(61 days)
No
The device description and performance studies focus on the physical properties and mechanical function of a surgical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is a urethral sling used for the surgical treatment of female urinary stress incontinence.
No
The device is a surgical sling used for treatment, not for diagnosing conditions.
No
The device description clearly states it is a "totally disposable tape mesh" made of "polypropylene tape with integral fixation zones," indicating it is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
- Device Description: The Minitape Urethral Sling is a surgical implant made of polypropylene tape and mesh. It is designed to be surgically placed inside the body to support the urethra.
- Intended Use: The intended use is the surgical treatment of urinary stress incontinence. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
The information provided clearly describes a surgical implant used for treatment, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The Minitape* Urethral Sling is indicated for the surgical treatment of urodynamically proven female urinary stress incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Product codes
PAH
Device Description
The subject device is a totally disposable tape mesh intended to be used as a pubourethral sling for the treatment of female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. It consists of a polypropylene tape with integral fixation zones on either side of a central mesh sling. These fixation zones at the ends of the tape anchor the sling to surrounding soft tissues.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The device has been subjected to in-vitro and in-vivo testing which demonstrate the ability of the device to adequately restrain urethral tissue under conditions in excess of those encountered during normal clinical use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K023898 - Minitape RPTM Urethral Sling (Mpathy Medical Devices), K020007 - SAFYRE Sling (Corniche, LLC), K021263 - SPARC Sling System (American Medical Systems)
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.
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MPATHY MEDICAL. DEVICES. LTD. MODIFIED MINITAPE* URETHRAI . SLING ·SPECIAL 510(K) NOTIFICATION
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
FEE 25 20CC
| SUBMITTER | Mpathy Medical Devices Ltd.
Glasgow - United Kingdom |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON | Louis J. Mazzarese
U.S. Agent for Mpathy Medical Devices Ltd |
| DATE PREPARED | December 18, 2007 |
| CLASSIFICATION | Surgical Mesh; ref. 21 CFR 878.3300
Class II |
| COMMON NAME | Urethral Sling |
| PROPRIETARY
NAME | Modified Minitape* Urethral Sling |
| PREDICATE DEVICE | K023898 - Minitape RPTM Urethral Sling (Mpathy Medical
Devices)
K020007 - SAFYRE Sling (Corniche, LLC)
K021263 - SPARC Sling System (American Medical
Systems) |
| DEVICE
DESCRIPTION | The subject device is a totally disposable tape mesh intended
to be used as a pubourethral sling for the treatment of female
urinary incontinence resulting from urethral hypermobility
and/or intrinsic sphincter deficiency. It consists of a
polypropylene tape with integral fixation zones on either side
of a central mesh sling. These fixation zones at the ends of
the tape anchor the sling to surrounding soft tissues. |
| TESTING | The device has been subjected to in-vitro and in-vivo testing
which demonstrate the ability of the device to adequately
restrain urethral tissue under conditions in excess of those
encountered during normal clinical use. |
- FINAL TRADEMARK NAME TO BE DETERMINED
PAGE 23 OF 34
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Image /page/1/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 or bird in flight, composed of three curved lines that suggest the wings and body. The bird is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mpathy Medical Devices, Ltd. % Mr. Louis J. Mazzarese 24 Barberry Lane MADISON CT 06443
SEP 2 8 2012
K073646 Re: Trade/Device Name: Modified Minitape* Urethral Sling Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAH Dated: February 11, 2008 Received: February 13, 2008
Dear Mr. Mazzarese:
This letter corrects our substantially equivalent letter of February 25, 2008.
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
2
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 (OS) 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.
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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MPATHY MEDICAL DEVICES, LTD. Modified Minitape* Urethral Sling SPECIAL 510(K) NOTIFICATION
STATEMENT FOR INDICATIONS FOR USE
K073646 510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: Modified Minitape* Urethral Sling
Indications for Use: The Minitape* Urethral Sling is indicated for the surgical treatment of urodynamically proven female urinary stress incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Prescription Use: Yes
DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number 11073642