(246 days)
Not Found
No
The 510(k) summary describes a physical medical device (endotracheal tube) and its performance characteristics related to laser resistance and biocompatibility. There is no mention of AI, ML, image processing, or any software-based functionality that would suggest the use of these technologies.
No.
The device is an endotracheal tube used for intubation during surgical procedures involving lasers, and its function is to administer anesthetic gases or clear airway obstructions, rather than to treat a specific disease or condition.
No
This device is an endotracheal tube designed for intubation during surgical procedures involving lasers. Its function is to facilitate the administration of anesthetic gases and manage the airway, not to diagnose a condition.
No
The device description clearly describes a physical endotracheal tube with inflatable cuffs and mentions performance studies related to physical properties like dimensions, bend radius, cuff testing, and laser resistance, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Tenax® Laser Resistant Endotracheal Tube is a medical device used for endotracheal intubation. This is a procedure performed directly on a patient to secure their airway, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it's for "endotracheal intubation" during surgical procedures involving lasers. This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The description details a physical tube with inflatable cuffs, designed for insertion into the trachea. This aligns with a medical device for airway management, not an IVD.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, reagents, or diagnostic results, which are hallmarks of IVDs.
Therefore, based on the provided information, the Tenax® Laser Resistant Endotracheal Tube is a medical device used for airway management during surgery, not an in vitro diagnostic.
N/A
Intended Use / 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) 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.
Product codes
BTR, BSK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Trachea/Upper GI Tract
Indicated Patient Age Range
Adults (≥ 22 years old)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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)
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.
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 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.
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V. INDICATION 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) 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.
| Intended Population: | Adults (≥ 22 years old) requiring endotracheal intubation during
laser 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 Endotracheal
Tube | 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 |
| Regulation
Description | Tracheal tube | Tracheal tube |
| Common Name | Endotracheal tube | Endotracheal tube |
| 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) 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. | Xomed Laser-Shield® II 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
anesthesia gases or to overcome
emergency obstruction of an airway. |
| Sterility | Sterile (ethylene oxide)
SAL 10-6 | Sterile (method unknown) |
| Biocompatibility
Classification | Surface Device, Mucosal Membrane,
Limited Duration (