VORTRAN Manometer
Device Facts
| Record ID | K153733 |
|---|---|
| Device Name | VORTRAN Manometer |
| Applicant | Vortran Medical Technology 1, Inc. |
| Product Code | CAP · Anesthesiology |
| Decision Date | Sep 16, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.2600 |
| Device Class | Class 2 |
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.
Device Story
VORTRAN Manometer provides visual airway pressure monitoring (0-60 cm-H2O) during ventilation; single-patient use. Input: airway pressure from breathing circuit via 22mm or 15mm port. Operation: pressure displaces internal diaphragm against spring; movement drives rack-and-pinion gear; indicator needle rotates ~180° to display pressure. Output: visual needle position against color-coded scale (green 0-20, yellow 20-40, red >40 cm-H2O). Used in clinical settings by medical professionals; provides real-time PIP/PEEP data to assist in ventilation management. Benefits: provides immediate visual feedback on airway pressure to support clinical decision-making during manual or mechanical ventilation.
Clinical Evidence
Bench testing only; no clinical or animal studies performed. Performance testing verified pressure indication accuracy (±2 cm-H2O for 0-20 range; ±3 cm-H2O for 20-40 range; ±5 cm-H2O for >40 range) and compliance with ISO 5356-1 for conical connectors.
Technological Characteristics
Materials: Polycarbonate (tee/vertical connectors, diaphragm support), Acetal (rack), Silicon (diaphragm). Sensing: Diaphragm displacement against spring counter-force. Mechanism: Rack and pinion gear. Form factor: Translucent enclosure with 22mm male-female adaptor or 15mm port. Connectivity: Standalone. Sterilization: Not specified. Software: None.
Indications for Use
Indicated for patients requiring visual monitoring of airway pressure during ventilation (0-60 cm-H2O) via resuscitators, resuscitation bags, hyperinflation bags, CPAP masks, or CPAP circuits.
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
- Mercury Medical® Disposable Airway Pressure Manometer (K954486)
- Ambu® Disposable Pressure Manometer (K040991)
- DPM™ – Disposable Pressure Monitor (K003497)
Reference Devices
- VORTRAN Automatic Resuscitator (VAR-Plus) (K041473)
- Percussiveneb (K003684)
- MiniNEB and VISAN-Neonatal (K920443)
Submission Summary (Full Text)
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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)
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) | |
|------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
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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)<br>(For Material Compatibility Only) |
| K003684 | Percussiveneb<br>(For Material Compatibility Only) |
| K920443 | MiniNEB and VISAN-Neonatal<br>(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 | | | PREDICATE DEVICE | |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------|---------------------------------------------------|--------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Device<br>Name | VORTRAN®<br>Manometer /<br>Tee<br>Connection | VORTRAN®<br>Manometer /<br>Vertical<br>Connection | Mercury Medical®<br>Disposable Airway<br>Pressure Manometer | Ambu® Disposable<br>Pressure Manometer | DPM™ – Disposable Pressure<br>Monitor |
| Technology / Mechanisms Similar or Different | | | | | |
| Pressure<br>Barrier | • Diaphragm | | • Diaphragm<br>Similar | • Diaphragm<br>Similar | • Sealed O-ring Slider<br>Different |
| Counter<br>Force | • Spring | | • Spring<br>Similar | • Spring<br>Similar | • Spring<br>Similar |
| Method of<br>translating<br>in-line air<br>pressure | • Displacement of diaphragm<br>against spring (counter<br>force) | | • Displacement of<br>diaphragm against spring<br>(counter force)<br>Similar | • Displacement of<br>diaphragm against<br>spring (counter force)<br>Similar | • Displacement of sealed O-ring<br>slider moving upwared<br>Different |
| Indicator<br>Mechanism | • Rack and Pinion Gear | | • Screw (Spiral Gear)<br>Different | • Extending Diaphragm<br>Different | • Displacing O-ring Slider<br>Different |
| Indicator<br>Movement | • Rotational - force pushes<br>the rack, resulting in<br>rotation of pinion<br>gear/indicator | | • Rotational - force pushes<br>threaded screw<br>component, rotating the<br>indicator<br>Similar | • Linear - force pushes the<br>center of diaphragm,<br>which extends upwards<br>until it lines up with<br>pressure indication<br>labels<br>Different | • Linear - force pushes the<br>slider upwards until it lines<br>up with pressure indication<br>labels<br>Different |
| Pressure<br>Limits | • 0~60 cm H2O | | • 0~60 cm H2O<br>Similar | • 0 ~ 60 cm H2O<br>Similar | • 0 ~ 60 cm H2O<br>Similar |
| | | NEW DEVICE | | PREDICATE DEVICE | |
|--------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|------------------------------------------|
| Device<br>Name | VORTRAN®<br>Manometer /<br>Tee<br>Connection | VORTRAN®<br>Manometer /<br>Vertical<br>Connection | Mercury Medical®<br>Disposable Airway<br>Pressure Manometer | Ambu® Disposable<br>Pressure Manometer | DPMTM - Disposable<br>Pressure Monitor |
| Display<br>Increments | • 10, 20, 30, 40<br>and 60 cm H2O | • 10, 20, 30, 40<br>and 60 cm H2O | • 5, 10, 15, 20, 30, 40<br>and 60 cm H2O | • 5, 10, 15, 20, 30, 40<br>and 60 cm H2O | • 0, 10, 20, 30, 40, 50<br>and 60 cm H2O |
| Color<br>Coded | Color coded:<br>• Green 0 ~ 20 cm H2O<br>• Yellow 20 ~ 40 cm H2O<br>• Red 40 ~ 60 cm H2O | Color coded:<br>• Green 0 ~ 20 cm H2O<br>• Yellow 20 ~ 40 cm H2O<br>• Red 40 ~ 60 cm H2O | Color coded:<br>• Green 0 ~ 20 cm H2O<br>• Yellow 20 ~ 40 cm H2O<br>• Red 40 ~ 60 cm H2O | Color coded:<br>• Green 0 ~ 20 cm H2O<br>• Yellow 20 ~ 40 cm H2O<br>• Red 40 ~ 60 cm H2O | Not color coded |
| Color<br>Coded<br>Feature | Image: Color coded feature | Image: Color coded feature | Image: Color coded feature | Image: Color coded feature | Not color coded |
| Operating &<br>Storage<br>Temp | Not Recorded | Not Recorded | Not Recorded | Operating: - 18℃ to 50℃<br>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 &<br>Vertical Connector | Polycarbonate /<br>Clear Blue | VORTRAN MiniNEB<br>(a.k.a. MiniHEART<br>Nebulizer) | K920443 /<br>July 02, 1992 |
| Diaphragm Support<br>Disk | Polycarbonate /<br>Clear Blue | VORTRAN MiniNEB<br>(a.k.a. MiniHEART<br>Nebulizer) | K920443 /<br>July 02, 1992 |
| Rack | Acetal | VORTRAN Device,<br>Positive Pressure,<br>Breathing | K003684 /<br>February 23, 2001 |
| Diaphragm | Silicon | VORTRAN Ventilator,<br>emergency, powered | K041473 /<br>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.
