The Melker Emergency Cricothyrotomy Catheter Set is used for emergency airway access.
. In patients whom conventional endotracheal intubation and ventilation cannot be performed.
The device will be supplied sterile and is intended for one-time use.

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

Device Description

The Melker Emergency Cricothyrotomy Catheter with a standard inner diameter of 3.5, 4, or 6 mm and a length of either 3.8, 4.2, 7.5 cm with a proximal fitting and a coaxial dilator tapered to a 0.038-inch wire guide.

AI/ML Overview

This 510(k) premarket notification for the Melker Emergency Cricothyrotomy Catheter Set (K013916) does not contain the detailed information necessary to fully address all aspects of your request. The submission is primarily focused on demonstrating substantial equivalence to a predicate device (K010016) based on indications for use, material, and physical characteristics, and adherence to quality system procedures.

Here's an analysis based on the provided text, highlighting what is available and what is missing:

Acceptance Criteria and Study for K013916: Melker Emergency Cricothyrotomy Catheter Set

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Reported Device Performance	Comments
Specific Performance Criteria	Not explicitly stated in terms of measurable thresholds or pass/fail criteria.	The document states "Specific performance of the device subject of this submission is assured through adherence to the firm's quality system procedures for device quality. Various device design specifications and quality specifications are used to produce a device that meets predetermined acceptance criteria." However, the specific acceptance criteria themselves and the performance metrics against those criteria are not detailed in this 510(k) summary.
Substantial Equivalence	"This device is the same with respect to indications for use, material and physical characteristics to the Melker Cuffed Cricothyrotomy Catheter Set cleared under K010016 on 10/09/01."	This is the primary "performance" being demonstrated for regulatory clearance. The device is deemed to perform acceptably because it is equivalent to a previously cleared device.
Sterility	"The Melker Emergency Cricothyrotomy Catheter Set will be sterilized using an Ethylene Oxide (ETO) gas cycle validated to assure a 10⁻⁶ sterility assurance level."	This is a specific performance criterion and the reported result (validation to 10⁻⁶ SAL) meets the industry standard for sterile medical devices.
Packaging Integrity	"Each unit is packaged and sealed within a Tyvek-Poly pouch and properly labeled."	Implies that packaging integrity is a criterion, though specific test results (e.g., seal strength, barrier properties) are not provided.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not describe a specific "test set" in the context of a clinical or performance study with human or simulated cases for K013916.
The comparison is based on the characteristics of the device being "the same" as a predicate device (K010016).
Therefore, no sample size for a test set is provided, and data provenance for such a test set is not applicable in this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable. As no specific "test set" or clinical study requiring ground truth establishment is described for K013916, there is no mention of experts or their qualifications for this purpose.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring an adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done or reported in this submission. The submission relies on substantial equivalence to the predicate device, not on demonstrating improved human reader performance with or without AI.

6. Standalone Performance Study (Algorithm Only):

Not applicable. This device is a catheter set, not an algorithm or AI-driven system. Therefore, a standalone (algorithm only) performance study is not relevant.

7. Type of Ground Truth Used:

Not applicable. As there is no described test set or study involving diagnostic performance, the concept of "ground truth" (e.g., pathology, outcomes data) is not relevant to this 510(k) submission for K013916. The "ground truth" for the clearance is essentially the established performance and safety profile of the predicate device (K010016).

8. Sample Size for the Training Set:

Not applicable. As this is a physical medical device (catheter set) and not an AI/ML algorithm requiring a training set, the concept of a "training set" is not relevant to this submission.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set mentioned, the establishment of its ground truth is also not applicable.

Summary of Study (as presented in the 510(k) for K013916):

The "study" for K013916 is a substantial equivalence comparison to a predicate device (Melker Cuffed Cricothyrotomy Catheter Set, K010016). The manufacturer asserts that the new device is "the same with respect to indications for use, material and physical characteristics" as the predicate device. Therefore, the "acceptance criteria" in this context are that the new device replicates the key attributes of the cleared predicate device. The "study" largely involves documentation of device design, materials, manufacturing processes, and sterilization validation, aligning them with those of the predicate device and the firm's quality system.

The submission does not involve clinical trials, comparative studies against human performance, or studies typically associated with AI/ML devices that would require test sets, ground truth, or statistical power calculations for diagnostic accuracy.

Summary

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

K013916

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

DEC 2 0 2001

9 510K SUMMARY

Submitted By:

Heidi Masten, RT(T), MBA Regulatory Affairs Coordinator COOK INCORPORATED 925 South Curry Pike P.O. Box 489 Bloomington, In 47402 (812) 339-2235

Device:

Trade Name:	Melker Emergency Cricothyrotomy Catheter Set
Common/Usual Name:	Catheter, emergency airway access needle
Proposed Classification Name:	Emergency Airway Needle21 CFR Part 868.5090Class II

Intended Use:

The Melker Emergency Cricothyrotomy Catheter Set is used for emergency airway access.

. In patients whom conventional endotracheal intubation and ventilation cannot be performed.
The device will be supplied sterile and is intended for one-time use.

Device Description:

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

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

Substantial Equivalence:

The device will be manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to currently marketed devices. This device is the same with respect to indications for use, material and physical characteristics to the Melker Cuffed Cricothyrotomy Catheter Set cleared under K010016 on 10/09/01.

Performance Information:

Specific performance of the device subject of this submission is assured through adherence to the firm's quality system procedures for device quality. Various device design specifications and quality specifications are used to produce a device that meets predetermined acceptance criteria. This is the same as for the Melker Cuffed Cricothyrotomy Catheter Set cleared under K010016 on 10/09/01.

Packaging Information:

Each unit is packaged and sealed within a Tyvek-Poly pouch and properly labeled.

Sterilization Information:

The Melker Emergency Cricothyrotomy Catheter Set will be sterilized using an Ethylene Oxide (ETO) gas cycle validated to assure a 10° sterility assurance level.

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

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three curved lines representing its wings. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2001

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

Re: K013916

Melker Emergency Cricothyrotomy Catheter Set Regulation Number: 868.5090 and 868.5800 Regulation Name: Emergency Airway Needle and Tracheostomy Tube and Tube Cuff Regulatory Class: Class II (two) Product Code: 73 BWC, JOH Dated: November 26, 2001 Received: November 27, 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 for abound in the 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 I ou mayy atterest, while 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.

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

Page 2 - Ms. Heidi Masten

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 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

I Dank Tille

Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

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

INDICATIONS FOR USE

Melker 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)

Signature

Division of Cardiovascular & Respiratory Devices
510(k) Number	R013116

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

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).