ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET

K013241 · Cook, Inc. · BWC · Feb 21, 2002 · Anesthesiology

Device Facts

• Record ID: K013241
• Device Name: ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET
• Applicant: Cook, Inc.
• Product Code: BWC · Anesthesiology
• Decision Date: Feb 21, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5090
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arndt Cricothyroid Catheter is used for emergency airway access when conventional endotracheal intubation cannot be performed. It is provided in peel-open packages and is intended for one-time use.

Device Story

The Arndt Emergency Cricothyrotomy Catheter is a medical kit designed for emergency airway access. The device consists of a catheter with a proximal connector, a dilator, and a wire guide. It is deployed using the Seldinger technique to establish an airway in critical situations where conventional endotracheal intubation is not feasible. The device is intended for one-time use and is supplied in a sterile, peel-open package. It is operated by healthcare professionals in emergency clinical settings. By providing a reliable method for emergency ventilation, the device helps maintain patient oxygenation during airway crises.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use similarities to legally marketed predicate devices.

Technological Characteristics

Kit includes catheter with proximal connector, dilator, and wire guide. Employs Seldinger technique for insertion. Materials are similar to predicate devices. Single-use, sterile. No electronic components or software.

Indications for Use

Indicated for emergency airway access in patients requiring ventilation when conventional endotracheal intubation cannot be performed.

Regulatory Classification

Identification

An emergency airway needle is a device intended to puncture a patient's cricothyroid membrane to provide an emergency airway during upper airway obstruction.

Predicate Devices

• Melker Cuffed Cricothyroid Catheter Set (K010016)
• The Pertrach (K914743)

Submission Summary (Full Text)

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

Arndt Emergency Cricothyrotomy Catheter Response to request for additional information COOK INCORPORATED

# FEB 2 1 2002

Pertrach Inc. (K914743)

K01324/

Set

# Safety and Effectiveness Information

| Submitted by: | Heidi Masten | |
|--------------------|--------------------------------|-----------------------------|
| | Regulatory Affairs Coordinator | |
| | COOK INCORPORATED | |
| | 750 Daniels Way | |
| | P.O. Box 489 | |
| | Bloomington, IN 47402-0489 | |
| | 812-339-2235 | |
| Device: | Trade Name: | Arndt Cricothyroid Catheter |
| | Proposed Classification: | Emergency Airway Needle |
| Predicate Devices: | Melker Cuffed | Marketed & Distributed by |
| | Cricothyroid Catheter | Cook Inc. (K010016) |
| | The Pertrach | Marketed and Distributed b |

## Device Description:

The Arndt Cricothyroid Catheter consists of a connector on the proximal end connected to tubing with an inner diameter. Through the catheter lumen is a dilator. The dilator provides a transition to a wire guide for insertion. The device is placed using the Seldinger technique. The catheter will be included in a set consisting of appropriately sized components.

#### Indications for Use:

The Arndt Cricothyroid Catheter is used for emergency airway access when conventional endotracheal intubation cannot be performed. It is provided in peel-open packages and is intended for one-time use.

## Substantial Equivalence:

The Arndt Cricothyrotomy Catheter is similar in design and intended use to two legally marketed devices including: The Melker Cuffed Cricothyrotomy Catheter Set, manufactured by Cook Inc. and the Pertrach, manufactured by Pertrach Inc.

These devices are used for airway access, have similar technical characteristics and are made of similar materials.

27

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

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 1 2002

Ms. Heidi Masten Cook Incorporated P.O. Box 489 Bloomington, IN 47402-0489

Re: K013241

Arndt Emergency Cricothyrotomy Catheter Set Regulation Number: 868.5090, 868.5800 Regulation Name: Emergency Airway Needle, Tracheostomy Tube and Tube Cuff Regulatory Class: II (two) Product Code: 73 BWC, 73 BTO Dated: December 21, 2001 Received: December 26, 2001

Dear Ms. Masten:

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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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

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

Page 2 - Ms. Heidi Masten

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 (21 CFR Part 807); 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.

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 the labeling regulation (21 CFR Part 801 and additionally 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"(21 CFR 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,

L. Darden Mell

ram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Arndt Emergency Cricothyrotomy Catheter Set 510(k) Premarket Notification Cook Incorporated

# INDICATIONS FOR USE

Arndt Emergency Cricothyrotomy Catheter Set Device Name

Indications for Use:

- Used for emergency airway access when conventional endotracheal . intubation and ventilation cannot be performed.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number

Prescription Use √
(Per 21 CFR 801.109)
OR
Over-the-Counter Use

4