H&H EMERGENCY CRICOTHYROTOMY KIT

K133528 · H & H Medical Corporation · JOH · Jul 3, 2014 · Anesthesiology

Device Facts

• Record ID: K133528
• Device Name: H&H EMERGENCY CRICOTHYROTOMY KIT
• Applicant: H & H Medical Corporation
• Product Code: JOH · Anesthesiology
• Decision Date: Jul 3, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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).

Device Story

Sterile, single-use cuffed cricothyrotomy tube; provides emergency airway access when upper airway is occluded or compromised by trauma. Device features 8mm outer diameter, 6mm inner diameter, and PVC flange 8cm from distal end to prevent over-insertion. Inflatable cuff seals trachea to prevent aspiration and ensure gas delivery. Used by clinicians in hospital or out-of-hospital emergency settings. Device facilitates ventilation in patients where standard intubation fails.

Clinical Evidence

No clinical data. Bench testing only, including connector bonding strength, flange bonding strength, connector fit, and biocompatibility (ISO 10993-1). Device met all requirements of ISO 5366-1:2012.

Technological Characteristics

PVC airway tube with inflatable PVC cuff; 8mm OD, 6mm ID, 8cm length. Includes radiopaque strip. Sterilized via Gamma radiation. Designed for percutaneous entry. Complies with ISO 5366-1:2012 and ISO 10993-1 for biocompatibility.

Indications for Use

Indicated for emergency airway access in adult patients when conventional endotracheal intubation is not feasible. Used in hospital (OR, ICU, ER) or out-of-hospital settings. Limited duration use (<24 hours).

Regulatory Classification

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.

Predicate Devices

• Cook Melton Emergency Cricothyrotomy Kit (cuffed) (K010016)

Submission Summary (Full Text)

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K123528

JUL 0 3 2014

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# 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

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.

#### 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)<br>Emergency Cricothyrotomy Kit<br>(K010016) | H & H Emergency<br>Cricothyrotomy (cuffed) Kit<br>(TBD) |
| Indications for Use | The Melker Emergency<br>Cricothyrotomy (cuffed) catheter is<br>used for emergency access when<br>conventional endotracheal intubation<br>cannot be performed. | H & H Emergency<br>Cricothyrotomy (cuffed) Kit is<br>indicated for emergency airway<br>access when conventional<br>endotracheal intubation cannot<br>be performed.<br>Intended for Limited Duration<br>(<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 Percutaneous<br>Entry | 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 sealed<br>bag |

## 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 to<br>Standard (If<br>Applicable) | Principle of Test | Acceptance Criteria |
|-----------------------------------------|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Connector Bonding<br>Strength | ISO 5366-1, Section<br>6.1 Machine end | The security of the<br>attachment of the<br>connector to the tube is<br>tested by applying an<br>axial separation force to<br>the connector | Must be able to sustain<br>axial force of $15 \pm 1.5N$<br>without movement |
| Flange (neck-plate)<br>Bonding Strength | ISO 5366-1 Section<br>6.2 Neck-plate | The security of the<br>attachment of the neck-<br>plate to the<br>tracheosotomy tube is<br>tested by applying an<br>axial separation force to<br>the neck-plate (flange) | Must be able to sustain<br>axial force of $15 \pm 1.5N$<br>without movement |
| Connector Fit Test | ISO 5366 Section 5.1 | To ensure the<br>connector is compatible<br>with other supporting<br>connectors and devices | The connector's leading<br>edge shall lie between<br>the min and max diam<br>steps of the gauge |
| Biocompatibility<br>Testing | ISO 10993-1 | Testing performed<br>based on<br>mucosal/external<br>communicating contact<br>of limited duration (<24<br>hrs) to include,<br>Cytotoxicity,<br>Intracutaneous,<br>Sensitization (0.9%<br>NaCl & Cottonseed oil).<br>Hemocompatibility and<br>Acute Systemic testing<br>also completed due to<br>possible blood contact | Must meet requirements<br>outlined in ISO 10993-1<br>and specified by FDA. |

## Clinical Data

NA

## 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.

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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