(391 days)
The VORTRAN® APM-Plus is used to measure airway pressure for patients utilizing positive pressure devices where monitoring is desired.
The VORTRAN® APM-Plus is a battery (2 x AA) operated, microprocessor controlled, portable, self-contained device designed for monitoring a positive airway-pressure device such as a resuscitator or CPAP. The VORTRAN® APM-Plus is housed in a plastic enclosure. It connects to the positive-pressure device under monitor via pneumatic pressure tubing and receives the pressure signals using its solid-state pressure transducer. The pressure signals are used to calculate the related characteristics which are displayed on the LCD screen. The values are used to trigger alarms that alert the user of any abnormal pressure conditions. The software algorithm constantly monitors the data and if/when the pressure characteristics are outside of the user-set limits, an alarm will be activated. The alarms are both visual and audible. For ease of use, the VORTRAN® APM-Pus software provides two modes of operations: Resuscitator Mode and PAP Mode. When the device is turned on, the user can select one of the two modes. In each mode, the pressure data shown is suitable for the device under monitoring.
The VORTRAN® APM-Plus is an airway pressure monitor. The provided text outlines the device's technical specifications and comparison to predicate devices, but it explicitly states "Clinical Studies None" under the "Performance Data" section (Page 11).
Therefore, based on the provided text, a study proving the device meets acceptance criteria through clinical performance data, a multi-reader multi-case (MRMC) study, or a standalone algorithm-only study was not conducted or provided as part of this 510(k) submission.
The performance data provided for the VORTRAN® APM-Plus focuses on:
- Biocompatibility Testing: Comparing patient-contacting materials to a cleared reference device (K103639).
- Electrical Safety and Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8.
- Software Verification and Validation Testing: Development in accordance with FDA guidelines and IEC 62304.
- Risk Management: Compliance with ISO 14971.
- Shelf Life: An accelerated shelf life test showing a simulated age of 1 year.
Therefore, it is not possible to provide the requested information regarding acceptance criteria and performance based on clinical study data, human reader performance, or standalone algorithm performance from the given document.
The tables of "Performance Specifications" (starting on page 8) list the device's stated ranges and accuracies, essentially defining its intended performance characteristics or "acceptance criteria" from a technical specification standpoint rather than from a clinical study outcome.
However, if we interpret "acceptance criteria and reported device performance" as the technical specifications and their stated values, we can construct the following table based on the "Performance Specifications" section (pages 8-9):
Technical Acceptance Criteria and Reported Device Performance (Based on Stated Specifications)
| Acceptance Criteria (Target Specification) | Reported Device Performance (Stated Value) |
|---|---|
| Pressure Display Range | 0 to 55 cm-H2O |
| Pressure Display Accuracy | ± 1 cm-H2O |
| Pressure Display Resolution (Resuscitator Mode) | 1 cm-H2O |
| Pressure Display Resolution (PAP Mode) | 0.1 cm-H2O |
| Respiratory Rate Display Range | 0 to 99 BPM |
| Respiratory Display Rate Accuracy | ± 10% |
| Respiratory Rate Display Resolution | 1 Breath per Minute |
| I-Time & E-Time Display Range | 0 to 9.9 seconds |
| I-Time & E-Time Display Accuracy | ± 10% |
| I-Time & E-Time Display Resolution | 0.1 second |
| I:E Ratio Display Range | 1:0.0 to 1:9.9 |
| I:E Ratio Display Accuracy | ± 10% |
| I:E Ratio Display Resolution | 0.1 |
| Alarm Delay (Non-Cycling Alarm Only) | 1-20 seconds |
| High Pressure Alarm Range | 1 to 50 cm-H2O |
| High Pressure Alarm Resolution | 1 cm-H2O |
| Low Pressure Alarm Range | 1 to 15 cm-H2O |
| Low Pressure Alarm Resolution | 1 cm-H2O |
| High Rate Alarm Range | 12 to 99 BPM |
| High Rate Alarm Resolution | 1 BPM |
| Non-Cycling Alarm Range | 1 to 20 seconds |
| Non-Cycling Alarm Resolution | 1 second |
| Low Battery Alarm | YES |
| Battery Life (Worst-Case) | 164 Hours |
| Calibration | None (Stated) |
Since "Clinical Studies None" is stated, the following information cannot be extracted from the provided document:
- Sample sizes used for the test set and data provenance: Not applicable as no clinical test set was described.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for clinical performance. The software verification and validation would have tested the algorithm's functionality against its specified requirements, but not in a clinical "standalone" performance study.
- The type of ground truth used: Not applicable for clinical performance. Ground truth for technical specifications would be derived from laboratory calibration and testing.
- The sample size for the training set: Not applicable as a clinical training set is not described. This device is an airway pressure monitor, not typically an AI/ML device that requires a "training set" in the conventional sense for clinical performance. Its software capabilities are described as "microprocessor controlled" and for "calculating related characteristics" and triggering alarms (Page 4).
- How the ground truth for the training set was established: Not applicable.
In summary, the 510(k) clearance for the VORTRAN® APM-Plus was based on substantial equivalence to predicate devices and adherence to relevant electrical safety, software, and quality system standards, without the need for clinical performance studies.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 18, 2019
VORTRAN Medical Technology 1, Inc. James Lee Executive VP & COO 21 Goldenland Court, Suite 100 Sacramento, California 95834
Re: K182292
Trade/Device Name: VORTRAN APM-Plus Regulation Number: 21 CFR 868.2600 Regulation Name: Airway Pressure Monitor Regulatory Class: Class II Product Code: CAP Dated: August 30, 2019 Received: September 16, 2019
Dear James 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
James Lee Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182292
Device Name VORTRAN® APM-Plus
Indications for Use (Describe)
The VORTRAN® APM-Plus is a multiple-patient-use device intended to monitor a positive-pressure device that connects to an adult or pediatric patient ≥ 10 kg. The device alarms when the conditions (pressure and/or rate, as applicable) are outside of the user selected high and low alarm limits. In PAP Mode, it displays only real-time breasure; in Resuscitator Mode, it displays ventilation parameters in addition to the pressure information. It may be used with positive pressure devices which do not include pressure measurement capabilities, e.g. resuscitation bags, automatic resuscitators, and CPAP, or as an independent backup pressure monitor for devices with pressure measurement capability. The device is designed to be portable and can be used in stationary or portable situations in hospitals and sub-acute institutions. For professional use only.
| Type of Use (Select one or both , as applicable) | |
|---|---|
| ---------------------------------------------------------------- | -- |
X 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 Contact Title: Executive Vice President & COO Date Prepared: August 17, 2018
II. DEVICE
Name of Device: VORTRAN® APM-Plus Common or Usual Name: Airway Pressure Monitor Classification Name: Monitor, Airway Pressure (Includes Gauge And /or Alarm) Regulation Number: 21 CFR 868.2600 Regulatory Class: II Product Code: CAP Classification Advisory Committee: Anesthesiology
PREDICATE DEVICE III.
| K992101 | Criterion 40 Airway Pressure Monitor (Primary) |
|---|---|
| K103639 | VORTRAN® Airway Pressure Monitor (Reference) |
DEVICE DESCRIPTION/PRINCIPLE OF OPERATION IV.
The VORTRAN® APM-Plus is a battery (2 x AA) operated, microprocessor controlled, portable, self-contained device designed for monitoring a positive airway-pressure device such as a resuscitator or CPAP. The VORTRAN® APM-Plus is housed in a plastic enclosure. It connects to the positive-pressure device under monitor via pneumatic pressure tubing and receives the pressure signals using its solid-state pressure transducer. The pressure signals are used to calculate the related characteristics which are displayed on the LCD screen. The values are used to trigger alarms that alert the user of any abnormal pressure conditions. The software algorithm constantly monitors the data and if/when the pressure
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characteristics are outside of the user-set limits, an alarm will be activated. The alarms are both visual and audible. For ease of use, the VORTRAN® APM-Pus software provides two modes of operations: Resuscitator Mode and PAP Mode. When the device is turned on, the user can select one of the two modes. In each mode, the pressure data shown is suitable for the device under monitoring:
- . Monitoring/Alarms, Resuscitator Mode: The VORTRAN® APM-Plus will display PIP, PEEP, Respiratory Rate, Inspiratory and Expiratory Time, and I:E Ratio. When a connected pressure-cycled device stops cycling for a user-set time or the pressure falls under the user-set limit, the VORTRAN® APM-Plus will activate the NON-CYCLING ALARM or LOW PEEP ALARM, respectively. In addition, when respiratory rate or the pressure exceeds their user-set limits, the HIGH RATE or HIGH PIP alarm will activate, respectively.
- . Monitoring/Alarms, PAP Mode: The VORTRAN® APM-Plus will display real-time pressure. When a connected constant-pressure device falls outside of the user-set range, the HIGH PRESSURE or LOW PRESSURE ALARM will activate.
The VORTRAN® APM-Plus has a flashing red LED and an audible sound, while simultaneously displaying the alarm condition on the LCD.
The accessories were all cleared with the reference device's 510(k) submission K103639 (VORTRAN® Airway Pressure Monitor) and include:
- Pressure tubing for connecting the VORTRAN® APM-Plus to a breathing circuit .
- A hydrophobic filter for protecting the device from any condensate that may pass ● through the breathing circuit
- . A luer connector for connecting the pressure tubing to the hydrophobic filter
- . A tee adapter for connecting the pressure tubing in-line with a breathing circuit that does not have its own outlet
V. INTENDED USE
The VORTRAN® APM-Plus is used to measure airway pressure for patients utilizing positive pressure devices where monitoring is desired.
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VI. INDICATIONS FOR USE
The VORTRAN® APM-Plus is a multiple-patient-use device intended to monitor a positive-pressure device that connects to an adult or pediatric patient ≥ 10 kg. The device alarms when the conditions (pressure and/or rate, as applicable) are outside of the user selected high and low alarm limits. In PAP Mode, it displays only real-time breathing circuit pressure; in Resuscitator Mode, it displays ventilation parameters in addition to the pressure information. It may be used with positive pressure devices which do not include pressure measurement capabilities, e.g. resuscitation bags, automatic resuscitators, and CPAP, or as an independent backup pressure monitor for devices with pressure measurement capability. The device is designed to be portable and can be used in stationary or portable situations in hospitals and sub-acute institutions. For professional use only.
DIFFERENCES IN INDICATIONS FOR USE TO THE VII. PRIMARY PREDICATE DEVICE
The VORTRAN® APM-Plus and its primary predicate device have the following differences in their Indications for Use:
- . The Criterion 40 Airway Pressure Monitor displays real-time pressure as well as peak pressure. The VORTRAN® APM-Plus, when in PAP Mode, only displays the real-time pressure.
- In Resuscitator Mode, the VORTRAN® APM-Plus displays Peak Inspiratory Pressure (PIP), Positive End-Expiratory Pressure (PEEP), Breath Rate, Inspiratory Time (I-Time), Expiratory Time (E-Time), and the ratio of Inspiratory Time to Expiratory Time (I:E Ratio), while the Criterion 40 only displays real-time pressure and peak pressure. These technological differences do not raise different questions of safety and effectiveness, as evidence by the substantial equivalence comparison to the reference predicate device, the VORTRAN® Airway Pressure Monitor, which has all the aforementioned parameters.
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VIII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The following tables provide a comparison between device characteristics:
| General Characteristics: | |||
|---|---|---|---|
| NEW DEVICE | PRIMARY | REFERENCE | |
| Device Name | VORTRAN® APM-Plus | Criterion 40 AirwayPressure Monitor | VORTRAN® AirwayPressure Monitor |
| Patient Population | Adult or pediatric patients (10 kg and above) utilizing positive pressure devices | Any patient utilizing positive pressure devicesand the clinician desires to have pressure monitoring. | Adults 40 kg and above(Model 3900) andPediatrics 10 kg and above(Model 3800) |
| PatientInterface/Method ofDeployment | Connected via pneumatic tubing (of the connection kit) to a tee fitting or Luer outlet within the breathing circuit of a resuscitator, CPAP, or other positive pressure device. | Airway adapter placed in the circuit or connection to a face mask | Connects to any breathing circuit that is connected to a patient. |
| Environment of Care | Hospitals and sub-acute institutions;designed to be used in stationary or portable situations | Hospitals, sub-acute institutions, home care settings; stationary and intra-institution transport only. | To be used by properly trained personnel in an environment in which the clinician desires to have pressure monitoring. |
| Sterility | Non-sterile (device and accessories) | Non-sterile | Non-sterile |
| Type of Use | Prescription Use (21CFR801 Subpart D) | Not specified | Prescription Use(21CFR801 Subpart D) |
General Characteristics:
Physical Characteristics:
| Physical Characteristics. | |||
|---|---|---|---|
| NEW DEVICE | PRIMARY | REFERENCE | |
| Device Name | VORTRAN® APM-Plus | Criterion 40 Airway Pressure Monitor | VORTRAN® Airway PressureMonitor |
| Size | 110 mm x 64 mm 33 mm (4.3 inx 2.5 in x 1.3 in) | 198 mm x 94 mm x 188 mm (7.9 in x3.7 in x 7.4 in) | 81 mm x 56 mm x 48 mm (3.2 in x2.2 in x 1.9 in) |
| Weight | 150 g (with 2 AA batteries) | 680 g | 125 g (with 9V battery) |
| EnclosureConstruction | ABS Plastic | Unspecified Plastic | ABS Plastic |
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Technological/Principles of Operation Characteristics:
| NEW DEVICE | PRIMARY | REFERENCE | |
|---|---|---|---|
| Device Name | VORTRAN® APM-Plus | Criterion 40 AirwayPressure Monitor | VORTRAN® AirwayPressure Monitor |
| Method ofConnection | Female Luer connection | Female Luerconnection | Female Luerconnection |
| Alarms | YES | YES | YES |
| MeasurementDevice | Solid state pressure sensor | Solid state pressuresensor | Solid state pressuresensor |
| Output | Digital readout of pressures | Digital readout ofpressures | Digital readout ofpressures |
| Control Method | Internal microprocessor | Internalmicroprocessor | Internalmicroprocessor |
| Power Type | DC input (2 x AA alkaline batteries) | AC Mains input (andDC input backupbattery) | DC input (1 x 9Valkaline battery) |
Performance Specifications:
| NEW DEVICE | PRIMARY | REFERENCE | |
|---|---|---|---|
| Device Name | VORTRAN® APM-Plus | Criterion 40 AirwayPressure Monitor | VORTRAN® AirwayPressure Monitor |
| Connected Devices | Positive pressure devices (includingpressure-cycled devices) | Positive pressuredevices (e.g. bubbleCPAP, resuscitators) | Pressure-cycled devices(e.g. resuscitators) |
| DisplayedMeasurements | Resuscitator Mode: PIP, PEEP,Respiratory Rate, Inspiratory Time,Expiratory Time, Inspiratory: ExpiratoryRatioPAP Mode: Real-time Pressure | Real-time Pressure,Peak Pressure | PIP, PEEP, RespiratoryRate, Inspiratory Time,Expiratory Time,Inspiratory: ExpiratoryRatio |
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| Performance Specifications, continued: | |||
|---|---|---|---|
| NEW DEVICE | PRIMARY | REFERENCE | |
| Device Name | VORTRAN® APM-Plus | Criterion 40 AirwayPressure Monitor | VORTRAN® Airway PressureMonitor |
| Pressure DisplayRange | 0 to 55 cm-H2O | 0 to 99.5 cm-H2O | 0 to 50 cm-H2O |
| Pressure DisplayAccuracy | ± 1 cm-H2O | ± (1 cm-H2O + 3% ofreading) rounded up tonearest 0.5 cm-H2O | ± 10% of reading |
| Pressure DisplayResolution | Resuscitator Mode: 1 cm-H2OPAP Mode: 0.1 cm-H2O | 0.5 cm-H2O | 1 cm-H2O |
| Respiratory RateDisplay Range | 0 to 99 BPM | N/A | 0 to 55 BPM |
| Respiratory DisplayRate Accuracy | ± 10% | N/A | ± 10% |
| Respiratory RateDisplay Resolution | 1 Breath per Minute | N/A | 1 Breath per Minute |
| I-Time & E-TimeDisplay Range | 0 to 9.9 seconds | N/A | 0 to 9.9 seconds |
| I-Time & E-TimeDisplay Accuracy | ± 10% | N/A | ± 10% |
| I-Time & E-TimeDisplay Resolution | 0.1 second | N/A | 0.1 second |
| I:E Ratio DisplayRange | 1:0.0 to 1:9.9 | N/A | 1:0.0 to 1:9.9 |
| I:E Ratio DisplayAccuracy | ± 10% | N/A | ± 10% |
Performance Specifications, continued:
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| NEW DEVICE | PRIMARY | REFERENCE | |
|---|---|---|---|
| Device Name | VORTRAN® APM-Plus | Criterion 40 AirwayPressure Monitor | VORTRAN® Airway PressureMonitor |
| I:E Ratio DisplayResolution | 0.1 | N/A | 0.1 |
| Alarm Delay | Yes, Non-Cycling AlarmOnly: 1-20 s | Yes: 1-20 s | Yes, Non-Cycling Alarm Only- 15 s for Adult Model 3900, 8s for Pediatric Model 3800 |
| High PressureAlarm Range andResolution | 1 to 50 cm-H2O,Resolution of 1 cm-H2O | 5 to 99 cm-H2O,Resolution of 1 cm-H2O | Fixed at 50 cm-H2O for AdultModel 3900,Fixed at 35 cm-H2O forPediatric Model 3800 |
| Low PressureAlarm Range andResolution | 1 to 15 cm-H2O,Resolution of 1 cm-H2O | 1 to 20 cm-H2O,Resolution of 1 cm-H2O | N/A |
| High Rate AlarmRange andResolution | 12 to 99 BPM, Resolutionof 1 BPM | N/A | Fixed at 50 BPM for AdultModel 3900,Fixed at 55 BPM for PediatricModel |
| Non-Cycling AlarmRange andResolution | 1 to 20 seconds,Resolution of 1 second | N/A | Fixed at 15 seconds for AdultModel 3900,Fixed at 8 seconds for PediatricModel 3800 |
| Low Battery Alarm | YES | YES (when using internalbackup battery) | YES |
| Battery Life | 164 Hours (Worst-Case) | Unknown | 27 Hours (Worst-Case) |
| Calibration | None | Unknown | None |
Performance Specifications, continued:
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IX. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination:
Biocompatibility Testing .
The patient contacting materials, considered to be in the patient's gas flow pathway, include the accessory kit (pressure tubing, hydrophobic filter, luer connector, and tee adapter) and solid-state pressure transducer. The materials in said components of the VORTRAN® APM-Plus, in their final finished form are identical to the accessory kit and solid-state pressure transducer of the cleared reference device in K103639, the VORTRAN® Airway Pressure Monitor, in formulation, processing, and sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).
. Electrical Safety and Electromagnetic Compatibility (EMC)
The VORTRAN® APM-Plus was evaluated as medical electrical equipment, under the classification of "Internally Powered Device" and was found to be compliant with the following IEC standards (and applicable IEC collateral standards, as required by ISO 80601-2-55):
- Electrical safety testing per IEC 60601-1 o
- Electromagnetic compatibility testing per IEC 60601-1-2 O
- Usability Study as per IEC 60601-1-6 O
- O Alarms designed as per IEC 60601-1-8
- Software Development Process as per IEC 62304 о
Software Verification and Validation Testing ●
The embedded software was developed in accordance with FDA guidelines for a MODERATE Level of Concern. Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software lifecycle process was assessed to be in accordance with IEC 62304.
. Risk Management
Risk Management and FMEA was assessed to (and found to be in compliance with) ISO 14971.
- . Shelf Life
An accelerated shelf life test was performed and met the acceptance criteria for a simulated age of 1 year.
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- . Clinical Studies None
X. CONCLUSION
The VORTRAN® APM-Plus's capabilities have been tested and compared to the predicate devices and the results support the substantial equivalence of the VORTRAN® APM-Plus.
§ 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).