NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM

K082724 · Newport Medical Instruments, Inc. · CBK · Dec 16, 2008 · Anesthesiology

Device Facts

• Record ID: K082724
• Device Name: NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM
• Applicant: Newport Medical Instruments, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Dec 16, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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.

Device Story

Electrically powered, microprocessor-controlled, variable flow ventilator; provides Assist/Control, SIMV, and SPONT/CPAP ventilation with servo-solenoid-controlled PEEP. Features DUAL PAC™ internal battery system (Lead Acid + Nickel-Metal Hydride) with independent charging. Operates on AC (100-240V) or DC (12-30V) power. Used in hospitals, sub-acute, ER, home care, and transport by trained personnel. Provides mechanical support to patients ≥ 10 kg. Output includes ventilation delivery and alarm notifications (Low Battery, Battery Empty) to alert clinicians to remaining battery life (min 30 mins for Low Battery, 15 mins for Empty). Benefits include increased margin of safety for battery-powered operation during transport or power loss.

Clinical Evidence

No clinical or animal data included. Bench testing only. Validation included verification of battery switching, charging circuit functionality, ventilator operation on main/backup power, and alarm accuracy. Environmental and EMC testing performed per MIL-STD-810E and IEC 68-2 standards.

Technological Characteristics

Microprocessor-controlled, variable flow ventilator. Power: 100-240 VAC or 12-30 VDC. Battery: DUAL PAC™ system (Lead Acid + NiMH). Modes: Assist/Control, SIMV, SPONT/CPAP. Servo-solenoid PEEP control. Standards: MIL-STD-810E, IEC 68-2. Connectivity: Not specified.

Indications for Use

Indicated for adult and pediatric patients (infant, child, adolescent) ≥ 10 kg requiring continuous or intermittent mechanical ventilatory support (positive pressure ventilation with Assist/Control, SIMV, and SPONT/CPAP modes). Restricted to use by qualified personnel under physician direction.

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

• NEWPORT HT50 Ventilator (K992133)
• Pulmonetic Systems LTV 1000 (K981371, K984056, K002881, K010608, K032226, K040540, K051767)
• Versamed Medical Systems IVENT201 (K981668, K011957, K021981, K042468, K052554, K053270, K061627)

Submission Summary (Full Text)

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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.<br>1620 Sunflower Avenue<br>Costa Mesa, CA 92626 |
|-----|------------------------|------------------------------------------------------------------------------------|
| | Contact Person: | Dana Rodriguez<br>Vice President, RAQA |
| | Summary Date: | 16 December 2008 |
| II. | Device Name | |
| | Proprietary: | NEWPORT HT50® Ventilator<br>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.

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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; .

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- 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.

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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.

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## 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 [phone]. 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 [phone] or [phone] 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

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# 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Zu. M. Zi.

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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KD82774 510(k) Number: