I-STOP TRANS OBTURATOR MALE SLING

K063079 · Cl Medical · OTM · Nov 7, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K063079
• Device Name: I-STOP TRANS OBTURATOR MALE SLING
• Applicant: Cl Medical
• Product Code: OTM · General, Plastic Surgery
• Decision Date: Nov 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

I-STOP® Trans Obturator Male / Female Sling is intended to be used as a sub-urethral sling implant for the treatment of male stress urinary incontinence post-prostatectomy. And for females: for the treatment of urinary stress incontinence due to intrinsic sphincter deficiency and/or intrinsic sphincter deficiency.

Device Story

I-STOP Trans Obturator Male/Female Sling is a sterile, single-use surgical kit; consists of knitted monofilament polypropylene sling, two stainless steel needles, and two polycarbonate handles. Used as sub-urethral sling implant for treatment of stress urinary incontinence. Operated by surgeons in clinical/surgical settings. Device provides mechanical support to urethra to restore continence. No electronic, software, or algorithmic components.

Clinical Evidence

Summary includes three studies on the surgical technique and three anatomical studies. No specific clinical performance metrics provided.

Technological Characteristics

Materials: knitted monofilament polypropylene sling, stainless steel needles, polycarbonate handles. Sterile, single-use kit. Mechanical device; no energy source, connectivity, or software.

Indications for Use

Indicated for male patients with stress urinary incontinence post-prostatectomy and female patients with urinary stress incontinence due to intrinsic sphincter deficiency.

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

• I-STOP (K051533)
• AMS Male Transobturator Sling System (K053371)

Submission Summary (Full Text)

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# 510(k) Summary

NOW - 7 2006

- Submitter's name: CL Médical Address: 28 avenue Général de Gaulle Pre Center II F - 69110 Sainte Foy Les Lyon - FRANCE + 33.(0)4.78.59.54.93 Tel: + 33.(0)4.78.59.89.78 Fax: Contact person: Mr. Vincent GORIA . October 2nd, 2006 Date of summary preparation: . Device common name: Surgical mesh, Sling, Urethral Sling . I-STOP® Trans Obturator Male / Female Sling . Device trade name: Surgical mesh, polymeric (21 CFR 878.3300) Device classification name: .
- Product code: .

. Regulatory status:

- Predicate Device: .
FTL Class II I-STOP K051533 AMS Male Transobturator Sling System K053371

# Device description: .

I-STOP® Trans Obturator Male / Female Sling is a sterile, single use kit consisting of one sling of knitted monofilament polypropylene, two stainless two polycarbonate handles and two stainless steel needles molded with polycarbonate handles.

### . Indications for Use:

I-STOP® Trans Obturator Male / Female Sling is intended to be used as a sub-urethral sling implant for the treatment of male stress urinary incontinence post-prostatectomy. And for females: for the treatment of urinary stress incontinence due to intrinsic sphincter deficiency and/or intrinsic sphincter deficiency.

### Comparison to predicate device: .

This is exactly the same device than I-STOP (K051533) with the same knitted sling and the same needles and handles. The device is similar to the AMS Male Transobturator Sling System (K053371).

### . Summary of testing:

Mechanical tests. biocompatibility tests in compliance with ISO 10993 and chemical tests.

# . Summary of clinical tests:

Three studies on this surgical technique and three anatomical studies.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CL Medical % Mr. Vincent GORIA CEO 28 avenue Général de Gaulle Pré Center II 69110 Sainte Foy Les Lyon France

Re: K063079

Trade/Device Name: I-STOP Trans Obturator Malc/Female Sling Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: October 2, 2006 Received: October 10, 2006

Dear Mr. GORIA:

We have reviewed your Scction 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.

NOV - 7 2006

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 – Mr. Vincent GORIA

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours

Mark N. Melkerson
Director

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K063079

# Indications for Use

| 510(k) Number (if known): | K063079 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | I-STOP Trans Obturator Male / Female Sling |
| Indications for Use: | I-STOP® Trans Obturator Male / Female Sling is intended to be used as a sub-urethral sling implant for the treatment of male stress urinary incontinence post-prostatectomy. And for females: for the treatment of urinary stress incontinence due to intrinsic sphincter deficiency and/or intrinsic sphincter deficiency. |

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

PDP

(Division Sign-Of Division of General, Restorative, and Neurological Devices

**510(k) Number** 1663079