(314 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.
Yes
The device, a Foley Catheter, is inserted into the body to facilitate the passage of fluid, which is a therapeutic action.
No
The device, a Foley Catheter, is intended for fluid passage from/to the urinary tract, which is a therapeutic or supportive function, not for diagnosing a condition.
No
The device description explicitly states "Urological 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 describes the device being inserted into the body (urethra to bladder) to manage fluid flow. This is a direct interaction with the patient's anatomy for therapeutic or diagnostic purposes within the body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health.
The description clearly indicates an in-vivo (within the body) application, not an in-vitro (outside the body) diagnostic test.
N/A
Intended Use / Indications for Use
VitalCare's Foley Catheter are intended to be inserted through the urethra to the bladder and utilized for passage of fluid from/to the urinary tract.
Product codes
78 EZL
Device Description
Urological Foley Catheter
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra, bladder, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Kendall Foley Catheter
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
APR 2 2 2003
Ko2/939
510(k) Summary
| Submitter: | VitalCare
15800 NW 13th Avenue
Miami Fl. 33169 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Michael McAvenia
Director of Quality Assurance
(305) 620-4007
Fax: (305) 620-5220
Internet: michaelm@vitalcare.com |
| Name of Device: | VitalCare Foley Catheter |
| Predicate Device: | Kendall Foley Catheter |
| Description of the New Device: | Urological Foley Catheter |
Intended Use of the New Device:
VitalCare's Foley Catheter are intended to be inserted through the urethra to the bladder and utilized for passage of fluid from/to the urinary tract.
Comparison of the Technological Features of the New Device and Predicate Device: The new device features and predicate features are similar. The pouch and contents of the pouch are simiļar.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing right, with three curved lines above them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 2003
Mr. Michael McAvenia Director of Quality Assurance Vital Care, Inc. 15800 NW 13th Avenue MIAMI FL 33169
Re: K021939 Trade/DeviceName: VitalCare Urethral
Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories
Regulatory Class: II Product Code: 78 EZL Dated: February 25, 2003 Received: February 27, 2003
Dear Mr. McAvenia:
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.
2
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
3
INDICATIONS FOR USE
510(k) Number:
Device Name:
VitalCare Foley Catheter
Indications for Use:
VitalCare's Foley Catheters are intended to be inserted through the urethra to the bladder and utilized for passage of fluid from /to the urinary tract.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
David A. Legman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number