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.

AI/ML Overview

The provided text does not contain information about specific acceptance criteria or a study that rigorously proves the device meets those criteria with statistical measures. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against predefined acceptance criteria.

However, based on the provided text, here’s an attempt to extract relevant information and note what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Clinical Performance for Intended Use	Not explicitly stated in terms of specific thresholds (e.g., success rate, continence improvement).	"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."
Safety	Not explicitly stated in terms of specific adverse event rates or complication rates.	Implied by "Any differences between the two devices do not raise new questions of safety and effectiveness."
Technological Equivalence	To be "the same" as the predicate device.	"Technologically, both the new device and the predicate device are the same (i.e. both are meshes that provide pubourethral support) and are indicated for the treatment of urinary incontinence."

Missing Information Regarding Acceptance Criteria and Performance:

No quantitative acceptance criteria are defined for clinical outcomes (e.g., success rate, reduction in leakage, quality of life improvement).
No specific performance metrics are reported from the clinical evaluations. The statements are general affirmations of function.

Study Details:

The provided document highlights that "Results of in vitro and clinical evaluations were used to show that the Male Remeex System functioned as clinically intended." However, it does not provide granular details about these studies. Therefore, much of the requested information is not available in the given text.

2. Sample Size for the Test Set and Data Provenance:

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). It only mentions "clinical evaluations."

3. Number of Experts and Qualifications for Ground Truth:

Not specified. The document does not detail how the results of the "clinical evaluations" were formally assessed or how ground truth for clinical intended function was established by experts.

4. Adjudication Method:

Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This type of study (comparing human readers with and without AI assistance) is not applicable to this medical device, which is a physical surgical implant (a pubourethral sling), not an AI diagnostic or image analysis tool.

6. Standalone (Algorithm Only) Performance Study:

No. This is not an AI algorithm but a physical medical device.

7. Type of Ground Truth Used:

Implicitly, the "clinical evaluations" would have relied on clinical outcomes data related to urinary continence, subjective patient reports, and potentially objective measures associated with the sling's function. However, the specific methodology for establishing "ground truth" (e.g., through physical examination by urologists, patient diaries, objective stress tests) is not detailed.

8. Sample Size for the Training Set:

Not applicable/Not specified. This device is a physical product, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable.

Summary

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K062341
510K Notification
Remcex System
Page 1/2

510K(k) SUMMARY

SUBMITTER:	Specialities Remeex International, s.l.55 Trende BaixTerrassa 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:

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)DocumentNumber	Date Cleared	Indications
REMEEX SYSTEM	K033310	1/15/2004	UrinaryIncontinence

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 (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. 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)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

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

Page 1 of 1
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CONFIDENTIAL

000174

Regulation Number and Section

§ 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.