Respiree Cardio-Respiratory Monitor

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format. 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. 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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). 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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 {2}------------------------------------------------ # 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) | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div><span style="font-size:10px"></span><span style="font-family:Arial,sans-serif"> <svg height="10" width="10"> <rect height="10" style="fill:lightgrey;stroke-width:1;stroke:rgb(0,0,0)" width="10"></rect> <path d="M1 1 L9 9 M9 1 L1 9" stroke="black"></path> </svg> </span>Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div><span style="font-size:10px"></span><span style="font-family:Arial,sans-serif"> <svg height="10" width="10"> <rect height="10" style="fill:lightgrey;stroke-width:1;stroke:rgb(0,0,0)" width="10"></rect> </svg> </span>Over-The-Counter Use (21 CFR 801 Subpart C)</div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 PRAStaff(@fda.hhs.gov "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." {3}------------------------------------------------ # 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)<br>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. {4}------------------------------------------------ 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-<br>Respiratory Monitor<br>(Subject device) | Philips Intellivue CL<br>Respiration Pod (Primary<br>Predicate) | Differences and<br>SE | |----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) No. | K223681 | K122223 | -- | | Primary<br>Product Code | BZQ | BZQ | Same | | Intended<br>Use/Indications<br>for Use | The Respiree Cardio-<br>Respiratory Monitor is a<br>respiratory monitor<br>intended for hospitals and<br>hospital-type facilities in<br>non-ICU settings. The<br>Respiree Cardio-<br>Respiratory Monitor is<br>indicated for the non-<br>invasive spot checking of<br>respiration rate (RR) for<br>adult patients. | The IntelliVue CL Respiration<br>Pod is indicated for use by health<br>care professionals whenever<br>there is a need for intermittent or<br>spot-check acquisition and<br>monitoring of physiological<br>patient parameters respiration<br>rate and pulse rate wirelessly in<br>specific hospital areas. The<br>IntelliVue CL Respiration Pod is<br>mainly indicated for use in<br>general medical and surgery<br>wards and in waiting areas of<br>emergency rooms. It is not<br>indicated for use in hospital<br>areas in which continuous patient<br>monitoring is needed, such as<br>intensive care units or operating<br>rooms. The intended use of the<br>IntelliVue CL Respiration Pod<br>when used together with a<br>patient monitor is for intermittent<br>or spot-check monitoring and<br>recording of, and to generate | Similar. Minor text<br>difference does not<br>suggest a new or<br>different intended<br>use/ indication for<br>use. There is no<br>change to the use,<br>users or conditions<br>of use.<br>Both devices<br>measure respiration<br>rate in adults for<br>spot check<br>monitoring.<br>Both devices are<br>indicated for use by<br>healthcare<br>professional in<br>hospital settings. | # Comparison to the Predicate Device {5}------------------------------------------------ | alarms for respiration rate and<br>pulse rate of adult patients. The<br>IntelliVue CL Respiration Pod is<br>also intended for acquisition of<br>respiration rate and pulse rate<br>data of adult patients for a<br>clinical information management<br>system. The Intellivue CL<br>Respiration Pod is intended for<br>use by health care professionals.<br>It is not intended for<br>home use. It is not a therapeutic<br>device. | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | The IntelliVue CL Respiration<br>Pod is not intended for use on<br>patients with extremely high<br>values for respiration rate (above<br>60 rpm). The IntelliVue CL<br>Respiration Pod is not intended<br>for use on acutely ill cardiac<br>patients with the potential to<br>develop life threatening<br>arrhythmias, e.g. very fast atrial<br>fibrillation or ventricular<br>tachycardia (rapid irregular pulse<br>rate). For monitoring of these<br>patients, a device for continuous<br>ECG monitoring is necessary.<br>The IntelliVue CL Respiration<br>Pod is not a substitute for<br>an ECG monitor. | | {6}------------------------------------------------ | | Respiree Cardio-Respiratory<br>Monitor | Philips Intellivue CL<br>Respiration Pod | Differences and SE | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------| | Measurement<br>Principle | Uses optical sensor to measure<br>thoracic movements. | Uses accelerometer<br>sensor to measure<br>thoracic movements. | Similar technology<br>method. Sensor<br>technology of subject<br>device is different from<br>predicate but is similar<br>to reference device. | | Patient interface | Sensor is adhesively attached to<br>the patient's chest<br>Image: [Sensor is adhesively attached to the patient's chest] | Pod is adhesively<br>attached to left costal<br>arch of patient's chest<br>Image: [Pod is adhesively attached to left costal arch of patient's chest] | Same. Sensor is attached<br>to the patient's chest. | | Environment of<br>Use | Hospital and hospital-type<br>environment only (non-ICU<br>settings) | Hospital | Same | | Target<br>population | Adult only | Adult only | Same | | Displayed<br>parameters | Respiration rate is shown on the<br>Cardio- respiration monitor<br>display. Retrospective data can<br>be viewed and/or downloaded<br>from Respiree Health App | Respiration data is sent<br>to an assigned<br>compatible intelliVue<br>Patient Monitor or<br>IntelliVue Guardian<br>Software. | Difference in the way<br>the data is displayed<br>does not raise new<br>questions of safety and<br>effectiveness. | | Mode of<br>operation | Spot checking | Intermittent or spot-<br>check | Same | | Performance<br>range | 5 - 50 rpm | 5 - 60 bpm | Similar. Performance<br>and clinical study<br>confirm the essential<br>performance of the<br>device at the extremes of<br>the stated performance<br>range. | | Performance<br>accuracy<br>(ARMS) | <3 rpm | <2 rpm | Similar. Clinical study<br>demonstrates respiration<br>rate accuracy. | | Alarms | None | Yes | Difference do not raise<br>new questions of safety<br>and effectiveness. The<br>subject device is only<br>intended for spot | | | | | monitoring of<br>respiration rate. | | Power Supply | Rechargeable Lithium- ion<br>battery | Rechargeable Lithium-ion battery | Same | | Wireless<br>Interface | Bluetooth LE | Short Range Radio | Similar principle of<br>operation | | Biocompatibility | Complies with ISO 10993-1,<br>ISO 10993-<br>5, and ISO 10993-10 | Not available | Adhesive patch used in<br>subject device is<br>biocompatible. | | Safety and EMC<br>Specifications | AAMI IEC ES 60601-1:2005,<br>IEC 60601-1-2: 2020, ANSI<br>IEEE 63.27-2017 | AAMI ANSI ES<br>60601-1:2005, IEC<br>60601-1-2:2007 IEC<br>60601-1-8:2006 | Same. Subject device<br>complies with current<br>versions of the<br>applicable standards. | | Dimensions | 40 mm x 40 mm x 13 mm | Pod: 45 mm x 14 mm x<br>65 mm ±5% (without<br>accessories) | Similar. | {7}------------------------------------------------ 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-<br>Respiratory<br>Monitor (Subject) | PneumaCare<br>Thora-3Di<br>Model T-01<br>(Reference) | Differences<br>and SE | |--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) No. | K223681 | K151940 | - | | Product Code | BZQ | BZQ | Same | | | | | | | Intended<br>Use/Indications for Use | The Respiree Cardio-<br>Respiratory Monitor is a<br>respiratory monitor<br>intended for hospitals<br>and hospital-type<br>facilities in non- ICU<br>settings.<br>The Respiree Cardio-<br>Respiratory Monitor is<br>indicated for the non-<br>invasive spot checking<br>of respiration rate (RR)<br>for adult patients. | The Thora-3Di is<br>intended for a one-<br>time measurement<br>of respiratory rate<br>as part of a vital<br>signs assessment.<br>The device is<br>indicated for<br>hospital or clinical<br>use in adult<br>patients. The<br>device is intended<br>to be operated by<br>clinicians and<br>medically qualified<br>personnel. It is<br>available for sale<br>only upon the order<br>of a physician or<br>licensed health care<br>provider. The<br>Thora- 3Di is not<br>intended to<br>monitor vital signs.<br>This device is not<br>an apnea monitor. | Both devices measure<br>respiration rate in<br>adults.<br>While the subject<br>device is intended for<br>spot check<br>monitoring, the<br>reference device is<br>intended for one-time<br>measurement.<br>Both devices are<br>indicated for use by<br>healthcare<br>professional in<br>hospital settings.<br>As a reference device,<br>this difference does<br>not impact<br>safety/effectiveness,<br>as both subject and<br>primary predicate are<br>SE for spot-checking. | | Sensor Technology and<br>measurement | Uses optical sensor to<br>measure thoracic<br>movements. | Uses optical sensor<br>to measure thoracic<br>movements. | The reference device<br>uses visual technique<br>using cameras and a<br>projector to look at<br>chest and<br>abdominal wall<br>movement, while the<br>subject device captures<br>thoracic movement<br>emitting optical<br>radiation and intensity<br>changes at the skin are<br>captured by an<br>integrated<br>photodetector. Both<br>methods are evaluating<br>signals generated from<br>chest wall<br>displacement to assess<br>respiratory rate. | | Intended Application<br>Site | Chest (direct contact) | Chest (non-contact) | As a reference device,<br>this difference does not<br>impact<br>safety/effectiveness, as<br>both subject and<br>primary predicate are<br>spot-checking. | {8}------------------------------------------------ {9}------------------------------------------------ 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 | Recognition<br>Number | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------| | ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and<br>testing within a risk management process | 2-258 | | ISO 10993-5, 2009, Biological Evaluation of Medical Devices - Part 5: Test for<br>In Vitro Cytotoxicity | 2-245 | | ISO 10993-10, 2010, Biological Evaluation of Medical Devices - Part 10: Tests<br>for Irritation and Skin Sensitization | 2-174 | | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and<br>A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1:<br>General requirements for basic safety and essential performance (IEC 60601-<br>1:2005, MOD) | 19-4 | | IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION, Medical<br>electrical equipment - Part 1-2: General requirements for basic safety and<br>essential performance - Collateral Standard: Electromagnetic disturbances -<br>Requirements and tests | 19-36 | {10}------------------------------------------------ | IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6:<br>General requirements for basic safety and essential performance - Collateral<br>standard: Usability | 5-89 | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------| | IEC 62366-1 Edition 1.1 2020-06 Consolidated Version Medical devices –<br>Part 1: Application of usability engineering to medical devices | 5-129 | | Title 47 Telecommunication, Part 15 Code of Federal Regulations- Radio<br>Frequency Devices | N/A | | Title 47 Telecommunication, Part 18 Code of Federal Regulations- Industrial,<br>Scientific, and Medical Equipment | N/A | | ISO 14971:2019 Medical devices - Application of risk management to medical<br>devices. | 5-125 | | UL 1642 Standard for Lithium Batteries | 19-10 | | ANSI IEEE C63.27-2017 American National Standard for Evaluation of<br>Wireless 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.