(125 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the use of "Algorithms" which is a general term and does not specifically indicate AI/ML. The performance studies are based on standard bench tests and comparison to a predicate device, not on training or testing of an AI/ML model.
No
The device is described as a "diagnostic spirometer for the measurement of patient breath flow and volume" and is intended for "performing basic lung function tests", indicating it is used for diagnosis and monitoring, not for providing therapy.
Yes
A spirometer is used to diagnose lung conditions. The device description explicitly states, "The Cohero Health SpiroThor Spirometer is a hand-held portable diagnostic spirometer."
No
The device description explicitly states it consists of a "compact main unit and an ultrasonic flowmeter sensor" and is a "hand-held portable diagnostic spirometer," indicating it includes hardware components beyond just software.
Based on the provided information, the SpiroThor spirometer is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The SpiroThor measures breath flow and volume directly from the patient's respiratory system. It does not analyze a biological sample like blood, urine, or tissue.
- The intended use describes a functional measurement. The device is used to perform "basic lung function tests," which are physiological measurements, not laboratory analyses of biological samples.
- The device description focuses on physical measurement. It describes an ultrasonic sensor measuring flow and algorithms determining values based on this flow measurement. This is a physical measurement process, not a chemical, immunological, or molecular analysis of a biological sample.
Therefore, the SpiroThor spirometer falls under the category of a diagnostic medical device that performs physiological measurements, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SpiroThor spirometer is a freestanding laboratory instrument for performing basic lung function tests in adults and children over the age of four years.
It is intended to be used by physicians or professional medical personnel for testing in physicians' offices, industrial medical, and hospital settings.
Product codes
BZG
Device Description
The Cohero Health SpiroThor Spirometer is a hand-held portable diagnostic spirometer for the measurement of patient breath flow and volume. The proposed device consists of a compact main unit and an ultrasonic flowmeter sensor used with a pulmonary function filter. The device uses an ultrasonic sensor that measures flow. Algorithms are used to determine values based on this flow measurement. Tabular and graphical data are displayed on the spirometer LCD display.
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
adults and children over the age of four years.
Intended User / Care Setting
It is intended to be used by physicians or professional medical personnel for testing in Physicians' offices, industrial medical, and hospital settings.
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)
Non-Clinical Testing Summary -
For K092813, THOR performed a number of bench tests.
These included:
- American Thoracic Society (ATS) 24 standard waveforms
- ISO 26782:2009
- Accuracy of waveform generator -
- Flow resistance test
- EN 60601-1:2006/AC:2010 -
- EN 60601-1-2:2007/AC:2010 -
- EN 60601-1-6:2010
- Performance to specifications with each bacterial filter -
The testing demonstrated that the SpiroThor performed as intended and met its performance specifications and was found to be substantially equivalent to the predicate K092813 - SDI AstraSonic Diagnostic Spirometer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K092813 – AstraSonic Spirometer, K051712 – Air Safety Model 2800 PFT Filter
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
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" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stylized to resemble a bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 27, 2015
Cohero Health LLC c/o Mr. Paul Dryden Consultant 335 Madison Avenue, 3rd Floor New York, New York 10017
Re: K150137
Trade/Device Name: SpiroThor Regulation Number: 21 CFR 868.1840 Regulation Name: Spirometer, diagnostic Regulatory Class: II Product Code: BZG Dated: April 21, 2015 Received: April 22, 2015
Dear Mr. Dryden:
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.
1
Page 2 - Mr. Dryden
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance 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,
Teiashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K150137
Device Name
SpiroThor
Indications for Use (Describe)
SpiroThor spirometer is a freestanding laboratory instrument for performing basic lung function tests in adults and children over the age of four years.
It is intended to be used by physicians or professional medical personnel for testing in physicians' offices, industrial medical, and hospital settings.
Type of Use (Select one or both, as applicable)
| XX 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)
Page 1 of 1
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510(k) Summary Page 1 of 5
| Date Prepared: | 26-May-2015 |
|---|---|
| Cohero Health LLC | |
| 335 Madison Ave., 3rd Floor | |
| New York, NY 10017 | Phone - 917.363.5408 |
| Fax - 212.423.2998 | |
| Official Contact: | Melissa Manice, Ph.D., CEO |
| Proprietary or Trade Name: | SpiroThor |
| Common/Usual Name: | Spirometer |
| Classification Name: | 21CFR 868.1840 |
| 73 BZG – Spirometer, Diagnostic | |
| Class II | |
| Predicate Devices: | K092813 – AstraSonic Spirometer |
| K051712 – Air Safety Model 2800 PFT Filter |
Device Description:
The Cohero Health SpiroThor Spirometer is a hand-held portable diagnostic spirometer for the measurement of patient breath flow and volume. The proposed device consists of a compact main unit and an ultrasonic flowmeter sensor used with a pulmonary function filter. The device uses an ultrasonic sensor that measures flow. Algorithms are used to determine values based on this flow measurement. Tabular and graphical data are displayed on the spirometer LCD display.
We note that the proposed SpiroThor is identical to the AstraSonic Spirometer cleared under K092813 with these differences, name change and that another cleared bacterial filter may be used with the device.
Indications for Use:
SpiroThor spirometer is a freestanding laboratory instrument for performing basic lung function tests in adults and children over the age of four years.
It is intended to be used by physicians or professional medical personnel for testing in Physicians' offices, industrial medical, and hospital settings.
Substantial Equivalence Discussion:
The proposed device is substantially equivalent to the predicate device, manufactured by Thor Medical for SDI Diagnostics and cleared under the SDI name K092813 as the AstraSonic spirometer except as noted above, i.e. name change and another bacterial filter may be used.
Tables 1 and 2 compare the key features of the proposed SpiroThor with the identified predicate and demonstrate that the proposed device is substantially equivalent.
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510(k) Summary Page 2 of 5
26-May-2015
Table 1 – Comparison to Predicate
| Specification | K092813 - SDI AstraSonic
Diagnostic Spirometer | Proposed Device
SpiroThor |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Indicationsfor Use | The SDI AstraSonic Spirometer
is a freestanding laboratory
instrument for performing basic
lung function tests. | The SpiroThor Spirometer is a
freestanding laboratory
instrument for performing basic
lung function tests. |
| Environment of Use | Physicians' offices, industrial
medical and hospital settings | Physicians' offices, industrial
medical and hospital settings |
| Patient Population | Adults and children over the age
of four years | Adults and children over the age
of four years |
| Temperature Sensor | Semiconductor
(-25 °C - +85 °C) | Semiconductor
(-25 °C - +85 °C) |
| Display | Graphic Quarter VGA (320x240
pixels), 262K colors | Graphic Quarter VGA (320x240
pixels), 262K colors |
| Keyboard | 20-key keyboard | 20-key keyboard |
| Connection Type | USB, BlueTooth | USB, BlueTooth |
| Flow Tube
Dimensions | Ø30 mm x 150 mm | Ø30 mm x 150 mm |
| Power Supply | Internal 3.7 V Li-Ion battery
(Rechargeable via 5V 500mA
mini USB charger) | Internal 3.7 V Li-Ion battery
(Rechargeable via 5V 500mA
mini USB charger) |
| Dimensions | 85x120x35 mm
(Flow tube: 26 mm(ID)x150 mm) | 85x120x35 mm
(Flow tube: 26 mm(ID)x150 mm) |
| Weight | 300g | 300g |
| Flow/Volume | Bidirectional, ultrasound | Bidirectional, ultrasound |
| Measurement System | Ultrasonic technology (referred to
as "WaveFront™ technology" | Ultrasonic technology (referred
to as "WaveFront™ technology" |
| Volume Range | ± 20 L (BTPS) | ± 20 L (BTPS) |
| Flow Range | ± 18 L/s (BTPS) | ± 18 L/s (BTPS) |
| Volume Accuracy | ± 3% or 50 mL | ± 3% or 50 mL |
| Flow Accuracy | ± 3% or 20 mL/s | ± 3% or 20 mL/s |
| Dynamic
Resistance at 14 L/s |