(165 days)
The PulmOne MiniBox+ is intended to measure lung function in adult and pediatric patients, 5 years and older, while at rest (including spirometry, lung volumes and diffusing capacity). The PulmOne MiniBox+ is to be used by a physician, respiratory therapist, or technician in a hospital or clinic setting
The PulmOne MiniBox+ is intended to measure lung function in adult and pediatric patients while at rest (including spirometry, lung volumes and diffusing capacity). The PulmOne MiniBox+ is to be used by either a physician, respiratory therapist, or technician. A cleared single-use, disposable viral-bacterial filter separates the patient from the internal components of the device.
The MiniBox+ measures all common spirometric measurements as well as relative and absolute lung volumes and diffusing capacity.
The MiniBox+ is equipped with a diffusing capacity module which is embedded into the MiniBox+ enclosure and located in the upper end of the device. This feature allows easy measurement of the volumes and concentrations (CO and CH4) of inspired and expired breath, of the test gas mixture and patient sample respectively, making possible the calculation of the diffusion capacity [DLco]. MiniBox + DLco [diffusing capacity factor of the lung for carbon monoxide (CO)] module uses the single breath concept and enables the measurements by setting and controlling the maneuver stages as defined in ATS/ETS DLco guidelines.
Here's a breakdown of the acceptance criteria and study information for the PulmOne MiniBox+ device, based on the provided document:
Acceptance Criteria and Device Performance
The document describes the performance and technical specifications of the MiniBox+ and compares them to predicate devices. The MiniBox+ is a pulmonary function data calculator, and its performance is evaluated against established standards for spirometry, lung volumes, and diffusing capacity measurements.
Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from Predicate/Standards) | Reported Device Performance (MiniBox+) | Notes |
|---|---|---|---|
| Spirometry | Identical to MiniBoxPFT™ 2.0 (K141793) | ||
| Flow range | +/- 16 L/s (MiniBoxPFT™ 2.0) | +/- 16 L/s | Same as predicate. |
| Volume accuracy | +/- 3% or 50mL (MiniBoxPFT™ 2.0) | +/- 3% or 50mL | Same as predicate. |
| Flow accuracy | +/- 5% or 200mL/s (MiniBoxPFT™ 2.0) | +/- 5% or 200mL/s | Same as predicate. |
| Dynamic resistance at 14 L/s | < 0.7 cmH2O/(L/s) (MiniBoxPFT™ 2.0) | < 0.7 cmH2O/(L/s) | Same as predicate. |
| DLco (Diffusing Capacity) | Equivalent to ZAN LUNG-FUNCTION LAB (K052328) | ||
| CO Analyzer Measurement range | 0 to 3000 ppm (ZAN 500) | 0 to 3000 ppm | Identical. |
| CO Analyzer Accuracy | < 1% (ZAN 500) | < 1% | Identical. |
| CO Analyzer Neutral point drift | < 2% per week (ZAN 500) | < 2% per week | Identical. |
| CO Analyzer Linearity | < 1% (ZAN 500) | < 1% | Identical. |
| CH4 Analyzer Measurement range | 0 to 3000 ppm (ZAN 500) | 0 to 3000 ppm | Identical. |
| CH4 Analyzer Accuracy | 1% (ZAN 500) | 2.5% | The document states this difference is "Equivalent" because DLco is computed by the ratio of CH4-in/CH4-out, and linearity is more important. Linearity was tested and verified by the OEM manufacturer and through extensive tests versus a DLco gas simulator. Human measurements and comparison to the ZAN 500 found no adverse impact on substantial equivalence. |
| CH4 Analyzer Neural point drift | < 2% per week (ZAN 500) | < 2% per week | Identical. |
| CH4 Analyzer Linearity | < 1% (ZAN 500) | < 1% | Identical. |
| Test gas mixture | 0.3% Carbon monoxide (CO), 0.3% Methane (CH4), 21% Oxygen (O2) with balance Nitrogen (N2) (ZAN 500) | 0.3% Carbon monoxide (CO), 0.3% Methane (CH4), 21% Oxygen (O2) with balance Nitrogen (N2) | Identical. |
| Demand Valve | OEM by MSA (ZAN 500) | OEM by MSA | Equivalent (same component). |
| Lung Volume Measurement | Identical to MiniBoxPFT™ 2.0 (K141793) | ||
| Measurements (Mouth pressure and flow) | Mouth pressure and mouth flow (MiniBoxPFT™ 2.0) | Mouth pressure and mouth flow | Identical. |
| Calculations (TLC, TGV (FRC), RV, VC, IC and ERV) | TLC, TGV (FRC), RV, VC, IC and ERV (MiniBoxPFT™ 2.0) | TLC, TGV (FRC), RV, VC, IC and ERV | Identical. |
| Air Container | 15L elliptic container (MiniBoxPFT™ 2.0) | 15L elliptic container | Identical. |
Study Information
-
Sample size used for the test set and the data provenance:
- DLco human comparative testing: Not specified in the provided text.
- DLco human reproducibility testing: Not specified in the provided text.
- No other "test set" sample sizes or data provenance (e.g., country of origin, retrospective/prospective) are mentioned for non-clinical or clinical studies in this document. The focus of the non-clinical testing appears to be on simulator and comparative studies rather than a large clinical test set.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document mentions "DLco human comparative testing" and "DLco human reproducibility testing," but does not detail how ground truth was established for these or the number/qualifications of experts involved.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was mentioned. The device is a "Pulmonary-Function Data Calculator," and the documentation does not describe an AI component that would assist human readers in interpreting images or data in an MRMC setting. It's for direct measurement and calculation.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The document implies standalone performance testing for the device's measurement accuracy, particularly for DLco using a simulator ("DLco performance verification against simulator [Hans Rudolf]"). However, the "human comparative testing" and "human reproducibility testing" suggest interaction with humans, but not necessarily in an AI-assistive role. The core function is measurement and calculation, which is inherently "standalone" in its data generation, regardless of human interaction for the test.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the DLco gas analyzer, ground truth was established through OEM manufacturer verification (linearity) and testing against a DLco gas simulator [Hans Rudolf, Inc.].
- For human measurements, the ground truth was implied to be established through internal repeatability measurements and comparison against the predicate device, ZAN Function Lab [ZAN-500]. This suggests that the ZAN 500's measurements served as a de-facto ground truth for comparative purposes.
-
The sample size for the training set:
- Not applicable as this device is a measurement and calculation device, not a machine learning model that requires a training set in the conventional sense. Its "training" or calibration would involve ensuring its sensors and algorithms accurately reflect physical properties.
-
How the ground truth for the training set was established:
- Not applicable for the same reasons as above. The internal algorithms are based on established scientific principles of pulmonary function testing (e.g., ATS/ETS guidelines, Boyle's law for lung volume calculation) and calibrated against known standards and other validated devices.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 21, 2016
PulmOne Advanced Medical Devices, Ltd % Dr. Susan Alpert Principal SFA Consulting, LLC 200 Park Avenue, Unit 111 Minneapolis, Minnesota 55415
Re: K161295
Trade/Device Name: MiniBox + Regulation Number: 21 CFR 868.1880 Regulation Name: Pulmonary-Function Data Calculator Regulatory Class: Class II Product Code: BZC, BZG Dated: September 20, 2016 Received: September 22, 2016
Dear Dr. Susan 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 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
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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
Tina Kiang, Ph.D. 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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Indications for Use
510(k) Number (if known) K161295
Device Name MiniBox+
Indications for Use (Describe)
The PulmOne MiniBox+ is intended to measure lung function in adult and pediatric patients, 5 years and older, while at rest (including spirometry, lung volumes and diffusing capacity). The PulmOne MiniBox+ is to be used by a physician, respiratory therapist, or technician in a hospital or clinic setting
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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5 SECTION 5 – 510(K) SUMMARY
5.1 Administrative Information
| Date: | 15-October-2016 |
|---|---|
| Submitter: | PulmOne Advanced Medical Devices, Ltd.14 HaMelacha Street, Ra'ananna 4366107 , ISRAELTel: +972 77 5100 938Fax: +972 77 5100 939 |
| Official Correspondent: | Avi Lazar, CEO |
| Trade Name: | MiniBox+ |
| Classification Name:Classification Number:Product Code:Device Class: | Pulmonary-function data calculator21 CFR 868.1880BZC, BZGClass II |
| Predicate Devices: | Primary Predicate:PulmOne MiniBoxPFT™ 2.0510(k) Number -K141793Secondary Predicate:ZAN LUNG-FUNCTION LAB510(k) Number - K052328 |
| Application Correspondent: | Dr. Susan AlpertSFA Consulting, LLC200 Park Ave., unit 111Minneapolis, MN 55415Phone- 612-202-7019drsusanalpert@gmail.com |
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5.2 DEVICE DESCRIPTION
The PulmOne MiniBox+ is intended to measure lung function in adult and pediatric patients while at rest (including spirometry, lung volumes and diffusing capacity). The PulmOne MiniBox+ is to be used by either a physician, respiratory therapist, or technician. A cleared single-use, disposable viral-bacterial filter separates the patient from the internal components of the device.
The MiniBox+ measures all common spirometric measurements as well as relative and absolute lung volumes and diffusing capacity.
The MiniBox+ is equipped with a diffusing capacity module which is embedded into the MiniBox+ enclosure and located in the upper end of the device. This feature allows easy measurement of the volumes and concentrations (CO and CH4) of inspired and expired breath, of the test gas mixture and patient sample respectively, making possible the calculation of the diffusion capacity [DLco]. MiniBox + DLco [diffusing capacity factor of the lung for carbon monoxide (CO)] module uses the single breath concept and enables the measurements by setting and controlling the maneuver stages as defined in ATS/ETS DLco guidelines.
5.3 INTENDED USE AND INDICATIONS FOR USE
The PulmOne MiniBox+ is intended to measure lung function in adult and pediatric patients, 5 years and older, while at rest (including spirometry, lung volumes and diffusing capacity). The PulmOne MiniBox+ is to be used by a physician, respiratory therapist, or technician in a hospital or clinic setting.
5.4 Summary of Technical Characteristics
The MiniBox+ has been updated from the predicate version K141793. There have been no changes to the general intended use of the device to measure lung function or to the fundamental scientific technology. The Indications for use were updated to include the diffusing capacity module which is substantially equivalent to the one in ZAN 500 [K052328] and both utilize the same technologies and methods of operations. In addition, the software, firmware and hardware for the MiniBox+ in this submission has been updated to introduce minor software, firmware and hardware modifications to support this change.
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5.4.1 Summary table of Comparison
| Specification | MiniBox+ | MiniBoxPFT™ 2.0 | ZAN LUNG-FUNCTION LAB(ZAN 500 BodyPlethysmograph) | Differences discussion |
|---|---|---|---|---|
| 510(k) Number | Proposed Device | K141793 | K052328 | NA |
| Product Code / | BZC- Calculator, Pulmonary | BZC- Calculator, Pulmonary | BZC- Calculator, Pulmonary | Identical |
| Classification | Function Data | Function Data | Function Data | |
| BZG- Spirometer, DiagnosticClass II | BZG- Spirometer, DiagnosticClass II | BZG- Spirometer, DiagnosticClass II | ||
| Intended Use and | The PulmOne MiniBox+ is | The PulmOne MiniBoxPFT™ | ZAN Lung-Function Lab may | Equivalent. |
| Indications for | intended to measure lung | 2.0 is intended to measure | measure or monitor pulmonary | MiniBox + shares the same |
| Use | function in adult and | lung function in adult and | function in adult and pediatric | intended use as the cleared |
| pediatric patients, 5 years | pediatric patients while at | subjects during exercise | MiniBoxPFT™ 2.0 device with | |
| and older, while at rest | rest (including spirometry | (including diagnosis, training, | addition of diffusing capacity | |
| (including spirometry, lung | and lung volumes). The | and stress testing) or while at | module. diffusing capacity | |
| volumes and diffusing | PulmOne MiniBoxPFT™ 2.0 | rest | module added to Minibox + is | |
| capacity). The PulmOne | is to be used by either a | (including spirometry, airway | included with ZAN 500 | |
| MiniBox+ is to be used by a | physician, respiratory | strength and compliance, | intended use | |
| physician, respiratory | therapist, or technician. | diffusion capacity, body | ||
| therapist, or technician in ahospital or clinic setting | plethysmography, nutritionalassessment, and indirect | |||
| cardiac output) for diagnosis, | ||||
| rehabilitation, performance | ||||
| enhancement, and other | ||||
| related activities | ||||
| Target | Adult and Pediatric, 5 years | Adult and Pediatric | Adult and Pediatric | Identical to MiniBoxPFT™ 2.0 |
| Population | and older | |||
| Standards / | General medical device | General medical device | General medical device safety: | Equivalent. |
| Performance | safety: IEC 60601- | safety: | EN 60601-1 Medical electrical | MiniBox + complies with the |
| guideline | 1:2005+A1:2012 [3.1 Ed. ] | IEC 60601-1:2005 (3rd Ed) | safety: Electromagnetic | IEC 60601-1 [3.1Ed] and IEC60601-1-2[4th Ed] |
| compliance | Medical electrical safety:Electromagnetic | Electromagnetic | compatibility: EN 60601-1-2 | |
| compatibility: IEC 60601-1- | compatibility: | |||
| 2:2014 [4th Ed] | IEC 60601-1-2:2007 (3rd Ed) | |||
| - ATS/ETS :2005, | -Performance per ATS 2005 | |||
| Standardization of lung | Standards | |||
| function testing | - ISO 26782 compliance to | |||
| -- ISO 26782 compliance to | section 7.2, 7.4-7.6 & 7.8-7.9 | |||
| section 7.2, 7.4-7.6 & 7.8-7.9 | ||||
| Patient | Patient direct contact with | Patient direct contact with | Single-use, disposable FDA- | Identical to MiniBoxPFT™ 2.0 |
| Contacting Parts | the cleared disposable viral | the cleared disposable viral | cleared viral bacterial filter or a | |
| and bacterial filter, K051712 | and bacterial filter, K051712 | mouthpiece. Single-use, | ||
| User Interface | LCD display with touch panel; | LCD display with touch panel; | disposable nose clipsLCD display with keyboard and | Identical to MiniBoxPFT™ 2.0 |
| and reports | top table device | top table device | mouse | |
| Physical | 21 x 10.5 x 4.5 cm | 21 x 10.5 x 4.5 cm | Dimensions: 71 x 87 x 174 cm | Equivalent. |
| Dimension | Weight: ~10 kg | Weight: ~300gr | Volume: 980 L Weight: 145 kg | Additional Weight due toembedded DLco module |
| DIFFUSING CAPACITY [Gas Analyzer] | ||||
| -Technology: Infrared | Not Applicable | -Technology: Infrared | Identical | |
| CO Analyzer | absorption | absorption | ||
| Specification | MiniBox+ | MiniBoxPFT™ 2.0 | ZAN LUNG-FUNCTION LAB(ZAN 500 BodyPlethysmograph) | Differences discussion |
| -Measurement range: 0 to3000 ppm-Accuracy: <1%-Neutral point drift: <2% perweek-Linearity: <1% | -Measurement range: 0 to 3000ppm-Accuracy: <1%-Neutral point drift: <2% perweek-Linearity: <1% | |||
| CH4 analyzer | Technology: Infraredabsorption-Measurement range: 0 to3000 ppm-Accuracy: 2.5%-Neutral point drift: <2% perweek-Linearity: <1% | Not Applicable | -Technology: Infraredabsorption-Measurement range: 0 to 3000ppm-Accuracy: 1%-Neutral point drift: <2% perweek-Linearity: <1% | Equivalent.Since DLco is computed bythe ratio of CH4-in/CH4-out,the more important GasAnalyzer parameter is –linearity. That linearity wastested and verified by theOEM manufacturer andthrough extensive testsversus the DLco gas simulator[Hans Rudolf, Inc. The GasAnalyzer accuracy was alsoestablished by humanmeasurements, based oninternal repeatabilitymeasurements as well asversus the predicate device -the ZAN Function Lab [ZAN-500] concluded that MiniBox+didn't adversely impact thesubstantial equivalence toZAN 500 , the predicatedevice |
| Test gas | mixture of 0.3% Carbonmonoxide (CO), 0.3%Methane (CH4),21% Oxygen (O2) withbalance Nitrogen (N2). | Not Applicable | mixture of 0.3% Carbonmonoxide (CO), 0.3% Methane(CH4),21% Oxygen (O2) with balanceNitrogen (N2). | Identical |
| Demand Valve | OEM by MSA | Not Applicable | OEM by MSA | EquivalentSame component as includedwith ZAN 500 |
| Calculation andDisplayedparameters | BHT , DLco, VA,VI, CO , CH4and KCO | Not Applicable | BHT , DLco, VA,VI, CO , CH4 andKCO | Identical |
| LUNG VOLUME MEASUREMENT | ||||
| Measurements | Mouth pressure and mouthflow | Mouth pressure and mouthflow | Mouth pressure and mouthflow | Identical |
| Calculations | TLC, TGV (FRC), RV, VC, IC andERV | TLC, TGV (FRC), RV, VC, IC andERV | TLC, FRC, RV, IC, VC, TV, IRV,ERV | Identical |
| Principle ofOperation | 1) Pressure and flow aremeasured at the mouth2) Spirometry is measuredwith the handheldspirometer.3) Proprietary equation isused to calculate total lung | 1) Pressure and flow aremeasured at the mouth2) Spirometry is measuredwith the handheldspirometer.3) Proprietary equation isused to calculate total lung | 1) Pressure and flow aremeasured at the mouth2) Pressure is measured in thebody box3) Equation based on Boyle'slaw is used to calculate totallung capacity | Identical to MiniBoxPFT™ 2.0 |
| Specification | MiniBox+ | MiniBoxPFT™ 2.0 | ZAN LUNG-FUNCTION LAB(ZAN 500 BodyPlethysmograph) | Differences discussion |
| capacity | capacity | |||
| Method ofOperation | 1) Patient seated atdesk/table | 1) Patient seated atdesk/table | 1) Patient seated in body box 2)30 sec shallow panting (1 Hz)3) 1-5 second shutter closure4) Inspiration to TLC5) Slow expiration to RV | Identical to MiniBoxPFT™ 2.0 |
| 2) 1-2 minutes normalbreathing | 2) 1-2 minutes normalbreathing | |||
| 3) 100 ms shutter closure perbreath | 3) 100 ms shutter closure perbreath | |||
| 4) Inspiration to TLC | 4) Inspiration to TLC | |||
| 5) Slow expiration to RV | 5) Slow expiration to RV | |||
| Air Container | 15L elliptic container | 15L elliptic container | Body Box Chamber | Identical to MiniBoxPFT™ 2.0 |
| SPIROMETRY MEASUREMENT | ||||
| Measurements | Mouth flow | Mouth flow | Mouth flow | Identical |
| FEF25-75, FEV3, FEV3/FVC, | FEF25-75, FEV3, FEV3/FVC, | Flow-volume loop, FVC, FEV1,FEV1/FVC%, PEF, FEF25%,FEF50%, FEF75%, PIF | Identical to MiniBoxPFT™ 2.0 | |
| CalculatedParameters | FET, FEF 25, FEF50, FEF75,Evol, FIVC, FIV1, FIVC1/FIVC,PIF, IC, SVC, ERV, TV, IVC,EVC, MVV, MVV rate | FET, FEF 25, FEF50, FEF75,Evol, FIVC, FIV1, FIVC1/FIVC,PIF, IC, SVC, ERV, TV, IVC,EVC, MVV, MVV rate | ||
| DisplayedParameters | 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 andMVV Rate | 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 andMVV Rate | Flow-volume loop, FVC, FEV1,FEV1/FVC%, PEF, FEF25%,FEF50%, FEF75%, PIF | Identical to MiniBoxPFT™ 2.0 |
| TechnicalSpecifications | Flow range: +/- 16 L/sVolume accuracy: +/- 3% or50mLFlow accuracy: +/- 5% or 200mL/sDynamic resistance at 14 L/s:<0.7 cmH2O/(L/s)Dimension: 210x105x45 mmWeight: 300 grams | Flow range: +/- 16 L/sVolume accuracy: +/- 3% or50mLFlow accuracy: +/- 5% or 200mL/sDynamic resistance at 14 L/s:<0.7 cmH2O/(L/s)Dimension: 210x105x45 mmWeight: 300 grams | Flow range: +/- 20 L/s Volumeaccuracy: <2% Flow accuracy:+/- 2% Dynamic resistance at14 L/s:<0.8 cmH2O/(L/s) Dimensions:100x50x50 mm Weight: 57grams | Identical to MiniBoxPFT™ 2.0 |
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5.5 UTILIZATION OF STANDARDS AND GUIDANCE'S:
The MiniBox+ met the following standards and guidance's:
IEC 60601-1:2005+A1:2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
ASTM D4169-14, Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM D4332-14, Standard practice for conditioning containers, packages, or packaging components for testing
ISO 26782:2009, to section 7.2, 7.4-7.6 & 7.8-7.9
ATS/ETS :2005, Standardization of lung function testing
5.6 Summary of Non-Clinical Performance Testing
Summary of Non-Clinical Tests:
The MiniBox+ has been thoroughly tested through verification of Specifications and validation, including software validation. The following verification and validation testing were applied to the development of the system:
DLco performance verification against simulator [Hans Rudolf],DLco human comparative testing and DLco human reproducibility testing.
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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 bench tests performed, the PulmOne MiniBox+ is substantially equivalent to the predicate devices.
§ 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).