(206 days)
The CathAssist™ Female Urinary Catheter Insertion Accessory is used to assist routine adult female urethral catheterization in both hospital and office settings. Some of the clinical situations in which female catheterization is indicated include:
- Major surgery;
- Urinary retention;
- Collection of a sterile "cath" urine specimen;
- Bladder irrigation; and
- Labor and Delivery.
The CathAssist™ Female Urinary Catheter Insertion Accessory is intended for use by: - Nurses and caregivers in the rapid and easy insertion of a female urinary catheter;
- By adult females who are required to perform intermittent self catheterization following surgery; and
- By adult females required to self-catheterize and who have motor or visual disabilities.
Not Found
The provided FDA letter does not contain the detailed information necessary to fully address all parts of your request regarding acceptance criteria and a study proving device performance for the "CathAssist" device. The letter is a 510(k) clearance document, which confirms substantial equivalence to a predicate device but does not typically include a detailed performance study summary or specific acceptance criteria met by the device itself, beyond the general understanding that it functions as intended for its stated indications for use.
Based only on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
This information is not available in the provided document. The 510(k) letter confirms clearance based on substantial equivalence, but it does not detail specific acceptance criteria (e.g., success rates, complication rates) established for the CathAssist device itself, nor does it report the device's performance against such criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not available in the provided document. The letter does not describe any specific test set or clinical study conducted for the CathAssist device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not available in the provided document. No test set or related ground truth establishment is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not available in the provided document.
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
Given that "CathAssist" is described as a "Female Urinary Catheter Insertion Accessory" and not an AI-powered diagnostic imaging device, it is highly unlikely that an MRMC comparative effectiveness study involving human readers (like radiologists) and AI assistance would have been conducted or would be relevant. This information is not available and not applicable given the device type.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not applicable to a physical medical device like a catheter insertion accessory. There is no "algorithm only" performance for such a device. This information is not available.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not available in the provided document.
8. The sample size for the training set
This information is not available in the provided document. No training set is described.
9. How the ground truth for the training set was established
This information is not available in the provided document. No training set or ground truth establishment is described.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAY 2 4 2006
Physician Technologies, Inc. % Mr. Randall May Principal Consultant Randall May Consulting 4932 East Holbrook Street ANAHEIM CA 92807
Re: K052952
Trade/Device Name: CathAssist Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: KNY Dated: April 26, 2006 Received: April 28, 2006
Dear Mr. May:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Docuren by of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the encready to region date of the Medical Device Amendments, or to devices that provision in way 26, 1970, and characters with the provisions of the Federal Food, Drug, and Cosmetic have been roomasinou in a premarket 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 controls provisions or allabeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is elassinod (500 as 11) atitional controls. Existing major regulations affecting your Applo rar, tt fits) '60 objector 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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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 vours.
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
K052952 510(k) Number:
CathAssist™ Female Urinary Catheter Insertion Accessory Device Name:
Insertion Catheter Urinary CathAssist™ Female Indications for Use: The Accessory is used to assist routine adult female urethral catheterization in both hospital and office settings. Some of the clinical situations in which female catheterization is indicated include:
-
- Major surgery;
-
- Urinary retention;
-
- Collection of a sterile "cath" urine specimen;
-
- Bladder irrigation; and
-
- Labor and Delivery.
Insertion CathAssist™ Urinary Catheter Female The Accessory is intended for use by:
-
- Nurses and caregivers in the rapid and easy insertion of a female urinary catheter;
-
- By adult females who are required to perform intermittent self catheterization following surgery; and
-
- By adult females required to self-catheterize and who have motor or visual disabilities.
Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Thompson
Division Sign-Off
and Radiological Dev 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.