NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL

K992133 · Newport Medical Instruments, Inc. · CBK · Aug 4, 2000 · Anesthesiology

Device Facts

• Record ID: K992133
• Device Name: NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL
• Applicant: Newport Medical Instruments, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Aug 4, 2000
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients, greater than 10 kg or 22 lbs., who require the following general types of ventilatory support, as prescribed by an attending physician: positive pressure ventilation and assist/control. SIMV, CPAP modes of ventilation. The ventilator is suitable for use in post-acute, emergency room, home care environments (P/N HT50-H) and for transport applications (P/N HT50-T). Transport application is only applicable to the HT50-T.

Device Story

Newport HT50 is a self-contained, electrically powered, microprocessor-controlled ventilator. It provides mechanical ventilatory support (positive pressure, assist/control, SIMV, CPAP) to pediatric (≥10 kg) and adult patients. Device features internal battery (up to 10 hours) and patented self-contained gas supply, eliminating need for external air compressors. Used in sub-acute, emergency, home care, and transport environments. Operated by trained personnel; front panel controls allow mode selection and parameter adjustment. Built-in alarm system monitors safety limits. Output informs clinical decision-making regarding patient respiratory support. Benefits include portability and self-sufficiency for patients requiring mechanical ventilation.

Clinical Evidence

Bench testing only. The device met all applicable performance specification requirements identified in FDA reviewer guidance for ventilators and heated humidifiers. No clinical trial data presented.

Technological Characteristics

Electrically powered, microprocessor-controlled ventilator. Features internal battery and self-contained gas supply. Modes: volume control, pressure control, pressure support, SIMV, CPAP. Form factor: portable unit for sub-acute, home, and transport use. Software-controlled alarm system and safety limits.

Indications for Use

Indicated for adult and pediatric patients (≥10 kg/22 lbs) requiring continuous or intermittent mechanical ventilatory support, including positive pressure ventilation, assist/control, SIMV, and CPAP modes. Restricted to use by qualified, trained personnel under physician direction in post-acute, emergency, home, or transport settings.

Regulatory Classification

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.

Predicate Devices

• TBird Legacy Ventilator
• Pulmonetics LTV1000 ventilator

Submission Summary (Full Text)

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# AUG 4 2000

# K992133

### NEWPORT MEDICAL INSTRUMENTS Newport HT50 Ventilator 510(k) Submission

# Section XV

510(k) Summary or 510(k) Statement

- Submitter's Name and Address A.
Newport Medical Instruments, Inc. 760 West 16th Street Costa Mesa, California 92627

Mailing Address: P.O. Box 2600 Newport Beach, California 92658

- B. Submitter's Phone and FAX Number (949) 642 - 3910 Telephone (949) 645 - 5026 FAX
- C. Name of Contact Person

Karon Morell Vice President, Quality Assurance & Regulatory Affairs

#### D. Date the Summary was Prepared

June 22, 1999

- E. Name of the Device
- 1. Trade or Proprietary Name

Newport HT50 Ventilator

- 2. Common or Usual Name
Ventilator

- 3. Classification Name
Respiratory Ventilator

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### NEWPORT MEDICAL INSTRUMENTS Newport HT50 Ventilator 510(k) Submission

#### F. Summary of Substantial Equivalence

The Newport HT50 Ventilator, the TBird Legacy Ventilator and the Pulmonetics LTV1000 ventilator are intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The performance and clinical features of each ventilator is to support pediatric (≥ 10 kg) through adult applications.

#### G. Description of the Device

The Newport HT50 Ventilator is a self-contained, electrically powered, microprocessor controlled ventilator. With performance characteristics and clinical features that can support pediatric (≥10 kg) through adult patients, the HT50 is the device of choice for use in sub-acute, emergency room and home care environments (P/N HT50-H) and for transport applications (P/N HT50-T).

Front panel controls allow trained operators to select between a number of operational modes, pressure support and volume or pressure control. A comprehensive alarm system is built-in to alert the user to violations of preset safety limits. When fully charged, the internal battery provides up to 10 hours of power. With its patented, self-contained gas supply source, the HT50 requires no external air compressor.

#### H. Device Intended Use

The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients, greater than 10 kg or 22 lbs., who require the following general types of ventilatory support, as prescribed by an attending physician: positive pressure ventilation and assist/control. SIMV, CPAP modes of ventilation. The ventilator is suitable for use in post-acute, emergency room, home care environments (P/N HT50-H) and for transport applications (P/N HT50-T). Transport application is only applicable to the HT50-T.

I.

### Summary of Comparison of Technological Characteristics

The HT50-H and HT50-T share substantial equivalency with the TBird Legacy ventilator and the Pulmonetics LTV1000 ventilator across the spectrum of the patient population (pediatric to adult) for which each was

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### NEWPORT MEDICAL INSTRUMENTS Newport HT50 Ventilator 510(k) Submission

All of the devices share common modalities (volume control, designed. pressure control, pressure support) and significantly overlap in the clinical range of function for their target population. Although some differences in design application are noted the essential clinical function of each device is significantly similar and mimics each other in the typical frame of use by the health care provider. Each provide significant safety features in terms of alarms, back up ventilation, and fail safe mechanisms. The HT50-T and Pulmonetics unit share significant functions in their use as transport units. Each provide internal battery, ease of use, simple circuit design and matching clinical function.

#### J. Summary of Nonclinical Tests

The Newport HT50 Ventilator meets all applicable device specification requirements for performance testing as identified in the FDA Reviewer guidance for ventilators and heated humidifiers.

#### K. Conclusion

The Newport HT50 Ventilator as a self-contained, electrically powered, microprocessor controlled ventilator has clinically and functionally proven to be safe and efficacious. With performance characteristics and clinical features that can support pediatric (≥10 kg) through adult patients, the HT50 is the device of choice for use in sub-acute, emergency room and home care environments (P/N HT50-H) and for transport applications (P/N HT50-T).

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 4 2000

Ms. Susan Miller Newport Medical Instruments, Inc. 760 West 16th Street, Building N Costa Mesa, CA 92627

- K992133 Re: Newport HT50 Ventilator Regulatory Class: II (two) Product Code: 73 CBK Dated: May 11, 2000 Received: May 12, 2000
Dear Ms. Miller:

We have reviewed your Section 510(k) notification of intent to market We have reviewed your section July have determined the device is the device referenced above and we nave acoosa.for use stated in the substantially equivalent (ror the ricesse devices marketed in enclosure) to legally marketed predicate at troom and ment date of the interstate commerce prior to May 2011-1970 thave been reclassified
Medical Device Amendments, or to devices that have Drug, and Medical Device Amendments, or co createral Food, Drug, and in accordance with the provisions of the reabst the device, subject to Cosmetic Act (ACC). Tou may, chercrororoman money of the general controls the general controls provisions of the for annual registration,
provisions of the Act include requirements for annual registration, provisions of the Act Incrace Ecquiring proctice, labeling, and IIsting of devices) good mander and adulteration.

If your device is classified (see above) into either class II (Special If your device Is classified (See above), it may be subject to such Controls) or class III (Fremarket approvulations affecting your device
additional controls. Existing major regulations after 21, Parts 800 additional controls. Existing major regulations, Title 21, Parts 800
can be found in the Code of Federal Regulation accumes compliance ound in the code of reactar negarmination assumes compliance to 895. to 895. A substantially equivating assetice requirements, as set
with the Current Good Manufacturing Practice for Medical Dovices: with the Current Good handreasang on (QS) for Medical Devices:
forth in the Quality System Regulation and that - through poriodic i forth in the Quarry System Regardershat, through periodic QS
General regulation (21 CFR Part 820) and that, (700) will worify Sh General regulation (2) Cric rure odo) and (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. assumptions. Fallure Co Compry Wen may publish further announcements
regulatory action. In addition, FRA may publish floase note: this regulatory action. In adares, and Register. Please note:
concerning your device in the Federal Register in dass not this concerning your device in the icacia notification does not affect any
response to your premarket notification submission 542 of the Act response to your premarket noctricacions 531 through 542 of the Act
obligation you might have under sections Control provision obligation you might have under Sections our chooly
for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Susan Miller

This letter will allow you to begin marketing your device as This letter will allow you to begin market notification. The FDA finding of
described in your 510(k) premarket notification. The FDA finding of described in your 510 (k) premarker not reaction. " Include of the state and thus, pedicate
substantial equivalence of your device and thus, permits substantial equivalence of your device co a rogation for your device and thus, permits device and thus, permits device and thus, permits device and thus, permits device marke device resures in the market.

If you desire specific advice for your device on our labeling
If you desire and 201 and edditionally 809.10 for in vi If you desire specific advice for your aclive 09.10 for in vitro
regulation (21 CFR Part 801 and additionally 809.10 for in vitro regulation (21 CFR Part our and and the office of Compliance at
diagnostic devices), please contact the office of the promotion an diagnostic devices), please concacc city or the promotion and (301) 594–4648. Additionaly, for questions on the promoted in and the many of the propliance at
advertising of your device, please contact the office of contribut, our device, please concursion entitled, [phone]. [phone]. Also, please note to premarket notification" (21 CER 807.97) .
"Misbranding by reference to premarket notification" (21 CER 807.97) "Misbranding by reference to premarket notallities under the Act may Other general information of Small Manufacturers Assistance at its
be obtained from the Division of Small Manufacturers Assistance at its internet be obtained from the Division of Silari HanaraGEa722 com at its internet to
toll-free number [phone] or [phone], or at its internet toll-free number [phone] 05sma/dsmamain.html".
address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

sincerely yours,
Mark n Milken

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Center for Devices and Radiological Health

Page 1 of 1

510(k) Number (if known): K992133

Device Name: Newport HT50 Ventilator

Indications for Use:

The device is intended to provide continuous or intermittent mechanical ventilator support for the The active is intellided to quire mechanical ventilation. The ventilator is a restricted medical ours of marriedals who by qualified, trained personnel under the direction of a physician. de roomlendod for as applicable for adult and pediatric patients, greater than 10 kg or 22 Dpoornean's the following general types of ventilatory support, as prescribed by an attending physician: positive pressure ventilation and assist/control. SIMV, CPAP modes of ventilation: The physielaan poster o prostate in post-acute, emergency room, home care environments (P/N HT50-Ventiator is bunable 101 ass in pown HT50-T). Transport application is only applicable to the HT50-T.

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for

Division of Cardiovascular & Respiratory Devices
510(k) Number K992/33

- OR -

PRESCRIPTION, USE

OVER-THE-COUNTER USE

(Optional Format 3-10-98)