(18 days)
The proposed Pelvic Floor Repair System 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.
The proposed device is a sterile, single use kit, consisting of two synthetic mesh assemblies and a needle holder. Each 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 Capio™ Open Access Suture Capturing Device. The disposable lead was designed to facilitate the passage of the proposed mesh through bodily tissues for placement. The proposed mesh configurations were designed for performing vaginal wall repair to facilitate treatment of anterior, apical and posterior prolapse repairs.
The provided text pertains to a 510(k) summary for a medical device called the "Pelvic Floor Repair System" (Tradename: TBD, later identified as Pinnacle Pelvic Repair Kit). A 510(k) submission is a premarket notification demonstrating that a medical device is at least as safe and effective as a legally marketed device (predicate device). This type of submission relies on demonstrating substantial equivalence, not necessarily on new clinical trials or detailed performance study reports with specific acceptance criteria that one would find for a novel device or a Premarket Approval (PMA) application.
Therefore, the document does not contain the acceptance criteria and a study proving the device meets those criteria in the way you've outlined. This is because the 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and intended use, rather than fulfilling specific performance metrics from a new, independent study with pre-defined acceptance criteria.
The document indicates that substantial equivalence was demonstrated by comparing key characteristics of the proposed device to predicate devices (K071957 and K081048, both also "Pinnacle Pelvic Floor Repair Kit"). It states: "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."
Without a new performance study being conducted for this specific 510(k) submission, the requested information (acceptance criteria, sample size, ground truth, MRMC study details, etc.) cannot be extracted from this document. The "performance characteristics tested" mentioned likely refer to bench testing or material characterization to ensure similarity to the predicate, rather than a clinical study with human subjects.
Therefore, I cannot populate the table or answer the specific questions because the detailed information about a study proving the device meets acceptance criteria is not present in this 510(k) summary. The summary focuses on showing equivalence to existing devices.
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K.091131
Pg. 1 of 2
510(k) Summary for the Pelvic Floor Repair System
- A. Sponsor
Boston Scientific Corporation Urology and Gynecology Division 100 Boston Scientific Way Marlborough, MA 01756
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: Oly- Mesh, Surgical, Polymeric 21 CFR 878.3300, Class II
D. Predicate Device(s)
Tradename: Common/usual name: Classification Name:
Premarket Notification:
Pinnacle Pelvic Floor Repair Kit Surgical Mesh OP- Mesh, Surgical, Polymeric 21 CFR 878.3300, Class II Boston Scientific, K071957 and K081048
E. Device Description
The proposed device is a sterile, single use kit, consisting of two synthetic mesh assemblies and a needle holder. Each 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 Capio™ Open Access Suture Capturing Device. The disposable lead was designed to facilitate the passage of the proposed mesh through bodily tissues for placement. The proposed mesh configurations were designed for performing vaginal wall repair to facilitate treatment of anterior, apical and posterior prolapse repairs.
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.
MAY - 8 2009
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K091131
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17
G. Technological Characteristics
The proposed device has the same technological characteristics (i.e. mesh design and mesh material) as the predicates.
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 shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Boston Scientific % Ms. Michelle Berry Senior, Regulatory Affairs Specialist 100 Boston Scientific Way MARLBOROUGH MA 01760
SEP 2 8 2012
Re: K091131 Trade/Device Name: Pinnacle Pelvic Repair Kit Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP Dated: May 4, 2009 Received: May 5, 2009
Dear Ms. Berry:
This letter corrects our substantially equivalent letter of May 8, 2009.
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,
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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510(k) Number (if Known): K091131
Device Name: Undetermined
Indications For Use:
The proposed Pelvic Floor Repair System 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)
Daniel Krone for MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091131
14 .
§ 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.