MALE REMEEX SYSTEM

K062341 · Specialities Remeex International, S.L. · OTM · Nov 2, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K062341
• Device Name: MALE REMEEX SYSTEM
• Applicant: Specialities Remeex International, S.L.
• Product Code: OTM · General, Plastic Surgery
• Decision Date: Nov 2, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Male Remeex System is intended to be used as a pubourethral sling for treatment of male stress urinary incontinence.

Device Story

Male Remeex System is a surgical mesh device for treating male stress urinary incontinence. It consists of a pubourethral sling placed under the urethra, connected via traction threads to an external mechanical regulation prosthesis. The prosthesis is positioned over the abdominal rectus muscle fascia, allowing physicians to adjust sling tension post-operatively to achieve optimal bladder neck angle and patient continence. Used in a surgical setting; operated by a physician. The device provides adjustable mechanical support to the urethra, enabling clinicians to fine-tune continence levels based on patient response, potentially improving outcomes for male stress incontinence.

Clinical Evidence

The submission relies on in vitro and clinical evaluations to demonstrate that the Male Remeex System functions as intended. No specific quantitative clinical metrics (e.g., p-values, CIs) are provided in the summary document.

Technological Characteristics

Surgical mesh for pubourethral support; includes traction threads and an external mechanical regulation prosthesis. Device is a mechanical system for tension adjustment. No software or electronic components.

Indications for Use

Indicated for male patients with stress urinary incontinence requiring a pubourethral sling for support.

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

• REMEEX SYSTEM (K033310)

Submission Summary (Full Text)

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K062341
510K Notification
Remcex System
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### 510K(k) SUMMARY

| SUBMITTER: | Specialities Remeex International, s.l.<br>55 Trende Baix<br>Terrassa Barcelona, Spain 08223 |
|-----------------------|----------------------------------------------------------------------------------------------|
| DATE PREPARED: | September 10 ^th 2002 |
| DEVICE NAME: | MALE REMEEX SYSTEM |
| CLASSIFICATION NAMES: | Mesh, Surgical, Polymeric |
| PREDICATE DEVICE: | REMEEX SYSTEM |

NOV - 2 2006## Device Description:

The MALE REMEEX SYSTEM (EXternal MEchanical REqulation) is included in the sling techniques for the treatment of urinary incontinence. This system is comprised of a pubourethral sling that permits the patient continence level regulation. This system use a sling, placed under the urethra that can be regulated at any time to get the most adequate bladder neck angle for a particular patient. The sling is connected by traction threads to the prosthesis. The prosthesis is situated over the fascia of the abdominal rectus muscle and is a mechanism that permits the regulation of the sling level.

## Predicate Devices:

There has been a device previously cleared by the FDA in the following 510(K) Notification indicated as a pubourethral sling for the treatment of urinary incontinence:

| Device | 510(k)<br>Document<br>Number | Date Cleared | Indications |
|---------------|------------------------------|--------------|-------------------------|
| REMEEX SYSTEM | K033310 | 1/15/2004 | Urinary<br>Incontinence |

Technologically, both the proposed and predicate devices are the same (i.e. both are meshes that provide pubourethral support) and are indicated for the treatment of urinary incontinence. Additionally, both devices utilize accessories for us in the surgical procedure.

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#### Intended Use:

### REMEEX SYSTEM Indications:

The Male Remeex System is intended to be used as a pubourethral sling for treatment of male stress urinary incontinence.

## Technological Characteristics:

Technologically, both the new device and the predicate device are the same (i.e. both are meshes that provide pubourethral support). Additionally, both devices utilize accessories for use in the surgical procedure. Any differences between the two devices do not raise new questions of safety and effectiveness

#### Performance Data:

Results of in vitro and clinical evaluations were used to show that the Male Remeex System functioned as clinically intended. Sufficient data has been gathered from testing to assess that the Remeex System performs as intended

#### Conclusions:

Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the proposed device is substantially equivalent to the existing legally marketed device under the Federal Food, Drug and Cosmetic Act.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Specialties Remneex International S.L. % International Medical Products, Corp. Mr. Jeffrey R. Shideman President 7307 Glouchester Drive EDINA MN 55435

OCT 1 2 2012

Re: K062341 Trade/Device Name: MALE REMEEX SYSTEM Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTM Dated: October 6, 2006 Received: October 13, 2006

Dear Mr. Shideman:

This letter corrects our substantially equivalent letter of November 2, 2006.

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/CDRH/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/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Benjamin R. Perkins

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):

Device Name: MALE REMEEX SYSTEM

Indications for Use:

The Male Remeex System is intended to be used as a pubourethral sling for the treatment of male stress urinary incontinence

Prescription Use X
(Part 21 CFR 801 Subpart D)

ﻧﻴ

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)


| (Division Sign-Off) | |
|-----------------------------------|---------|
| Division of General, Restorative, | |
| and Neurological Devices | |
| 510(k) Number | 206234/ |

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CONFIDENTIAL

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