(240 days)
Not Found
No
The device description mentions "real-time pattern recognition algorithms" and "computes the 3-dimensional coordinates," which are standard signal processing techniques, not necessarily AI/ML. There is no mention of AI, ML, deep learning, or training/test sets for such models.
No
The device is intended for measurement and assessment, not for treatment or therapy. It explicitly states it is "not intended to monitor vital signs" and is "not an apnea monitor," further indicating it does not provide therapeutic intervention.
Yes
The Thora-3Di is a diagnostic device because its "Intended Use" states it is "intended for a one-time measurement of respiratory rate," and measuring vital signs like respiratory rate is a diagnostic function used to assess a patient's health status.
No
The device description explicitly states that the Thora-3Di uses hardware components including a projector to project a structured grid pattern of light and two digital video cameras to record changes. It also mentions a dedicated parallel processor. This indicates it is a hardware device with integrated software, not a software-only device.
Based on the provided information, the Thora-3Di is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Thora-3Di's Function: The Thora-3Di measures respiratory rate by projecting light onto the external surface of the body (thoracoabdominal wall) and analyzing the movement of that surface. It does not analyze any biological specimens taken from the patient.
Therefore, the Thora-3Di falls under the category of a non-invasive medical device used for physiological measurement, not an IVD.
N/A
Intended Use / 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 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.
Product codes
BZO
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Structured Light Plethysmography (SLP) utilizing two digital video cameras.
Anatomical Site
thoracoabdominal wall
Indicated Patient Age Range
Adult Patients
Intended User / Care Setting
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.
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
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)
§ 868.2375 Breathing frequency monitor.
(a)
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.(b)
Classification. Class II (performance standards).
0
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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
1
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 (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 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
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
2
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)
This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number
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510(k) SUMMARY
| Submitter Name: | PneumaCare Limited | |
|---|---|---|
| Submitter Address: | Prospect House, 3 St Thomas' Place | |
| Cambridgeshire Business Park, Ely | ||
| 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 | |
| Product Code BZQ | ||
| Predicate Device: | K090273, Kai Spot KMS200, Kai Medical | |
| Predicate Device | ||
| Classification: | 21 CFR 868.2375, Breathing Frequency Monitor | |
| 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
4
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
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-
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. | 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 Kai Sensors Non-Contact
Respiratory Rate Spot Check Model
100 is not intended to monitor vital
signs. This device is not an apnea
monitor. |
| Intended use
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
distance through clothing | Non patient contacting, works from
distance through clothing |
| Measurement positions | Subject is seated | Subject can be sitting or lying down |
| Clinical validation | Validated against Capnography
(Clinician Over-Scored Capnography) | Validated against Embletta, Welch
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
K090273 |
|---------------------|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Technology Platform | Visual technique using two cameras
and a projector to look at chest and
abdominal wall movement | Uses a low power radar to sense chest
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) 1 Droitcour et al, Non-Contact Respiratory Rate Measurement Validation for Hospitalized Patients, Conf Proc IEEE Eng Med Biol Soc. 2009; 2009: 4812-4815