(270 days)
No
The description focuses on standard physiological measurement techniques and data processing based on established physical principles (ultrasound transit time, Boyle's Law, gas concentration analysis). There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No.
The device is used for measurement and data collection of lung function parameters that aid in a diagnosis; it does not provide therapy.
Yes
The device is explicitly stated to "provide information that aids in a diagnosis by a clinician." This phrase directly indicates its role in the diagnostic process.
No
The device description explicitly details hardware components such as ultrasound transducers, pressure sensors, an air-tight chamber, and a gas analyzer, indicating it is not software-only.
Based on the provided information, the PowerCube+ Series is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. These tests are performed in vitro (in glass or outside the body).
- PowerCube+ Function: The PowerCube+ Series performs pulmonary function tests by measuring physiological parameters directly from the patient's breathing and within a body plethysmography chamber. While it uses gas analysis for the Lung Diffusion test, this is done on exhaled breath, which is a direct measurement from the patient, not a sample taken from the body for in vitro analysis.
- Intended Use: The intended use describes the device as measuring and collecting lung function parameters and providing information that aids in a diagnosis. This is consistent with a diagnostic device, but not specifically an in vitro diagnostic device.
- Device Description: The description details the methods used (Spirometry, Body Plethysmography, Lung Diffusion, etc.), all of which involve direct interaction with the patient's respiratory system or body.
- Lack of Sample Analysis: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) which is a hallmark of IVD devices.
Therefore, the PowerCube+ Series is a diagnostic medical device, but it falls under the category of devices that perform measurements directly on the patient, rather than in vitro analysis of samples.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
JEH, BZG
Device Description
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 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lungs
Indicated Patient Age Range
5 years and older
Intended User / Care Setting
clinician in a professional healthcare setting
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)
Non-Clinical and Clinical Tests Summary
- Cleaning Validation: The subject device and the cleaning / disinfection instructions for the subject device have been tested in accordance with FDA Guidance and the following standards: ISO 17664-1:2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: 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. Test results indicate that the subject device complies with its predetermined specification.
- Biocompatibility Testing: The subject device has direct surface contact with patient skin for a limited (
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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
3
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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 |
5
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:
6
- . 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.
7
Technological Comparison
| Characteristic | Subject Device
Ganshorn PowerCube+ Series | Predicate Device
K072061 - Viasys MasterScreen | Discussion of Differences |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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, and Lung Diffusion
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 Masterscreen PFT Body is intended
to be used for measurement and data
collection of lung function parameters.
The system performs cooperation-
dependent pulmonary function tests
which include Spirometry/Flow-
Volume/Resistance measurements, lung
diffusion measurements and body
plethysmography measurement. The
device provides data / information and
supports help for a diagnosis.
MasterScreen PFT CT (Clinical Trial
version) includes Spirometry/Flow-
Volume/Resistance measurements and
lung diffusion measurements with
individual access rights defined for
different user roles (e.g. Investigator,
doctor, study nurse, trainer and service
personnel).
MasterScreen PFT includes
Spirometry/Flow-Volume/Resistance and
lung diffusion measurements.
Measurements will be performed under
the direction of a physician in the clinic,
doctor's office or hospital. It can be
utilized for patients from 4 years on and
older as long as they can cooperate in the
performance.
The MS-PFT Body is powered from
100-240V / 50-60Hz wall outlets. No
energy is transferred to the patient. | Substantially equivalent.
Both devices offer Spirometry,
Body Plethysmography and
Lung Diffusion measurement
programs.
Both devices provide
information that aids in a
diagnosis by a clinician.
The predicate device offers a
special clinical trial version that
is outside of the Intended Use
scope. |
| Environment of use | Professional healthcare setting | Same | N/A |
8
| K240706 | |
|---|---|
| --------- | -- |
| Characteristic | Subject Device
Ganshorn PowerCube+ Series | Predicate Device
K072061 - 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 Breath
Diffusion method) Occlusive Resistance
measurement Respiratory Muscle Strength
measurement | Same | The predicate device offers
the same lung function
measurement programs as
the subject device. |
| Spirometry technology
(flow measurement) | Ultrasound
(transit-time between 2 ultrasound
sensors) | Pneumotachograph
(pressure drop across a resistive
element) | Different technologies, but
for same Intended Use.
Subject device uses the
same technology as the
SpiroScout reference
device (K160116). |
| Flow Parameters | Range: ±18 l/s Accuracy: ±2% or 50 ml/s,
whichever is greater Resolution: 10 ml/s | Similar | Conforms to ISO
23747:2015 |
| Spirometry technology
(volume measurement) | Integration of flow measurement
data | Same | N/A |
| Characteristic | Subject Device
Ganshorn PowerCube+ Series | Predicate Device
K072061 - Viasys MasterScreen | Discussion of Differences |
| Volume Parameters | Range: 0-20 litersAccuracy: ±2% or 50 ml, whichever is greaterResolution: 1 ml | Similar | Conforms to ISO
26782:2009 |
| Body Plethysmography
technology | An air-tight chamber of fixed shape
and volume.
A pressure sensor that measures
the pressure inside the chamber
relative to ambient pressure.
A pressure sensor that measures
mouth pressure, which is used as a
proxy for alveolar pressure when
measured under a zero-flow
condition.
The use of Boyle's Law to infer the
volume in the lungs from changes in
chamber pressure. | Similar | The subject device
incorporates an airtight
chamber, mouth pressure
sensor, and application of
Boyle's Law, which are
standard and well-
established principles for
body plethysmography. |
| Characteristic | Subject Device
Ganshorn PowerCube+ Series | Predicate Device
K072061 - Viasys MasterScreen | Discussion of Differences |
| Lung Diffusion (Single
Breath Diffusion method)
technology | A test gas that includes known
quantities of helium and carbon
monoxide (provided by the
customer, not part of the subject
device).
A gas analyzer that measures
helium concentration during
inhalation and exhalation.
A gas analyzer that measures
carbon monoxide concentration
during inhalation and exhalation.
A comparison of the inhaled and
exhaled gas concentrations to infer
lung diffusing capacity. | Similar | The subject device uses a
helium and carbon
monoxide test gas,
alongside gas analyzers, to
measure lung diffusion
capacity based on
established ATS/ERS
standards. |
| Gas mixture: | helium: 18% carbon monoxide: 0.25% oxygen: 17-21% nitrogen: balance | Similar | Helium and carbon
monoxide concentrations
are consistent with
ATS/ERS guidelines |
| Carbon monoxide gas
analyzer | Type: non-dispersive infrared absorption Range: 0-3000 ppm CO Accuracy: ±2.5% FSO | Similar | Sensor measurement range
in the subject device is
sufficient for Intended Use |
| Helium gas analyzer | Type: ultrasound Range: 0-20 Vol% He Accuracy: ±2.5% FSO | Similar | Sensor measurement range
in the subject device is
sufficient for Intended Use |
| Characteristic | Subject Device
Ganshorn PowerCube+ Series | Predicate Device
K072061 - Viasys MasterScreen | Discussion of Differences |
| Occlusive Resistance
Measurement technology | A pressure sensor that measures
mouth pressure, which is used as a
proxy for alveolar pressure when
measured under a zero-flow
condition.
A shutter mechanism that
momentarily blocks the airflow at
the mouth by transient occlusion. | Similar | The subject device's use of
pressure sensors and a
shutter mechanism for
transient occlusion aligns
with well-established
principles in pulmonary
diagnostics and does not
introduce new questions of
safety or effectiveness. |
| Respiratory Muscle
Strength Measurement
technology | A pressure sensor that measures
mouth pressure, which is used as a
proxy for alveolar pressure when
measured under a zero-flow
condition.
A shutter mechanism that
momentarily blocks the airflow at
the mouth by transient occlusion. | Similar | The subject device's use of
pressure sensors and a
shutter mechanism for
transient occlusion aligns
with well-established
principles in pulmonary
diagnostics and does not
introduce new questions of
safety or effectiveness. |
| Characteristic | Subject Device
Ganshorn PowerCube+ Series | Predicate Device
K072061 - Viasys MasterScreen | Discussion of Differences |
| Spirometry Slow Vital
Capacity reported
measurements | • VT
• ERV
• IRV
• VC max
• VC ex
• VC in
• VC
• IC
• BF | Similar | Mathematically derived
based on physiological
parameters. Although data
for the predicate device
(K072061 – Viasys
MasterScreen) is not
publicly available, the
derivation of these
measurements adheres to
standard spirometric
calculation principles,
ensuring equivalent clinical
relevance and accuracy. |
| Spirometry Forced Vital
Capacity reported
measurements | • 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 in
compliance with ATS/ERS
standards and ISO 26782
and ISO 23747. Testing
validated accurate
measurements of key
parameters, including
FEV1, FEV6, FVC, and
PEF. Other reported
parameters are
mathematically derived
from these core
measurements, |
| Characteristic | Subject Device
Ganshorn PowerCube+ Series | Predicate Device
K072061 - Viasys MasterScreen | Discussion of Differences |
| Spirometry Maximum
Voluntary Ventilation
reported measurements | • MVV | Similar | Mathematically derived
based on validated
spirometric measurements,
such as FEV1 and tidal
volume. |
| Body Plethysmography
reported 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 the
Body Plethysmography
component by conducting
bench testing comparing
the PowerCube+ Series to
the FDA-cleared
MasterScreen Body device,
demonstrating that
measurements for Thoracic
Gas Volume (TGV) and
Specific Airway Resistance
(sRaw) fall within a 5%
deviation threshold,
consistent with ATS/ERS
guidelines and regulatory
standards. Additionally, the
device's piezo-resistive
sensors and chamber
design were validated to
provide accurate and
reliable measurements
under clinical conditions |
| Characteristic | Subject Device
Ganshorn PowerCube+ Series | Predicate Device
K072061 - Viasys MasterScreen | Discussion of Differences |
| Lung Diffusion (Single
Breath Diffusion method)
reported measurements | DLCO DLCOc VA KCO TLC FRC RV RV%TLC | Similar | Bench testing using
simulated inhalation and
exhalation with calibrated
gas mixtures, demonstrated
compliance with ATS/ERS
2017 standards for single-
breath carbon monoxide
uptake. The testing
confirmed that all
measurements, including
Diffusing Capacity of the
Lungs for Carbon Monoxide
(DLCO) and Alveolar
Volume (VA), fall within
acceptable tolerances,
validating the accuracy and
reliability of the device for
clinical use. |
| Characteristic | Subject Device
Ganshorn PowerCube+ Series | Predicate Device
K072061 - Viasys MasterScreen | Discussion of Differences |
| Occlusive Resistance
Measurement
reported measurements | ROcc GOcc | Similar | Bench testing that
demonstrated compliance
with a strict acceptance
criterion of ≤2% deviation.
Comparative testing with
the FDA-cleared
MasterScreen Body device
confirmed that
measurements of Rocc and
derived parameters such as
Occlusive Conductance
(Gocc) were consistent and
accurate, aligning with
ATS/ERS standards. |
| Respiratory Muscle
Strength Measurement
reported measurements | Plmax PEmax P0.1 P0.1max P0.1 / Plmax P0.1 / MV | Similar | Bench testing that adhered
to a strict acceptance
criterion of ≤2% deviation.
Comparative testing with
the FDA-cleared
MasterScreen Body device
confirmed the accuracy and
reliability of these
measurements,
demonstrating compliance
with ATS/ERS standards
and validating their clinical
utility. |
| Characteristic | Subject Device
Ganshorn PowerCube+ Series | Predicate Device
K072061 - 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 Device
Ganshorn PowerCube+ Series | Predicate Device
K072061 - Viasys MasterScreen | Discussion of Differences |
| Body Plethysmography
chamber characteristics | Security glass, aluminum frame Door lock: magnetic Standard-sized, XL-sized | Similar | Chamber is fixed in shape
and volume, which is
required for the
measurement process.
A specific volume (standard
vs XL) is not required for
the measurement process,
as long as the volume is
known and fixed in nature. |
| Software –
user interface | LFX software module,
running on a PC | Similar | Each device has its own
software program,
supporting the same
Intended Use |
| Software –
signal processing | LFX software module,
running on a PC | Similar | Each device has its own
software program,
supporting the same
Intended Use |
| EMR connectivity support | Yes | Similar | The Ganshorn
PowerCube+ Series
includes EMR connectivity
support, enabling seamless
integration with electronic
medical record systems to
streamline data
management and improve
clinical workflows. |
| Characteristic | Subject Device
Ganshorn PowerCube+ Series | Predicate Device
K072061 - Viasys MasterScreen | Discussion of Differences |
| Environmental Use
Conditions (Operating) | Temperature: +15 - +35°C Relative Humidity: 10-95% (non-condensing) Atmospheric Pressure: 700-1060 hPa | Similar | The Ganshorn
PowerCube+ Series, the
specified environmental use
conditions for both
operating and transport
include a wide range of
temperature, humidity, and
atmospheric pressure
values, ensuring reliable
performance in various
environment. |
| Environmental Use
Conditions (Transport) | Temperature: -20 - +50°C Relative Humidity: 10-95% (non-condensing) Atmospheric Pressure: 600-1060 hPa | Similar | The Ganshorn
PowerCube+ Series, the
specified environmental use
conditions for both
operating and transport
include a wide range of
temperature, humidity, and
atmospheric pressure
values, ensuring reliable
performance in various
environments. |
9
10
11
12
13
14
15
16
17
18
19
Non-Clinical and Clinical Tests Summary
| Category | Testing Summary |
|---|---|
| Cleaning Validation | The subject device and the cleaning / disinfection instructions |
| for the subject device have been tested in accordance with | |
| FDA Guidance and the following standards: | |
| ISO 17664-1:2021 Processing of health care products — | |
| Information to be provided by the medical device | |
| manufacturer for the processing of medical devices - Part | |
| 1: 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. Test | |
| results indicate that the subject device complies with its | |
| predetermined specification. | |
| Biocompatibility Testing | The subject device has direct surface contact with patient skin |
| for a limited ( |