(136 days)
The VPOD™ Intrathoracic Pressure Regulator is indicated for the temporary decrease in intrathoracic pressure to increase blood circulation, as prescribed by a physician, licensed practitioner, or qualified technician. Recommended duration of use is up to four hours.
The proposed VPOD Intrathoracic Pressure Regulator (ITPR) is also intended to be used with patients who would benefit from increased venous return back to the heart for treatment of a number of different clinical conditions associated with severe hypotension but generates its own vacuum via the VPOD Motor and connects with a positive pressure source such as a separate ventilator or manual resuscitator bag.
The provided text is a 510(k) summary for the VPOD™ Intrathoracic Pressure Regulator. It describes the device, its indications for use, and its comparison to a predicate device (CirQlator™). The document outlines various tests conducted to demonstrate substantial equivalence but does not explicitly provide a table of acceptance criteria with reported device performance in the format requested.
However, based on the non-clinical testing and comparative performance sections, we can infer some of the performance aspects and the studies that support them.
Here's an attempt to structure the information as requested, though some details like specific numerical acceptance criteria are not explicitly stated in the document.
Acceptance Criteria and Study Details for VPOD™ Intrathoracic Pressure Regulator
The provided document, a 510(k) summary for the VPOD™ Intrathoracic Pressure Regulator (K172388), describes various tests and comparisons to establish substantial equivalence with its predicate device, the CirQlator™ (K070490). While explicit numerical acceptance criteria are not tabulated, the document details performance characteristics that were compared and found to be equivalent or superior.
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Metric | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (VPOD™ ITPR) |
|---|---|---|
| Biocompatibility | Non-cytotoxic, non-irritating, non-mutagenic, margin of safety > 1 per ISO 10993. | PASS: Materials were found to be non-cytotoxic, non-irritating, non-mutagenic, and with a margin of safety > 1 for Externally Communicating, Tissue, Limited durations (<24 hours) per ISO 10993-1. Specific tests included: Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Gas emission VOC with risk based assessment, Particulate Matter (PM2.5). |
| Electrical Safety, EMC | Compliance with AAMI ANSI ES 60601-1, IEC 60601-1-2. | PASS: Device tested for compliance. |
| Alarms | Compliance with IEC 60601-1-8. | PASS: Device tested for compliance. |
| Ventilator Compatibility | Compliance with applicable requirements of ISO 80601-2-12. | PASS: Device tested for compliance. |
| Vacuum Accuracy | Capable of achieving negative intrathoracic pressure up to -9 mmHg (-12 cmH2O). | PASS: Achieved negative expiratory airway pressure of approximately -9 mmHg (-12 cmH2O). Continuously variable from -2 to -12 cmH2O. Monitored by microprocessor and pressure sensors. Any out of range performance (greater than -9 mmHg) causes Motor to shut down. |
| Mean Arterial Pressure (MAP) Improvement | Comparable improvement to predicate CirQlator in compromised circulation model. | PASS: Both VPOD and CirQlator improved mean arterial pressure by 17 mmHg (after bleed and recovery) at minute 30 of device use in an animal study. |
| Maximum Airway Pressure | No significant difference compared to predicate during device use. | PASS: No significant difference between the positive airway pressures of the CirQlator and the VPOD during device use. |
| Maximum Negative Airway Pressure (Expiratory) | No significant difference compared to predicate. Capable of -9 mmHg (-12 cmH2O). | PASS: No significant differences between the negative airway pressures achieved with either device, demonstrating substantial equivalence. Both devices achieved a negative expiratory airway pressure of approximately -9 mmHg (-12 cmH2O). |
| Perturbation of Ventilator Monitors (Exhaled Volume) | No perturbation of exhaled volume or other ventilator monitors. | PASS: VPOD does not perturb exhaled volume or other ventilator monitors. (In contrast, the predicate CirQlator directs exhaled gas to wall suction, activating ventilator alarms requiring silencing/disabling). |
| Adjustable Vacuum Level | (Predicate fixed at -12 cmH2O) | PASS: VPOD allows user to adjust expiratory airway pressure in increments of -1 cmH2O from -2 to -12 cmH2O, offering more clinical latitude. |
| Cleaning, Shelf-life, Aging Effects | Ensured validation and verification of VPOD Motor and effects of aging. | PASS: Validation and verification of VPOD Motor effects of aging were performed. |
| Other Bench Tests | Accuracy of airway pressure measurement, flow rates, simulated altitude, resistance to flow, compatibility with ventilator (pressure/flow), mechanical drop, dead space, blower leakage, induced temperature rise/change. | PASS: These bench performance tests were conducted. (Specific results not detailed beyond "Device performance testing included"). |
| Battery Safety | Compliance with UL 2054. | PASS: Device tested for compliance. |
| Usability | Demonstrated usability. | PASS: Usability testing was conducted. (Specific results not detailed). |
2. Sample Size Used for the Test Set and Data Provenance:
-
Animal Study: The document explicitly mentions an "Animal Study" was conducted comparing the subject device to the predicate.
- Sample Size: Not explicitly stated.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It is a "comparative performance" study.
-
Bench Performance: No explicit sample sizes are provided for the various bench tests listed (e.g., Accuracy – airway pressure, flow rates, vacuum accuracy, etc.). These tests are presumed to be conducted in a laboratory setting.
- Sample Size: Not explicitly stated.
- Data Provenance: Laboratory testing.
-
Biocompatibility: Tests were performed on materials.
- Sample Size: Not explicitly stated for each specific test, but representative material samples would have been used.
- Data Provenance: Laboratory testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
This information is not provided in the document. The studies described are primarily technical performance tests (bench and animal), not clinical studies requiring expert ground truth for interpretation of outcomes from patient-derived data (e.g., image interpretation).
4. Adjudication Method for the Test Set:
This information is not applicable as the described tests are technical performance evaluations (bench and animal studies), not studies involving human interpretation or adjudication of diagnostic findings.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not conducted. The studies described are an animal study comparing device performance and various bench tests.
- Effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is neither an AI device nor a human reader study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done:
This question is not directly applicable as the VPOD™ Intrathoracic Pressure Regulator is a medical device, not an AI algorithm. Its standalone performance was evaluated through bench testing and, presumably, the animal study where its intrinsic function was assessed without human intervention in the mechanism of action. The device itself is designed to be "standalone" in its vacuum generation, while still being used with assisted ventilation by a clinician.
7. The Type of Ground Truth Used:
- Biocompatibility: Laboratory standard tests for cytotoxicity, irritation, sensitization, etc., against established ISO standards.
- Bench Performance: Engineering specifications, physical measurements, and compliance with relevant IEC/AAMI standards.
- Animal Study: Physiological parameters (e.g., mean arterial pressure, airway pressure measurements) directly measured in an animal model of compromised circulation, compared against predicate device performance.
8. The Sample Size for the Training Set:
This information is not applicable. The VPOD™ is a hardware medical device with integrated microprocessor control, not a machine learning model that requires a "training set" of data in the typical sense.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as #8. The device's control system and operational parameters would be based on engineering design, physiological principles, and iterative testing rather than a data training set.
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December 22, 2017
Advanced Circulatory System, a wholly owned subsidiary of ZOLL Paul Dryden Manager, Regulatory consultant for Advanced Circulatory System, a wholly owned subsidiary of ZOLL c/o ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704
Re: K172388
Trade/Device Name: VPOD™ Intrathoracic Pressure Regulator Regulation Number: 21 CFR 868.5690 Regulation Name: Incentive Spirometer Regulatory Class: Class II Product Code: BWF Dated: August 6. 2017 Received: August 8, 2017
Dear Paul Dryden:
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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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 of medical device-related 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tina Kiang -
s
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K172388
Device Name
VPOD™ Intrathoracic Pressure Regulator
Indications for Use (Describe)
The VPOD™ Intrathoracic Pressure Regulator is indicated for the temporary decrease in intrathoracic pressure to increase blood circulation, as prescribed by a physician, licensed practitioner, or qualified technician.
Recommended duration of use is up to four hours.
Type of Use (Select one or both, as applicable)
XX Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary Page 1 of 7 22-Dec-17
| Company: | Advanced Circulatory Systema wholly owned subsidiary of ZOLL1905 County Rd C WestRoseville, MN 55113 |
|---|---|
| Official Contact: | Anja Metzger, PhDVP, Research and Development and Grant AffairsTel - 651.226.1626 |
| Proprietary or Trade Name: | VPOD™ Intrathoracic Pressure Regulator |
| Common/Usual Name: | Intrathoracic Pressure Regulator |
| Classification Name: | 21 CFR 868.5690Procode – BWFIncentive spirometerClass II |
| Predicate Device: | K070490 – ACS CirQlator™ |
Device Description:
Advanced Circulatory Systems ("ACS") which is now part of Zoll, received clearance for the CirQlator™ Intrathoracic Pressure Regulator in 2007 under K070490. This device was developed to increase the return of venous blood back to the heart for treatment of a number of different clinical conditions associated with severe hypotension.
The predicate CirQlator Intrathoracic Pressure Regulator (ITPR) is used in combination with a positive pressure source such as a separate ventilator or manual resuscitation bag and an external vacuum source.
The proposed VPOD Intrathoracic Pressure Regulator (ITPR) is also intended to be used with patients who would benefit from increased venous return back to the heart for treatment of a number of different clinical conditions associated with severe hypotension but generates its own vacuum via the VPOD Motor and connects with a positive pressure source such as a separate ventilator or manual resuscitator bag.
Indications for Use:
The VPOD™ Intrathoracic Pressure Regulator is indicated for the temporary decrease in intrathoracic pressure to increase blood circulation, as prescribed by a physician, licensed practitioner, or qualified technician. Recommended duration of use is up to four hours.
Contraindications:
- persons with pneumothorax
- · persons with hemothorax
- · persons with hypertension
- · persons with uncontrolled hemorrhage
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510(k) Summary Page 2 of 7
22-Dec-17
Predicate Device Comparison
| Table 1 – High Level Features and DifferencesC | ||
|---|---|---|
| ---------------------------------------------------- | -- | -- |
| PredicateCirQlator | ProposedVPOD ITPR | |
|---|---|---|
| Vacuum source | External | Integrated - generated by VPODMotor |
| Connects to separatepositive pressure source | Yes | Yes |
| Fixed negative pressure | Yes-12 cmH2O | Adjustable-2 to -12 cmH2O |
| Table 2 - Comparison of Similarities | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | -------------------------------------- |
| Features | PredicateK070490 - CirQlator ™ | ProposedVPOD™ ITPR |
|---|---|---|
| Indications for use | The CirQlator™ Intrathoracic Pressure Regulatoris indicated for the temporary decrease inintrathoracic pressure to increase bloodcirculation and blood pressure, as prescribed by aphysician, licensed practitioner, or qualifiedtechnician. Recommended duration of use is up tofour hours. | The VPOD™ Intrathoracic Pressure Regulator isindicated for the temporary decrease inintrathoracic pressure to increase bloodcirculation, as prescribed by a physician, licensedpractitioner, or qualified technician.Recommended duration of use is up to fourhours. |
| Environment of Use | Hospital, Pre-Hospital (EMS) | Same |
| Patient Population | Patients needing assisted ventilation that sufferfrom states of poor circulation, low bloodpressure, or insufficient cardiac preload that maybe reflected by low blood pressure. | Same |
| Contraindications | persons with pneumothoraxpersons with hemothoraxpersons with hypertensionpersons with uncontrolled hemorrhage | Same |
| Interfaces | Airway (Endotracheal tube, Combitube,facemask, laryngeal mask airway) | Same |
| Positive Pressure source (Manual resuscitator,anesthesia machine, ventilator) | Same | |
| Vacuum source - external | No external vacuum source required; vacuumcreated by spinning impeller inside VPODBlower. | |
| Design | When connected to a vacuum source, this positivepressure breath results in mechanical movementof piston to allow patient to be ventilated,shutting off flow of vacuum. In between positivepressure breaths, vacuum path open which createsthe negative intrathoracic pressure during theexpiratory phase of ventilation | VPOD Motor and Blower generate a vacuum.The Motor is magnetically coupled to the Blower.The Blower contains an impeller that when spun,creates a vacuum. In between the positivepressure breaths, the vacuum creates the negativeintrathoracic pressure during the expiratory phaseof ventilation |
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| 510(k) SummaryPage 3 of 722-Dec-17 | ||
|---|---|---|
| Safety Valve | Silicone valve acts as a safety valve to ensurenegative pressure does not exceed -9 mmHg | No external valving mechanism required.Microprocessor controlled blower continuouslyvaries the negative intrathoracic pressure from -0.5 to -9 mmHg (-2 to -12 cmH2O). This pressureis continuously monitored by microprocessor andthe pressure sensors in the Motor. Any out ofrange performance (greater than -9 mmHg) willcause the Motor to shut down resulting in thediscontinuation of the negative pressure. Whenblower is not spinning (In Standby Mode), thereis no effect on airway pressure. |
| Safety Feature | Patient can breathe through device while deviceis attached to mask or endotracheal tube | Same |
| Vacuum level | Same for safety valve on device. Vacuum isprimarily regulated by commercially availableregulator placed at vacuum source | VPOD employs a miniature microprocessorcontrolled and monitored blower. Within theVPOD blower, three high-stability airwaypressure sensors monitor ventilator and patientpressures, and each other, to ensure that the speedof the blower and the resultant pressure are withinsafety limits and that the single patient use blowerand the motor are within safe temperature limits.Multiple alarm conditions (see hazards analysistable) will cause the blower to stop spinning andallowing breathing gasses to pass freely. |
| Patient status | Requires assisted ventilation | Requires assisted ventilation |
| Features | PredicateK070490 - CirQlatorTM | ProposedVPODTM ITPR |
|---|---|---|
| Biocompatibility | Externally communicatingTissueProlonged duration of use (>24 hours, <30 days) | Externally communicatingTissueProlonged duration of use (>24 hours, <30 days) |
Table 3 – Description of the Differences
| Features | PredicateK070490 - CirQlator™ | ProposedVPOD™ ITPR |
|---|---|---|
| Vacuum source tocreate negativeintrathoracicpressure | External vacuum source | Microprocessor controlled and monitoredminiature blower |
| Design | Vacuum port for external vacuum | Does not require external vacuum source.Vacuum controlled by software from GraphicUser Interface (GUI) with alarms and batterybacked power supply. |
| Maximum level ofnegative pressureapplied to airway | -9 mmHg (-12 cmH2O) Fixed | -9 mmHg (-12 cmH2O) Maximum andcontinuously variable as set by user from -2 to -12 cmH2O. |
| Software driven | No | Yes |
| Operating conditions | 0°C to 40°C 30% to 85% RH | 10°C to 35°C 30% to 95% RH |
| Storage conditions | -20°C to 60°C 10% to 90% RH | -20°C to 50°C 10% to 90% RH |
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510(k) Summary Page 4 of 7 22-Dec-17
Substantial Equivalence Discussion
The VPOD ITPR is viewed as substantially equivalent to the predicate device because:
Indications –
- . The VPOD ITPR is indicated for the temporary decrease in intrathoracic pressure to increase blood circulation and blood pressure, as prescribed by a physician, licensed practitioner, or qualified technician. Recommended duration of use is up to four hours.
- This is similar to the predicate - ACSI CirQlator™ - K070490.
Discussion -
There are no differences between the indications for use for the subject device and the predicate (K070490).
General Notes -
The VPOD™ Intrathoracic Pressure Regulator may benefit people needing assisted ventilation that suffer from states of poor circulation, low blood pressure, or insufficient cardiac preload that may be reflected by low blood pressure. The device is not intended for those patients who would not benefit from an increase in cardiac preload.
Routine monitoring (e.g., heart rate, blood pressure, oxygen saturation), and appropriate sedation that may include neuromuscular blockade, is required for use.
Patient Population -
- . The patient population is those patient needing assisted ventilation that suffer from states of poor circulation, low blood pressure, or insufficient cardiac preload that may be reflected by low blood pressure.
- This is similar to the predicate ACSI CirOlator™ K070490. .
Discussion -
There are no differences in the patient population for the subject device and the predicate (K070490).
Environment of Use -
● It is intended for pre-hospital (including EMS) and hospital use.
Discussion -
There are no differences in environment of use.
Technology -
- The principle of operation, namely applying a negative pressure to increase intrathoracic ● pressure is the same as the predicate.
- . The subject device has its own means of generating a vacuum, the motor and blower, whereas the predicate must be connected to an external vacuum source.
- o As discussed above the difference of how vacuum is provided based upon our risk assessment and testing does not raise new concerns of safety or effectiveness.
- . The ability to adjust the amount of negative pressure in the subject device vs. a fixed vacuum negative of the predicate allows the clinician more latitude in using the subject device on patients. Some patients may not tolerate the higher negative pressure initially and require a gradual increase to the maximum of -12 cmH2O.
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510(k) Summary Page 5 of 7 22-Dec-17
Discussion -
The differences as discuss below do not raise new concerns of safety and performance when compared to the predicate and tested.
Non-clinical Testing
Biocompatibility of Materials -
- The materials are considered Externally Communicating, Tissue, Limited durations (<24 ● hours) per ISO 10993-1
- Testing included .
- o Cytotoxicity (ISO 10993-5)
- o Sensitization (ISO 10993-10)
- Irritation (ISO 10993-10) O
- Acute Systemic Toxicity (ISO 10993-11) o
- Gas emission VOC with risk based assessment o
- Particulate Matter (PM2.5) O
- Discussion -
The materials used in the subject device were tested and found to be non-cytotoxic, nonirritating, non-mutagenic, and with a margin of safety > 1.
Bench Performance
Device performance testing included:
| Cleaning, Shelf-life, Effectsof Aging | Validation and Verification ofVPOD MotorEffects of aging |
|---|---|
| Electrical Safety, EMC | AAMI ANSI ES 60601-1IEC 60601-1-2 |
| Alarms | IEC 60601-1-8 |
| Applicable requirements ofventilators | ISO 80601-2-12Applicable requirements |
| Bench | Accuracy – airway pressureFlow ratesVacuum accuracySimulated altitudeResistance to flowCompatibility with ventilatorPressure / flowMechanical dropDead spaceLeakage of blowerInduced temperature rise / change |
| Batteries | UL 2054 |
| Usability |
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510(k) Summary Page 6 of 7 22-Dec-17
Comparative Performance
We have performed comparative performance testing: see the specific sections for full details. These tested included:
Animal Study
We performed an animal study comparing the subject device to the predicate. The results showed:
Improved Mean Arterial Pressure
Both the VPOD and the CirQlator improved mean arterial pressure by 17 mmHg (after bleed and recovery) at minute 30 of device use.
Maximum airway pressure
VPOD and CirQlator are initiated (turned on) after the 0 minute data is collected during inspiration by the ventilator throughout the study. The results showed no significant difference between the positive airway pressures of the CirOlator and the VPOD during device use.
Maximum negative airway pressure
There are no significant differences between the negative airway pressures achieved with either device demonstrating their substantial equivalence. Both devices achieved a negative expiratory airway pressure of approximately -9 mmHg (-12 cmH2O).
Conclusion
Both devices are able to create equivalent negative airway pressures during the expiratory phase and improve circulation comparably when utilized in this model of compromised circulation.
These studies demonstrate the substantial equivalence of the VPOD to the CirQlator.
Discussion of Differences
The major differences between the proposed device and the predicate are:
The proposed device (VPOD) employs a miniature blower connected to the patient's airway (tracheal tube, etc.) and in series with the mechanical ventilator connection (WYE piece) which allows the patient to receive breaths through the blower. When the blower is not spinning and the VPOD is placed in the breathing circuit, it serves to freely pass breathing gas to-and-fro. When active, VPOD spins up to the user defined pressure setting and while still allowing the patient to receive breaths to-and-fro, it imparts a constant, regulated difference in pressure between the patient and the ventilator. The CirQlator is a mechanical device that relies upon regulated external vacuum (wall vacuum) in concert with a pressure driven valve to cycle between inspiration and exhalation. Inspiration cycling is driven by the positive pressure ventilation source. An integral regulator valve ensures that the maximum vacuum (-12 cmH2O) is not exceeded.
VPOD allows exhaled gas to return through the mechanical ventilator's exhalation system. Sophisticated mechanical ventilators monitor and alarm based on measured exhaled volume from the patient. The VPOD does not perturb exhaled volume, or other ventilator monitors. The predicate CirQlator directs exhaled gas from the patient to wall suction, thereby causing the
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mechanical ventilator low exhaled tidal and minute volume alarms to activate. Hence, the predicate requires that the mechanical ventilator's exhaled alarms be silenced or disabled during its use. Consequently, a clinician must constantly attend the patient during the use of the predicate to ensure that the patient is receiving adequate ventilation and that the breathing circuit connections are secure.
VPOD allows the user to adjust the vacuum level, whereas CirQlator was a fixed vacuum level of -12 cmH2O expiratory airway pressure. In VPOD, the user can adjust the expiratory airway pressure in increments of -1 cmH2O from -2 to -12 cmH2O.
It is our view that the only significant difference that affects the safety or effectiveness of the intended device as compared to the predicate device is the integration of its microprocessor controlled vacuum source, patient and device monitors and alarms. The effect on intrathoracic pressure regulation is the same as CirQlator, but the proposed device does not perturb the performance of sophisticated mechanical ventilators and provides self-checking and monitoring features by virtue of the microprocessor based control system and graphic user interface.
Substantial Equivalence Conclusion
Based upon the performance testing and comparison to the legally marketed predicate device for indications for use, technology, and performance we believe we have demonstrated that the VPOD ITPR is substantially equivalent to the predicate device.
§ 868.5690 Incentive spirometer.
(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).