(391 days)
No
The description mentions a "microprocessor controlled" device with a "software algorithm" that monitors data and triggers alarms based on user-set limits. This describes standard digital signal processing and control logic, not AI or ML. There is no mention of learning, adaptation, or complex pattern recognition beyond simple threshold comparisons.
No
The device is a monitor used to measure airway pressure and trigger alarms; it does not directly treat a medical condition.
No
The device is described as monitoring airway pressure and triggering alarms for abnormal conditions, but it does not diagnose patient conditions or diseases. It monitors the performance of other medical devices.
No
The device description explicitly states it is a "battery (2 x AA) operated, microprocessor controlled, portable, self-contained device" housed in a plastic enclosure with a pressure transducer and LCD screen, indicating it is a hardware device with embedded software.
Based on the provided information, the VORTRAN® APM-Plus is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The VORTRAN® APM-Plus measures airway pressure directly from a patient using pneumatic pressure tubing. It does not analyze biological samples like blood, urine, or tissue.
- The intended use is to monitor airway pressure during positive pressure therapy. This is a physiological measurement taken directly from the patient's respiratory system, not an analysis of a biological specimen.
- The device description focuses on pressure measurement and alarm functions. This aligns with a physiological monitoring device, not an IVD.
Therefore, the VORTRAN® APM-Plus is a physiological monitoring device, specifically an airway pressure monitor, and not an IVD.
N/A
Intended Use / 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.
Product codes
CAP
Device Description
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:
- .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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
adult or pediatric patient ≥ 10 kg
Intended User / Care Setting
For professional use only.
Hospitals and sub-acute institutions; designed to be used in stationary or portable situations
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 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.
Clinical Studies: None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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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3
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
4
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.
5
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.
6
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 Airway | |
| Pressure Monitor | VORTRAN® Airway | ||
| Pressure Monitor | |||
| Patient Population | Adult or pediatric patients (10 kg and above) utilizing positive pressure devices | Any patient utilizing positive pressure devices | |
| and the clinician desires to have pressure monitoring. | Adults 40 kg and above | ||
| (Model 3900) and | |||
| Pediatrics 10 kg and above | |||
| (Model 3800) | |||
| Patient | |||
| Interface/Method of | |||
| Deployment | 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 Pressure |
| Monitor | |||
| Size | 110 mm x 64 mm 33 mm (4.3 in | ||
| x 2.5 in x 1.3 in) | 198 mm x 94 mm x 188 mm (7.9 in x | ||
| 3.7 in x 7.4 in) | 81 mm x 56 mm x 48 mm (3.2 in x | ||
| 2.2 in x 1.9 in) | |||
| Weight | 150 g (with 2 AA batteries) | 680 g | 125 g (with 9V battery) |
| Enclosure | |||
| Construction | ABS Plastic | Unspecified Plastic | ABS Plastic |
7
Technological/Principles of Operation Characteristics:
| NEW DEVICE | PRIMARY | REFERENCE | |
|---|---|---|---|
| Device Name | VORTRAN® APM-Plus | Criterion 40 Airway | |
| Pressure Monitor | VORTRAN® Airway | ||
| Pressure Monitor | |||
| Method of | |||
| Connection | Female Luer connection | Female Luer | |
| connection | Female Luer | ||
| connection | |||
| Alarms | YES | YES | YES |
| Measurement | |||
| Device | Solid state pressure sensor | Solid state pressure | |
| sensor | Solid state pressure | ||
| sensor | |||
| Output | Digital readout of pressures | Digital readout of | |
| pressures | Digital readout of | ||
| pressures | |||
| Control Method | Internal microprocessor | Internal | |
| microprocessor | Internal | ||
| microprocessor | |||
| Power Type | DC input (2 x AA alkaline batteries) | AC Mains input (and | |
| DC input backup | |||
| battery) | DC input (1 x 9V | ||
| alkaline battery) |
Performance Specifications:
| NEW DEVICE | PRIMARY | REFERENCE | |
|---|---|---|---|
| Device Name | VORTRAN® APM-Plus | Criterion 40 Airway | |
| Pressure Monitor | VORTRAN® Airway | ||
| Pressure Monitor | |||
| Connected Devices | Positive pressure devices (including | ||
| pressure-cycled devices) | Positive pressure | ||
| devices (e.g. bubble | |||
| CPAP, resuscitators) | Pressure-cycled devices | ||
| (e.g. resuscitators) | |||
| Displayed | |||
| Measurements | Resuscitator Mode: PIP, PEEP, | ||
| Respiratory Rate, Inspiratory Time, | |||
| Expiratory Time, Inspiratory: Expiratory | |||
| Ratio | |||
| PAP Mode: Real-time Pressure | Real-time Pressure, | ||
| Peak Pressure | PIP, PEEP, Respiratory | ||
| Rate, Inspiratory Time, | |||
| Expiratory Time, | |||
| Inspiratory: Expiratory | |||
| Ratio |
8
| Performance Specifications, continued: | |||
|---|---|---|---|
| NEW DEVICE | PRIMARY | REFERENCE | |
| Device Name | VORTRAN® APM-Plus | Criterion 40 Airway | |
| Pressure Monitor | VORTRAN® Airway Pressure | ||
| Monitor | |||
| Pressure Display | |||
| Range | 0 to 55 cm-H2O | 0 to 99.5 cm-H2O | 0 to 50 cm-H2O |
| Pressure Display | |||
| Accuracy | ± 1 cm-H2O | ± (1 cm-H2O + 3% of | |
| reading) rounded up to | |||
| nearest 0.5 cm-H2O | ± 10% of reading | ||
| Pressure Display | |||
| Resolution | Resuscitator Mode: 1 cm- | ||
| H2O | |||
| PAP Mode: 0.1 cm-H2O | 0.5 cm-H2O | 1 cm-H2O | |
| Respiratory Rate | |||
| Display Range | 0 to 99 BPM | N/A | 0 to 55 BPM |
| Respiratory Display | |||
| Rate Accuracy | ± 10% | N/A | ± 10% |
| Respiratory Rate | |||
| Display Resolution | 1 Breath per Minute | N/A | 1 Breath per Minute |
| I-Time & E-Time | |||
| Display Range | 0 to 9.9 seconds | N/A | 0 to 9.9 seconds |
| I-Time & E-Time | |||
| Display Accuracy | ± 10% | N/A | ± 10% |
| I-Time & E-Time | |||
| Display Resolution | 0.1 second | N/A | 0.1 second |
| I:E Ratio Display | |||
| Range | 1:0.0 to 1:9.9 | N/A | 1:0.0 to 1:9.9 |
| I:E Ratio Display | |||
| Accuracy | ± 10% | N/A | ± 10% |
Performance Specifications, continued:
9
| NEW DEVICE | PRIMARY | REFERENCE | |
|---|---|---|---|
| Device Name | VORTRAN® APM-Plus | Criterion 40 Airway | |
| Pressure Monitor | VORTRAN® Airway Pressure | ||
| Monitor | |||
| I:E Ratio Display | |||
| Resolution | 0.1 | N/A | 0.1 |
| Alarm Delay | Yes, Non-Cycling Alarm | ||
| Only: 1-20 s | Yes: 1-20 s | Yes, Non-Cycling Alarm Only |
- 15 s for Adult Model 3900, 8
s for Pediatric Model 3800 |
| High Pressure
Alarm Range and
Resolution | 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 Adult
Model 3900,
Fixed at 35 cm-H2O for
Pediatric Model 3800 |
| Low Pressure
Alarm Range and
Resolution | 1 to 15 cm-H2O,
Resolution of 1 cm-H2O | 1 to 20 cm-H2O,
Resolution of 1 cm-H2O | N/A |
| High Rate Alarm
Range and
Resolution | 12 to 99 BPM, Resolution
of 1 BPM | N/A | Fixed at 50 BPM for Adult
Model 3900,
Fixed at 55 BPM for Pediatric
Model |
| Non-Cycling Alarm
Range and
Resolution | 1 to 20 seconds,
Resolution of 1 second | N/A | Fixed at 15 seconds for Adult
Model 3900,
Fixed at 8 seconds for Pediatric
Model 3800 |
| Low Battery Alarm | YES | YES (when using internal
backup battery) | YES |
| Battery Life | 164 Hours (Worst-Case) | Unknown | 27 Hours (Worst-Case) |
| Calibration | None | Unknown | None |
Performance Specifications, continued:
10
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.
11
- . 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.