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

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.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

The document describes the Rusch EasyCric Emergency Cricothyrotomy Set and its substantial equivalence to a predicate device. The "study" in this context refers to various performance tests conducted to demonstrate that the new device meets established safety and performance standards equivalent to the predicate. This is not a clinical study involving human patients or complex diagnostic algorithms.

Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Connector bonding strength	Must be able to sustain axial force of 15 ± 1.5N without movement	Met (Implied by "Pass/fail criteria has been met")
Flange (neck-plate) bonding strength	Must be able to sustain axial force of 15 ± 1.5N without movement	Met (Implied by "Pass/fail criteria has been met")
Connector Fit Test (ring gauge test)	The connector's leading edge shall lie between the minimum and maximum diameter steps of the gauge.	Met (Implied by "Pass/fail criteria has been met")
Coating consistency on the tube	Smooth and even coating on the tube	Met (Implied by "Pass/fail criteria has been met")
Coating lubricity	Wear value of less than 150%	Met (Implied by "Pass/fail criteria has been met")
Visual Inspection of Saline, Scalpel and Neckband	No torn packaging or damage to the product	Met (Implied by "Pass/fail criteria has been met")
Guidewire testing	Smooth insertion without restriction	Met (Implied by "Pass/fail criteria has been met")
Biocompatibility testing	Must meet the requirements as outlined in ISO 10993-1	Met (Implied by "Pass/fail criteria has been met" and "All patient contacting materials are in compliance with ISO 10993-1")

Study Details:

Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the numerical sample size for each performance test (e.g., how many connectors were tested for bonding strength). It lists the types of tests performed.
- Data Provenance: Not specified, but these are likely laboratory-based tests conducted by the manufacturer (Teleflex Medical). No country of origin for the data or whether it's retrospective/prospective is indicated, as this typically applies to clinical or observational studies on patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. These are engineering/performance bench tests, not evaluations requiring expert medical interpretation to establish ground truth such as in diagnostic imaging studies. The "ground truth" is defined by the physical or chemical properties being measured against established standards (e.g., force, dimension, visual integrity, biocompatibility standards).
Adjudication method for the test set:
- Not applicable in the context of expert consensus or multi-reader reviews, as these are technical performance tests against objective criteria. The pass/fail criteria for each test serves as the "adjudication."
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic performance of imaging devices or algorithms with human readers, which is not the nature of this device's submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (cricothyrotomy set), not an AI algorithm. Its performance is assessed through its physical and functional integrity, not through algorithmic output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance tests consists of established engineering standards, physical measurement criteria, and adherence to recognized international standards (e.g., ISO 5366-1, ISO 5356, ISO 10993-1).
The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI models.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary of Device Performance Study:

The "study" presented here is a series of bench and laboratory performance tests designed to demonstrate that the Rusch EasyCric Emergency Cricothyrotomy Set is substantially equivalent to a predicate device. The tests evaluate physical characteristics and safety aspects of the device components (e.g., connector strength, coating quality, biocompatibility). The acceptance criteria for these tests are derived from international standards (ISO) or internal specifications designed to ensure the device is safe and performs as intended. The document states that all pass/fail criteria were met, leading to the conclusion of substantial equivalence. This is primarily a regulatory submission focused on engineering and material performance.

Summary

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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: 919-433-4908 Fax: 919-433-4996

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

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 EmergencyCricothyrotomy Set	Melker Emergency CricothyrotomyCatheter Set
Indications for use	Rusch EasyCric EmergencyCricothyrotomy Set is indicated toprovide emergency airway accesswhen conventional intubationcannot be performed	Melker Emergency CricothyrotomyCatheter Set is used for emergencyairway access in patients whomconventional endotracheal intubationand ventilation cannot be performed
FDA Product Code	BWC 868.5090	BWC 868.5090JOH 868.5800
Class	II	II
Environment of Use	Hospital Operating Room,Intensive Care Unit, theEmergency Room or out of theHospital	Not Stated
Patient Population	Adult	Same
Contraindications	None	None
Technology applied	Seldinger Technique via thecricothyroid 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 toventilation source	15 mm connector	Same
Method ofSterilization	Ethylene Oxide 10-6 SAL	Same
Basic Materials ofconstruction	PolypropylenePolyethyleneNylonPVCABSNickelStainless steel	PVCRemainder Unknown

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Features	Proposed	PredicateK013916
Set Components	Main tubeCurved dilatorGuidewire with flexible tipScalpelMetal NeedleComfort NeckbandSyringeSaline Pouch	Main tubeCurved dilatorGuidewire with flexible tipScalpelTFE Catheter needle, Entry needleSyringeTrach tape
Performance testing	• Connector bonding strength• Flange (neck-plate) bondingstrength• Connector Fit Test (ring gaugetest)• Coating consistency on thetube• Coating lubricity• Visual Inspection of Saline,Scalpel and Neckband• 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 toStandard (ifapplicable)	Principle of Test	AcceptanceCriteria
Connector bondingstrength	ISO 5366-1Section 6.1Machine end	The security of theattachment of theconnector to thetracheostomy tube istested by applying anaxial separation force tothe connector	Must be able tosustain axial forceof 15 ± 1.5Nwithout movement
Flange (neck-plate)bonding strength	ISO 5366-1Section 6.2.Neck-plate	The security of theattachment of the neck-plate to the tracheostomytube is tested by applyingan axial separation forceto the neck-plate (flange)	Must be able tosustain axial forceof 15 ± 1.5Nwithout movement
Connector Fit Test(ring gauge test)	ISO 5356:Section 5.1	To ensure the connectoris compatible with othersupporting connectorsand devices	The connector'sleading edge shalllie between theminimum andmaximumdiameter steps ofthe gauge.
Coating consistencyon the tube	N/A	Determines coatingconsistency	Smooth and evencoating on thetube
Coating lubricity	N/A	Determines coatinglubricity	Wear value of lessthan 150%
Visual Inspection ofSaline, Scalpel andNeckband	N/A	Demonstrates thesecomponents remainintact	No torn packagingor damage to theproduct
Guidewire testing	N/A	Demonstrates guidewireremains compatible withthe introducer andneedle post worst caseconditions	Smooth insertionwithout restriction
Biocompatibilitytesting	10993-1	Testing was performedbased onmucosal/externalcommunicating contactof limited duration (<24hrs.). Hemolysis testingwas also performed dueto possible tissuecontact.	Must meet therequirements asoutlined in ISO10993-1

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 (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/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

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).