(114 days)
Not Found
No
The summary describes a physical mesh implant and delivery system, with no mention of software, algorithms, or any terms related to AI/ML.
Yes
The device is intended for the treatment of stress urinary incontinence, which indicates a therapeutic purpose.
No
The device description indicates it is a mesh implant used for treatment (suburethral sling for stress urinary incontinence), not for diagnosis.
No
The device description clearly states it is a sterile, single-use device consisting of a synthetic mesh sling assembly and a delivery device, 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 is for the treatment of stress urinary incontinence by acting as a suburethral sling. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a surgical implant (mesh sling) with a delivery device. This is a physical device used in a surgical procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any such use or interaction with biological specimens for diagnostic purposes.
Therefore, this device falls under the category of a surgical implant or medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Product codes (comma separated list FDA assigned to the subject device)
PAH
Device Description
The proposed device is a sterile, single use device, consisting of a synthetic mesh sling assembly and packaged with a delivery device. The mesh assembly consists of a knitted polypropylene monofilament fiber mesh body with polypropylene carriers, each are attached to separate ends.
The proposed mesh sling configuration is packaged with other legally marketed accessories (e.g., Delivery Device; Class I exempt: 876.4730 Manual gastroenterology-urology surgical instrument and accessories).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
§ 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.
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K081275
pg 1 of 2
510(k) Summary for Surgical Mesh
A. Sponsor
Boston Scientific Corporation Urology and Gynecology Division 100 Boston Scientific Way Marlborough, MA 01756
B. Contact
Janet A. McGrath Principal Regulatory Affairs Specialist 508-683-4726 or Donna Gardner Director, Regulatory Affairs 508-683-4398
C. Device Name
Tradename: Surgical Mesh, (SIS) Common/usual name: Surgical Mesh Classification Namer 7447 - Mesh, Surgical, Polymeric 21 CFR 878.3300, Class II
D. Predicate Device(s)
Tradename:
Advantage® Transvaginal Mid Urethral Sling System Advantage Fit™ System Lynx ® Suprapubic Mid Urethral Sling System Obtryx® Transobturator Mid Urethral Sling System Prefyx PPS® System AMS MiniArcTM Sling System
Common/usual name: Surgical Mesh Classification Name: (PAH) - Mesh, Surgical, Polymeric 21 CFR 878.3300, Class II
Premarket
Notification: Boston Scientific Corporation: K020110. K040787 American Medical System.Inc .: K073703
E. Device Description
The proposed device is a sterile, single use device, consisting of a synthetic mesh sling assembly and packaged with a delivery device. The mesh assembly consists of a knitted polypropylene monofilament fiber mesh body with polypropylene carriers, each are attached to separate ends.
Accessories
The proposed mesh sling configuration is packaged with other legally marketed accessories (e.g., Delivery Device; Class I exempt: 876.4730 Manual gastroenterology-urology surgical instrument and accessories).
AUG 2.7 2008
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K081275
kg 2022
F. Intended Use
The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
G. Technological Characteristics
The proposed device has the same and/or equivalent technological characteristics (i.e. mesh design and mesh material) as the predicate(s).
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 consists of a stylized eagle with three stripes forming its body and wing. The eagle faces right, and its head is slightly tilted upwards. 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. Janet A. McGrath Principal Regulatory Affairs Specialist Boston Scientific Corporation 100 Boston Scientific Way MARLBOROUGH MA 01752
SEP 2 8 2012
K081275 Re: Trade/Device Name: Surgical Mesh, (SIS) Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAH Dated: August 13, 2008 Received: August 14, 2008
Dear Ms. McGrath:
This letter corrects our substantially equivalent letter of August 27, 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
3
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 (OS) 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. Runkle
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): K081275
Device Name: Surgical Mesh , (SIS)
Indications For Use:
The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Prescription Use ਮ (21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General. Restorative, and Neurosogical Devices
510(k) Number