PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET

K013252 · Cook, Inc. · BWC · Feb 21, 2002 · Anesthesiology

Device Facts

• Record ID: K013252
• Device Name: PATIL 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

Used for emergency airway access when conventional endotracheal intubation and ventilation cannot be performed.

Device Story

Patil Emergency Cricothyrotomy Catheter Set provides emergency airway access. Device consists of catheter with proximal connector, internal dilator, and insertion needle. Used in emergency settings when conventional endotracheal intubation fails. Physician inserts needle/dilator assembly to establish airway; catheter remains for ventilation. Single-use, sterile device. Benefits patient by providing rapid, temporary airway access in life-threatening respiratory distress scenarios.

Clinical Evidence

Bench testing only. Testing confirmed device design and performance conform to requirements for use as a cricothyrotomy catheter.

Technological Characteristics

Catheter with proximal connector and internal dilator; insertion via needle. Single-use, sterile, peel-open packaging. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients requiring emergency airway access when conventional endotracheal intubation and ventilation cannot be performed. Intended for one-time use.

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 (K010016)
• The Pertrach (K914743)

Submission Summary (Full Text)

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

# FEB 2 1 2002

K013252

#### Safety and Effectiveness Information

| Submitted by: | Heidi Masten<br>Regulatory Affairs Coordinator<br>COOK INCORPORATED<br>750 Daniels Way<br>P.O. Box 489<br>Bloomington, IN 47402-0489<br>812-339-2235 | |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Device: | Trade Name: | Patil Cricothyroid Catheter Se |
| | Proposed Classification: | Emergency Airway Needle |
| Predicate Devices: | Melker Cuffed<br>Cricothyroid Catheter | Marketed & Distributed by<br>Cook Inc. (K010016) |
| | The Pertrach | Marketed and Distributed by<br>Pertrach Inc. (K914743) |

#### Device Description:

The Patil 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 over a needle is used for insertion. The catheter will be included in a set consisting of appropriately sized components.

#### Indications for Use:

The Patil 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 Patil 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.

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### Test Data:

The results of the tests performed provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a cricothyrotomy catheter.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.

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: K013252

Patil 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 wone reviewed your was your we device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for about in 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 and Councell Prov (110). - 100). - 100 are responsible to determine that the medical devices you prorisions of the Frea 110 it 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 May 20, 1973, and entires components in bulk (i.e., unfinished) and further process (e.g., sterilize) parenase your a ree 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

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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 I lease be actived that I Dr. over device complies with other requirements of the Act that I DA has made a covernment in the maintistered 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 requirements as bet form in moduct 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) This icher will anow you to begin maing of substantial equivalence of your device to a legally prematicate 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 (21 Of Compliance at [phone]. Additionally, for questions on the promotion and Office of Compliance at (301) se contact the Office of Compliance at [phone]. Also, advertising or your devices, preference to premarket notification"(21 CFR please note the regulation on your responsibilities under the Act may be obtained I art 007.97). Other general 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,

Dakota

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

Enclosure

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

### INDICATIONS FOR USE

Patil 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 K013252

ription Use OR Over-the-Counter Use

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________