THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM

K973191 · Pulmonx · BTR · Feb 13, 1998 · Anesthesiology

Device Facts

• Record ID: K973191
• Device Name: THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM
• Applicant: Pulmonx
• Product Code: BTR · Anesthesiology
• Decision Date: Feb 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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. 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 Story

The Pulmonx VETT system integrates fiberoptic visualization components into a standard endotracheal tube wall. It captures real-time endoscopic images from the distal tip of the tube, transmitting them to a Compact Video System (5-inch LCD display) or head-mounted display. The system allows clinicians to visualize the airway continuously or intermittently without disconnecting the patient from a mechanical ventilator. Used in clinical settings by healthcare providers for difficult intubations, tube placement verification, and airway inspection. The output provides direct visual feedback to the physician, facilitating accurate tube positioning and airway management, potentially reducing complications associated with blind intubation or tube displacement.

Clinical Evidence

Bench testing only. Performance data included measurements of cannula flexibility, lumen patency (ASTM1242), and cuff integrity (symmetry, herniation, compliance, leak resistance, tracheal sealing pressure, fatigue, and burst performance). Fiberoptic system performance was validated for image quality and light output. All tests demonstrated substantial equivalence to predicate devices.

Technological Characteristics

Thermosensitive medical-grade PVC cannula; high volume-low pressure PVC cuff. Features 70° forward-looking field of view. Illumination via light guide system with 5000°K metal halide lamp. Connectivity via custom LEMO fiberoptic connector. Mechanical shutter intensity control (0-100%). Video output in NTSC or PAL format to LCD display. Sterilized by ethylene oxide; single-use. Sizes: 7.0, 7.5, 8.0 mm ID.

Indications for Use

Indicated for adult patients requiring mechanical ventilation via oral or nasal intubation. Used for difficult intubation, tube placement verification/repositioning, suctioning, and airway inspection.

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

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

Submission Summary (Full Text)

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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.<br>1047 Elwell Ct.<br>Palo Alto, CA 94303 | Contact Person: Tony Wondka<br>Director, Product Development<br>ph.: [phone]; 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.

- 3. 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

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.

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**Pulmon**x

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.

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.

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

| CHARACTERISTIC | PULMONX<br>VISUALIZED<br>ENDOTRACHEAL<br>TUBE<br>SYSTEM | (1) Mallinckrodt Medical HI-LO<br>Tracheal Tube,<br>(2) Olympus LF-1/LF-2 Tracheal<br>Intubation Fiberscope and American<br>Optical LS-6A / LS-7 Fiberoptic<br>Laryngoscope<br>(3) Welch Allyn HI-LUX HLS-<br>24W Light Source<br>(4) UroHealth END-101 Video Display |
|---------------------------------|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cannula material | Thermosensitive Medical<br>Grade PVC | Thermosensitive Medical Grade PVC (1) |
| Cuff design and<br>material | Compliant Medical Grade<br>PVC, high volume-low<br>pressure | Compliant Medical Grade PVC, high<br>volume-low pressure (1) |
| Endoscope Type | Flexible | Flexible (2) |
| Field and direction of<br>View | 70° minimum forward<br>looking. | 60° forward looking (2, LS-6A) |
| Illumination method | Light Guide system | Light Guide system (2) |
| Lamp Type | Welch Allyn Hi-Lux (Metal<br>Halide) or equivalent. | Welch Allyn Hi-Lux (Metal Halide) (3) |
| Color Temp | 5000 °K | 5000 °K (3) |
| Fiber Optic Bundle<br>Interface | Custom LEMO Fiberoptic<br>Connector | ACMI (2,3) |
| Intensity Control<br>System | Mechanical Shutter (0% -<br>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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Pulmon_

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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.

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.

(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

OR

K473191 510(k) Number

Prescription Use

Over-the-Counter Use

(Optional Format 1-2-96)