(363 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and intended use do not suggest AI/ML capabilities.
Yes
The device is intended for treating urinary incontinence through perineal reeducation, biofeedback, and electro-stimulation therapy, which are all therapeutic modalities.
No
The "Intended Use / Indications for Use" states the device is used for "treating urinary incontinence" and can be used for "performing biofeedback and electro-stimulation therapy as treatment modalities." This indicates a therapeutic, rather than diagnostic, function. While it uses biofeedback, which involves gathering data, the primary stated purpose is treatment.
No
The device description explicitly states "UROSTYM™ Biofeedback and Stimulation Device," indicating it includes hardware components for biofeedback and electro-stimulation therapy, not just software.
Based on the provided information, the Laborie UROSTYM™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for treating urinary incontinence through perineal reeducation using biofeedback and electro-stimulation. This is a therapeutic treatment applied directly to the patient's body.
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological or pathological state, or to monitor therapeutic measures. The UROSTYM™ does not involve the analysis of such specimens.
- Device Description: The description "Biofeedback and Stimulation Device" aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD-related information: The provided text lacks any mention of specimen collection, analysis, or diagnostic purposes.
Therefore, the Laborie UROSTYM™ is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Laborie UROSTYM™ is intended to be used in treating urinary incontinence (stress incontinence (hypermobility) and bladder instability) by way of perineal reeducation. Using the available accessories, the system can be used for performing biofeedback and electro-stimulation therapy as treatment modalities for urinary incontinence.
Product codes
78 KPI, 85 HIR
Device Description
UROSTYM™ Biofeedback and Stimulation Device
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
perineal
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5320 Nonimplanted electrical continence device.
(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a serif font. The text is black and the background is white.
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine and healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
20 1997 MAY
Mr. Thomas G. Hirte Regulatory Affairs Manager Laborie Medical Technologies Corporation -6 Hurricane Lane Williston, Vermont 05495
Re: K962009
UROSTYM™ Biofeedback and Stimulation Device Dated: March 24, 1997 . ... --Received: March 27, 1997 Regulatory class: II 21 CFR §876.5320/Product code: 78 KPI 21 CFR §884.1425/Product code: 85 HIR
Dear Mr. Hirte:
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 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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) 594-4616. 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 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/dsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat/ and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
Page 1 of 1
(Optional Format 1-2-96)
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
UROSTYM™ Biofeedback and Stimulation Device Device Name: . . .
Indications For Use:
CHICH THE CHILIP CONTINE
The Laborie UROSTYM™ is intended to be used in treating urinary incontinence (stress incontinence (hypermobility) and bladder instability) by way of perineal reeducation. Using the available accessories, the system can be used for performing biofeedback and electro-stimulation therapy as treatment modalities for urinary incontinence.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Robert R Salling (Division Sign-Off) | |
|---|---|
| -- | ----------------------------------------------------------- |
Division of Reproductive, Abdominal, ENT, and Radiological Devices
| 510(k) Number | K962009 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109) | ✓ OR Over-The-Counter Use _____ |
|---|---|
| --------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------- |