(314 days)
VitalCare's Urethral Catheters are intended to be inserted through the urethra to the bladder and utilized for passage of fluid from/to the urinary tract.
Urological Urethral Catheter
The provided text describes a 510(k) premarket notification for a medical device called the "VitalCare Urethral Catheter." It focuses on the regulatory approval process and states that the device is substantially equivalent to a predicate device.
However, the document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria in terms of performance metrics, clinical outcomes, or specific technical specifications with quantitative results.
The information provided only covers:
- Device Identification: VitalCare Urethral Catheter.
- Intended Use: "intended to be inserted through the urethra to the bladder and utilized for passage of fluid from/to the urinary tract."
- Predicate Device: Kendall Urethral Catheter.
- Comparison of Technical Features: States "The new device features and predicate features are similar. The pouch and contents of the pouch are similar."
- Regulatory Determination: Substantial Equivalence to the predicate device.
Therefore, I cannot provide the requested table or detailed information on acceptance criteria and a study to prove they are met because this information is not present in the provided text.
The document is a regulatory approval letter based on "substantial equivalence," meaning that the FDA found the new device to be as safe and effective as a legally marketed predicate device. This type of review often relies on demonstrating similarity in materials, design, intended use, and manufacturing processes, rather than presenting new clinical study data with specific performance metrics against pre-defined acceptance criteria.
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APR 2 2 2003
K021938
| Submitter: | VitalCare15800 NW 13th AvenueMiami Fl. 33169 |
|---|---|
| Contact: | Michael McAveniaDirector of Quality Assurance(305) 620-4007Fax: (305) 620-5220Internet: michaelm@vitalcare.com |
| Name of Device: | VitalCare Urethral Catheter |
| Predicate Device: | Kendall Urethral Catheter |
| Description of the New Device: | Urological Urethral Catheter |
510(k) Summary
Intended Use of the New Device:
VitalCare's Urethral Catheter are intended to be inserted ithrough 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 similar.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of an eagle.
APR 2 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael McAvenia Director of Quality Assurance Vital Care, Inc. 15800 NW 13th Avenue MIAMI FL 33169
Re: K021938
Trade/DeviceName: VitalCare Urethral Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories
Regulatory Class: II Product Code: 78 GBM 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.
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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. Snogdon
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:
Device Name:
Urethral Catheter
Indications for Use:
VitalCare's Urethral 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 R. Searson
(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 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.