The TELEFLEX ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Port is indicated for airway management by oral intubation during mechanical ventilation and anesthesia including the capability to aid in the removal of subglottic secretions.

Device Description

The Teleflex ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port is a single-use, sterile tracheal tube made of a polyvinyl chloride tube body, cuff inflation line and a compatible pilot balloon and one-way valve. A radiopaque line is incorporated into the full length of the tracheal tube. Each tracheal tube is supplied with an appropriately sized 15mm connector. The Teleflex ISIS™ HVTTM Tracheal Tube, Cuffed with Subglottic Secretion Suction Port is sold in Murphy eye style. Each tube has a dorsal lumen with an opening above the cuff and a male suction connector port attached to the tube, which is close to the machine end of the tube. Access to the suction lumen is accomplished via a connection of the suction accessory pack (P/N 5-23000) directly to the male suction connector.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification for the Teleflex ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port. This document describes the device and its substantial equivalence to a predicate device, rather than an AI/ML powered device. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, and MRMC studies, which are typically relevant for AI/ML device evaluations, is not present in this document.

The document primarily focuses on demonstrating that the new device is substantially equivalent to a previously cleared predicate device (K091761) by comparing their characteristics and conducting non-clinical performance testing.

Here's an analysis of the information that is available in the document, framed as closely as possible to your request, but highlighting the difference in context:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with numerical performance targets and reported results in the way it would for an AI/ML algorithm's accuracy, sensitivity, or specificity. Instead, it describes "bench testing" to verify performance is "substantially equivalent" to the predicate. The "Principle of Test" column serves as the qualitative "acceptance criteria" for these non-clinical tests.

Test	Principle of Test (Acceptance Criteria - qualitative)	Reported Device Performance (Qualitative)
Ink adherence	Ink adherence is tested by application and removal of tape to the inked surface according to the test parameters and inspected to a rating scale. (ISO 5361, Section 5.3.2)	"Bench testing has been performed to verify that the performance of the proposed Teleflex ISIS™ HVT™ Tracheal Tube... is substantially equivalent to the predicate device, and that the Teleflex ISIS™ HVT™ Tracheal Tube... will perform as intended." (Implicitly passed)
Cytotoxicity	Tests the potential biological reactivity of a mammalian cell culture in response to exposure to the extract of the test article. (ISO 10993-5)	"Bench testing has been performed to verify that the performance of the proposed Teleflex ISIS™ HVT™ Tracheal Tube... is substantially equivalent to the predicate device, and that the Teleflex ISIS™ HVT™ Tracheal Tube... will perform as intended." (Implicitly passed)
Irritation	Test the potential of the test article to produce primary skin irritation after topical application when extracted in sodium chloride for injections and cottonseed oil. (ISO 10993-10)	"Bench testing has been performed to verify that the performance of the proposed Teleflex ISIS™ HVT™ Tracheal Tube... is substantially equivalent to the predicate device, and that the Teleflex ISIS™ HVT™ Tracheal Tube... will perform as intended." (Implicitly passed)
Sensitization	Test the potential of the test article to produce allergenic reaction when extracted in sodium chloride and cottonseed oil. (ISO 10993-10)	"Bench testing has been performed to verify that the performance of the proposed Teleflex ISIS™ HVT™ Tracheal Tube... is substantially equivalent to the predicate device, and that the Teleflex ISIS™ HVT™ Tracheal Tube... will perform as intended." (Implicitly passed)
Extractables & Leachables	Assesses the ET tube relative to leachable/extractable profiles with GC/MS, LC/MS, LC/UV, ICP and FTIR under clinical use conditions.	"Bench testing has been performed to verify that the performance of the proposed Teleflex ISIS™ HVT™ Tracheal Tube... is substantially equivalent to the predicate device, and that the Teleflex ISIS™ HVT™ Tracheal Tube... will perform as intended." (Implicitly passed)

2. Sample size used for the test set and the data provenance

The document refers to "bench testing" but does not specify sample sizes for these tests. For a physical device, this would typically involve a certain number of units manufactured for testing. The provenance of material or components isn't explicitly stated beyond the manufacturer, Teleflex Medical, Inc. The document does not describe the use of "data" in the context of an AI/ML algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable to this type of device submission. Ground truth, in the context of AI/ML, involves human expert annotations or definitive outcomes, which are not relevant for the bench testing described here. The tests rely on established ISO standards and methods.

4. Adjudication method for the test set

Not applicable. Adjudication methods are used to resolve discrepancies in expert interpretations, which is not relevant for the objective bench tests described.

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 is not an AI/ML device that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is defined by the objective pass/fail criteria of the referenced ISO standards (e.g., ISO 10993-5 for cytotoxicity). This is not "expert consensus, pathology, or outcomes data" in the AI/ML sense, but rather adherence to validated scientific and engineering testing protocols.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires training data.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 24,2014

Teleflex Medical, Inc. James Cochie Sr. Regulatory Affairs Specialist 2917 Weck Dr. Research Triangle Park, NC 27709

Re: K141939

Trade/Device Name: Teleflex ISIS HVT Tracheal Tube, Cuffed With Subglottic Secretion Suction Port Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: October 28, 2014 Received: October 29, 2014

Dear Mr. Cochie,

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 device

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runne DDS, mA

Erin Keith 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) K141939

Device Name

TELEFLEX ISIS™ HVTM Tracheal Tube, Cuffed with Subglottic Secretion Suction Port

Indications for Use (Describe)

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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Teleflex ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port

510(k) Summary

510(k) SUMMARY

TELEFLEX ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port

A. Name, Address, Phone and Fax Number of Applicant

Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-433-8083 Fax: 919-433-4996

B. Contact Person

James Cochie Sr. Regulatory Affairs Specialist

C. Date Prepared

November 24, 2014

D. Device Name

Trade Name: Teleflex ISIS™ HVTTM Tracheal Tube, Cuffed with Subglottic Secretion Suction Port

Common Name: Tracheal Tube

Classification Name: Tracheal Tube (W/Wo Connector) (21 CFR 868.5730, Product Code BTR)

E. Device Description

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Section 29 - 510(k) Summary

F. Indications for Use

The Teleflex ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port is indicated for airway management by oral intubation during mechanical ventilation and anesthesia including the capability to aid in the removal of subglottic secretions.

G. Target Population

This device is intended for use on adult patients

H. Intended Environment of use

This device is intended for locations where endotracheal intubation may be performed.

This product is single use only.

I. Contraindications

There are no known contraindications.

J. Substantial Equivalence

The modified Teleflex ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port is substantially equivalent to the predicate device:

ComparativeCharacteristics	Proposed Device,Teleflex ISIS™ HVT™Tracheal Tube, Cuffed withSubglottic SecretionSuction Port	Predicate Device,Teleflex ISIS™ HVT™Tracheal Tube, Cuffed withSubglottic SecretionSuction Port
Manufacturer	Teleflex Medical, Inc.	Teleflex Medical, Inc.
510(k) Number	N/A	K091761
Indications for Use	Identical	The Teleflex ISIS™ HVT™Tracheal Tube, Cuffed withSubglottic Secretion SuctionPort is indicated for airwaymanagement by oralintubation during mechanicalventilation and anesthesiaincluding the capability to aidin the removal of subglotticsecretions.
Main Tube	Identical	Yes
Inflation Line	Identical	Yes

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Teleflex ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port

Pilot Balloon	Identical	Yes
Bi-directional Valve	Identical	Yes
Cuff Balloon	Identical	Yes
15mm Connector	Identical	Yes
Male Suction LumenConnector	Identical	Yes
Black Ink	Printing Ink – 2405 Black Ink, Markem-Imaja Solvent – Medical Ink Reducer, Colorcon	Black Ink, Nazdar Thinner, Nazdar Retarder, Nazdar
Descriptive Size (ID)	Identical	6.0mm, 6.5mm, 7.0mm,7.5mm, 8.0mm, 8.5mm,9.0mm
Biocompatibility	Identical	Meets ISO 10993-1
Sterilization	Ethylene Oxide	Ethylene Oxide
Single Use	Yes	Yes
Shelf Life	12 Months (extending to 60months as data becomesavailable)	12 Months (extending to 60months as data becomesavailable)
Packaging	Identical	10 individually packaged ineither banana pack or Tyvekpouches per dispenser box

Section 29 – 510(k) Summary

K. Non-clinical Comparative Performance Testing

Bench testing has been performed to verify that the performance of the proposed Teleflex ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port is substantially equivalent to the predicate device, and that the Teleflex ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port will perform as intended.

Test	Reference to Standard (if	Principle of Test
Performed	applicable)
Ink adherence	ISO 5361, Section 5.3.2 (check	Ink adherence is tested by application
	compliance by inspection, as	and removal of tape to the inked surface
	indicated in 6.4.1 of ASTM	according to the test parameters and
	D3002.	inspected to a rating scale.
Cytotoxicity	ISO 10993-5, Biological	Tests the potential biological reactivity of
	Evaluation of Medical Devices -	a mammalian cell culture in response to
	Part 5: Tests for In Vitro	exposure to the extract of the test article.
	Cytotoxicity
Irritation	ISO 10993-10, Biological	Test the potential of the test article to
	Evaluation of Medical Devices -	produce primary skin irritation after
	Part 10: Tests for Irritation and	topical application when extracted in
	Skin Sensitization	sodium chloride for injections and
		cottonseed oil.

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Teleflex ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port

Sensitization	ISO 10993-10, BiologicalEvaluation of Medical Devices –Part 10: Tests for Irritation andSkin Sensitization	Test the potential of the test article toproduce allergenic reaction whenextracted in sodium chloride andcottonseed oil.
Extractables& Leachables	N/A	Assesses the ET tube relative toleachable/extractable profiles withGC/MS, LC/MS, LC/UV, ICP and FTIRunder clinical use conditions

Section 29 – 510(k) Summary

L. Substantial Equivalence

The modified Teleflex ISIS™ HVTTM Tracheal Tube, Cuffed with Subglottic Secretion Suction Port is substantially equivalent in intended use, design, performance and principles of operation to the identified predicate device cleared under 510(k) K091761. The differences between the ISIS Tube and the predicated device are minor and raise no new issues of safety and efficacy. The ISIS Tube is substantially equivalent to the currently marketed 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).