DUAL-LUMEN CATHETER

K024165 · Bistech, Inc. · EOQ · Jan 10, 2003 · Ear, Nose, Throat

Device Facts

• Record ID: K024165
• Device Name: DUAL-LUMEN CATHETER
• Applicant: Bistech, Inc.
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Jan 10, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 874.4680
• Device Class: Class 2

Intended Use

The Dual-Lumen Catheter is intended for use with a bronchoscope to deliver fluids to or withdraw fluids from the lung.

Device Story

Dual-lumen catheter designed for use with a bronchoscope to facilitate fluid delivery to or withdrawal from the lung. Device features proximal bifurcation, luer hubs, and a removable stylette to provide support and prevent kinking during insertion through the bronchoscope working channel. Used in clinical settings by healthcare professionals. Provides a pathway for fluid management within the tracheobronchial tree. Benefits include improved access for fluid administration or sampling.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing demonstrating conformity with ISO 10555-1:1999 (Sterile, Single Use Intravascular Catheters).

Technological Characteristics

Two-lumen catheter with proximal bifurcation and luer hubs. Outer diameter: 1.7 mm. Working length: 100 cm. Includes removable stylette for support. Sterile, single-use. Packaging: Tyvek/Plastic Pouch. Complies with ISO 10555-1:1999.

Indications for Use

Indicated for use with a bronchoscope to deliver fluids to or withdraw fluids from the lung in patients requiring bronchial access.

Regulatory Classification

Identification

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

Predicate Devices

• Aspiration Needle Set (Unknown)
• Stifcor Transbronchial Aspiration Needle (K963252)
• Combicath Double Plugged Telescoping Catheter (K974632)

Submission Summary (Full Text)

{0}------------------------------------------------

## 510(k) Summary

JAN 1 0 2003

| Trade Name: | Dual-Lumen Catheter |
|-------------|-------------------------------------------------------------------------------------------|
| Sponsor: | Bistech, Inc.<br>10A Roessler Road<br>Woburn, MA 01801<br>Registration # not yet assigned |

Device Generic Name: Multi-Lumen Catheter

Classification: According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II.

#### Predicate Devices:

| Product Name | 510(k) # | Manufacturer |
|-----------------------------------------------------|----------|------------------------------------|
| Aspiration Needle Set | Unknown | Olympus |
| Stifcor Transbronchial<br>Aspiration Needle | K963252 | Boston Scientific –<br>Microvasive |
| Combicath Double<br>Plugged Telescoping<br>Catheter | K974632 | Plastimed |

#### Product Description:

The proposed device consists of a two-lumen catheter with proximal bifurcation and luer hubs. The device will be supplied with a removable stylette in one of the lumens that is intended to provide support and prevent kinking as the catheter is inserted through the working channel of a bronchoscope.

#### Indications for Use:

The Dual-Lumen Catheter is intended for use with a bronchoscope to deliver fluids to or withdraw fluids from the lung.

#### Safety and Performance:

This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Bistech, Inc. has provided information to demonstrate conformity with the following FDA-recognized consensus standard:

- . ISO 10555-1;1999 (Amendment 1) Sterile, Single Use Intravascular Catheters
#### Conclusion:

Based on its indications for use, technological characteristics, and comparison to predicate devices, the Dual-Lumen Catheter has been shown to be safe and effective for its intended use.

{1}------------------------------------------------

| Product<br>Feature | Bistech Dual-<br>Lumen Catheter<br>(current<br>submission) | Olympus<br>Aspiration<br>Needle Set<br>(510(k) #<br>unknown) | BSC-Microvasive<br>Stifcor<br>Transbronchial<br>Aspiration Needle<br>(K963252) | Plastimed<br>Combicath<br>Double Plugged<br>Telescoping<br>Catheter<br>(K974632) |
|----------------------------|---------------------------------------------------------------|----------------------------------------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Outer Diameter | 1.7 mm | 1.85 mm | 1.8 mm | 2.6 mm |
| Working Length | 100 cm | 105 cm | 150 cm | Unknown |
| # of Lumens | Two | One | One | Two |
| Design | Dual-lumen catheter | Reusable metallic<br>coil sheath;<br>single-use<br>disposable needle | Extendable coaxial<br>needle within<br>single lumen<br>catheter | Dual-lumen<br>catheter with distal<br>polyethylene glycol<br>plug |
| Packaging | Tyvek/Plastic Pouch | Tyvek/Plastic<br>Pouch | Tyvek/Plastic<br>Pouch | Tyvek/Plastic<br>Pouch |
| Sterile/<br>Non-Sterile | Sterile | Non-sterile<br>(reprocessable)<br>sheath;<br>Sterile needle | Sterile | Sterile |
| Single Use/<br>Reusable | Single Use | Reusable sheath;<br>Single use needle | Single Use | Single Use |
| Anatomical Sites<br>of Use | Tracheobronchial<br>tree | Tracheobronchial<br>tree | Tracheobronchial<br>tree | Tracheobronchial<br>tree |
| Indications for<br>Use | To deliver fluids<br>into or withdraw<br>fluids from the lung | To aspirate tissue<br>and cells from the<br>respiratory organs | Bronchial<br>aspiration | Mini-<br>bronchoalveolar<br>lavage; collection<br>of bronchoalveolar<br>samples |

# Substantial Equivalence: Bistech Dual-Lumen Catheter

:

{2}------------------------------------------------

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" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three figures or lines representing people.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 0 2003

Bistech, Inc. c/o Pamela Papineau, RAC Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, MA 01432

Re: K024165

Trade/Device Name: Bistech Dual-Lumen Catherer Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope and accessories Regulatory Class: Class II Product Code: EOQ Dated: December 5, 2002 Received: December 17, 2002

Dear Ms. Papineau:

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 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

{3}------------------------------------------------

### Page 2 - Pamela Papineau, RAC

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. 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), 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) you may obtain. 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,

A. Joseph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Bistech, Inc. Abbreviated 510(k) Premarket Notification

December 5, 2002 Dual-Lumen Catheter

Page

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Dual-Lumen Catheter

Indications for Use:

For use with a bronchoscope to deliver fluids to or withdraw fluids from the lung.

(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

Keven Baker

(Division Sian-C Division of Ophthalmic Nose and Throat Devi

5(i)(k) Number. K024165

000007