(130 days)
Not Found
No
The summary describes a physical mesh and delivery system, with no mention of software, algorithms, or any terms related to AI/ML.
Yes
The device is intended for "tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse," directly addressing a medical condition (vaginal wall prolapse) and providing a therapeutic effect (reinforcement and stabilization).
No
The device is described as a tissue reinforcement and stabilization product for surgical treatment of vaginal wall prolapse, serving as mechanical support or bridging material. It is purely interventional and has no diagnostic function.
No
The device description clearly states it is a sterile, single-use device consisting of a synthetic mesh assembly and needle holder, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device 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 description details a "synthetic mesh assembly and needle holder" designed for surgical placement. This is consistent with a surgical device, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological specimens (like blood, urine, tissue samples, etc.) to provide diagnostic information. IVDs are typically used in laboratories or point-of-care settings to detect, measure, or identify substances or characteristics in these specimens.
Therefore, this device falls under the category of a surgical implant or device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
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.
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)
Not Found
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.
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
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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, Polymeric |
| 21 CFR 878.3300, Class II | |
| Premarket Notification: | Boston Scientific, K071957 |
| and | |
| Tradename: | Prolift Pelvic Floor Repair Systems |
| Common/usual name: | Surgical Mesh |
| Classification Name: | OTP-Mesh, Surgical, Polymeric |
| 21 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.
2
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