(68 days)
The Minitape* Extra 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 totally disposable mesh tape 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 monocomponent polypropylene tape with integral fixation zones on either side of a central sling. These fixation zones at the ends of the tape anchor the sling to surrounding soft tissues.
The provided text is a 510(k) summary for the Minitape* Extra Urethral Sling, a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. While it mentions "in-vitro and in-vivo testing which demonstrate the ability of the device to adequately restrain urethral tissue," it does not provide detailed information about acceptance criteria or specific study results in the format requested.
Here's why and what information is missing:
- 510(k) Summaries vs. Detailed Study Reports: A 510(k) summary is a high-level overview. It typically asserts that a device meets performance requirements based on testing but does not usually include the granular details of test protocols, acceptance criteria, sample sizes, or specific performance metrics in the way a full study report or journal publication would.
- Focus on Substantial Equivalence: The primary goal of a 510(k) is to demonstrate substantial equivalence to a predicate device, not necessarily to prove absolute safety and effectiveness through extensive, detailed clinical trials with specified acceptance criteria as might be seen for a PMA (Premarket Approval) application.
Therefore, much of the requested information is not present in the provided text.
Based on the available text, here's what can be inferred or explicitly stated:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred/General) | Reported Device Performance |
|---|---|
| Ability to adequately restrain urethral tissue | Demonstrated ability to adequately restrain urethral tissue |
| Performance under conditions in excess of normal clinical use | Demonstrated performance under conditions in excess of those encountered during normal clinical use |
| Substantial equivalence to predicate devices (K023898, K020007, K021263) | The FDA determined the device is substantially equivalent to the listed predicate devices |
- Note: The specific, quantitative acceptance criteria are not provided in this summary. The performance is broadly stated as "adequately restrain urethral tissue" and "under conditions in excess of those encountered during normal clinical use." Substantial equivalence is the overarching acceptance criterion for a 510(k).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for in-vitro or in-vivo testing.
- Data Provenance: Not specified.
- Retrospective or Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not provided. The testing described (in-vitro, in-vivo) would typically involve laboratory or animal models, not human experts establishing ground truth in the context of diagnoses or classifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable and not provided. This typically relates to expert consensus in medical image analysis or similar diagnostic studies, which is not the nature of the testing described for this device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable and not provided. The device is a surgical sling, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable and not provided. The device is a physical surgical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the "in-vitro" testing, ground truth would likely be defined by engineering specifications, material properties, and mechanical performance measurements against established standards.
- For the "in-vivo" testing, ground truth would likely be based on physiological or histological assessments in animal models (e.g., tissue response, integration, stability).
- Specifics are not provided.
8. The sample size for the training set
- Not applicable and not provided. The device testing described involves in-vitro and in-vivo (likely animal) studies, not a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable. (See point 8)
Summary of what the document does tell us about the study:
- Study Type: The device was subjected to "in-vitro and in-vivo testing."
- Purpose of Study: To "demonstrate the ability of the device to adequately restrain urethral tissue under conditions in excess of those encountered during normal clinical use."
- Outcome: The FDA determined the device to be "substantially equivalent" to predicate devices, implying that the testing supported this equivalence claim. However, the specific data that led to this conclusion is not in the summary.
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MPATHY MEDICAL. DEVICES, LTD. MINITAPE* EXTRA URETHRAL SLING SPECIAL 510(K) NOTIFICATION
MAR - 3 2008
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
| SUBMITTER | Mpathy Medical Devices, Ltd.Glasgow - United Kingdom |
|---|---|
| CONTACT PERSON | Louis J. MazzareseU.S. Agent for Mpathy Medical Devices Ltd |
| DATE PREPARED | December 18, 2007 |
| CLASSIFICATION | Surgical Mesh; ref. 21 CFR 878.3300Class II |
| COMMON NAME | Urethral Sling |
| PROPRIETARYNAME | Minitape* Extra Urethral Sling |
| PREDICATE DEVICE | K023898 - Minitape RP™ Urethral Sling (Mpathy MedicalDevices)K020007 - SAFYRE Sling (Corniche, LLC)K021263 - SPARC Sling System (American MedicalSystems) |
| DEVICEDESCRIPTION | The subject device is a totally disposable mesh tape intendedto be used as a pubourethral sling for the treatment of femaleurinary incontinence resulting from urethral hypermobilityand/or intrinsic sphincter deficiency. It consists of amonocomponent polypropylene tape with integral fixationzones on either side of a central sling. These fixation zonesat the ends of the tape anchor the sling to surrounding softtissues. |
| 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 Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Louis J. Mazzarese U.S. Agent for Mpathy Medical Devices, Ltd. Mpathy Medical Devices, Ltd. 24 Barberry Lane MADISON CT 06443
SEP 2 8 2012
K073647 Re: Trade/Device Name: Modified Minitape* Extra Urethral Sling Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: February 11, 2008 Received: February 13, 2008
Dear Mr. Mazzarese:
This letter corrects our substantially equivalent letter of March 3, 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
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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/CDRH0ffices/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. Weeks
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* EXTRA URETHRAL SLING SPECIAL 510(K) NOTIFICATION
STATEMENT FOR INDICATIONS FOR USE
510(k) Number:
Device Name: Minitape* Extra Urethral Sling
Indications for Use: The Minitape* Extra 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
Mark A. Millikin
Restorative, and Neurolog 510(k) Number
- FINAL TRADEMARK NAME TO BE DETERMINED
PAGE 20 OF 35
§ 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.