(75 days)
Not Found
No
The description focuses on a mechanical valve for controlling urine flow and does not mention any computational or data-driven features indicative of AI/ML.
Yes
The device is described as "management of urinary drainage" and to "temporarily control the flow of urine from the bladder" for "bladder conditioning, diagnostic procedures or patient comfort," which are therapeutic applications.
No
The device description states "Temporary control of urine may be desired for bladder conditioning, diagnostic procedures or patient comfort." While it mentions "diagnostic procedures," the device itself is described as a valve to control urine flow, not to obtain or process diagnostic information. Its function is to manage drainage, not to diagnose a condition.
No
The device description clearly states it is a "CareVent valve" which is inserted into a Foley catheter, indicating a physical, hardware component.
Based on the provided information, the CareVent device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "management of urinary drainage" with a Foley catheter. This is a mechanical function related to controlling the flow of urine, not for diagnosing a condition or analyzing a sample in vitro (outside the body).
- Device Description: The description focuses on the physical mechanism of the valve to control urine flow. It doesn't mention any analysis of urine or other biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are typically used to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The CareVent's function is purely mechanical and related to managing the physical flow of urine.
N/A
Intended Use / Indications for Use
The CareVent is intended for use with a Foley Urinary Catheter for the management of urinary drainage.
Product codes (comma separated list FDA assigned to the subject device)
KNY
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 continuous drainage or manually operated for temporarily closure. The device is provided sterile and for single patient use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician/user
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Product testing was conducted to evaluate conformance to product specification. Testing included general operation, valve operation, and fluid leak. All testing was successful.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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
1
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.
2
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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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)
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