(115 days)
Not Found
No
The device description focuses on the physical components (mesh, needles, sleeves) and their mechanical function for tissue reinforcement. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is indicated for "tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse," serving as "mechanical support or bridging material for the fascial defect," which directly addresses a medical condition and aims to restore normal function.
No
The device description indicates it is a surgical mesh for tissue reinforcement, not for diagnosing medical conditions.
No
The device description clearly states it consists of a synthetic mesh assembly and needle holder, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse, where surgical treatment is intended." This describes a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The device is a "sterile, single use device, consisting of a synthetic mesh assembly and needle holder." This is a physical implant and delivery system, not a reagent, instrument, or system intended for use in vitro (outside the body) to examine specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on laboratory testing.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical implant used to physically repair a structural defect.
N/A
Intended Use / Indications for Use
The Pinnacle Thi Pelvic Floor Repair Kits are 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.
Product codes
OTP
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. The proposed mesh will be offered in three mesh models: Total, Anterior/Apical and Posterior designed for performing total vaginal repair, anterior vaginal defects and posterior and/or apical vaginal vault defects respectively.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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510(k) Summary for the Pinnacle™ Pelvic Floor Repair Mesh
A. Sponsor
Boston Scientific Corporation Urology and Gynecology Division 100 Boston Scientific Way Marlborough, MA 01756
B. Contact
NOV U 8 2007
Michelle M. Berry Senior, Regulatory Affairs Specialist 508-683-4941
Or
Donna Gardner Director, Regulatory Affairs 508-683-4398
C. Device Name
| Tradename: | Pinnacle™ Pelvic Floor Repair Kits |
|---|---|
| Common/usual name: | Surgical Mesh |
| Classification Name: | FTL – Mesh, Surgical, Polymeric |
| 21 CFR 878.3300, Class II |
D. Predicate Device(s)
| Tradename: | Polyform Synthetic Mesh |
|---|---|
| Common/usual name: | Surgical Mesh |
| Classification Name: | OTP- Mesh, Surgical, Polymeric |
| 21 CFR 878.3300, Class II | |
| Premarket Notification: | Proxy Biomedical, Ltd., K051245 |
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. The proposed mesh will be offered in three mesh models: Total, Anterior/Apical and Posterior designed for performing total vaginal repair, anterior vaginal defects and posterior and/or apical vaginal vault defects respectively.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Michelle M. Berry Senior Regulatory Affairs Specialist Boston Scientific Corporation 100 Boston Scientific Way MARLBOROUGH MA 01752
SEP 2 8 2012
Re: K071957 Trade/Device Name: Undetermined Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP Dated: October 3, 2007 Received: October 4, 2007
Dear Ms. Berry:
This letter corrects our substantially equivalent letter of November 8, 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
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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 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. 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): KOZI957
Device Name: Undetermined
Indications For Use:
The Pinnacle Thi Pelvic Floor Repair Kits are 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 a Evaluation (ODE)
(Division Division of General, Restorative, and Neurological Devices
510(k) Number 1671987
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