The Remeex System is intended to be used as a pubourethral sling for treatment of female stress urinary incontinence (SUI) resulting from urethral hypomobility or hypermobility and / or intrinsic sphincter deficiency.

Device Description

The REMEEX SYSTEM (EXternal MEchanical REgulation) 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 K033310 ("Specialities Remeex International, s.l. Remeex System") is a 510(k) premarket notification for a medical device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific, pre-defined acceptance criteria through a full clinical trial.

Therefore, the document does not contain the specific information requested in your prompt regarding acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance data.

Here's why and what information can be gleaned:

1. Table of Acceptance Criteria and Reported Device Performance:

Not Applicable. The document explicitly states that "Results of in vitro and clinical evaluations were used to show that the Remeex System functioned as clinically intended. Sufficient data has been gathered from clinical testing to assess that the Remeex System performs as clinically intended." However, it does not provide quantifiable acceptance criteria or a table comparing performance against such criteria. The basis for clearance is substantial equivalence to the predicate device (Ethicon/Gynecare Pubourethral Sling, K974098), implying that if the device performs comparably to the predicate, it is considered safe and effective for its intended use.

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

Not provided. The document mentions "clinical evaluations" and "clinical testing" but does not specify the sample size, design of the study (retrospective or prospective), or the country of origin of the data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable/Not provided. In a 510(k) submission based on substantial equivalence, the concept of "ground truth" established by experts for a test set, in the way it's used for AI/diagnostic device validation, is generally not present. The assessment is usually through clinical outcomes in a comparative study or by demonstrating similar performance to the predicate device.

4. Adjudication Method for the Test Set:

Not applicable/Not provided. Since there's no mention of a diagnostic performance study requiring ground truth establishment, adjudication methods are not discussed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

Not provided. There is no mention of an MRMC study or any assessment of human reader improvement with or without AI assistance. This device is a surgical mesh, not an AI-powered diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical surgical implant, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used:

Not explicitly defined in the context of typical AI/diagnostic device validation. For a surgical device like this, "ground truth" would generally refer to observed clinical outcomes (e.g., resolution of stress urinary incontinence, complication rates) in a clinical evaluation, compared to the predicate device or a recognized standard of care. The document states "Results of in vitro and clinical evaluations were used to show that the Remeex System functioned as clinically intended," implying clinical outcomes were assessed, but the specifics are not detailed.

8. The Sample Size for the Training Set:

Not applicable/Not provided. This device is not an AI algorithm that requires a training set.

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

Not applicable/Not provided. As there is no AI algorithm or training set, this information is not relevant.

Summary based on the document:

The 510(k) submission for the Remeex System relies on demonstrating substantial equivalence to a predicate device (Ethicon/Gynecare Pubourethral Sling, K974098). The claim of substantial equivalence is supported by:

Technological Characteristics: Both the new device and the predicate device are described as "meshes that provide pubourethral support" and utilize accessories for surgical procedures, with no differences raising new questions of safety and effectiveness.
Performance Data: The document states that "Results of in vitro and clinical evaluations were used to show that the Remeex System functioned as clinically intended" and "Sufficient data has been gathered from clinical testing to assess that the Remeex System performs as clinically intended." However, specific quantitative data, sample sizes, or detailed methodology for these evaluations are not included in the provided excerpts.

The document does not provide the detailed information requested in your prompt regarding acceptance criteria tables, specific sample sizes for test/training sets, expert qualifications, or adjudication methods, as these are typically required for different types of device submissions (e.g., new technology requiring de novo classification or devices with AI components).

Summary

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K03310 Rh

JAN 1 5 2004

510K(k) SUMMARY

SUBMITTER:	Specialities Remeex International, s.l.55 Trende BaixTerrassa Barcelona, Spain 08223
DATE PREPARED:	September 10th 2002
DEVICE NAME:	Specialities Remeex International, s.l.Remeex System
CLASSIFICATION NAMES:	Mesh, Surgical, Polymeric
PREDICATE DEVICE:	Ethicon/Gynecare Pubourethral Sling

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) Document Number	Date Cleared	Indications
Gynecare/ Ethicon Pubourethral Sling	K974098	January 28th, 1998	Urinary 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.

Intended Use:

CONFIDENTIAL

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K033310
510K Notification
Remcex System

Intended Use:

REMEEX SYSTEM Indications:

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 Remeex System functioned as clinically intended. Sufficient data has been gathered from clinical testing to assess that the Remeex System performs as clinically intended

Conclusions:

Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the modified 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 eagle or bird-like figure with three heads, suggesting a sense of unity or collaboration. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle.

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

Specialities Remeex International, s.l. % Dr. Jeffrey R. Shideman President International Medical Products Corporation 7307 Glouchester Drive EDINA MN 55435

SEP 28 2012

Re: K033310

Trade/Device Name: Specialities Remeex International, s.l. Remeex System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: December 15, 2003 Received: December 24, 2003

Dear Dr. Shideman:

This letter corrects our substantially equivalent letter of January 15, 2004.

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 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/ResourcesforYou/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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K0333/0
510K Notification
Remecx System

Indications for Use:

Specialities Remeex International, s.l. Remeex System

REMEEX SYSTEM Indications:

Prescription Use
(Part 21 CFR 801 Subpart D) ✓

AND/OR

Over-The-Counter Use _____________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

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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.