Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip

K162729 · Cook Incorporated · BSR · Aug 11, 2017 · Anesthesiology

Device Facts

• Record ID: K162729
• Device Name: Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip
• Applicant: Cook Incorporated
• Product Code: BSR · Anesthesiology
• Decision Date: Aug 11, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5790
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

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.

Device Story

Respiratory Management Sets consist of single-lumen catheters (polyurethane or polyethylene) with blunt or tapered distal tips and sideports. Used by clinicians for establishing, re-establishing, or maintaining airways via endotracheal tube (ETT) or supraglottic airway device (SAD) exchange. Catheters feature incremental depth markings for accurate placement. Sets include Rapi-Fit adapters (15 mm or Luer lock) for high-pressure oxygenation during procedures. Some sets include wire guides or double swivel connectors. Used in clinical settings (emergency, urgent, elective). Clinicians insert catheters orally or nasally to guide ETT/SAD placement. Output is a physical airway conduit facilitating ventilation and tube exchange. Benefits include maintained oxygenation during airway management and facilitated tube placement.

Clinical Evidence

Bench testing only. Performance verified via catheter shaft/sideport tensile testing (BS EN ISO 10555-1), kink radius (ISO 5361:2012), wire guide integrity (BS EN ISO 11070), and Luer/15-mm hub compliance (ISO 594-2, ISO 5356:2015). High-pressure oxygenation performance validated using ASL 5000 Breathing Simulator across infant, child, adolescent, and adult patient subgroups. Biocompatibility confirmed per ISO 10993-1.

Technological Characteristics

Single-lumen catheters made of polyurethane or polyethylene. Distal tips are blunt or tapered with 2-6 sideports. Includes Rapi-Fit adapters (15 mm, Luer lock), wire guides, and double swivel connectors. Sterilized via Ethylene Oxide. Complies with BS EN ISO 10555-1 (tensile), ISO 5361:2012 (kink), BS EN ISO 11070 (wire guide), and ISO 594-2/ISO 5356:2015 (hubs).

Indications for Use

Indicated for endotracheal tube (ETT) exchange and supraglottic airway device (SAD) to ETT exchange in adult and pediatric patients. Used for emergency, urgent, and elective airway management. Specific French sizes recommended based on patient age and ETT/SAD inner diameter requirements.

Regulatory Classification

Identification

A tracheal tube stylet is a device used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.

Predicate Devices

• Sheridan Catheter Corp. Tube Exchanger (K862347)

Submission Summary (Full Text)

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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 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

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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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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 [phone] or [phone] 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

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| 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

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 [e-mail]

"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)

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| 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 [e-mail]

"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)

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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."

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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 [e-mail]

"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."

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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: [phone] 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 Incorporated<br>750 Daniels Way<br>Bloomington, IN 47404 |
| Contact Phone Number: | [phone] x102630 |
| Contact Fax Number: | [phone] |

### Device Information:

| Device Trade Name | Classification Name | Regulation | Product<br>Code | Common<br>Name |
|-------------------------------------------------------------|------------------------------------|------------------|-----------------|--------------------|
| Aintree Intubation Catheter | Tube, Tracheal<br>(w/wo connector) | 21 CFR §868.5730 | BTR | |
| Arndt Airway Exchange Catheter Set | Tube, Tracheal<br>(w/wo connector) | 21 CFR §868.5730 | BTR | Respiratory |
| Cook Airway Exchange Catheter | Tube, Tracheal<br>(w/wo connector) | 21 CFR §868.5730 | BTR | Management<br>Sets |
| Cook Airway Exchange Catheter -<br>Extra-Firm with Soft Tip | Tube, Tracheal<br>(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.

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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

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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:

| Respiratory<br>Management Sets | Indication for Use |
|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Aintree Intubation<br>Catheter | The Aintree Intubation Catheter is intended for exchange of a<br>supraglottic airway device (SAD) to an endotracheal tube (ETT) under<br>bronchoscopic assistance, and for ETT exchange in adult and pediatric<br>patients.<br>The 19 French catheter is recommended for use with a supraglottic<br>airway device and placement of a single-lumen endotracheal tube with<br>an inner diameter of 7 mm or larger.<br>When used for high pressure oxygenation with a Luer Lock connector,<br>the 19 French catheter is recommended for patients older than 12 years<br>of age. |
| Respiratory<br>Management Sets | Indication for Use |
| Arndt Airway Exchange<br>Catheter Set | The Arndt Airway Exchange Catheter Set is intended for exchange of a<br>supraglottic airway device (SAD) to an endotracheal tube (ETT) under<br>bronchoscopic assistance, and for ETT exchange in adult and pediatric<br>patients.<br><br>The product may be used for emergency, urgent, and elective airway<br>management.<br><br>The 14 French catheter is recommended for placement of an<br>endotracheal tube or a supraglottic airway device with an inner<br>diameter of 5 mm or larger.<br>When used for high pressure oxygenation with a Luer Lock connector,<br>the 14 French catheter is recommended for patients older than 12 years<br>of age. |
| Cook Airway Exchange<br>Catheter | The Cook Airway Exchange Catheter is intended for endotracheal tube<br>exchange in adult and pediatric patients.<br><br>The 8 French catheter is recommended for placement of an<br>endotracheal tube with an inner diameter of 3 mm or larger.<br>When used for high pressure oxygenation with a Luer Lock connector,<br>the 8 French catheter is recommended for patients older than 1 month<br>of age.<br><br>The 11 French catheter is recommended for placement of an<br>endotracheal tube with an inner diameter of 4 mm or larger.<br>When used for high pressure oxygenation with a Luer Lock connector,<br>the 11 French catheter is recommended for patients older than 2 years<br>of age.<br><br>The 14 French catheter is recommended for placement of an<br>endotracheal tube with an inner diameter of 5 mm or larger.<br>When used for high pressure oxygenation with a Luer Lock connector,<br>the 14 French catheter is recommended for patients older than 2 years<br>of age.<br><br>The 19 French catheter is recommended for placement of an<br>endotracheal tube with an inner diameter of 7 mm or larger.<br>When used for high pressure oxygenation with a Luer Lock connector,<br>the 19 French catheter is recommended for patients older than 12 years<br>of age. |
| Respiratory<br>Management Sets | Indication for Use |
| Cook Airway Exchange<br>Catheter – Extra-Firm<br>with Soft Tip | The Cook Airway Exchange Catheter – Extra-Firm with Soft Tip is<br>intended for endotracheal tube exchange in adult and pediatric patients. |
| | The 11 French catheter is recommended for placement of an<br>endotracheal tube with an inner diameter of 4 mm or larger.<br>When used for high pressure oxygenation with a Luer Lock connector,<br>the 11 French catheter is recommended for patients older than 2 years<br>of age. |
| | The 14 French catheter is recommended for placement of an<br>endotracheal tube with an inner diameter of 5 mm or larger.<br>When used for high pressure oxygenation with a Luer Lock connector,<br>the 14 French catheter is recommended for patients older than 2 years of age. |

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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.

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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.

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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.<br><br>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 mm<br>14 Fr - $\geq$ 5 mm<br>19 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 connector<br>2 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

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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. Tube<br>Exchanger (K862347) | Arndt Airway Exchange Catheter Set |
| Regulation | 21 CFR 868.5730 | Identical |
| Product Code | BTR | Identical |
| Classification | II | Identical |
| Intended Use/Indications for<br>Use | For extubation and exchange of<br>endotracheal tubes | The Arndt Airway Exchange Catheter<br>Set is intended for exchange of a<br>supraglottic airway device (SAD) to an<br>endotracheal tube (ETT) under<br>bronchoscopic assistance, and for ETT<br>exchange in adult and pediatric patients.<br><br>The product may be used for<br>emergency, urgent, and elective airway<br>management.<br><br>The 14 French catheter is recommended<br>for placement of an endotracheal tube or<br>a supraglottic airway device with an<br>inner diameter of 5 mm or larger. When<br>used for high pressure oxygenation with<br>a Luer Lock connector, the 14 French<br>catheter is recommended for patients<br>older than 12 years of age. |
| One-time use | Yes | Identical |
| Catheter insertion method | Orally or nasally | Identical |
| Adapter provided for<br>oxygenation 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 compatible<br>endotracheal tube | 11 Fr -≥ 4 mm<br>14 Fr -≥ 5 mm<br>19 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 (for<br>convenience should patient<br>oxygenation be necessary<br>during exchange procedure) | 1 wire guide<br>1 double swivel connector<br>2 Rapi-Fit adapters (one with 15 mm<br>connector and one with Luer lock<br>connector) provided if patient must be<br>oxygenated during intubation procedure |
| Sterilization Method | Ethylene Oxide | Identical |
| Packaging | Unknown | Placed within a tray and then sealed in a<br>Tyvek pouch |

### Table 2: Substantial Equivalence Comparison Table – Arndt Airway Exchange Catheter Set

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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.<br>Tube Exchanger (K862347) | Cook Airway Exchange Catheter |
| Regulation | 21 CFR 868.5730 | Identical |
| Product Code | BTR | Identical |
| Classification | II | Identical…