MiniBox +

K161295 · Pulmone Advanced Medical Devices, Ltd. · BZC · Oct 21, 2016 · Anesthesiology

Device Facts

• Record ID: K161295
• Device Name: MiniBox +
• Applicant: Pulmone Advanced Medical Devices, Ltd.
• Product Code: BZC · Anesthesiology
• Decision Date: Oct 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1880
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

MiniBox+ measures lung function, including spirometry, lung volumes, and diffusing capacity (DLco). Device inputs include patient breath samples (inspired/expired gas concentrations of CO and CH4) and mouth pressure/flow measurements. It utilizes an embedded infrared absorption gas analyzer and a single-breath maneuver to calculate DLco, following ATS/ETS guidelines. Lung volumes are calculated using proprietary equations based on mouth pressure and flow. Used in hospitals or clinics by physicians, respiratory therapists, or technicians. Output is displayed on an integrated LCD touch panel for clinical assessment of pulmonary function. Benefits include non-invasive, resting-state lung function diagnostics.

Clinical Evidence

No clinical study was conducted. Evidence consists of bench testing, including DLco performance verification against a Hans Rudolf simulator, human comparative testing, and human reproducibility testing.

Technological Characteristics

Class II pulmonary-function data calculator. Features an embedded infrared absorption gas analyzer for CO/CH4. Uses a single-use, disposable viral-bacterial filter. Complies with IEC 60601-1 (3.1 Ed) and IEC 60601-1-2 (4th Ed). Dimensions: 21 x 10.5 x 4.5 cm; Weight: ~10 kg. Software/firmware updated to support the DLco module.

Indications for Use

Indicated for measuring lung function (spirometry, lung volumes, diffusing capacity) in adult and pediatric patients aged 5 years and older at rest. Used by physicians, respiratory therapists, or technicians in clinical settings.

Regulatory Classification

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.

Predicate Devices

• PulmOne MiniBoxPFT™ 2.0 (K141793)
• ZAN LUNG-FUNCTION LAB (K052328)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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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## 5 SECTION 5 – 510(K) SUMMARY

#### 5.1 Administrative Information

| Date: | 15-October-2016 |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | PulmOne Advanced Medical Devices, Ltd.<br>14 HaMelacha Street, Ra'ananna 4366107 , ISRAEL<br>Tel: [phone]<br>Fax: [phone] |
| Official Correspondent: | Avi Lazar, CEO |
| Trade Name: | MiniBox+ |
| Classification Name:<br>Classification Number:<br>Product Code:<br>Device Class: | Pulmonary-function data calculator<br>21 CFR 868.1880<br>BZC, BZG<br>Class II |
| Predicate Devices: | Primary Predicate:<br>PulmOne MiniBoxPFT™ 2.0<br>510(k) Number -K141793<br><br>Secondary Predicate:<br>ZAN LUNG-FUNCTION LAB<br>510(k) Number - K052328 |
| Application Correspondent: | Dr. Susan Alpert<br>SFA Consulting, LLC<br>200 Park Ave., unit 111<br>Minneapolis, MN 55415<br>Phone- 612-202-7019<br>[e-mail] |

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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<br>(ZAN 500 Body<br>Plethysmograph) | 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, Diagnostic<br>Class II | BZG- Spirometer, Diagnostic<br>Class II | BZG- Spirometer, Diagnostic<br>Class 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 a<br>hospital or clinic setting | | plethysmography, nutritional<br>assessment, 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 IEC<br>60601-1-2[4th Ed] |
| compliance | Medical electrical safety:<br>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 clips<br>LCD 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 to<br>embedded 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<br>(ZAN 500 Body<br>Plethysmograph) | Differences discussion |
| | -Measurement range: 0 to<br>3000 ppm<br>-Accuracy: <1%<br>-Neutral point drift: <2% per<br>week<br>-Linearity: <1% | | -Measurement range: 0 to 3000<br>ppm<br>-Accuracy: <1%<br>-Neutral point drift: <2% per<br>week<br>-Linearity: <1% | |
| CH4 analyzer | Technology: Infrared<br>absorption<br>-Measurement range: 0 to<br>3000 ppm<br>-Accuracy: 2.5%<br>-Neutral point drift: <2% per<br>week<br>-Linearity: <1% | Not Applicable | -Technology: Infrared<br>absorption<br>-Measurement range: 0 to 3000<br>ppm<br>-Accuracy: 1%<br>-Neutral point drift: <2% per<br>week<br>-Linearity: <1% | Equivalent.<br>Since DLco is computed by<br>the ratio of CH4-in/CH4-out,<br>the more important Gas<br>Analyzer parameter is –<br>linearity. That linearity was<br>tested and verified by the<br>OEM manufacturer and<br>through extensive tests<br>versus the DLco gas simulator<br>[Hans Rudolf, Inc. The Gas<br>Analyzer accuracy was also<br>established by human<br>measurements, based on<br>internal repeatability<br>measurements as well as<br>versus the predicate device -<br>the ZAN Function Lab [ZAN-<br>500] concluded that MiniBox+<br>didn't adversely impact the<br>substantial equivalence to<br>ZAN 500 , the predicate<br>device |
| Test gas | mixture of 0.3% Carbon<br>monoxide (CO), 0.3%<br>Methane (CH4),<br>21% Oxygen (O2) with<br>balance Nitrogen (N2). | Not Applicable | mixture of 0.3% Carbon<br>monoxide (CO), 0.3% Methane<br>(CH4),<br>21% Oxygen (O2) with balance<br>Nitrogen (N2). | Identical |
| Demand Valve | OEM by MSA | Not Applicable | OEM by MSA | Equivalent<br>Same component as included<br>with ZAN 500 |
| Calculation and<br>Displayed<br>parameters | BHT , DLco, VA,VI, CO , CH4<br>and KCO | Not Applicable | BHT , DLco, VA,VI, CO , CH4 and<br>KCO | Identical |
| LUNG VOLUME MEASUREMENT | | |…