(30 days)
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.
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.
This document is a 510(k) premarket notification for a modification to a medical device, specifically the Tenax® Laser Resistant Endotracheal Tube. It primarily addresses the addition of 445 nm Blue Laser compatibility to the device's indications for use.
Based on the provided text, here's information related to acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Laser resistance to CO2 (10.60 microns) | The device is designed with an inner aluminum scattering layer for laser resistance. (Implicitly met as it's a feature of both subject and predicate devices, and the modification adds Blue Laser compatibility, not removes CO2 capabilities). |
| Laser resistance to KTP (532 nm) | The device is designed with an inner aluminum scattering layer for laser resistance. (Implicitly met as it's a feature of both subject and predicate devices, and the modification adds Blue Laser compatibility, not removes KTP capabilities). |
| Laser resistance to Blue Laser (445 nm) | The performance data provided for "Laser resistance" supports the substantial equivalence of the modified device, implying it meets resistance for 445 nm Blue Laser. Specific numerical performance data is not detailed in this summary. |
| Atraumatic outer layer for patient tissue protection | The device has an atraumatic outer layer. (Feature shared with predicate). |
| Inflatable cuffs | The device has inflatable cuffs. (Feature shared with predicate). |
| Use of internal dye as a warning indicator | The device uses internal dye as a warning indicator. (Feature shared with predicate). |
| Overall safety (non-clinical) | Non-clinical data supports the safety of the device. |
| Performance as intended | Verification and validation testing demonstrate the device performs as intended. |
| Comparability to predicate | Data demonstrates the Tenax® Laser Resistant Endotracheal Tube performs comparably to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific details about the sample size used for the test set of the laser resistance testing. It simply states "Laser resistance" as performance data.
The document does not specify data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This document is a regulatory submission for a medical device (endotracheal tube) and focuses on engineering/performance testing, not on clinical interpretation or AI model accuracy that would require expert-established ground truth. Therefore, this information is not applicable and not provided in the document.
4. Adjudication Method for the Test Set
This document is a regulatory submission for a medical device (endotracheal tube) and focuses on engineering/performance testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving expert reviews of diagnostic images/interpretations. This information is not applicable and not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document does not describe a multi-reader multi-case comparative effectiveness study. This type of study is relevant for AI-driven diagnostic tools, not for a physical medical device like an endotracheal tube.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This document does not describe a standalone algorithm performance study. This type of study is relevant for AI-driven diagnostic tools, not for a physical medical device like an endotracheal tube.
7. Type of Ground Truth Used
The "ground truth" for this device's performance would be established through a combination of engineering specifications, material science testing, and laser interaction physics rather than expert consensus, pathology, or outcomes data in the typical sense for diagnostic devices. The document mentions "verification and validation testing" which implies objective measurement against predefined technical requirements for laser resistance and other physical characteristics.
8. Sample Size for the Training Set
This document does not refer to a training set. The "Tenax® Laser Resistant Endotracheal Tube" is a physical medical device, not an AI/machine learning algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this physical medical device.
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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
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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.
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| Image: bryan MEDICAL, INC. logo | Special 510(k): Modification toTenax® Laser Resistant EndotrachealTube | Page 2 |
|---|---|---|
| --------------------------------- | -------------------------------------------------------------------------------- | -------- |
| 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 beused in patients with narrow airways, which could restrictventilation, resulting in excessive elevation of intratrachealpressure. Do not use in any patient suffering from conditions thatmay preclude endotracheal intubation. Do not use this device forany 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 EndotrachealTube | Predicate Device:Tenax® Laser Resistant EndotrachealTube | |
|---|---|---|
| Manufacturer | Bryan Medical, Inc. | Bryan Medical, Inc. |
| 510(k)Number | To be assigned. | K200761 |
| Product Code | BTR, BSK | BTR, BSK |
| RequlationNumber | 868.5730 | 868.5730 |
| RegulationDescription | Tracheal tube | Tracheal tube |
| CommonName | Endotracheal tube | Endotracheal tube |
| Indicationsfor Use | The Tenax® Laser ResistantEndotracheal Tube is intended forendotracheal intubation. It is indicated foruse for all types of surgical proceduresinvolving carbon dioxide (10.60 microns),Blue (445 nm), or KTP (532 nm) laseruse (normal pulsed or continuous beamdelivery in the non-contact mode), whenendotracheal intubation is required toadminister anesthetic gases or toovercome emergency obstruction of anairway. | The Tenax® Laser ResistantEndotracheal Tube is intended forendotracheal intubation. It is indicated foruse for all types of surgical proceduresinvolving carbon dioxide (10.60 microns)or KTP (532 nm) laser use (normalpulsed or continuous beam delivery inthe non-contact mode), whenendotracheal intubation is required toadminister anesthetic gases or toovercome emergency obstruction of anairway. |
| 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.
§ 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).