(90 days)
The MTI ST#1 Silicone Pessary is intended for prescription use to be used in the treatment of genuine stress urinary incontinence. It is not intended to be used while sleeping and thus must be removed on a daily basis before going to bed.
The MTI ST#1 Silicone Pessary is geometrically shaped such that when inserted in the patient's vagina, the urethra is aligned between the legs of the device and the bladder is fully supported, thus allowing the bladder to function normally.
The provided text is a 510(k) summary for the MTI ST#1 Silicone Pessary. It doesn't contain the detailed information necessary to answer all the questions regarding acceptance criteria and a study design for evaluating the device's performance in the way typically found for AI/imaging devices.
The document primarily focuses on demonstrating substantial equivalence to predicate devices. This means that instead of presenting novel performance data from an extensive study, the manufacturer is asserting their new device is as safe and effective as devices already on the market, by having similar technological characteristics and intended use.
Here's an attempt to answer your questions based on the available information, noting where data is not present in the document.
Acceptance Criteria and Device Performance
Since this is a substantial equivalence submission for a traditional medical device (not an AI/imaging device), the "acceptance criteria" are primarily related to biocompatibility and functional equivalence to predicate devices rather than specific performance metrics like sensitivity, specificity, or accuracy derived from a clinical efficacy study.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Non-irritating and non-toxic | Data demonstrates the device is nonirritating and nontoxic |
| Intended Use: Treatment of genuine stress urinary incontinence | Performs as intended for this use |
| Technological Characteristics: Similar to predicate devices | Has the same technological characteristics |
| Safety and Effectiveness: Equivalent to predicate devices | Concluded to be safe and effective for its intended use |
| Design: Geometrically shaped for bladder support and urethra alignment | Designed to align urethra and support bladder when inserted |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: The submission does not detail a specific "test set" or clinical study with a sample size for evaluating clinical performance against quantitative metrics. The evaluation relies on "Information on this and similar devices," which suggests a reliance on existing knowledge and biocompatibility testing rather than a new clinical trial for efficacy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided: No clinical ground truth establishment by experts is described in this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: No adjudication method is described as there isn't a specific clinical test set requiring it.
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: This device is a physical medical device (a pessary), not an AI/imaging diagnostic tool. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this type of submission is primarily established through bench testing for biocompatibility and historical performance data on similar, legally marketed predicate devices. The claim is that because the device is technologically similar and biocompatiible, it will perform equivalently to the predicate devices, which are assumed to be safe and effective.
8. The sample size for the training set
- Not Applicable / Not Provided: This device is not an AI/ML model, so there is no training set in the typical sense.
9. How the ground truth for the training set was established
- Not Applicable: As above, there is no training set for an AI/ML model.
Summary of the Study Mentioned in the Document:
The document mentions a "Summary of Device Evaluation" where it states: "Information on this and similar devices demonstrates that the MTI ST#1 Silicone Pessary performs as intended. Biocompatibility data demonstrates that the device is nonirritating and nontoxic."
This indicates that the "study" demonstrating the device meets its (implied) acceptance criteria is based on:
- Biocompatibility testing: To ensure the material is non-irritating and non-toxic. The details of these tests (e.g., specific standards followed, number of samples) are not provided in this summary.
- Comparison to predicate devices: The primary justification is that the device has "the same technological characteristics" as the previously cleared DesChutes Medical Products, Inc. PelvX Incontinence Ring (K974116) and the Milex Silicone Gehrung with Knob Pessary. This comparison, along with general "Information on this and similar devices," serves as the basis for concluding safety and effectiveness, rather than a de novo clinical trial.
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MAY 1 6 2002
510(k) SUMMARY, K020512
Medical Technology & Innovations, Inc.
MTI ST#1 Silicone Pessary
March 14, 2002
Submitter Information:
| Submitter's Name: | Larry W. James, P.A.Senior VV – Research & DevelopmentMedical Technology & Innovations, Inc.1072 N.W. High Point DriveLee's Summit, MO 64081 |
|---|---|
| Phone: | (816) 525-6677 |
| Fax: | (816) 525-8428 |
| Device Name: |
MTI ST#1 Silicone Pessary Proprietary name:
Vaginal pessary Common Name:
Classification Name: Vaginal pessary
Predicate Device Equivalence:
Substantial equivalence is claimed to the DesChutes Medical Products, Inc. Pelvx Incontinence Ring, cleared for commercial distribution per K974116, and to the Milex Silicone Gehrung with Knob Pessary, 510(k) number unknown.
Device Description:
The MTI ST#1 Silicone Pessary is geometrically shaped such that when inserted in the patient's vagina, the urethra is aligned between the legs of the device and the bladder is fully supported, thus allowing the bladder to function normally.
P.
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Intended Use:
The MTI ST#1 Silicone Pessary is intended for prescription use to be used in the treatment of genuine stress urinary incontinence. It is not intended to be used while sleeping and thus must be removed on a daily basis before going to bed.
Device Classification:
Class II, 21 CFR 884.3575, Product Code HHW
Predicate Devices:
DesChutes Medical Products, Inc. PelvX Incontinence Ring, K974116
Milex Silicone Gehrung Folding Pessary, 510(k) number unknown
Comparison of Technological Characteristics:
The MTI ST#1 Silicone Pessary has the same technological characteristics as the predicate devices.
Summary of Device Evaluation:
Information on this and similar devices demonstrates that the MTI ST#1 Silicone Pessary performs as intended. Biocompatibility data demonstrates that the device is nonirritating and nontoxic.
Conclusions:
Based on the above, we concluded that the MTI ST#1 Silicone Pessary is substantially equivalent to a legally marketed predicate device and is safe and effective for its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 6 2002
Larry W. James, P.A. Senior Vice President Research and Development Medical Technology & Innovations. Inc. 3725 Investment RIVIERA BEACH FL 33404
Re: K020512
Trade/Device Name: MTI ST#1 Silicone Pessary Regulation Number: 21 CFR 884.3575 Regulation Name: Vaginal pessary Regulatory Class: II Product Code: 85 HHW Dated: February 14, 2002 Received: February 15, 2002
Dear Mr. James:
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 application (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. Iisting 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
Image /page/2/Picture/11 description: The image shows a partial view of a circular seal or emblem. The words "DEPARTMENT OF HEALTH" are visible, arranged along the curve of the circle. To the right of the text, there is a stylized graphic element, possibly part of a larger design within the seal. The image is in black and white, with the text and graphic elements appearing in solid black against a white background.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Device Name:
MTI ST#1 Silicone Pessary
Indications for Use:
The MTI ST#1 Silicone Pessary is intended for prescription use to be used in the used in the The MTTST#1 Slicone Pessaly is litended in procurption intended to be used while
treatment of genuine stress unnary incontinence. It is not intentional to be used while treatment of genume stress unnary incontinent. In the surfore going to bed.
Prescription Use
Ethel C. Segman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 020512 510(k) Number ________________________________________________________________________________________________________________________________________________________________
§ 884.3575 Vaginal pessary.
(a)
Identification. A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.(b)
Classification. Class II (performance standards).