AMERICAN CATHETER, MODEL W3

• K Number: K030538
• Device Name: AMERICAN CATHETER, MODEL W3
• Manufacturer: CATHETER LLC.
• Date Cleared: 2003-03-10 ( 18 days)
• Product Code: EZD , PRE
• Regulation Number: 876.5130
• Type: Traditional
• Panel: Gastroenterology/Urology
• Age Range: All
• Reference & Predicate Devices: K863082
• Predicate For: N/A

Intended Use

Used for female intermittent self-catheterization of the bladder. Curved design permits easier insertion and makes the catheter easier for patients to manipulate.

Device Description

Not Found

AI/ML Overview

I'm sorry, but this document does not contain the information requested. This document is a 510(k) premarket notification decision letter from the FDA for a urological catheter. It confirms that the device is substantially equivalent to a legally marketed predicate device.

The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Information on sample sizes, data provenance, or details about test sets.
3. Details about expert involvement in establishing ground truth.
4. Adjudication methods.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results of a standalone algorithm performance study.
7. The type of ground truth used.
8. Information about the training set or how its ground truth was established.

The content focuses on regulatory approval based on substantial equivalence to an existing device, rather than detailed performance study results against specific acceptance criteria.

Summary

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K030538

510(K) SUMMARY

Device Classification Name: Catheter, Urological Requlation Number: 876.5130 Not yet assigned 510 (K) Number: Device Name: W3 American Catheter Applicant: Catheter LLC. P.O. Box 917 106 Groppo Drive Winsted, CT 06098-0917 Email: [e-mail] Telephone: [phone] Fax: [phone] John C. Devanney Contact: KOD Product Code: Predicate device: Catheter, Urological Device Classification Name: Requlation Number: 876.5130 510(K) Number: K863082 COOK-VPI INTERMITTENT Device Name: CATHETER Cook Urological, Inc. Applicant: 1100 West Morgan Street P.O. Box 227 Spencer, IN 47460 Gerald J. French Contact: KOD Product Code: 08/12/1986 Date Received: Decision Date: 11/07/1986 Substantially Equivalent Decision: (SE) Classification Advisory Gastroenterology Committee: Review Advisory Gastroenterology Committee: Traditional Type : Reviewed by Third Party: No

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three abstract human figures or faces, stacked vertically.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Catheter LLC c/o Mr. John C. Devanney

Re: K030538

MAR 1 0 2003

Trade/Device Name: American Catheter, W3 Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II

Product Code: 78 EZD Dated: February 17, 2003 Received: February 20, 2003

Dear Mr. Devanney:

106 Groppo Drive

WINSTED, CT 06098 0917

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	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Yancy 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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Kv 30538

510(k) Number Not-assigned

Device Name: W3 American Catheter with stop shield

Indications for Use:

Used for female intermittent self-catheterization of the bladder. Curved design permits Osed for remare interminent betw makes the catheter easier for patients to manipulate.

Non-sterile

Reusable.

Intended for single patient use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Broadon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030538

Prescription Use (Per 21 CFR 801.109)

(Optional Format 3-10-98)

L

Regulation Number and Section

§ 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.