(90 days)
Not Found
No
The summary describes a microprocessor-controlled ventilator with standard ventilation modes and battery management features. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
Yes
The device is a ventilator intended to provide mechanical ventilation, which is a form of medical treatment to support breathing for individuals who require it. This directly relates to the restoration or maintenance of health, qualifying it as a therapeutic device.
No
Explanation: The device is a ventilator, which is used for mechanical ventilatory support, not for diagnosis. Its intended use is to deliver assisted breathing, not to identify or characterize a disease or condition.
No
The device description explicitly states it is an "electrically powered, microprocessor controlled, variable flow generating ventilator" and mentions components like a "servo-solenoidcontrolled, built-in PEEP" and an "internal battery system," indicating it is a hardware device with embedded software, not a software-only medical device.
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 provides "continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation." This describes a device that directly interacts with the patient's respiratory system to provide life support.
- Device Description: The description details a "mechanical ventilator" that controls airflow and provides different modes of ventilation. This is consistent with a device used for respiratory support, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples outside of the body to gain diagnostic information. This device is a therapeutic device used to assist breathing directly in the patient.
N/A
Intended Use / Indications for Use
The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 lbs), who require the following general types of ventilatory support: positive pressure ventilation with Assist/Control, SIMV and SPONT/CPAP modes of ventilation.
The NEWPORT HT50 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it 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 modified NEWPORT HT50 Ventilator is an electrically powered, microprocessor controlled, variable flow generating ventilator which provides Assist Control, SIMV and SPONT/CPAP modes of ventilation in combination with servo-solenoidcontrolled, built-in PEEP.
The modified NEWPORT HT50 may be powered by external power (100-240 VAC or 12-30 VDC) or internal battery system power. Any time external power is connected to the ventilator, the internal battery system is charging.
The modified NEWPORT HT50 combines a secondary, internal, back-up Nickel-Metal Hydride (NiMH) battery with an independent charging system with the existing Lead Acid (LA) internal battery and charging system, thereby creating the DUAL PAC™ Internal Battery system. When the primary internal LA battery charge level reaches the low battery threshold, the Low Battery alarm activates (message, LED indicator and audible alarm). The unit will automatically add in the power of the secondary NiMH battery and both batteries will continue to power the ventilator and the alarms for a minimum of 30 minutes before shut down. This alarm message (Low Battery), the blinking LED indicator and audible alarm give notice that a minimum of 30 minutes remains to find an alternate power source before the unit will shutdown. When the combined battery power reaches the battery empty threshold, a Battery Empty alarm is activated (message, LED indicator and audible alarm) alerting the user that there is a minimum of 15 minutes to shut down. Ensuring these defined time periods for battery life increases the margin of safety for battery usage.
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
adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 lbs)
Intended User / Care Setting
qualified, trained personnel under the direction of a physician; it 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
Testing supporting transport use of the device was based on the following standards:
- MIL-STD-810E Environmental Test Methods and Engineering Guidelines .
- IEC 68-2 Environmental Testing .
Testing for the DUAL PAC Internal Battery design encompassed validation and verification of the new design, re-verification of all functional and alarm aspects, and EMC and safety testing; this testing is summarized following:
-
A. Validation and Verification of New Design
The battery pack and charging circuits were tested to verify functionality, including: -
Correct switching to back-up battery at target voltage; .
-
Proper charging circuit function; .
-
Ventilator operation on main battery and back up battery; .
-
Verification of proper warnings; .
-
Verification of proper switching to back up battery if main battery is defective; and
-
Verification of proper warning to user in the event that back up battery . is defective.
-
B. Re-Verification of All Functions and Alarms
The NEWPORT HT50 was tested to ensure proper functionality and alarming for ventilator operations. This complete re-verification of all functions/alarms assured that software revisions associated with the DUAL PAC Internal Battery system did not inadvertently affect any ventilator function or alarm. -
C. EMC and Safety Testing
Testing was also performed to assure that the ventilator with the new battery pack configuration meets electrical safety, environmental, and EMC requirements.
Key Metrics
Not Found
Predicate Device(s)
K992133, K981371, K984056, K002881, K010608, K032226, K040540, K051767, K981668, K011957, K021981, K042468, K052554, K053270, K061627
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
K082724
page 1 of 3
Newport
MEDICAL
DEC 1 6 2008
510(k) Summary NEWPORT HT50® Ventilator
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| I. | Submitter Information: | Newport Medical Instruments, Inc.
1620 Sunflower Avenue
Costa Mesa, CA 92626 |
|-----|------------------------|------------------------------------------------------------------------------------|
| | Contact Person: | Dana Rodriguez
Vice President, RAQA |
| | Summary Date: | 16 December 2008 |
| II. | Device Name | |
| | Proprietary: | NEWPORT HT50® Ventilator
Models HT50-H, HT50-HB, HT50-H1, and HT50-H1B |
| | Common: | Continuous Ventilator |
| | Classification: | II |
| | Product Code: | CBK |
| | CFR Section: | 868.5895 |
Predicate Device III.
The predicate devices for modified NEWPORT HT50 Ventilator are:
- NEWPORT HT50 Ventilator cleared under K992133; 트
- Pulmonetic Systems LTV 1000 cleared under K981371, K984056, K002881, l K010608, K032226, K040540, and K051767); and
- Versamed Medical Systems IVENT201 cleared under K981668, K011957, 하 K021981, K042468, K052554, K053270, K061627.
IV. Device Description
The modified NEWPORT HT50 Ventilator is an electrically powered, microprocessor controlled, variable flow generating ventilator which provides Assist Control, SIMV and SPONT/CPAP modes of ventilation in combination with servo-solenoidcontrolled, built-in PEEP.
1
The modified NEWPORT HT50 may be powered by external power (100-240 VAC or 12-30 VDC) or internal battery system power. Any time external power is connected to the ventilator, the internal battery system is charging.
V. Intended Use
This modified NEWPORT HT50 is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 lbs), who require the following general types of ventilatory support: positive pressure ventilation with Assist/Control, SIMV and SPONT/CPAP modes of ventilation.
The modified NEWPORT HT50 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
Technological Characteristics VI.
The modified NEWPORT HT50 combines a secondary, internal, back-up Nickel-Metal Hydride (NiMH) battery with an independent charging system with the existing Lead Acid (LA) internal battery and charging system, thereby creating the DUAL PAC™ Internal Battery system. When the primary internal LA battery charge level reaches the low battery threshold, the Low Battery alarm activates (message, LED indicator and audible alarm). The unit will automatically add in the power of the secondary NiMH battery and both batteries will continue to power the ventilator and the alarms for a minimum of 30 minutes before shut down. This alarm message (Low Battery), the blinking LED indicator and audible alarm give notice that a minimum of 30 minutes remains to find an alternate power source before the unit will shutdown. When the combined battery power reaches the battery empty threshold, a Battery Empty alarm is activated (message, LED indicator and audible alarm) alerting the user that there is a minimum of 15 minutes to shut down. Ensuring these defined time periods for battery life increases the margin of safety for battery usage.
VII. Device Testing
Testing supporting transport use of the device was based on the following standards:
- MIL-STD-810E Environmental Test Methods and Engineering Guidelines .
- IEC 68-2 Environmental Testing .
Testing for the DUAL PAC Internal Battery design encompassed validation and verification of the new design, re-verification of all functional and alarm aspects, and EMC and safety testing; this testing is summarized following:
-
A. Validation and Verification of New Design
The battery pack and charging circuits were tested to verify functionality, including: -
Correct switching to back-up battery at target voltage; .
-
Proper charging circuit function; .
-
Ventilator operation on main battery and back up battery; .
2
- Verification of proper warnings; .
- Verification of proper switching to back up battery if main battery is defective; and
- Verification of proper warning to user in the event that back up battery . is defective.
Re-Verification of All Functions and Alarms B.
The NEWPORT HT50 was tested to ensure proper functionality and alarming for ventilator operations. This complete re-verification of all functions/alarms assured that software revisions associated with the DUAL PAC Internal Battery system did not inadvertently affect any ventilator function or alarm.
C. EMC and Safety Testing
Testing was also performed to assure that the ventilator with the new battery pack configuration meets electrical safety, environmental, and EMC requirements.
Clinical and Animal Testing VIII.
No clinical or animal data were included in this submission.
IX. Conclusions
All testing demonstrates that the modified NEWPORT HT50 Ventilator performs as intended and is therefore suitable for its intended use.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle symbol on the right and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the left side. The eagle symbol is composed of three thick, curved lines representing the body and wings, with a smaller curved line at the bottom representing the tail.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 6 2008
Ms. Dana Rodriguez Vice President of Regulatory Affairs and Quality Assurance Newport Medical Instruments, Incorporated 1620 Sunflower Avenue Costa Mesa. California 92626
Re: K082724
Trade/Device Name: NEWPORT HT50® Ventilator Models HT50-H, HT50-HB, HT50-H1, and HT50-H1B
Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK, NOU Dated: September 15, 2008
Received: September 17, 2008
Dear Ms. Rodriguez:
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 - Ms. Rodriguez
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 vours.
Snyte Y. Mckee Omd.
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
5
Indications for Use
510(k) Number (if known): K082724
NEWPORT HT50® Ventilator Device Name: Models HT50-H, HT50-HB, HT50-H1, and HT50-H1B
Indications for Use:
The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 lbs), who require the following general types of ventilatory support: positive pressure ventilation with Assist/Control, SIMV and SPONT/CPAP modes of ventilation.
The NEWPORT HT50 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it 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 (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)
Zu. M. Zi.
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of
KD82774 510(k) Number: