The Tenax® Laser Resistant Endotracheal Tube is intended for endotracheal intubation. It is indicated for use for all types of surgical procedures involving carbon dioxide (10.60 microns) or KTP (532 nm) laser use (normal pulsed or continuous beam delivery in the non-contact mode), when endotracheal intubation is required to administer anesthetic gases or to overcome emergency obstruction of an airway.

Device Description

The Tenax® Laser Resistant Endotracheal Tube is an endotracheal tube with two inflatable cuffs. It is indicated for use in surgical procedures where intubation is required in the presence of KTP or CO2 lasers.

The device is provided sterile (EO). After use, the device is discarded and disposed of in accordance with local regulations. There are no associated device accessories.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device and describes various tests performed to demonstrate substantial equivalence to a predicate device, rather than a study designed to prove the device meets specific acceptance criteria in a clinical or AI performance context.

Therefore, much of the requested information (like sample size for test sets, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness, standalone performance, and training set details) is not applicable or cannot be extracted from this document, as it pertains to specific types of clinical or AI performance studies which are not described here.

However, I can extract information related to the performance data provided to support the substantial equivalence claim.

Acceptance Criteria and Reported Device Performance

The document describes various performance tests conducted for the Tenax® Laser Resistant Endotracheal Tube to support its substantial equivalence. While specific numerical acceptance criteria are not explicitly detailed in this summary, the tests implicitly demonstrate that the device performs as intended and is safe and effective when compared to the predicate device.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the provided test types):

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Dimensional Conformance (Dimensions meet specified requirements for safe and effective use)	Dimensional testing performed. Dimensions: Length: 34cm. ID: 5.0mm, 5.5mm, 6.0mm, 6.5mm, 7.0mm, 7.5mm. OD: 7.9mm, 8.6mm, 9.3mm, 10.0mm, 10.6mm, 11.0mm.
Mechanical Integrity - Bend Radius (Device maintains integrity and functionality when bent)	Bend radius testing performed.
Cuff Functionality (Cuffs inflate/deflate correctly within specified time/pressure, and do not burst prematurely)	Cuff inflation/deflation/burst testing (time and pressure) performed.
Leak/Damage Indication (Internal dye clearly visible upon puncture/damage)	Dye visibility testing performed.
Laser Resistance (Device effectively resists specified CO2 and KTP laser energies)	Laser resistance testing performed. Maximum power density for CO2 laser: 10,394 W/cm². Maximum power density for KTP laser: 5,305 W/cm². Maximum continuous irradiation: 30 seconds.
Tracheal Tube Dimensions Conformance (Specific dimensions conform to standards for tracheal tubes)	Tracheal tube dimensions testing performed.
Connector Integrity (Connector to ventilation source does not leak)	Connector leakage testing performed.
Biocompatibility (Device materials are safe for human contact)	Biocompatibility evaluation conducted in accordance with ISO 10993-1. Tests included: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity. Device is considered tissue-contacting for less than 24 hours.

Study Information (Based on available text):

Sample size used for the test set and the data provenance: Not explicitly stated for each test. The document mentions "The non-clinical test data support the safety of the device and the verification and validation testing data demonstrate that the Tenax® Laser Resistant Endotracheal Tube shall perform as intended in the specified use conditions." The nature of these tests (e.g., dimensional, mechanical, laser resistance) suggests laboratory-based testing on samples of the device. Data provenance (country of origin, retrospective/prospective) is not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are non-clinical engineering and laboratory performance tests, not studies requiring expert interpretation of clinical data for ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. These are objective engineering and material performance tests.
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 document describes a medical device (endotracheal tube), not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for an endotracheal tube, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the performance tests listed (e.g., dimensional, bend radius, cuff function, laser resistance), the "ground truth" would be established by validated engineering specifications, material standards, and physical measurements/observations during the tests. For biocompatibility, it's compliance with ISO 10993-1 standards and the results of the specific biological tests.
The sample size for the training set: Not applicable. There is no AI model or training set described in this document.
How the ground truth for the training set was established: Not applicable. No training set is described.

Summary

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November 25, 2020

Bryan Medical, Inc. % Ian Broome Regulatory Affairs Consultant AlvaMed, Inc. 1116 Great Plain Avenue, Suite 1 Needham, Massachusetts 02492

Re: K200761

Trade/Device Name: Tenax Laser Resistant Endotracheal Tube Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: Class II Product Code: BTR, BSK Dated: October 23, 2020 Received: October 26, 2020

Dear Ian Broome:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200761

Device Name Tenax® Laser Resistant Endotracheal Tube

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)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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5.0 TRADITIONAL 510(K) SUMMARY FOR TENAX® LASER RESISTANT ENDOTRACHEAL TUBE

K200761

I. SUBMITTER

Bryan Medical, Inc. 5725 Dragon Way, Suite 300 Cincinnati, OH 45227 Phone: (888) 331-3485, x 700 Fax: (617) 249-0955 Contact Person: lan Broome, AlvaMed, Inc. Date Prepared: November 23, 2020

II. DEVICE

Name of Device: Tenax® Laser Resistant Endotracheal Tube Common or Usual Name: Endotracheal tube (cuffed) Classification Name: Tracheal tube (21 CFR 868.5730) Requlatory Class: II Product Code: BTR, BSK

III. PREDICATE DEVICE

Laser-Shield® II, K993582

IV. DEVICE DESCRIPTION

The device is provided sterile (EO). After use, the device is discarded and disposed of in accordance with local regulations. There are no associated device accessories.

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V. INDICATION FOR USE

Intended Population:	Adults (≥ 22 years old) requiring endotracheal intubation duringlaser surgery procedures in the upper gastro-respiratory tract.
Intended Environment of Use:	Trachea/Upper GI Tract
Contraindications:	The Tenax® Laser Resistant Endotracheal Tube should not be used in patients with narrow airways, which could restrict ventilation, resulting in excessive elevation of intratracheal pressure. Do not use in any patient suffering from conditions that may preclude endotracheal intubation. Do not use this device for any purpose other than its intended use. To avoid device damage, do not exceed a power density of 10,394 W/cm² when used with a CO2 laser. To avoid device damage, do not exceed a power density of 5,305 W/cm² when used with a KTP laser. Do not use with continuous irradiation lasting longer than 30 seconds.

Intended Population:

Adults (≥ 22 years old) requiring endotracheal intubation duringlaser surgery procedures in the upper gastro-respiratory tract.

Intended Environment of Use:

Trachea/Upper GI Tract

Contraindications:

The Tenax® Laser Resistant Endotracheal Tube should not be used in patients with narrow airways, which could restrict ventilation, resulting in excessive elevation of intratracheal pressure. Do not use in any patient suffering from conditions that may preclude endotracheal intubation. Do not use this device for any purpose other than its intended use. To avoid device damage, do not exceed a power density of 10,394 W/cm² when used with a CO2 laser. To avoid device damage, do not exceed a power density of 5,305 W/cm² when used with a KTP laser. Do not use with continuous irradiation lasting longer than 30 seconds.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

	Subject:Tenax® Laser Resistant EndotrachealTube	Predicate Device:Laser-Shield® II
Manufacturer	Bryan Medical, Inc.	Medtronic/Xomed
510(k) Number	K200761	K993582
Product Code	BTR, BSK	BTR
Regulation	868.5730	868.5730
RegulationDescription	Tracheal tube	Tracheal tube
Common Name	Endotracheal tube	Endotracheal tube
Indications forUse	The Tenax® Laser Resistant EndotrachealTube is intended for endotrachealintubation. It is indicated for use for alltypes of surgical procedures involvingcarbon dioxide (10.60 microns) or KTP (532nm) laser use (normal pulsed or continuousbeam delivery in the non-contact mode),when endotracheal intubation is required toadminister anesthetic gases or to overcomeemergency obstruction of an airway.	Xomed Laser-Shield® II is intended forendotracheal intubation. It is indicated foruse for all types of surgical proceduresinvolving carbon dioxide (10.60 microns) orKTP (532 nm) laser use (normal pulsed orcontinuous beam delivery in the non-contact mode), when endotrachealintubation is required to administeranesthesia gases or to overcomeemergency obstruction of an airway.
Sterility	Sterile (ethylene oxide)SAL 10-6	Sterile (method unknown)
BiocompatibilityClassification	Surface Device, Mucosal Membrane,Limited Duration (< 24h)	Surface Device, Mucosal Membrane,Limited Duration (< 24h)
Design Features	● Endotracheal tube with cuffs at distalend● Aluminum wrapping for laserresistance● Outer atraumatic silicone covering● Blue dye within pilot balloons forleak/damage indication	● Endotracheal tube with cuffs at distalend● Aluminum wrapping for laserresistance● Outer atraumatic polymer covering● Blue dye within pilot balloons forleak/damage indication
	Subject:	Predicate Device:
	Tenax® Laser Resistant EndotrachealTube	Laser-Shield® II
Connection toVentilationSource	Standard straight connector to anesthesiagas supply	Standard straight connector to anesthesiagas supply
Dimensions	Length: 34cmID: (6 sizes)5.0mm (model TG-0050) 5.5mm (TG-0055) 6.0mm (TG-0060) 6.5mm (TG-0065) 7.0mm (TG-0070) 7.5mm (TG-0075)	Length: 33cmID: (9 sizes)4.0mm (model 7060100) 4.5mm (7060150) 5.0mm (7060200) 5.5mm (7060250) 6.0mm (7060300) 6.5mm (7060350) 7.0mm (7060400) 7.5mm (7060450) 8mm (7060500)OD:6.6mm (7060100)
	OD:7.9mm (TG-0050) 8.6mm (TG-0055) 9.3mm (TG-0060) 10.0mm (TG-0065) 10.6 (TG-0070) 11.0mm (TG-0075)	7.3mm (7060150)8.0mm (7060200)8.6mm (7060250)9.0mm (7060300)10.0mm (7060350)10.5mm (7060400)11.0mm (7060450)11.5mm (7060500)
Single Use?	Yes	Yes

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Both devices are laser resistant endotracheal tubes. They share an identical indication for use and are intended for use in the same manner. The subject and predicate devices also share the following technological characteristics:

Laser resistance using an inner aluminum scattering layer, ●
. Atraumatic outer layer for protection of patient tissue,
Inflatable cuffs,
. Use of internal dye as a warning indicator to alert practitioners of device puncture or damage.

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination:

Dimensional testing, ●
Bend radius,
. Cuff inflation/deflation/burst testing (time and pressure),
Dye visibility.
. Laser resistance,
Tracheal tube dimensions, ●
. Connector leakage.
●

Biocompatibility Testing

The biocompatibility evaluation for the Tenax® Laser Resistant Endotracheal Tube was conducted in accordance with the FDA's guidance "International Standard ISO 10993-1 'Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process." The biocompatibility testing included the following tests:

Cytotoxicity,
Sensitization, ●
Irritation, ●
Acute Systemic Toxicity, ●
Material-Mediated Pyrogenicity. .

The Tenax® Laser Resistant Endotracheal Tube is considered tissue-contacting for a duration of less than 24 hours. The device's materials are well-characterized for medical use.

VIII. CONCLUSIONS

The non-clinical test data support the safety of the device and the verification and validation testing data demonstrate that the Tenax® Laser Resistant Endotracheal Tube shall perform as intended in the specified use conditions. The subject device and the predicate device have the same intended use, and the technological differences do not raise different questions of safety and effectiveness.

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).