The PulmOne MiniBoxPFT™ 2.0 is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung volumes). The PulmOne MiniBoxPFT™ 2.0 is to be used by either a physician, respiratory therapist, or technician. A single-use, disposable viral-bacterial filter separates the patient from the internal components of the device.

The MiniBoxPFT™ 2.0 measures all common spirometric measurements as well as relative and absolute lung volumes, including the following (the full list is detailed in Section 11 - Device Description):

Absolute Lung Volumes:
Total lung capacity (TLC) L
Thoracic Gas Volume (TGV) L
Residual volume (RV) L

Relative Lung Volumes:
Inspiratory capacity (IC) L
Expiratory reserve volume (ERV) L

Spirometry:
Forced vital capacity (FVC) L
Forced inspiratory vital capacity (FIVC) L
Slow vital capacity (SVC) L
Slow inspiratory vital capacity (IVC) L
Forced expiratory volume in 1 second (FEV1) L
Forced inspiratory volume in 1 second (FIV1) L
Ratio of FEV1 to SVC (FEV1/SVC) %
Ratio of FEV1 to FVC (FEV1/FVC) %
Forced expiratory volume in 6 seconds (FEV6) L
Ratio of FEV1 to FEV6 (FEV1/FEV6) %
Peak expiratory flow (PEF) L/s
Peak inspiratory flow (PIF) L/s
Forced Expiratory Flow at 50% of FVC (FEF50) L/s
Maximum Voluntary Ventilation (MVV) L/min

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the PulmOne MiniBoxPFT™ 2.0 device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

Feature/Test	Acceptance Criteria	Reported Device Performance
Spirometry Measurements	Met ATS guidelines for accuracy and repeatability.	Successfully met ATS guidelines.
Lung Volume Measurement Repeatability & Reproducibility	Inter-device repeatability and intra-device reproducibility within accepted known range.	Validated to be within the accepted known range.
Total Lung Capacity (TLC) Measurement (vs. Predicate)	Met pre-defined success criteria demonstrating substantial equivalence to predicate.	Successfully met study success criteria and demonstrated substantial equivalence.
Flow range	+/- 16 L/s (Predicate)	+/- 16 L/s (Proposed Device)
Volume accuracy	+/- 3% or 50mL (Predicate)	+/- 3% or 50mL (Proposed Device)
Flow accuracy	+/- 5% or 200 mL/s (Predicate)	+/- 5% or 200 mL/s (Proposed Device)
Dynamic resistance	<0.5 cmH2O/(L/s) at 12 L/s (Predicate)	<0.7 cmH2O/(L/s) at 14 L/s (Proposed Device)
Biocompatibility (Hand-Held sub-system)	Cleared OEM handle MIR [K122384] (Predicate)	Biocompatible Makrolon 2825 Polycarbonate material in compliance with ISO10993-1 (Proposed Device)
Standards Compliance	- IEC 60601-1:2005- IEC 60601-1-2:2007- Performance per ATS 2005 Standards	- IEC 60601-1:2005- IEC 60601-1-2:2007- ATS 2005 Standards- Additional: ISO 26782:2009 (sections 7.2, 7.4-7.6 & 7.8-7.9)

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "lab and bench tests" and "non-clinical bench testing" which were conducted to verify performance. These are likely mechanical or simulated tests, not human subject tests.
For the LVM validation test, the study compared the proposed device with the predicate device, but the specific sample size of subjects or data points used in this comparative test is not explicitly stated in the provided text.
Data Provenance: The tests were conducted internally by the manufacturer ("Laboratory tests were performed") and are non-clinical (bench testing). No information is provided regarding the country of origin of data if human subjects were involved, but given it's bench testing, this is not applicable. The data is from retrospective bench testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The ground truth for spirometry and lung volume measurements in bench testing typically comes from established standards (e.g., ATS guidelines) and comparisons against a validated predicate device, rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set:

This information is not provided. Given that the performance validation was through bench testing against standards and comparison with a predicate device, an adjudication method in the context of human expert review is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study was conducted to support this application." The studies were non-clinical bench tests comparing the device's measurements against set standards and a predicate device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, standalone performance was assessed. The entire document describes the performance of the device itself (PulmOne MiniBoxPFT™ 2.0) in measuring lung function, independently. The summary of non-clinical performance testing clearly details the device's ability to meet spirometry guidelines and its equivalence to the predicate in lung volume measurements. This is a standalone performance assessment.

7. The Type of Ground Truth Used:

For Spirometry: Established guidelines/standards (ATS guidelines, specifically "Standardization of spirometry; Eur Respir J 2005; 26: 319-338").
For Lung Volume Measurements (TLC): Comparison against the measurements obtained from the predicate device (PulmOne MiniBoxPFT™ K133051).

8. The Sample Size for the Training Set:

The document does not mention any training set or machine learning components. This device is a diagnostic spirometer and lung volume measurement device, not an AI/ML algorithm that requires a training set. The performance validation is based on physical and software functionality tests, not on learned patterns from a dataset.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no mention of a training set for an AI/ML component.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 6, 2015

PulmOne Advanced Medical Devices, Ltd. Dr. Susan Alpert Principal 200 Park Ave, Unit 403 Minneapolis, MN 55415

Re: K141793

Trade/Device Name: PulmOne MiniBoxPFT™ 2.0 Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic spirometer Regulatory Class: Class II Product Code: BZG, BZC Dated: January 27, 2015 Received: January 30, 2015

Dear Dr. Alpert:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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Page 2 - Dr. Susan Alpert

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin Keith Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141793 pending

Device Name PulmOne MiniBoxPFT™ 2.0

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

즈 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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SECTION 5 - 510(K) SUMMARY 5

5.1 ADMINISTRATIVE INFORMATION

Date:	November 12, 2014
Submitter:	PulmOne Advanced Medical Devices, Ltd.14 HaCharoshet St., Ra'ananna 4365707 , ISRAELTel: +972 77 5100 938Fax: +972 77 5100 939
Official Correspondent:	Avi Lazar, CEO
Trade Name:	PulmOne MiniBoxPFT TM 2.0
Classification Name:	Diagnostic spirometer
Classification Number:	21 CFR 868.1840
Product Code:	BZG
Additional Code:	BZC
Device Class:	Class II
Predicate Devices:	PulmOne MiniBoxPFTTM510(k) Number – K133051

5.2 DEVICE DESCRIPTION

Absolute Lung Volumes:	units
Total lung capacity (TLC)	L
Thoracic Gas Volume (TGV)	L
Residual volume (RV)	L
Relative Lung Volumes:
Inspiratory capacity (IC)	L
Expiratory reserve volume (ERV)	L

Spirometry:

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Forced vital capacity (FVC)	L
Forced inspiratory vital capacity (FIVC)	L
Slow vital capacity (SVC)	L
Slow inspiratory vital capacity (IVC)	L
Forced expiratory volume in 1 second (FEV1)	L
Forced inspiratory volume in 1 second (FIV1)	L
Ratio of FEV1 to SVC (FEV1/SVC)	%
Ratio of FEV1 to FVC (FEV1/FVC)	%
Forced expiratory volume in 6 seconds (FEV6)	L
Ratio of FEV1 to FEV6 (FEV1/FEV6)	%
Peak expiratory flow (PEF)	L/s
Peak inspiratory flow (PIF)	L/s
Forced Expiratory Flow at 50% of FVC (FEF50)	L/s
Maximum Voluntary Ventilation (MVV)	L/min

5.3 -INTENDED USE AND INDICATIONS FOR USE

5.4 SUMMARY OF TECHNICAL CHARACTERISTICS

The MiniBoxPFT" 2.0 provides both lung volume and spirometry measurements in a single device. The MiniBoxPFT™ 2.0's predicate device is the MiniBoxPFT™ which also provides both lung volume and spirometry measurements however the predicate is comprised of two modules.

The MiniBoxPFT™ 2.0 is substantially equivalent to the MiniBoxPFT™ and both utilize the same technologies and methods of operations, with the main difference being that the MiniBoxPFT™ uses an OEM spirometer and the MiniBoxPFT™ 2.0 integrates all measurements in one integrated device. The lab and bench testing demonstrates that the differences between the devices do not raise any new questions and that the proposed device is substantially equivalent to the predicate device.

Device Construction: Both devices utilize well-recognized flow sensors, the same pressure sensor, a valve and a sealed container in their operation. The MiniBoxPFT110 2.0 has a detachable hand-held unit for use with the spirometric measurements as opposed to an OEM spirometer in MiniBoxPFT™

Methods of Operation: The methods of operation for both devices require the subject to perform breathing maneuvers – breathing via a disposable viral-bacterial filter during flow interruptions. The MiniBoxPFT™ 2.0 requires less time to perform some of the breathing maneuvers, and has shorter duration flow interruptions.

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Principles of Operation: The principles of operation for both devices are the same. Both devices uses data from spirometry measurements and data obtained during flow interruptions with a proprietary formula to calculate Total Lung Capacity.

5.4.1 Summary table of Comparison

	MiniBoxPFTTM[K133051]	MiniBoxPFTTM2.0[Proposed Device]
Intended Use andIndications for Use	The PulmOne MiniBoxPFTTM isintended to measure lung function inadult and pediatric patients while atrest (including spirometry and lungvolumes).The PulmOne MiniBoxPFTTM is tobe used by either a physician,respiratory therapist, or technician.	Identical
Target Population	Adult and pediatric subjects	Identical
Biocompatibility	- Mouthpiece:Single-use FDA-cleared viralbacterial filter (K051712)- Hand-Held sub-system:Skin Contact - Using Cleared OEMhandle MIR , [K122384]	- Mouthpiece:Identical- Hand-Held sub-system:Skin Contact , Using BiocompatibleMakrolon 2825 Polycarbonate materialin compliance with ISO10993-1
Standards /Performanceguidelinecompliance	-General medical device safety: IEC60601-1:2005 (3rd Ed)-Electromagnetic compatibility:IEC 60601-1-2:2007 (3rd Ed)-Performance per ATS 2005Standards	Same with additional of ISO 26782compliance to section 7.2, 7.4-7.6 &7.8-7.9
EnvironmentalOperatingConditions	Temperature: 0 to 40 °CRelative Humidity: 20 to 90 %Atmospheric Pressure: 900 to 1060cmH2O	Identical
Flow Sensor	1. Bi-directional hot-wire massairflow sensorRange: +/- 5.0 L/s2. Bi-directional digital turbineRange: +/- 16.0 L/s[Part of the incorporatedOEM cleared MIR Minispir,K122384]	Bi-directional Symmetric andaveraging Pitot-TubeRange: +/- 16.0 L/s
Pressure Sensor	Bi-directional piezo-resistiveMouth Sensor:Range: ±70 cmH2O (±1 PSI)Accuracy: ±0.25% Full Scale	Identical
Valve	Computer-controlled solenoid valveClosing response time: <30 msClosing duration: less than 300 ms	Computer-controlled solenoid valveClosing response time:<30 msClosing duration: ~100 ms
Software	PulmOne 4.0, Matlab based	PulmOne C# .NET application
LUNG VOLUMEMEASUREMENT
Measurements	Mouth pressure and mouth flow	Identical
Calculations	TLC, TGV (FRC), RV, VC, IC	Same with addition of ERV
Principle of Operation	1) Pressure and flow are measured at the mouth2) Spirometry is measured with the handheld spirometer.3) Proprietary equation is used to calculate total lung capacity	Identical
Method of Operation	1) Patient seated at desk/table2) 1-2 minutes normal breathing3) 300 ms shutter closure per breath4) Inspiration to TLC5) Slow expiration to RV	Same, except shutter closure per breath is 100 ms
Container	16.3 round container	15L elliptic container
SPIROMETRYMEASUREMENT	Cleared OEM MIR Minispirspirometer [K122384] incorporated	MiniBox spirometer design incorporated
Measurements	Mouth flow	Identical
CalculatedParameters	Used a cleared OEM MIR Minispir [K122384] incorporated :FEV1, FVC, FEV6, FEV1/FVC,FEV1/SVC, FEV1/VC, EFV1/FEV6,PEF, FEF25-75, FEV3, FEV3/FVC,FET, FEF 25, FEF50, FEF75, Evol,FIVC, FIV1, FIVC1/FIVC, PIF, IC,SVC, ERV, TV, IVC, EVC, MVV	same calculated parameters with addition of MVV Rate
DisplayedParameters byMiniBox GUI	FVC, FEV1, FEV1/SVC,FEV1/FVC, FEV6, FEV1/FEV6,PEF, SVC, IC, ERV	FEV1, FVC, FEV6, FEV1/FVC,FEV1/SVC, FEV1/VC, EFV1/FEV6,PEF, FEF25-75, FEV3, FEV3/FVC,FET, FEF 25, FEF50, FEF75, Evol,FIVC, FIV1, FIVC1/FIVC, PIF, IC,SVC, ERV, TV, IVC, EVC, MVV and MVV Rate
TechnicalSpecifications	Flow range: +/- 16 L/sVolume accuracy: +/- 3% or 50mLFlow accuracy: +/- 5% or 200 mL/sDynamic resistance at 12 L/s: <0.5 cmH2O/(L/s)Dimension: 142x49.7x26 mm	Flow range: +/- 16 L/sVolume accuracy: +/- 3% or 50mLFlow accuracy: +/- 5% or 200 mL/sDynamic resistance at 14 L/s: <0.7 cmH2O/(L/s)Dimension: 210x105x45 mm
BTPS Correction	Manual	Automatic
ACCESSORIES
Bacterial Filters	FDA 510(K) Number K051712Air Safety Spiroguard - Integral Mouthpiecesingle-use, disposable viral-bacterial filter	Identical

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5.5 UTILIZATION OF STANDARDS

The MiniBoxPFT™ 2.0 has met the following recognized standards:

IEC 60601-1:2005 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, 3td edition

IEC 60601-1-2:2007 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, 3td edition.

ASTM D4169-09, Standard Practice for Performance Testing of Shipping Containers and Systems

ASTM D4332-01, Standard practice for conditioning containers, packages, or packaging components for testing

ASTM D999-01 Standard Test Methods for Vibration Testing of Shipping Containers

ISO 26782:2009, to section 7.2, 7.4-7.6 & 7.8-7.9

SUMMARY OF NON-CLINICAL PERFORMANCE TESTING 5.6

Laboratory tests were performed to establish substantially equivalent performance of the MiniBoxPFTM 2.0 vs its predicate, and included electrical safety, software validation, and environmental testing. In addition, non-clinical bench testing was conducted to verify the performance of both the spirometry and lung volume measurements of the device.

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The spirometry bench tests (FDA 510(k) sections 18-1 and 18-2) verified that the performance of the MiniBoxPFT TM 2.0 spirometry measurements met the ATS guidelines - requirements of accuracy and repeatability for spirometry equipment.

A Repeatability & Reproducibility test was conducted (FDA 510(k) sections 18-3 and 18-4) and validated that inter-device repeatability and intra-device reproducibility were within the accepted known range for lung volume measurement.

An LVM validation test was conducted (FDA 510(k) sections 18-5 and 18-6), comparing the Total Lung Capacity (TLC) measurement of the proposed device with that of the predicate. TLC measurements were performed using the proposed device, MiniBoxPFTM 2.0 and the predicate device and pre-defined success criteria were set which demonstrate substantial equivalence of Lung Volume Measurement of the proposed device and the predicate device. The study results demonstrate that the MiniBoxPFTTM 2.0 successfully met the study success criteria and the performances of the Lung Volume Measurements are substantially equivalent to those of the predicate device.

5.7 SUMMARY OF CLINICAL PERFORMANCE DATA

No clinical study was conducted to support this application.

5.8 CONCLUSIONS

Based on its underlying technology and the lab and bench tests performed, the PulmOne MiniBoxPFT™ 2.0 is substantially equivalent to the predicate device.

4 M.R. Miller et al. Standardization of spirometry; Eur Respir J 2005; 26: 319-338

Regulation Number and Section

§ 868.1840 Diagnostic spirometer.

(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).