Tenax® Laser Resistant Endotracheal Tube
Device Facts
| Record ID | K251794 |
|---|---|
| Device Name | Tenax® Laser Resistant Endotracheal Tube |
| Applicant | Bryan Medical, Inc. |
| Product Code | BTR · Anesthesiology |
| Decision Date | Sep 3, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5730 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
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), KTP (532 nm) or Blue (445nm) 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. The device is intended for use in adult patients.
Device Story
Laser-resistant endotracheal tube; provides airway access for anesthetic gas administration or emergency obstruction relief during laser surgery. Features inner aluminum scattering layer for laser resistance; atraumatic outer layer; inflatable cuffs; internal dye warning indicator for puncture detection. Used in clinical surgical settings; operated by physicians. Device is single-use; sterile (EO). Modifications include expanded size range (4.0mm–8.5mm) and updated shaft/pilot balloon materials. Output is physical airway maintenance; clinical benefit is protection of patient airway from laser-induced ignition or damage during upper gastro-respiratory tract procedures.
Clinical Evidence
No clinical or animal studies were conducted. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993, ISO 18562), dimensional inspection, mechanical performance (burst, kink, leakage, connector durability), simulated distribution/aging, and laser resistance testing per ISO 11990.
Technological Characteristics
Single silicone shaft; coiled 0.0015" thick aluminum laser-resistant barrier; inflatable cuffs; internal dye warning indicator. Sizes: 4.0mm to 8.5mm. Sterilization: Ethylene Oxide (ISO 11135). Standards: ISO 5361 (tracheal tubes), ISO 5356-1 (connectors), ISO 11990 (laser resistance), ISO 14408 (marking), ISO 10993/18562 (biocompatibility).
Indications for Use
Indicated for adult patients (≥ 22 years) requiring endotracheal intubation during surgical procedures in the upper gastro-respiratory tract involving CO2, KTP, or Blue lasers.
Regulatory Classification
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.
Predicate Devices
- Tenax® Laser Resistant Endotracheal Tube (K213028)
Submission Summary (Full Text)
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**FDA** U.S. FOOD & DRUG
ADMINISTRATION
September 3, 2026
Bryan Medical, Inc.
% Keira Jessop
Regulatory Affairs Consultant
AlvaMed, Inc.
935 Great Plain Ave.
Suite 166
Needham, Massachusetts 02492
Re: K251794
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: August 4, 2026
Received: August 4, 2026
Dear Keira Jessop:
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 (the 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 available 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K251794 - Keira Jessop
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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.
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K251794 - Keira Jessop
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See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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,
Bradley Q. Quinn -S
Bradley Quinn
Assistant Director
DHT1C: Division of Anesthesia,
Respiratory, and Sleep 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 | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K251794_S001 | ? |
| Please provide the device trade name(s). | | ? |
| Tenax® Laser Resistant Endotracheal Tube | | |
| Please provide your Indications for Use below. | | ? |
| 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), KTP (532 nm) or Blue (445nm) 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. The device is intended for use in adult patients. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
Tenax® Laser Resistant Endotracheal Tube
Page 8 of 50
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# 510(k) Summary
## 1.1 Name and Address of Submitter
David Rattigan
General Manager
Bryan Medical, Inc.
6100 Wooster Pike
Cincinnati, OH 45227
## 1.2 Correspondent/Primary Contact Person
Keira Jessop, M.S., RAC
Regulatory Affairs Consultant
AlvaMed, Inc.
935 Great Plain Avenue, Unit 166
Needham, MA 02492 USA
kjessop@alvamed.com
Phone: +1 (888) 331-3485 Fax: +1 (617) 249-0955
## 1.3 Submission Information
#### Date Summary Prepared:
August 3, 2026
#### Subject Device:
| Trade/Device Name: | Tenax® Laser Resistant Endotracheal Tube |
| --- | --- |
| Manufacturer: | Bryan Medical, Inc. |
| Regulation Number: | 21 CFR 868.5730 |
| Regulation Name: | Tracheal Tube |
| Regulation Class | II |
| Product Code: | BTR, BSK |
| Review Panel: | Anesthesiology |
#### Primary Predicate
| Clearance: | K213028 |
| --- | --- |
| Trade/Device Name: | Tenax® Laser Resistant Endotracheal Tube |
| Manufacturer: | Bryan Medical, Inc. |
| Regulation Number: | 21 CFR 868.5730 |
| Regulation Name: | Tracheal Tube |
| Regulation Class | II |
| Review Panel: | Anesthesiology |
#### Device:
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#### 1.4 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, 445nm Blue Laser, 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.
#### 1.5 Indications for Use
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), KTP (532 nm) or Blue (445nm) 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. The device is intended for use in adult patients.
#### 1.6 Comparison of Manufacturer's Cleared Device and Modified Device
The following table provides an overview of general technological characteristics in comparison to the predicate devices. Any differences in the technological characteristics are minor and reflect market strategy and/or perceived user preferences and do not impact the safety, effectiveness, or substantial equivalence of the device.
**Table 2: Comparison of subject device to the predicate device.**
| | **Subject Device:** **Tenax® Laser Resistant Endotracheal Tube** | **Predicate Device:** **Tenax® Laser Resistant Endotracheal Tube** | **Discussion of Differences** |
| --- | --- | --- | --- |
| **510(k) Number** | K251794 | K213028 | N/A |
| **Manufacturer** | Bryan Medical, Inc. | Bryan Medical, Inc. | Same |
| **Product Code** | BTR, BSK | BTR, BSK | Same |
| **Regulation Number** | 868.5730 | 868.5730 | Same |
| **Regulation Description** | Tracheal tube | Tracheal tube | Same |
| **Common Name** | Endotracheal tube | Endotracheal tube | Same |
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| | **Subject Device:** Tenax® Laser Resistant Endotracheal Tube | **Predicate Device:** Tenax® Laser Resistant Endotracheal Tube | **Discussion of Differences** |
| --- | --- | --- | --- |
| **Indications for Use** | 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), Blue (445 nm), 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. The device is intended for use in adult patients. | 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), Blue (445 nm), 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. | Similar - The intended patient population has been included to clarify that all sizes are intended for adults only. |
| **Sterility** | Sterile (ethylene oxide) | Sterile (ethylene oxide) | Same |
| **Available Sizes** | The device ranges in size from a 4.0mm diameter device to a 8.5mm diameter device. The sizes are as follows: 4.0mm, 4.5mm, 5.0mm, 5.5mm, 6.0mm, 6.5mm, 7.0mm, 7.5mm, 8.5mm. | The device ranges in size from a 5.0mm diameter device to a 7.5mm diameter device. The sizes are as follows: 5.0mm, 5.5mm, 6.0mm, 6.5mm, 7.0mm, 7.5mm. | Different - The additional sizes have been added to provide options based on the adult patient size and desired surgical procedure. All sizes are intended for adults only and there is no change to the intended patient population. All new sizes are the same length and are constructed in the same manner as the predicate. Performance testing has proven no impact to safety and effectiveness. |
| **Shaft Inner Diameter** | 4.0; 4.5; 5.0; 5.5; 6.0; 6.5; 7.0; 7.5; 8.5 | 5.0; 5.5; 6.0; 6.5; 7.0; 7.5. | Same for existing sizes |
| **Shaft Outer Diameter** | 6.6; 7.1; 7.9; 8.6; 9.3; 10.0; 10.6; 11.0; 12.2 | 7.9; 8.6; 9.3; 10.0; 10.6; 11.0 | Same for existing sizes |
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| | **Subject Device: Tenax® Laser Resistant Endotracheal Tube** | **Predicate Device: Tenax® Laser Resistant Endotracheal Tube** | **Discussion of Differences** |
| --- | --- | --- | --- |
| **Length** | All sizes: 34 cm | All sizes: 34 cm | Same |
| **Single Use** | Yes | Yes | Same |
| **Intended Population** | Adults (≥ 22 years old) requiring endotracheal intubation during laser surgery procedures in the upper gastro-respiratory tract. | Adults (≥ 22 years old) requiring endotracheal intubation during laser surgery procedures in the upper gastro-respiratory tract. | Same |
| **Shaft material** | Single Silicone material | Combination of two silicones | Similar - The change from a blended material to a single material enables a consistent shaft composition and provides uniform stiffness along the shaft. Performance testing has proven no impact to safety and effectiveness. |
| **Pilot balloon material** | Alternate Medical grade LSR | LSR | Similar – This change was made because of because of supply chain availability. Performance testing has proven no impact to safety or effectiveness. |
| **Primary Laser Resistant Barrier** | Coiled 0.0015' Thick Aluminum | Coiled 0.0015' Thick Aluminum | Same |
| **Packaging** | Support card with tabs placed in Tyvek/LDPE Pouch and chipboard unit box. Five unit boxes are placed in a corrugated shipping box. | Support card with tabs placed in Tyvek/LDPE Pouch and chipboard unit box. Five unit boxes are placed in a corrugated shipping box. | Similar - All materials and sizes on packaging components are the same between the subject and predicate device. The tabs on the subject device have been relocated to incorporate the larger size. Packaging testing has demonstrated no impact to safety or effectiveness. |
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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.
### 1.7 Summary of Modification
Three additional sizes of the Tenax Laser Resistant Endotracheal Tube have been added to the versions originally cleared in K200761. There are two sizes that will be smaller than our currently offered smallest model, at 4.0 and 4.5mm, as well as a larger size at 8.5mm. In addition to the new sizes, two material changes are being made to all sizes of the endotracheal tube.
### 1.8 Performance Testing Summary
Summary of Biocompatibility Testing:
The Tenax® Laser Resistant Endotracheal Tube is considered to be a surface device with breached or compromised surfaces contact with a limited duration (< 24 hrs). The biocompatibility evaluation for the Tenax® Laser Resistant Endotracheal Tube was conducted in accordance with the guidance document “Use of International Standard ISO 10993-1, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process,’” The testing included the following:
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Material Medicated Pyrogenicity
Per ISO 18562-1 “Biocompatibility evaluation of breathing gas pathways in healthcare applications” the following was conducted:
- Particulate Matter
- Volatile Organic Compounds
- Toxicological Risk Assessment
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## Summary of Performance Testing
The following testing was completed:
- Visual inspection included testing for damage after transit, print legibility following transit, Dye Strip migration from the Pilot Balloon, color coding presence on pilot balloons, connector size marking, device marking inclusions, and the aluminum wrap was free of gaps.
- Dimensional inspection evaluated the overall and effective length, distal cuff position, outer and inner diameters, cuff positions, depth marking coverage, bevel angles, connector diameters, connector clearances, connector taper measurements, and the murphy eye area.
- Benchtop performance testing ensured that inflation and deflation times for the subject devices met acceptance criteria. Burst testing, kink resistance, connector separation force, connector durability, system leakage, and bend testing were also performed.
- Simulated distribution and sterile barrier testing were performed to ensure that the larger device size and packaging change do not impact the sterile barrier.
- Simulated aging testing was performed to evaluate all device and packaging performance characteristics after 3.5 years of accelerated aging.
- Simulated testing for intubation, removal, inflation, and deflation was also performed.
## Standards
The following standards were used or referenced for the testing outlined above as applicable.
Biocompatibility:
ISO 10993-1 Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO 10993-1:2025)
ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-23 Biological evaluation of medical devices - Part 23: Tests for irritation
ISO 18562-1 Biocompatibility evaluation of breathing gas pathways in healthcare applications
ISO 18562-2 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 2: Tests for emissions of particulate matter
ISO 18562-3 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 3: Tests for emissions of volatile organic substances
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# Performance Testing:
ISO 5361 Anaesthetic and respiratory equipment – Tracheal tubes and connectors
ISO 5356-1 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
ISO 80369-7 Small-bore connectors for liquids and gases in healthcare applications – Part 7: Connector for intravascular or hypodermic applications
ISO 80369-20 Small-bore connectors for liquids and gases in healthcare applications – Part 20: Common test methods
ISO 11607-1, Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems.
ISO 11607-2, Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing, and assembly processes.
ASTM D4169-23E1 Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
ASTM F88 / F88M -23 Standard Test Method for Seal Strength of Flexible Barrier Materials
ISTA 3A Packaged-Products for Parcel Delivery system Shipment 70kg (150lb) or Less
ISO 11990 Lasers and laser-related equipment – Determination of laser resistance of tracheal tube shaft and tracheal tube cuffs
ISO 14408 Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information
# Sterilization :
ISO 11135 Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
AAMI TIR Product adoption and process equivalence for ethylene oxide sterilization
ISO 11138 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
ISO 10993-7 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
# Summary of Animal and Clinical Data
No animal or clinical studies were conducted for this submission.
# 1.9 Conclusion
All testing met the acceptance criteria. The data demonstrates that the Tenax® Laser Resistant Endotracheal Tube performs comparably to the predicate device currently marketed for the same
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intended use and can therefore be considered substantially equivalent.
