(90 days)
No
The 510(k) summary describes a surgical sling made of biological material for tissue reinforcement and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is intended to treat medical conditions such as stress urinary incontinence and various prolapses by reinforcing soft tissues, which aligns with the definition of a therapeutic device.
No
The device description indicates it is a surgical implant (Surgisis® Sling) intended to reinforce soft tissues, not to diagnose a condition.
No
The device description clearly states the device is supplied in "sheet form" and is a physical implantable material ("Surgisis® Sling"). This indicates it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Surgisis® Sling is for implantation to reinforce soft tissues in the urological, gynecological, and gastroenterological anatomy. This is a surgical implant used in vivo (within the body).
- Device Description: The device is described as a sheet of material supplied in various sizes, intended for surgical implantation.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on samples.
The information provided describes a surgical implant, not a diagnostic device.
N/A
Intended Use / Indications for Use
The Surgisis® Sling is intended for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy including but not limited to the following procedures: transvaginal repair of stress urinary incontinence, such as pubourethral support and bladder support, and transabdominal repair of apical vaginal prolapse, colon and rectal prolapse, and sacrocolposuspension. By providing pubourethral support, the sling may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
Product codes
PAG, PAJ, FTM
Device Description
The Surgisis® Sling is supplied in sheet form in sizes ranging from 20 cm2 to 140 cm2. The device is packaged in sterile, sealed double pouches.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urological, gynecological and gastroenterological anatomy
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)
The Surgisis® Sling was subjected to a panel of tests to assess biocompatibility, integrity, and performance. The Surgisis® Sling passed the requirements of all tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Surgisis® Mesh (K980431), Glycar Staple Strips (K954665), Mentor Suspend™ Sling (K980483), Surgical Fabrics (K963226)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
September 11, 2013
Cook Biotech Incorporated
Surgisis® Sling
Manufacturer Name:
Cook Biotech Incorporated 1425 Innovation Place West Lafayette, Indiana 47906 Telephone: +1 (765) 497-3355 FAX: +1 (765) 807-7709
Official Contact:
Perry W. Guinn
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Name: Classification Regulations: Product Code:
Surgisis® Sling Surgical mesh Class II, 21 CFR §878.3300 PAG, PAJ, FTM
INTENDED USE:
The Surgisis® Sling is intended for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy including but not limited to the following procedures: transvaginal repair of stress urinary incontinence, such as pubourethral support and bladder support, and transabdominal repair of apical vaginal prolapse, colon and rectal prolapse, and sacrocolposuspension. By providing pubourethral support, the sling may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
PREDICATE DEVICES:
Surgisis® Mesh (K980431) manufactured by Cook Biotech Incorporated Glycar Staple Strips (K954665) manufactured by Glycar, Incorporated Mentor Suspend™ Sling (K980483) manufactured by Mentor Corporation Surgical Fabrics (K963226) manufactured by Boston Scientific
DEVICE DESCRIPTION:
The Surgisis® Sling is supplied in sheet form in sizes ranging from 20 cm2 to 140 cm2. The device is packaged in sterile, sealed double pouches.
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K992159: Surgisis® Sling
SUBSTANTIAL EQUIVALENCE TO MARKETED DEVICES
The Surgisis® Sling is substantially equivalent to the predicate devices, having the same intended use and technological characteristics.
DISCUSSION OF TESTS AND TEST RESULTS:
The Surgisis® Sling was subjected to a panel of tests to assess biocompatibility, integrity, and performance. The Surgisis® Sling passed the requirements of all tests.
CONCLUSIONS DRAWN FROM THE TESTS:
The device is, with respect to intended use and technological characteristics, substantially equivalent to the predicate devices.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 13, 2013
Cook Biotech Incorporated % Neal E. Fearnot, Ph.D. President 3055 Kent Avenue West Lafavette, IN 47906
Re: K992159 Trade/Device Name: Surgisis Sling
Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: PAG, PAJ, FTM Dated (Date on orig SE Itr): June 23, 1999 Received (Date on orig SE Itr): June 25, 1999
Dear Neal E. Fearnot, Ph.D.,
This letter corrects our substantially equivalent letter of September 23, 1999.
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 waranties. 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 - Neal E. Fearnot, Ph.D.
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
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Indications for Use
510(k) Number (if known): K992159
Surgisis® Sling Device Name:
Indications For Use:
The Surgisis® Sling is intended for implantation to reinforce soft tissues where weakness exists in the urological gynecological and gastroenterological anatomy including but not limited to the following procedures: transvaginal repair of stress urinary incontinence, such as pubourethral support and bladder support, and transabdominal repair of apical vaginal prolapse, colon and rectal prolapse, and sacrocolposuspension. By providing pubourethral support, the sling may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
The device is supplied sterile and is intended for one-time use.
Prescription Use X (Part 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)
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