(82 days)
Not Found
No
The summary describes a physical mesh implant and delivery system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a suburethral sling for the treatment of stress urinary incontinence, which indicates a therapeutic purpose.
No
The device is a mesh implant designed for the treatment of stress urinary incontinence, serving a therapeutic purpose rather than a diagnostic one.
No
The device description clearly states it is a physical mesh implant and delivery device, 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: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVDs are used in vitro (outside the body) to analyze samples and provide diagnostic or other information. This device is used in vivo (inside the body) for treatment.
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)
OTN
Device Description
The proposed sling 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 implant, dilators, mesh sleeve and center tab.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
suburethral
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)
Non-Clinicial Testing: Material testing was performed to demostrate that the material properites are suitable for the intended use. Bench testing was performed to demostrate that the device as manufactured meets nerformance specifications. Test results demostrate that the device meets the predetermine specifications and is acceptable for clinical use. Biocompatiblity testing was performed in accordance to standard EN ISO 10993-1 for each of the patient contacting materials, and results demonstrate that the device is biocompatible for its intended 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.
K974098 (TVT), K945377 (BSC), K010533 (INJECTX, INC), K980483 (MENTOR)
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
020110
510(k) Summary for Surgical Mesh
A. Sponsor
Boston Scientific Corporation Urology and Gynecology Division 100 Boston Scientific Way Marlborough, MA 01752
B. Contact
Janet A. McGrath Principal Specialist Global Regulatory Affairs 508-683-4726 or Donna Gardner Director. Regulatory Affairs 508-683-4398
C. Device Name
Tradename: Advantage™ System , Advantage Fit™ and Lynx TM System Common/usual name: Surgical Mesh Classification Name: OTN - Mesh, Surgical, Polymeric
21 CFR 878.3300, Class II
D. Predicate Device(s)
Tradename:
-
- Tension Free Vaginal Tape
-
- Trelex Mesh
-
- BioSling Bioabsorable Polymer Sling and Surgical Mesh
-
- Suspend Sling
Common/usual name: Surgical Mesh
Classification Name: OTN- Mesh, Surgical, Polymeric
21 CFR 878.3300, Class II
Premarket Notification: 1. K974098 (TVT)
E. Device Description
The proposed sling 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 implant, dilators, mesh sleeve and center tab.
Addition of documentation for Traditional 510(k) K020110 Surgical Mesh April 11, 2013
1
Accessories
The proposed sling is packaged with other legally marketed accessories (e.g., Delivery Device; Class I exempt: 876.4730 Manual gastroenterology-urology surgical instrument and accessories).
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 intended use of the surgical mesh is equivalent to all the predicate devices listed. As stated in this 510K the materials and the technological characteristics are equivalent to the predicate Tension Free Vaginal Tape, K974098.
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 sling is substantially equivalent to the predicate sling in terms of intended use, technological characteristics, and performance characteristics tested. The proposed sling is as safe, as effective, and performs as well as the predicate device.
I . Non-Clinicial Testing
Material testing was performed to demostrate that the material properites are suitable for the intended use.
Bench testing was performed to demostrate that the device as manufactured meets nerformance specifications. Test results demostrate that the device meets the predetermine specifications and is acceptable for clinical use.
Biocompatiblity testing was performed in accordance to standard EN ISO 10993-1 for each of the patient contacting materials, and results demonstrate that the device is biocompatible for its intended use.
Conclusion:
Based on material, biocompatiblity, bench testing, and the proposed device labeling, the device is substantially equivalent to the identified predicate devices previously classified under 21 CFR 878.3300 as Class II, mesh surgical, polymeric, in terms of intended use and thefore do not adversely effect safety and effectiveness.
Addition of documentation for Traditional 510(k) K020110 Surgical Mesh April 11, 2013
2
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 wing and a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The eagle is positioned above the text, and the entire logo is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 13, 2013
Boston Scientific Corporation Urology and Gynecology Division % Lorraine M. Hanley Director One Boston Scientific Place Natick, MA 01760
Re: K020110
Trade/Device Name: Advantage™ System, Advantage™ Fit System and Lynx™ System Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated (Date on orig SE ltr): January 9, 2002 Received (Date on orig SE Itr): January 11, 2002
Dear Lorraine M. Hanley,
This letter corrects our substantially equivalent letter of April 3, 2002.
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.
3
Page 2 - Lorraine M. Hanley
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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for 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
4
Boston Scientific Corporation
CONFIDENTIAL
Indications for Use Statement
510(k) Number (if Known): K020110
Device Name: Advantage™ System, Advantage™ Fit System and Lynx™ System
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 _ 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)