The PulmOne MiniBoxPFT is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung volumes). The PulmOne MiniBoxPFT is to be used by either a physician, respiratory therapist, or technician.

Device Description

The MiniBoxPFT™ is a table-top pulmonary function testing (PFT) device that measures both spirometry and lung volumes. It is developed and manufactured by PulmOne Advanced Medical Devices, Ltd. The MiniBoxPFT™ is composed of two modules: an OEM 510(k) cleared Spirometry module and a Lung Volume Measurement (LVM) module. A single-use, disposable viral-bacterial filter separates the patient from the internal components of the modules.

AI/ML Overview

The PulmOne MiniBoxPFT is a pulmonary function testing (PFT) device that measures spirometry and lung volumes. The pivotal study aimed to demonstrate that the Total Lung Capacity (TLC) measured by the device's Lung Volume Measurement (LVM) module is substantially equivalent to the TLC measured by the ZAN 500 Plethysmograph (predicate device).

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions "pre-defined success criterion was established from scientific literature that reported on the accuracy of FDA-cleared devices that measure TLC and compared these devices to TLC measured with body plethysmography." However, the specific numerical acceptance criteria (e.g., a specific percentage agreement or correlation coefficient) and the exact reported performance metrics (beyond "successfully met its primary success criterion for accuracy" and "no erroneous results") are not explicitly detailed in the provided text.

Acceptance Criteria	Reported Device Performance
Accuracy of TLC measurement compared to predicate device, based on scientific literature for FDA-cleared devices and body plethysmography.	The MiniBoxPFT™ successfully met its primary success criterion for accuracy of the TLC measurement compared to the predicate device.
Avoidance of erroneous results.	No erroneous results were obtained.
Substantial equivalence to the predicate device regarding TLC measurement.	The clinical data demonstrate that the performance of the MiniBoxPFT™ is substantially equivalent to the predicate device for measurement of TLC.

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

Sample Size: The document does not specify the exact sample size for the pivotal study. It states that the study "randomized subjects (healthy and non-healthy) of varying age, sex, and race."
Data Provenance: The study was "multi-centered," implying data was collected from multiple locations. The country of origin of the data is not specified. The study was prospective as subjects were measured on both the proposed device and the predicate device within the context of the study.

3. Number of Experts and Qualifications for Ground Truth:

This information is not provided in the document. The ground truth for the test set was the TLC measurements from the predicate device (ZAN 500 Plethysmograph).

4. Adjudication Method:

The document does not describe an adjudication method for the test set. The comparison was directly between the MiniBoxPFT™ and the predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This study focuses on the agreement between the new device and a predicate device for measuring physiological parameters, not on the improvement of human readers with AI assistance.

6. Standalone Performance Study:

Yes, a standalone study (algorithm only without human-in-the-loop performance) was performed. The pivotal study directly evaluated the MiniBoxPFT™'s ability to measure TLC by comparing its results to a predicate device. This is a standalone evaluation of the device's core function.

7. Type of Ground Truth Used:

The ground truth used for the pivotal study was the Total Lung Capacity (TLC) measurements obtained from the ZAN 500 Plethysmograph, which is the predicate device. This represents a reference standard for TLC measurement.

8. Sample Size for the Training Set:

A "feasibility study was conducted to determine the ability of the device to measure TLC and to develop the algorithm for measuring TLC." However, the sample size for this training set is not provided.

9. How Ground Truth for Training Set was Established:

The document states that the feasibility study was used "to develop the algorithm for measuring TLC." It implies that data collected during this feasibility study was used to train or refine the algorithm. However, it does not explicitly detail how the "ground truth" for this training data was established within the feasibility study (e.g., whether it was also compared to a reference standard like plethysmography, or if it was based on expert-defined physiological parameters).

Summary

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SECTION 5 - 510(K) SUMMARY 5

5.1 ADMINISTRATIVE INFORMATION

Date: September 30, 2013 Submitter: PulmOne Advanced Medical Devices, Ltd. 64 Asher Street Ra'anana, Israel 4355332 Tel: +972 77 5100 938 Fax: +972 77 5100 939 Official Correspondent: Avi Lazar, CEO Trade Name: PulmOne MiniBoxPFTTM Classification Name: Pulmonary-function data calculator Classification Number: 21 CFR 868.1880, 21 CFR 868.1840 Product Code: BZC, BZG Device Class: Class II 510(k) Number: K133051 Predicate Devices: Lung Volume Measurement Module

ZAN Messgeräte GmbH ZAN Lung-Function Lab 510(k) Number - K052328

Spirometry Module MIR Medical International Research Minispir 510(k) Number - K122384

5.2 DEVICE DESCRIPTION

Absolute Lung Volumes: Total lung capacity (TLC)

units L

CONFIDENTIAL AND PROPRIETARY

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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
Slow vital capacity (SVC)	L
Forced expiratory volume in 1 second (FEV1)	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

5.3 INTENDED USE AND INDICATIONS FOR USE

5.4 SUMMARY OF TECHNICAL CHARACTERISTICS

The MiniBoxPFT™ is comprised of two modules, each of which has its own predicate device:

1. The Lung Volume Measurement (LVM) module of the MiniBoxPFTM is substantially equivalent to the nSpire ZAN Lung-Function Lab (K052328). While there are slight differences in the technology between the proposed device and the predicate device (described below), the clinical performance testing demonstrates that these differences do not raise new questions of safety or effectiveness and that the proposed device is substantially equivalent to the predicate device.
1. The Spirometry module of the MiniBoxPFT™ has been sourced from Medical International Research and is identical in all respects to Medical International Research's Minispir (K122384). No changes were made to this module to allow its incorporation into the MiniBoxPFTM

In comparison to the ZAN 500 Plethysmograph, the LVM module of the MiniBoxPFT™ is technically similar in device construction (see Device Construction below) and methods of operation.

CONFIDENTIAL AND PROPRIETARY

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Device Construction: Both devices utilize well-recognized pressure sensors, flow sensors, and a valve in their operation. The MiniBoxPFT™ is technically simpler as it does not have a body chamber, which requires additional calibrations and can be influenced by the environmental surroundings.

Methods of Operation: The methods of operation for both devices require the subject to perform breathing maneuvers on a disposable viral-bacterial filter during flow interruptions while wearing disposable nose-clips. The MiniBoxPFTTM requires less time to perform the breathing maneuvers, has shorter duration flow interruptions, and only requires tidal breathing instead of panting.

The primary difference between the two devices is in their methods to calculate TLC from the measured data, as is described below.

Principles of Operation: The primary difference between the two devices is the equations used to calculate TLC. The ZAN 500 relies on pressure data obtained from the body box chamber to calculate TLC. Without a body box chamber, the MiniBoxPFTM only uses pressure and flow data measured at the mouth to calculate TLC.

ર્સ્ડ UTILIZATION OF STANDARDS

The MiniBoxPFT™ has met the following recognized standards:

IEC 60601-1 Ed.3 General Medical Device Safety

IEC 60601-1-1 Ed. 3 Medical Electrical Safety

IEC 60601-1-2 Ed.3 Electromagnetic Compatibility

ASTM D4332 - 01 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing

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

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

5.6 SUMMARY OF NON-CLINICAL PERFORMANCE TESTING

Non-clinical bench tests were performed to establish substantially equivalent performance and included electrical safety, software validation, and environmental testing. In addition,

CONFIDENTIAL AND PROPRIETARY

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bench testing was conducted to verify that the MiniBoxPFT did not alter the spirometry values calculated by the OEM spirometer, and to demonstrate repeatability and reproducibility of the TLC measurement.

The spirometry bench test verified that spirometry values calculated by the OEM spirometer were correctly reported by the MiniBoxPFT. The device successfully passed this test.

The repeatability and reproducibility bench test found that both intra-device repeatability and inter-device reproducibility values (reported as coefficients of variation) fell within pre-defined thresholds, and the device successfully passed this assessment.

5.7 SUMMARY OF CLINICAL PERFORMANCE DATA

A feasibility study was conducted to determine the ability of the device to measure TLC and to develop the algorithm for measuring TLC.

The pivotal study was conducted to demonstrate that the TLC measured with the Lung Volume Measurement (LVM) module of the MiniBoxPFT™ is substantially equivalent to the TLC measured with the ZAN 500 Plethysmograph. The study was multi-centered and randomized subjects (healthy and non-healthy) of varying age, sex, and race. All subjects were measured on both the proposed device and the predicate device. The primary endpoint was total lung capacity (TLC). Pre-defined success criterion was established from scientific literature that reported on the accuracy of FDA-cleared devices that measure TLC and compared these devices to TLC measured with body plethysmography. The clinical data demonstrate that the MiniBoxPFT successfully met its primary success criterion for accuracy of the TLC measurement compared to the predicate device. In addition, no erroneous results were obtained and thus the MiniBoxPFT successfully met its primary success criterion for specified performance. Further, no adverse events occurred during the study. Therefore, the clinical data demonstrate that the performance of the MiniBoxPFT is substantially equivalent to the predicate device for measurement of TLC. Based on these results, the clinical data demonstrate that the MiniBoxPFT is substantially equivalent to the predicate device with respect to TLC measurement.

5.8 CONCLUSIONS

The differences between the MiniBoxPFT™ and the ZAN 500 Plethysmograph do not raise new questions of safety or effectiveness .and, therefore, based on its underlying technology and both non-clinical and clinical performance testing, the PulmOne MiniBoxPFT™ is substantially equivalent to the predicate device.

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

May 2, 2014

Pulmone Advanced Medical Devices, Limited C/O Ms. Rhona Shanker Z & B Enterprises, Incorporated 12154 Darnestown Road, #236 Gaithersburg, MD 20878

Re: K133051

Trade/Device Name: MiniBoxPFT Regulation Number: 21 CFR 868.1880 Regulation Name: Pulmonary-function Data Calculator, Regulatory Class: II Product Code: BZC, BZG Dated: April 2, 2014 Received: April 2, 2014

Dear Ms. Shanker:

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

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

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Page 2 - Ms. Shanker

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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" (21CFR 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.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K 13305 I

Device Name

PulmOne MiniBoxPFT

Indications for Use (Describe)

The PulmOne MiniBoxPFT is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung volumes). The PulmOne MiniBox PFT is to be used by cither a physician, respiratory therapist, or technician.

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

Prescription Use (Pan 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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Digitally signed by James J. Lee DN: CAUS, o=U.S. Government, ou=HHS, ou=FDA, e, cn=James J. Lee,

2342 19200300.100.1.1=2000954859 Date: 2014.04.24 10:10:42 -04'00'

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FORM FDA 3881 (1/14)

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ISC/Holding Forevers (P) Ltd. M6745 EF

Regulation Number and Section

§ 868.1880 Pulmonary-function data calculator.

(a)
Identification. A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.(b)
Classification. Class II (performance standards).