VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC

K103639 · Vortran Medical Technology 1, Inc. · CAP · Sep 15, 2011 · Anesthesiology

Device Facts

• Record ID: K103639
• Device Name: VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC
• Applicant: Vortran Medical Technology 1, Inc.
• Product Code: CAP · Anesthesiology
• Decision Date: Sep 15, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2600
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The VORTRAN Airway Pressure Monitor (VAPM) is to be used by properly trained personnel to monitor the delivery of emergency, short term, ventilatory support to adult (using VAPM-3900 Adult Model) and/or pediatric (using VAPM-3800 Pediatric Model).

Device Story

VAPM is a portable, battery-operated (9 VDC) airway pressure monitor; connects to resuscitators (e.g., VORTRAN Automatic Resuscitator) via tubing through an HME/bacteria filter; no gas flow between monitor and patient circuit. Device inputs airway pressure signals; processes signals to calculate and display Peak Inspiratory Pressure (PIP), Positive End Expiratory Pressure (PEEP), respiratory rate, inspiratory/expiratory time, and I:E ratio on an LCD. Includes alarm system for non-cycling, high respiratory rate, and high PIP; alerts via flashing red LED and audible sound. Used by trained personnel in clinical settings to monitor ventilatory support delivery; output assists clinicians in assessing patient respiratory function and identifying abnormalities.

Clinical Evidence

No clinical data. Bench testing only; device met all predetermined acceptance criteria for applicable performance standards.

Technological Characteristics

Portable, battery-operated (9 VDC) monitor. Sensing principle: airway pressure signal processing. Display: LCD for pressure (cm-H2O) and respiratory parameters. Connectivity: standalone. Standards: IEC/UL-60601-1 (Safety), IEC 60601-1-8 (Alarms), IEC 60601-1-2 (EMC).

Indications for Use

Indicated for monitoring emergency, short-term ventilatory support in adult (VAPM-3900) and pediatric (VAPM-3800) patients by trained personnel.

Regulatory Classification

Identification

An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.

Predicate Devices

• VAR with VAR-Monitor (K073261)
• VAR with Manometer (K001430)
• VAR-Plus with Manometer (K041473)

Submission Summary (Full Text)

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VORTRAN Medical Technology 1, Inc.

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# 510(k) Summary - VORTRAN APM™ K103639

| 1. | Submitter<br>Information | VORTRAN Medical Technology 1, Inc.<br>21 Goldenland Court, Suite 100, Sacramento, CA 95834 |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact<br>Information | James Lee, Executive Vice President & COO<br>TEL: [phone]<br>FAX: [phone] |
| 3. | Trade Name | VAPM™ (VORTRAN Airway Pressure Monitor) Kit |
| 4. | Device<br>Classification<br>Name | Monitor, Airway Pressure<br>(Includes Gauge And/or Alarm) |
| 5. | Device Class | Class II |
| 6. | Regulation<br>Number | 868.2600 |
| 7. | Classification<br>Product Code | CAP |
| 8. | Classification<br>Advisory<br>Committee | Anesthesiology |
| 9. | Review<br>Advisory<br>Committee | Anesthesiology |
| 10. | Predicate<br>Device | VAR® with VAR-Monitor™ 510(k) No.: K073261<br>VAR with Manometer 510(k) No.: K001430<br>VAR-Plus with Manometer 510(k) No.: K041473 |
| 11. | Device<br>Description | The VAPM is a battery (9 VDC) operated, portable, self-<br>contained device that is connected to the patient via the<br>connection tubing for monitoring cycling conditions of<br>resuscitators such as the VORTRAN® Automatic Resuscitator. |
| 12. | Intended Use | The VORTRAN Airway Pressure Monitor (VAPM) is to be used<br>by properly trained personnel to monitor the delivery of<br>emergency, short term, ventilatory support to adult (using VAPM-<br>3900 Adult Model) and/or pediatric (using VAPM-3800 Pediatric<br>Model). |
| 13. | Substantial<br>Equivalency<br>Evaluation | The VAPM is substantially equivalent (SE) to legally marketed<br>predicates like the VAR with VAR-Monitor (K073261) and other<br>commercially available pressure manometer / alarm devices. |
| 14. | Clinical<br>Application | The VAPM is connected to the VAR and patient via a ¼"<br>diameter tubing through an HME/bacteria filter. There will be no<br>flow of gas between the VAPM and VAR/patient circuit. |
| 15. Compliance<br>with<br>Performance<br>Standards | The VAPM complies with the following INTERNATIONAL<br>ELECTROTECHNICAL COMMISSION performance standards<br>for medical electrical equipment, such as [i] IEC/UL-60601-1:<br>General Requirements for Safety and; [ii] IEC 60601-1-8: --<br>Collateral Standard: General requirements, tests and guidance<br>for alarm systems in medical electrical equipment and medical<br>electrical systems; [iii] IEC 60601-1-2: Collateral standard:<br>Electromagnetic compatibility - Requirements and tests. | |
| 16. Functional<br>Characteristics | [a] MONITORS: The VAPM is designed to monitor the operation<br>of the VAR device when it is connected to a patient. The VAPM<br>will display airway pressure like a pressure manometer and the<br>LCD shows PIP (Peak Inspiratory Pressure) and PEEP (Positive<br>End Expiratory Pressure) in cm-H2O. Other respiratory functions<br>such as Respiratory Rate (breaths per minute), inspiratory and<br>expiratory time (seconds) and I:E Ratio are also displayed on the<br>LCD using the same airway pressure signals.<br>[b] ALARMS: An alarm function is also built into the VAPM to<br>facilitate monitoring of the patient's respiratory function and to<br>alert clinicians of any abnormalities. When the VAR stops<br>cycling for a predetermined time, the VAPM will activate the<br>NON-CYCLING ALARM. In addition, when the respiratory rate<br>or airway pressure exceeds the preset limit, the HIGH RATE and<br>/ or HIGH PIP alarms will be activated. The VAPM has a flashing<br>red LED and makes an audible sound when the alarm conditions<br>display on the LCD. | |
| 17. Clinical Tests | None | |
| 18.<br>Adverse<br>S & E Info | None | |
| 19. Conclusion | The VAPM passed all required tests and demonstrated that it<br>meets all predetermined acceptance criteria for applicable<br>standards. | |

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## 510(k) Summary - VORTRAN APM™ K103639

James Lee

[Signature]

James Lee

[Typed Name]

July 25, 2011

[Dated]

Executive VP & COO

[Title]

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird-like shape, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. James Lee Executive Vice President & COO Vorton Medical Technology 1, Incorporated 21 Golden Land Court Sacramento, California 95834

SEP 1 5 2011

Re: K103639

Trade/Device Name: VORTRAN® Airway Pressure Monitor Regulation Number: 21 CFR 868.2600 Regulation Name: Airway Pressure Monitor Regulatory Class: 11 Product Code: CAP Dated: September 14, 2011 Received: September 14, 2011

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. 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.

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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); 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 CDRH'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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

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

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# Indications for Use

July 25, 2011

#### K103639 510(k) Number (if known):

### VORTRAN® Airway Pressure Monitor Device Name:

Indications for Use:

:

The VORTRAN Airway Pressure Monitor (VAPM) is to be used by properly trained personnel to monitor the delivery of emergency, short term, ventilatory support to adult (using VAPM-3900 Adult Model) and/or pediatric (using VAPM-3800 Pediatric Model).

X AND/OR Prescription Use : (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (Part 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)

L. Shutter

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

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510(k) Number: K103639