(90 days)
Philips IntelliVue CL Respiration Pod (K122223)
No
The description mentions "adaptive signal processing method" but does not explicitly state or imply the use of AI or ML. The clinical validation section describes a traditional benchmarking approach against a reference device and manual scoring, not training or testing of an AI/ML model.
No.
The device is indicated for non-invasive spot checking of respiration rate, which is a diagnostic function for monitoring a physiological parameter, not for treating or preventing a disease or condition.
Yes
The device is described as a "respiratory monitor" indicated for "non-invasive spot checking of respiration rate (RR)". While it doesn't provide a diagnosis itself, monitoring a physiological parameter like respiration rate for clinical use is considered a diagnostic function in the broader sense of providing data used in diagnosis. The comparison to a reference EtCO2 waveform (a diagnostic tool) in its performance study further supports its role in aiding clinical assessment.
No
The device description clearly outlines hardware components including a vertical-cavity surface-emitting diode, photodetector, battery, and USB charging cable, and describes how it is physically affixed to the chest.
Based on the provided information, the Respiree Cardio-Respiratory Monitor is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Respiree's function: The Respiree Cardio-Respiratory Monitor is a non-invasive device that measures respiration rate by sensing diffused light from the skin. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's a respiratory monitor for non-invasive spot checking of respiration rate. This is a physiological measurement, not a diagnostic test performed on a sample.
Therefore, the Respiree Cardio-Respiratory Monitor falls under the category of a medical device that performs a physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Respiree Cardio-Respiratory Monitor is a respiratory monitor intended for hospital-type facilities in non-ICU settings. The Respiree Cardio-Respiratory Monitor is indicated for the non-invasive spot checking of respiration rate (RR) for adult patients.
Product codes (comma separated list FDA assigned to the subject device)
BZQ
Device Description
The Respiree Cardio-Respiratory Monitor, Model RS001, is a small respiratory monitor. For measurement of respiration rate (RR), the device is affixed to the chest using a disposable adhesive patch with a hook-and-loop fastener to attach to the monitor. The device uses a vertical-cavity surface-emitting diode to emit optical radiation directed toward the skin. An integrated photodetector in a nearby position senses the diffused collected light. An adaptive signal processing method is used to enhance the device respiratory rate measurements by splitting the signal processing optimizations across different respiratory rate bands.
The monitor is powered by a 3.7V rechargeable, lithium-ion battery and a USB charging cable is provided. The Respiree Cardio-Respiratory Monitor also includes optional Bluetooth wireless technology for the wireless transfer of patient data to mobile devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical sensor
Anatomical Site
Chest
Indicated Patient Age Range
Adult only
Intended User / Care Setting
hospitals and hospital-type facilities in non-ICU settings.
healthcare professional
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
The clinical validation was conducted to demonstrate that the Respiree Cardio- respiratory Monitor performs adequately for all groups within the intended population. The study had a wide, well-distributed range of comorbidities, age (20-80 years), race (white, black and others), BMI (19.1-45.2) and skin tone (Fitzpatrick skin tone type II-VI), as well as a balanced mix of gender (50% male).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical validation of the Respiree Cardio-respiratory Monitor was performed for respiratory rate. Respiree Cardio-respiratory Monitor was benchmarked to Reference EtCO2 waveform (from Datex-Ohmeda) that was manually scored by counting the respiratory peaks per minute on a total of 46 subjects.
The clinical studies demonstrated Respiree Cardio- respiratory Monitor met the respiratory rate accuracy Ams of
§ 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).
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March 8, 2023
Respiree PTE Ltd. % Cherita James Regulatory Consultant M Squared Associates. Inc 127 West 30th St. Floor 9 New York, New York 10001
Re: K223681
Trade/Device Name: Respiree Cardio-Respiratory Monitor Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: BZO Dated: December 8, 2022 Received: December 8, 2022
Dear Cherita James:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Rachana Visaria -S
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223681
Device Name Respiree Cardio-Respiratory Monitor
Indications for Use (Describe)
The Respiree Cardio-Respiratory Monitor is a respiratory monitor intended for hospital-type facilities in non-ICU settings. The Respiree Cardio-Respiratory Monitor is indicated for the non-invasive spot checking of respiration rate (RR) for adult patients.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
The following information is provided as required by 21 CFR § 807.87 for Respiree Cardio-Respiratory Monitor 510(k) premarket notification.
- Respiree PTE Ltd. Sponsor: 176 Orchard Road Level 5, Unit 5 Singapore 238843 Ph: 65-90617570
Contact: Cherita James M Squared Associates, Inc. 127 West 30th Street 9th Floor New York, New York 10001 Ph: 347-954-0624 Fax: 703-562-9797 Email: Cjames@MSquaredAssociates.com
Date Prepared: March 8, 2023
| Trade/Device Name: | Respiree Cardio-Respiratory Monitor |
|---|---|
| Regulation Number: | 21 CFR 868.2375 |
| Regulation Name: | Breathing Frequency Monitor |
| Regulatory Class: | Class II |
| Product Code: | BZQ |
| Predicate Device(s): | Primary – Philips IntelliVue CL Respiration Pod (K122223) |
| Reference - PneumaCare Thora-3Di, Model T-01 (K151940) |
Device Description: The Respiree Cardio-Respiratory Monitor, Model RS001, is a small respiratory monitor. For measurement of respiration rate (RR), the device is affixed to the chest using a disposable adhesive patch with a hook-and-loop fastener to attach to the monitor. The device uses a vertical-cavity surface-emitting diode to emit optical radiation directed toward the skin. An integrated photodetector in a nearby position senses the diffused collected light. An adaptive signal processing method is used to enhance the device respiratory rate measurements by splitting the signal processing optimizations across different respiratory rate bands.
The monitor is powered by a 3.7V rechargeable, lithium-ion battery and a USB charging cable is provided. The Respiree Cardio-Respiratory Monitor also includes optional Bluetooth wireless technology for the wireless transfer of patient data to mobile devices.
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Indication for Use: The Respiree Cardio-Respiratory Monitor is a respiratory monitor intended for hospitals and hospital-type facilities in non-ICU settings. The Respiree Cardio-Respiratory Monitor is indicated for the non-invasive spot checking of respiration rate (RR) for adult patients.
Substantial Equivalence
The claim of substantial equivalence of the Respiree Cardio-Respiratory Monitor to the primary predicate identified above is based on the comparison of the intended use, product technical characteristics, and performance characteristics. The Respiree Cardio-Respiratory Monitor is essentially a smaller, simplified version of the predicate device with similar technologic features to a reference device.
| | Respiree Cardio-
Respiratory Monitor
(Subject device) | Philips Intellivue CL
Respiration Pod (Primary
Predicate) | Differences and
SE |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | K223681 | K122223 | -- |
| Primary
Product Code | BZQ | BZQ | Same |
| Intended
Use/Indications
for Use | The Respiree Cardio-
Respiratory Monitor is a
respiratory monitor
intended for hospitals and
hospital-type facilities in
non-ICU settings. The
Respiree Cardio-
Respiratory Monitor is
indicated for the non-
invasive spot checking of
respiration rate (RR) for
adult patients. | The IntelliVue CL Respiration
Pod is indicated for use by health
care professionals whenever
there is a need for intermittent or
spot-check acquisition and
monitoring of physiological
patient parameters respiration
rate and pulse rate wirelessly in
specific hospital areas. The
IntelliVue CL Respiration Pod is
mainly indicated for use in
general medical and surgery
wards and in waiting areas of
emergency rooms. It is not
indicated for use in hospital
areas in which continuous patient
monitoring is needed, such as
intensive care units or operating
rooms. The intended use of the
IntelliVue CL Respiration Pod
when used together with a
patient monitor is for intermittent
or spot-check monitoring and
recording of, and to generate | Similar. Minor text
difference does not
suggest a new or
different intended
use/ indication for
use. There is no
change to the use,
users or conditions
of use.
Both devices
measure respiration
rate in adults for
spot check
monitoring.
Both devices are
indicated for use by
healthcare
professional in
hospital settings. |
Comparison to the Predicate Device
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| alarms for respiration rate and
pulse rate of adult patients. The
IntelliVue CL Respiration Pod is
also intended for acquisition of
respiration rate and pulse rate
data of adult patients for a
clinical information management
system. The Intellivue CL
Respiration Pod is intended for
use by health care professionals.
It is not intended for
home use. It is not a therapeutic
| device. | |
|---|---|
| The IntelliVue CL Respiration | |
| Pod is not intended for use on | |
| patients with extremely high | |
| values for respiration rate (above | |
| 60 rpm). The IntelliVue CL | |
| Respiration Pod is not intended | |
| for use on acutely ill cardiac | |
| patients with the potential to | |
| develop life threatening | |
| arrhythmias, e.g. very fast atrial | |
| fibrillation or ventricular | |
| tachycardia (rapid irregular pulse | |
| rate). For monitoring of these | |
| patients, a device for continuous | |
| ECG monitoring is necessary. | |
| The IntelliVue CL Respiration | |
| Pod is not a substitute for | |
| an ECG monitor. |
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| | Respiree Cardio-Respiratory
Monitor | Philips Intellivue CL
Respiration Pod | Differences and SE |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Measurement
Principle | Uses optical sensor to measure
thoracic movements. | Uses accelerometer
sensor to measure
thoracic movements. | Similar technology
method. Sensor
technology of subject
device is different from
predicate but is similar
to reference device. |
| Patient interface | Sensor is adhesively attached to
the patient's chest
Image: [Sensor is adhesively attached to the patient's chest] | Pod is adhesively
attached to left costal
arch of patient's chest
Image: [Pod is adhesively attached to left costal arch of patient's chest] | Same. Sensor is attached
to the patient's chest. |
| Environment of
Use | Hospital and hospital-type
environment only (non-ICU
settings) | Hospital | Same |
| Target
population | Adult only | Adult only | Same |
| Displayed
parameters | Respiration rate is shown on the
Cardio- respiration monitor
display. Retrospective data can
be viewed and/or downloaded
from Respiree Health App | Respiration data is sent
to an assigned
compatible intelliVue
Patient Monitor or
IntelliVue Guardian
Software. | Difference in the way
the data is displayed
does not raise new
questions of safety and
effectiveness. |
| Mode of
operation | Spot checking | Intermittent or spot-
check | Same |
| Performance
range | 5 - 50 rpm | 5 - 60 bpm | Similar. Performance
and clinical study
confirm the essential
performance of the
device at the extremes of
the stated performance
range. |
| Performance
accuracy
(ARMS) |