(270 days)
The PowerCube+ Series is indicated for use in the measurement and data collection of lung function parameters. The system performs cooperation-dependent pulmonary function tests which include Spirometry/Flow-Volume measurement, Body Plethysmography measurement, Lung Diffusion measurement, Occlusive Resistance measurement and Respiratory Muscle Strength measurement. The device provides information that aids in a diagnosis by a clinician.
The PowerCube+ Series is indicated for use by a clinician in a professional healthcare setting on adult and pediatric patients who are 5 years and older that can cooperate in the testing.
The GANSHORN PowerCube+ Series is a device that performs cooperation-dependent pulmonary function tests, including Spirometry, Body Plethysmography, Lung Diffusion measurement, Occlusive Resistance measurement and Respiratory Muscle Strength measurement. The device provides information that aids in a diagnosis by a clinician.
Spirometry is a set of non-invasive pulmonary function tests where the flow of inhaled/exhaled air is measured to determine physiological parameters such as Peak Expiratory Flow and Forced Vital Capacity. The patient's breathing flow is measured with ultrasound technology inside a breathing insert. Two ultrasound transducers measure the difference in ultrasound wave transit time to calculate breathing flow direction, speed, and volume.
Body Plethysmography provides for the measurement of physiological parameters such as Functional Residual Capacity and Specific Airway Resistance. The patient is seated in an air-tight chamber which has a fixed shape and volume. Pressure sensors measure the chamber pressure and the pressure close to the mouth, which is used as a proxy for alveolar pressure when measured under a zero-flow condition. Boyle's Law is used to infer the volume in the lungs from changes in chamber pressure.
Lung Diffusion testing is a non-invasive process for measuring diffusion capacity and lung volume. The patient inhales a test gas with known concentrations of helium and carbon monoxide. The patient's breath is held for 10 seconds during which time the helium dilutes into the lungs and the carbon monoxide diffuses through the alveoli into the blood. After 10 seconds of breath-hold time, the patient exhales and the difference between inhaled and exhaled gas concentrations is measured with a gas analyzer. The differences in gas concentration are used to determine physiological parameters such as DLCO (diffusing capacity of the lungs for carbon monoxide) and Alveolar Volume.
Occlusive Resistance measurement is an established method for measuring airway resistance during tidal breathing, using a shutter and mouth pressure sensor.
Respiratory Muscle Strength measurement is an established method for measuring the maximal strength of respiratory muscles, using a shutter and mouth pressure sensor.
The PowerCube+ Series has the following product model configurations:
- . PowerCube Body+ includes Spirometry and Body Plethysmography measurement
- . PowerCube Diffusion+ includes Spirometry and Lung Diffusion measurement
- . PowerCube Body+ / Diffusion+ includes Spirometry, Body Plethysmography, and Lung Diffusion measurement
All product model configurations support Occlusive Resistance measurement and Respiratory Muscle Strength measurement.
The PowerCube+ Series is mains-powered and not intended for mobile/transportable use.
The provided text focuses on the substantial equivalence of the GANSHORN PowerCube+ Series to predicate devices for regulatory clearance. It does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria in the format requested (i.e., a clinical study with human readers and AI).
The document outlines a series of bench tests to demonstrate performance in various modalities, but these are not structured as clinical studies with acceptance criteria for device performance parameters related to a "ground truth" established by experts in a diagnostic context. Instead, the performance testing focuses on compliance with international standards (e.g., ISO 23747, ISO 26782, ATS/ERS guidelines) and comparison against a calibrated flow/volume simulator or an FDA-cleared device.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to clinical performance and AI integration, which are not detailed here.
However, I can provide what is available regarding performance testing and some related details:
1. A table of acceptance criteria and the reported device performance
The document mentions compliance with various standards and internal requirements, and comparative bench testing. Here's what can be extracted, focusing on quantitative performance where available:
| Acceptance Criterion (Standard/Requirement) | Reported Device Performance |
|---|---|
| Spirometry Flow Parameters: Range | ±18 l/s |
| Spirometry Flow Parameters: Accuracy | ±2% or 50 ml/s, whichever is greater |
| Spirometry Flow Parameters: Resolution | 10 ml/s |
| Spirometry Flow Parameters: Compliance | Conforms to ISO 23747:2015 |
| Spirometry Volume Parameters: Range | 0-20 liters |
| Spirometry Volume Parameters: Accuracy | ±2% or 50 ml, whichever is greater |
| Spirometry Volume Parameters: Resolution | 1 ml |
| Spirometry Volume Parameters: Compliance | Conforms to ISO 26782:2009 |
| Body Plethysmography (TGV, sRaw): Deviation threshold for comparative testing | ≤5% deviation from FDA-cleared MasterScreen Body device |
| Body Plethysmography (TGV, sRaw): Compliance | Consistent with ATS/ERS guidelines and regulatory standards. Accurate and reliable measurements. |
| Lung Diffusion (DLCO, VA): Compliance | Demonstrated compliance with ATS/ERS 2017 standards for single-breath carbon monoxide uptake. All measurements fall within acceptable tolerances. |
| Carbon monoxide gas analyzer: Range | 0-3000 ppm CO |
| Carbon monoxide gas analyzer: Accuracy | ±2.5% FSO |
| Helium gas analyzer: Range | 0-20 Vol% He |
| Helium gas analyzer: Accuracy | ±2.5% FSO |
| Occlusive Resistance Measurement (Rocc, Gocc): Deviation threshold for comparative testing | ≤2% deviation. Consistent and accurate with ATS/ERS standards compared to FDA-cleared MasterScreen Body device. |
| Respiratory Muscle Strength Measurement: Deviation threshold for comparative testing | ≤2% deviation. Accurate and reliable with ATS/ERS standards compared to FDA-cleared MasterScreen Body device. |
Regarding the study that proves the device meets acceptance criteria:
The study referenced is a series of bench tests and comparative bench testing against an FDA-cleared device.
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not explicitly stated in terms of number of patient cases. The "test set" for performance was described as using a "calibrated Hans-Rudolph flow/volume simulator at a range of physiological test points" and "simulated inhalation and exhalation with calibrated gas mixtures." For comparative testing with the predicate device, it mentions comparing measurements, but not a specific sample size of test points or patient data.
- Data provenance: Bench testing results and simulated data. No real-world patient data is mentioned for testing device performance against ground truth in a clinical context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for bench testing was established by calibrated instruments and simulators, not human experts.
4. Adjudication method for the test set
Not applicable, as ground truth was established by calibrated instruments, not human review requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document describes a medical device for measuring lung function parameters, not an AI-assisted diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a measurement system; its "performance" is its accuracy in providing these measurements. The document outlines standalone performance evaluations through bench testing to ensure the device accurately measures lung function parameters. There is no mention of a separate "algorithm only" performance study in the context of an AI-based diagnostic algorithm.
7. The type of ground truth used
For the performance testing, the ground truth was established by:
- Calibrated instruments and simulators (e.g., Hans-Rudolph flow/volume simulator, calibrated gas mixtures).
- Compliance with recognized international standards (e.g., ISO 23747, ISO 26782, ATS/ERS guidelines).
- Measurements from an FDA-cleared predicate device for comparative analysis.
8. The sample size for the training set
Not applicable. This is a medical measurement device, not an AI/machine learning model that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/machine learning model mentioned.
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December 9, 2024
GANSHORN Medizin Electronic GmbH % Jim Chickering Regulatory Consultant 15 Belleau Woods Georgetown, New Hampshire 01833
Re: K240706
Trade/Device Name: PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) Regulation Number: 21 CFR 868.1760 Regulation Name: Volume Plethysmograph Regulatory Class: Class II Product Code: JEH, BZG Dated: November 4, 2024 Received: November 4, 2024
Dear Jim Chickering:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory
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assistance/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,
Rachana Visaria -S
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep 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) K240706
Device Name
PowerCube+ Series (PowerCube Body+) PowerCube+ Series (PowerCube Diffusion+) PowerCube+ Series (PowerCube Body+ / Diffusion+)
Indications for Use (Describe)
The PowerCube+ Series is indicated for use in the measurement and data collection of lung function parameters. The system performs cooperation-dependent pulmonary function tests which include Spirometry/Flow-Volume measurement, Body Plethysmography measurement, Lung Diffusion measurement, Occlusive Resistance measurement and Respiratory Muscle Strength measurement. The device provides information that aids in a diaician.
The PowerCube+ Series is indicated for use by a clinician in a professional healthcare setting on adult and pediatric patients who are 5 years and older that can cooperate in the testing.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K240706 510(k) Summary
Contact Details
Date Prepared:
Applicant Name: Applicant Address: Applicant Contact Telephone: Applicant Contact: Applicant Contact Email:
Correspondent Name: Correspondent Address: Correspondent Contact Telephone: Correspondent Contact Email:
December 9, 2024
GANSHORN Medizin Electronic GmbH Industriestr 6-8, Niederlauer D-97618 Germany +49 (9771) 6222 Dr. Stefan Ponto Stefan.Ponto@ganshorn.de
Jim Chickering 15 Belleau Woods, Georgetown MA USA (978) 808-8196 jimchickering@gmail.com
Device Name
Device Trade Name: PowerCube+ Series (PowerCube Body+) PowerCube+ Series (PowerCube Diffusion+) PowerCube+ Series (PowerCube Body+ / Diffusion+) Common Name: Volume Plethysmograph Volume Plethysmograph Classification Name: Regulation Number: 868.1760, 868.1840 JEH, BZG Product Codes: Device Class: 2
Legally Marketed Predicate Device
| Predicate #: | K072061 |
|---|---|
| Trade Name: | MASTERSCREEN PFT, MASTERSCREEN PFT CT, |
| MASTERSCREEN PFT BODY | |
| Common/Classification Name: | Volume plethysmograph |
| Regulation Number: | 868.1760 |
| Product Codes: | JEH |
| Device Class: | 2 |
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Legally Marketed Reference Device
| Reference #: | K160116 |
|---|---|
| Trade Name: | SpiroScout |
| Common/Classification Name: | Diagnostic spirometer. |
| Regulation Number: | 868.1840 |
| Product Codes: | BZG |
| Device Class: | 2 |
Device Description Summary
The GANSHORN PowerCube+ Series is a device that performs cooperation-dependent pulmonary function tests, including Spirometry, Body Plethysmography, Lung Diffusion measurement, Occlusive Resistance measurement and Respiratory Muscle Strength measurement. The device provides information that aids in a diagnosis by a clinician.
Spirometry is a set of non-invasive pulmonary function tests where the flow of inhaled/exhaled air is measured to determine physiological parameters such as Peak Expiratory Flow and Forced Vital Capacity. The patient's breathing flow is measured with ultrasound technology inside a breathing insert. Two ultrasound transducers measure the difference in ultrasound wave transit time to calculate breathing flow direction, speed, and volume.
Body Plethysmography provides for the measurement of physiological parameters such as Functional Residual Capacity and Specific Airway Resistance. The patient is seated in an air-tight chamber which has a fixed shape and volume. Pressure sensors measure the chamber pressure and the pressure close to the mouth, which is used as a proxy for alveolar pressure when measured under a zero-flow condition. Boyle's Law is used to infer the volume in the lungs from changes in chamber pressure.
Lung Diffusion testing is a non-invasive process for measuring diffusion capacity and lung volume. The patient inhales a test gas with known concentrations of helium and carbon monoxide. The patient's breath is held for 10 seconds during which time the helium dilutes into the lungs and the carbon monoxide diffuses through the alveoli into the blood. After 10 seconds of breath-hold time, the patient exhales and the difference between inhaled and exhaled gas concentrations is measured with a gas analyzer. The differences in gas concentration are used to determine physiological parameters such as DLCO (diffusing capacity of the lungs for carbon monoxide) and Alveolar Volume.
Occlusive Resistance measurement is an established method for measuring airway resistance during tidal breathing, using a shutter and mouth pressure sensor.
Respiratory Muscle Strength measurement is an established method for measuring the maximal strength of respiratory muscles, using a shutter and mouth pressure sensor.
The PowerCube+ Series has the following product model configurations:
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- . PowerCube Body+ includes Spirometry and Body Plethysmography measurement
- . PowerCube Diffusion+ includes Spirometry and Lung Diffusion measurement
- . PowerCube Body+ / Diffusion+ includes Spirometry, Body Plethysmography, and Lung Diffusion measurement
All product model configurations support Occlusive Resistance measurement and Respiratory Muscle Strength measurement.
The PowerCube+ Series is mains-powered and not intended for mobile/transportable use.
Intended Use/Indications for Use
The PowerCube+ Series is indicated for use in the measurement and data collection of lung function parameters. The system performs cooperation-dependent pulmonary function tests which include Spirometry/Flow-Volume measurement, Body Plethysmography measurement, Lung Diffusion measurement, Occlusive Resistance measurement and Respiratory Muscle Strength measurement. The device provides information that aids in a diagnosis by a clinician.
The PowerCube+ Series is indicated for use by a clinician in a professional healthcare setting on adult and pediatric patients who are 5 years and older that can cooperate in the testing.
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Technological Comparison
| Characteristic | Subject DeviceGanshorn PowerCube+ Series | Predicate DeviceK072061 - Viasys MasterScreen | Discussion of Differences |
|---|---|---|---|
| Indications for Use | The PowerCube+ Series is indicated foruse in the measurement and datacollection of lung function parameters.The system performs cooperation-dependent pulmonary function testswhich include Spirometry/Flow- Volumemeasurement, Body Plethysmographymeasurement, and Lung Diffusionmeasurement. The device providesinformation that aids in a diagnosis by aclinician.The PowerCube+ Series is indicated foruse by a clinician in a professionalhealthcare setting on adult and pediatricpatients who are 5 years and older thatcan cooperate in the testing. | The Masterscreen PFT Body is intendedto be used for measurement and datacollection of lung function parameters.The system performs cooperation-dependent pulmonary function testswhich include Spirometry/Flow-Volume/Resistance measurements, lungdiffusion measurements and bodyplethysmography measurement. Thedevice provides data / information andsupports help for a diagnosis.MasterScreen PFT CT (Clinical Trialversion) includes Spirometry/Flow-Volume/Resistance measurements andlung diffusion measurements withindividual access rights defined fordifferent user roles (e.g. Investigator,doctor, study nurse, trainer and servicepersonnel).MasterScreen PFT includesSpirometry/Flow-Volume/Resistance andlung diffusion measurements.Measurements will be performed underthe direction of a physician in the clinic,doctor's office or hospital. It can beutilized for patients from 4 years on andolder as long as they can cooperate in theperformance.The MS-PFT Body is powered from100-240V / 50-60Hz wall outlets. Noenergy is transferred to the patient. | Substantially equivalent.Both devices offer Spirometry,Body Plethysmography andLung Diffusion measurementprograms.Both devices provideinformation that aids in adiagnosis by a clinician.The predicate device offers aspecial clinical trial version thatis outside of the Intended Usescope. |
| Environment of use | Professional healthcare setting | Same | N/A |
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| K240706 | |
|---|---|
| --------- | -- |
| Characteristic | Subject DeviceGanshorn PowerCube+ Series | Predicate DeviceK072061 - Viasys MasterScreen | Discussion of Differences |
|---|---|---|---|
| Prescription Use only | Yes | Same | N/A |
| Patient population | 5 years and older | 4 years and older | Substantially equivalent |
| Measurement programs | Spirometry (Slow Vital Capacity,Forced Vital Capacity,Maximum Voluntary Ventilation) Body Plethysmography Lung Diffusion (Single BreathDiffusion method) Occlusive Resistancemeasurement Respiratory Muscle Strengthmeasurement | Same | The predicate device offersthe same lung functionmeasurement programs asthe subject device. |
| Spirometry technology(flow measurement) | Ultrasound(transit-time between 2 ultrasoundsensors) | Pneumotachograph(pressure drop across a resistiveelement) | Different technologies, butfor same Intended Use.Subject device uses thesame technology as theSpiroScout referencedevice (K160116). |
| Flow Parameters | Range: ±18 l/s Accuracy: ±2% or 50 ml/s,whichever is greater Resolution: 10 ml/s | Similar | Conforms to ISO23747:2015 |
| Spirometry technology(volume measurement) | Integration of flow measurementdata | Same | N/A |
| Characteristic | Subject DeviceGanshorn PowerCube+ Series | Predicate DeviceK072061 - Viasys MasterScreen | Discussion of Differences |
| Volume Parameters | Range: 0-20 litersAccuracy: ±2% or 50 ml, whichever is greaterResolution: 1 ml | Similar | Conforms to ISO26782:2009 |
| Body Plethysmographytechnology | An air-tight chamber of fixed shapeand volume.A pressure sensor that measuresthe pressure inside the chamberrelative to ambient pressure.A pressure sensor that measuresmouth pressure, which is used as aproxy for alveolar pressure whenmeasured under a zero-flowcondition.The use of Boyle's Law to infer thevolume in the lungs from changes inchamber pressure. | Similar | The subject deviceincorporates an airtightchamber, mouth pressuresensor, and application ofBoyle's Law, which arestandard and well-established principles forbody plethysmography. |
| Characteristic | Subject DeviceGanshorn PowerCube+ Series | Predicate DeviceK072061 - Viasys MasterScreen | Discussion of Differences |
| Lung Diffusion (SingleBreath Diffusion method)technology | A test gas that includes knownquantities of helium and carbonmonoxide (provided by thecustomer, not part of the subjectdevice).A gas analyzer that measureshelium concentration duringinhalation and exhalation.A gas analyzer that measurescarbon monoxide concentrationduring inhalation and exhalation.A comparison of the inhaled andexhaled gas concentrations to inferlung diffusing capacity. | Similar | The subject device uses ahelium and carbonmonoxide test gas,alongside gas analyzers, tomeasure lung diffusioncapacity based onestablished ATS/ERSstandards. |
| Gas mixture: | helium: 18% carbon monoxide: 0.25% oxygen: 17-21% nitrogen: balance | Similar | Helium and carbonmonoxide concentrationsare consistent withATS/ERS guidelines |
| Carbon monoxide gasanalyzer | Type: non-dispersive infrared absorption Range: 0-3000 ppm CO Accuracy: ±2.5% FSO | Similar | Sensor measurement rangein the subject device issufficient for Intended Use |
| Helium gas analyzer | Type: ultrasound Range: 0-20 Vol% He Accuracy: ±2.5% FSO | Similar | Sensor measurement rangein the subject device issufficient for Intended Use |
| Characteristic | Subject DeviceGanshorn PowerCube+ Series | Predicate DeviceK072061 - Viasys MasterScreen | Discussion of Differences |
| Occlusive ResistanceMeasurement technology | A pressure sensor that measuresmouth pressure, which is used as aproxy for alveolar pressure whenmeasured under a zero-flowcondition.A shutter mechanism thatmomentarily blocks the airflow atthe mouth by transient occlusion. | Similar | The subject device's use ofpressure sensors and ashutter mechanism fortransient occlusion alignswith well-establishedprinciples in pulmonarydiagnostics and does notintroduce new questions ofsafety or effectiveness. |
| Respiratory MuscleStrength Measurementtechnology | A pressure sensor that measuresmouth pressure, which is used as aproxy for alveolar pressure whenmeasured under a zero-flowcondition.A shutter mechanism thatmomentarily blocks the airflow atthe mouth by transient occlusion. | Similar | The subject device's use ofpressure sensors and ashutter mechanism fortransient occlusion alignswith well-establishedprinciples in pulmonarydiagnostics and does notintroduce new questions ofsafety or effectiveness. |
| Characteristic | Subject DeviceGanshorn PowerCube+ Series | Predicate DeviceK072061 - Viasys MasterScreen | Discussion of Differences |
| Spirometry Slow VitalCapacity reportedmeasurements | • VT• ERV• IRV• VC max• VC ex• VC in• VC• IC• BF | Similar | Mathematically derivedbased on physiologicalparameters. Although datafor the predicate device(K072061 – ViasysMasterScreen) is notpublicly available, thederivation of thesemeasurements adheres tostandard spirometriccalculation principles,ensuring equivalent clinicalrelevance and accuracy. |
| Spirometry Forced VitalCapacity reportedmeasurements | • FVC• FIVC• FEV1• FEV6• FEV1 / FVC• FEV1 / VCmax• FEV1 / FEV6• FEF 25 (MEF 75)• FEF 50 (MEF 50)• FEF 75 (MEF 25)• FEF 25-75• PEF• PIF• VC max | Similar | Bench testing incompliance with ATS/ERSstandards and ISO 26782and ISO 23747. Testingvalidated accuratemeasurements of keyparameters, includingFEV1, FEV6, FVC, andPEF. Other reportedparameters aremathematically derivedfrom these coremeasurements, |
| Characteristic | Subject DeviceGanshorn PowerCube+ Series | Predicate DeviceK072061 - Viasys MasterScreen | Discussion of Differences |
| Spirometry MaximumVoluntary Ventilationreported measurements | • MVV | Similar | Mathematically derivedbased on validatedspirometric measurements,such as FEV1 and tidalvolume. |
| Body Plethysmographyreported measurements | • TGV• FRCpleth• ERV• RV• TLC• VC• IC• sRaw eff• sRaw tot• sRaw mid• sRaw peak• sRaw 0.5• Raw eff• Raw tot• Raw 0.5• RV%TLC | Similar | SE demonstrated for theBody Plethysmographycomponent by conductingbench testing comparingthe PowerCube+ Series tothe FDA-clearedMasterScreen Body device,demonstrating thatmeasurements for ThoracicGas Volume (TGV) andSpecific Airway Resistance(sRaw) fall within a 5%deviation threshold,consistent with ATS/ERSguidelines and regulatorystandards. Additionally, thedevice's piezo-resistivesensors and chamberdesign were validated toprovide accurate andreliable measurementsunder clinical conditions |
| Characteristic | Subject DeviceGanshorn PowerCube+ Series | Predicate DeviceK072061 - Viasys MasterScreen | Discussion of Differences |
| Lung Diffusion (SingleBreath Diffusion method)reported measurements | DLCO DLCOc VA KCO TLC FRC RV RV%TLC | Similar | Bench testing usingsimulated inhalation andexhalation with calibratedgas mixtures, demonstratedcompliance with ATS/ERS2017 standards for single-breath carbon monoxideuptake. The testingconfirmed that allmeasurements, includingDiffusing Capacity of theLungs for Carbon Monoxide(DLCO) and AlveolarVolume (VA), fall withinacceptable tolerances,validating the accuracy andreliability of the device forclinical use. |
| Characteristic | Subject DeviceGanshorn PowerCube+ Series | Predicate DeviceK072061 - Viasys MasterScreen | Discussion of Differences |
| Occlusive ResistanceMeasurementreported measurements | ROcc GOcc | Similar | Bench testing thatdemonstrated compliancewith a strict acceptancecriterion of ≤2% deviation.Comparative testing withthe FDA-clearedMasterScreen Body deviceconfirmed thatmeasurements of Rocc andderived parameters such asOcclusive Conductance(Gocc) were consistent andaccurate, aligning withATS/ERS standards. |
| Respiratory MuscleStrength Measurementreported measurements | Plmax PEmax P0.1 P0.1max P0.1 / Plmax P0.1 / MV | Similar | Bench testing that adheredto a strict acceptancecriterion of ≤2% deviation.Comparative testing withthe FDA-clearedMasterScreen Body deviceconfirmed the accuracy andreliability of thesemeasurements,demonstrating compliancewith ATS/ERS standardsand validating their clinicalutility. |
| Characteristic | Subject DeviceGanshorn PowerCube+ Series | Predicate DeviceK072061 - Viasys MasterScreen | Discussion of Differences |
| Components | Spirometry flow meter Body Plethysmography chamber Breathing gas analyzers Patient-applied parts, used for the acquisition of breathing gases Software module, running on a PC | Similar | The components of the subject device are consistent with those typically found in volume plethysmograph devices. These include a spirometry flow meter, body plethysmography chamber, breathing gas analyzers, patient-applied parts, and a software module running on a PC. |
| Patient-applied parts | Spirometry breathing tube Spirometry bacterial filter Nose clip Gas analysis intermediate adapter (draws an air sample for Lung Diffusion measurement) | Similar | Subject device applied parts are similar to other cleared devices of this type. |
| Device energy type | 110-240 VAC 50/60 Hz | Same | N/A |
| Characteristic | Subject DeviceGanshorn PowerCube+ Series | Predicate DeviceK072061 - Viasys MasterScreen | Discussion of Differences |
| Body Plethysmographychamber characteristics | Security glass, aluminum frame Door lock: magnetic Standard-sized, XL-sized | Similar | Chamber is fixed in shapeand volume, which isrequired for themeasurement process.A specific volume (standardvs XL) is not required forthe measurement process,as long as the volume isknown and fixed in nature. |
| Software –user interface | LFX software module,running on a PC | Similar | Each device has its ownsoftware program,supporting the sameIntended Use |
| Software –signal processing | LFX software module,running on a PC | Similar | Each device has its ownsoftware program,supporting the sameIntended Use |
| EMR connectivity support | Yes | Similar | The GanshornPowerCube+ Seriesincludes EMR connectivitysupport, enabling seamlessintegration with electronicmedical record systems tostreamline datamanagement and improveclinical workflows. |
| Characteristic | Subject DeviceGanshorn PowerCube+ Series | Predicate DeviceK072061 - Viasys MasterScreen | Discussion of Differences |
| Environmental UseConditions (Operating) | Temperature: +15 - +35°C Relative Humidity: 10-95% (non-condensing) Atmospheric Pressure: 700-1060 hPa | Similar | The GanshornPowerCube+ Series, thespecified environmental useconditions for bothoperating and transportinclude a wide range oftemperature, humidity, andatmospheric pressurevalues, ensuring reliableperformance in variousenvironment. |
| Environmental UseConditions (Transport) | Temperature: -20 - +50°C Relative Humidity: 10-95% (non-condensing) Atmospheric Pressure: 600-1060 hPa | Similar | The GanshornPowerCube+ Series, thespecified environmental useconditions for bothoperating and transportinclude a wide range oftemperature, humidity, andatmospheric pressurevalues, ensuring reliableperformance in variousenvironments. |
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Non-Clinical and Clinical Tests Summary
| Category | Testing Summary |
|---|---|
| Cleaning Validation | The subject device and the cleaning / disinfection instructionsfor the subject device have been tested in accordance withFDA Guidance and the following standards:ISO 17664-1:2021 Processing of health care products —Information to be provided by the medical devicemanufacturer for the processing of medical devices - Part1: Critical and semi-critical medical devices |
| Shelf-Life Testing | The subject device has a disposable bacterial filter patient-applied part that has been tested for shelf-life stability. Testresults indicate that the subject device complies with itspredetermined specification. |
| Biocompatibility Testing | The subject device has direct surface contact with patient skinfor a limited (< 24 hours) duration and indirect contact withpatient gas pathway.The patient-contacting materials in the subject device havebeen tested for biocompatibility in accordance with thefollowing standards: ISO 10993-1:2020 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk managementsystem ISO 18562-1 First edition - Biocompatibility evaluation ofbreathing gas pathways in healthcare applications - Part 1:Evaluation and testing within a risk management process ISO 18562-2 First edition - Biocompatibility evaluation ofbreathing gas pathways in healthcare applications - Part 2:Tests for emissions of particulate matter ISO 18562-3 First edition - Biocompatibility evaluation ofbreathing gas pathways in healthcare applications - Part 3:Tests for emissions of volatile organic compounds ISO 18562-4 First edition - Biocompatibility evaluation ofbreathing gas pathways in healthcare applications - Part 4:Tests for leachables in condensate |
| Software/CybersecurityTesting | The subject device has been designed and developed inaccordance with internal software development processes,FDA Guidance for the Content of Premarket Submissions forSoftware Contained in Medical Devices, FDA Content ofPremarket Submissions for Management of Cybersecurity inMedical Devices, and has been verified and validated. Testresults indicate that the subject device complies with itspredetermined specification. |
| Category | Testing Summary |
| Electrical Safety | The subject device has been tested for safety in accordance with the following standards:IEC 60601-1 Edition 3.2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ElectromagneticCompatibility (EMC) | The subject device has been tested for EMC in accordance with the following standards:IEC 60601-1-2 Edition 4.1 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| Performance Testing -Bench | The subject device has been tested in accordance with internal requirements and procedures, and test results indicate that the device complies with the predetermined requirements.The subject device has been tested for clinical accuracy performance in accordance with the following standards:ISO 23747:2015 - Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans ISO 26782:2009 - Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans ATS - Standardization of Spirometry 2019 Update 2017 ERS/ATS standards for single-breath carbon monoxide uptake in the lung ATS/ERS Statement on Respiratory Muscle Testing (2002) ERS statement on respiratory muscle testing at rest and during exercise (2018) ATS/ERS Standardization of the measurement of lung volumes (2023) Comparative bench testing against an FDA cleared device was also conducted to validate the additional parameters of the subject device. The two devices were compared against a calibrated Hans-Rudolph flow/volume simulator at a range of physiological test points, and test results indicate that the subject device complies with its predetermined specification. |
| Performance Testing -Animal | Animal performance testing was not performed with the subject device and is not necessary to demonstrate safety and effectiveness. |
| Category | Testing Summary |
| Performance Testing -Clinical | Clinical performance testing was not performed with thesubject device and is not necessary to demonstrate safety andeffectiveness. |
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Conclusions
The information provided above supports that the GANSHORN PowerCube+ Series is substantially equivalent to the predicate device. Although minor differences in design and technology exist between the subject and predicate device, the testing supports that these differences do not raise new questions of safety and effectiveness.
Therefore, it is concluded that the GANSHORN PowerCube+ Series is substantially equivalent to the predicate device.
§ 868.1760 Volume plethysmograph.
(a)
Identification. A volume plethysmograph is an airtight box, in which a patient sits, that is used to determine the patient's lung volume changes.(b)
Classification. Class II (performance standards).