(47 days)
Not Found
No
The summary describes a video-enabled endotracheal tube for visualization during intubation and airway inspection. There is no mention of AI, ML, image processing for analysis, or any data processing beyond displaying the video feed. The performance studies are bench tests focused on physical and material properties, not algorithmic performance.
No
A therapeutic device is one that treats a disease or condition. This device is used for intubation, a procedure to assist ventilation and for diagnostic viewing of the airway, but it does not directly treat a disease or condition.
No
The device is primarily intended for intubation procedures and viewing the airway during these procedures and for tube placement verification. While viewing the airway involves observation, the indicated uses do not describe a diagnostic function, which would typically involve identifying or determining the nature of a disease or condition. The device's function is centered on providing visualization for a procedural task, not for diagnosing medical conditions.
No
The device description explicitly states it includes hardware components such as an embedded video imaging device, light source, integrated cable, connector, and a monitor, in addition to the endotracheal tube itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for intubation procedures, providing a temporary artificial airway, viewing during intubation and airway inspection, and verifying tube placement. These are all procedures performed on the patient's body, not on samples taken from the patient's body.
- Device Description: The device is an endotracheal tube with an embedded video camera and light source. It is used to visualize the airway in vivo.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device is a tool for visualization and airway management during a medical procedure.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The ETView Tracheoscopic Ventilation Tube (TVT™) is intended 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 TVT™ is a single use, cuffed, endotracheal tube with an embedded video imaging device, and light source at its tip and integrated cable with connector to transfer the video signal to the display. The video image is displayed for as long as the Endotracheal tube (ETT) is inside the patient's trachea. The video image can be displayed on ETView's display or on most other TV/VCR displays. The ETView Tracheoscopic Ventilation Tube (TVT™) system consists of: - Endotracheal tube (ETT) with: . - Embedded Video camera o - Embedded Light source o - Integrated cable with connector o - Monitor .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway, trachea
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)
Series of bench tests were performed to ensure that the device performs as intended. Tests were done according to ISO 5361:1999 Anaesthetic and respiratory equipment - Tracheal tubes and according to ISO 10933-1:2003 (for surface device-mucosal membrane-prolonged duration). All testing results demonstrated satisfactory performance.
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
Image /page/0/Picture/0 description: The image shows a logo with the letters "ET" stacked on top of the letters "iel". To the right of the letters is a graphic of a circle with a smaller circle inside of it. There are four smaller circles surrounding the larger circle. The logo is black and white.
OCT 0 8 2008
Image /page/0/Picture/2 description: The image contains a series of handwritten characters. The characters appear to be 'KO 89420'. The characters are written in black ink on a white background. The handwriting is somewhat stylized.
Endotracheal Management
510(K) SUMMARY
ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT™)
510(k) Number K_
Applicant's Name: ETView Ltd. 5 Palyam Ave. Haifa, 33095 ISRAEL Tel: (972)4-861-5020 Fax: (972)4-865-0666
Contact Person: Yoram Levy, Qsite 31 Haavoda St. Binyamina, Israel 30500 Tel (972)4-638-8837 Fax (972)4-638-0510 Yoram@qsitemed.com
Trade Name: ETView Tracheoscopic Ventilation Tube (TVTTM)
Classification and Classification Name:
Name: Tracheal tube Product Code: BTR Regulation No: 868.5730 Class: II Panel: Anesthesiology
Indications for Use Statement:
The ETView Tracheoscopic Ventilation Tube (TVT™) is intended for intubation procedures.
2-2 ETView. | TVT™ 510k Notification
1
The ETView Tracheoscopic Ventilation Tube (TVTTM) 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.
Device Description:
The ETView TVT™ is a single use, cuffed, endotracheal tube with an embedded video imaging device, and light source at its tip and integrated cable with connector to transfer the video signal to the display. The video image is displayed for as long as the Endotracheal tube (ETT) is inside the patient's trachea. The video image can be displayed on ETView's display or on most other TV/VCR displays.
The ETView Tracheoscopic Ventilation Tube (TVT™) system consists of:
- Endotracheal tube (ETT) with: .
- Embedded Video camera o
- Embedded Light source ం
- Integrated cable with connector o
- Monitor .
Predicate Device: ETView Tracheoscopic Ventilation Tube (TVT™); cleared under K052233.
Technological Characteristics
Both the modified ETView Tracheoscopic Ventilation Tube (TVT™) device and its predicate device (ETView Tracheoscopic
2-3 ETView. | TVT™ 510k Notification
2
Ventilation Tube (TVT); K052233) are endotracheal tubes with a tiny video camera and a light source embedded in their wall. Both devices generate a video image of the patient's trachea as long as the tube is inside the patient airways.
Technological Modifications from Predicate Device
The main modifications between the proposed ETView Tracheoscopic Ventilation Tube (TVT™) and its predicate device ETView Tracheoscopic Ventilation Tube (TVT); K052233 are:
- · New generation of camera.
- Standard NTSC signal output for direct display (no need for . dedicated software).
Substantial equivalence:
The modified ETView Tracheoscopic Ventilation Tube (TVTTM):
- . has the same intended use
- . incorporates the same technology
- the tube is made from the same material (as its predicate . device).
ETView Ltd. believes that the ETView Tracheoscopic Ventilation Tube (TVT™) device is substantially equivalent to its predicate device without raising any new safety and/or effectiveness concerns.
Performance Validation: Performance Testing - bench tests
Series of bench tests were performed to ensure that the device performs as intended.
Tests were done according to ISO 5361:1999 Anaesthetic and respiratory equipment - Tracheal tubes and according to ISO 10933-1:2003 (for surface device-mucosal membrane-prolonged duration). All testing results demonstrated satisfactory performance.
Materials:
3
Image /page/3/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 logo is the text "Endotracheal Management" in a smaller, simpler font. The logo is likely for a medical device or service related to endotracheal intubation.
Materials of the ETView Tracheoscopic Ventilation Tube (TVT™) device system that are in contact with the human body were tested and found to be biocompatible in accordance with ISO 10993-1.
ETView Ltd. believes that, based on the information provided in this Conclusion: submission, the modified ETView Tracheoscopic Ventilation Tube (TVT™) System is substantially equivalent to its predicate devices without raising any new safety and/or effectiveness concerns.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
OCT 0 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ETView Limited C/O Mr. Yoram Levy OSite 31 Haavoda Street Binvamina. ISRAEL 30500
Re: K082420
Trade/Device Name: ETView Tracheoscopic Ventilation Tube (TVTTM) Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: September 24, 2008 Received: September 30, 2008
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.
5
Page 2 - Mr. Levy
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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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) 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
VKhmuels Rudins foil
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
6
Endotracheal Management
510(k) Number (if known):
Device Name:
ETView Tracheoscopic Ventilation Tube (TVTTM)
- . Indications for Use:
The ETView Tracheoscopic Ventilation Tube (TVT™) is intended 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.
Prescription Use ______________________________________________________________________________________________________________________________________________________________________________ (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)
510(k) Number
SuryAimid.
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082420
1-2 ETView. | TVT™ 510k Notification