(130 days)
The proposed device is intended for tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
The proposed device is a sterile, single use device, consisting of a synthetic mesh assembly and needle holder. The mesh assembly consists of a polypropylene knitted mesh body with integrated legs that are protected by disposable polymer sleeves. At the distal end of the disposable polymer sleeve is a lead with needle designed for use with the currently legally marketed Capio™ Open Access Suture Capturing Device. The disposable lead was designed to facilitate the passage of the proposed mesh through bodily tissues for placement.
This document is a 510(k) summary for a surgical mesh device, the "Modified Pinnacle Pelvic Floor Repair Kit - Apical." It largely focuses on establishing substantial equivalence to predicate devices based on intended use, technological characteristics, and performance characteristics.
The provided text does not contain any information regarding acceptance criteria, study data, sample sizes, ground truth establishment, or expert involvement for proving the device meets performance criteria. The document explicitly states that "the proposed device is as safe, as effective, and performs as well as the predicate device" based on a direct comparison of key characteristics, but it does not present any specific data or studies to support this claim in the context of device performance metrics against acceptance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I fill in the requested table and sample size details, as this information is absent from the provided text.
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510(k) Summary
A. Sponsor
Boston Scientific Corporation Urology and Gynecology Division 100 Boston Scientific Way Marlborough, MA 01752
B. Contact
Michelle Berry Senior, Regulatory Affairs Specialist 508-683-4941 or Donna Gardner Director, Regulatory Affairs 508-683-4398
C. Device Name
Tradename: TBD Common/usual name: Surgical Mesh Classification Name: ON. - Mesh, Surgical, Polymeric 21 CFR 878.3300, Class II
D. Predicate Device(s)
| Tradename: | Pinnacle Pelvic Floor Repair Kit |
|---|---|
| Common/usual name: | Surgical Mesh |
| Classification Name: | OTP- Mesh, Surgical, Polymeric21 CFR 878.3300, Class II |
| Premarket Notification: | Boston Scientific, K071957and |
| Tradename: | Prolift Pelvic Floor Repair Systems |
| Common/usual name: | Surgical Mesh |
| Classification Name: | OTP-Mesh, Surgical, Polymeric21 CFR 878.3300, Class II |
| Premarket Notification: | Gynecare, K071512 |
E. Device Description
The proposed device is a sterile, single use device, consisting of a synthetic mesh assembly and needle holder. The mesh assembly consists of a polypropylene knitted mesh body with integrated legs that are protected by disposable polymer sleeves. At the distal end of the disposable polymer sleeve is a lead with needle designed for use with the currently legally marketed Capio™ Open Access Suture Capturing Device. The disposable lead was designed to facilitate the passage of the proposed mesh through bodily tissues for placement.
AUG 2 2 2008
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pg 2.4)2-
F. Intended Use
The proposed device is intended for tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
G. Technological Characteristics
The proposed device has the same technological characteristics (i.e. mesh design and mesh material) as the predicate.
H. Substantial Equivalence
Utilizing FDA's Guidance for Industry and FDA Staff "Format for Traditional and Abbreviated 510(k)s" and "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh", a direct comparison of key characteristics demonstrates that the proposed mesh is substantially equivalent to the predicate mesh in terms of intended use, technological characteristics, and performance characteristics tested. The proposed device is as safe, as effective, and performs as well as the predicate device.
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, symbolizing strength and protection. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle, emphasizing the organization's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Michelle Berry Senior Regulatory Affairs Specialist Boston Scientific Corporation 100 Boston Scientific Way MARLBOROUGH MA 01752
SEP 2 8 2012
Re: K081048 Trade/Device Name: Modified Pinnacle Pelvic Floor Repair Kit - Apical Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP Dated: August 13, 2008 Received: August 14, 2008
Dear Ms. Berry:
This letter corrects our substantially equivalent letter of August 22, 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
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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/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
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Indications for Use Statement
510(k) Number (if Known):
Device Name: Pinnacle™ Pelvic Floor Repair Kit - Apical
Indications For Use:
The proposed Pinnacle Pelvic Floor Repair Kit is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
Prescription Use X (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
Mark A Mikkelsen
(Division Sign.Off) Division of General, Restorative, and Neurological Devices
510(k) Number
§ 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.