(223 days)
No
The summary describes a standard mechanical ventilator with various modes and features, but there is no mention of AI or ML technology. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is a ventilator, which provides mechanical ventilatory support to patients. This directly addresses medical conditions by assisting or replacing the breathing function, making it a therapeutic device.
No
Explanation: The Newport HT70 ventilator is described as providing "positive pressure mechanical ventilatory support" and is intended for patients who "require mechanical ventilation." Its function is to provide life support by assisting with breathing, not to diagnose a medical condition. While it has a "Trends screen for displaying data graphically," this data display is for monitoring the ventilation process, not for diagnostic interpretation.
No
The device description clearly describes a physical ventilator with hardware components such as a touch screen, integrated battery system, and connections for external power sources. It is not solely software.
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 examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Newport HT70 family of ventilators provides mechanical ventilatory support by assisting or controlling breathing. It interacts directly with the patient's respiratory system, not with specimens taken from the body.
- Intended Use: The intended use clearly states providing "continuous or intermittent positive pressure mechanical ventilatory support." This is a life-support function, not a diagnostic test performed on a sample.
- Device Description: The description focuses on the mechanics of ventilation, power sources, modes of operation, and user interface. There is no mention of analyzing biological samples.
Therefore, the Newport HT70 ventilator is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Newport HT70 family of ventilators is intended to provide continuous or internittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the Newport HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs).
The Newport HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician.
The Newport HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
Product codes
CBK, NOU
Device Description
The Newport HT70 Ventilator provides ventilatory support for neonate, infant, pediatric and adult patients. It can be used in hospital, sub-acute, emergency response, transport and homecare environments under the direction of a physician. The HT70 ventilator design provides maximum mobility and safety for short or long distance transport of critically ill patients and also for patients who are going about their normal activities of daily life.
The HT70 may be operated from AC or DC external power sources or from the integrated battery system. Any time the ventilator is connected to external power, the integrated battery system is charged, including while the ventilator is in use. The HT70 ventilator has A/CMV, SIMV and SPONT ventilatory modes (Pressure or Volume).
The controls of the HT70 ventilator are easily found on the front touch screen and panel. The touch screen can be set up in Hospital, Transport or Basic functional Domains to provide the user with full or limited access. The HT70 has a Trends screen for displaying data graphically. User Help screens present information for all controls and features.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs)
Intended User / Care Setting
The Newport HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician.
The Newport HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
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 Newport HT70 ventilator has undergone extensive verification, validation and design safety testing, all of which confirms that the device meets its design, performance, and safety requirements. All testing demonstrates that the Newport HT70 performs as intended and has acceptable mechanical properties when used in accordance with its labeling; the device is therefore suitable for its intended use.
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
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
DEC - 1 2011
Newport
MEDICAL
Breathing care into all we do.
510(k) Summary
Newport HT70™ Ventilator
| I. | Submitter Information: | Newport Medical Instruments, Inc. |
|---|---|---|
| 1620 Sunflower Avenue | ||
| Costa Mesa, CA 92626 |
Contact Person: Tom Colonna Director, RA/QE
Summary Date: 18 July 2011
ll. Device Name
| Proprietary: | Newport HT70® |
|---|---|
| Common: | Ventilator, Continuous, Facility Use; Ventilator, Continuous, Home Use |
| Classification: | II |
| Product Code: | CBK; NOU |
| CFR Section: | 868.5895 |
III. Predicate Devices
The HT70 is substantially equivalent to the following legally marketed predicate devices:
- NEWPORT HT70® Ventilator cleared under K090888; .
- CareFusion LTV® 1200 cleared under K060647; .
- Versamed Medical Systems iVENT™ 201 cleared under K073694. .
IV. Device Description
The Newport HT70 Ventilator provides ventilatory support for neonate, infant, pediatric and adult patients. It can be used in hospital, sub-acute, emergency response, transport and homecare environments under the direction of a physician. The HT70 ventilator design provides maximum mobility and safety for short or long distance transport of critically ill patients and also for patients who are going about their normal activities of daily life.
1
The HT70 may be operated from AC or DC external power sources or from the integrated battery system. Any time the ventilator is connected to external power, the integrated battery system is charged, including while the ventilator is in use. The HT70 ventilator has A/CMV, SIMV and SPONT ventilatory modes (Pressure or Volume).
The controls of the HT70 ventilator are easily found on the front touch screen and panel. The touch screen can be set up in Hospital, Transport or Basic functional Domains to provide the user with full or limited access. The HT70 has a Trends screen for displaying data graphically. User Help screens present information for all controls and features.
V. Intended Use
The Newport HT70 family of ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the Newport HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs).
The Newport HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician.
The Newport HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
VI. Reason for the Submission
The purpose of this traditional 510(k) is to request authorization for enhancement to the Newport HT70 ventilator to include the following features:
- On-airway flow sensor for exhaled volume monitoring and flow trigger .
- SpO2 monitoring using a cleared accessory device. .
The Newport HT70 ventilator has been determined to be substantially equivalent to other legally marketed predicate ventilators. The HT70 ventilator is an extension of the current HT70 design and technology.
VII. Nonclinical Data
The Newport HT70 ventilator has undergone extensive verification, validation and design safety testing, all of which confirms that the device meets its design, performance, and safety requirements.
VIII. Conclusions
All testing demonstrates that the Newport HT70 performs as intended and has acceptable mechanical properties when used in accordance with its labeling; the device is therefore suitable for its intended use. As the device's intended use is comparable to the referenced predicate devices, and its operating principles, ventilation modes and performance parameters are comparable to the predicate devices, the HT70 is substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the words "Public Health Service". The text is written in a simple, sans-serif font. The words are arranged on a single line, with "Public Health" appearing before "Service".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC - 1 2011
Mr. Tom Colonna Director, Regulatory Affairs/QE Newport Medical Instruments, Incorporated 1620 Sunflower Avenue Costa Mesa, California 92626
Re: K111146
Trade/Device Name: Newport HT70" Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK, NOU Dated: November 11, 2011 Received: November 14, 2011
Dear Mr. Colonna:
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. 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.
3
Page 2 - Mr. Colonna
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRA's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Morton
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K ) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Device Name: Newport HT70™ Ventilator
Indications for Use:
The Newport HT70 family of ventilators is intended to provide continuous or internittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the Newport HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs).
The Newport HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician.
The Newport HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
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)
Schulthe
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K1119
Page 1 of
510(k) Number: .