FAS ENDOLUMINAL BRUSH

K012641 · Fas Medical , Ltd. · LJS · Oct 15, 2001 · General Hospital

Device Facts

• Record ID: K012641
• Device Name: FAS ENDOLUMINAL BRUSH
• Applicant: Fas Medical , Ltd.
• Product Code: LJS · General Hospital
• Decision Date: Oct 15, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The FAS Endoluminal Brush is intended to collect and remove obstructing material from the internal lumen surface of an indwelling central venous catheter to restore or improve catheter flow rate, and to provide a biofilm or fibrin sample which is suitable for microbiological analysis.

Device Story

Single-use, sterile endoluminal brush; nylon bristles on flexible stainless steel wire; housed in plastic sheath with Luer lock. Device inserted into indwelling central venous catheter lumen; manual operation by clinician. Mechanical brushing action removes obstructing material (biofilm/fibrin) from internal lumen surface; restores catheter flow rate; collects material for microbiological analysis. Kit includes patient drape, wire clippers, and specimen container. Benefits include improved catheter patency and diagnostic capability for catheter-related infections.

Clinical Evidence

Bench testing only. Testing performed to international standards for biocompatibility, sterility, and general device safety. Performance testing confirmed device conforms to design specifications.

Technological Characteristics

Nylon bristles; stainless steel flexible wire; stainless steel tubular handle; plastic sterile sheath; Luer lock connection. Single-use; sterile. Mechanical sensing/actuation via manual brushing. No software or electronic components.

Indications for Use

Indicated for patients with indwelling central venous catheters requiring removal of obstructing material to restore flow or collection of biofilm/fibrin samples for microbiological analysis.

Regulatory Classification

Identification

A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

Predicate Devices

• FAS Endoluminal Brush (K993613)
• Thrombolytic Brush Catheter (K963925)
• Fogarty Adherent Clot Catheter (K993816)

Submission Summary (Full Text)

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K012641

OCT 1 5 2001

## 510(k) Summary FAS Endoluminal Brush

## Submitter (Consultant) Name and Address

Morningstar Consulting Group, Inc. P. O. Box 219 Indian Hills, CO 80454

#### Submitter (Consultant) Contact Person

Thomas Kroenke, Senior Consultant phone [phone] fax: [phone]

#### Manufacturer Name and Address

FAS Medical Limited Unit E4. Brooklands Close Sunbury, Middlesex TW16 7DX United Kingdom

## Manufacturer Contact Person

Laura Garcia, COO Phone [phone] Fax [phone]

#### Common Classification & Proprietary Names

| Common Name: | Central Venous Catheter Biopsy Brush |
|----------------------|--------------------------------------|
| Classification Name: | Intravascular Catheter, Accessory to |
| Proprietary Name: | FAS Endoluminal Brush |

#### Predicate Devices

| K993613 | FAS Endoluminal Brush |
|---------|--------------------------------|
| K963925 | Thrombolytic Brush Catheter |
| K993816 | Fogarty Adherent Clot Catheter |

## Device Description

The FAS Endoluminal Brush is a single use, sterile disposable medical device. The device itself consists of nylon bristles wound into a stainless steel flexible wire, which is further wound into a stainless steel tubular handle. The brush is enclosed in a plastic sterile sheath that is heat sealed at the proximal end is attached to a Luer lock at its distal end. The Luer lock attachment provides the brush access to catheter lumens in a sterile environment.

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The FAS Endoluminal Brush kit also contains accessory items including a patient drape, instructions for use, wire clippers, and specimen container and cap, and a patient identification label.

# Indications for Use

The FAS Endoluminal Brush is intended to collect and remove obstructing material from the internal lumen surface of an indwelling central venous catheter to restore or improve catheter flow rate, and to provide a biofilm or fibrin sample which is suitable for microbiological analysis.

# Technological Characteristics Comparison

The FAS Endoluminal brush is an accessory to a central venous catheter. The purpose of the FAS Endoluminal Brush is to collect a biosample for subsequent microbiological analysis in much the same way as intended for a cytology brush and a microbiology brush, both described as predicates. Additionally, the FAS Endoluminal Brush removes obstructing material from the internal lumen surface of an indwelling central venous catheter and restores or improves catheter flow rate.

The FAS Endoluminal Brush and its predicates are constructed in a similar way, with brush bristles wound around the distal end of a flexible or rigid stainless steel wire.

# Test Discussion

Testing was performed according to international standards to assure biocompatibility, sterility assurance, and general device safety.

# Test Conclusions

Test results support the conclusion that actual device performance satisfies the design intent. Actual device performance as tested internally and by a third party conforms to the device performance specifications.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 2001

FAS Medical Limited C/O Mr. Thomas Kroenke Senior Consultant Morningstar Consulting Group, Incorporated P.O. Box 219 Indian Hills, Colorado 80454

Re: K012641

Trade/Device Name: FAS Endoluminal Brush Regulation Number: 880.5970 Regulation Name: Accessory to, Percutaneous, implanted, long-term intravascular catheter Regulatory Class: II Product Code: LJS Dated: August 10, 2001 Received: August 13, 2001

Dear Mr. Kroenke:

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 such additional controls. Existing major regulations affecting vour 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

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of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I ouclar states requirements, including, but not limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 CF R Part 807), adolity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quadiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Ruaves
Erika A. Ulatawski

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): KO 12 6 Y

FAS Endoluminal Brush Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The FAS Endoluminal Brush is intended to collect and remove obstructing material from the internal lumen surface of an indwelling central venous catheter to restore or improve catheter intornal lamon banded of biofilm or fibrin sample which is suitable for microbiological analysis.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

Ann Nemecek for PxC

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 1510(k) Number Kolace

(Optional Format 1-2-96)