MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER

K012374 · Astra Tech, Inc. · GBM · Aug 23, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K012374
• Device Name: MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER
• Applicant: Astra Tech, Inc.
• Product Code: GBM · Gastroenterology, Urology
• Decision Date: Aug 23, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

LoFric® Plus is a single-use urinary catheter designed for intermittent bladder drainage. Device features a hydrophilic coating that becomes slippery upon immersion in water or saline for 30 seconds, facilitating insertion. Available in various lengths and sizes, including a 15 cm option. Used by patients or clinicians for urethral catheterization. Output is the establishment of a drainage pathway for urine. Benefits include reduced friction during insertion, aiding patient comfort and ease of use.

Clinical Evidence

Bench testing only. Laboratory and biocompatibility testing conducted to determine device functionality and conformance to design input requirements.

Technological Characteristics

Hydrophilic-coated urinary catheter; single-use; various lengths and sizes (including 15 cm). Activated by 30-second immersion in water or saline. Class II device (21 CFR 876.5130).

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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K01237
Page 1 of 2

AUG 2 3 2001

## 510K Summary of Safety and Effectiveness

Astra Tech AB Lofric Plus Catheter

- 1. Sponsor Name Astra Tech, INC. 430 Bedford St. Lexington, MA 02173
- 2. Device Name

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

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

### 4. Device Description

The LoFric® Plus 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 andsizes.

### 5. Intended Use

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

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K012374
Page 2 of 2

### Comparison of Technological Characteristics 6

The modified The LoFric® Plus Single Use Urinary Catheter is substantially equivalent in intended use and design to the currently marketed The LoFric® Plus Single Use Urinary Catheter (K896750).

The only difference between the LoFric® Plus Single Use Urinary Catheter and The only difference both on the addition of a 15 cm size length to the the product line. These differences do 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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Public Health Service

AUG 2 3 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Astra Tech AB % Mr. Bruce R. Manning New England Biomedical Research, Inc. 96 West Main Street NORTHBOROUGH MA 01532

Re: K012374

Astra Tech AB LoFric® Plus Single Use Urinary Catheter (Urological Catheters and Accessories) Dated: July 25, 2001 Received: July 26, 2001 Regulatory Class: II 21 CFR 876.5130/Procode: 78 GBM

Dear Mr. Manning:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have and assisses We have reviewed your Secuent 116(k) houtsation of mises to the enclosure) to begally marketed predicate contracts on the device is substantaly equiralin (or the marceles). 16, the enactment date of the Medical Device Amendments, or to devices marked in interstate continete provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, that have been reclassified in accordance will the provisions of the Act. The general controls provisions of the Act therefore, market the device, subject on the gallering pro notice, and manufacturing procice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Prematet Approval), it may be subjections If your device is classince (Secadore) into clubs to copied on to topodate over found in the Code of Feaced Regulations, to such additional controls. Existure high regulation assumes compliance with the Current Good Manufacturing
Title 21, Parts 800 to 895. A substantialion assumes of Alabora I I III 21, Patts 800 to 692. A Subsantany Quirtual Collection (QS) for Medical Device: Cencral regulation (2) CFR Pat Practice requirements, is set four in the Quality Of Sock to Aministration (FDA) will verify such assumptions. Failure 820) and that, through periodic QS hispections, the regulatory action. In addition, FDA may publish further announcements to comply with the Unit Tegulation nay result in regalatory this response to your premarket notification sumission in the lucture comerning your device in all I cocral Regised. " Tease notes with a ct 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 the read the substantial equivalence of your device to a legally market 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 vite If you done specific arriver to your derite of Campliance at [phone]. Additionally, for questions on the promotion and diagnosite of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, advising of your derres, promotet notification" (21CFR 807.97). Other general information on your responsibilities under Nisulanding of Icelerice to premation "QS to the manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmadsmamain.html".

Sincerely yours,

Nancy C. Brogdon

Nancy C. B 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): ____________________________________________________________________________________________________________________________________________________

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

Indications For Use:

The LoFric® Plus 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) OR Over-The-Counter Use Prescription Use (Per 21 CFR 801.109) (Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012374