(118 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on the physical components and basic imaging capabilities.
No
The device is used for intubation, mechanical ventilation, and airway visualization, which are procedures, not therapies.
No
Explanation:
The device is described as an "endotracheal tube" intended for "intubation procedures" and use as a "temporary artificial airway" for "mechanical ventilation." While it offers "viewing during non-difficult and difficult intubation procedures, for verifying tube placement and repositioning, for viewing during suctioning and for general inspection of the airway," these functions are for guiding and verifying placement and health of the airway, not for diagnosing a medical condition or disease. The product information does not mention diagnosing any condition or disease.
No
The device description explicitly states it is a "visualized endotracheal tube" and includes a "tiny CMOS video camera and light source," indicating it is a hardware device with integrated components, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for intubation procedures, providing a temporary artificial airway, and for viewing the airway during these procedures. This is a therapeutic and diagnostic imaging use, not a diagnostic test performed on samples taken from the body (which is the definition of an IVD).
- Device Description: The description details a visualized endotracheal tube with a camera and light source. This is a medical device used directly on the patient, not a reagent, instrument, or system intended for use in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
The device is a medical device used for direct visualization and airway management within the body, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The ETView Tracheoscopic Ventilation Tube (TVT) is intended for oral and nasal intubation.
The ETView Tracheoscopic Ventilation Tube (TVT) System has the following specific indications:
- Temporary artificial airway in adults requiring mechanical ventilation, for oral and . nasal intubation.
- Viewing during non-difficult and difficult intubation procedures, for verifying tube . placement and repositioning, for viewing during suctioning and for general inspection of the airway.
for . Indications The ETView Tracheoscopic Ventilation Tube (TVT) is intended Use: for intubation procedures. The ETView Tracheoscopic Ventilation Tube (TVT) is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral and nasal intubations. The TVT System is indicated for viewing during non-difficult and 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 ETView Tracheoscopic Ventilation Tube (TVT) System is a visualized endotracheal tube The ETV10 Pacelleosooped Pulmonx VETT System (K973191), except that the ETView System same as tiny CMOS video camera and light source and the Pulmonx device uses fiberoptic components.
The TVT has two Murphy eyes like the Parker Medical Flex -Tip Endotracheal Tube (K984528), and an additional lens clearing lumen. The inherent radiopacity of the TVT obviates the need for a radiopaque strip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
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)
Bench testing demonstrated that the Tracheoscopic Ventilation Tube (TVT) System is at least as Donor loomig demonstrations and Pulmonx VETT System for oral and nasal intubation and in providing visualization of the airway.
The following performance tests have been done and the results are attached to this submission: Determination of Cuff Resting Diameter, Resistance to Tube Collapse, Resistance to Cuff Herniation, Cuff Symmetry, Air Flow Resistance, Thermal Safety, Imaging Performance, Cuff Leak Resistance Integrity, Mechanical Integrity ( Fatigue, Burst, and Cuff Compliance as part of the Mechanical Integrity test), Efficacy of Selective Suctioning, Software Validation.
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).
0
DEC 13 2005
Image /page/0/Picture/2 description: The image shows the logo for "ETView Endotracheal Management". The logo is black and white. The "ET" is in a bold, blocky font, and the "View" is in a cursive font with a circle of dots above the "i". "Endotracheal Management" is written in a smaller, sans-serif font to the right of "View".
510(k) Summary
| Applicant's Name | Yoram Levy
Consultant |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ETView Ltd. |
| | Misgav Technological Center |
| | 6 Kahol Street, |
| | Teradion Industrial Park |
| | ISRAEL 20179 |
| | Telephone: (972)4-999-1996 |
| | Fax: (972)4-999-1901 |
| Contact Person: | Yoram Levy, QSite |
| | 31 Haavoda St. |
| | Binyamina, Israel 30500 |
| | Tel (972)4-638-8837; Fax (972)4-638-0510 |
| | Yoram@qsitemed.com |
| A. Trade Name: | Tracheoscopic Ventilation Tube (TVT) System |
| B. Manufacturer: | ETView Ltd. |
| | Misgav Technological Center |
| | 6 Kahol Street, |
| | Teradion Industrial Park |
| | ISRAEL 20179 |
| | Telephone: (972)4-999-1996 |
| | Fax: (972)4-999-1901 |
| C. Classification: | Classification name: (1) Tracheal Tube, adult, cuffed
(2) Bronchoscope, flexible |
| | Common/usual name: (1) Tracheal Tube (or Endotracheal Tube) with
(2) image transmission, (3) integral video imager (4) external monitor, (5) Integral light source |
| | Class II device |
| | Product Code: BTR |
| | Regulation No.: 868.5730 |
| D. Contract Sterilizer: | Mediplast Israel Ltd. |
| | 7 Hayarkon St., |
| | P.O.B. 13214 Yavne 81227 |
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Image /page/1/Picture/0 description: The image shows the logo for "ETView Endotracheal Management". The logo is black and white and features the letters "ET" in a stylized font, with a graphic of a circle with smaller circles inside it. The words "Endotracheal Management" are written in a smaller font to the right of the logo.
Tel (972)8-932-7766 Fax (972)8-932-7992
E. Reason for the Premarket Notification Submission:
New device
ETV ev intends to market the Tracheoscopic Ventilation Tube (TVT) System as an endotracheal tube that enables intubation and at the same time viewing of the airways during non-difficult and difficult intubation procedures, for verifying tube placement and repositioning, for viewing during suctioning and for general inspection of the airway. The TVT System provides higher video resolution and thus accuracy compared to the existing cleared device.
F. Identification of Legally Marketed Predicate Devices:
Pulmonx Visualized Endotracheal Tube (VETT) (K973191) Parker Medical Flex -Tip Endotracheal Tube (K984528)
G. Performance Standards or Special Controls:
The ETView TVT conforms to ISO 5361 (Dated December 15, 1999) and to Anaesthetic and Respiratory Equipment - Tracheal Tubes and Connectors. This standard replaces ASTM F 1242-96, "Standard Specification for Cuffed and Uncuffed Tracheal Tubes for the same devices, except where stated
The TVT conforms to ANSI/AAMI/ISO 11135 (Medical devices - Validation and routine control of ethylene oxide sterilization).
H. Indications for Use:
The ETView Tracheoscopic Ventilation Tube (TVT) is intended for oral and nasal intubation.
The ETView Tracheoscopic Ventilation Tube (TVT) System has the following specific indications:
- Temporary artificial airway in adults requiring mechanical ventilation, for oral and . nasal intubation.
- Viewing during non-difficult and difficult intubation procedures, for verifying tube . placement and repositioning, for viewing during suctioning and for general inspection of the airway.
2
Image /page/2/Picture/0 description: The image shows the logo for "ETview Endotracheal Management". The logo is black and white and features the text "ETview" in a stylized font. To the right of the text is the phrase "Endotracheal Management" in a smaller, simpler font. The logo is likely used to represent a company or product related to endotracheal management.
I. Technological Characteristics:
The ETView Tracheoscopic Ventilation Tube (TVT) System is a visualized endotracheal tube The ETV10 Pacelleosooped Pulmonx VETT System (K973191), except that the ETView System same as tiny CMOS video camera and light source and the Pulmonx device uses fiberoptic components.
J. Performance Testing
Bench testing demonstrated that the Tracheoscopic Ventilation Tube (TVT) System is at least as Donor loomig demonstrations and Pulmonx VETT System for oral and nasal intubation and in providing visualization of the airway.
The following performance tests have been done and the results are attached to this submission: Determination of Cuff Resting Diameter, Resistance to Tube Collapse, Resistance to Cuff Herniation, Cuff Symmetry, Air Flow Resistance, Thermal Safety, Imaging Performance, Cuff Leak Resistance Integrity, Mechanical Integrity ( Fatigue, Burst, and Cuff Compliance as part of the Mechanical Integrity test), Efficacy of Selective Suctioning, Software Validation.
K. Comparison to the Predicate Device
The ETView Tracheoscopic Ventilation Tube (TVT) System has the same intended use, general and specific indications and principles of operation as the cleared Pulmonx Visualized Endotracheal Tube (VETT) System.
In addition, the TVT employs similar technology as the cleared VETT except for the different type of camera and illumination.
The TVT has two Murphy eyes like the Parker Medical Flex -Tip Endotracheal Tube (K984528), and an additional lens clearing lumen. The inherent radiopacity of the TVT obviates the need for a radiopaque strip.
The minor differences between the TVT and the VETT do not raise any new questions of safety or efficacy. Moreover, bench testing of the TVT System (bench testing is provided in Attachments 6B, and 6C) demonstrated that the TVT is as safe and effective as the VETT. Thus, the ETView TVT System is substantially equivalent to the already cleared VETT System.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 2005
ETView Limited Mr. Yoram Levy QSite 31 Haavoda Street Binyamina, ISRAEL 30500
Re: K052233
Trade/Device Name: Tracheoscopic Ventilation Tube (TVT) Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: November 28, 2005 Received: December 7, 2005
Dear Mr. Levy:
We have reviewed your 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. 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Mr. Levy
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA Sissuance of a sabstanter and busether Fodarel agencies mean that FDA has made a decemmance in administered by other Federal agencies.
of the Act or any Federal statutes and regulations and regulations negistration of the Act of ally rederal statutes and regirements, including, but not limited to: registration
You must comply with all the Act's requirements, including and recurse You must comply with an the Act 3 requirements (100); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing (21 CFR Part 8 and listing (21 CFR Part 807), laocing (21 OFF Parvals on (21 CFR Patt 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Patt 820); and if requirements as set form in the quality systems (QD) regained (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k)
the success of the consisted on the first of the spinsions of your device to a I his letter will anow you to begin maliceant 5 your device of your device to a
premarket notification. The FDA finding of substantial equivalence and thus, pa premarket notification. The PDA miding of substants of Submitted on the spermits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Patt 801), If you desire specific advice for your device of our our and on please note the regulation please contact the Office or Comphanes an (210) - 11 CFR Part 807.97). You
entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free DIVIsion of Simall Manufactar (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sylte y. Michael Oms.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the logo for ETView Endotracheal Management. The logo is in black and white and features the letters "ET" in a stylized font. To the right of the letters is the word "View" with a graphic of a circle with dots inside. The words "Endotracheal Management" are to the right of the logo.
510(k) Number (if known): イインS223
Tracheoscopic Ventilation Tube (TVT) Device Name: for . Indications The ETView Tracheoscopic Ventilation Tube (TVT) is intended Use: for intubation procedures. The ETView Tracheoscopic Ventilation Tube (TVT) is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral and nasal intubations. The TVT System is indicated for viewing during non-difficult and difficult intubation procedures, for verifying tube placement and repositioning, for viewing during suctioning and for general inspection of the airway.
AND/OR Use X ________________________________________________________________________________________________________________________________________________________________________ Prescription (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(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 510(k) Number
ાયન mon dign-Of ) trian of Aheathesicingy, General Hospital, John Control, Dantal Devices - Nomber
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ETView Ltd., Misgav Technological Center, Teradion Industrial Zone, 20179 israel