(82 days)
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.
The subject device is a surgical mesh. The proprietary mesh is supplied along with ancillary tools for placement of the device (convenience kit). The kit consists of: Minitape Urethral Sling (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; Disposable needle introducers, optionally used to aid in placement of the Minitape mesh; Polydioxanone absorbable sutures (CP Medical; Portland, OR), used to secure the mesh in place; Polypropylene suture bolsters (Ethicon Inc.; Sommerville, NJ), optionally used to aid in tightening ("snugging") the mesh following surgical placement.
This 510(k) summary (K091180) describes the Minitape Urethral Sling. However, the provided document does not contain acceptance criteria for device performance nor a detailed study that proves the device meets such criteria in terms of clinical effectiveness or specific quantitative measures.
Instead, it focuses on demonstrating substantial equivalence to predicate devices, primarily mentioning "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." This is a qualitative statement about the type of testing performed, not a report of results against specific performance metrics.
Therefore, many of the requested details cannot be extracted from the provided text.
Here is an attempt to address the points based only on the provided information, noting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The document states "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." This is a general statement about the testing's purpose, not a set of measurable criteria or quantitative results. | The document does not provide specific quantitative results or metrics for device performance (e.g., success rates, complication rates, force measurements). It only states that the testing demonstrated the device's ability to "adequately restrain urethral tissue." |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified in the provided document.
- Data Provenance: Not specified in the provided document. The document mentions "in-vitro and in-vivo testing," but does not give details on the origin, nature (retrospective/prospective), or location of data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set
- Adjudication method: Not specified.
5. Multi-reader multi-case (MRMC) comparative effectiveness study
- MRMC Study: No, an MRMC comparative effectiveness study is not mentioned or described in the provided document. The device is a surgical mesh, and the testing described is related to its mechanical properties and biological interaction, not to image interpretation or AI assistance for human readers.
- Effect Size of Human Readers with AI vs. without AI: Not applicable, as no MRMC study or AI component is mentioned.
6. Standalone (algorithm only without human-in-the-loop performance) study
- Standalone Study: Not applicable. This device is a surgical mesh; there is no algorithm or AI component described that would have a standalone performance. The testing mentioned (in-vitro, in-vivo) refers to the physical device itself.
7. Type of ground truth used
- Type of Ground Truth: Not explicitly stated in the context of specific performance metrics or clinical outcomes. The testing broadly "demonstrate[s] the ability of the device to adequately restrain urethral tissue." For "in-vivo" testing, this implies observation of physiological outcomes or biomechanical responses, but the method of establishing a definitive "ground truth" for success or adequate restraint is not detailed. For "in-vitro" testing, ground truth would likely be based on engineering measurements (e.g., tensile strength, elasticity).
8. Sample size for the training set
- Sample Size (Training Set): Not applicable, as there is no mention of an algorithm or AI requiring a training set. The device is a physical surgical implant.
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not applicable, as there is no mention of an algorithm or AI requiring a training set.
Summary of Missing Information:
The provided 510(k) summary document for the Minitape Urethral Sling primarily focuses on establishing substantial equivalence to predicate devices and generally describing the types of testing performed. It explicitly states: "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."
However, it does not provide any specific quantitative acceptance criteria or detailed results from these tests, nor does it describe specific study methodologies (like sample sizes, expert involvement, or adjudication) that would be typically found for performance studies. This is often the case in 510(k) summaries where the detailed test reports are part of the full submission but not included in this public summary.
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pg. 1 of 2
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17. 510(k) SUMMARY OF SAFETY & EFFECTIVENESS
:
| SUBMITTER | Ms Melissa PeloquinDirector of Office AdministrationMpathy Medical Devices Inc.175 Paramount DriveRaynham, MA 02767 | JUL 1 4 2009 |
|---|---|---|
| CONTACT PERSON | Dr Caroline StrettonQuality & Regulatory Affairs DirectorMpathy Medical Devices, Ltd.208 Wright Business CentreLonmay RoadGlasgow G33 4EL (United Kingdom) | |
| DATE PREPARED | 15 April 2009 | |
| CLASSIFICATION | Surgical Mesh; ref. 21 CFR 878.3300Product Code PAHClass II | |
| COMMON NAME | Surgical mesh | |
| PROPRIETARYNAME | Minitape® Urethral Sling | |
| PREDICATE DEVICE | K073646 - Modified Minitape Urethral Sling (MpathyMedical Devices)K020007 - SAFYRE Sling (Corniche, LLC)K033310 - Remeex System (Remeex)K011251, K013355, K021263 & K020663 - SPARCSling System (American Medical Systems)K052401 - TVT® Secur (Gynecare)K073703 - MiniArc® (American Medical Systems). | |
| DEVICEDESCRIPTION | The subject device is a surgical mesh. Theproprietary mesh is supplied along with ancillary toolsfor placement of the device (convenience kit). The kitconsists of: Minitape Urethral Sling (mesh) intendedto be used as a pubourethral sling for the treatmentof female urinary incontinence resulting from urethralhypermobility and/or intrinsic sphincter deficiency;Disposable needle introducers, optionally used to aidin placement of the Minitape mesh; Polydioxanoneabsorbable sutures (CP Medical; Portland, OR), usedto secure the mesh in place; Polypropylene suturebolsters (Ethicon Inc.; Sommerville, NJ), optionallyused to aid in tightening ("snugging") the meshfollowing surgical placement. |
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K091180
pg. 2 of 2
Minitape® Urethral Sling is indicated for the surgical INDICATIONS treatment of urodynamically proven female urinary stress incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. Minitape® Urethral Sling has the same intended use, TECHNOLOGICAL general design, material and fundamental scientific CHARACTERISTICS
technology as the predicate Modified Minitape Urethral Sling device, with the exception of a shorter overall sling length.
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/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings spread and head facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MPathy Medical Devices, Ltd. % Dr. Caroline Stretton Quality & Regulatory Affairs Director 208 Wright Business Centre Lonmay Road Glasgow G33 4EL United Kingdom
SEP 2 8 2012
Re: K091180
Trade/Device Name: Minitape Urethral Sling Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAH Dated: July 1, 2009 Received: July 8, 2009
Dear Dr. Stretton:
This letter corrects our substantially equivalent letter of July 14, 2009.
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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin R. Rooks
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. MINITAPE URETHSAL SLING SPECIAL 510(K) NOTIFICATION
- STATEMENT FOR INDICATIONS FOR USE
510(k) Number:
Device Name: Minitape Urethral Sling
Indications for Use: 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
Concurrence of CDRH, Office of Device Evaluation
Daniel Kramer for MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091180
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§ 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.