(93 days)
Not Found
No
The description focuses on a mechanical system for adjusting a pubourethral sling and does not mention any AI or ML components.
Yes
The device is described as a pubourethral sling for the treatment of female stress urinary incontinence, indicating a therapeutic purpose.
No.
The device description and intended use clearly state that the Remeex System is a pubourethral sling for the treatment of stress urinary incontinence. It is a therapy device used to mechanically regulate continence, not to diagnose a condition.
No
The device description clearly outlines hardware components including a pubourethral sling, traction threads, and a prosthesis, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "pubourethral sling for treatment of female stress urinary incontinence (SUI)". This describes a surgical implant used to physically support the urethra, not a test performed on biological samples to diagnose a condition.
- Device Description: The description details a physical system of a sling, traction threads, and a prosthesis. This is a mechanical device, not a reagent, instrument, or system intended for in vitro examination of specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests in a lab setting, or providing diagnostic information based on the results of such tests.
Therefore, the Remeex System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
OTN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra, bladder neck, abdominal rectus muscle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K03310 Rh
JAN 1 5 2004
510K(k) SUMMARY
| SUBMITTER: | Specialities Remeex International, s.l.
55 Trende Baix
Terrassa 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:
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.
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
1
K033310
510K Notification
Remcex System
Intended Use:
REMEEX SYSTEM Indications:
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.
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.
000195
2
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
3
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
4
K0333/0
510K Notification
Remecx System
Indications for Use:
Specialities Remeex International, s.l. Remeex System
REMEEX SYSTEM Indications:
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.
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
Page 1 of
.(k) Number Kc 33.3/0...
000199