(208 days)
Not Found
No
The device description and performance studies focus on the physical properties and surgical placement of a mesh sling, with no mention of AI/ML technologies or data-driven analysis.
Yes
The device is described as a 'pubourethral sling' used for 'treatment of female urinary incontinence', which directly indicates a therapeutic purpose.
No
The device description clearly states its purpose is a "pubourethral sling for the treatment of female urinary incontinence," indicating it is a therapeutic implantable device, not one for diagnosis.
No
The device description clearly states it is a physical polypropylene sling with integral anchoring arms and is supplied with metal needles, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states the device is a "pubourethral sling" made of polypropylene with anchoring arms and needles for surgical placement. This is a surgically implanted device used to physically support the urethra.
- Intended Use: The intended use is for the "treatment of female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency." This is a therapeutic use, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, performing tests on bodily fluids, or providing diagnostic information.
The device is a surgical implant used for treatment, not a diagnostic tool used to analyze samples.
N/A
Intended Use / Indications for Use
To be used as a pubourethral sling for the treatment of female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Product codes (comma separated list FDA assigned to the subject device)
PAH
Device Description
The device consists of a polypropylene sling with integral serrated anchoring arms. The sling has an overall length of 14cm. It is supplied with two metal needles to aid in surgical placement of the device. The device is supplied sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethral
Indicated Patient Age Range
female
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K974098, K010553, K020007, K020110, K020652, K020705, K021263
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
JUN 1 8 2003
Gyne Ideas Ltd. 510(k) Notification
Image /page/0/Picture/2 description: The image shows a handwritten string of characters. The string appears to be "K023898". The characters are written in a bold, dark font, and the image is in black and white. The characters are slightly uneven and have a handwritten appearance.
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
| SUBMITTER | Gyne Ideas, Ltd.
West of Scotland Science Park
Glasgow, U.K. |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON | Louis J. Mazzarese
(U.S. Agent for GyneIdeas, Ltd.) |
| DATE PREPARED | November 20, 2002 |
| CLASSIFICATION | Polymeric Surgical Mesh |
| COMMON NAME | Urethral Sling |
| PROPRIETARY NAME | Gyne Ideas Minitape RP™ |
| PREDICATE DEVICES | K974098 - Tension Free Vaginal Tape (TVT) System
(Ethicon, Inc.)
K010553 - Biosling (Injetx, Inc.)
K020007 - SAFYRE Sling (Corniche, LLC)
K020110 - Surgical Mesh (Boston Scientific)
K020652 - T-Sling (Herniamesh USA, Inc.)
K020705 - SiiS#1 Tissue Suspension System (T.A.G.
Medical Products, Ltd.)
K021263 - SPARC Sling System (American Medical Systems) |
| DEVICE
DESCRIPTION | The device consists of a polypropylene sling with integral
serrated anchoring arms. The sling has an overall length of
14cm. It is supplied with two metal needles to aid in surgical
placement of the device. The device is supplied sterile. |
| INTENDED USE | To be used as a pubourethral sling for the treatment of
female urinary incontinence resulting from urethral
hypermobility and/or intrinsic sphincter deficiency. |
| 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. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure composed of three human profiles facing to the right. The profiles are stacked on top of each other, creating the shape of the bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Louis J. Mazzarese Gyne Ideas, Ltd. 150 Aran Hill Road FAIRFIELD CT 06824-1712
SEP 28 2012
Re: K023898 Trade/Device Name: Gyne Ideas Minitape RPTM Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAH Dated: April 4, 2003 Received: April 7, 2003
Dear Mr. Mazzarese:
This letter corrects our substantially equivalent letter of June 18, 2003.
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 (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/ReportalProblem/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. Krebs
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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ψ23898
Gyne Ideas Ltd. 510(k) Notification
STATEMENT FOR INDICATIONS FOR USE
The subject device is intended to be used as a pubourethral sling for the treatment
and the subject the first for the blogs and chility and/or intrinsin of female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Muriam C. Provost
Division Sign-Off
vision of General, Restorative and Neurological Devices
510(k) Number K023898
Gyne Ideas Minitape RP™