(316 days)
The Cook Airway Exchange Catheter is intended for endotracheal tube exchange in adult and pediatric patients.
The 8 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 3 mm or larger.
When used for high-pressure oxygenation with a Luer Lock connector, the 8 French catheter is recommended for patients older than 1 month of age.
The 11 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 4 mm or larger.
When used for high-pressure oxygenation with a Luer Lock connector, the 11 French catheter is recommended for patients older than 2 years of age.
The 14 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 5 mm or larger.
When used for high-pressure oxygenation with a Luer Lock connector, the 14 French catheter is recommended for patients older than 2 years of age.
The 19 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 7 mm or larger.
When used for high-pressure oxygenation with a Luer Lock connector, the 19 French catheter is recommended for patients older than 12 years of age.
The Cook Airway Exchange Catheter - Extra-Firm with Soft Tip is intended for endotracheal tube exchange in adult and pediatric patients.
The 11 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 4 mm or larger.
When used for high-pressure oxygenation with a Luer Lock connector, the 11 French catheter is recommended for patients older than 2 years of age.
The 14 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 5 mm or larger.
When used for high-pressure oxygenation with a Luer Lock connector, the 14 French catheter is recommended for patients older than 2 years of age.
The Arndt Airway Exchange Catheter Set is intended for exchange of a supraglottic airway device (SAD) to an endotracheal tube (ETT) under bronchoscopic assistance, and for ETT exchange in adult and pediatric patients.
The product may be used for emergency, urgent, and elective airway management.
The 14 French catheter is recommended for placement of an endotracheal tube or a supraglottic airway device with an inner diameter of 5 mm or larger.
When used for high-pressure oxygenation with a Luer lock connector, the 14 French catheter is recommended for patients older than 12 years of age.
The Aintree Intubation Catheter is intended for exchange of a supraglottic airway device (SAD) to an endotracheal tube (ETT) under bronchoscopic assistance, and for ETT exchange in adult and pediatric patients.
The 19 French catheter is recommended for use with a supraglottic airway device and placement of a single-lumen endotracheal tube with an inner diameter of 7 mm or larger.
When used for high-pressure oxygenation with a Luer lock connector, the 19 French catheter is recommended for patients older than 12 years of age.
The Respiratory Management Sets are a family of airway management products, designed for establishing, re-establishing, or maintaining an airway. The catheters may be manufactured from polyurethane or polyethylene. They are single lumen catheters and are designed with a blunt or tapered distal tip. Incremental markings on the catheter shafts facilitate the accurate placement of the catheters into the airway. The subject device catheters have sideports at the distal end and the subject devices are provided with two Rapi-Fit adapters for ventilation when oxygen requirement is high and the supraglottic airway device or endotracheal tube is not in the trachea of the patients.
The Aintree Intubation Catheter is comprised of an intubation catheter, two Rapi-Fit adapters (one with a 15 mm connector, and one with a Luer lock connector), and a double swivel connector. The intubation catheter is made of polyurethane and is 19 Fr in diameter and 56 cm long. The distal end of the intubation catheter is open and designed with a straight and tapered tip, with two sideports aligned opposite to each other.
The Arndt Airway Exchange Catheter Set is comprised of an exchange catheter, a wire guide, two Rapi-Fit adapters (one with a 15 mm connector, and one with a Luer lock connector), and a double swivel connector. The catheter is made of polyurethane and is 14 Fr in diameter and 70 cm long. The distal end of the exchange catheter is open and designed with a straight and tapered tip, with six sideports spiraled along the distal tip.
The Cook Airway Exchange Catheter is comprised of an exchange catheter and two Rapi-Fit adapters (one with a 15 mm connector, and one with a Luer lock connector). The 8, 11, and 14 Fr catheters are made of polyurethane, while the 19 Fr catheter is made of polyethylene. The 8 Fr catheter is 45 cm long, while the 11, 14, and 19 Fr catheters are 83 cm long. The distal ends of the exchange catheters are open and designed with a straight and tapered tip. The 8 Fr, 14 Fr, and 19 Fr catheters have two sideports aligned opposite to each other, while the 11 Fr catheter has six sideports spiraled along the distal end.
The Cook Airway Exchange Catheter – Extra-Firm with Soft Tip are comprised of an exchange catheter and two Rapi-Fit adapters (one with a 15 mm connector, and one with a Luer lock connector). The exchange catheter is made of polyurethane intermittent extrusion tubing, with a stiff shaft and a softer distal 7 cm of the catheter is made of a softer and more flexible polyurethane). The catheter is available in diameters of 11 or 14 Fr, and a length or 100 cm. The distal ends of the exchange catheters are open and designed with a straight and blunt tip. The 11 Fr catheter has six sideports spiraled along the distal end, while the 14 Fr catheter has two sideports aligned opposite to each other.
This document is a 510(k) premarket notification for several airway management devices from Cook Incorporated. It outlines the devices, their intended use, comparison to a predicate device, and performance testing conducted.
Here's the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists several performance tests and states that "The acceptance criterion was met" for each. Specific quantitative acceptance criteria or detailed performance results are generally summarized as "met," rather than providing precise numerical values.
| Test Category | Specific Test | Acceptance Criteria (General) | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Catheter shaft tensile (Zero time and aged) | Peak load $\geq$ applicable load requirement (BS EN ISO 10555-1) | Met |
| Catheter sideport tensile (Zero time and aged) | Peak load $\geq$ applicable load requirement (BS EN ISO 10555-1) | Met | |
| Rapi-Fit adapter-to-catheter attachment (Aged) | Separation force $\geq$ catheter tensile force requirement | Met | |
| Wire guide tensile (Zero time and aged) | Peak load of failure $\geq$ 10 N (Annex H of BS EN ISO 11070) | Met | |
| Wire guide flex (Zero time and aged) | No defects or damage after repeat flexing (Annex G of BS EN ISO 11070) | Met | |
| Wire guide fracture (Zero time and aged) | No fracture when wound around appropriate former (Annex F of BS EN ISO 11070) | Met | |
| Luer Lock hub of Rapi-Fit Adapter unscrewing torque | Met (Sections 4.4 and 5.5 of ISO 594-2) | Met | |
| Luer Lock hub of Rapi-Fit Adapter resistance to overriding | Met (Sections 4.6 and 5.7 of ISO 594-2) | Met | |
| Luer Lock hub of Rapi-Fit Adapter separation force | Met (Sections 4.3 and 5.4 of ISO 594-2) | Met | |
| 15-mm hub of Rapi-Fit Adapter compliance verification | Met (Section 3.1.2 of ISO 5356:2015) | Met | |
| Device Characteristics & Functionality | Catheter shaft radiopacity (Zero time and aged) | Fall along the gradient of an aluminum X-ray step wedge gauge | Met |
| Catheter shaft kink radius (Aged) | Meets kink requirement (Annex H of ISO 5361:2012) | Met | |
| High pressure oxygenation insufflation | Delivered minute volume and average maximum airway pressure measured for various patient subgroups (implicit acceptance of safe and effective delivery) | Met | |
| Catheter dimensional and ink marking verification | Length and ink marking verified (implicit acceptance of meeting specifications) | Met | |
| Double Swivel Connector compatibility analysis | Catheters can be inserted and removed through septum into an endotracheal tube | Met | |
| Biocompatibility | Biocompatibility testing | Meets ISO 10993-1 and FDA guidance for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, and material-mediated pyrogenicity. | Met |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample sizes used for each test. The data provenance is internal testing conducted by Cook Incorporated as part of their 510(k) submission. No information is provided regarding country of origin or whether the data is retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This document describes performance testing for medical devices (catheters, wire guides, adapters). For these types of physical/mechanical tests, "ground truth" is typically established by engineering specifications, accepted industry standards (e.g., ISO, BS EN ISO), and established testing methodologies, rather than expert clinical consensus or pathology. Therefore, there is no mention of human experts establishing ground truth for the technical performance tests described.
4. Adjudication Method for the Test Set
Not applicable. As described above, the acceptance is based on meeting predefined technical specifications and standards, not on human adjudication of subjective data.
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 submission is for physical medical devices (catheters and their accessories), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not relevant or reported.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for physical medical devices, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the performance tests described is based on engineering specifications and established international standards (e.g., BS EN ISO 10555-1, ISO 5361:2012, BS EN ISO 11070, ISO 594-2, ISO 5356:2015, ISO 10993-1). For biocompatibility, it's based on adherence to ISO standards and FDA guidance.
8. The Sample Size for the Training Set
Not applicable. This is for physical medical devices, which do not have a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or relevant for these devices.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of 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
August 11, 2017
Cook Incorporated Kotei Aoki Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, Indiana 47404
Re: K162729
Trade/Device Name: Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip Regulation Number: 21 CFR 868.5730
Regulation Name: Tracheal Tube Regulatory Class: Class II Product Code: BTR Dated: July 12, 2017 Received: July 13, 2017
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.
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
{1}------------------------------------------------
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,
Tara A. Ryan -S
for Lori Wiggins 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}------------------------------------------------
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Cook Airway Exchange Catheter
Indications for Use (Describe)
The Cook Airway Exchange Catheter is intended for endotracheal tube exchange in adult and pediatric patients.
The 8 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 3 mm or larger.
When used for high-pressure oxygenation with a Luer Lock connector, the 8 French catheter is recommended for patients older than 1 month of age.
The 11 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 4 mm or larger.
When used for high-pressure oxygenation with a Luer Lock connector, the 11 French catheter is recommended for patients older than 2 years of age.
The 14 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 5 mm or larger.
When used for high-pressure oxygenation with a Luer Lock connector, the 14 French catheter is recommended for patients older than 2 years of age.
The 19 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 7 mm or larger.
When used for high-pressure oxygenation with a Luer Lock connector, the 19 French catheter is recommended for patients older than 12 years of age.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
{3}------------------------------------------------
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration |
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K162729
Device Name
Cook Airway Exchange Catheter - Extra-Firm with Soft Tip
Indications for Use (Describe)
The Cook Airway Exchange Catheter - Extra-Firm with Soft Tip is intended for endotracheal tube exchange in adult and pediatric patients.
The 11 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 4 mm or larger.
When used for high-pressure oxygenation with a Luer Lock connector, the 11 French catheter is recommended for patients older than 2 years of age.
The 14 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 5 mm or larger.
When used for high-pressure oxygenation with a Luer Lock connector, the 14 French catheter is recommended for patients older than 2 years of age.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
{4}------------------------------------------------
510(k) Number (if known) K162729
Device Name Arndt Airway Exchange Catheter Set
Indications for Use (Describe)
The Arndt Airway Exchange Catheter Set is intended for exchange of a supraglottic airway device (SAD) to an endotracheal tube (ETT) under bronchoscopic assistance, and for ETT exchange in adult and pediatric patients.
The product may be used for emergency, urgent, and elective airway management.
The 14 French catheter is recomment of an endotracheal tube or a supraglottic airway device with an inner diameter of 5 mm or larger.
When used for high-pressure oxygenation with a Luer lock connector, the 14 French catheter is recommended for patients older than 12 years of age.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{5}------------------------------------------------
510(k) Number (if known) K162729
Device Name Aintree Intubation Catheter
Indications for Use (Describe)
The Aintree Intubation Catheter is intended for exchange of a supraglottic airway device (SAD) to an endotracheal tube (ETT) under bronchoscopic assistance, and for ETT exchange in adult and pediatric patients.
The 19 French catheter is recommended for use with a supraglottic airway device and placement of a single-lumen endotracheal tube with an inner diameter of 7 mm or larger.
When used for high-pressure oxygenation with a Luer lock connector, the 19 French catheter is recommended for patients older than 12 years of age.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the Cook Medical logo. The logo is set against a red background. The word "COOK" is in white, large, sans-serif font. Below "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font.
COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
Respiratory Management Sets 21 CFR §868.5730 Date Prepared: 4 August 2017
Submitted By:
| Applicant: | Cook Incorporated |
|---|---|
| Contact: | Kotei Aoki |
| Applicant Address: | Cook Incorporated750 Daniels WayBloomington, IN 47404 |
| Contact Phone Number: | (812) 335-3575 x102630 |
| Contact Fax Number: | (812) 332-0281 |
Device Information:
| Device Trade Name | Classification Name | Regulation | ProductCode | CommonName |
|---|---|---|---|---|
| Aintree Intubation Catheter | Tube, Tracheal(w/wo connector) | 21 CFR §868.5730 | BTR | |
| Arndt Airway Exchange Catheter Set | Tube, Tracheal(w/wo connector) | 21 CFR §868.5730 | BTR | Respiratory |
| Cook Airway Exchange Catheter | Tube, Tracheal(w/wo connector) | 21 CFR §868.5730 | BTR | ManagementSets |
| Cook Airway Exchange Catheter -Extra-Firm with Soft Tip | Tube, Tracheal(w/wo connector) | 21 CFR §868.5730 | BTR |
Predicate Device:
- K862347, Tube Exchanger (Sheridan Catheter Corp.)
Device Description:
The Respiratory Management Sets are a family of airway management products, designed for establishing, re-establishing, or maintaining an airway. The catheters may be manufactured from polyurethane or polyethylene. They are single lumen catheters and are designed with a blunt or tapered distal tip. Incremental markings on the catheter shafts facilitate the accurate placement of the catheters into the airway. The subject device catheters have sideports at the distal end and the subject devices are provided with two Rapi-Fit adapters for ventilation when oxygen requirement is high and the supraglottic airway device or endotracheal tube is not in the trachea of the patients.
{7}------------------------------------------------
Image /page/7/Picture/1 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, block letters on a red background. Below the word "COOK" is the word "MEDICAL" in smaller, white letters on a red background. The bottom left corner of the red background is cut off at an angle.
| Catheter size | Recommended Minimum | ||
|---|---|---|---|
| Subject device | O.D | Length | Endotracheal Tube Size (I.D.) |
| Aintree Intubation Catheter | 19 Fr | 56 cm | 7.0 mm |
| Arndt Airway Exchange Catheter Set | 14 Fr | 70 cm | 5.0 mm |
| Cook Airway Exchange Catheter | 8 Fr | 45 cm | 3.0 mm |
| Cook Airway Exchange Catheter | 11 Fr | 83 cm | 4.0 mm |
| Cook Airway Exchange Catheter | 14 Fr | 83 cm | 5.0 mm |
| Cook Airway Exchange Catheter | 19 Fr | 83 cm | 7.0 mm |
| Cook Airway Exchange Catheter - Extra-Firm with Soft Tip | 11 Fr | 100 cm | 4.0 mm |
| Cook Airway Exchange Catheter - Extra-Firm with Soft Tip | 14 Fr | 100 cm | 5.0 mm |
The subject device catheters are designed to be compatible with a specified range of endotracheal tubes for adult and pediatric patients, as shown in the table below.
The Aintree Intubation Catheter is comprised of an intubation catheter, two Rapi-Fit adapters (one with a 15 mm connector, and one with a Luer lock connector), and a double swivel connector. The intubation catheter is made of polyurethane and is 19 Fr in diameter and 56 cm long. The distal end of the intubation catheter is open and designed with a straight and tapered tip, with two sideports aligned opposite to each other.
The Arndt Airway Exchange Catheter Set is comprised of an exchange catheter, a wire guide, two Rapi-Fit adapters (one with a 15 mm connector, and one with a Luer lock connector), and a double swivel connector. The catheter is made of polyurethane and is 14 Fr in diameter and 70 cm long. The distal end of the exchange catheter is open and designed with a straight and tapered tip, with six sideports spiraled along the distal tip.
The Cook Airway Exchange Catheter is comprised of an exchange catheter and two Rapi-Fit adapters (one with a 15 mm connector, and one with a Luer lock connector). The 8, 11, and 14 Fr catheters are made of polyurethane, while the 19 Fr catheter is made of polyethylene. The 8 Fr catheter is 45 cm long, while the 11, 14, and 19 Fr catheters are 83 cm long. The distal ends of the exchange catheters are open and designed with a straight and tapered tip. The 8 Fr, 14 Fr, and 19 Fr catheters have two sideports aligned opposite to each other, while the 11 Fr catheter has six sideports spiraled along the distal end.
The Cook Airway Exchange Catheter – Extra-Firm with Soft Tip are comprised of an exchange catheter and two Rapi-Fit adapters (one with a 15 mm connector, and one with a Luer lock connector). The exchange catheter is made of polyurethane intermittent extrusion tubing, with a stiff shaft and a softer distal 7 cm of the catheter is made of a softer and more flexible polyurethane). The catheter is available in diameters
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in white, block letters in the upper portion of the logo. Below the word "COOK" is the word "MEDICAL" in white letters, set against a slightly darker red background.
of 11 or 14 Fr, and a length or 100 cm. The distal ends of the exchange catheters are open and designed with a straight and blunt tip. The 11 Fr catheter has six sideports spiraled along the distal end, while the 14 Fr catheter has two sideports aligned opposite to each other.
Intended Use:
The Respiratory Management Sets are intended to assist / facilitate placement of a supraglottic airway device or an endotracheal tube through intubation or exchange.
Indication for Use:
| RespiratoryManagement Sets | Indication for Use |
|---|---|
| Aintree IntubationCatheter | The Aintree Intubation Catheter is intended for exchange of asupraglottic airway device (SAD) to an endotracheal tube (ETT) underbronchoscopic assistance, and for ETT exchange in adult and pediatricpatients.The 19 French catheter is recommended for use with a supraglotticairway device and placement of a single-lumen endotracheal tube withan inner diameter of 7 mm or larger.When used for high pressure oxygenation with a Luer Lock connector,the 19 French catheter is recommended for patients older than 12 yearsof age. |
| RespiratoryManagement Sets | Indication for Use |
| Arndt Airway ExchangeCatheter Set | The Arndt Airway Exchange Catheter Set is intended for exchange of asupraglottic airway device (SAD) to an endotracheal tube (ETT) underbronchoscopic assistance, and for ETT exchange in adult and pediatricpatients.The product may be used for emergency, urgent, and elective airwaymanagement.The 14 French catheter is recommended for placement of anendotracheal tube or a supraglottic airway device with an innerdiameter of 5 mm or larger.When used for high pressure oxygenation with a Luer Lock connector,the 14 French catheter is recommended for patients older than 12 yearsof age. |
| Cook Airway ExchangeCatheter | The Cook Airway Exchange Catheter is intended for endotracheal tubeexchange in adult and pediatric patients.The 8 French catheter is recommended for placement of anendotracheal tube with an inner diameter of 3 mm or larger.When used for high pressure oxygenation with a Luer Lock connector,the 8 French catheter is recommended for patients older than 1 monthof age.The 11 French catheter is recommended for placement of anendotracheal tube with an inner diameter of 4 mm or larger.When used for high pressure oxygenation with a Luer Lock connector,the 11 French catheter is recommended for patients older than 2 yearsof age.The 14 French catheter is recommended for placement of anendotracheal tube with an inner diameter of 5 mm or larger.When used for high pressure oxygenation with a Luer Lock connector,the 14 French catheter is recommended for patients older than 2 yearsof age.The 19 French catheter is recommended for placement of anendotracheal tube with an inner diameter of 7 mm or larger.When used for high pressure oxygenation with a Luer Lock connector,the 19 French catheter is recommended for patients older than 12 yearsof age. |
| RespiratoryManagement Sets | Indication for Use |
| Cook Airway ExchangeCatheter – Extra-Firmwith Soft Tip | The Cook Airway Exchange Catheter – Extra-Firm with Soft Tip isintended for endotracheal tube exchange in adult and pediatric patients. |
| The 11 French catheter is recommended for placement of anendotracheal tube with an inner diameter of 4 mm or larger.When used for high pressure oxygenation with a Luer Lock connector,the 11 French catheter is recommended for patients older than 2 yearsof age. | |
| The 14 French catheter is recommended for placement of anendotracheal tube with an inner diameter of 5 mm or larger.When used for high pressure oxygenation with a Luer Lock connector,the 14 French catheter is recommended for patients older than 2 years of age. |
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the Cook Medical logo. The word "COOK" is in white, bold, sans-serif font on a red background. Below the word "COOK" is a red rectangle with the word "MEDICAL" in white, bold, sans-serif font.
{10}------------------------------------------------
Image /page/10/Picture/1 description: The image shows the logo for Cook Medical. The word "COOK" is in large, white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font on a red background that is shaped like a banner.
Comparison to Predicates:
The Respiratory Management Sets are substantially equivalent to the predicate device in that they have the same intended use as the predicate device, which is to assist / facilitate exchange of a supraglottic airway device (SAD) or an endotracheal tube(ETT), even though the exact wording might differ slightly. The predicate is indicated for extubation and exchange of ETT. The exchange portion of the indication for use of the predicate is the same as the subject device catheters. The subject device catheters are also indicated for pediatric use while the predicate is not. This difference does not raise different questions of safety or effectiveness between the predicate and subject device because selection of the size of the exchange catheters depends on the size of the ETT or SAD that is appropriate for each patient based on weight and age. In addition, verification and validation testing on the subject device catheters support the conclusion that the differences in technological characteristics between the predicate and subject device catheters do not raise different questions on safety and effectiveness. The substantial equivalence comparison with each subject device and its respective predicate device is provided in Tables 1 through 4.
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the Cook Medical logo. The word "COOK" is in white, bold, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, bold, sans-serif font on a darker red background.
| Predicate | Subject Device | |
|---|---|---|
| Sheridan Catheter Corp. Tube Exchanger (K862347) | Aintree Intubation Catheter | |
| Regulation | 21 CFR 868.5730 | Identical |
| Product Code | BTR | Identical |
| Classification | II | Identical |
| Intended Use/Indications for Use | For extubation and exchange of endotracheal tubes. | The Aintree Intubation Catheter is intended for intended for exchange of a supraglottic airway device (SAD) to an endotracheal tube (ETT) under bronchoscopic assistance, and for ETT exchange in adult and pediatric patients.The 19 French catheter is recommended for use with a supraglottic airway device and placement of a single-lumen endotracheal tube with an inner diameter of 7 mm or larger. When used for high pressure oxygenation with a Luer Lock connector, the 19 French catheter is recommended for patients older than 12 years of age. |
| One-time use | Yes | Identical |
| Catheter insertion method | Orally or nasally | Identical |
| Adapter provided for oxygenation through catheter | Yes | Identical |
| Catheter distal tip | Straight and blunt | Identical |
| Catheter depth marking | Yes | Identical |
| Patient population | Not specified | Pediatric and adult |
| Visualization guidance | Not specified | Bronchoscopy |
| Catheter outer diameter | 11, 14, and 19 Fr | 19 Fr - for pediatric and adult use |
| Inner diameter of compatible endotracheal tube | 11 Fr - $\geq$ 4 mm14 Fr - $\geq$ 5 mm19 Fr - $\geq$ 7 mm | 19 Fr - $\geq$ 7 mm |
| Catheter length | 80 cm | 56 cm |
| Catheter material | Polyvinyl Chloride | Polyurethane |
| Catheter distal end | Open with 4 sideports | Open with 2 sideports |
| Accessory set components | 1 15 mm adapter (for convenience should patient oxygenation be necessary during exchange procedure) | 1 double swivel connector2 Rapi-Fit adapters (one with 15 mm connector and one with Luer lock connector) provided if patient must be oxygenated during intubation procedure |
| Sterilization Method | Ethylene Oxide | Identical |
| Packaging | Unknown | Sealed in a Tyvek pouch |
Table 1: Substantial Equivalence Comparison Table – Aintree Intubation Catheter
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the Cook Medical logo. The logo consists of the word "COOK" in white, block letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, block letters on a red background.
| Table 2: Substantial Equivalence Comparison Table – Arndt Airway Exchange Catheter Set | ||
|---|---|---|
| Predicate | Subject Device | |
| Sheridan Catheter Corp. TubeExchanger (K862347) | Arndt Airway Exchange Catheter Set | |
| Regulation | 21 CFR 868.5730 | Identical |
| Product Code | BTR | Identical |
| Classification | II | Identical |
| Intended Use/Indications forUse | For extubation and exchange ofendotracheal tubes | The Arndt Airway Exchange CatheterSet is intended for exchange of asupraglottic airway device (SAD) to anendotracheal tube (ETT) underbronchoscopic assistance, and for ETTexchange in adult and pediatric patients.The product may be used foremergency, urgent, and elective airwaymanagement.The 14 French catheter is recommendedfor placement of an endotracheal tube ora supraglottic airway device with aninner diameter of 5 mm or larger. Whenused for high pressure oxygenation witha Luer Lock connector, the 14 Frenchcatheter is recommended for patientsolder than 12 years of age. |
| One-time use | Yes | Identical |
| Catheter insertion method | Orally or nasally | Identical |
| Adapter provided foroxygenation through catheter | Yes | Identical |
| Catheter depth marking | Yes | Identical |
| Patient population | Not specified | Pediatric and adult |
| Visualization guidance | Not specified | Bronchoscopy |
| Catheter distal tip | Straight and blunt | Straight and tapered |
| Catheter outer diameter | 11, 14, and 19 Fr | 14 Fr |
| Inner diameter of compatibleendotracheal tube | 11 Fr -≥ 4 mm14 Fr -≥ 5 mm19 Fr -≥ 7 mm | 14 Fr -≥ 5 mm |
| Catheter length | 80 cm | 70 cm |
| Catheter material | Polyvinyl Chloride | Polyurethane |
| Catheter distal end | Open with 4 sideports | Open with 6 sideports |
| Accessory set components | 1 15 mm adapter (forconvenience should patientoxygenation be necessaryduring exchange procedure) | 1 wire guide1 double swivel connector2 Rapi-Fit adapters (one with 15 mmconnector and one with Luer lockconnector) provided if patient must beoxygenated during intubation procedure |
| Sterilization Method | Ethylene Oxide | Identical |
| Packaging | Unknown | Placed within a tray and then sealed in aTyvek pouch |
Table 2: Substantial Equivalence Comparison Table – Arndt Airway Exchange Catheter Set
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in white, block letters in the upper portion of the logo, and the word "MEDICAL" is in white, block letters in the lower portion of the logo.
| Predicate | Subject Device | |
|---|---|---|
| Sheridan Catheter Corp.Tube Exchanger (K862347) | Cook Airway Exchange Catheter | |
| Regulation | 21 CFR 868.5730 | Identical |
| Product Code | BTR | Identical |
| Classification | II | Identical |
| Intended Use/Indications for Use | For extubation and exchange of endotracheal tubes | The Cook Airway Exchange Catheter is intended for endotracheal tube exchange in adult and pediatric patients.The 8 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 3 mm or larger. When used for high pressure oxygenation with a Luer Lock connector, the 8 French catheter is recommended for patients older than 1 month of age.The 11 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 4 mm or larger. When used for high pressure oxygenation with a Luer Lock connector, the 11 French catheter is recommended for patients older than 2 years of age.The 14 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 5 mm or larger. When used for high pressure oxygenation with a Luer Lock connector, the 14 French catheter is recommended for patients older than 2 years of age.The 19 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 7 mm or larger. When used for high pressure oxygenation with a Luer Lock connector, the 19 French catheter is recommended for patients older than 12 years of age. |
| One-time use | Yes | Identical |
| Catheter insertion method | Orally or nasally | Identical |
| Adapter provided foroxygenation through catheter | Yes | Identical |
| Catheter distal tip | Straight and blunt | Identical |
| Catheter depth marking | Yes | Identical |
| Predicate | Subject Device | |
| Sheridan Catheter Corp.Tube Exchanger (K862347) | Cook Airway Exchange Catheter | |
| Patient population | Not specified | Pediatric and adult |
| Catheter outer diameter | 11, 14, and 19 Fr | 8 Fr - pediatric use |
| 11 Fr - pediatric and adult use | ||
| 14 Fr - pediatric and adult use | ||
| 19 Fr - pediatric and adult use | ||
| Inner diameter of compatible | 8 Fr - ≥3 mm | |
| endotracheal tube | 11 Fr - ≥4 mm | 11 Fr - ≥4 mm |
| 14 Fr - ≥5 mm | 14 Fr - ≥5 mm | |
| 19 Fr - ≥7 mm | 19 Fr - ≥7 mm | |
| Catheter length | 80 cm | 8 Fr - 45 cm |
| 11 Fr - 83 cm | ||
| 14 Fr - 83 cm | ||
| 19 Fr - 83 cm | ||
| Catheter material | Polyvinyl Chloride | 8 Fr - polyurethane |
| 11 Fr - polyurethane | ||
| 14 Fr - polyurethane | ||
| 19 Fr - polyethylene | ||
| Catheter distal end | Open with 4 sideports | 8 Fr - open with 2 sideports |
| 11 Fr - open with 6 sideports | ||
| 14 Fr - open with 2 sideports | ||
| 19 Fr - open with 2 sideports | ||
| Accessory set components | 1 15 mm adapter (for | 2 Rapi-Fit adapters (one with 15 mm |
| convenience should patient | connector and one with Luer lock | |
| oxygenation be necessary | connector) provided if patient must be | |
| during exchange procedure) | oxygenated during intubation procedure | |
| Sterilization Method | Ethylene Oxide | Identical |
| Packaging | Unknown | Sealed in a Tyvek pouch |
| Predicate | Subject Device | |
| Sheridan Catheter Corp. TubeExchanger (K862347) | Cook Airway Exchange Catheter –Extra-Firm with Soft Tip | |
| Regulation | 21 CFR 868.5730 | Identical |
| Product Code | BTR | Identical |
| Classification | II | Identical |
| Intended Use/Indications forUse | For extubation and exchange ofendotracheal tubes | The Cook Airway Exchange Catheter –Extra-Firm with Soft Tip is intended forendotracheal tube exchange in adult andpediatric patients. |
| The 11 French catheter is recommendedfor placement of an endotracheal tubewith an inner diameter of 4 mm orlarger. When used for high pressureoxygenation with a Luer Lockconnector, the 11 French catheter isrecommended for patients older than 2years of age. | ||
| The 14 French catheter is recommendedfor placement of an endotracheal tubewith an inner diameter of 5 mm orlarger. When used for high pressureoxygenation with a Luer Lockconnector, the 14 French catheter isrecommended for patients older than 2years of age. | ||
| One-time use | Yes | Identical |
| Catheter insertion method | Orally or nasally | Identical |
| Adapter provided foroxygenation through catheter | Yes | Identical |
| Catheter distal tip | Straight and blunt | Identical |
| Catheter depth marking | Yes | Identical |
| Patient population | Not specified | Pediatric and adult |
| Catheter material | Polyvinyl Chloride | Polyurethane |
| Catheter outer diameter | 11, 14, and 19 Fr | 11, 14 Fr |
| Catheter length | 80 cm | 100 cm |
| Catheter distal end | Open with 4 sideports | 11 Fr - open with 6 sideports |
| 14 Fr - open with 2 sideports | ||
| Inner diameter of compatibleendotracheal tube | 11 Fr $\geq$ 4 mm | 11 Fr $\geq$ 4 mm |
| 14 Fr $\geq$ 5 mm | 14 Fr $\geq$ 5 mm | |
| 19 Fr $\geq$ 7 mm | ||
| Accessory set components | 1 15 mm adapter (forconvenience should patientoxygenation be necessaryduring exchange procedure) | 2 Rapi-Fit adapters (one with 15 mmconnector and one with Luer lockconnector) provided if patient must beoxygenated during intubation procedure |
| Sterilization Method | Ethylene Oxide | Identical |
| Packaging | Unknown | Sealed in a Tyvek pouch |
Table 3: Substantial Equivalence Comparison Table – Cook Airway Exchange Catheter
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows the logo for Cook Medical. The logo is white text on a red background. The word "COOK" is in a large, bold, sans-serif font. Below the word "COOK" is the word "MEDICAL" in a smaller, sans-serif font. The word "MEDICAL" is on a red background that is slightly darker than the background behind the word "COOK".
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image shows the Cook Medical logo. The word "COOK" is in white, bold, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a red background.
Table 4: Substantial Equivalence Comparison Table - Cook Airway Exchange Catheter - Extra-Firm with Soft Tip
{16}------------------------------------------------
Image /page/16/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in white, bold, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a darker red background. The darker red background is shaped like a rectangle with a notch cut out of the upper left corner.
Technological Characteristics:
The following tests have been conducted to ensure reliable design and performance under the specified design requirements:
Performance Testing:
- . Catheter shaft tensile (Zero time and aged) – the peak load of specified catheter shaft section shall be greater than or equal to the applicable load requirement (based on outer diameter) in accordance with BS EN ISO 10555-1. The acceptance criterion was met.
- Catheter sideport tensile (Zero time and aged) the peak load of specified catheter . shaft section shall be greater than or equal to the applicable load requirement (based on outer diameter) in accordance with BS EN ISO 10555-1. The acceptance criterion was met.
- Catheter shaft radiopacity (Zero time and aged) the radiopacity of the catheter shaft . shall fall along the gradient of an aluminum X-ray step wedge gauge. The acceptance criterion was met.
- Catheter shaft kink radius (Aged) the catheter shaft meets the kink requirement in . accordance with Annex H of ISO 5361:2012. The acceptance criteria were met.
- Rapi-Fit adapter-to-catheter attachment (Aged) – the separation for between the adapter and the catheter shall be greater than that of the catheter tensile force requirement. The acceptance criterion was met.
- High pressure oxygenation insufflation on catheters (Zero time and aged) the ASL ● 5000 Breathing Simulator from IngMar Medical was used to simulate breathing profiles of infant (> 1 month to 2 years old), child (> 2 years to 12 years old), adolescent (> 12 years through 21 years old), and adult (> 21 years old) patient subgroups. Delivered minute volume and average maximum airway pressure were measured for each patient sub-group.
- Catheter dimensional and ink marking verification (Zero time) Catheter length and . ink marking on catheters was verified. The acceptance criterion was met.
- Wire guide corrosion (Zero time and aged) wire guides should not have any visual . evidence of corrosion that could affect the functional performance when tested in accordance with Annex B of BS EN ISO 11070. The acceptance criterion was met.
{17}------------------------------------------------
Image /page/17/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in white, bold, sans-serif font. Below "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font.
- Wire guide tensile (Zero time and aged) the peak load of failure shall be greater ● than or equal to 10 N in accordance with Annex H of BS EN ISO 11070. The acceptance criterion was met.
- . Wire guide flex (Zero time and aged) – wire guides shall not show signs of defects or damage when subjected to repeat flexing in accordance with Annex G of BS EN ISO 11070. The acceptance criterion was met.
- Wire guide fracture (Zero time and aged) wire guides shall not fracture when . wound around an appropriate former in accordance with Annex F of BS EN ISO 11070. The acceptance criterion was met.
- Luer Lock hub of Rapi-Fit Adapter unscrewing torque (Zero time and aged) Testing . was conducted in accordance with Sections 4.4 and 5.5 of ISO 594-2. The acceptance criterion was met.
- Luer Lock hub of Rapi-Fit Adapter resistance to overriding (Zero time and Aged) -. Testing was conducted in accordance with Sections 4.6 and 5.7 of ISO 594-2. The acceptance criterion was met.
- Luer Lock hub of Rapi-Fit Adapter separation force (Zero time and aged) - Testing was conducted in accordance with Sections 4.3 and 5.4 of ISO 594-2. The acceptance criterion was met.
- 15-mm hub of Rapi-Fit Adapter compliance verification (Zero time and aged) -● Testing was conducted in accordance with Section 3.1.2 of ISO 5356:2015. The acceptance criterion was met.
- Double Swivel Connector compatibility analysis of (Aged) catheters shall be able to ● be inserted and removed through the septum of the double swivel connector into an endotracheal tube. The acceptance criterion was met.
Biocompatibility testing
- . Per ISO 10993-1 and FDA guidance, testing for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity (when applicable), and materialmediated pyrogenicity (when applicable) were performed to ensure the biocompatibility of the subject devices.
The results of these tests show that the subject devices meet the design input requirements based on the intended use and support the conclusion that these devices do
{18}------------------------------------------------
Image /page/18/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font on a red background that is shaped like a trapezoid.
COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
not raise new questions of safety or effectiveness and are substantially equivalent to the predicate device.
§ 868.5790 Tracheal tube stylet.
(a)
Identification. A tracheal tube stylet is a device used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.