SpiroThor

K150137 · Cohero Health, LLC · BZG · May 27, 2015 · Anesthesiology

Device Facts

• Record ID: K150137
• Device Name: SpiroThor
• Applicant: Cohero Health, LLC
• Product Code: BZG · Anesthesiology
• Decision Date: May 27, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Hand-held portable diagnostic spirometer; measures patient breath flow and volume via ultrasonic flowmeter sensor. Device consists of main unit and pulmonary function filter. Ultrasonic technology (WaveFront™) measures bidirectional flow; algorithms calculate lung function parameters (e.g., FVC, FEV1, PEF). Data displayed on LCD; supports USB/Bluetooth connectivity. Used by physicians/medical personnel in clinics/hospitals. Output provides diagnostic lung function metrics to assist clinical decision-making. Benefits include portable, objective assessment of respiratory function.

Clinical Evidence

No clinical testing performed. Substantial equivalence supported by bench testing, including ATS 24 standard waveforms, ISO 26782:2009 compliance, flow resistance testing, and electrical safety/EMC testing (EN 60601-1, EN 60601-1-2, EN 60601-1-6).

Technological Characteristics

Ultrasonic flow measurement (WaveFront™ technology); semiconductor temperature sensor (-25°C to +85°C). Dimensions: 85x120x35 mm; weight: 300g. Power: 3.7V Li-Ion battery. Connectivity: USB, Bluetooth. Materials: Identical to predicate, compliant with ISO 10993-1:2009 for limited duration (<24h) mucosal/gas pathway contact. Software: Embedded algorithms for flow/volume calculation.

Indications for Use

Indicated for adults and children over age four requiring basic lung function testing in clinical, industrial, or hospital settings.

Regulatory Classification

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.

Predicate Devices

• AstraSonic Spirometer (K092813)
• Air Safety Model 2800 PFT Filter (K051712)

Reference Devices

• AstraGuard (K062913)

Submission Summary (Full Text)

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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" 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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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#### 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<br>335 Madison Ave., 3rd Floor<br>New York, NY 10017 | Phone - 917.363.5408<br>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<br>73 BZG – Spirometer, Diagnostic<br>Class II |
| Predicate Devices: | K092813 – AstraSonic Spirometer<br>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<br>Diagnostic Spirometer | Proposed Device<br>SpiroThor |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Indicationsfor Use | The SDI AstraSonic Spirometer<br>is a freestanding laboratory<br>instrument for performing basic<br>lung function tests. | The SpiroThor Spirometer is a<br>freestanding laboratory<br>instrument for performing basic<br>lung function tests. |
| Environment of Use | Physicians' offices, industrial<br>medical and hospital settings | Physicians' offices, industrial<br>medical and hospital settings |
| Patient Population | Adults and children over the age<br>of four years | Adults and children over the age<br>of four years |
| Temperature Sensor | Semiconductor<br>(-25 °C - +85 °C) | Semiconductor<br>(-25 °C - +85 °C) |
| Display | Graphic Quarter VGA (320x240<br>pixels), 262K colors | Graphic Quarter VGA (320x240<br>pixels), 262K colors |
| Keyboard | 20-key keyboard | 20-key keyboard |
| Connection Type | USB, BlueTooth | USB, BlueTooth |
| Flow Tube<br>Dimensions | Ø30 mm x 150 mm | Ø30 mm x 150 mm |
| Power Supply | Internal 3.7 V Li-Ion battery<br>(Rechargeable via 5V 500mA<br>mini USB charger) | Internal 3.7 V Li-Ion battery<br>(Rechargeable via 5V 500mA<br>mini USB charger) |
| Dimensions | 85x120x35 mm<br>(Flow tube: 26 mm(ID)x150 mm) | 85x120x35 mm<br>(Flow tube: 26 mm(ID)x150 mm) |
| Weight | 300g | 300g |
| Flow/Volume | Bidirectional, ultrasound | Bidirectional, ultrasound |
| Measurement System | Ultrasonic technology (referred to<br>as "WaveFront™ technology" | Ultrasonic technology (referred<br>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<br>Resistance at 14 L/s | < 1.1 cmH2O/L/s | < 1.1 cmH2O/L/s |
| Disposable in-line<br>filter | AstraGuard - K062913 | Air Safety - K051712 |
| Electrical<br>Protection | Internal battery power | Internal battery power |
| Printer | External printer via RS232 or<br>BlueTooth | External printer via RS232 or<br>BlueTooth |

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## 510(k) Summary Page 3 of 5 26-May-2015

#### Table 2 - Comparison to Predicate

| | Predicate<br>K092813 | SpiroThor |
|---------------------------------------------------------|----------------------|-----------|
| FVC (Forced Vital Capacity) | Yes | Yes |
| FEV.5 (Volume Expired in the first half second of test) | No | No |
| FEV 1 (Volume Expired in the first second of test) | Yes | Yes |
| FEV3 (Volume Expired in the first three second of test) | Yes | Yes |
| FEV6 (Volume Expired in the first six second of test) | Yes | Yes |
| FEV1/FEV6 - Ratio | No | No |
| FEV.5/FVC - Ratio | No | No |
| FEV1/FVC - Ratio | Yes | Yes |
| FEV1/VC - Ratio | No | No |
| PEF (Peak Expiratory Flow) | Yes | Yes |
| FEF25 (Maximum flow at 25% of FVC) | Yes | Yes |
| FEF50 (Maximum flow at 50% of FVC) | Yes | Yes |
| FEF75 (Maximum flow at 75% of FVC) | Yes | Yes |
| FEF25-75 (Average flow between 25% and 75% of FVC) | Yes | Yes |
| FEF75-85 (Average flow between 75% and 85% of FVC) | No | No |
| FET25-75 (Time between 25% and 75% of FVC) | No | No |
| FET100 (Forced Expiratory Time) | Yes | Yes |
| FIVC (Forced Inspiratory Vital Capacity) | Yes | Yes |
| *FVC (Best FVC) | No | No |
| IVC (Inspiratory Slow Vital Capacity) | Yes | Yes |
| MVV (Maximum Voluntary Ventilation) | Yes | Yes |
| PIF (Peak Inspiratory Flow) | Yes | Yes |
| Te (Expiratory Time) | No | No |
| Ti (Inspiratory Time) | No | No |
| Ti/Tt (Ratio of Inspiratory Time to Total Time) | No | No |
| TV (Tidal Volume) | Yes | Yes |
| TV/Ti Ratio | No | No |
| VE (Minute Ventilation at Rest) | No | No |
| Vext (Extrapolated Volume) | Yes | Yes |
| VC (Slow Vital Capacity) | Yes | Yes |

Differences:

The SpiroThor and predicate, K092813 – SDI AstraSonic Diagnostic Spirometer, are identical devices with minor differences. Namely, both products are produced by Thormed ("THOR") and the only differences are the name of the device and that another bacterial filter may be used with the proposed device. THOR produced the SDI AstraSonic that was cleared in 2009, under the SDI AstraSonic name K092813.

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## 510(k) Summary Page 4 of 5 26-May-2015

There are no changes in technology, materials, design, performance, or any other difference that would render the device not substantially equivalent except as noted above.

In summary, one can conclude that substantial equivalence is met based upon the following:

## Indications for Use -

The indications for use are identical for the proposed device when compared to the predicate -K092813 - SDI AstraSonic Diagnostic Spirometer.

Discussion – Each device is indicated for use as a freestanding laboratory instrument for performing basic lung function tests in adults and children over the age of four years.

## Technology and construction -

The design, components, shape, size, etc. are identical to the predicate, K092813 - SDI AstraSonic Diagnostic Spirometer.

Discussion - The technology and construction are identical to the predicate, K092813 - SDI AstraSonic Diagnostic Spirometer. It is noted that the proposed SpiroThor uses a different bacterial filter than the predicate, but comparative testing demonstrated that there is no differences in the performance of the SpiroThor with either filter.

## Environment of Use -

The environments of use are identical to the predicate, K092813 - SDI AstraSonic Diagnostic Spirometer.

Discussion - physicians' offices, industrial medical and hospital settings.

## Patient Population -

The patient population of adults and children over 4 years old.

Discussion - The patient populations are equivalent to the predicate, K092813 - SDI AstraSonic Diagnostic Spirometer.

## 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.

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## 510(k) Summary Page 5 of 5 26-May-2015

#### Materials:

The materials for each component, patient contact and predicate for the material per G95-1 and ISO 10993-1:2009 would be considered as both:

- External Communicating (Indirect gas pathway),
- . Tissue contacting
- Duration of Use limited (< 24 hours) .

And

- Surface Contact
- Mucosal contacting
- Duration of Use limited (< 24 hours) ●

The following tests would be required if a material certification cannot be provided.

- Cytotoxicity ●
- Sensitization
- Intracutaneous / Irritation

The materials are identical to the predicates and we have provided a material certification.

## Clinical Testing -

No clinical testing was required or performed.

## Discussion of Differences -

There are no significant differences between the proposed device and the predicate except that the proposed device may utilize the Air Safety PFT filter and a name change, but we have demonstrated that there are no functional performance differences between the AstraGuard and Air Safety filters.

## Substantial Equivalence Conclusion -

All testing demonstrated that the proposed device is substantially equivalent to the predicate device.