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.

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

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.

AI/ML Overview

This document (K013252) does not contain detailed information about specific acceptance criteria or a dedicated study proving that the device meets those criteria. Instead, it seems to be a 510(k) premarket notification for a medical device (Patil Cricothyrotomy Catheter), which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive performance studies with predefined acceptance criteria.

The phrase "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" (from {1}) indicates that some testing was done, but the specifics of those tests, the acceptance criteria, and the detailed results are not included in this document.

Therefore, most of the information requested in your prompt cannot be extracted from this document. However, I can provide what is available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified in this document.	The document states, "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." No specific performance metrics or values are provided.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not specified, as no study with a test set requiring expert-established ground truth is detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study is mentioned in this document. The device is a physical catheter, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a physical catheter.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not specified, as no study with a ground truth determination process is detailed.

8. The sample size for the training set

Not applicable, as this device is a physical component, not an AI/algorithmic system that typically involves training sets.

9. How the ground truth for the training set was established

Not applicable.

Summary

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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 MastenRegulatory Affairs CoordinatorCOOK INCORPORATED750 Daniels WayP.O. Box 489Bloomington, IN 47402-0489812-339-2235
Device:	Trade Name:	Patil Cricothyroid Catheter Se
	Proposed Classification:	Emergency Airway Needle
Predicate Devices:	Melker CuffedCricothyroid Catheter	Marketed & Distributed byCook Inc. (K010016)
	The Pertrach	Marketed and Distributed byPertrach Inc. (K914743)

Device Description:

Indications for 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.

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

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.

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

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

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

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 (301) 594-4648. Additionally, for questions on the promotion and Office of Compliance at (301) se contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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__________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 868.5090 Emergency airway needle.

(a)
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.(b)
Classification. Class II (performance standards).