The H & H Emergency Cricothyrotomy (cuffed) Tube is indicated for emergency airway access when conventional endotracheal intubation cannot be performed. It is intended for adult patients for use in the following environments: Hospital Operating Room, Intensive Care Unit, the Emergency Room or out of the Hospital. This device is intended for Limited Duration Use (<24 hours).

Device Description

The H & H Emergency Cricothyrotomy Tube is a sterile, single-use cuffed cricothyrotomy tube (airway tube) designed to provide an emergency airway to the patient's lungs when the upper airway/larynx/pharynx or oral & nasal routes are occluded or compromised due to traumatic injury. The outer diameter of the airway tube is 8mm and the inner diameter is 6mm. The inflatable cuff on the airway tube provides a seal against the trachea, ensuring that inspiratory and expiratory gasses are routed through the airway tube and not allowed to escape into the patient's upper airway, thus preventing loss of ventilation as well as protecting against aspiration of stomach contents, blood, and body fluid. The airway tube incorporates a PVC flange 8cm from the distal end, which serves as a positive stop and prevents over insertion of the airwav tube and thereby minimizes the likelihood of right main stem bronchial intubation.

AI/ML Overview

The provided information describes a K123528 510(k) submission for the "H & H Emergency Cricothyrotomy Tube (cuffed)". This is a medical device and not an AI/ML algorithm, therefore, many of the typical questions for AI/ML device studies are not applicable.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is assessed through non-clinical testing against established standards.

Test	Acceptance Criteria	Reported Device Performance
Connector Bonding Strength	Must be able to sustain axial force of $15 \pm 1.5N$ without movement	Met requirements (implied by "device met all requirements/clauses of ISO 5366-1:2012")
Flange (neck-plate) Bonding Strength	Must be able to sustain axial force of $15 \pm 1.5N$ without movement	Met requirements (implied by "device met all requirements/clauses of ISO 5366-1:2012")
Connector Fit Test	The connector's leading edge shall lie between the min and max diam steps of the gauge	Met requirements (implied by "device met all requirements/clauses of ISO 5366-1:2012")
Biocompatibility Testing	Must meet requirements outlined in ISO 10993-1 and specified by FDA.	Met requirements (implied by "device met all requirements/clauses of ISO 5366-1:2012")
Functionality, Packaging, Sterilization, Shelf-life	N/A (General design requirements)	Met all design requirements

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

This is a physical medical device, not an AI/ML algorithm. Therefore, the concept of a "test set" with data provenance (country of origin, retrospective/prospective) doesn't directly apply in the same way. The testing involved physical samples of the manufactured device. The document does not specify the exact number of units tested for each non-clinical test, but it is implied that a sufficient number was tested to demonstrate compliance with the standards.

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

Not applicable. Ground truth for physical device testing is established by engineering standards and specifications, not by expert consensus on clinical data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of clinical data, which is not relevant here.

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

Not applicable. This is a physical medical device, not an AI/ML algorithm. No human readers or AI assistance are involved in its primary function or testing.

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

Not applicable. This is a physical medical device, not an AI/ML algorithm.

7. The Type of Ground Truth Used

The ground truth for this device's performance is based on engineering standards and specifications. For instance, the "axial force" for bonding strength is a predefined physical parameter. Biocompatibility is assessed against ISO 10993-1 which provides methodologies and acceptance criteria for biological evaluation.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm; thus, there is no "training set."

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

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary

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K123528

JUL 0 3 2014

510(k) Summary

H & H Emergency Cricothvrotomy Tube (cuffed)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The FDA Group on behalf of: H & H Associates

CAGE 1NNH6 Ordinary, VA 23131

Paul Harder .

July 1, 2014

General Information

Submitter Name:

Address:

Contact Person: Date Prepared:

Device Name

Proprietary Name: Common Name: Classification Name: Device Class: Product Code: CFR Section:

Emergency Cricothyrotomy Tube Cricothvrotomy Tube Tracheostomy tube and tube cuff Class II ીଠାન 868.5800

Description

Intended Use/Indications for Use

The H & H Emergency Cricothyrotomy Tube is indicated for emergency airway access when conventional endotracheal intubation cannot be performed. It is intended for adult patients for use in the following environments: Hospital Operating Room, Intensive Care Unit, the Emergency Room or out of the Hospital.

This device is intended for Limited Duration Use (<24 hours).

Predicate Device

K010016 - Cook Melton Emergency Cricothyrotomy Kit (cuffed) cleared 10/9/2001.

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Table 1 - Comparison to Predicate Device

	Predicate Device:	Proposed Device:
Characteristics	Cook Melker (cuffed)Emergency Cricothyrotomy Kit(K010016)	H & H EmergencyCricothyrotomy (cuffed) Kit(TBD)
Indications for Use	The Melker EmergencyCricothyrotomy (cuffed) catheter isused for emergency access whenconventional endotracheal intubationcannot be performed.	H & H EmergencyCricothyrotomy (cuffed) Kit isindicated for emergency airwayaccess when conventionalendotracheal intubation cannotbe performed.Intended for Limited Duration(<24 hours)
Tube Material	PVC	Same
Cuff Material	PVC	Same
Tube Inner Diameter	5mm	6mm
Tube Outer Diameter	Unknown	8mm
Tube Length	8cm	8cm (flange to tip)
Radiopaque Strip	Yes	Yes
Designed for PercutaneousEntry	Yes	Yes
Provided as Sterile Kit	Yes	Yes
Sterilization	ETO	Gamma
Single Use	Yes	Yes
Packaging	Peel open Tyvek package	5 mil nylon/poly vacuum sealedbag

Non-Clinical Testing

Non-clinical testing was completed to confirm that the device meets all design requirements for functionality, packaging, sterilization, shelf-life and biocompatibility. The H&H Cricothyrotomy Tube met all requirements/clauses of ISO 5366-1:2012.

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Table 2 – Non-Clinical Testing

Test	Reference toStandard (IfApplicable)	Principle of Test	Acceptance Criteria
Connector BondingStrength	ISO 5366-1, Section6.1 Machine end	The security of theattachment of theconnector to the tube istested by applying anaxial separation force tothe connector	Must be able to sustainaxial force of $15 \pm 1.5N$without movement
Flange (neck-plate)Bonding Strength	ISO 5366-1 Section6.2 Neck-plate	The security of theattachment of the neck-plate to thetracheosotomy tube istested by applying anaxial separation force tothe neck-plate (flange)	Must be able to sustainaxial force of $15 \pm 1.5N$without movement
Connector Fit Test	ISO 5366 Section 5.1	To ensure theconnector is compatiblewith other supportingconnectors and devices	The connector's leadingedge shall lie betweenthe min and max diamsteps of the gauge
BiocompatibilityTesting	ISO 10993-1	Testing performedbased onmucosal/externalcommunicating contactof limited duration (<24hrs) to include,Cytotoxicity,Intracutaneous,Sensitization (0.9%NaCl & Cottonseed oil).Hemocompatibility andAcute Systemic testingalso completed due topossible blood contact	Must meet requirementsoutlined in ISO 10993-1and specified by FDA.

Clinical Data

Summary

ﺮ

All testing demonstrates that the H & H Emergency Cricothyrotomy Tube performs as intended when used in accordance with its labeling.

As the intended use, operating principle, materials and technological characteristics are comparable to the predicate device, the proposed H & H Emergency Cricothyrotomy Tube is substantially equivalent. The minor differences between the proposed device and the predicate device do not raise any new questions of safety or effectiveness.

iii

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of a human figure embracing a three-barred symbol, which is often interpreted as representing the interconnectedness of health, services, and humanity.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 3, 2014

H & H Medical Corporation Mr. Paul Harder President 4173 George Washington Memorial Highway Ordinary, VA 23121

Re: K133528

Trade/Device Name: H & H Emergency Cricothyrotomy Tube Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy tube and tube cuff Regulatory Class: II Product Code: JOH Dated: June 25, 2014 Received: June 26, 2014

Dear Mr. Harder:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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.

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Page 2 - Mr. Harder

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part

807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D. Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K133528

Device Name: H & H Emergency Cricothyrotomy Tube

Indications for Use:

The H & H Emergency Cricothyrotomy (cuffed) Tube is indicated for emergency airway access when conventional endotracheal intubation cannot be performed.

It is intended for adult patients for use in the following environments: Hospital Operating Room, Intensive Care Unit, the Emergency Room or out of the Hospital.

This device is intended for Limited Duration Use (<24 hours).

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anya C. Harry -S 2014.07.03 11:21:36 -04'00' Page 1 of 1

Regulation Number and Section

§ 868.5800 Tracheostomy tube and tube cuff.

(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.