OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818

K990509 · Implemed, Inc. · EZL · May 18, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990509
• Device Name: OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818
• Applicant: Implemed, Inc.
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: May 18, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Intended Use

The device is intended to pass fluids to or from the urinary tract.

Device Story

Dual lumen Foley catheter; manufactured from silicone; coated with proprietary OLIGON™ silver-based material. Device functions by passing fluids to or from urinary tract; silver coating actively releases silver ions when exposed to saline. Supplied sterile for single use in 16 Fr and 18 Fr sizes. Used in clinical settings for urinary drainage. Silver ion release provides antimicrobial properties; intended to reduce potential for catheter-associated complications.

Clinical Evidence

Bench testing only. Laboratory testing demonstrated silver ion release rates of ≥ 5.0 x 10-5 mg/cm2·hour on first extraction. 16 Fr catheters released 3.4 mg of silver over 28 days; 18 Fr catheters released 3.6 mg over 28 days. Biocompatibility evaluated per ANSI/AAMI/ISO 10993.

Technological Characteristics

100% silicone dual lumen Foley catheter; coated with silver-based OLIGON™ material. Conforms to ASTM F 623-89. Sterilized via EtO (ANSI/AAMI/ISO 11135). Sizes: 16 Fr and 18 Fr.

Indications for Use

Indicated for patients requiring a urinary drainage catheter to pass fluids to or from the urinary tract.

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

• Kendall 100% Silicone Foley Catheter (K933400)

Submission Summary (Full Text)

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MAY 1 8 1999

510(k) SUMMARY [Refer to 21 CFR §807.92] Page 1 of 2

(99050

| Submitted by: | Implemed, Inc.<br>313 Pleasant Street<br>Watertown, MA 02472<br>[phone] |
|----------------------|------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Anthony L. Blank |
| Date Prepared: | May 13, 1999 |
| Proprietary Name: | OLIGON™ FOLEY CATHETER |
| Common Name: | Urinary Drainage Catheter (Foley) |
| Classification Name: | urological catheter, retention type, balloon (78 EZL)<br>Class II as described in 21 CFR 876.5130 (b) |
| Predicate Device: | Kendall 100% Silicone Foley Catheter<br>Kendall Healthcare Products Company<br>510(k) Document Control Number: K933400 |

The OLIGON™ FOLEY CATHETER is an all Description of the Device: siliconc, dual lumen Folcy catheter (manufactured for Implemed, Inc. by Kendall I Icalthcare Products Company) which has been coated with Implemed's proprietary OLIGON'IM matcrial. The OLIGON™ coating is a patented silver based coating which has been shown in laboratory testing to actively release silver ions when exposed to saline. Under these test conditions, the 16 Fr catheters (91 cnt surface area) released a total of 3,4 milligrams of silver over 28 days and the 18 Fr catheters (96 cm2 surface arca) would release a total of 3.6 milligrams of silver over 28 days.

The OLIGON™ FOLEY CATHETER is supplied in two sizes; 16 Fr. and 18 Fr. (outer diameler). OLIGON™ Folcy catheters are supplied storile for single use. Individual catheters are packaged in sterilizable Tyvek/mylar pouches.

Intended Use of the Device: The subject device has the same intended use as the prodicate device. The device is intended to pass fluids to or from the urinary lract.

Technological Characteristics: The technological characteristics of the OLIGON™ FOLEY CATHETER are substantially equivalent to those of the predicate device. Both the subject device and the predicate device conform to the requirements of the ASTM Standard F 623-89, entitled Standard Performance Specification for Foley Catheter. In addition, the OLIGON™ FOLEY CATHETER has been evaluated according to the applicable Parts of the

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K990509
1.2k

510(k) SUMMARY [Refer to 21 CFR §807.92] Page 2 of 2

ANSI/AAMI/ISO Standard 10993: Biological Evaluation of Medical Devices and has successfully met the biocompatibility requirements contained within the standard. Both the subject device and the prodicate device are supplied sterille via EtO sterilization processes conforming to the ANSUAAMI/ISO Standard 11135, entitled Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization.

Functionally the OLIGON™ FOLEY CATHETER and the Kendall Curity 100% Silicone Folcy Cathetcr are identical with respect to intended use of the catheter to pass fluids to and from the urinary tract. The only technological difference in the subject device and predicate device concerns the OLIGON™ coating of the OLIGON™ FOLEY CATHETER. The OLIGON™ coating applied to the surface of the subject device has becn shown to release silver ions at a rate of ≥ 5.0 x 10-5 mg/cm2 · hour on first extraction. The predicate device does not have such a coating.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/16 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", also in black. The text is arranged in a circular fashion around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 8 1999

Mr. Anthony Blank Director, Regulatory and Clinical Affairs Implemed. Inc. 313 Pleasant Street Watertown, Massachusetts 02472

Re: K990509 Implemed Oligon™Foley Catheter Dated: February 9, 1999 Received: February 18, 1999 Regulatory Class: II 21 CFR §876.5130/Product Code: 78 EZL

Dear Mr. Blank:

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 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). 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 III (Special Controls) or 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 requirements, 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting 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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## INDICATIONS FOR USE STATEMENT VII.

#K 510(k) Number:

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OLIGON™ FOLEY CATHETER Device Name:

The OLIGON™ FOLEY CATHETER is used to pass fluids to or from Indications for Use: the urinary tract.

(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)

OR

Over-The-Counter Use **__**

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number **__**K990509

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