(208 days)
To be used as a pubourethral sling for the treatment of female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
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.
This is a 510(k) premarket notification for a medical device called "Gyne Ideas Minitape RP™", which is a polymeric surgical mesh intended for use as a pubourethral sling for the treatment of female urinary incontinence.
The provided text only contains a 510(k) summary and the FDA's clearance letter. It does not contain a study that proves the device meets specific acceptance criteria in the way a clinical trial report or a detailed testing protocol would. The 510(k) process is about demonstrating substantial equivalence to a legally marketed predicate device, not necessarily proving efficacy through extensive clinical studies with specific performance metrics against pre-defined acceptance criteria, especially for Class II devices.
Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted from this document because it is not present. The document focuses on device description, intended use, and comparison to predicate devices, along with some general mentions of testing.
Here's a breakdown of what can be extracted and what information is not provided:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as quantifiable acceptance criteria with numerical targets. The closest is the general statement about testing ensuring "adequate restraint of urethral tissue under conditions in excess of those encountered during normal clinical use."
- Reported Device Performance: No specific numerical performance metrics are reported in this summary.
| Acceptance Criteria (Not explicitly stated in numerical terms within this document) | Reported Device Performance (No specific numerical data provided in this document) |
|---|---|
| Ability to adequately restrain urethral tissue under conditions in excess of normal clinical use. | "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." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing is described generally as "in-vitro and in-vivo testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The document makes no mention of experts or how ground truth was established for "in-vivo" studies, if they were clinical. Given the nature of a 510(k) for a surgical mesh, the "in-vivo" testing might refer to animal studies or biomechanical testing, rather than human clinical trials with expert assessment, though this is not clear.
4. Adjudication method for the test set
- This information is not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No, an MRMC comparative effectiveness study was not done or at least not reported in this 510(k) summary. This type of study is typically for diagnostic imaging devices involving multiple human readers interpreting cases. This device is a surgical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device is a physical surgical mesh, not an algorithm or AI.
7. The type of ground truth used
- The document implies that the "testing" (in-vitro and in-vivo) would have objective measures related to tissue restraint. However, the specific "type of ground truth" (e.g., pathology, direct measurement of tissue support, clinical outcomes) for the "in-vivo" component is not detailed.
8. The sample size for the training set
- This question is not applicable as the device is a physical surgical mesh, not an AI or algorithm that requires a training set.
9. How the ground truth for the training set was established
- This question is not applicable for the same reason as above.
Summary of Device and Testing (from the provided text):
- Device: Gyne Ideas Minitape RP™, a polypropylene sling with integral serrated anchoring arms, 14cm long, supplied with two metal needles, 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."
- Predicate Devices: Several previously cleared surgical mesh devices are listed, indicating the substantial equivalence pathway for this submission.
The 510(k) summary focuses on demonstrating that the device is substantially equivalent to existing legally marketed devices, rather than presenting a detailed clinical study with quantifiable performance metrics against specific acceptance criteria. For many Class II devices cleared via 510(k), extensive clinical trial data with predefined acceptance criteria and detailed reporting of expert involvement might not be required, especially if performance can be established through bench testing and comparison to predicates.
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JUN 1 8 2003
Gyne Ideas Ltd. 510(k) Notification
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510(k) SUMMARY OF SAFETY & EFFECTIVENESS
| SUBMITTER | Gyne Ideas, Ltd.West of Scotland Science ParkGlasgow, 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) |
| DEVICEDESCRIPTION | The device consists of a polypropylene sling with integralserrated anchoring arms. The sling has an overall length of14cm. It is supplied with two metal needles to aid in surgicalplacement of the device. The device is supplied sterile. |
| INTENDED USE | To be used as a pubourethral sling for the treatment offemale urinary incontinence resulting from urethralhypermobility and/or intrinsic sphincter deficiency. |
| TESTING | The device has been subjected to in-vitro and in-vivo testingwhich demonstrate the ability of the device to adequatelyrestrain urethral tissue under conditions in excess of thoseencountered 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
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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 (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™
§ 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.