(90 days)
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.
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.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Predicate) | Reported Device Performance (Respiree Cardio-Respiratory Monitor) |
|---|---|---|
| Performance range | 5 - 60 rpm | 5 - 50 rpm |
| Accuracy (ARMS) | <2 rpm | <3 rpm |
2. Sample Size for Test Set and Data Provenance
- Sample Size: 46 subjects
- Data Provenance: The document does not explicitly state the country of origin.
- Retrospective/Prospective: The study was a clinical validation, which typically implies a prospective design where the device is used to collect new data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: The document states the reference EtCO2 waveform was "manually scored by counting the respiratory peaks per minute." It does not specify the number of experts.
- Qualifications of Experts: The qualifications of the individuals who performed the manual scoring are not specified in the provided text.
4. Adjudication Method for the Test Set
- The document implies that the ground truth was established by manual scoring of the EtCO2 waveform. It does not describe an adjudication method (such as 2+1 or 3+1 consensus) for this manual scoring.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The study described compared the device's performance against a reference standard (EtCO2 waveform) and did not involve human readers using or not using AI.
6. Standalone (Algorithm Only) Performance
- Yes, a standalone study was done. The clinical validation was conducted to assess the performance of the Respiree Cardio-Respiratory Monitor device itself in measuring respiratory rate, comparing its output directly to a reference standard.
7. Type of Ground Truth Used
- The ground truth used was the EtCO2 waveform manually scored by counting the respiratory peaks per minute. This can be categorized as a type of expert-derived physiological measurement.
8. Sample Size for the Training Set
- The document does not specify the sample size for the training set. It only describes the clinical validation study (test set).
9. How the Ground Truth for the Training Set Was Established
- As the training set size is not specified, the method for establishing its ground truth is also not provided in the given text.
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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 CLRespiration Pod (PrimaryPredicate) | Differences andSE | |
|---|---|---|---|
| 510(k) No. | K223681 | K122223 | -- |
| PrimaryProduct Code | BZQ | BZQ | Same |
| IntendedUse/Indicationsfor Use | The Respiree Cardio-Respiratory Monitor is arespiratory monitorintended for hospitals andhospital-type facilities innon-ICU settings. TheRespiree Cardio-Respiratory Monitor isindicated for the non-invasive spot checking ofrespiration rate (RR) foradult patients. | The IntelliVue CL RespirationPod is indicated for use by healthcare professionals wheneverthere is a need for intermittent orspot-check acquisition andmonitoring of physiologicalpatient parameters respirationrate and pulse rate wirelessly inspecific hospital areas. TheIntelliVue CL Respiration Pod ismainly indicated for use ingeneral medical and surgerywards and in waiting areas ofemergency rooms. It is notindicated for use in hospitalareas in which continuous patientmonitoring is needed, such asintensive care units or operatingrooms. The intended use of theIntelliVue CL Respiration Podwhen used together with apatient monitor is for intermittentor spot-check monitoring andrecording of, and to generate | Similar. Minor textdifference does notsuggest a new ordifferent intendeduse/ indication foruse. There is nochange to the use,users or conditionsof use.Both devicesmeasure respirationrate in adults forspot checkmonitoring.Both devices areindicated for use byhealthcareprofessional inhospital settings. |
Comparison to the Predicate Device
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| alarms for respiration rate andpulse rate of adult patients. TheIntelliVue CL Respiration Pod isalso intended for acquisition ofrespiration rate and pulse ratedata of adult patients for aclinical information managementsystem. The Intellivue CLRespiration Pod is intended foruse by health care professionals.It is not intended forhome use. It is not a therapeuticdevice. | |
|---|---|
| The IntelliVue CL RespirationPod is not intended for use onpatients with extremely highvalues for respiration rate (above60 rpm). The IntelliVue CLRespiration Pod is not intendedfor use on acutely ill cardiacpatients with the potential todevelop life threateningarrhythmias, e.g. very fast atrialfibrillation or ventriculartachycardia (rapid irregular pulserate). For monitoring of thesepatients, a device for continuousECG monitoring is necessary.The IntelliVue CL RespirationPod is not a substitute foran ECG monitor. |
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| Respiree Cardio-RespiratoryMonitor | Philips Intellivue CLRespiration Pod | Differences and SE | |
|---|---|---|---|
| MeasurementPrinciple | Uses optical sensor to measurethoracic movements. | Uses accelerometersensor to measurethoracic movements. | Similar technologymethod. Sensortechnology of subjectdevice is different frompredicate but is similarto reference device. |
| Patient interface | Sensor is adhesively attached tothe patient's chestImage: [Sensor is adhesively attached to the patient's chest] | Pod is adhesivelyattached to left costalarch of patient's chestImage: [Pod is adhesively attached to left costal arch of patient's chest] | Same. Sensor is attachedto the patient's chest. |
| Environment ofUse | Hospital and hospital-typeenvironment only (non-ICUsettings) | Hospital | Same |
| Targetpopulation | Adult only | Adult only | Same |
| Displayedparameters | Respiration rate is shown on theCardio- respiration monitordisplay. Retrospective data canbe viewed and/or downloadedfrom Respiree Health App | Respiration data is sentto an assignedcompatible intelliVuePatient Monitor orIntelliVue GuardianSoftware. | Difference in the waythe data is displayeddoes not raise newquestions of safety andeffectiveness. |
| Mode ofoperation | Spot checking | Intermittent or spot-check | Same |
| Performancerange | 5 - 50 rpm | 5 - 60 bpm | Similar. Performanceand clinical studyconfirm the essentialperformance of thedevice at the extremes ofthe stated performancerange. |
| Performanceaccuracy(ARMS) | <3 rpm | <2 rpm | Similar. Clinical studydemonstrates respirationrate accuracy. |
| Alarms | None | Yes | Difference do not raisenew questions of safetyand effectiveness. Thesubject device is onlyintended for spot |
| monitoring ofrespiration rate. | |||
| Power Supply | Rechargeable Lithium- ionbattery | Rechargeable Lithium-ion battery | Same |
| WirelessInterface | Bluetooth LE | Short Range Radio | Similar principle ofoperation |
| Biocompatibility | Complies with ISO 10993-1,ISO 10993-5, and ISO 10993-10 | Not available | Adhesive patch used insubject device isbiocompatible. |
| Safety and EMCSpecifications | AAMI IEC ES 60601-1:2005,IEC 60601-1-2: 2020, ANSIIEEE 63.27-2017 | AAMI ANSI ES60601-1:2005, IEC60601-1-2:2007 IEC60601-1-8:2006 | Same. Subject devicecomplies with currentversions of theapplicable standards. |
| Dimensions | 40 mm x 40 mm x 13 mm | Pod: 45 mm x 14 mm x65 mm ±5% (withoutaccessories) | Similar. |
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The subject device and the Primary Predicate (K122223) have the following key similarities:
- Both devices have similar intended and indications for use. ●
- . Both devices measure respiration rate as spot monitoring.
- Both devices measure respiration rate from the chest and are patient contacting.
- Both devices use the similar technology method of looking at signals generated from . chest wall or thoracic movement to assess respiration rate.
- Both devices have similar performance range (Predicate is 5 60 rpm, subject device is . 5 - 50 rpm) and performance accuracy (Predicate is <2 rpm, subject device is <3 rpm)
- Both devices use BZQ primary product code. .
The subject device and the Primary Predicate (K122223) have the following key difference:
- The subject device uses optical sensor for respiration rate measurement whereas the primary predicate uses an accelerometer sensor.
Comparison to reference device
- A reference device was used to further support the sensor technology of the subject device for . respiration rate measurement.
| Respiree Cardio-RespiratoryMonitor (Subject) | PneumaCareThora-3DiModel T-01(Reference) | Differencesand SE | |
|---|---|---|---|
| 510(k) No. | K223681 | K151940 | - |
| Product Code | BZQ | BZQ | Same |
| IntendedUse/Indications for Use | The Respiree Cardio-Respiratory Monitor is arespiratory monitorintended for hospitalsand hospital-typefacilities in non- ICUsettings.The Respiree Cardio-Respiratory Monitor isindicated for the non-invasive spot checkingof respiration rate (RR)for adult patients. | The Thora-3Di isintended for a one-time measurementof respiratory rateas part of a vitalsigns assessment.The device isindicated forhospital or clinicaluse in adultpatients. Thedevice is intendedto be operated byclinicians andmedically qualifiedpersonnel. It isavailable for saleonly upon the orderof a physician orlicensed health careprovider. TheThora- 3Di is notintended tomonitor vital signs.This device is notan apnea monitor. | Both devices measurerespiration rate inadults.While the subjectdevice is intended forspot checkmonitoring, thereference device isintended for one-timemeasurement.Both devices areindicated for use byhealthcareprofessional inhospital settings.As a reference device,this difference doesnot impactsafety/effectiveness,as both subject andprimary predicate areSE for spot-checking. |
| Sensor Technology andmeasurement | Uses optical sensor tomeasure thoracicmovements. | Uses optical sensorto measure thoracicmovements. | The reference deviceuses visual techniqueusing cameras and aprojector to look atchest andabdominal wallmovement, while thesubject device capturesthoracic movementemitting opticalradiation and intensitychanges at the skin arecaptured by anintegratedphotodetector. Bothmethods are evaluatingsignals generated fromchest walldisplacement to assessrespiratory rate. |
| Intended ApplicationSite | Chest (direct contact) | Chest (non-contact) | As a reference device,this difference does notimpactsafety/effectiveness, asboth subject andprimary predicate arespot-checking. |
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The reference device is similar to the subject device as follows:
- . Same application site for respiration rate measurement on the chest
- Same technology for respiration rate measurement using optical technology .
The reference device only differs from the subject device by the fact that the reference device is a non-contact approach versus the subject device that is a contact approach.
Performance Data
- . Device conforms to software requirements for Moderate Level of Concern devices in accordance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
- Device conforms to FDA's Cybersecurity Guidance on Content of Premarket ● Submissions for Management of Cybersecurity in Medical Devices
- Device conforms to FDA's guidance document "Use of International Standard ISO 0 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Patient contacting components were found to be biocompatible in accordance with ISO 10993-1, -5 and -10 for prolonged contact with intact skin.
- Human factors and usability testing was conducted by intended users to support the 0 acceptability of the human factors and usability risks associated with clinical use.
- Other testing included bench testing of Respiratory Rate, Adhesive Patch Peal Force, and ● Bluetooth.
Conformity to Standards
Respiree Cardio-Respiratory Monitor has been tested and meets the requirements of the relevant sections of the following performance standards:
| Standard | RecognitionNumber |
|---|---|
| ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation andtesting within a risk management process | 2-258 |
| ISO 10993-5, 2009, Biological Evaluation of Medical Devices - Part 5: Test forIn Vitro Cytotoxicity | 2-245 |
| ISO 10993-10, 2010, Biological Evaluation of Medical Devices - Part 10: Testsfor Irritation and Skin Sensitization | 2-174 |
| ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 andA2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1:General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) | 19-4 |
| IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION, Medicalelectrical equipment - Part 1-2: General requirements for basic safety andessential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests | 19-36 |
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| IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6:General requirements for basic safety and essential performance - Collateralstandard: Usability | 5-89 |
|---|---|
| IEC 62366-1 Edition 1.1 2020-06 Consolidated Version Medical devices –Part 1: Application of usability engineering to medical devices | 5-129 |
| Title 47 Telecommunication, Part 15 Code of Federal Regulations- RadioFrequency Devices | N/A |
| Title 47 Telecommunication, Part 18 Code of Federal Regulations- Industrial,Scientific, and Medical Equipment | N/A |
| ISO 14971:2019 Medical devices - Application of risk management to medicaldevices. | 5-125 |
| UL 1642 Standard for Lithium Batteries | 19-10 |
| ANSI IEEE C63.27-2017 American National Standard for Evaluation ofWireless Coexistence | 19-29 |
Clinical Data
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 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).
Effectiveness:
The clinical studies demonstrated Respiree Cardio- respiratory Monitor met the respiratory rate accuracy Ams of <3 rpm when compared to the reference EtCO2 waveform that is scored by counting the respiratory peaks per minute.
Safety:
There is no adverse event and complication observed in the clinical studies.
Summary:
Based on the clinical performance, Respiratory system is found to have a safety and effectiveness profile that is similar to the predicate device.
Conclusion
Respiree Cardio-respiratory Monitor has similar intended use and indications statements, fundamental technology as the predicate device for the measurement of respiratory rate. The differences do not raise new questions of safety and effectiveness.
Performance testing, clinical data and conformity to standards confirm that the device performs as intended. Therefore, the Respiree Cardio-respiratory Monitor is substantially equivalent to the predicate device.
§ 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).