LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER

K043241 · Astra Tech, Inc. · GBM · Dec 23, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K043241
• Device Name: LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER
• Applicant: Astra Tech, Inc.
• Product Code: GBM · Gastroenterology, Urology
• Decision Date: Dec 23, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LoFric® Hydro-Kit II Single Use Urinary Catheter is intended for intermittent catheterization of the urethra.

Device Story

The LoFric® Hydro-Kit II is a single-use urinary catheter system designed for intermittent bladder drainage. The device features a hydrophilic-coated catheter that becomes slippery when activated with water or saline. The system includes an integrated urine collection bag and an internal water sachet; the user activates the catheter by applying pressure to the sachet within the closed bag. The device is intended for use by patients or clinicians to facilitate catheterization. The primary benefit is a self-contained, sterile, and lubricated system for intermittent urethral access.

Clinical Evidence

Bench testing and biocompatibility testing were conducted to verify device functionality and conformance to design requirements. No clinical data was provided.

Technological Characteristics

Hydrophilic-coated urinary catheter; includes integrated urine collection bag and water sachet for surface activation. Single-use, sterile. Dimensions vary by size/length. No electronic components or software.

Indications for Use

Indicated for intermittent catheterization of the urethra for patients requiring bladder drainage.

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

• LoFric® Single Use Urinary Catheter (K896750)

Submission Summary (Full Text)

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K043241
Page 1 of 2

Astra Tech, Inc

DEC 2 3 2004

## 510K Summary of Safety and Effectiveness

## Astra Tech AB Lofric Hydro-Kit II Single Use Urinary Catheter

- Sponsor Name 1. Astra Tech, Inc.
- Device Name 2.

| Proprietary Name: | Astra Tech AB LoFric® Hydro-Kit II Single Use<br>Urinary Catheter |
|----------------------|--------------------------------------------------------------------------|
| Common/Usual Name: | Urethral Catheters |
| Classification Name: | Urethral Catheters and Accessories<br>72 GBM, Class II - Urology Devices |

- Identification of Legally Marketed Device 3.
The modified The LoFric® Hydro-Kit II Single Use Urinary Catheter is substantially equivalent in intended use to the LoFric® Single Use Urinary Catheter (K896750).

## 4. Device Description

The LoFric® Hydro-Kit II Single Use Urinary Catheter is designed as an intermittent pathway for drainage of the bladder. The device consists of a catheter, coated with a hydrophilic low-friction coating.

The surface is hydrophilic and when the catheter is immersed in water or physiological saline solution for 30 seconds, it becomes slippery and ready to use. The catheter is provided in a variety of lengths and sizes.

The catheter is packed within a bag for urine collection. The urine collection bag is used as a wetting container prior to catheterization. Inside the closed urinary bag, a water sachet is placed. By holding the product upright and exerting a light pressure on the folded water sachet, the water will activate the hydrophilic catheter surface.

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K043241
Page 2 of 2

- ട. Intended Use
The LoFric® Hydro-Kit II Single Use Urinary Catheter is intended for intermittent catheterization of the urethra.

- Comparison of Technological Characteristics රි
The modified The LoFric® Hydro-Kit II Single Use Urinary Catheter is substantially equivalent in intended use and design to the currently marketed The LoFric® Single Use Urinary Catheter (K896750).

The difference between the LoFrio® Hydro-Kit II Single Use Urinary Catheter and the predicate is the packaging concept and addition of accessories as urine collection bag and water sachet. The method of sterilization is changed. This difference does not raise new questions of safety and effectiveness. Laboratory data demonstrates this.

- 6. Performance Testing
Laboratory testing and biocompatibility testing was conducted to determine device functionality and conformance to design input requirements.

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 2004

Mr. Niklas Lidskog President Astra Tech, Inc. 890 Winter Street, Suite 310 WALTHAM MA 02451

Re: K043241

Ro452 Fi
Trade/Device Name: Astra Tech AB LoFric® Hydro-Kit II Single Use Urinary Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 GBM Dated: November 22, 2004 Received: December 1, 2004

Dear Mr. Lidskog:

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 Section 510(k) I mis letter will and w you'll collection of substantial equivalence of your device to a legally premarked notheadon: "The PDF mastification 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 if you desire specific active as one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Allo, production other general information on your responsibilities under the Act from the 801:27). " Ou may octurers, International and Consumer Assistance at its toll-free number (800) DIVISION of Unian Hallacturess http://www.fda.gov/cdrl/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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K043241 510(k) Number (if known):

Astra Tech AB LoFric® Hydro-Kit II Single Use Urinary Catheter Device Name:

Indications For Use:

The LoFric® Hydro-Kit II Single Use Urinary Catheter is intended for intermittent catheterization of the urethra.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

1 Prescription Use __

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

David A. Hegmann

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