(172 days)
END-101
Not Found
No
The device description and performance studies focus on the physical properties of the endotracheal tube, the integrated fiberoptic system for visualization, and the associated video system. There is no mention of any software algorithms, image processing beyond basic display, or any learning capabilities. The predicate devices are also traditional medical devices without AI/ML.
No.
The device is used to establish and visualize an artificial airway for mechanical ventilation, not to directly treat a disease or medical condition.
Yes
The device 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." This involves assessing the patient's airway and the placement of the tube, which are diagnostic functions.
No
The device description clearly outlines physical components like the endotracheal tube itself, fiberoptic components, a cuff, and a separate Compact Video System with an LCD display, light source, and handpiece. This indicates a hardware-based medical device with integrated visualization technology, not a software-only device.
Based on the provided information, the Pulmonx Visualized Endotracheal Tube (VETT) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the VETT is for use as a temporary artificial airway and for viewing during intubation procedures, verifying tube placement, repositioning, suctioning, and general airway inspection. These are all procedures performed in vivo (within the living body).
- Device Description: The description details a device designed to be inserted into the airway for ventilation and visualization of the airway.
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health status. IVDs are specifically designed for this purpose.
Therefore, the VETT is a medical device used for airway management and visualization in vivo, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
BTR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fiberoptic Endoscopy
Anatomical Site
Airway (Tracheal)
Indicated Patient Age Range
adults
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
(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
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).
0
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 Wondka
Director, Product Development
ph.: (650) 934-2606; fax.: X-2601 |
| -------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
|---|
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.
-
- 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.
1
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.
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
VISUALIZED
ENDOTRACHEAL
TUBE
SYSTEM | (1) Mallinckrodt Medical HI-LO
Tracheal Tube,
(2) Olympus LF-1/LF-2 Tracheal
Intubation Fiberscope and American
Optical LS-6A / LS-7 Fiberoptic
Laryngoscope
(3) Welch Allyn HI-LUX HLS-
24W Light Source
(4) UroHealth END-101 Video Display |
|---------------------------------|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cannula material | Thermosensitive Medical
Grade PVC | Thermosensitive Medical Grade PVC (1) |
| Cuff design and
material | Compliant Medical Grade
PVC, high volume-low
pressure | Compliant Medical Grade PVC, high
volume-low pressure (1) |
| Endoscope Type | Flexible | Flexible (2) |
| Field and direction of
View | 70° minimum forward
looking. | 60° forward looking (2, LS-6A) |
| Illumination method | Light Guide system | Light Guide system (2) |
| Lamp Type | Welch Allyn Hi-Lux (Metal
Halide) or equivalent. | Welch Allyn Hi-Lux (Metal Halide) (3) |
| Color Temp | 5000 °K | 5000 °K (3) |
| Fiber Optic Bundle
Interface | Custom LEMO Fiberoptic
Connector | ACMI (2,3) |
| Intensity Control
System | 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) |
2
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.
3
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.
4
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
5
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)