inc.) K033337
- AMS APOGEE Vault Suspension System (American Medical Systems, Inc.) K040537
- AMS PERIGEE System (American Medical Systems, Inc.) K040623 .
Statement of Intended Use:
The GYNECARE PROLIFT* Total, Anterior, and Posterior Pelvic Floor Repair Systems, through the placement of GYNECARE GYNEMESH PS* PROLENE Soft Mesh, 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.
The GYNECARE PROLIFT+M* Total, Anterior, and Posterior Pelvic Floor Repair Systems, through the placement of GYNECARE GYNEMESH M* Partially Absorbable Mesh, 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.
Device Description:
The GYNECARE PROLIFT Total, Anterior, and Posterior Pelvic Floor Repair Systems consist of pre-cut non-absorbable mesh implants and a set of instruments to facilitate mesh implant placement. The following table summarizes the instruments included with each system:
510(k) Summary
1
| REPAIR SYSTEM | COMPONENTS | |||
|---|---|---|---|---|
| Mesh Implant | Guide | Retrieval Devices | Cannulas | |
| Total | 1 Total | 1 | 6 | 6 |
| Anterior | 1 Anterior | 1 | 4 | 4 |
| Posterior | 1 Posterior | 1 | 2 | 2 |
The GYNECARE PROLIFT+M Total, Anterior, and Posterior Pelvic Floor Repair Systems consist of pre-cut partially absorbable mesh implants and a set of instruments to facilitate mesh implant placement. The following table summarizes the instruments included with each system:
1071512
2022
| REPAIR SYSTEM | COMPONENTS | |||
|---|---|---|---|---|
| Mesh Implant | Guide | Retrieval Devices | Cannulas | |
| Total | 1 Total | 1 | 6 | 6 |
| Anterior | 1 Anterior | 1 | 4 | 4 |
| Posterior | 1 Posterior | 1 | 2 | 2 |
Summary of Technological Characteristics of New Device to Predicate Devices:
The modified devices have similar technological characteristics as the predicate devices.
GYNECARE PROLIFT: Like currently marketed devices, the implantable component is a sterile, mesh implant intended for the repair of pelvic floor defects. The mesh implant component of the proposed device is made of nonabsorbable polymers, which are identical to those found in GYNECARE GYNEMESH PS, currently marketed by ETHICON, Inc. ....
GYNECARE PROLIFI+M: Like currently marketed devices, the implantable component is a sterile, mesh implant intended for the repair of pelvic floor defects. The mesh implant component of the proposed device is made of nonabsorbable and absorbable polymers, which are identical to those found in ULTRAPRO Mesh, currently marketed by ETHICON, Inc.
Performance Data:
Biological reactivity of the materials has been assessed using methods specified in ISO 10993-1. and the materials were found to be acceptable for their intended uses. Results of functional performance testing (bench and cadaver testing) indicate that the proposed device meets or exceeds all functional requirements, based on FDA's Guidance Document "Guidance for the Preparation of a Premarket Notification Arplication for a Surgical Mesh". Preclinical modelling was used to evaluate procedural performance of the systems.
Conclusions:
Based on the similarities to the predicate devices identified in this submission, we conclude that the modified device is substantially equivalent to the predicate devices under the Federal Food, Drug, and Cosmetic Act.
- Trademark of ETHICON, Inc.
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Image /page/2/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 its wings outstretched, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 2 8 2012
Ethicon, Inc. % Mr. Bryan A. Lisa Route 22 West P.O. Box 151 SOMERVILLE NJ 08876
Re: K071512
Trade/Device Name: Gynecare Prolifi™ Total, Anterior, and Posterior Pelvic Floor Repair Systems; Gynecare Prolift +MTM Total, Anterior, and Posterior Pelvic Floor Repair Systems
Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP Dated: February 22, 2008 Received: February 25, 2008
Dear Mr. Lisa:
This letter corrects our substantially equivalent letter of May 15, 2008.
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/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. Perkins
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
BAL-2007-002
Indications for Use
510(k) Number (if known): K071512
Device Name: GYNECARE PROLIFT* and GYNECARE PROLIFT+M* Total, Anterior, and Posterior Pelvic Floor Repair Systems
Indications for Use:
The GYNECARE PROLIFT* Total, Anterior, and Posterior Pelvic Floor Repair Systems 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.
The GYNECARE PROLIFT+M* Total, Anterior, and Posterior Pelvic Floor Repair Systems, through the placement of GYNECARE GYNEMESH M* Partially Absorbable Mesh, 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.
*Trademark.
(21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
NILREOL for reims
Division of General, Restorative, and Neurological Devices
510(k) Number K071512
INDICATIONS FOR USE
ETHICON CONFIDENTIAL