(28 days)
Not Found
No
The summary describes a surgical sling and associated tools, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended for the treatment of stress urinary incontinence, which is a therapeutic purpose.
No
Explanation: The device description states that the 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 female urinary stress incontinence. This indicates it is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a kit consisting of physical components like a sling, handles, and needles, indicating it is a hardware 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 that the device is 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". This describes a surgical implant used within the body to treat a medical condition.
- Device Description: The description details a physical implant (sling) and surgical tools (needles, handles). This is consistent with a surgical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition in vitro (outside the living organism).
IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device is a therapeutic implant.
N/A
Intended Use / 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.
Product codes
FTL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sub-urethral
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)
Mechanical tests. biocompatibility tests in compliance with ISO 10993 and chemical tests.
Three studies on this surgical technique and three anatomical studies.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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:
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.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with stylized wings.
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
2
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
3
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