I-STOP

K051533 · Cl Medical · OTN · Aug 11, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051533
• Device Name: I-STOP
• Applicant: Cl Medical
• Product Code: OTN · General, Plastic Surgery
• Decision Date: Aug 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

I-STOP is a sterile, single-use surgical kit for treating female urinary incontinence. The device consists of a knitted monofilament polypropylene mesh sling and two to four stainless steel needles with polycarbonate handles. It is used by surgeons in a clinical setting to position the sling via various surgical approaches. The device acts as a sub-urethral support to treat incontinence. The surgeon manually manipulates the needles to place the mesh, providing mechanical support to the urethra. The device is intended to improve patient outcomes by addressing the underlying anatomical cause of stress urinary incontinence.

Clinical Evidence

Evidence includes one multicenter retrospective study on a large population published in Urology (January 2006) and one additional retrospective study.

Technological Characteristics

Knitted monofilament polypropylene mesh; stainless steel needles; polycarbonate handles. Sterile, single-use kit. Biocompatibility testing performed in compliance with ISO 10993.

Indications for Use

Indicated for female patients suffering from urinary incontinence requiring a pubo-urethral sling.

Regulatory Classification

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.

Predicate Devices

• Gynecare TVT System (K012628)
• SPARC Sling System (K013355)
• MONARC Sling System (K023516)
• Gynecare TVT-O System (K033568)
• Uretex TO (K041176)
• Mentor ARIS TOT (K050148)

Submission Summary (Full Text)

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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

- SPARC Sling System: K013355
- MONARC Sling System: K023516
- Gynecare TVT-O Šystem: K033568
- Uretex TO: K041176
- Mentor ARIS TOT: K050148

#### 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.

# 1/ 1

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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 [phone] or [phone] 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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# 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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