(40 days)
Not Found
Not Found
No
The provided text does not mention AI, ML, or any related concepts like image processing, deep neural networks (DNNs), or descriptions of training/test sets typically associated with AI/ML development. The device description focuses on pelvic floor stimulation and EMG assessment, which are standard functionalities for this type of device.
Yes
The device is used for treatment of urinary incontinence, which is a therapeutic purpose.
Yes
The device is indicated for "assessment of EMG activity of the pelvic floor muscles," which is a diagnostic function.
No
The device description is not found, but the intended use explicitly mentions a "Skylark Uro Probe" and "pelvic floor stimulation," which strongly suggests a hardware component is involved for stimulation and EMG activity assessment.
Based on the provided information, the Skylark Uro Probe is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "pelvic floor stimulation use in the treatment of urinary incontinence and allows assessment of EMG activity of the pelvic floor muscles." This describes a device used on the patient's body for therapeutic and diagnostic purposes related to muscle function.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health.
The Skylark Uro Probe interacts directly with the patient's body (pelvic floor) and measures electrical activity (EMG) in vivo, not in a lab setting using a specimen.
N/A
Intended Use / Indications for Use
The Skylark Uro Probe is indicated for pelvic floor stimulation use in the treatment of urinary incontinence and allows assessment of EMG activity of the pelvic floor muscles.
Product codes
KPI
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor
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/1 description: The image shows a logo with a stylized bird in flight. The bird is composed of three curved lines that suggest feathers or wings. To the left of the bird, there is text arranged in a circular fashion, likely the name of an organization or department. The text is oriented vertically, following the curve of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 5 2005
2005
George Chang, Ph.D. President Skylark Device & Systems Co., LTD 4th Fl., No. 34, Sec. 3 Chung Shan North Rd. Taipei TAIWAN 104
Re: K053007
Trade/Device Name: Skylark Uro Probe Regulation Number: 21 CFR §876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: II Product Code: KPI Dated: September 15, 2005 Received: October 27, 2005
Dear Dr. Chang:
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 (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 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.
1
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to ough mattering of substantial equivalence of your device to a legally prematication. The I Dri mailig of online of our 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 11 you desire specific advice for your of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, proase note togetting there), formation on your responsibilities under the Act from the 001:37). I od may oodlin only golder 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/industry/support/index.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
2
Indications for Use
510(k) Number (if known): Kos 3_007
Device Name: Skylark Uro Probe
Indications for Use:
The Skylark Uro Probe is indicated for pelvic floor stimulation use in the treatment of urinary incontinence and allows assessment of EMG activity of the pelvic floor muscles.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE D() NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page __ of
Nancy Britton
(Posted November 13, 2003)
and Radiological Devi 510(k) Number