(30 days)
Not Found
No
The summary describes a physical medical device (endotracheal tube) and its laser resistance properties. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on laser resistance, not algorithmic performance.
No
The device is an endotracheal tube used for intubation and administering anesthetic gases during surgical procedures involving lasers. Its primary function is to facilitate ventilation and protect the airway, not to treat or cure a disease or condition.
No.
The device is an endotracheal tube used for intubation during surgical procedures involving lasers; its purpose is to administer anesthetic gases or clear airway obstructions, not to diagnose a medical condition.
No
The device description clearly states it is an "endotracheal tube," which is a physical, hardware device. The summary focuses on the laser resistance of the tube itself, not on any software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for endotracheal intubation during surgical procedures involving lasers. This is a direct medical intervention on a patient's airway.
- Device Description: The device is an endotracheal tube, which is a physical device inserted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for a therapeutic and procedural purpose.
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), KTP (532 nm) or Blue Laser (445mm) 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, 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.
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: Laser resistance.
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 21, 2021
Bryan Medical, Inc. % Martha Russell Director of Regulatory Affairs AlvaMed. Inc. 1116 Great Plain Avenue, Suite 1 Needham, Massachusetts 02492
Re: K213028
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: September 17, 2021 Received: September 21, 2021
Dear Martha Russell:
We have reviewed vour 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.
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
1
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 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)
K213028
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), KTP (532 nm) or Blue Laser (445mm) 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)
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Image /page/3/Picture/2 description: The image shows the logo for Bryan Medical, Inc. The logo consists of two blue, angled rectangles on the left side, followed by the word "bryan" in black, sans-serif font. Below "bryan" is the text "MEDICAL, INC." in a smaller, sans-serif font, also in black.
Special 510(k): Modification to Tenax® Laser Resistant Endotracheal Tube
Page 1
1.0 SPECIAL 510(K) SUMMARY FOR TENAX® LASER RESISTANT ENDOTRACHEAL TUBE
This Special 510(k) for the Tenax® Laser Resistant Endotracheal Tube is submitted based on the FDA Guidance document "The Special 510(k) Program: Guidance for Industry and Food and Drug Administration Staff' issued September 13, 2019. This Special 510(k) addresses labeling revisions to the Tenax® Instructions for Use to add the use of a 445 nm Blue Laser, and that the device is not made with natural rubber latex. In addition, the Indications for Use statement was modified to add the 445nm Blue Laser.
1.1. Submitter
Bryan Medical, Inc. 5725 Dragon Way, Suite 300 Cincinnati, OH 45227
Phone: (617) 517-4932
Fax: (617) 249-0955
Contact Person: Martha Kamrow-Russell, AlvaMed, Inc.
Date Prepared: September 17, 2021
1.2. Device
Name of Device: Tenax® Laser Resistant Endotracheal Tube
Common or Usual Name: Endotracheal tube
Classification Name: Tracheal tube (21 CFR 868.5730)
Regulatory Class: II
Product Code: BTR, BSK
1.3. Predicate Device
Tenax® Laser Resistant Endotracheal Tube, K200761
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. 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), KTP (532 nm), or Blue (445 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.
4
| Image: bryan MEDICAL, INC. logo | Special 510(k): Modification to
Tenax® Laser Resistant Endotracheal
Tube | Page 2 |
| --------------------------------- | -------------------------------------------------------------------------------- | -------- |
|---|
| 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. |
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Image /page/5/Picture/2 description: The image shows the logo for Bryan Medical, Inc. The logo features a blue, stylized "B" shape on the left, followed by the word "bryan" in black, sans-serif font. Below "bryan" is the text "MEDICAL, INC." in a smaller, sans-serif font, also in black. The overall design is clean and professional.
1.6. Comparison of Technological Characteristics with the Predicate Device
| | Subject Device:
Tenax® Laser Resistant Endotracheal
Tube | Predicate Device:
Tenax® Laser Resistant Endotracheal
Tube |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Bryan Medical, Inc. | Bryan Medical, Inc. |
| 510(k)
Number | To be assigned. | K200761 |
| Product Code | BTR, BSK | BTR, BSK |
| Requlation
Number | 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),
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 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. |
| Sterility | Sterile (ethylene oxide) | Sterile (ethylene oxide) |
| Single Use | Yes | Yes |
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Image /page/6/Picture/2 description: The image shows the logo for Bryan Medical, Inc. The logo consists of two blue rectangles stacked on top of each other on the left side. To the right of the rectangles is the word "bryan" in black, with the words "MEDICAL, INC." in smaller black letters underneath.
Special 510(k): Modification to Tenax® Laser Resistant Endotracheal Tube
Both devices are laser resistant endotracheal tubes. They share an identical indication for use (outside of the addition of the Blue 445 nm laser for the subject device) 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. Performance Data
The following performance data were provided in support of the substantial equivalence determination:
- Laser resistance
1.8. Conclusion
The non-clinical data support the safety of the device and the verification and validation testing demonstrate that the Tenax® Laser Resistant Endotracheal Tube shall perform as intended in the specified use conditions. The data demonstrate that the Tenax® Laser Resistant Endotracheal Tube performs comparably to the predicate device currently marketed for the same intended use.