(146 days)
No
The device description and intended use focus on a physical pessary for supporting the urethra, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
Yes
The device is intended to treat stress urinary incontinence by supporting the urethra, which is a therapeutic purpose.
No
The device is a pessary designed to physically support the urethra to prevent urine leakage, which is a treatment for stress urinary incontinence, not a diagnostic tool.
No
The device description clearly states it is a "bell-shaped vaginal pessary" made of "medical grade injection moulded Santoprene," which is a physical, hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The uresta™ Pessary is a physical device inserted into the vagina to provide support to the urethra and prevent urine leakage. It does not analyze any biological samples.
- Intended Use: The intended use is to physically manage stress urinary incontinence, not to diagnose or monitor a condition through the analysis of biological specimens.
Therefore, the uresta™ Pessary falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device is for the use in adult women, over 18 years of age who experience involuntary urine loss with physical activity (stress urinary incontinence).
Product codes
HHW
Device Description
The uresta™ Pessary is designed for adult women who experience involuntary urine loss from the most common type of incontinence; stress incontinence, from physical activity such as coughing, laughing and/or exercising.
uresta™ Pessary is a bell-shaped vaginal pessary with a handle at its base for easy insertion and removal (Figure 1).
uresta™ Pessary stops leaking from the bladder by supporting the urethra. The narrow tip allows for easy insertion into the vaginal introitus. It is inserted directly into the vagina like a tampon and seats itself so that the wide base provides support to the urethra. It is made of medical grade injection moulded Santoprene (non-latex thermoplastic rubber).
uresta™ Pessary is available individually in sizes1 (30 mm), 2 (34 mm), 3 (38 mm), 4 (43 mm), 5 (48 mm), 6 (52 mm). The products are sold individually, and as a kit including one each of sizes 3, 4, 5, the most commonly used sizes. After initial fitting, a patient may request to try a different size for maximum benefit. All sizes are available to accommodate patients requiring larger or smaller than average sizes, and for periodic replacements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina, urethra
Indicated Patient Age Range
adult women, over 18 years of age
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Introl Bladder Neck Support Prosthesis, Johnson & Johnson (K930618, K965040), PelvX Incontinence Dish, Deschutes Medical Products Inc. (K990593)
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
OCT 0 9 2008
Revised 510(k) Summary
| Manufacturer Name: | EastMed Inc. |
|---|---|
| Contact Name: | Karen Farrell |
| Title: | VP of Regulatory Affairs, Health Education |
| Postal Address: | 1721 Lower Water Street |
| Halifax, NS B3J 1S5 | |
| Canada | |
| Phone Number: | 902-421-5677 |
| Fax: | 902-421-5695 |
| Email: | kfarrell@eastmed.ca |
| Date Prepared: | September 22, 2008 |
| Proprietary Name: | uresta™ Pessary |
| Common/Usual Name: | Vaginal Pessary |
| Classification Name: | Pessary, Vaginal |
| Classification Code: | HHW |
Predicate Devices
Substantial equivalence is claimed to the following devices as related to intended use, mechanism of action and design characteristics:
- Milex Incontinence Ring, Flexible Pessary, Cooper Surgical .
- Milex Incontinence Ring with Knob and Support, Cooper Surgical .
- Introl Bladder Neck Support Prosthesis, Johnson & Johnson (K930618, K965040) .
- PelvX Incontinence Dish, Deschutes Medical Products Inc. (K990593) .
Description of the Device
The uresta™ Pessary is designed for adult women who experience involuntary urine loss from the most common type of incontinence; stress incontinence, from physical activity such as coughing, laughing and/or exercising.
uresta™ Pessary is a bell-shaped vaginal pessary with a handle at its base for easy insertion and removal (Figure 1).
1
Figure 1: urestaTM pessaries Sizes 3, 4, and 5
Image /page/1/Picture/1 description: The image shows three white, mushroom-shaped objects against a black background. The objects are arranged in a row, with the center object facing directly forward and the other two objects angled slightly to the left and right. The objects appear to be made of a smooth, matte material and have a rounded cap and a short stem. The lighting in the image is soft and diffused, creating subtle shadows that highlight the shape of the objects.
uresta™ Pessary stops leaking from the bladder by supporting the urethra. The narrow tip allows for easy insertion into the vaginal introitus. It is inserted directly into the vagina like a tampon and seats itself so that the wide base provides support to the urethra. It is made of medical grade injection moulded Santoprene (non-latex thermoplastic rubber).
uresta™ Pessary is available individually in sizes1 (30 mm), 2 (34 mm), 3 (38 mm), 4 (43 mm), 5 (48 mm), 6 (52 mm). The products are sold individually, and as a kit including one each of sizes 3, 4, 5, the most commonly used sizes. After initial fitting, a patient may request to try a different size for maximum benefit. All sizes are available to accommodate patients requiring larger or smaller than average sizes, and for periodic replacements.
For proper use (insertion/removal techniques) and maintenance see package insert.
Intended Use of the Device
This device is for the use in adult women, over 18 years of age who experience involuntary urine loss with physical activity (stress urinary incontinence).
Technological Characteristics
The urestaTM Pessary and the predicate devices alleviate stress incontinence by pressure through the anterior vaginal wall onto the urethra.
Conclusion
The uresta™ Pessary is substantially equivalent to the predicate devices in term of functional design, indications of use and principles of operation.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, placed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the circumference of the circle. The logo is black and white.
OCT 0 9 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EastMed, Inc. c/o Shirley Furesz, Ph.D. Senior Regulatory Affairs Associate CanReg Inc. 4 Innovation Drive DUNDAS ON L9H 7P3 CANADA
Re: K081385
Trade Name: Uresta™ Pessary Regulation Number: 21 CFR §884.3575 Regulation Name: Vaginal pessary Regulatory Class: II Product Code: HHW Dated: September 29, 2008 Received: September 30, 2008
Dear Dr. Furesz:
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, 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 such 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.
3
Page 2
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.
This letter will allow you to begin marketing your device as described in your Section 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:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jorgu M. Whang
Joyce M. Whang, Ph.D. Acting Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K 081385 510(k) Number (if known):
Device Name:
Indications for Use:
This device is for the use in adult women, over 18 years of age who experience involuntary urine loss with physical activity (stress urinary incontinence).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Vorzu Martin
Page of of
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Device 510(k) Number