(165 days)
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No
The document does not mention AI, ML, or related terms, and the device description focuses on standard lung function measurement techniques.
No
The device is intended to measure lung function (diagnostic), not to treat or cure a condition.
Yes
The device measures lung function, which can be used to diagnose respiratory conditions.
No
The device description explicitly mentions physical components like an enclosure, a diffusing capacity module, and a disposable viral-bacterial filter, indicating it is a hardware device with embedded software.
Based on the provided information, the PulmOne MiniBox+ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- PulmOne MiniBox+ Function: The PulmOne MiniBox+ measures lung function directly in the patient by analyzing inhaled and exhaled breath. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it measures lung function in patients while at rest.
- Device Description: The description details the measurement of breath volumes and concentrations, not the analysis of bodily fluids or tissues.
Therefore, the PulmOne MiniBox+ falls under the category of a medical device used for physiological measurement, but not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BZC, BZG
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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
Indicated Patient Age Range
Adult and pediatric patients, 5 years and older
Intended User / Care Setting
physician, respiratory therapist, or technician in a hospital or clinic setting
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
No clinical study was conducted to support this application.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
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
1
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
2
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)
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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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 , ISRAEL | |
| Tel: +972 77 5100 938 | |
| Fax: +972 77 5100 939 | |
| Official Correspondent: | Avi Lazar, CEO |
| Trade Name: | MiniBox+ |
| Classification Name: | |
| Classification Number: | |
| Product Code: | |
| Device Class: | Pulmonary-function data calculator |
| 21 CFR 868.1880 | |
| BZC, BZG | |
| Class II | |
| Predicate Devices: | Primary Predicate: |
| PulmOne MiniBoxPFT™ 2.0 | |
| 510(k) Number -K141793 |
Secondary Predicate:
ZAN LUNG-FUNCTION LAB
510(k) Number - K052328 |
| Application Correspondent: | Dr. Susan Alpert
SFA Consulting, LLC
200 Park Ave., unit 111
Minneapolis, MN 55415
Phone- 612-202-7019
drsusanalpert@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 Body
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
Class II | BZG- Spirometer, Diagnostic
Class II | BZG- Spirometer, Diagnostic
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
hospital or clinic setting | | plethysmography, nutritional
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
60601-1-2[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 clips
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
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
(ZAN 500 Body
Plethysmograph) | Differences discussion |
| | -Measurement range: 0 to
3000 ppm
-Accuracy: