(90 days)
No
The summary describes a physical, non-electronic device (a pessary) and makes no mention of software, algorithms, or any terms related to AI/ML.
Yes
The device is described as "intended for prescription use to be used in the treatment of genuine stress urinary incontinence," which indicates a therapeutic purpose.
No
Explanation: The device is intended for treatment of stress urinary incontinence by supporting the bladder, not for diagnosis.
No
The device description clearly states it is a "Silicone Pessary," which is a physical, non-software medical device.
Based on the provided information, the MTI ST#1 Silicone Pessary is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The MTI ST#1 Silicone Pessary is a physical device inserted into the vagina to provide structural support for the bladder and urethra. It does not perform any tests on bodily samples.
- Intended Use: The intended use is for the treatment of stress urinary incontinence through physical support, not through analysis of biological samples.
Therefore, the MTI ST#1 Silicone Pessary falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
HHW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescription use
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K974116, Milex Silicone Gehrung with Knob Pessary, 510(k) number unknown
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 & Development
Medical Technology & Innovations, Inc.
1072 N.W. High Point Drive
Lee'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.
1
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.
2
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.
3
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
4
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 ________________________________________________________________________________________________________________________________________________________________