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K Number
K051533
Device Name
I-STOP
Manufacturer
CL MEDICAL
Date Cleared
2005-08-11

(63 days)

Product Code
OTN
Regulation Number
878.3300
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
I-STOP® is intended to be used as a pubo-urethral sling for the treatment of female urinary incontinence.
Device Description
I-STOP is a sterile, single use kit consisting of knitted monofilament polypropylene, two to four stainless steel needles and two polycarbonate handles. The kit is designed to be used with any of the surgical approaches to position the sling.
More Information

K012628, K013355, K023516, K033568, K041176, K050148

Not Found

No
The device description and performance studies focus on the physical properties and clinical outcomes of a surgical sling, with no mention of AI or ML technologies.

Yes.
The device is intended to be used as a pubo-urethral sling for the treatment of female urinary incontinence, which is a therapeutic purpose.

No
The I-STOP device is described as a "pubo-urethral sling for the treatment of female urinary incontinence," indicating it is a therapeutic implant rather than a diagnostic tool. Its function is to support anatomical structures to treat a condition, not to identify or monitor a condition.

No

The device description clearly states it is a sterile, single-use kit consisting of physical components like knitted monofilament polypropylene, stainless steel needles, and polycarbonate handles. This indicates it is a hardware medical device, not software-only.

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 female urinary incontinence by acting as a pubo-urethral sling. This is a surgical implant used directly within the body for therapeutic purposes.
  • Device Description: The device is a sterile kit containing a sling, needles, and handles. These are surgical tools and implants, not reagents, instruments, or software intended for the examination of specimens derived from the human body.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is mechanical support.

IVD devices are specifically designed to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. The I-STOP device does not fit this description.

N/A

Intended Use / Indications for Use

I-STOP® is intended to be used as a pubo-urethral sling for the treatment of female urinary incontinence.

Product codes (comma separated list FDA assigned to the subject device)

OTN

Device Description

I-STOP is a sterile, single use kit consisting of knitted monofilament polypropylene, two to four stainless steel needles and two polycarbonate handles. I-STOP is intended to be inserted through any of the surgical approaches to position the sling.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

pubo-urethral

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)

Mechanical tests, biocompatibility tests in compliance with ISO 10993 and chemical tests. One multicenter retrospective study on a large population, published on Urology (January 2000) and one multicenter retrospective study with 0 patients which is published soon.

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.

K012628, K013355, K023516, K033568, K041176, K050148

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

510(k) SUMMAR KOSIS 33

  • Submitter's name:

Address:

  • Tel:
  • Fax:
  • Contact person:
  • Date of summary preparation:
  • Device common name: .
  • Device trade name: .
  • Device classification name: .
  • Product code: .
  • Regulatory status:
  • Predicate Devices:

CL Médical 28, avenue Général de Gaulle F - 69110 Sainte Foy Les Lyon - FRANCE 00.33.(0)4.78.59.54.93 00.33.(0)4.78.59.89.78 Vincent GORIA June 1st, 2005 Surgical mesh, Sling, Urethral Sling I-STOP Surgical mesh, polymeric (21 CFR 878.3300) OTN Class II - Gynecare TVT System: K012628

Device description:

Device description.
I-STOP is a sterile, single use kit consisting of knitted monorilement I-STOP is a stefile, single use int ochologic one two polycarbonate handles.
polypropylene, two to four stainless steel needles and two polycarbon to position the polypropylene, two to four stainless stoch novalso and any of the surgical approaches to position the sling.

Indications for Use:

Indications for Use.
I-STOP® is intended to be used as a pubo-urethral sling for the treatment of female urinary incontinence.

Comparison to predicate devices:

Companson to preditute actriously of I-STOP is the same compared to the The lundamental scientific toolinology of . Or one raw material and with the same predicate devices. The sing is made of the same surgical approaches.

Summary of testing:

Summary of testing.
Mechanical tests, biocompatibility tests in compliance with ISO 10993 and chemical tests.

Summary of clinical tests:

Summary of climied toob.
One multicenter retrospective study on a large population, published on alle One multicenter retrospective study on a farge populated in cospective study with Orology (January 2000) and one march and published soon.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine and healing. The caduceus is depicted as a staff with two snakes entwined around it and wings at the top.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

Mr. Vincent Goria CEO CL Medical 28, avenue General de Gaulle 69110 Sainte Foy Les Lyon FRANCE

SEP 2 8 2012

Re: K051533 Trade/Device Name: I-STOP Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: June 1, 2005 Received: June 9, 2005

Dear Mr. Goria:

This letter corrects our substantially equivalent letter of August 11, 2005.

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/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/ReportalProblem/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. 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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Image /page/3/Picture/0 description: The image contains a handwritten word that appears to be "KOSTSS". The letters are written in a cursive style, with some connections between the letters. The writing is dark and clear against a white background, making it easily readable.

Indications for Use

510(k) Number (if known): ´K051533

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I-STOP Device Name:

  • Indications For Use:
    I-STOP® is intended to be used as a pubo-urethral sling for the treatment of female urinary incontinence.

Prescription Use × (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)

Bairire Buchm

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_K051533

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