(189 days)
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Not Found
No
The summary describes a simple urinary catheter and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as a urinary incontinence device designed to drain urine from the bladder, which addresses a physiological condition, but it is not explicitly called a therapeutic device and it does not treat the underlying cause of the incontinence.
No
The device is described as a urinary incontinence device designed to drain urine from the bladder, which is a therapeutic rather than a diagnostic function.
No
The 510(k) summary describes a physical catheter, which is a hardware device, not software.
Based on the provided information, the MMG InstantCath Pre-lubricated Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to drain urine from the bladder, which is a direct interaction with the body for therapeutic or diagnostic purposes in vivo.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. They are performed outside the body.
The MMG InstantCath is a medical device used within the body for a therapeutic purpose (draining urine), not for analyzing a sample outside the body.
N/A
Intended Use / Indications for Use
The MMG InstantCath Pre-lubricated Catheter is intended to be used as a urinary incontinence device designed to drain urine from the bladder.
Product codes
78 GMB
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
bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 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 top half of the circle. Inside the circle is an abstract image of an eagle.
FEB 2 5 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
YOMASA
Re: K973120
Mr. Richard Starke Vice President Medical Technologies of Georgia 5335 Dividend Drive Decatur, GA 30035
INSTANTCATH (Readycath) Catheter Dated: January 27, 1998 Received: February 3, 1998 Regulatory Class: II 21 CFR 876.5130/Procode: 78 GMB
Dear Mr. Starke:
We have reviewed your Section 510(k) notifiestion 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 Current Good Manufacturing Practice requirement, 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 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 marked 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 yitzo diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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/cdrf/dsmamain.hitml".
Sincerely vours.
Willian 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
INTENDED USE
The MMG InstantCath Pre-lubricated Catheter is intended to be used as a urinary incontinence device designed to drain urine from the bladder.
Richard Starke
Vice President, Medical Technologies of Georgia
Robert R Satling/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K973120 510(k) Number_
Prescription Use
(Per 21 CFR 801.109)
(Per 21 CFR 801.109)
Over-the-Counter Use_
ATTACHMENT #5
Dated 1/28/98