(247 days)
Not Found
No
The summary describes a device for measuring lung function using standard spirometry and lung volume techniques. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The performance studies focus on verifying the accuracy and repeatability of standard measurements against established guidelines and a predicate device.
No
The device is intended to measure lung function, not to provide therapy or treatment.
Yes
The device is intended to measure lung function (spirometry and lung volumes), which are physiological measurements used by medical professionals to diagnose respiratory conditions. The "Intended Use" explicitly states it's for measuring lung function, and the detailed list of measurements further supports its role in assessing a patient's physiological state for diagnostic purposes.
No
The device description explicitly mentions a "single-use, disposable viral-bacterial filter" and refers to "internal components of the device," indicating the presence of hardware beyond just software.
Based on the provided information, the PulmOne MiniBoxPFT™ 2.0 is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The intended use and device description clearly state that the MiniBoxPFT™ 2.0 measures lung function in patients by having them breathe into the device. It does not analyze biological samples like blood, urine, or tissue.
- The measurements are physiological. The device measures physical parameters related to breathing and lung capacity (volumes and flows), which are direct physiological measurements, not analyses of biological components.
Therefore, the PulmOne MiniBoxPFT™ 2.0 is a diagnostic device, but it falls under the category of a physiological measurement device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
BZG, BZC
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
Used by either a physician, respiratory therapist, or technician.
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)
SUMMARY OF NON-CLINICAL PERFORMANCE TESTING
Laboratory tests were performed to establish substantially equivalent performance of the MiniBoxPFT™ 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.
The spirometry bench tests (FDA 510(k) sections 18-1 and 18-2) verified that the performance of the MiniBoxPFT™ 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, MiniBoxPFT™ 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 MiniBoxPFT™ 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.
SUMMARY OF CLINICAL PERFORMANCE DATA
No clinical study was conducted to support this application.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PulmOne MiniBoxPFT™ K133051
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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
1
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
2
Indications for Use
510(k) Number (if known) K141793 pending
Device Name PulmOne MiniBoxPFT™ 2.0
Indications for Use (Describe)
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.
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)
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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 , ISRAEL | |
| Tel: +972 77 5100 938 | |
| Fax: +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 MiniBoxPFTTM |
| 510(k) Number – K133051 |
5.2 DEVICE DESCRIPTION
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: | 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
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.
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 and
Indications for Use | The PulmOne MiniBoxPFTTM is
intended to measure lung function in
adult and pediatric patients while at
rest (including spirometry and lung
volumes).
The PulmOne MiniBoxPFTTM is to
be used by either a physician,
respiratory therapist, or technician. | Identical |
| Target Population | Adult and pediatric subjects | Identical |
| Biocompatibility | - Mouthpiece:
Single-use FDA-cleared viral
bacterial filter (K051712)
- Hand-Held sub-system:
Skin Contact - Using Cleared OEM
handle MIR , [K122384] | - Mouthpiece:
Identical - Hand-Held sub-system:
Skin Contact , Using Biocompatible
Makrolon 2825 Polycarbonate material
in compliance with ISO10993-1 |
| Standards /
Performance
guideline
compliance | -General medical device safety: IEC
60601-1:2005 (3rd Ed)
-Electromagnetic compatibility:
IEC 60601-1-2:2007 (3rd Ed)
-Performance per ATS 2005
Standards | Same with additional of ISO 26782
compliance to section 7.2, 7.4-7.6 &
7.8-7.9 |
| Environmental
Operating
Conditions | Temperature: 0 to 40 °C
Relative Humidity: 20 to 90 %
Atmospheric Pressure: 900 to 1060
cmH2O | Identical |
| Flow Sensor | 1. Bi-directional hot-wire mass
airflow sensor
Range: +/- 5.0 L/s
- Bi-directional digital turbine
Range: +/- 16.0 L/s
[Part of the incorporated
OEM cleared MIR Minispir,
K122384] | Bi-directional Symmetric and
averaging Pitot-Tube
Range: +/- 16.0 L/s |
| Pressure Sensor | Bi-directional piezo-resistive
Mouth Sensor:
Range: ±70 cmH2O (±1 PSI)
Accuracy: ±0.25% Full Scale | Identical |
| Valve | Computer-controlled solenoid valve
Closing response time: 4 M.R. Miller et al. Standardization of spirometry; Eur Respir J 2005; 26: 319-338