INTERMITTENT URETHRAL CATHETERS

• K Number: K033023
• Device Name: INTERMITTENT URETHRAL CATHETERS
• Manufacturer: RUSCH INTL.
• Date Cleared: 2003-12-23 ( 88 days)
• Product Code: KOD
• Regulation Number: 876.5130

Intended Use

The Intermittent Urethral Catheters are sterile, single-use, flexible tubular devices that are to be inserted through the urethra and used to pass fluids to or from urinary tracts.

Device Description

The Intermittent Urethral Catheters will be offered in two rne Incernitions Both styles will be offered with or without Catheter. The Standard Urethral Catheter will be hydrophilic coating. offered in three tip configurations.

Predicate Devices

K003784, K896729

Reference Devices

K964575

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard medical device (catheter) and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as for details related to training/test sets and performance metrics typically associated with AI/ML devices.

Therapeutic

No
The device is described as a 'flexible tubular device' for passing fluids to or from urinary tracts, which is a diagnostic or management tool rather than a device intended for therapy or treatment of a disease or condition.

Diagnostic

No
Explanation: The device is described as a tubular device for passing fluids to or from urinary tracts, which is a therapeutic or interventional function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "flexible tubular device" and mentions "hydrophilic coating" and "tip configurations," indicating a physical hardware component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states the device is for passing fluids to or from urinary tracts by insertion through the urethra. This is a direct interaction with the body for therapeutic or diagnostic purposes related to the urinary system, not for testing samples in vitro (outside the body).
• Device Description: The description focuses on the physical characteristics and configurations of a catheter, which is a medical device used for insertion into the body.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (like urine), using reagents, or performing tests in vitro.

IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on interacting with the urinary tract in vivo.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Intermittent Urethral Catheters are sterile, single-use, flexible tubular devices that are to be inserted through the urethra and used to pass fluids to or from urinary tracts.

Product codes

78 KOD

Device Description

The Intermittent Urethral Catheters will be offered in two rne Incernitions Both styles will be offered with or without Catheter. The Standard Urethral Catheter will be hydrophilic coating. offered in three tip configurations.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

urethra, urinary tracts

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

Not Found

Key Metrics

Not Found

Predicate Device(s)

Mentor Self-Cath - Preamendment, Mentor Self-Cath Plus - K003784, Maersk Female, Nelaton and Tiemann Catheters - Originally marketed by Unoplast A/S - K896729

Reference Device(s)

Rüsch International SympaCath Hydrogel Coated Foley Catheter -K964575

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

DEC 2 3 2003

Image /page/0/Picture/1 description: The image shows the logo for RUSCH INTERNATIONAL Group Regulatory Affairs, with the words "A Subsidiary of Teleflex Incorporated (USA)" underneath. The word "RUSCH" is in large, bold letters, with the rest of the text in a smaller font. The logo is black and white.

Tall Pines Park Jaffrey, NH 03452 [phone] FAX [phone] or 6108

K033023
Page 1 of 2

510 (k) Summary

Submitter Name, Address, and Date of Submission: 1.

Rick Lykins Group RA Manager - US Rüsch International Tall Pines Park Jaffrey, NH 03452 Telephone Number: [phone] Fax Number: [phone]

Same as above Contact:

• Name of the Device, Common, Proprietary (if known), and 2. Classification:
  Catheter, Urological Classification Name:

Common Name: Intermittent Urethral Catheters

Proprietary Name: Intermittent Urethral Catheters

Identification of the legally marketed device to which the 3 . submitter claims equivalence:

substantially Urethral -Catheters are Intermittent The equivalent in design and materials to:

Mentor Self-Cath - Preamendment Mentor Self-Cath Plus - K003784 Maersk Female, Nelaton and Tiemann Catheters - Originally marketed by Unoplast A/S - K896729 Rüsch International SympaCath Hydrogel Coated Foley Catheter -K964575

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Page 2

K035023
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Description of the Device: 4 .

The Intermittent Urethral Catheters will be offered in two rne Incernitions Both styles will be offered with or without Catheter. The Standard Urethral Catheter will be hydrophilic coating. offered in three tip configurations.

Intended Use of the Device: ട്.

The Intermittent Urethral Catheters are sterile, single-use, flexible tubular devices that are to be inserted through the Frexible cabared to pass fluids to or from urinary tracts.

Summary of Technological Characteristics: 6.

The following technological characteristics are the same as or equivalent to the predicate devices.

All predicate catheters are PVC, single use and intended for one-time intermittent catheterization.

substantially Catheters are Urethral Intermittent The equivalent to the Maersk (formerly Unoplast) Female, Nelaton equirent co one mas, the Mentor Urethral Catheters (Self-Self-Cath Plus, Self-Cath Olive Tip) and the Mentor Cath, Self-Cath Plus (K003784), which is hydrophilic coated.

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing wings and a wavy line representing the body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 2003

Mr. Rick Lykins Group RA Manager-US Rüsch International Tall Pines Park JAFFREY NH 03452

Re: K033023

Trade/Device Name: Intermittent Urethral Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 KOD Dated: September 25, 2003 Received: September 29, 2003

Dear Mr. Lykins:

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.

3

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/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

4

Page 1_ of _1 K033023

(033023 510(k) Number (if known):

Intermittent Urethral Catheters Device Name:

Indications for Use:

single-use, The Intermittent Urethral Catheters are sterile, The Intermittent breakthat cathere to be inserted through the flexible tubular devices that are of as and there tracts.
urethra and used to pass fluids to or from urinary tracts.

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

Concurrence of CDRH, Office of Device Evaluation i (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use_

David B. Ingram

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic

510(k) Number K033023

(Optional Format 1-2-96)