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 Description

The VAPM is a battery (9 VDC) operated, portable, self-contained device that is connected to the patient via the connection tubing for monitoring cycling conditions of resuscitators such as the VORTRAN® Automatic Resuscitator.

AI/ML Overview

Table of Acceptance Criteria and Reported Device Performance:

The provided document describes the VORTRAN Airway Pressure Monitor (VAPM) and states that "The VAPM passed all required tests and demonstrated that it meets all predetermined acceptance criteria for applicable standards." However, the document does not explicitly list the specific numerical acceptance criteria for each measured parameter (e.g., accuracy for Peak Inspiratory Pressure, PEEP, Respiratory Rate, etc.) nor does it provide a table of the device's reported performance against these criteria.

Instead, it lists the performance standards with which the VAPM complies:
- IEC/UL-60601-1: General Requirements for Safety
- IEC 60601-1-8: Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC 60601-1-2: Collateral standard: Electromagnetic compatibility - Requirements and tests
Without specific performance criteria (e.g., "PIP accuracy ±X cm-H2O") and corresponding reported performance, a table cannot be fully generated from this document. The document only offers a general statement of compliance.
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: This information is not provided in the document.
- Data Provenance: This information is not provided in the document.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not provided in the document. As this is a medical device for monitoring physiological parameters, the "ground truth" would typically come from calibrated reference instruments or established methodologies rather than expert consensus on interpretive data like images.
Adjudication Method for the Test Set:
- Not applicable as the document does not describe a test set requiring adjudication in the context of interpretation (e.g., image reading). Testing for this device would involve comparing its measurements against reference standards.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. The device is an objective measurement tool, not an interpretive AI system that assists human readers.
- The document states "Clinical Tests: None."
Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
- The relevant "standalone performance" for this type of device would be its accuracy and reliability in measuring airway pressure and related parameters. While the document states "The VAPM passed all required tests," detailed information about the specific standalone performance study (e.g., protocols, results of accuracy tests for PIP, PEEP, respiratory rate, alarm activation thresholds, and timing) is not provided. The document indicates compliance with international performance standards, implying such tests were conducted.
Type of Ground Truth Used:
- The document implies that the ground truth for validation would be derived from calibrated reference standards or established measurement methodologies for airway pressure and respiratory parameters as per the IEC/UL standards it complies with. Specific details are not given, but for devices measuring physical quantities, this is the standard approach (e.g., a highly accurate pressure transducer for pressure measurements, a timer for rate measurements, etc.).
Sample Size for the Training Set:
- Not applicable. This device is a hardware-based monitor, not an AI/ML algorithm that requires a "training set" in the conventional sense.
How the Ground Truth for the Training Set Was Established:
- Not applicable as there is no training set for this type of device.

Summary

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VORTRAN Medical Technology 1, Inc.

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510(k) Summary - VORTRAN APM™ K103639

1.	SubmitterInformation	VORTRAN Medical Technology 1, Inc.21 Goldenland Court, Suite 100, Sacramento, CA 95834
2.	ContactInformation	James Lee, Executive Vice President & COOTEL: (800) 434-4034FAX: (916) 648-9751
3.	Trade Name	VAPM™ (VORTRAN Airway Pressure Monitor) Kit
4.	DeviceClassificationName	Monitor, Airway Pressure(Includes Gauge And/or Alarm)
5.	Device Class	Class II
6.	RegulationNumber	868.2600
7.	ClassificationProduct Code	CAP
8.	ClassificationAdvisoryCommittee	Anesthesiology
9.	ReviewAdvisoryCommittee	Anesthesiology
10.	PredicateDevice	VAR® with VAR-Monitor™ 510(k) No.: K073261VAR with Manometer 510(k) No.: K001430VAR-Plus with Manometer 510(k) No.: K041473
11.	DeviceDescription	The VAPM is a battery (9 VDC) operated, portable, self-contained device that is connected to the patient via theconnection tubing for monitoring cycling conditions ofresuscitators such as the VORTRAN® Automatic Resuscitator.
12.	Intended Use	The VORTRAN Airway Pressure Monitor (VAPM) is to be usedby properly trained personnel to monitor the delivery ofemergency, short term, ventilatory support to adult (using VAPM-3900 Adult Model) and/or pediatric (using VAPM-3800 PediatricModel).
13.	SubstantialEquivalencyEvaluation	The VAPM is substantially equivalent (SE) to legally marketedpredicates like the VAR with VAR-Monitor (K073261) and othercommercially available pressure manometer / alarm devices.
14.	ClinicalApplication	The VAPM is connected to the VAR and patient via a ¼"diameter tubing through an HME/bacteria filter. There will be noflow of gas between the VAPM and VAR/patient circuit.
15. CompliancewithPerformanceStandards	The VAPM complies with the following INTERNATIONALELECTROTECHNICAL COMMISSION performance standardsfor medical electrical equipment, such as [i] IEC/UL-60601-1:General Requirements for Safety and; [ii] IEC 60601-1-8: --Collateral Standard: General requirements, tests and guidancefor alarm systems in medical electrical equipment and medicalelectrical systems; [iii] IEC 60601-1-2: Collateral standard:Electromagnetic compatibility - Requirements and tests.
16. FunctionalCharacteristics	[a] MONITORS: The VAPM is designed to monitor the operationof the VAR device when it is connected to a patient. The VAPMwill display airway pressure like a pressure manometer and theLCD shows PIP (Peak Inspiratory Pressure) and PEEP (PositiveEnd Expiratory Pressure) in cm-H2O. Other respiratory functionssuch as Respiratory Rate (breaths per minute), inspiratory andexpiratory time (seconds) and I:E Ratio are also displayed on theLCD using the same airway pressure signals.[b] ALARMS: An alarm function is also built into the VAPM tofacilitate monitoring of the patient's respiratory function and toalert clinicians of any abnormalities. When the VAR stopscycling for a predetermined time, the VAPM will activate theNON-CYCLING ALARM. In addition, when the respiratory rateor airway pressure exceeds the preset limit, the HIGH RATE and/ or HIGH PIP alarms will be activated. The VAPM has a flashingred LED and makes an audible sound when the alarm conditionsdisplay on the LCD.
17. Clinical Tests	None
18.AdverseS & E Info	None
19. Conclusion	The VAPM passed all required tests and demonstrated that itmeets all predetermined acceptance criteria for applicablestandards.

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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 (800) 638-2041 or (301) 796-7100 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:

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

Page 1 of 1

510(k) Number: K103639

Regulation Number and Section

§ 868.2600 Airway pressure monitor.

(a)
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.(b)
Classification. Class II (performance standards).