(131 days)
Not Found
No
The description focuses on the physical components and basic video visualization for placement verification, with no mention of AI/ML for image analysis, decision support, or other advanced functions.
Yes
The device is described as an "endobronchial tube intended to be used for isolation of the left or right lung of a patient for one lung ventilation" and is used in procedures like "mechanical ventilation," which are therapeutic interventions.
No
The device is primarily an endobronchial tube for lung isolation and ventilation. While it features an embedded video camera for "verifying tube placement and repositioning," this visualization serves as a procedural aid rather than providing a medical diagnosis of a condition or disease. The product's intended use and indications for use also do not mention diagnostic purposes.
No
The device description clearly states it is a physical, sterile, single-use double-lumen endobronchial tube with an embedded video camera, light source, and integrated video cable. It is a hardware device with software components for visualization.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Ambu VivaSight 2 DLT is a double-lumen endobronchial tube used for intubation, lung isolation, and ventilation. It has an embedded camera for visualization during the procedure and to verify placement.
- Lack of Sample Testing: The device does not perform any tests on samples taken from the patient's body. Its function is to facilitate a medical procedure (intubation and ventilation) and provide visual guidance.
The device is clearly described as a medical device used for a surgical/procedural purpose, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
Intubation with Ambu VivaSight 2 DLT is indicated for pathological lung conditions or other medical conditions that require endobronchial intubation, mechanical ventilation of one lung from the other, e.g. for thoracic surgery.
Product codes (comma separated list FDA assigned to the subject device)
CBI
Device Description
Ambu VivaSight 2 DLT is a sterile, single-use, left-sided, double-lumen endobronchial tube with an embedded video camera and light source at the distal end of the tracheal lumen and integrated video cable with video connector.
The embedded video camera is used for visualization during the intubation procedure and to verify the tube placement. The picture is shown on an Ambu displaying unit, which Ambu VivaSight 2 DLT is connected to via Ambu VivaSight 2 Adapter Cable. Ambu VivaSight 2 Adapter Cable is a non-sterile, single patient use accessory to Ambu VivaSight 2 DLT. Ambu VivaSight 2 DLT is connected to and powered by an Ambu displaying unit via Ambu VivaSight 2 Adapter Cable; the whole system is referred to as the VivaSight 2 DLT system.
Ambu VivaSight 2 DLT is indicated for left or right lung isolation and use as a temporary artificial airway in adults requiring mechanical one-lung ventilation and is fitted with a stylet to enable shaping of the tube for navigation during intubation.
A colorless tracheal cuff provides sealing against tracheal wall and the corresponding pilot balloon indicates state of cuff inflation/deflation. Similarly, a blue bronchial cuff provides sealing against bronchial wall and the corresponding pilot balloon indicates state of cuff inflation/deflation.
A flush line with flush exits next to the camera lens ensures possibility for cleaning of the camera lens.
Ambu VivaSight 2 DLT can be connected to ventilation equipment via a Y-connector, which is included with the product. The Y-connector is sterile, single-use. The Y-connector caps enable lung deflation and use of accessories such as bronchoscopes and suction catheters in Ambu VivaSight 2 DLT. Furthermore, valves on the Y-connector enables opening and closing of the ventilation flow to each of the tracheal and bronchial lumens. The Y-connector airway tubes are colour coded to indicate tracheal and bronchial connection.
Ambu VivaSight 2 DLT will be available in four sizes: 35 Fr, 37 Fr, 39 Fr, and 41 Fr.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung, endobronchial, tracheal
Indicated Patient Age Range
adult patients
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)
Testing - Bench Declaration of conformity to the following applicable recognized consensus standards:
- ISO 16628:2008 Tracheobronchial tubes - Sizing and marking
- ISO 5356-1:2015 Anesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
Result: All tests passed.
Performance test reports to document the following properties:
- Product dimensions, incl. cuff diameters
- Effective inside diameter
- Tube connector dimensions
- Markings and color
- Kink and flow resistance
- Cuff leakage and herniation
- Cuffed tube collapse
- Leakage of lumens
- Mechanical resistance of junctions
- Duration of use
- Adapter cable connection to video connector
- Connect and power sequence
- Adapter cable connectors pull force
- Photobiological safety
Result: All tests passed.
Performance test reports to document shelf life. Tests were performed on finished, sterilized and aged products:
- Performance tests
- Sterile packaging integrity
Result: All tests passed.
Biocompatibility test reports to document compliance with the requirements of these standards (ISO 18562-1 and ISO 10993-1):
- Cytotoxicity (ISO 10993-5)
- Sensitization (ISO 10993-10)
- Intracutaneous reactivity test (ISO 10993-10)
- Particulate matter emissions (ISO 18562-2)
- Volatile Organic Compound (VOC) emissions (ISO 18562-3)
- Leachable substances in condensate (ISO 18562-4)
Result: All tests passed.
Test reports that verify the Electromagnetic Compatibility and Electrical Safety:
- Electromagnetic Compatibility in compliance with IEC 60601-1-2
- Electrical Safety in compliance with IEC 60601-1 and IEC 60601-2-18
Result: All tests passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5740 Tracheal/bronchial differential ventilation tube.
(a)
Identification. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.
May 3, 2021
Ambu A/S % Sanjay Parikh Director, OA/RA Ambu Inc. 6230 Old Dobbin Lane, Suite 250 Columbia, Maryland 21045
Re: K203749
Trade/Device Name: Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable Regulation Number: 21 CFR 868.5740 Regulation Name: Tracheal/Bronchial Differential Ventilation Tube Regulatory Class: Class II Product Code: CBI Dated: March 29, 2021 Received: March 30, 2021
Dear Sanjay Parikh:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Todd Courtnev Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory. ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K203749
Device Name Ambu VivaSight 2 DLT
Indications for Use (Describe)
Intubation with Ambu VivaSight 2 DLT is indicated for pathological lung conditions or other medical conditions that require endobronchial intubation, mechanical ventilation of one lung from the other, e.g. for thoracic surgery.
Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/0 description: The image shows the logo for Ambu, a medical device company. The logo consists of the word "Ambu" in a bold, red font, with the tagline "Ideas that work for life" underneath in a smaller, gray font. To the right of the wordmark is a gray, stylized asterisk symbol, which is composed of three intersecting lines.
510(k) Summary – Ambu® VivaSight™ 2 DLT
This 510(k) summary has been prepared in accordance with 21 CFR 807.87(h) and the content and format of the 510(k) summary has been prepared in accordance with 21 CFR 807.92.
| Submitter | Ambu A/S
Baltorpbakken 13
2750 Ballerup
Denmark
Tel.: +45 7225 2000
Fax.: +45 7225 2050 |
|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Name: Karina Matthiesen
Job Title: Senior Regulatory Affairs Professional
Address: Ambu A/S, Baltorpbakken 13, 2750 Ballerup
Email: kama@ambu.com
Telephone number: +45 7225 2000
Fax number: +45 7225 2050 |
| Date Summary
Prepared | March 26, 2021 |
| Device Trade
Name | Ambu® VivaSight™ 2 DLT
Accessory: Ambu® VivaSight™ 2 Adapter Cable |
| Device Common
Name | Double-lumen endobronchial tube |
| Device
Classification | Tracheal/bronchial differential ventilation tube
Product Code: CBI
21 CFR 868.5740
Class II |
| Predicate device | Substantial equivalence to the following legally marketed device is
claimed: |
| | K181886
VivaSight-DL™, ETView Ltd. |
| Device
Description | Ambu VivaSight 2 DLT is a sterile, single-use, left-sided, double-lumen
endobronchial tube with an embedded video camera and light source at
the distal end of the tracheal lumen and integrated video cable with video
connector.
The embedded video camera is used for visualization during the intubation
procedure and to verify the tube placement. The picture is shown on an
Ambu displaying unit, which Ambu VivaSight 2 DLT is connected to via
Ambu VivaSight 2 Adapter Cable. Ambu VivaSight 2 Adapter Cable is a
non-sterile, single patient use accessory to Ambu VivaSight 2 DLT. Ambu
VivaSight 2 DLT is connected to and powered by an Ambu displaying unit
via Ambu VivaSight 2 Adapter Cable; the whole system is referred to as
the VivaSight 2 DLT system.
Ambu VivaSight 2 DLT is indicated for left or right lung isolation and use
as a temporary artificial airway in adults requiring mechanical one-lung
ventilation and is fitted with a stylet to enable shaping of the tube for
navigation during intubation.
A colorless tracheal cuff provides sealing against tracheal wall and the
corresponding pilot balloon indicates state of cuff inflation/deflation.
Similarly, a blue bronchial cuff provides sealing against bronchial wall and
the corresponding pilot balloon indicates state of cuff inflation/deflation.
A flush line with flush exits next to the camera lens ensures possibility for
cleaning of the camera lens.
Ambu VivaSight 2 DLT can be connected to ventilation equipment via a Y-
connector, which is included with the product. The Y-connector is sterile,
single-use. The Y-connector caps enable lung deflation and use of
accessories such as bronchoscopes and suction catheters in Ambu
VivaSight 2 DLT. Furthermore, valves on the Y-connector enables opening
and closing of the ventilation flow to each of the tracheal and bronchial
lumens. The Y-connector airway tubes are colour coded to indicate tracheal
and bronchial connection.
Ambu VivaSight 2 DLT will be available in four sizes: 35 Fr, 37 Fr, 39 Fr,
and 41 Fr. |
| Intended Use | Ambu VivaSight 2 DLT is a sterile, single-use, double-lumen endobronchial
tube intended to be used for isolation of the left or right lung of a patient
for one lung ventilation.
The VivaSight 2 DLT system is intended to be used for verifying tube
placement and repositioning.
Ambu VivaSight 2 DLT is intended for adult patients. |
| Indications for
Use | Intubation with VivaSight 2 DLT is indicated for patients with pathological
lung conditions or other medical conditions that require endobronchial
intubation, mechanical ventilation and isolation of one lung from the
other, e.g. for thoracic surgery. |
| Technological
characteristics
in comparison to
the predicate
device | Both Ambu VivaSight 2 DLT and the predicate device, ETView VivaSight-
DL, are left-sided double-lumen endobronchial tubes with embedded
video camera and light source.
Both devices share similar technological characteristics such as tube size,
effective inside diameters, outside bronchial diameters and tube length. |
4
5
Both devices have flush lines with flush exits in front of the camera lens to enable cleaning of camera lens. Both devices are connected to Ambu displaying units via an adapter cable. The camera sensor resolution for Ambu VivaSight 2 DLT is higher than for ETView VivaSight-DL and the picture format slightly different. Both devices have the same materials or substances in contact with the same human tissues or body fluids, except for small differences in the camera module and video connector. Performance The following data have been submitted in the premarket notification to support safety and effectiveness of the device: Testing - Bench Declaration of conformity to the following applicable recognized consensus standards: . ISO 16628:2008 Tracheobronchial tubes - Sizing and marking . ISO 5356-1:2015 Anesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets Result: All tests passed. Performance test reports to document the following properties: Product dimensions, incl. cuff diameters ● . Effective inside diameter . Tube connector dimensions ● Markings and color Kink and flow resistance ● . Cuff leakage and herniation . Cuffed tube collapse . Leakage of lumens . Mechanical resistance of junctions . Duration of use . Adapter cable connection to video connector . Connect and power sequence . Adapter cable connectors pull force . Photobiological safety Result: All tests passed. Performance test reports to document shelf life. Tests were performed on finished, sterilized and aged products: . Performance tests . Sterile packaging integrity Result: All tests passed. Ambu VivaSight 2 DLT is classified as a breathing gas-pathway device and as a surface device having direct contact with mucosal membrane for limited duration in accordance with ISO 18562-1 and ISO 10993-1. Biocompatibility test reports to document compliance with the requirements of these standards: Cvtotoxicity (ISO 10993-5) . Sensitization (ISO 10993-10) . . Intracutaneous reactivity test (ISO 10993-10) Particulate matter emissions (ISO 18562-2) . . Volatile Organic Compound (VOC) emissions (ISO 18562-3) Leachable substances in condensate (ISO 18562-4) . Result: All tests passed.
6
Test reports that verify the Electromagnetic Compatibility and Electrical Safety: . Electromagnetic Compatibility in compliance with IEC 60601-1-2
- Electrical Safety in compliance with IEC 60601-1 and IEC 60601-. 2-18
Result: All tests passed.
Conclusion Ambu VivaSight 2 DLT and its accessory, Ambu VivaSight 2 Adapter Cable, have the same intended use, technological characteristics and principles of operation as the predicate device.
The minor technological differences between Ambu VivaSight 2 DLT and its predicate device raises no new questions regarding safety or effectiveness.
Performance testing has demonstrated that the device is as safe and effective as the predicate device.
Thus, Ambu VivaSight 2 DLT is substantially equivalent to its predicate device.