PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)

Q: Who is the manufacturer of PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)?

Ganshorn Medizin Electronic GmbH filed the 510(k) submission for PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) (K240706).

Q: What is the FDA product code for PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)?

JEH. It is classified under 21 CFR 868.1760 as a Class 2 device in the Anesthesiology panel.

Q: What is the regulatory pathway for PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K240706 · Ganshorn Medizin Electronic GmbH · JEH · Dec 9, 2024 · Anesthesiology

Device Facts

Record ID	K240706
Device Name	PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)
Applicant	Ganshorn Medizin Electronic GmbH
Product Code	JEH · Anesthesiology
Decision Date	Dec 9, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1760
Device Class	Class 2
Attributes	Pediatric

Intended 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.

Device Story

PowerCube+ Series performs cooperation-dependent pulmonary function tests; inputs include patient-generated airflow, chamber pressure, and gas concentrations (He/CO). Spirometry uses ultrasound transit-time transducers; Body Plethysmography uses air-tight chamber pressure and mouth pressure (Boyle's Law); Lung Diffusion uses gas analyzers to measure concentration differences after 10-second breath-hold. Device is mains-powered; used in professional healthcare settings by clinicians. Output consists of physiological parameters (e.g., FVC, TGV, DLCO, sRaw, respiratory muscle strength) displayed via PC software. Clinicians use data to aid in diagnosis of pulmonary conditions. Benefits include non-invasive assessment of lung function and respiratory mechanics.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including comparative testing against the predicate device using a calibrated Hans-Rudolph flow/volume simulator. Compliance with ISO 23747, ISO 26782, and ATS/ERS standards for all measurement modalities (Spirometry, Body Plethysmography, Lung Diffusion, Occlusive Resistance, Respiratory Muscle Strength) was verified.

Technological Characteristics

Mains-powered (110-240 VAC) pulmonary function system. Spirometry: ultrasound transit-time flow measurement. Body Plethysmography: air-tight chamber with pressure sensors. Lung Diffusion: NDIR CO analyzer and ultrasound He analyzer. Occlusive Resistance/Respiratory Muscle Strength: shutter mechanism and mouth pressure sensors. Software-based data processing on PC. Biocompatibility per ISO 10993 and ISO 18562. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2.

Indications for Use

Indicated for adult and pediatric patients 5 years and older capable of cooperation in testing, for measurement and data collection of lung function parameters including spirometry, body plethysmography, lung diffusion, occlusive resistance, and respiratory muscle strength.

Regulatory Classification

Identification

A volume plethysmograph is an airtight box, in which a patient sits, that is used to determine the patient's lung volume changes.

Predicate Devices

MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY (K072061)

Reference Devices

SpiroScout (K160116)

Related Devices

K161295 — MiniBox + · Pulmone Advanced Medical Devices, Ltd. · Oct 21, 2016
K190853 — Vyntus BODY · Vyaire Medical, Inc. · Aug 16, 2019
K221030 — Model 9100 PFT/DICO · Vitalograph Ireland, Ltd. · Jul 15, 2022
K133428 — MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO · Medikro OY · May 21, 2014
K052328 — ZAN LUNG-FUNCTION LAB · Zan Messgerate GmbH · Dec 22, 2005

Submission Summary (Full Text)

{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 (< 24 hours) duration and indirect contact with patient gas pathway. The patient-contacting materials in the subject device have been tested for biocompatibility in accordance with the following standards: ISO 10993-1:2020 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system ISO 18562-1 First edition - Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process ISO 18562-2 First edition - Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter ISO 18562-3 First edition - Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds ISO 18562-4 First edition - Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate…