The Pulmonx Visualized Endotracheal Tube (VETT) is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation, for oral and nasal intubations.

The VETT System is indicated for viewing during difficult intubation procedures, for verifying tube placement and repositioning, for viewing during suctioning and for general inspection of the airway.

Device Description

The Pulmonx Visualized Endotracheal Tube (VETT) with Cuff utilizes the fiberoptic components of a bronchoscope and integrates them into the wall of a standard endotracheal tube. Real-time endoscopic visualization from the distal end of the tracheal tube is possible on a continuous or intermittent basis without disconnecting the patient from the mechanical ventilator.

The VETT is made with biocompatible materials. The device is supplied with a preformed arc, pre-cut to length and with depth markings and a full length radiopaque stripe. The distal tip is a hooded bevel with a Murphy's eye. The cuff is a low pressure-high volume cuff. The inflation system has a self sealing valve. The airway connector is a standard 15mm connector. The device is sterilized by ethylene oxide and is designed for single use. The sizes are 7.0, 7.5 and 8.0 mm ID.

The VETT works in conjunction with the Pulmonx Compact Video System which includes a 5 inch LCD display, an integral Light Source and a Remote Handpiece and Cable. A Head Mounted Display is provided as a supplement to the primary display.

AI/ML Overview

The Pulmonx Visualized Endotracheal Tube System (VETT) was evaluated for substantial equivalence to predicate devices. The study did not involve AI, human readers, or a multi-reader multi-case design.

Here's a breakdown of the acceptance criteria and performance based on the provided document:

1. Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Substantial Equivalence to Predicate Devices)	Reported Device Performance
VETT Cannula Flexibility	Substantially equivalent force to conform to patient anatomy as the Mallinckrodt Medical Hi-Lo EndoTracheal Tube.	The force is "substantially equivalent" to the predicate Mallinckrodt Medical Hi-Lo EndoTracheal Tube.
VETT Cannula Lumen Patency	Pass the lumen patency test (e.g., by passing a steel ball (ASTM1242, A1.2)).	Passes the lumen patency test (by passing a steel ball (ASTM1242, A1.2)).
VETT Cuff Symmetry	Meets ASTM requirement.	Meets the ASTM requirement.
VETT Cuff Herniation	Meets ASTM requirement.	Meets the ASTM requirement.
VETT Cuff Compliance	Meets ASTM requirement.	Meets the ASTM requirement.
VETT Cuff Leak Resistance	Meets ASTM requirement (ASTM1242).	Meets the ASTM requirement.
VETT Cuff Tracheal Sealing Pressure	Meets or exceeds that of the Mallinckrodt Hi-Lo Tracheal Tube.	Meets or exceeds that of the Mallinckrodt Hi-Lo Tracheal Tube.
VETT Cuff Fatigue	Meets or exceeds that of the Mallinckrodt Hi-Lo Tracheal Tube.	Meets or exceeds that of the Mallinckrodt Hi-Lo Tracheal Tube.
VETT Cuff Burst Performance	Meets or exceeds that of the Mallinckrodt Hi-Lo Tracheal Tube.	Meets or exceeds that of the Mallinckrodt Hi-Lo Tracheal Tube.
Biocompatibility	All applicable biocompatibility testing is acceptable.	All applicable biocompatibility testing is acceptable.
Fiberoptic System Image Quality	Good performance, substantially equivalent to predicate devices.	Good performance and "substantially equivalent" to the predicate devices.
Fiberoptic System Light Output	Good performance, substantially equivalent to predicate devices.	Good performance and "substantially equivalent" to the predicate devices.

2. Sample Size and Data Provenance

The document does not explicitly state specific sample sizes for each test. Instead, it refers to "all samples" for the fiberoptic system testing. The provenance of the data is not specified; it is assumed to be internal testing conducted by Pulmonx, Inc. and not from clinical trials involving human subjects or external data sources. The study is a retrospective comparison against existing product specifications and performance characteristics of predicate devices.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. This device utilizes objective physical and performance measurements (e.g., force, patency, ASTM standards) rather than expert interpretation of images or clinical data for establishing ground truth.

4. Adjudication Method

Not applicable. The evaluation is based on objective measurements and comparisons to established standards or predicate device specifications, not on subjective expert opinions requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this is a physical medical device, not an AI or imaging diagnostic tool.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The document describes various tests performed on the VETT cannula, cuff, and fiberoptic system to demonstrate its safety and effectiveness. These tests were conducted on the device itself (e.g., measuring forces, lumen patency, cuff properties, image quality, light output).

7. Type of Ground Truth Used

The ground truth used is primarily based on:

Established Standards: ASTM1242 for lumen patency, cuff leak resistance, symmetry, herniation, and compliance.
Predicate Device Specifications/Performance: Performance benchmarks set by the Mallinckrodt Medical Hi-Lo Tracheal Tube for cannula flexibility, minimum tracheal sealing pressure, fatigue, and burst performance, and by the Olympus LF1/LF2, American Optical LS-6A/LS-7, Welch Allyn Hi-Lux, and UroHealth END-101 for the fiberoptic and video system characteristics.
Objective Measurements: Internal testing to quantify properties like image quality, light output, and force.

8. Sample Size for the Training Set

Not applicable. This device is not an AI or machine learning system, and therefore does not have a "training set" in the conventional sense. The development of the device would have involved internal testing and iteration, but this is not reported as a formal training set for algorithm development.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for an algorithm. The design and performance targets for the VETT were established based on the characteristics of existing predicate devices and relevant industry standards.

Summary

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FEB | 3 1998

Pulmon r

Vision in Airway Management

510(k) - Premarket Notif

Visualized Endotracheal Tube System

Appendix 1; 510(k) Summary, page 1 of 3:

Submission Date: August 21, 1997

Submitter: Pulmonx, Inc.1047 Elwell Ct.Palo Alto, CA 94303	Contact Person: Tony WondkaDirector, Product Developmentph.: (650) 934-2606; fax.: X-2601
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Pulmonx Visualized Endotracheal Tube System, or, VETT System 1. Device Trade Name: (includes Pulmonx VETT and Pulmonx Compact Video System).

(1) Tracheal Tube (or Endotracheal Tube) with (2) integral 2. Device Common Name: Fiberoptic Flexible Bronchoscope. Also, (3) Fiberoptic Light Source/Carrier and (4) Video Display.

1. Device Classification Name:
(1) Tracheal Tube, Adult, Cuffed
(2) Bronchoscope, Flexible
(3) Fiberoptic Light Source and Carrier

Device to which this device is substantially equivalent: 4.

(1) Mallinckrodt Hi-Lo Tracheal Tube with Cuff
(2) Olympus LF1/LF2 Tracheal Intubation Fiberscope, A.O. LS6A/LS7 Fiberoptic Laryngoscope.
(3) Welch Allyn Hi-Lux HLS-24W Illuminator
(4) UroHealth Integrated Visualization System, END-101

5. Description of Device

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Pulmonx

Vision in Airway Management

Visualized Endotrachea! Tube System

Appendix 1; 510(k) Summary, continued, page 2 of 3:

6. Intended Use of the Device:

The Pulmonx Visualized Endotracheal Tube (VETT) is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral and nasal intubations.

7. Technical Characteristics, Comparison to Predicate Device(s)

CHARACTERISTIC	PULMONXVISUALIZEDENDOTRACHEALTUBESYSTEM	(1) Mallinckrodt Medical HI-LOTracheal Tube,(2) Olympus LF-1/LF-2 TrachealIntubation Fiberscope and AmericanOptical LS-6A / LS-7 FiberopticLaryngoscope(3) Welch Allyn HI-LUX HLS-24W Light Source(4) UroHealth END-101 Video Display
Cannula material	Thermosensitive MedicalGrade PVC	Thermosensitive Medical Grade PVC (1)
Cuff design andmaterial	Compliant Medical GradePVC, high volume-lowpressure	Compliant Medical Grade PVC, highvolume-low pressure (1)
Endoscope Type	Flexible	Flexible (2)
Field and direction ofView	70° minimum forwardlooking.	60° forward looking (2, LS-6A)
Illumination method	Light Guide system	Light Guide system (2)
Lamp Type	Welch Allyn Hi-Lux (MetalHalide) or equivalent.	Welch Allyn Hi-Lux (Metal Halide) (3)
Color Temp	5000 °K	5000 °K (3)
Fiber Optic BundleInterface	Custom LEMO FiberopticConnector	ACMI (2,3)
Intensity ControlSystem	Mechanical Shutter (0% -100%)	Mechanical Shutter (20% - 80%) (3)
Display Type	LCD	LCD (4)
Camera Format	High resolution	High resolution (4)
Video Format	NTSC or PAL	NTSC (4)

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Vision in Airway Management

Appendix 1; 510(k) Summary, continued, page 3 of 3:

8. Performance Data

The VETT cannula flexibility has been tested by means of measuring forces to conform to patient anatomy. The force is substantially equivalent to the predicate Mallinckrodt Medical Hi-Lo EndoTracheal Tube. The Pulmonx VETT cannula lumen patency has been tested by means of passing a steel ball (ASTM1242, A1.2) and the device passes the lumen patency test. The cannula of the VETT (with regard to lumen patency and ability to conform to patient anatomy) is demonstrated to be safe and effective.

The VETT cuff has been tested for symmetry about the tube, herniation over the distal tip of the tube, compliance, and leak resistance integrity (ASTM1242). All of these properties meet the ASTM requirement. Minimum tracheal sealing pressure, fatigue and burst performance are also evaluated and these properties meet or exceed that of the Mallinckrodt Hi-Lo Tracheal Tube. The Cuff of the VETT is demonstrated to be safe and effective.

All applicable biocompatibility testing is acceptable.

The fiberoptic system of the VETT and the Compact Video System is tested for image quality and light output. All samples show good performance and are substantially equivalent to the predicate devices. This aspect of the device is demonstrated to be safe and effective.

9. Conclusions

Based on the data described above, the Pulmonx VETT is safe and effective and it is substantially equivalent to the Mallinckrodt Hi-Lo Tracheal Tube in design and performance. Also, the design and performance of the Pulmonx VETT fiberoptic system and the Pulmonx Compact Video System is substantially equivalent to the predicate device(s) and is safe and effective.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, represented by three curved lines that suggest wings and a body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 1998

Mr. Robert Kotmel V.P., Research and Development Pulmonx, Inc. 1049 Elwell Court Palo Alto, CA 94303

K973191 Re: Visualized Endotracheal Tube System Requlatory Class: II (two) Product Code: BTR Dated: January 22, 1998 Received: January 26, 1998

Dear Mr. Kotmel:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Pulmonx

Vision in Airway Management

510(k) - Premarket Notification

Visualized Endotracheal Tube System

12973191 510(k) Number (if known):

Device Name:

Visualized Endotracheal Tube System

Indications for Use:

The Pulmonx Visualized Endotracheal Tube (VETT) is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation, for oral and nasal intubations.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Cardiovascular, Respiratory, - ---------------------and Neurological Devices

K473191 510(k) Number

Prescription Use

Over-the-Counter Use

(Optional Format 1-2-96)

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).