(228 days)
Polyform™ Synthetic Mesh (K051245)
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No
The device description and intended use describe a passive surgical mesh made of polypropylene fibers. There is no mention of any computational or analytical capabilities, let alone AI/ML. The modification is solely to the instructions for use.
Yes
The device is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor, serving as mechanical support or bridging material for fascial defects. These actions are therapeutic as they treat or alleviate a medical condition.
No
The device, a surgical mesh, is used for tissue reinforcement and stabilization. Its function is to support or bridge fascial defects, not to diagnose medical conditions.
No
The device description clearly states it is a physical mesh made of polypropylene fibers, which is a hardware component.
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 via an abdominal approach." This describes a surgical implant used directly on the patient's body for structural support.
- Device Description: The device is a "monofilament polypropylene fibers knitted into a sheet" that is "implanted." This is a physical implantable device.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the body (like blood, urine, or tissue) to diagnose a condition, monitor a disease, or screen for health issues.
IVD devices are specifically designed to perform tests in vitro (outside the body) on samples taken from the human body. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
Polyform Synthetic Mesh is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor via an abdominal approach, 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)
OTO
Device Description
The subject device consists of monofilament polypropylene fibers knitted into a sheet. It is rectangular in shape and available in two sizes, 10 x 15 cm and 15 x 20 cm. Surgeons implanting the subject device cut the mesh to the size and shape needed for an individual patient. The subject device is single use only, supplied sterile, and individually packaged in a Tyvek/Mylar pouch. The subject and predicate device are identical.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
pelvic floor
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons
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)
The Polyform Synthetic Mesh submitted herein is a modification of the predicate mesh device, Polyform Synthetic Mesh (K051245). The modification is an update to the device instructions for use packaged with the product. No performance data are needed to support the modifications to the instructions for use.
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.
Polyform™ Synthetic Mesh (K051245)
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
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 15, 2017
Boston Scientific Corporation Elizabeth Renken Principal Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752
Re: K171271
Trade/Device Name: Polyform™ Synthetic Mesh Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: OTO Dated: November 10, 2017 Received: November 15, 2017
Dear Elizabeth Renken:
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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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You must 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows the text "Benjamin R. Fisher -S". The text is written in a clear, sans-serif font and is horizontally aligned. The background of the image is plain and does not contain any other elements.
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
510(k) Number (if known) K171271
Device Name Polyform™ Synthetic Mesh
Indications for Use (Describe)
Polyform Syntheic Mesh is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor via an abdominal approach, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary for Polyform™ Synthetic Mesh
K171271
Date of Summary: December 14, 2017
A. Sponsor
Boston Scientific Corporation Urology and Women's Health Division 100 Boston Scientific Way Marlborough, MA 01752
B. Contact
Elizabeth Renken Principal Specialist, Regulatory Affairs 508-683-6746 Elizabeth.Renken@bsci.com
Or
Lisa Sullivan Sr. Manager, Regulatory Affairs 508-683-4745 Lisa.Sullivan@bsci.com
C. Device Information
| Trade name: | Polyform™ Synthetic Mesh |
|---|---|
| Common/usual name: | Surgical Mesh |
| Classification Name: | Surgical Mesh (21 CFR 878.3300) |
| Class: | II |
| Product Code: | OTO – Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal and Uterine Prolapse, Trasabdominally Placed |
| Predicate: | Polyform™ Synthetic Mesh (K051245) |
The predicate device has not been subject to a design related recall.
E. Device Description
The subject device consists of monofilament polypropylene fibers knitted into a sheet. It is rectangular in shape and available in two sizes, 10 x 15 cm and 15 x 20 cm. Surgeons implanting the subject device cut the mesh to the size and shape needed for an individual patient. The subject device is single use only, supplied sterile, and individually packaged in a Tyvek/Mylar pouch. The subject and predicate device are identical.
F. Indications for Use
Polyform Synthetic Mesh is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor via an abdominal approach, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
The subject and predicate device have the same intended use.
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G. Technological Characteristics
The subject and predicate device are identical; and accordingly, they have the same technological characteristics.
H. Performance Summary
The Polyform Synthetic Mesh submitted herein is a modification of the predicate mesh device, Polyform Synthetic Mesh (K051245). The modification is an update to the device instructions for use packaged with the product. No performance data are needed to support the modifications to the instructions for use.
I. Substantial Equivalence
The proposed Polyform Synthetic Mesh is substantially equivalent to the predicate device.