(211 days)
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Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML technology.
Yes
The device is used for "Treating urinary incontinence by way of re-education and stimulation" and "therapy in the Treatment of urinary Incontinence," which clearly indicates a therapeutic purpose.
No
Explanation: The device is described as treating urinary incontinence through re-education and stimulation, with the probes applying electrical stimulation for therapy. This indicates a therapeutic function rather than a diagnostic one.
No
The device description explicitly mentions "Vaginal Probe Models 3AT2B and TP2B," which are hardware components used for biofeedback and stimulation. The intended use also describes "non-implanted electrical Stimulation applied to the pelvic floor musculature," indicating a physical device is involved.
Based on the provided information, 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.
- Device Function: The UROSTYM™ Biofeedback and Stimulation Probes are used for treating urinary incontinence through electrical stimulation and biofeedback applied directly to the pelvic floor musculature. This is a therapeutic intervention, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly states "Treating urinary incontinence" and "therapy in the Treatment of urinary Incontinence."
Therefore, the UROSTYM™ Biofeedback and Stimulation Probes are a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The UROSTYM™ Biofeedback and Stimulation Probes are for use in Treating urinary incontinence by way of muscle re-education and stimulation. The UROSTYM™ provides non-implanted electrical Stimulation applied via the vaginal probe to the pelvic floor musculature and surrounding Pelvic Structures for therapy in the Treatment of urinary Incontinence. The probes are provided for single patient use/disposable. These non-sterile probes are for office use under the direction of a physcian or licensed health care professional.
Product codes
78 KPI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
pelvic floor musculature and surrounding Pelvic Structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
office use under the direction of a physcian or licensed health care professional
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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
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§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three horizontal lines above it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 5 1999
Mr. Dale Coleman, MS, CQE, RAC Regulatory Affairs Manager Laborie Medical Technologies Corp. 310 Hurricane Lane #2 Williston. VT 05495-2070
Re: K990041
UROSTYM™ Biofeedback and Stimulation Device - Vaginal Probe Models 3AT2B and TP2B Dated: June 17, 1999 Received: June 18, 1999 Regulatory Class: II 21 CFR §876.5320/Procode: 78 KPI
Dear Mr. Coleman:
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 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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), piease 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 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/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
1
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NUMBER (IF KNOWN) : K 9900 4 | 510 (k) NAME: UROSTYM™ Dioteed back and INDICATIONS FOR USE:
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use
(Per 21 CFR 801.109)
Over - The - Counter - Use (Optional Format 1-2-96
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(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
Division of Reproductive, Abdominal, EN and Radiological Device, 510(k) Number