ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER

K050874 · Astra Tech, Inc. · GBM · May 5, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K050874
• Device Name: ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER
• Applicant: Astra Tech, Inc.
• Product Code: GBM · Gastroenterology, Urology
• Decision Date: May 5, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LoFric Primo Single Use Urinary Catheter is intended for intermittent catheterization of the urethra.

Device Story

LoFric Primo is a single-use urinary catheter for intermittent bladder drainage. Device consists of a catheter with a hydrophilic low-friction coating, packaged with an integrated water pocket. Operation involves manual pressure on the water pocket to wet the catheter, rendering it slippery for insertion. Used in clinical or home settings by patients or healthcare providers. Provides a sterile, lubricated pathway for urine drainage, reducing friction during insertion to improve patient comfort and safety.

Clinical Evidence

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

Technological Characteristics

Hydrophilic-coated urinary catheter; integrated water pocket for activation; single-use; sterile. Materials and dimensions are consistent with the predicate device.

Indications for Use

Indicated for intermittent catheterization of the urethra in 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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IC050874

MAY - 5 2005

Astra Tech, Inc

## 510K Summary

## Astra Tech AB Lofric Primo Single Use Urinary Catheter

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

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

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

#### Device Description 4.

The LoFric Primo 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 activated with the water integrated in the package, it becomes slippery and ready to use. The catheter is provided in a variety of lengths and sizes.

The catheter and the activation water is separated, sealed in one bag. By holding the product upright and exerting a light pressure on the folded water pocket, the water will run down and wet the catheter. The bag is opened and the catheter is inserted into the patient's urethra.[1]

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### Intended Use 5.

The LoFric Primo Single Use Urinary Catheter is intended for intermittent catheterization of the urethra.

### Comparison of Technological Characteristics ರಿ

The modified The LoFric Primo 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 LoFric Primo Single Use Urinary Catheter and the predicate is the packaging concept, which includes the addition of water. The method of sterilization is changed. This difference does not raise new questions of safety and effectiveness. Laboratory data demonstrates this.

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

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Image /page/2/Picture/2 description: The image shows a circular logo with text around the perimeter and a stylized bird-like symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES". The bird-like symbol consists of three curved lines that resemble wings or feathers.

MAY - 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Scott A. Root President Astra Tech, Inc. 890 Winter Street, Suite 310 WALTHAM MA 02451

Re: K050874

Trade/Device Name: LoFric® Primo™ Single Use Urinary Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: GBM Dated: April 5, 2005 Received: April 7, 2005

Dear Mr. Root:

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 as not one reguirements 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 (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 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 statues and regulations administered by other Federal agencies. You must comply with all the r caeral states and registration and 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) (2) 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 his ieter will anow you to oegin maneting your and equivalence of your device to a legally premarket nothication. The PDA midnig of backannal business 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 advice tor your de received by 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 Also, please note the regulation entired, formation on your responsibilities under the Act from the 807.97). I ou may obtain other general infonal and Consumer Assistance at its toll-free number (800) DIVISION of 301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmadsmamain.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):

K050874

Astra Tech AB LoFric® Primo™ Single Use Urinary Catheter Device Name:

Indications For Use:

The LoFric® Primo™ 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)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use***_***_

Nancy C Snowden
(Division Sign-Off)

Division of Reproductive, Abdominal. and Radiological Devi 510(k) Number

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