Thora-3Di, Model T-01

K151940 · Pneumacare Limited · BZQ · Mar 10, 2016 · Anesthesiology

Device Facts

• Record ID: K151940
• Device Name: Thora-3Di, Model T-01
• Applicant: Pneumacare Limited
• Product Code: BZQ · Anesthesiology
• Decision Date: Mar 10, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2

Intended Use

The Thora-3Di is intended for a one-time measurement of respiratory rate as part of a vital signs assessment. The device is indicated for hospital or clinical use in adult patients. The device is intended to be operated by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider. The Thora-3Di is not intended to monitor vital signs. This device is not an apnea monitor.

Device Story

Thora-3Di uses Structured Light Plethysmography (SLP) to measure respiratory rate; projects structured light grid onto thoracoabdominal wall; two digital cameras record grid pattern changes caused by chest wall movement. Parallel processor executes real-time pattern recognition algorithms to identify virtual grid marker positions; computes 3D coordinates to derive respiratory rate. Used in hospital/clinical settings by clinicians/medically qualified personnel. Output displayed to provider for vital signs assessment; assists in clinical decision-making by providing non-contact, one-time respiratory rate measurement. Benefits patient by enabling non-invasive assessment through clothing without patient contact.

Clinical Evidence

Prospective clinical trial with 35 adult subjects (ages 19-77). Primary endpoint: compare Thora-3Di respiratory rate output to Clinician Over-Scored Capnography (COSC) reference standard over one-minute epochs. Results: Mean Squared Difference (MSD) was 0.136 brpm (p=0.0002), significantly below the 0.81 brpm threshold. 95% limits of agreement were (-0.72, 0.75 brpm), meeting pre-defined criteria of +/- 2 brpm. Bench testing confirmed accuracy of +/- 1 brpm across simulated anatomies (2-60 brpm).

Technological Characteristics

Non-contact optical system using Structured Light Plethysmography (SLP). Components: light projector, two digital cameras, parallel processor. Dimensions/form factor: not specified. Connectivity: standalone (no wireless, cloud, or remote functionality). Software: rule-based/pattern recognition. Standards: IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 14971.

Indications for Use

Indicated for one-time respiratory rate measurement in adult patients in hospital or clinical settings. Intended for use by clinicians and medically qualified personnel. Not for vital signs monitoring or apnea monitoring.

Regulatory Classification

Identification

A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.

Predicate Devices

• Kai Spot KMS200 (K090273)

Reference Devices

• Embletta
• Welch Allyn Propaq

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

March 15, 2016

PneumaCare Limited c/o Ms. Nandini Murthy Regulatory Consultant to PneumaCare Alacrita, One Broadway, 14th Floor, Kendall Square Cambridge, Massachusetts 02142

Re: K151940

Trade/Device Name: Thora-3Di, Model T-01 Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: BZO Dated: February 9, 2016 Received: February 10, 2016

Dear Ms. Nandini Murthy:

This letter corrects our substantially equivalent letter of March 10, 2016.

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

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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR 801); medical device reporting (reporting of medical devicerelated 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 Industry and Consumer Education at its toll-free 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 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

Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page

510(k) Number (if known) K151940

Device Name

Thora-3Di, Model T-01

Indications for Use (Describe)

The Thora-3Di is intended for a one-time measurement of respiratory rate as part of a vital signs assessment. The device is indicated for hospital or clinical use in adult patients. The device is intended to be operated by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider.

The Thora-3Di is not intended to monitor vital signs. This device is not an apnea monitor.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)

□ Over-The-Counter Use (21 CFR 801

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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[e-mail]

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### 510(k) SUMMARY

| Submitter Name: | PneumaCare Limited | |
|-------------------------------------|----------------------------------------------------------------------------------------------------|--|
| Submitter Address: | Prospect House, 3 St Thomas' Place<br>Cambridgeshire Business Park, Ely<br>CB7 4EX, United Kingdom | |
| Contact Person: | Mark Harwood | |
| Phone Number: | 00 44 (0) 1223 967414 | |
| Fax Number: | 00 44 (0) 1353 666 692 | |
| Date Prepared: | 10 March 2016 | |
| Device Trade Name: | Thora-3Di, Model T-01 | |
| Device Common Name: | Breathing Frequency Monitor | |
| Device Classification: | 21 CFR 868.2375, Breathing Frequency Monitor<br>Product Code BZQ | |
| Predicate Device: | K090273, Kai Spot KMS200, Kai Medical | |
| Predicate Device<br>Classification: | 21 CFR 868.2375, Breathing Frequency Monitor<br>Product Code BZQ | |

## Device Description:

The Thora-3Di uses Structured Light Plethysmography (SLP) to derive respiratory rate. With the Thora-3Di, a structured grid pattern of light is projected onto the thoracoabdominal wall and two digital video cameras record changes in the grid pattern due to movement of the wall. A dedicated parallel processor executes real-time pattern recognition algorithms to identify the position of each part of the virtual grid in each camera. The system computes the 3-dimensional coordinates of the different markers to assess respiratory rate.

The Thora-3Di does not include any wireless transmission features, nor does it include a cloud or other remote functionality (no cybersecurity-related features).

### Indications for Use:

The Thora-3Di is intended for a one-time measurement of respiratory rate as part of a vital signs assessment. The device is indicated for hospital or clinical use in adult

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patients. The device is intended to be operated by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider.

The Thora-3Di is not intended to monitor vital signs. This device is not an apnea monitor.

| Characteristics | PneumaCare's Thora-3Di | Kai Non-Contact RR Spot Check<br>K090273 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | BZQ | BZQ |
| Primary output | Displays respiratory rate (RR) | Displays respiratory rate (RR) |
| Intended use | The Thora-3Di is intended for a one-<br>time measurement of respiratory rate<br>as part of a vital signs assessment.<br>The device is indicated for hospital or<br>clinical use in adult patients. The<br>device is intended to be operated by<br>clinicians and medically qualified<br>personnel. It is available for sale only<br>upon the order of a physician or<br>licensed health care provider.<br>The Thora-3Di is not intended to<br>monitor vital signs. This device is not<br>an apnea monitor. | Intended for a one-time measurement<br>of respiratory rate as part of a vital<br>signs assessment. The device is<br>indicated for hospital or clinical use in<br>adult patients. The device is intended<br>to be operated by clinicians and<br>medically qualified personnel. It is<br>available for sale only upon<br>the order of a physician or licensed<br>health care provider.<br>The Kai Sensors Non-Contact<br>Respiratory Rate Spot Check Model<br>100 is not intended to monitor vital<br>signs. This device is not an apnea<br>monitor. |
| Intended use<br>environment | In hospital or clinical care settings | In hospital or clinical care settings |
| Duration of monitoring | Up to 5 minutes (acute measurement) | Spot check measurement |
| Technology | Non patient contacting, works from<br>distance through clothing | Non patient contacting, works from<br>distance through clothing |
| Measurement positions | Subject is seated | Subject can be sitting or lying down |
| Clinical validation | Validated against Capnography<br>(Clinician Over-Scored Capnography) | Validated against Embletta, Welch<br>Allyn Propaq |
| Parameters displayed | Respiratory rate | Respiratory rate |

# Overview of Substantial Equivalence:

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| Characteristics | PneumaCare's Thora-3Di | Kai Non-Contact RR Spot Check<br>K090273 |
|---------------------|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Technology Platform | Visual technique using two cameras<br>and a projector to look at chest and<br>abdominal wall movement | Uses a low power radar to sense chest<br>displacement. |

## Rationale for Substantial Equivalence:

The Thora-3Di indications for use is identical to the predicate Kai Spot. The Thora-3Di and the predicate Kai Spot devices are similar in design in that both devices assess respiratory rate as a spot measurement, i.e. neither device is a continuous long term monitor. Both devices are non-patient contacting and have a similar technological approach of looking at signals generated from chest wall displacement to assess respiratory rate. The Thora-3Di uses Structured Light Plethysmography (SLP), an optical technique while the Kai Spot uses Doppler Radar to assess respiratory rate.

Both devices' respiratory rate output were compared to reference or predicate devices in clinical studies, and met the prospectively defined acceptance criteria, demonstrating substantial equivalence to their respective comparator devices.

## Relevant Standards:

The Thora-3Di has been tested and meets the requirements of the relevant sections of the following performance standards:

- IEC 60601-1 Standard: Medical Electrical Equipment Part 1: General O Requirements for Basic Safety and Essential Performance (2005)
- IEC 60601-1-2 Standard: Medical Electrical Equipment Part 1-2: General o Requirements for Basic Safety and Essential Performance, Collateral Standard: Electromagnetic Compatibility (2007)
- IEC 62304: First edition 2006-05, medical device software software life cycle o processes.
- ISO 14971: Second edition 2007-03-01, medical devices application of risk O management to medical devices.

Software documentation and processes also complied with the following FDA guidance documents:

- Draft Guidance for Industry and FDA Staff: Content of Premarket Submissions o for Software Contained in Medical Devices( May 2005)
- FDA General Principles of Software Validation: Final Guidance for Industry and o Staff (January 2002)

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- Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf o Software Use in Medical Devices (September 1999)
## Summary of Performance Data:

The Thora-3Di has been tested on the bench to demonstrate accuracy of respiratory rate between 2-60 brpm, where test conditions simulated different subject anatomies such as large abdomen and chest size, and weak breathing. The bench test also verified that the software displayed applicable user alerts as intended when measurements were taken outside of the labeled setup instructions. Software bench testing verified all software system requirements.

The Thora-3Di has also been evaluated in a clinical trial against the reference standard of capnography for the respiratory range of 8-25 brpm. 35 adult subjects between the ages of 19 and 77 meeting the study inclusion criteria were enrolled. The primary endpoint analysis was to compare the output respiratory rate of Thora-3Di with that of the COSC (Clinician Overscored CO2 derived from the reference capnograph device) measured over one randomly selected epoch of one minute for each subject.

The acceptance criterion was based on a mean squared difference (MSD) <0.81 brpm between the two devices which would indicate limits of agreement of +/- 2 brpm.

Results: The MSD was estimated to be 0.136 brpm which is significantly less than the null hypothesis value of 0.81 brpm (p-value=0.0002). The 95% limits of agreement were (-0.72, 0.75 brpm) which are much narrower than the pre-defined limits of agreement of (-2, 2 brpm).

## Conclusion:

The Thora-3Di has similar intended use and indications statements as the predicate device, for the measurement of respiratory rate. In the bench study, the Thora-3Di showed an accuracy of </= +/-1 brpm for different simulated anatomies and simulated weak breathing. In a pivotal clinical study, Thora-3Di was compared to the reference capnograph device, using COSC for the measurement of respiratory rate (RR) in healthy adults and adults with respiratory disease or impairment. The 95% CI was in between -0.72 to 0.75 breaths per minute, which is equivalent to the predicate device's published t 95% CI of +1.8 and -4.5 BPM. Therefore, the Thora-3Di is substantially equivalent to the predicate device.

¹ Droitcour et al, Non-Contact Respiratory Rate Measurement Validation for Hospitalized Patients, Conf Proc IEEE Eng Med Biol Soc. 2009; 2009: 4812-4815