The subject device, the Frova Intubating Introducer is designed for establishing a pathway to introduce an endotracheal tube to a patient's airway. The intubation introducer is an 8 French, 35 cm long, single lumen catheter printed with incremental markings on the external surface. The introducer is made of radiopaque polyurethane and features a blunt and open distal tip with two sideports located on opposite sides of the distal tip. The introducer is compatible with an endotracheal tube with an inner diameter of 3.0 mm or larger.

The subject device intubation introducer is also preloaded with a stiffening stylet to provide extra stiffness to the introducer while it is being advanced into the patient's trachea. The stainless-steel stiffening stylet has an outer diameter of 0.051 inches and a length of 31 cm. A polyamide obturator hub is bonded to the stylet.

The subject device set also provides two Rapi-Fit adapters (one with a 15 mm connector, and one with a Luer lock connector) for ventilation when the oxygen requirement of a patient is high and the endotracheal tube is not in the trachea of the patient. The 15 mm Rapi-Fit adapter is intended for attachment to traditional ventilator sources that are low pressure sources, or so-called continuous positive airway pressure (CPAP) ventilators. The Luer Lock Rapi-Fit adapter is intended for attachment to a high-pressure jet ventilation oxygen source, and is compatible with a variable connector or the standard Luer fitting of an oxygen tube which is connected to an oxygen source.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Frova Intubating Introducer, as extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Characteristic	Acceptance Criteria	Reported Device Performance
Catheter separation force with Rapi-Fit adapter	Separation force between catheter and adapter shall be greater than the catheter tensile force requirement (15 N).	The acceptance criterion was met.
Catheter shaft tensile strength	Peak load of specified catheter shaft section shall be greater than or equal to 15 N.	The acceptance criterion was met.
Catheter sideport tensile strength	Peak load of specified catheter shaft section shall be greater than or equal to 15 N.	The acceptance criterion was met.
Catheter shaft kink radius	Test articles shall pass the acceptance criteria as specified in ISO 5361.	The acceptance criteria were met.
Catheter shaft radiopacity	Radiopacity of the catheter shaft shall fall along the gradient of an aluminum X-ray step wedge gauge.	The acceptance criterion was met.
Stiffening stylet hub-to-shaft tensile	Peak load shall be greater than or equal to 15 N.	The acceptance criterion was met.
Design validation for pediatric use	Demonstrate that the Frova Intubation Introducer meets user needs and intended use for pediatric patients to assist intubation during difficult airway management procedures, when properly following the IFU.	The acceptance criteria were met.
Design validation for high pressure oxygenation insufflation during breathing simulator	No specific quantitative acceptance criteria are given in this document other than "Delivered minute volume and average maximum airway pressure were measured for each patient sub-group."Implied: performance should be acceptable for each subgroup.	No explicit "met" statement, but implies data was collected and analyzed for infant, child, adolescent, and adult patient subgroups using the ASL 5000 Breathing Simulator.
Biocompatibility testing	Per ISO 10993-1 and FDA guidance, testing for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, material-mediated pyrogenicity, volatile organic compound testing, and particulate matter testing.	Performed to ensure the biocompatibility of the subject device.
Acute performance evaluation on catheter via animal study	The catheter shall perform as intended in simulated clinical use.	The acceptance criteria were met.
Compatibility with ET tubes (for pediatric use validation)	Compatible with an endotracheal tube with an inner diameter of 3.0 mm and 3.5 mm.	The results demonstrate that the subject device introducer was compatible with an endotracheal tube with an inner diameter of 3.0 mm and 3.5 mm.

2. Sample Size Used for the Test Set and Data Provenance

Test Sets for Physical/Mechanical Tests (Catheter separation force, tensile strength, kink radius, radiopacity, stylet tensile): The document doesn't explicitly state the sample size for each of these tests. It generally refers to "test articles" or "specified catheter shaft section." Data provenance is not specified but is implied to be from laboratory testing.
Test Set for Design validation for pediatric use (Manikin Study): The document states that "airway training manikins that resemble appropriate patient anatomy of different sub-groups were used." It does not specify the exact number of manikins used or the number of trials. The data provenance is implicitly from a laboratory or simulation setting.
Test Set for Design validation for high pressure oxygenation (Breathing Simulator): The document mentions using the "ASL 5000 Breathing Simulator from IngMar Medical" to simulate breathing profiles for "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 sub-groups." The sample size (e.g., number of simulations, repetitions) is not specified. Data provenance is from a laboratory / simulator setting.
Test Set for Biocompatibility: The document states "Biocompatibility testing Per ISO 10993-1 and FDA guidance." The sample size for these specific tests (cytotoxicity, sensitization, etc.) is not detailed in this document.
Test Set for Acute performance evaluation (Animal Study): The document mentions "animal study" but does not provide the specific animal model, number of animals, or design of the study. Data provenance is from an animal study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts to establish ground truth for any of the described tests. The tests are primarily physical, mechanical, or simulation-based, or involve direct measurement against defined standards (e.g., ISO 5361, X-ray step wedge gauge).

4. Adjudication Method for the Test Set

Not applicable, as no expert-based ground truth establishment or subjective assessment requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done or described in this document. The device is a medical introducer, not an AI or imaging diagnostic tool that would typically involve a multi-reader study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The device is a physical medical introducer, not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the various tests mentioned is based on:

Engineering specifications and standards: For physical and mechanical tests (e.g., separation force, tensile strength, kink radius, radiopacity, stylet tensile), the ground truth is defined by specific numerical thresholds (e.g., >15 N) or compliance with international standards (ISO 5361).
Simulated clinical performance: For pediatric use validation and high-pressure oxygenation studies, the ground truth is performance within expected physiological parameters or successful function in simulation models (manikins, breathing simulators).
Biocompatibility standards: For biocompatibility, the ground truth is compliance with ISO 10993-1 and FDA guidance through specific toxicology tests.
Animal study observations: For acute performance, the ground truth would be observed performance as intended in the animal model.

8. The Sample Size for the Training Set

Not applicable. The device is a medical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set mentioned for this device.

Summary

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April 23, 2018

Cook Incorporated Kotei Aoki Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, Indiana 47404

Re: K171917

Trade/Device Name: Frova Intubating Introducer Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: Class II Product Code: BTR Dated: March 22, 2018 Received: March 23, 2018

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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Tina Kiang -5

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

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Indications for Use

510(k) Number (if known) K171917

Device Name Frova Intubating Introducer

Indications for Use (Describe)

To facilitate endotracheal intubation in adult and pediatric patients where visualization of the glottis is inadequate.

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.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM

Frova Intubating Introducer 21 CFR §807.92 Date Prepared: April 20, 2018

Submitted By:

Applicant:	Cook Incorporated
Contact:	Hui Ouyang, PhD, RACPaul Meyer
Applicant Address:	Cook Incorporated750 Daniels WayBloomington, IN 47404
Contact Phone Number:	(812) 335-3575 x105421
Contact Fax Number:	(812) 332-0281

Device Information:

Trade Name:	Frova Intubating Introducer
Device Common Names:	Frova Intubating Introducer
Classification Regulation:	21 CFR 868.5730, BTR
Device Classification:	Class II
Review Panel:	Anesthesiology
	Office of Device Evaluation: Division of Anesthesiology, General Hospital, InfectionControl, and Dental Devices (DAGRID)
	Anesthesiology Devices Branch (ANDB)

Predicate Device:

The Frova Intubating Introducer is substantially equivalent to the predicate device, the Frova Intubating Introducer (William Cook Europe Aps, K161813), cleared by FDA on May 19, 2017.

Device Description:

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distal tip. The introducer is compatible with an endotracheal tube with an inner diameter of 3.0 mm or larger.

Indication for Use:

The Frova Intubating Introducer is intended to facilitate endotracheal intubation in adult and pediatric patients where visualization of the glottis is inadequate.

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.

Comparison to Predicate:

The subject device is substantially equivalent to the predicate device in that they have the same fundamental design and intended use. Both are tubular devices with similar tip configuration and are intended for transient use to guide an endotracheal tube into the correct position within the trachea while providing continuous air flow. Furthermore, they have the same method of operation. The substantial equivalence comparison with the predicate device is provided in Table 1.

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Table 1: Substantial Equivalence Comparison Table

	Predicate Device	Subject Device
	William Cook Europe Aps
	Frova Intubating Introducer	Frova Intubating Introducer
	(K161813)
Regulation	21 CFR 868.5730	IDENTICAL TO PREDICATE
Product Code	BTR	IDENTICAL TO PREDICATE
Classification	II	IDENTICAL TO PREDICATE
Indication for Use		To facilitate endotracheal intubation in
	To facilitate endotracheal intubation	adult and pediatric patients where
	in patients when visualization of the	visualization of the glottis is inadequate.
	glottis is inadequate.
		The 8 French catheter is recommended for
	The 14 French catheter introducer	placement of an endotracheal tube with an
	has been designed for placement of a	inner diameter of 3 mm or larger.
	single lumen endotracheal tube
	whose inner diameter is 6 mm or	When used for high-pressure oxygenation
	larger.	with a Luer Lock connector, the 8 French
		catheter is recommended for patients older
		than 1 month of age.
One-time use	Yes	IDENTICAL TO PREDICATE
Catheter insertionmethod	Orally or nasally into trachea	IDENTICAL TO PREDICATE
Catheter distal	Coude tip	IDENTICAL TO PREDICATE
shape
Adapters available	1 15 mm adapter	IDENTICAL TO PREDICATE
for oxygenation	1 Luer lock adapter
Catheter depth	Yes	IDENTICAL TO PREDICATE
marking
Catheter distal tip	2 sideports	IDENTICAL TO PREDICATE
sideport
Catheter outer	14 Fr	8 Fr
diameter
Catheter length	70 cm	35 cm
Inner diameter of
compatible	$\u2265$ 6.0 mm	$\u2265$ 3.0 mm
endotracheal tube
Catheter distal end	Closed tip	Open endhole
Catheter material	Polyethylene	Polyurethane
Accessory set	1 15 mm adapter
component	1 Luer lock adapter	IDENTICAL TO PREDICATE
	1 stiffening stylet
Sterilization method	Ethylene Oxide	IDENTICAL TO PREDICATE

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The differences in Indication for Use statement between the predicate and subject device do not raise different questions of safety or effectiveness because:

Size of compatible endotracheal tubes: The predicate introducer is 14 French in outer diameter and is designed for placement of a single lumen endotracheal tube whose inner diameter is 6 mm or larger. The subject device introducer is 8 French in outer diameter and is designed for placement of a single lumen endotracheal tube whose inner diameter is 3 mm or larger. A validation study using a child training manikin was conducted and the results demonstrate that the subject device introducer was compatible with an endotracheal tube with an inner diameter of 3.0 mm and 3.5 mm.
Patient population: The predicate device does not specify patient population, while the subject device is indicated for adult and pediatric patients. Endotracheal tubes are critical in establishing and maintaining a patient airway and are used in both adult and pediatric patients. It is common in clinical practice to use relatively small intubation catheters in pediatric patients because they generally require a smaller endotracheal tube. The subject device is within this dimensional range and has similar recommended compatible ET tube size ranges for pediatric use. In addition, a validation study using a child training manikin was conducted and the results demonstrate that the subject device introducer was compatible with an endotracheal tube with an inner diameter of 3.0 mm and 3.5 mm. Furthermore, a 3-mm endotracheal tube can be used in pediatric patients with a minimum weight of 1 kg. Therefore, it is appropriate to recommend the subject device to be used in pediatric patients overall as well as adult patients.

Technological Characteristics:

The following tests have been conducted to ensure reliable design and performance under the specified design requirements:

. Catheter separation force with Rapi-Fit adapter - the separation force between the catheter and the adapter shall be greater than that of the catheter tensile force requirement (15 N). The acceptance criterion was met.
Catheter shaft tensile strength the peak load of specified catheter shaft section . shall be greater than or equal to 15 N. The acceptance criterion was met.

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Catheter sideport tensile strength the peak load of specified catheter shaft . section shall be greater than or equal to 15 N. The acceptance criterion was met.
. Catheter shaft kink radius – the test articles shall pass the acceptance criteria as specified in ISO 5361. The acceptance criteria were met.
. Catheter shaft radiopacity - the radiopacity of the catheter shaft shall fall along the gradient of an aluminum X-ray step wedge gauge. The acceptance criterion was met.
. Stiffening stylet hub-to-shaft tensile – the peak load shall be greater than or equal to 15 N. The acceptance criterion was met.
. Design validation for pediatric use of device in intubation - airway training manikins that resemble appropriate patient anatomy of different sub-groups were used to demonstrate that the Frova Intubation Introducer meets the user needs and intended use for pediatric patients to assist intubation during difficult airway management procedures, when properly following the IFU. The acceptance criteria were met.
Design validation for high pressure oxygenation insufflation during breathing . simulator - 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 sub-groups. Delivered minute volume and average maximum airway pressure were measured for each patient sub-group.
Biocompatibility testing Per ISO 10993-1 and FDA guidance, testing for ● cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, material-mediated pyrogenicity, volatile organic compound testing, and particulate matter testing were performed to ensure the biocompatibility of the subject device.
. Acute performance evaluation on catheter via animal study – the catheter shall perform as intended in simulated clinical use. The acceptance criteria were met.

The results of these tests show that the subject device meets the design input requirements based on the intended use and support the conclusion that the subject device does not raise different questions of safety or effectiveness and is substantially equivalent to the predicate device.

Regulation Number and Section

§ 868.5730 Tracheal tube.

(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).