VAR MONITOR

K073261 · Vortran Medical Technology 1, Inc. · BTL · May 23, 2008 · Anesthesiology

Device Facts

• Record ID: K073261
• Device Name: VAR MONITOR
• Applicant: Vortran Medical Technology 1, Inc.
• Product Code: BTL · Anesthesiology
• Decision Date: May 23, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5925
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is to be used by properly trained personnel to deliver emergency, short term, constant flow - pressure cycled ventilatory support.

Device Story

The VAR with VAR-Monitor is a powered emergency ventilator system. The VAR provides constant flow, pressure-cycled ventilatory support. The VAR-Monitor is a battery-operated (9 VDC) add-on module that monitors the ventilator's cycling conditions. It detects the pressure signal from the modulator; if no pressure change is detected for eight seconds, it triggers visual and audible alarms to alert personnel of non-cycling conditions such as supply gas failure, patient disconnect, airway leaks, or changes in patient condition. The device is intended for use by trained personnel in emergency settings for short-term support. It is not intended as a standalone ICU ventilator.

Clinical Evidence

No clinical data. Bench testing only. The device passed all required performance and safety tests, meeting predetermined acceptance criteria for applicable standards.

Technological Characteristics

Powered emergency ventilator with electronic monitoring module. Battery-operated (9 VDC). Constant flow, pressure-cycled operation. Includes visual and audible alarm system for non-cycling detection. Complies with ASTM F 920-93 (Reapproved 1999).

Indications for Use

Indicated for emergency, short-term, constant flow, pressure-cycled ventilatory support in patients requiring respiratory assistance, administered by trained personnel.

Regulatory Classification

Identification

A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.

Predicate Devices

• RespirTech PRO (K973975)
• RespirTech PRO O₂C (K001430)
• VAR-Plus Model PCM (K041473)

Submission Summary (Full Text)

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## 510(k) Summary

| | | | K07326 |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|-------------|
| 1. Submitter<br>Information | VORTRAN Medical Technology 1, Inc.<br>21 Golden Land Court, Sacramento, CA 95834 | | MAY 23 2008 |
| 2. Contact<br>Information | James Lee, Senior Vice President<br>TEL: [phone] FAX: [phone] | | |
| 3. Trade Name | VAR with VAR-Monitor™ | | |
| 4. Common Name | Ventilator, Emergency, Powered (Resuscitator) | | |
| 5. Device Class | Class II | | |
| 6. Product Code | 73 BTL | | |
| 7. Product<br>Classification | Per CFR section 868.5925 | | |
| 8. Classification<br>Panel | Anesthesiology | | |
| 9. Predicate<br>Device | RespirTech PRO<br>RespirTech PRO O₂C<br>VAR-Plus Model PCM | 510(k) No.: K973975<br>510(k) No.: K001430<br>510(k) No.: K041473 | |
| 10. Device<br>Description | The VAR-Monitor is a battery (9 VDC) operated device that is<br>mounted onto the VAR to monitor cycling conditions during<br>operation. | | |
| 11. Intended Use | The device is to be used by properly trained personnel to<br>deliver emergency, short term, constant flow - pressure cycled<br>ventilatory support. | | |
| 12. Substantial<br>Equivalency<br>Evaluation | The VAR with VAR-Monitor meets and exceeds "Standard<br>Specification for Minimum Performance and Safety<br>Requirements for Resuscitators Intended for Use with<br>Humans," ASTM Designation: F 920-93 (Reapproved 1999). | | |
| 13. Operational<br>Characteristics | VAR-Monitor detects a non-cycling condition of the VAR<br>modulator Indicating that no pressure changes have occurred.<br>When the VAR-Monitor is powered on and ready, the device<br>will check for the "pressure signal." If the pressure stays<br>unchanged for more than the preset time of eight (8) seconds,<br>both visual and audible alarms will be activated. | | |

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### 510(k) Summary

- The VAR with VAR-Monitor provides short term, pressure 14.Clinical cycled, constant flow ventilatory support using either pressure Application control or pressure support. The device is not an ICU stand alone ventilator. Set up and use of the VAR with VAR-Monitor is simple. Set desired flow and adjust pressure dial to obtain desired I-time and/or tidal volume (see tidal volume chart in instructions), and adjust rate dial to obtain desired rate and I to E ratio for the VAR. Power on the VAR-Monitor to monitor the VAR cycling and detect any VAR non-cycling condition. This non-cycling condition will trigger the alarm (audible and visual) to notify attending personnel of an abnormal condition. Possible changing conditions could include but are not limited to: (i) increases or decreases in supply gas flow or no gas flow because tank is empty or has been turned off; (ii) patlent disconnect or airway leak; or (iil) a change in patient All these conditions may cause the VAR to stop condition. cycling or stay in a spontaneous "pressure assisted" mode, waiting for the patient to trigger the next breath.
- 15. Clinical Tests None
- 16.Adverse S & E None Information
- The VAR with VAR-Monitor passed all required tests and 17. Conclusion demonstrated that it meets all predetermined acceptance criteria for applicable standards. In conclusion, the modified VAR with VAR-Monitor is substantially equivalent (SE) to legally marketed predicate devices.

[Signature]

James Lee

[Typed Name]

November 16, 2007

[Dated]

Senior Vice President

[Title]

VAR-P 510k Summary

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with outstretched wings. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### MAY 2 3 2008

Mr. James Lee Senior Vice President VORTRAN Medical Technology 1, Incorporated 21 Golden Land Court Sacramento, California 95834

Re: K073261 Trade/Device Name: VAR with VAR-Monitor Regulation Number: 21 CFR 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: II Product Code: BTL Dated: April 23, 2008 Received: April 28, 2008

Dear Mr. Lee:

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 - Mr. Lee

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours.

Svetta y Michael ms

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

Enclosure

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# Indications for Use

510(k) Number (if known): K073261

Device Name: VAR with VAR-Monitor

Indications For Use:

## The device is to be used by properly trained personnel to deliver emergency, short term, constant flow - pressure cycled ventilatory support.

Prescription Use 2 (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)

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

510(k) Number: 1607326