KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER

K973546 · Kendall Healthcare Products Co. Div.Of Tyco Health · EZD · Nov 7, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K973546
• Device Name: KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER
• Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
• Product Code: EZD · Gastroenterology, Urology
• Decision Date: Nov 7, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Kendall FAST-CATH Pre-Lubricated Urethral Catheter is intended for sterile intermittent catherization for urine drainage from the bladder.

Device Story

The Kendall FAST-CATH is a sterile, single-use system for intermittent bladder catheterization. It consists of a 1200cc plastic collection bag containing a 14 Fr rubber or vinyl catheter. A pre-lubricated introducer tip, protected by a removable cover, allows the catheter to be advanced through the bag for insertion. The device is used to drain urine from the bladder in both male and female patients. It is designed to maintain sterility during the catheterization process.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing performed per ISO-10993 confirmed no toxic diffusible substances. Functional testing evaluated flow rates and shaft stiffness, demonstrating equivalence to predicate systems.

Technological Characteristics

System includes 1200cc plastic collection bag and 14 Fr rubber or vinyl catheter. Features pre-lubricated introducer tip with removable sterility cover. Single-use, sterile. Materials evaluated per ISO-10993.

Indications for Use

Indicated for sterile intermittent catheterization for urine drainage from the bladder in male and female patients.

Regulatory Classification

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).

Predicate Devices

• MMG O'Neil Urinary Catheterization System (K910022)
• Bard Touchless Plus Unisex Pre-Lubricated Urethral Catheter

Submission Summary (Full Text)

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K973546
102

### EXHIBIT 8

## 510(k) Summary

# NOV - 7 1997

## Kendall FAST-CATH Pre-Lubricated Urethral Catherer

In accordance with Section 513(1) of the SMDA and as described in 21 CFR Part 807.3 Final Rule dated December 14, 1994, this Summary is submitted by:

Kendail Healthcare Products Company 15 Hampshire Street Mansfield, MA 02048

Date: September 15, 1997

#### Contact Person 1.

Paul W. Evans Manager, Regulatory Affairs Phone: [phone]

#### Name of the Device 2.

Urological Catheter and accessories Classification Name: Pre-Lubricated Urethral Catheter Common or Usual Name: Kendall FAST-CATH Pre-Lubricated Proprietary Name: Urethral Catheter

#### Statement of Substantial Equivalence నా

The Kendall PAST-CATH Pre-Lubricated Urethral Catheter is substantially equivalent in intended use, design, and function to the commercially marketed MMG O'Neil Urinary Catheterization System, 510(k) No. K910022, and the Bard Touchless Plus Unisex Pre-Lubricated Urethral Catheter.

#### Description of Device ರ್

The Kendall FAST-CATH Pro-Lubricated Urethral Catheter is a sterile, single use system designed for the sterile intermittent cathererization for urine drainage from the bladder. The system is designed for use in both male and female patients.

The system consists of a 1200cc plastic collection bag. A 14 Fr rubber or vinyl urological catheler is self contained within the collection bag. A pre-lubricated introducer up allows the catheter to be advanced through the top of the collection bag to perform wrinary cathelestization. A removable cover guards the introducer tip prior to use to maintain sterility.

#### Device Intended Use ਹੋਂ

The Kendall FAST-CATH Pre-Lubricated Urethral Catheter is intended for sterile intermittent catherization for urine drainage from the bladder.

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#### 6. Product Comparison

The Kendall FAST-CATH Pre-Lubricated Urethral Catherer is equivalent to the referenced predicate devices in that they are similar in design, fabricated from similar materials, have the same function, and identical indications for use.

#### 7. Nonclinical Testing

Biocompatibility testing was performed on the catherer system following ISO-10993 Biological Evaluation of Medical Devices. This testing found the materials contained no toxic diffusible substances.

Functional testing was performed to determine flow rates, shaft stifferss and other attributes. Testing demonstrated equivalence between the proposed cathetor system and commercially available intermittent urological catheterization systems.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 7 1997

Mr. Paul W. Evans Manager, Regulatory Affairs Kendall Healthcare Product Company 15 Hampshire Street Mansfield, Massachusetts 02048

Re: K973546

Kendall FAST-CATH Pre-Lubricated Urethral Catheter Dated: September 15, 1997 Received: September 18, 1997 Regulatory class: II 21 CFR §876.5130/Product code: 78 EZD

Dear Mr. Evans:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, subject to the general controls provisions of 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

W.Lilian Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| S 10fk) Number (if known): | K973546 |
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|----------------------------|---------|

Kendall Fast-Cath Pre-Lubricated Urethral Catheter

Device Name:

Sterile intermittent Catheterization for Urine Drainage from Indications For Use:

1 .

## the bladder.

W THIS LINE - CONTINUE ON ANOTHER. PAGE IF NEEDED) (PLEASE DO NOT WRITE BEL

# DRH, Office of Device E

Robert R Ratting/

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

510(k) Number K973546

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

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(Optional Formal 1-2-96)