RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET

K130405 · Teleflex Medical · BWC · Nov 6, 2013 · Anesthesiology

Device Facts

• Record ID: K130405
• Device Name: RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET
• Applicant: Teleflex Medical
• Product Code: BWC · Anesthesiology
• Decision Date: Nov 6, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5090
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Rusch EasyCric Emergency Cricothyrotomy Set is indicated to provide emergency airway access when conventional ventilation by intubation or face mask cannot be performed.

Device Story

Rusch EasyCric is a sterile, single-use emergency cricothyrotomy kit; utilizes Seldinger technique to establish artificial airway via cricothyroid membrane. Components include 5mm uncuffed tube, insertion dilator, scalpel, puncture needle, syringe, guidewire, neckband, and saline. Used in emergency settings (hospital OR, ICU, ER, or pre-hospital) by clinicians to bypass failed intubation. Device cuts link between cricoid and thyroid cartilage; guidewire facilitates tube placement. Provides rapid airway access compared to surgical tracheostomy. Output is a secured airway for ventilation via 15mm connector. Benefits include life-saving emergency ventilation when standard methods fail.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included connector/flange bonding strength (ISO 5366-1), connector fit (ISO 5356), coating consistency and lubricity, visual inspection of components, guidewire compatibility, and biocompatibility (ISO 10993-1).

Technological Characteristics

Materials: Polypropylene, Polyethylene, Nylon, PVC, ABS, Nickel, Stainless steel. Principle: Seldinger technique via cricothyroid membrane. Form factor: 5mm ID tube, 7cm length. Connectivity: 15mm connector for ventilation. Sterilization: Ethylene Oxide (10-6 SAL). Compliance: ISO 10993-1 (biocompatibility), ISO 5366-1 (bonding), ISO 5356 (connector fit).

Indications for Use

Indicated for adult patients requiring emergency airway access when conventional ventilation via intubation or face mask is not possible.

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 Emergency Cricothyrotomy Catheter Set (K013916)

Submission Summary (Full Text)

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## Name, Address, Phone and Fax Number of Applicant

· Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: [phone] Fax: [phone]

#### Contact Person

NOV 0 6 2013

Lori Pfohl Regulatory Affairs Specialist

#### Device Name

Trade Name: Rusch EasyCric Emergency Cricothyrotomy Set

Common Name: Emergency Cricothyrotomy Kit

Classification Name: Emergency Airway Needle (Class II per 21 CFR 868.5090, Product Code BWC, Class 2)

## Predicate Device

Melker Emergency Cricothyrotomy Catheter Set - K013916

## Device Description

The Rusch EasyCric Emergency Cricothyrotomy Set is a sterile, single use emergency cricothyroidotomy set available in size 5 mm. The device employs the Seldinger technique to provide an emergency artificial airway when attempts to intubate the trachea fail. Cricothyroidotomy provides faster access in emergency situations than surgical or percutaneous tracheostomy, which are time consuming procedures. The device gains access by cutting the link between the cricoid cartilage and the thyroid cartilage into the ligamentum conicum. It is available uncuffed. Components of the set include the EasyCric tube and insertion dilator, scalpel, puncture needle, syringe, guidewire, comport neckband and saline solution.

#### Indications for Use

Rusch EasyCric Emergency Cricothyrotomy Set is indicated to provide emergency airway access when conventional ventilation by intubation or face mask cannot be performed.

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Patient Population: Adult Patients

Environment of Use: Hospital Operating Room, Intensive Care Unit, the Emergency Room or out of the Hospital

# Substantial Equivalence

The proposed device is substantially equivalent to the predicate device:

| Features | Proposed | Predicate |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | K013916 |
| Device | Rusch EasyCric Emergency<br>Cricothyrotomy Set | Melker Emergency Cricothyrotomy<br>Catheter Set |
| Indications for use | Rusch EasyCric Emergency<br>Cricothyrotomy Set is indicated to<br>provide emergency airway access<br>when conventional intubation<br>cannot be performed | Melker Emergency Cricothyrotomy<br>Catheter Set is used for emergency<br>airway access in patients whom<br>conventional endotracheal intubation<br>and ventilation cannot be performed |
| FDA Product Code | BWC 868.5090 | BWC 868.5090<br>JOH 868.5800 |
| Class | II | II |
| Environment of Use | Hospital Operating Room,<br>Intensive Care Unit, the<br>Emergency Room or out of the<br>Hospital | Not Stated |
| Patient Population | Adult | Same |
| Contraindications | None | None |
| Technology applied | Seldinger Technique via the<br>cricothyroid membrane | Same |
| Single use | Yes | Same |
| Size (Main Tube) ID | 5 mm | 3.5mm, 4.0mm and 6.0mm |
| Main Tube length | 7cm | 3.8cm, 4.2cm, and 7.5cm |
| Cuff | No | Same |
| Available in sets | Yes | Same |
| Connection to<br>ventilation source | 15 mm connector | Same |
| Method of<br>Sterilization | Ethylene Oxide 10-6 SAL | Same |
| Basic Materials of<br>construction | Polypropylene<br>Polyethylene<br>Nylon<br>PVC<br>ABS<br>Nickel<br>Stainless steel | PVC<br>Remainder Unknown |

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| Features | Proposed | Predicate<br>K013916 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Set Components | Main tube<br>Curved dilator<br>Guidewire with flexible tip<br>Scalpel<br>Metal Needle<br>Comfort Neckband<br>Syringe<br>Saline Pouch | Main tube<br>Curved dilator<br>Guidewire with flexible tip<br>Scalpel<br>TFE Catheter needle, Entry needle<br>Syringe<br>Trach tape |
| Performance testing | • Connector bonding strength<br>• Flange (neck-plate) bonding<br>strength<br>• Connector Fit Test (ring gauge<br>test)<br>• Coating consistency on the<br>tube<br>• Coating lubricity<br>• Visual Inspection of Saline,<br>Scalpel and Neckband<br>• Guidewire testing | Not Stated |

- Indications for Use The indications for use are identical for the proposed . device when compared to the predicate -- K013916. Each device is indicated for use in emergency airway management when conventional intubation cannot be performed.
- Technology and construction The design, fabrication, shape, size, etc. are . equivalent to the predicate - K013916. Both the proposed and predicate devices use the Seldinger technique to gain access to the airway.
- Environment of use The environments of use are equivalent to predicate -. K013916
- Patient Population -The patient population is equivalent to the predicate -. K013916
- Materials -All patient contacting materials are in compliance with ISO 10993-1. . Testing performed is listed in the performance summary table below.

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Performance - A brief summary of tests relied upon to demonstrate substantial equivalence to the predicate can be found in the table below:

| Test | Reference to<br>Standard (if<br>applicable) | Principle of Test | Acceptance<br>Criteria |
|---------------------------------------------------------|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Connector bonding<br>strength | ISO 5366-1<br>Section 6.1<br>Machine end | The security of the<br>attachment of the<br>connector to the<br>tracheostomy tube is<br>tested by applying an<br>axial separation force to<br>the connector | Must be able to<br>sustain axial force<br>of 15 ± 1.5N<br>without movement |
| Flange (neck-plate)<br>bonding strength | ISO 5366-1<br>Section 6.2.<br>Neck-plate | The security of the<br>attachment of the neck-<br>plate to the tracheostomy<br>tube is tested by applying<br>an axial separation force<br>to the neck-plate (flange) | Must be able to<br>sustain axial force<br>of 15 ± 1.5N<br>without movement |
| Connector Fit Test<br>(ring gauge test) | ISO 5356:<br>Section 5.1 | To ensure the connector<br>is compatible with other<br>supporting connectors<br>and devices | The connector's<br>leading edge shall<br>lie between the<br>minimum and<br>maximum<br>diameter steps of<br>the gauge. |
| Coating consistency<br>on the tube | N/A | Determines coating<br>consistency | Smooth and even<br>coating on the<br>tube |
| Coating lubricity | N/A | Determines coating<br>lubricity | Wear value of less<br>than 150% |
| Visual Inspection of<br>Saline, Scalpel and<br>Neckband | N/A | Demonstrates these<br>components remain<br>intact | No torn packaging<br>or damage to the<br>product |
| Guidewire testing | N/A | Demonstrates guidewire<br>remains compatible with<br>the introducer and<br>needle post worst case<br>conditions | Smooth insertion<br>without restriction |
| Biocompatibility<br>testing | 10993-1 | Testing was performed<br>based on<br>mucosal/external<br>communicating contact<br>of limited duration (<24<br>hrs.). Hemolysis testing<br>was also performed due<br>to possible tissue<br>contact. | Must meet the<br>requirements as<br>outlined in ISO<br>10993-1 |

The Rusch EasyCric has the same indications for use, technological characteristics and construction as its predicate. Performance test results demonstrate that the proposed device does not raise new questions of safety and effectiveness and because pass/fail criteria has been met, the devices can be found substantially equivalent.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image contains the words "Public Health Service" in a bold, serif font. The text is black against a white background. The words are stacked on top of each other.

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

#### November 6, 2013

Teleflex Medical, Incorporated C/O Ms. Lori Pfohl Regulatory Affairs Specialist 2917 Weck Drive RESEARCH TRIANGLE PARK, NC 27709

Re: K130405

Trade/Device Name: Rusch EasyCric Emergency Cricothyrotomy Set Regulation Number: 21 CFR 868.5090 Regulation Name: Emergency Airway Needle Regulatory Class: Class II Product Code: BWC Dated: October 4, 2013 Received: October 7, 2013

Dear Ms. Pfohl:

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 adulterstion. 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 four of 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 - Ms. Pfohl

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 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 clectronic 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/McdicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mary S. Runner -S

Kwame Ulmer M.S. Acting Division 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 Statement

Page 1 of 1

510(k) Number:

K 130405

Device Name:

Rusch EasyCric Emergency Cricothyrotomy Set

Indications for Use:

Rusch EasyCric Emergency Cricothyrotomy Set is indicated to provide emergency airway access when conventional ventilation by intubation or face mask cannot be performed.

Patient Population: Adult patients

Environment of Use: Hospital Operating Room, Intensive Care Unit, the Emergency Room or out of the Hospital

Prescription Use XX (Part 21 CFR 801 Subpart D)

Over-the-counter use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Anval C