(63 days)
Not Found
Not Found
No
The summary describes a standard medical device (Foley catheter) and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is a Foley catheter, intended for drainage of fluid, which is a diagnostic or supportive function, not a therapeutic treatment.
No
The device is described as a Foley catheter, intended for fluid drainage from the urinary tract. This is a therapeutic or supportive function, not a diagnostic one that identifies the nature or cause of a disease.
No
The device description clearly identifies it as a "Foley Catheter," which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "drainage of fluids to, and from, the urinary tract." This describes a device used within the body for a physiological function (drainage), not a device used outside the body to examine specimens derived from the body for diagnostic purposes.
- Device Description: The description is a "Foley Catheter," which is a medical device used for urinary drainage, not for in vitro testing.
- Lack of IVD Indicators: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
- Performing tests in a laboratory setting
Therefore, the AMSure 100% Silicone Foley Catheter is a medical device used for therapeutic/physiological purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AMSure 100% Silicone Foley Catheter is intended for use in the drainage of fluids to, and from, the urinary tract.
Product codes
78 EZL
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract
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
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/1 description: The image shows a logo of the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF" is stacked vertically on the left side of the eagle, and "HEALTH & HUMAN SERVICES" is stacked vertically on the right side of the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville"MD 20850
JUN 2 8 2005
Ching Ching Seah, Ph.D. Director of Research and Development Amsino International, Inc. 855 Towne Center Drive POMONA CA 91767
RE: K051059
Trade/Device Name: AmSure 100% Silicone Foley Catheter Regulation Number: 21 CFR § 876.5130 Regulation Name: Urological catheter and accessories
Regulatory Class: II Product Code: 78 EZL Dated: June 14, 2005 Received: June 17, 2005
Dear Dr. Seah:
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 the choosed, to e enactment date of the Medical Device Amendments, or to devices that have been May 20, 1710, the sharantinent 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 do inot roquier appreval controls provisions of the Act. The general controls provisions of the Act action in the generate 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 It your de roo is excelled to such additional controls. Existing major regulations affecting your Apple rar, the 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 I loase or advisod 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 r carreres and registrating, 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) (2) Crice 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 mis letter will anow you to ought tuding of substantial equivalence of your device to a legally prematice notification: "The PDF mailig sification 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 If you desire specific acrise to your an 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, prodoc note the regulation on your responsibilities under the Act from the 607.97). " Ou may oount varers, 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. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Amsino International. Inc. 855 Fowne Center Driver ............ 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 2011 11
AMSINO
Tel (909) 626-5888 Fax (909) 626-90006 Toll Free 1-800-63-am-mo mail and million of any and too thank me a low
K051059
Page 5 of 8
Indications for Use Statement
510(k) Number: (if known)
AMSure 100% Silicone Foley Catheter Device Name:
Indications The AMSure 100% Silicone Foley Catheter is intended for use in the drainage of fluids to, and from, the urinary tract for Use:
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801. 109) OR
Over-The-Counter Use
Nancy C. Hogdon
(Divisiok Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K051059