Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a purely mechanical manometer that provides a visual indication of pressure using a needle and diaphragm. There is no mention of any computational or algorithmic processing, let alone AI/ML.

Therapeutic

No.

The device is intended to provide visual indications of airway pressure, not to treat a condition.

Diagnostic

Yes

This device provides a "visual indication of a patient's airway pressure during ventilation" and indicates "PIP (Peak Inspiratory Pressure) and PEEP (Positive End Expiratory Pressure)," which are measurements used by medical professionals to assess a patient's respiratory status and guide treatment. Although it doesn't diagnose a specific disease, providing quantitative measurements to aid in medical assessment makes it a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components like a diaphragm, indicator needle, linear rack and pinion gear, and a translucent enclosure, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The VORTRAN Manometer measures airway pressure during ventilation. This is a physical measurement of pressure within the respiratory system, not a test performed on a biological sample.
Intended Use: The intended use clearly states it provides "visual indication of a patient's airway pressure during ventilation." This aligns with monitoring a physiological parameter, not analyzing a biological sample.

Therefore, the VORTRAN Manometer falls under the category of a medical device used for monitoring a patient's physiological state, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

CAP

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

airway

Indicated Patient Age Range

Not Found

Intended User / Care Setting

medical professional

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Accuracy: ±2 cm-H2O for 0 to 20 cm-H2O; ±3 cm-H2O for 20 to 40 cm-H2O; and ±5 cm-H2O for pressures above 40 cm-H2O.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K954486, K040991, K003497

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K041473, K003684, K920443

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol featuring three overlapping profiles facing upwards and to the right, representing the department's focus on people and health.

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)

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.

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

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.

INDICATIONS FOR USE V.

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.

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
Device
Name	VORTRAN®
Manometer /
Tee
Connection	VORTRAN®
Manometer /
Vertical
Connection	Mercury Medical®
Disposable Airway
Pressure Manometer	Ambu® Disposable
Pressure Manometer	DPM™ – Disposable Pressure
Monitor
Technology / Mechanisms Similar or Different
Pressure
Barrier	• Diaphragm		• Diaphragm
Similar	• Diaphragm
Similar	• Sealed O-ring Slider
Different
Counter
Force	• Spring		• Spring
Similar	• Spring
Similar	• Spring
Similar
Method of
translating
in-line air
pressure	• Displacement of diaphragm
against spring (counter
force)		• Displacement of
diaphragm against spring
(counter force)
Similar	• Displacement of
diaphragm against
spring (counter force)
Similar	• Displacement of sealed O-ring
slider moving upwared
Different
Indicator
Mechanism	• Rack and Pinion Gear		• Screw (Spiral Gear)
Different	• Extending Diaphragm
Different	• Displacing O-ring Slider
Different
Indicator
Movement	• Rotational - force pushes
the rack, resulting in
rotation of pinion
gear/indicator		• Rotational - force pushes
threaded screw
component, rotating the
indicator
Similar	• Linear - force pushes the
center of diaphragm,
which extends upwards
until it lines up with
pressure indication
labels
Different	• Linear - force pushes the
slider upwards until it lines
up with pressure indication
labels
Different
Pressure
Limits	• 0~60 cm H2O		• 0~60 cm H2O
Similar	• 0 ~ 60 cm H2O
Similar	• 0 ~ 60 cm H2O
Similar

		NEW DEVICE		PREDICATE DEVICE
Device
Name	VORTRAN®
Manometer /
Tee
Connection	VORTRAN®
Manometer /
Vertical
Connection	Mercury Medical®
Disposable Airway
Pressure Manometer	Ambu® Disposable
Pressure Manometer	DPMTM - Disposable
Pressure Monitor
Display
Increments	• 10, 20, 30, 40
and 60 cm H2O	• 10, 20, 30, 40
and 60 cm H2O	• 5, 10, 15, 20, 30, 40
and 60 cm H2O	• 5, 10, 15, 20, 30, 40
and 60 cm H2O	• 0, 10, 20, 30, 40, 50
and 60 cm H2O
Color
Coded	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
Color
Coded
Feature	Image: Color coded feature	Image: Color coded feature	Image: Color coded feature	Image: Color coded feature	Not color coded
Operating &
Storage
Temp	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
Tee Connector &
Vertical Connector	Polycarbonate /
Clear Blue	VORTRAN MiniNEB
(a.k.a. MiniHEART
Nebulizer)	K920443 /
July 02, 1992
Diaphragm Support
Disk	Polycarbonate /
Clear Blue	VORTRAN MiniNEB
(a.k.a. MiniHEART
Nebulizer)	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.