(70 days)
Not Found
No
The device description and intended use clearly describe a physical medical device (vaginal pessaries) made of silicone, with no mention of software, algorithms, or any computational components that would suggest the use of AI or ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used to treat conditions such as uterine prolapse," which indicates a therapeutic purpose.
No
The device, a vaginal pessary, is described as a "removable structure placed in the vagina to support the pelvic organs." Its intended use is to treat conditions like uterine prolapse, not to diagnose them.
No
The device description explicitly states that the devices are "manufactured from medical grade silicone elastomers," indicating they are physical objects, not software.
No, this device 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The provided description clearly states that this device is a "vaginal pessary," which is a "removable structure placed in the vagina to support the pelvic organs." It is a physical device used to provide mechanical support.
- Lack of Diagnostic Testing: The description does not mention any testing of biological samples or any diagnostic function. Its purpose is purely therapeutic and supportive.
The information provided focuses on the physical characteristics of the pessary, its intended use for supporting pelvic organs, and the specific conditions it treats through physical support. This aligns with the definition of a medical device used for treatment or support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
The specific indications for use by pessary style are as follows:
Donut Pessary: Support of third degree prolapse, cystocele and rectocele.
Ring Pessary: Support of first or mild degree prolapse. Ring Pessary with support can also be used on an accompanying cystocele.
Dish Pessary: Control of stress urinary incontinence and minor degrees of prolapse.
Oval Pessary: Support of first or second degree prolapse and cystocyle.
Shaatz Pessary: Support of first or mild second degree prolapse and cystocele.
Mar-Land Pessary: Control of stress urinary incontinence and minor degrees of prolapse.
Hodge Pessary: Support of first to second degree prolapse, uterine retroversion or incompetent cervix, stress urinary incontinence.
Gehrung Pessary: Support of cystocele and rectocele, support of second to third degree prolapse.
Gellhorn Pessary: Support of second to third degree prolapse or procidentia.
Cube Pessary: Support of third degree prolapse, procidentia, cystocele, and rectocele.
Fitting Set: Used to determine the proper size of pessary for each patient.
Product codes
85 HHW
Device Description
Mentor EvaCare™ Vaginal Pessaries are manufactured from medical grade silicone elastomers and are available in the following styles:
- Cube Pessarv
- Dish Pessary
- Gellhorn Pessary
- Ring Pessary
- Mar-Land Pessary
- Hodge Pessary
- Oval Pessary
- Gehrung Pessary
- Fitting Set
- Cube Pessary with Drainage
- Dish Pessary with Support
- Gellhorn Pessary with Drainage
- Ring Pessary with Support
- Mar-Land Pessary with Support t
- Hodge Pessary with Support
- Shaatz Pessary
- Donut Pessary
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina, pelvic organs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Mentor has previously performed biocompatibility testing on the pessary component materials.
Key Metrics
Not Found
Predicate Device(s)
K904026, K974117, K974116, K974115, K920747, K920187
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
DEC 1 3 1999
Mentor EvaCare™ Pessary 510(k) Notification
510(k) SUMMARY Mentor EvaCare™ Vaginal Pessaries
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92
The assigned 510(k) number is: K993308
Donna A. Crawford Contact Person: Manager, Corporate Regulatory Affairs Mentor Corporation 201 Mentor Drive Santa Barbara, CA 93111
- Telephone: (805) 879-6304 (805) 681-6004 FAX:
Date Prepared: September 30, 1999
Device Name and Classification:
| Proprietary Name: | Mentor EvaCare™ Vaginal Pessaries |
|---|---|
| Common Name: | Vaginal Pessary |
| Classification Name: | Vaginal Pessary |
| Classification: | Class II (21 CFR § 884.3575) |
| Product Code: | 85 HHW |
Manufacturer:
Mentor Urology 1615 West River Road North Minneapolis, MN 55411
1
510(k) SUMMARY Mentor EvaCare™ Vaginal Pessaries
Substantial Equivalence Claim:
Mentor EvaCare™ Vaginal Pessaries are substantially equivalent to preamendment devices and pessaries manufactured by:
- Milex Products, Inc. ● Inflat-o-Ball K904026
- . DesChutes Medical Products, Inc.
- Bioteque America, Inc. . Pessary Flexible Silicone Donut Ring K920747 Flexible Silicone Gellhorn K920187
Device Description:
Mentor EvaCare™ Vaginal Pessaries are manufactured from medical grade silicone elastomers and are available in the following styles:
- Cube Pessarv ●
- Dish Pessary ●
- Gellhorn Pessary ●
- Ring Pessary . ●
- Mar-Land Pessary .
- . Hodge Pessary
- Oval Pessary .
- Gehrung Pessary ●
- Fitting Set .
- . Cube Pessary with Drainage
- Dish Pessary with Support ●
- Gellhorn Pessary with Drainage ●
- Ring Pessary with Support ●
- Mar-Land Pessary with Support t
- . Hodge Pessary with Support
- Shaatz Pessary -.
- Donut Pessary ، .
Indications For Use:
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.
The specific indications for use by pessary style are as follows:
Donut Pessary: Support of third degree prolapse, cystocele and rectocele.
2
- Support of first or mild degree prolapse. Ring Pessary with Ring Pessary: support can also be used on an accompanying cystocele.
- Dish Pessary: Control of stress urinary incontinence and minor degrees of prolapse.
- Oval Pessary: Support of first or second degree prolapse and cystocyle.
- Shaatz Pessary: Support of first or mild second degree prolapse and cystocele.
- Mar-Land Pessary: Control of stress urinary incontinence and minor degrees of prolapse.
- Hodge Pessary: Support of first to second degree prolapse, uterine retroversion or incompetent cervix, stress urinary incontinence.
- Gehrung Pessary: Support of cystocele and rectocele, support of second to third degree prolapse.
- Gellhorn Pessary: Support of second to third degree prolapse or procidentia.
- Cube Pessary: Support of third degree prolapse, procidentia, cystocele, and rectocele.
- Fitting Set: Used to determine the proper size of pessary for each patient
Summary of Testing:
Mentor has previously performed biocompatibility testing on the pessary component materials.
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 1999
Ms. Donna A. Crawford Manager, Corporate Requlatory Affairs MENTOR Corporation 201 Mentor Drive Santa Barbara, CA 93111
Re: K993308 Mentor EvaCare™ Vaginal Pessaries Dated: October 25, 1999 Received: November 23, 1999 Regulatory Class: II 21 CFR 884.3575/Procode: 85 HHW
Dear Ms. Crawford:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls of the Act include requirements for annual registration, ilsting 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 requiation entitled. "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K 9g 3308
Mentor EvaCare™ Vaginal Pessary (various styles) Device Name:
Indications For Use:
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.
Please refer to the attached page for a listing of indications for use for each pessary style.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, | |
| and Radiological Devices | |
| 510(k) Number | K993308/5001 |
Prescription Use (Per 21 CFR 801.109)
OR Over the Counter Use
(Optional Format 1-2-96)
5
INDICATIONS FOR USE
- Donut Pessary: Support of third degree prolapse, cystocele and rectocele.
- Ring Pessary: Support of first or second degree prolapse. Ring with support can also be used on an accompanying cystocele.
- Dish Pessary: Control of stress urinary incontinence and support of minor degrees of prolapse.
- Oval Pessary: Support of first or second degree prolapse and accompanying cystocyle.
- Shaatz Pessary: Support of first or second degree prolapse and accompanying cystocyle.
- Mar-Land Pessary: Control of stress urinary incontinence and support of minor degrees of prolapse.
- Hodge Pessary: Support of first to second degree prolapse, a cystocele, stress urinary incontinence and an incompetent cervix or uterine retroversion..
- Gehrung Pessary: Support of cystocele and rectocele, as well as support of second to third degree prolapse.
- Gellhorn Pessary: Support of second to third degree prolapse or procidentia.
- Cube Pessary: Support of third degree prolapse, procidentia, cystocele, and rectocele.
- Fitting Set: Used to determine the proper size of pessary for each patient.