The VORTRAN Manometer is a single patient use device intended to provide visual indication of a patient's airway pressure during ventilation from 0 to 60 cm-H2O. It may be attached to the manometer port on ventilation devices such as resuscitators, resuscitation bags, hyperinflation bags, CPAP Masks or CPAP Circuits.

Device Description

The VORTRAN Pressure Manometer provides pressure readings from a breathing circuit in the range of 0 to 60 cm-H2O. The pressure readouts are approximate with an accuracy of ±2 cm-H2O for a low pressure range from 0 to 20 cm-H2O; ±3 cm-H2O for a pressure range of 20 to 40 cm-H2O; and ±5 cm-H2O for pressures above 40 cm-H2O. The manometer design requirements include: the pressure range of 0 to 60 cm-H2O, connection to a breathing circuit via a 22 mm male-female adaptor, and having a life expectancy as a single patient multiple use device. It accommodates connections through the option of a 22 mm tee or 15 mm port. The manometer includes a translucent enclosure that allows the pressure indicator needle to be seen from all sides.

The manometer label has three color zones of green, yellow, and red to give enhanced visual support during ventilation. The color coded scale indicates the following: green is 0 to 20 cm-H2O; yellow is 20 to 40 cm-H2O, and red is for pressures above 40 cm-H2O. The color coded scale is only for visual support and the correct ventilation pressure must be determined by the medical professional.

AI/ML Overview

The provided document describes the VORTRAN Manometer, an airway pressure monitor, and its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets acceptance criteria for an AI/ML powered device, nor does it detail a clinical trial or performance evaluation with statistical metrics such as sensitivity, specificity, or AUC, as would be typical for such devices.

The document primarily focuses on:

Device Description: The VORTRAN Manometer provides visual indication of airway pressure from 0 to 60 cm-H2O.
Technological Characteristics Comparison: A comparison of the VORTRAN Manometer's technology (pressure barrier, counter force, method of translating in-line air pressure, indicator mechanism, indicator movement, pressure limits, display increments, color coding, operating & storage temp) against several predicate devices.
Performance Data: The performance data section explicitly states "Animal Study: None" and "Clinical Studies: None." It only mentions "The VORTRAN Manometer will indicate airway pressure with an indicator needle..." and describes its mechanical operation.
Biocompatibility Testing: References to material compatibility with previously cleared devices.
Compliance with Performance Standards: Adherence to ISO 5356-1 for conical connectors.

Therefore, most of the requested information regarding acceptance criteria and a study proving an AI/ML device meets them cannot be extracted from this document. This typically indicates a 510(k) pathway for a traditional medical device, not an AI/ML-powered device. The "performance data" section in this document refers to bench testing of the mechanical performance, not a clinical trial or AI model validation.

However, based on the information provided, I can construct a partial response:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Functionality:
Visual indication of airway pressure	Met: The VORTRAN Manometer is intended to provide visual indication of a patient's airway pressure. The indicator needle shows PIP and PEEP in cm-H2O, associated with a linear rack and pinion gear tied to a moveable diaphragm. (Performance Data section)
Pressure range from 0 to 60 cm-H2O	Met: The device provides pressure readings from 0 to 60 cm-H2O. (Device Description, Performance Data section)
Accuracy:
±2 cm-H2O for 0 to 20 cm-H2O	Met: The pressure readouts are approximate with an accuracy of ±2 cm-H2O for a low pressure range from 0 to 20 cm-H2O. (Device Description section)
±3 cm-H2O for 20 to 40 cm-H2O	Met: The pressure readouts are approximate with an accuracy of ±3 cm-H2O for a pressure range of 20 to 40 cm-H2O. (Device Description section)
±5 cm-H2O for pressures above 40 cm-H2O	Met: The pressure readouts are approximate with an accuracy of ±5 cm-H2O for pressures above 40 cm-H2O. (Device Description section)
Connectivity:
Connection to breathing circuit via 22mm male-female adapter	Met: Connection to a breathing circuit via a 22 mm male-female adaptor, and accommodates connections through the option of a 22 mm tee or 15 mm port. Also, connected via a "Tee" 15 mm/22 mm ID/OD or "Vertical" plastics connector. (Device Description, Clinical Application sections)
Biocompatibility:	Met: The device uses materials (Polycarbonate, Acetal, Silicon) for components with indirect patient contact that are the same as predicate devices previously cleared by FDA. (Biocompatibility Testing section)
Mechanical Standard Compliance:	Met: Compliance with ISO 5356-1 Anaesthetic and respiratory equipment -- Conical connectors - Part 1: Cones and sockets. (Compliance with Performance Standards section)

Note: The "acceptance criteria" here are derived directly from the device's specified performance characteristics and design requirements mentioned in the document, as no explicit "acceptance criteria table" for a study was provided. The "reported device performance" are the statements made in the document regarding the device's characteristics.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- No information provided regarding a test set sample size or data provenance. The document explicitly states "Clinical Studies: None" and "Animal Study: None." The performance data section describes the mechanical operation and accuracy specifications, likely derived from bench testing, not a clinical test set. Data provenance is not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. There was no clinical test set for which expert ground truth would be established. The accuracy claims are based on engineering specifications and likely bench testing/calibration.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set requiring expert adjudication was described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a mechanical manometer, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted or mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical device, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the accuracy claims, the ground truth would typically be established by validated calibration standards and highly accurate reference pressure measurement equipment during bench testing. This is not explicitly stated in the document but is implied by the nature of the device (a manometer).
The sample size for the training set:
- Not applicable. This device is a mechanical manometer; it does not involve machine learning or a training set.
How the ground truth for the training set was established:
- Not applicable. This device is a mechanical manometer; it does not involve machine learning or a training set.

In summary, the provided document pertains to a traditional, mechanical medical device (manometer) undergoing a 510(k) clearance process based on substantial equivalence, primarily supported by bench testing and comparison to predicate devices, rather than a clinical study involving human subjects or an AI/ML algorithm validation study. Therefore, much of the requested information, which is relevant for AI/ML powered devices, is not available or applicable.

Summary

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

September 16, 2016

VORTRAN Medical Technology 1, Inc. Mr. James Lee Executive Vice President & COO 21 Goldenland Court, #100 Sacramento, California 95834

Re: K153733

Trade/Device Name: VORTRAN Manometer Regulation Number: 21 CFR 868.2600 Regulation Name: Airway Pressure Monitor Regulatory Class: II Product Code: CAP Dated: August 9, 2016 Received: August 17, 2016

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. James 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, 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) Unknown K153733

Device Name

VORTRAN Manometer

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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I. SUBMITTER

VORTRAN Medical Technology 1, Inc. 21 Goldenland Court, Suite 100 Sacramento, CA 95834 USA

Phone: (800) 434-4034 Fax: (916) 648-9751

Contact Person: James Lee Date Prepared: August 9, 2016

II. DEVICE

Name of Device: VORTRAN® Manometer 510(k) Number: K153733 Regulation Description: Airway Pressure Monitor Device: Monitor, Airway Pressure (Includes Gauge And/Or Alarm) Regulation Number: 21 CFR 868.2600 Regulatory Class: II Product Code: CAP Classification Advisory Committee: Anesthesiology Review Advisory Committee: Anesthesiology

III. PREDICATE DEVICE

K954486	Mercury Medical® Disposable Airway Pressure Manometer
K040991	Ambu® Disposable Pressure Manometer
K003497	DPM™ – Disposable Pressure Monitor
K041473	VORTRAN Automatic Resuscitator (VAR-Plus)(For Material Compatibility Only)
K003684	Percussiveneb(For Material Compatibility Only)
K920443	MiniNEB and VISAN-Neonatal(For Material Compatibility Only)

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IV. DEVICE DESCRIPTION

INDICATIONS FOR USE V.

DISCUSSION:

The intended use of the new device and the predicate devices are to ● measure the airway pressure in the range of 0 to 60 cm -H2O.
The difference in the verbiage of how the manometers are connected . to a ventilation device is informational only and will not affect the safety and effectiveness of the manometer.
The device labeled as "single patient use" and the predicate labeled as "disposable" product have the same intended use and will not affect the safety and effectiveness.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The table below shows the technological differences and similarities of our manometer compared to the predicate devices.

	NEW DEVICE			PREDICATE DEVICE
DeviceName	VORTRAN®Manometer /TeeConnection	VORTRAN®Manometer /VerticalConnection	Mercury Medical®Disposable AirwayPressure Manometer	Ambu® DisposablePressure Manometer	DPM™ – Disposable PressureMonitor
Technology / Mechanisms Similar or Different
PressureBarrier	• Diaphragm		• DiaphragmSimilar	• DiaphragmSimilar	• Sealed O-ring SliderDifferent
CounterForce	• Spring		• SpringSimilar	• SpringSimilar	• SpringSimilar
Method oftranslatingin-line airpressure	• Displacement of diaphragmagainst spring (counterforce)		• Displacement ofdiaphragm against spring(counter force)Similar	• Displacement ofdiaphragm againstspring (counter force)Similar	• Displacement of sealed O-ringslider moving upwaredDifferent
IndicatorMechanism	• Rack and Pinion Gear		• Screw (Spiral Gear)Different	• Extending DiaphragmDifferent	• Displacing O-ring SliderDifferent
IndicatorMovement	• Rotational - force pushesthe rack, resulting inrotation of piniongear/indicator		• Rotational - force pushesthreaded screwcomponent, rotating theindicatorSimilar	• Linear - force pushes thecenter of diaphragm,which extends upwardsuntil it lines up withpressure indicationlabelsDifferent	• Linear - force pushes theslider upwards until it linesup with pressure indicationlabelsDifferent
PressureLimits	• 0~60 cm H2O		• 0~60 cm H2OSimilar	• 0 ~ 60 cm H2OSimilar	• 0 ~ 60 cm H2OSimilar

		NEW DEVICE		PREDICATE DEVICE
DeviceName	VORTRAN®Manometer /TeeConnection	VORTRAN®Manometer /VerticalConnection	Mercury Medical®Disposable AirwayPressure Manometer	Ambu® DisposablePressure Manometer	DPMTM - DisposablePressure Monitor
DisplayIncrements	• 10, 20, 30, 40and 60 cm H2O	• 10, 20, 30, 40and 60 cm H2O	• 5, 10, 15, 20, 30, 40and 60 cm H2O	• 5, 10, 15, 20, 30, 40and 60 cm H2O	• 0, 10, 20, 30, 40, 50and 60 cm H2O
ColorCoded	Color coded:• Green 0 ~ 20 cm H2O• Yellow 20 ~ 40 cm H2O• Red 40 ~ 60 cm H2O	Color coded:• Green 0 ~ 20 cm H2O• Yellow 20 ~ 40 cm H2O• Red 40 ~ 60 cm H2O	Color coded:• Green 0 ~ 20 cm H2O• Yellow 20 ~ 40 cm H2O• Red 40 ~ 60 cm H2O	Color coded:• Green 0 ~ 20 cm H2O• Yellow 20 ~ 40 cm H2O• Red 40 ~ 60 cm H2O	Not color coded
ColorCodedFeature	Image: Color coded feature	Image: Color coded feature	Image: Color coded feature	Image: Color coded feature	Not color coded
Operating &StorageTemp	Not Recorded	Not Recorded	Not Recorded	Operating: - 18℃ to 50℃Storage: - 40°C to 60°C	Not Recorded

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o Biocompatibility Testing
The VORTRAN Manometer has four components that have indirect patient contact that use the same material as the predicate devices manufactured by VORTRAN Medical. The following table lists the component name, their material, cleared device name, and 510k Number/Date.

Component Name	Material	Cleared Device Name	501k Number / Date
Tee Connector &Vertical Connector	Polycarbonate /Clear Blue	VORTRAN MiniNEB(a.k.a. MiniHEARTNebulizer)	K920443 /July 02, 1992
Diaphragm SupportDisk	Polycarbonate /Clear Blue	VORTRAN MiniNEB(a.k.a. MiniHEARTNebulizer)	K920443 /July 02, 1992
Rack	Acetal	VORTRAN Device,Positive Pressure,Breathing	K003684 /February 23, 2001
Diaphragm	Silicon	VORTRAN Ventilator,emergency, powered	K041473 /July 15, 2004

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Animal Study ●
None
Clinical Studies o
None
Performance Data ●
The VORTRAN Manometer will indicate airway pressure with an indicator needle that shows PIP (Peak Inspiratory Pressure) and PEEP (Positive End Expiratory Pressure) in cm-H2O. The indicator needle is associated with a linear rack and pinion gear tied to a moveable diaphragm. Changes in airway pressure are measured via the moveable diaphragm and with the indicator needle that will rotate approximately 180° to indicate pressure range from 0 to 60 cm- H2O

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Clinical Application .

The VORTRAN Manometer is connected to the patient via a "Tee" 15 mm/22 mm ID/OD or "Vertical" plastics connector.

Compliance with Performance Standards . ISO 5356-1 Anaesthetic and respiratory equipment -- Conical connectors -Part 1: Cones and sockets

VIII. CONCLUSIONS

Based on the performance comparison of bench testing, the VORTRAN Manometer will perform as intended in the specified use conditions. The equivalent (SE) comparison data demonstrate that the VORTRAN Manometer device performs substantially equivalent to the predicate device that is currently marketed for the same intended use.

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).