(267 days)
Not Found
No
The device description and performance studies focus solely on the physical characteristics and mechanical performance of a simple catheter and needle assembly. There is no mention of any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for emergency airway access, which is a medical intervention to treat a life-threatening condition (airway obstruction), thus making it a therapeutic device.
No
The device is a catheter-needle assembly intended for "emergency airway access when conventional endotracheal intubation cannot be performed." This indicates a therapeutic or intervention-based use to establish an airway, not to diagnose a condition.
No
The device description explicitly details physical components (catheter, needle, tubing, hubs, etc.) and the performance studies focus on the physical properties and functionality of these hardware components. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "emergency airway access when conventional endotracheal intubation cannot be performed." This is a direct intervention on the patient's body to establish an airway.
- Device Description: The device is a physical catheter and needle assembly designed to be inserted into the trachea.
- Lack of Diagnostic Function: The device does not perform any tests on samples taken from the body (like blood, urine, or tissue) to diagnose a condition or provide information about a patient's health status. Its purpose is purely therapeutic/interventional.
- Performance Studies: The performance studies focus on the physical properties and functionality of the device for insertion and maintaining an airway (bending rigidity, insertion force, breaking resistance, air leakage, etc.). These are not studies related to diagnostic accuracy or performance.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
The Emergency Transtracheal Airway Catheter is intended for emergency airway access when conventional endotracheal intubation cannot be performed.
Product codes (comma separated list FDA assigned to the subject device)
BWC
Device Description
The Emergency Transtracheal Airway Catheter is composed of a catheter and needle. The catheter-needle assembly cannulates the trachea through the cricothyroid membrane in order to establish an airway. The catheter is designed as a 6.0 French catheters manufactured from reinforced fluorinated ethylene propylene (FEP) tubing fitted to a 15 gage stainless steel needle with a lancet bevel. The nominal length of the catheter measures 5.0 or 7.5 centimeters, depending upon device specification. The catheter French size is stamped on the proximal fitting of the catheter. The Luer hub on the proximal end of the catheter connects to an oxygen source. The needle is manufactured with a nickel plated brass hub. The lancet bevel of the needle extends from the catheter at the beel of the bevel. The needle and the hub are soldered with tin-silver alloy material. The catheter-needle assembly cannulates the trachea through the cricothyroid membrane in order to establish an airway. The needle is removed from the catheter after the catheter-needle assembly establishes an airway through the cricothyroid membrane, leaving the catheter in the trachea.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trachea, cricothyroid membrane
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Design Validation-(Zero Time) The test articles shall be able to access the trachea . of an AirSim Advance Combo model when following the instructions provided in the Instructions for Use. The acceptance criterion was met.
- . Bending Rigidity of the Needle (Zero Time) – The purpose of the study was to verify that the peak load during compression within the specified deflection be greater than 7.5 N. The acceptance criterion was met.
- . Insertion Force of the Needle (Zero Time) – The purpose of the study was to determine the maximum compressive load. The acceptance criterion was met.
- . Breaking Resistance (Zero Time) - The purpose of the study was to confirm that the cannula of the device would withstand the forces experienced during clinical use without breaking. The predetermined acceptance criterion was met.
- Air Leakage of the Catheter (Zero Time) The purpose of the study was to verify . that the test articles meet the air leakage requirements of BS EN ISO 10555-1. The acceptance criterion was met.
- Resistance to Overriding (Zero-Time) The purpose of the study was was to . verify that the test articles meet the resistance to overriding requirements set forth in ISO 594-2. The acceptance criterion was met.
- . Unscrewing Torque (Zero-Time) - The purpose of the study was to verify that the test articles meet the unscrewing torque requirements set forth in ISO 594-2. The acceptance criterion was met.
- Separation Force (Zero-Time) - The purpose of the study was to verify that the test articles meet the separation force requirements set forth in ISO 594-2. The predetermined acceptance criterion was met.
- . Tensile Test of the Shaft of the Catheter (Three-year Accelerated Aging) –The purpose of study was to determine the peak tensile force of the shaft of the test articles after accelerated aging to the real-time equivalent of 3 years. The acceptance criterion was met.
- Tensile Test of the Hub to Shaft Bond of the Catheter (Three-year Accelerated . Aging) - The purpose of study was to determine the peak load of the hub-to-shaft bond of the test specimens after accelerated aging to the real-time equivalent of 3 years. The acceptance criterion was met.
- . Tensile Test of the Hub to Cannula Bond of the Needle (Three-year Accelerated Aging) - Testing per ISO 11070 showed that the needle cannula does not loosen from the hub when a tensile load of at least 20 N is applied. The acceptance criterion was met.
- . Air Leakage of the Catheter (Three-year Accelerated Aging and Two-year Real Time Aging) – The purpose of study was to verify that the test articles meet the air leakage requirements of BS EN ISO 10555-1 after accelerated aging to the real-time equivalent of 3 years. The acceptance criterion was met.
- . Biocompatibility Testing - Per ISO 10993-1 and FDA guidance, testing for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity and material-mediated pyrogenicity were performed to insure the biocompatibility of the subject device. The predetermined acceptance criteria were met.
- . Five Year Accelerated Aging Report for Packaging Validation - The purpose of study is to the accelerated aging of the packaging system to the real time equivalent of greater than or equal to 5 years. The acceptance criterion was met.
- . Sterility Testing - Testing confirms that the device meets the appropriate requirements for bioburden, endotoxins, and EO and ECH residuals.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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Image /page/0/Picture/1 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" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 22, 2016
Cook Incorporated Kotei Aoki Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404
Re: K153761
Trade/Device Name: Emergency Transtracheal Airway Catheter Regulation Number: 21 CFR 868.5090 Regulation Name: Emergency Airway Needle Regulatory Class: Class II Product Code: BWC Dated: August 19, 2016 Received: August 22, 2016
Dear Kotei Aoki:
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.
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Tina
Kiang -S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K153761
Device Name Emergency Transtracheal Airway Catheter
Indications for Use (Describe)
The Emergency Transtracheal Airway Catheter is intended for emergency airway access when conventional endotracheal intubation cannot be performed.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Emergency Transtracheal Airway Catheter 21 CFR §868.5090 Date Prepared: September 21, 2016
Submitted By:
| Applicant: |
|---|
| Contact: |
| Applicant Address: |
Cook Incorporated Kotei Aoki Cook Incorporated 750 Daniels Way Bloomington, IN 47404 (812) 335-3575 x102630 (812) 332-0281
Contact Fax Number:
Contact Phone Number:
Device Information:
Trade name: Common name: Classification Name: Regulation: Product Code:
Emergency Transtracheal Airway Catheter Tracheal Catheter Needle Emergency Airway Needle 21 CFR §868.5090 BWC
Predicate Devices:
The device subject of this submission is substantially equivalent to the predicate device. Patil Emergency Cricothyrotomy Catheter Set. cleared for market under 510(k) number K013252 on February 21, 2002.
Device Description:
The Emergency Transtracheal Airway Catheter is composed of a catheter and needle. The catheter-needle assembly cannulates the trachea through the cricothyroid membrane in order to establish an airway. The catheter is designed as a 6.0 French catheters manufactured from reinforced fluorinated ethylene propylene (FEP) tubing fitted to a 15 gage stainless steel needle with a lancet bevel. The nominal length of the catheter measures 5.0 or 7.5 centimeters, depending upon device specification. The catheter French size is stamped on the proximal fitting of the catheter. The Luer hub on the proximal end of the catheter connects to an oxygen source.
The needle is manufactured with a nickel plated brass hub. The lancet bevel of the needle extends from the catheter at the beel of the bevel. The needle and the hub are soldered
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Image /page/4/Picture/1 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in white, sans-serif font, with a registered trademark symbol to the right. Below "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font.
with tin-silver alloy material. The catheter-needle assembly cannulates the trachea through the cricothyroid membrane in order to establish an airway. The needle is removed from the catheter after the catheter-needle assembly establishes an airway through the cricothyroid membrane, leaving the catheter in the trachea.
Intended Use:
The Emergency Transtracheal Airway Catheter is intended for emergency airway access when conventional endotracheal intubation cannot be performed.
Comparison to Predicates:
The Emergency Transtracheal Airway Catheters are substantially equivalent to the predicate device, Patil Emergency Cricothyrotomy Catheter Set (K013252), in that these devices have the identical intended use, method of operation, and the same fundamental technological characteristics. The modifications to the needle, the airway catheter, and the needle hub have been included.
Furthermore, aside from the needle hub and the solder, no other changes to the material components of the subject device have been made with respect to the predicate device. However, biocompatibility testing has been performed to confirm the device remains biocompatible.
The substantial equivalence of the modified device to the predicate device is supported by testing. Table 1 is a chart that compares the subject device to the predicate device side-by-side.
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Table 1 Substantial Equivalence Comparison
| Predicate Devices | Subject Device | ||
|---|---|---|---|
| Patil Emergency Cricothyrotomy | |||
| Catheter Set | |||
| (K013252) | Emergency Transtracheal Airway | ||
| Catheter | |||
| Regulation | 21 CFR §868.5090 | ||
| Needle, Emergency Airway | Identical | ||
| Product Code | BWC | Identical | |
| Classification | II | Identical | |
| Intended Use | Intended for emergency airway | ||
| access when conventional | |||
| endotracheal intubation cannot be | |||
| performed. | Identical | ||
| Product Pictures (assembled) | Image: Patil Emergency Cricothyrotomy Catheter Set | Image: Emergency Transtracheal Airway Catheter | |
| Catheter | Material | Reinforced Fluorinated Ethylene | |
| Propylene Tubing | Identical | ||
| Diameter (Fr) | 6.0, 9.0 | 6.0 | |
| Length (cm) | 6.0 | 5.0, 7.5 | |
| Hub Material | Delrin, Polyvinylchloride, | ||
| Polysulfone, Polyamide, Acetal | Polyamide | ||
| Hub Connection | Loctite #M-31CL | Identical | |
| Curvature | Curved | Straight | |
| Needle | Gage | 19 | 15 |
| Material | Stainless Steel | Identical | |
| Hub Material | Polypropylene | Brass, Nickel Plated | |
| Hub Connection | Rencast 140 | Tin-Silver solder | |
| Sterilization Method | Ethylene Oxide | Identical | |
| Shelf Life | 3 years | 3 years | |
| Packaging | Sealed inside a Tyvek® Lidstock | Sealed inside a Tyvek® peel open | |
| pouch |
Technological Characteristics:
The Emergency Transtracheal Airway Catheter is intended for emergency airway access when conventional endotracheal intubation cannot be performed. The following tests have been conducted to ensure reliable design and performance under the specified design requirements:
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Image /page/6/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, white, sans-serif letters on a red background. Below "COOK" is the word "MEDICAL" in smaller, white, sans-serif letters on a red background. The logo is simple and clean, and the red and white color scheme is eye-catching.
- Design Validation-(Zero Time) The test articles shall be able to access the trachea . of an AirSim Advance Combo model when following the instructions provided in the Instructions for Use. The acceptance criterion was met.
- . Bending Rigidity of the Needle (Zero Time) – The purpose of the study was to verify that the peak load during compression within the specified deflection be greater than 7.5 N. The acceptance criterion was met.
- . Insertion Force of the Needle (Zero Time) – The purpose of the study was to determine the maximum compressive load. The acceptance criterion was met.
- . Breaking Resistance (Zero Time) - The purpose of the study was to confirm that the cannula of the device would withstand the forces experienced during clinical use without breaking. The predetermined acceptance criterion was met.
- Air Leakage of the Catheter (Zero Time) The purpose of the study was to verify . that the test articles meet the air leakage requirements of BS EN ISO 10555-1. The acceptance criterion was met.
- Resistance to Overriding (Zero-Time) The purpose of the study was was to . verify that the test articles meet the resistance to overriding requirements set forth in ISO 594-2. The acceptance criterion was met.
- . Unscrewing Torque (Zero-Time) - The purpose of the study was to verify that the test articles meet the unscrewing torque requirements set forth in ISO 594-2. The acceptance criterion was met.
- Separation Force (Zero-Time) - The purpose of the study was to verify that the test articles meet the separation force requirements set forth in ISO 594-2. The predetermined acceptance criterion was met.
- . Tensile Test of the Shaft of the Catheter (Three-year Accelerated Aging) –The purpose of study was to determine the peak tensile force of the shaft of the test articles after accelerated aging to the real-time equivalent of 3 years. The acceptance criterion was met.
- Tensile Test of the Hub to Shaft Bond of the Catheter (Three-year Accelerated . Aging) - The purpose of study was to determine the peak load of the hub-to-shaft bond of the test specimens after accelerated aging to the real-time equivalent of 3 years. The acceptance criterion was met.
- . Tensile Test of the Hub to Cannula Bond of the Needle (Three-year Accelerated Aging) - (Appendix D of the original submission, K153761) Testing per ISO
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11070 showed that the needle cannula does not loosen from the hub when a tensile load of at least 20 N is applied. The acceptance criterion was met.
- . Air Leakage of the Catheter (Three-year Accelerated Aging and Two-year Real Time Aging) – The purpose of study was to verify that the test articles meet the air leakage requirements of BS EN ISO 10555-1 after accelerated aging to the real-time equivalent of 3 years. The acceptance criterion was met.
- . Biocompatibility Testing - Per ISO 10993-1 and FDA guidance, testing for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity and material-mediated pyrogenicity were performed to insure the biocompatibility of the subject device. The predetermined acceptance criteria were met.
- . Five Year Accelerated Aging Report for Packaging Validation - The purpose of study is to the accelerated aging of the packaging system to the real time equivalent of greater than or equal to 5 years. The acceptance criterion was met.
- . Sterility Testing - Testing confirms that the device meets the appropriate requirements for bioburden, endotoxins, and EO and ECH residuals.
The results of these tests support a conclusion that the subject device meets the design input requirements based on the intended use and support the conclusion that these devices do not raise new questions of safety or effectiveness and are substantially equivalent to the predicate device (K013252).