(315 days)
The SunMed Foley Catheter is used to drain fluids to and from the urinary tract.
The catheters are comprised of a 2 lumen shaft with proximal funnel, inflation valve and distal retaining balloon. One lumen is for draining fuleds to and from the urinary tract. The second lumen is to inflate and deflate the balloon. On models with a third lumen, it is used in conjunction with the first lumen for flushing the urinary tract. The balloon fill volumes in ml and shaft size in French Gauge (Fr), Charriere (Ch) or millimeter (mm) are indicated on the funnel of each individual cathter and the distal tip type can be indicated on the individual pack label and / or outer carton. Sizes range from 6 to 30 Ch / Fr.
The provided text describes a 510(k) submission for the SunMed Foley Catheter, which is a medical device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for clinical studies that establish acceptance criteria for an AI/algorithm-driven device.
Therefore, the input does not contain the information necessary to answer the questions about acceptance criteria and a study proving device performance as typically understood for AI/algorithm devices.
Specifically, the document discusses:
- Intended Use: Draining fluids to and from the urinary tract.
- Product Description: Two-lumen shaft with proximal funnel, inflation valve, and distal retaining balloon.
- Predicate Device: Rusch Silicon Coated Foley Catheter (K980870).
- Substantial Equivalence: Claimed due to equivalent intended use, manufacturing materials, operating principles, and physical, operational, and biological specifications.
There is no mention of an AI/algorithm, performance metrics, acceptance criteria, test sets, ground truth establishment, expert adjudication, or MRMC comparative effectiveness studies.
In summary, the provided document relates to a traditional medical device (Foley catheter) and does not include the details required to answer your specific questions, which are geared towards the evaluation of AI/algorithm-driven medical devices.
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KO 62//2
510(K) SUMMARY (as required by 807.92(c))
JUN - 4 2007
| Submitter of 510(k): | SunMed12393 Belcher Road, #450Largo, FL 33773 USA | |
|---|---|---|
| Phone: | 800-433-2797 | |
| Fax: | 800-671-7988 | |
| Contact Person: | Barry Wall | |
| Date of Summary: | May 10, 2006 | |
| Trade/Proprietary Name: | SunMed Foley Catheter | |
| Classification Name: | Catheter, retention type, balloon | |
| Product Code: | EZL | |
| Intended Use: | The SunMed Foley Catheter is used to drain fluids to andfrom the urinary tract |
Product Description:
The catheters are comprised of a 2 lumen shaft with proximal funnel, inflation valve and distal retaining balloon. One lumen is for draining fuleds to and from the urinary tract. The second lumen is to inflate and deflate the balloon. On models with a third lumen, it is used in conjunction with the first lumen for flushing the urinary tract. The balloon fill volumes in ml and shaft size in French Gauge (Fr), Charriere (Ch) or millimeter (mm) are indicated on the funnel of each individual cathter and the distal tip type can be indicated on the individual pack label and / or outer carton. Sizes range from 6 to 30 Ch / Fr.
| Predicate Device: | Rusch Silicon Coated Foley Catheter – K980870 |
|---|---|
| ------------------- | ----------------------------------------------- |
Substantial Equivalence:
SunMed claims the proposed device to be substantially equivalent to the device previously cleared by FDA in K980870. SunMed claims this equivalence because the proposed device has an equivalent intended use, manufacturing materials, operating principles, and physical, operational and biological specification as compared to the predicate devices. A description of the similarities and differences is located in Section 9 of this submission.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 symbol of three human figures connected by flowing lines.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUN - 4 2007
SunMed. Inc. c/o Mr. Arthur J. Ward AJW Technology Consultants, Inc. 962 Allegro Lane APOLLO BEACH FL 33572
Re: K062112
Trade/Device Name: SunMed Foley Catheters Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: May 23, 2007 Received: May 29, 2007
Dear Mr. Ward;
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.
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Protecting and Promoting Public Health
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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.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 807.97). 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 (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
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Indications for Use
510(k) Number (if known): 062-112
Device Name: SunMed Foley Catheter
Indications for Use:
The SunMed Foley Catheter is used to drain fluids to and from the urinary tract.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
helentlessen
Division Sign-Off Division of Reproductive, Abdominal, and Radiological Device 510(k) Number.
Page 1 of 1
§ 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.