(75 days)
The CareVent is intended for use with a Foley Urinary Catheter for the management of urinary drainage.
The CareVent device is used with a Foley catheter for the management of urinary drainage. The CareVent offers the physician/user a means to temporarily control the flow of urine from the bladder. Temporary control of urine may be desired for bladder conditioning, diagnostic procedures or patient comfort. The CareVent valve is easily inserted into the distal end of a Foley catheter and may be left open for continuous drainage or manually operated for temporarily closure. The device is provided sterile and for single patient use.
The provided 510(k) summary for the CareVent device does not contain the detailed information requested for acceptance criteria and the study proving it meets those criteria. The document is a regulatory submission for premarket notification, not a full study report.
Here's a breakdown of what is and is not in the document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The document mentions "conformance to product specification" but doesn't define those specifications.
- Reported Device Performance:
- Qualitative: "All testing was successful."
- Specific tests mentioned: "general operation, valve operation, and fluid leak." No quantitative results (e.g., specific leak rates, operational pressures, durability cycles) are provided.
2. Sample size used for the test set and the data provenance
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective). It's implied the testing was conducted in-house by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the testing described ("general operation, valve operation, and fluid leak") does not involve expert interpretation or ground truth establishment in the clinical sense. These are engineering/performance verification tests.
4. Adjudication method for the test set
- Not applicable as no expert adjudication was involved.
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. This device is a mechanical component (a valve for a Foley catheter), not an AI-powered diagnostic or decision-support system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is a mechanical device, not an algorithm.
7. The type of ground truth used
- Not applicable in the clinical sense. The "ground truth" for the tests performed would be adherence to internal engineering specifications for general operation, valve function, and absence of fluid leaks.
8. The sample size for the training set
- Not applicable as this is a mechanical device, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable.
Summary of Information from the Document:
| Category | Information from Document |
|---|---|
| Acceptance Criteria & Device Performance | |
| Acceptance Criteria: | Not explicitly defined with quantifiable metrics. Stated as "conformance to product specification." |
| Reported Device Performance: | "All testing was successful." Specific tests included "general operation, valve operation, and fluid leak." No quantitative results or specific performance values are provided. |
| Study Details | |
| Sample Size (Test Set): | Not mentioned. |
| Data Provenance (Test Set): | Not mentioned (implied in-house testing). |
| Number of Experts & Qualifications (Ground Truth - Test Set): | Not applicable (testing involved device function, not expert interpretation). |
| Adjudication Method (Test Set): | Not applicable. |
| MRMC Comparative Effectiveness Study: | Not applicable (mechanical device, not AI). |
| Standalone Performance (Algorithm Only): | Not applicable (mechanical device). |
| Type of Ground Truth Used (Clinical Context): | Not applicable for the described tests (ground truth relates to engineering specifications for functionality). |
| Sample Size (Training Set): | Not applicable (mechanical device). |
| How Ground Truth for Training Set was Established: | Not applicable. |
| Overall Study Description: | "Product testing was conducted to evaluate conformance to product specification. Testing included general operation, valve operation, and fluid leak. All testing was successful." This indicates internal verification/validation, not a clinical study. |
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K06 2240
OCT 16 2006
510(k) Summary
General Information
Classification
Class II
Trade Name
CareVent
Submitter
Chief Medical LLC P.O. Box 772 105 Pioneer Lane Teton Village, WY. 83025
Contact
Scott Horn President
Intended Use
The CareVent is intended for use with a Foley Urinary Catheter for the management of urinary drainage.
Predicate Devices
K041983 Option-vm Urinary Catheter Opticon Medical, Inc.
- AMSURE 100% Silicone Foley Catheter K051059 Amsino International, Inc.
Device Description
The CareVent device is used with a Foley catheter for the management of urinary drainage. The CareVent offers the physician/user a means to temporarily control the flow of urine from the bladder. Temporary control of urine may be desired for bladder conditioning, diagnostic procedures or patient comfort. The CareVent valve is easily inserted into the distal end of a Foley catheter and may be left open for
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continuous drainage or manually operated for temporarily closure. The device is provided sterile and for single patient use.
Materials
All materials used in the manufacture of the CareVent are suitable for this use and have been used in numerous previously cleared products.
Testing
Product testing was conducted to evaluate conformance to product specification. Testing included general operation, valve operation, and fluid leak. All testing was successful.
Summary of Substantial Equivalence
The CareVent is equivalent to the predicate products. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like extensions. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure. The logo is black and white.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
OCT 1 & 2006
Chief Medical Devices, LLC c/o Mr. Scott D. Horn P.O. Box 772 105 Pioneer Lane TETON VILLAGE WY 83025
Re: K062240
Trade/Device Name: CareVent Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: KNY Dated: July 26, 2006 Received: August 2, 2006
Dear Mr. Horn:
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.
Image /page/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. In the center of the logo is the acronym "FDA" in a bold, stylized font. Below the acronym is the word "Centennial" in a cursive font. There are three stars below the word "Centennial". The text "A Century of Protecting Your Health" surrounds the central elements of the logo.
Promoting Public H
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Page 2 -
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.xxx . | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
NancyCbrogdon
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):
This application K062240
Device Name:
CareVent
Indications for Use:
The CareVent is intended for use with a Foley Urinary Catheter for the management of urinary drainage.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
& that's a valid JSON.
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number _
Over-The-Counter Use (Optional Format 1-2-96)
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.