(289 days)
The AMSure Foley Catheter is intended for use in the drainage of fluids to, and from, the urinary tract
Not Found
Here's an analysis of the provided text regarding the Amsure™ Foley Catheter (K030120) and the request for information on acceptance criteria and a supporting study.
Based on the provided FDA 510(k) clearance letter (K030120), no information is available about specific acceptance criteria or an associated study proving the device meets those criteria.
The 510(k) clearance process does not typically require clinical trials or performance studies with acceptance criteria in the same way a PMA (Pre-Market Approval) does. Instead, a 510(k) submission demonstrates "substantial equivalence" to a legally marketed predicate device. This means the new device has the same intended use and the same technological characteristics as the predicate, or has different technological characteristics but does not raise different questions of safety and effectiveness, and the information submitted demonstrates that the device is as safe and effective as the legally marketed device.
Therefore, the document does not contain the information you've requested regarding acceptance criteria and a study to prove they are met. The FDA letter is a confirmation of clearance based on the substantial equivalence determination.
To answer your questions as best as possible given the provided limitations:
1. A table of acceptance criteria and the reported device performance
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Acceptance Criteria for Substantial Equivalence (General, not specific to device performance):
- Same intended use as predicate: Yes, stated as "drainage of fluids to, and from, the urinary tract," which is a common intended use for Foley catheters.
- Same technological characteristics as predicate, or different technological characteristics that do not raise different questions of safety and effectiveness: This would have been demonstrated in the 510(k) submission, but the letter does not detail these characteristics or how they compare.
- As safe and effective as predicate: Assumed to be met through comparison of technological characteristics and any performance data submitted.
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Reported Device Performance: Not detailed in this document. The 510(k) summary (not provided here) would likely contain this information, referring to performance data (e.g., biocompatibility testing, sterility, dimensional conformity, mechanical integrity) submitted to demonstrate equivalence to the predicate.
2. Sample size used for the test set and the data provenance
- Not applicable for this 510(k) clearance. The letter indicates clearance based on substantial equivalence to a predicate, not on a specific clinical performance study with a test set. Design validation and verification testing (e.g., bench testing) would have been performed, but details are not in this FDA letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable for this 510(k) clearance. No clinical test set with expert-established ground truth is mentioned.
4. Adjudication method for the test set
- Not applicable for this 510(k) clearance.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable for this 510(k) clearance. This device is a Foley catheter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable for this 510(k) clearance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for this 510(k) clearance. The "ground truth" for a 510(k) device generally refers to its ability to meet design specifications and perform reliably for its intended use, typically assessed through engineering and bench testing, and comparison to a predicate, rather than clinical ground truth from patient data.
8. The sample size for the training set
- Not applicable for this 510(k) clearance. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable for this 510(k) clearance.
In summary: The provided document is an FDA 510(k) clearance letter for a medical device (Foley catheter). This type of clearance primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing details of independent clinical studies with specific acceptance criteria, ground truth, or statistical analyses of AI performance. Such detailed performance data and acceptance criteria would typically be found in the 510(k) summary document from the manufacturer or within the comprehensive submission provided to the FDA, neither of which is present here.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is a stylized image of an eagle.
Public Health Service
OCT 2 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Ching Ching Seah Director of Research Development and Regulatory Affairs Amsino International, Inc.. 4501 Brickell-Privado ONTARIO CA 91761
RE: K030120 Trade/Device Name: AMSure™ Foley Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 EZL Dated: August 1, 2003 Received: August 6, 2003
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 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 (PMA), it may be subject to 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.
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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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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K030120
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Indications for Use Statement
510(k) Number: (if known)
Device Name:
AMSure Foley Catheter
The AMSure Foley Catheter is intended for use in the drainage of Indications 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 ﺮ (Per 21 CFR 801. 109) OR
Over-The-Counter Use
David A. Seyram
Division of Reproduct and Radiological D
510(k) Number
§ 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.