RUSCH FLONEIL; FLOCATH INTROGEL

• K Number: K020714
• Device Name: RUSCH FLONEIL; FLOCATH INTROGEL
• Manufacturer: RUSCH INTL.
• Date Cleared: 2002-07-01 ( 118 days)
• Product Code: GBM
• Regulation Number: 876.5130
• Type: Traditional
• Panel: Gastroenterology/Urology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Aseptic Intermittent Self-Catheterization.

Device Description

The Rüsch FloNeil (coated, with Water Pack) / Rüsch Flocath IntroGel (uncoated, without Water Pack) - consists of a tubular PVC catheter, a split introducer, a silicone introducer tip. introducer cap, lubrication jelly and a pack of 15ml saline (for FloNeil -coated product) inside a closed urine collection bag.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (urinary catheters) and the subsequent FDA clearance letter. It does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway, not a performance study in the sense of accuracy, sensitivity, or specificity.

Therefore, I cannot fulfill your request for the detailed information because the source document does not provide it.

Here's a breakdown of what the document does include:

• Device Name: Rüsch FloNeil (coated, with Water Pack) and Rüsch FloCath IntroGel (uncoated, without Water Pack)
• Intended Use: Aseptic Intermittent Self-Catheterization
• Predicate Device: Rüsch MMG/O'Neil Catheter Set and the MMG O'Neil Urinary Catheter
• Substantial Equivalence: Claimed equivalence in materials, design, and use to the predicate.
• Classification: Class II medical device, 78 KOD, 21CFR 876.5130

To address your query regarding acceptance criteria and a study, these would typically be found in a performance study report, clinical trial summary, or a specific section of a 510(k) submission dedicated to performance testing (if non-clinical or clinical data were required to demonstrate substantial equivalence beyond material and design comparison). This document is a high-level summary.

Summary

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JUL 1 2002

Image /page/0/Picture/1 description: The image shows a document with the text "K020714 PAGE 1 OF 1 RUSCH INTERNATIONAL Group Regulatory Affairs A Subsidiary of Teleflex Incorporated (USA)". The document appears to be a formal communication from Rusch International, specifically from their Group Regulatory Affairs department. The document also indicates that Rusch International is a subsidiary of Teleflex Incorporated (USA).

510(k) Summary

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

Tall Pines Park

Jaffrey, NH 03452 [phone]

FAX [phone] or 6108

• Miss Karenann J. Brozowski Group Regulatory Affairs Director Rüsch International Tall Pines Park Jaffrey, NH 03452 Telephone Number [phone] Fax Number [phone] Contact: Same as above
• 2. Name of the Device, Common, Proprietary (if Known), and Classification.

Classification Name:	Urological Catheter & Accessories
Common Name:	Urinary Catheter
Proprietary Name:	Rüsch FloNeil (coated, with Water Pack) and RüschFloCath Introgel (uncoated, without Water Pack).
Classification:	Class II medical device, 78 KOD, 21CFR 876.5130

• 3. Identification of the legally marketed device to which the submitter claims equivalence.
     The Rusch FloNeil/Flocath IntroGel is substantially equivalent in materials, design and use to Rüsch MMG/O'Neil Catheter Set and the MMG O'Neil Urinary Catheter.

• র্বা Description of the Device.
  The Rüsch FloNeil (coated, with Water Pack) / Rüsch Flocath IntroGel (uncoated, without Water Pack) - consists of a tubular PVC catheter, a split introducer, a silicone introducer tip. introducer cap, lubrication jelly and a pack of 15ml saline (for FloNeil -coated product) inside a closed urine collection bag.

• งก Intended Use of the Device.
  Aseptic Intermittent Self-Catheterization.

• ર્. Summary of Technological Characteristics.
  The device is equivalent in design and intended use with Rüsch MMG/O'Neil Catheter Set and the MMG O'Neil Urinary Catheter.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three wing-like shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged around the eagle in a circular fashion. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JUL

1 2002

Re: K020714

Trade/Device Name: Rüsch FloNeil: FloCath IntroGel Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 GBM Dated: June 13, 2002 Received: June 14, 2002

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. Iisting 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 mav 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 (OS) 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.

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

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510(k) Number (if known): K020714/

Device Name: Rüsch FloNeil/FloCath IntroGel

Indications for Use:

Aseptic Intermittent Self Catheterization.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Omist A. Sugerman

(Division Sign-Off) Division of Reproductive and Radiological Devic 510(k) Number

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.