(228 days)
The Spire Health Remote Patient Monitoring System is intended for reusable bedside and mobile multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities or their own home. It is intended for monitoring of patients by trained healthcare professionals.
The Spire Health Remote Patient Monitoring System is intended for longitudinal monitoring of the following parameters in adults:
- Pulse Rate
- Respiratory Rate
- Sleep/Wake Behavior
- Activity associated with Movement
The Spire Health Remote Patient Monitoring System is intended only for general, non-diagnostic sleep and wake behavioral monitoring. It is not intended to assess sleep staging nor diagnose sleep disorders.
The Spire Health Remote Patient Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms.
The Spire Health Remote Patient Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG.
The Spire Health Remote Patient Monitoring System is not a substitute for an ECG monitor.
The Spire Health Remote Patient Monitoring System (RPM) is designed to capture, process, and longitudinally track clinically relevant patient health data and share this data with healthcare providers with a view to improving patient health and outcomes. The RPM is intended for longitudinal monitoring of pulse rate, respiratory rate, sleep/wake behavior, and activity associated with movement.
The RPM solution is comprised of four components - a Medical Health Tag (MHT), a Spire Mobile Application (Mobile App), a Cloud Platform (Platform) and a Healthcare Professional Dashboard (HPD). The patient facing components of the MHT and Mobile App) are intended for daily use in professional healthcare facilities or in the home. The MHT is a component designed to be affixed semi-permanently via an adhesive backing to the patient's first layer of clothing (e.g. underwear, bras, or pajamas), passing through laundry cycles without detaching. It does not require charging by the user.
The Spire Health Remote Patient Monitoring System was evaluated for various performance metrics, including Pulse Rate and Respiratory Rate Validation, and Activity associated with Movement Validation.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Pulse Rate Validation | The RPM was tested to confirm the accuracy of pulse rate monitoring of the system in accordance with ISO 80601-2-61. Detailed acceptance criteria for ISO 80601-2-61 are not provided in the document, but it generally refers to standards for basic safety and essential performance of medical electrical equipment. | PASS |
| Respiratory Rate Validation | The RPM was clinically tested in comparison to end-tidal CO2 to confirm the accuracy of respiration rate measurement. Specific numerical acceptance criteria (e.g., accuracy range relative to end-tidal CO2) are not provided in the document. | PASS |
| Activity associated with Movement Validation | The RPM was clinically tested to confirm the accuracy of the activity tracking. Specific numerical acceptance criteria (e.g., accuracy against a gold standard for movement tracking) are not provided in the document. | PASS |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide specific details on the sample sizes used for the test sets for Pulse Rate, Respiratory Rate, or Activity associated with Movement Validation. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth:
The document does not specify the number of experts used to establish the ground truth for any of the test sets, nor does it detail their qualifications.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method used for the test sets.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention any multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide an effect size of human readers improving with AI vs. without AI assistance. This type of study appears to be not applicable to the reported performance evaluations which focus on device accuracy for physiological parameters and activity.
6. Standalone Performance:
Yes, a standalone performance evaluation was done for the algorithm (device itself) without human-in-the-loop performance, as indicated by the "Pulse Rate Validation," "Respiratory Rate Validation," and "Activity associated with Movement Validation" tests. These tests assess the intrinsic accuracy and functionality of the device's measurements.
7. Type of Ground Truth Used:
- Pulse Rate Validation: Ground truth was established by comparison to the standards outlined in ISO 80601-2-61.
- Respiratory Rate Validation: Ground truth was established through a clinical comparison to end-tidal CO2.
- Activity associated with Movement Validation: Ground truth was established through clinical testing to confirm accuracy, though the specific reference method is not detailed.
8. Sample Size for the Training Set:
The document does not provide details on the sample size used for any training set for the device's algorithms.
9. How Ground Truth for the Training Set Was Established:
The document does not provide information on how ground truth was established for any training set.
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June 05, 2020
Spire, Inc. d/b/a Spire Health % Jared Seehafer Regulatory Consultant Enzyme Corporation 360 Langton St, Ste 100 San Francisco, California 94103
Re: K192952
Trade/Device Name: Spire Health Remote Patient Monitoring System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MSX, BZQ, DRG, LEL Dated: April 23, 2020 Received: April 27, 2020
Dear Jared Seehafer:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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 mediation-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,
for
Jennifer Shih Assistant Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192952
Device Name
Spire Health Remote Patient Monitoring System
Indications for Use (Describe)
The Spire Health Remote Patient Monitoring System is intended for reusable bedside and mobile multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities or their own home. It is intended for monitoring of patients by trained healthcare professionals.
The Spire Health Remote Patient Monitoring System is intended for longitudinal monitoring of the following parameters in adults:
- Pulse Rate
- Respiratory Rate
- Sleep/Wake Behavior
- Activity associated with Movement
The Spire Health Remote Patient Monitoring System is intended only for general, non-diagnostic sleep and wake behavioral monitoring. It is not intended to assess sleep staging nor diagnose sleep disorders.
The Spire Health Remote Patient Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms.
The Spire Health Remote Patient Monitoring System is not intended for use on acutely ill cardiac with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG.
The Spire Health Remote Patient Monitoring System is not a substitute for an ECG monitor.
| 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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5 510(k) Summary
| Submitter's Name: | Spire, Inc. |
|---|---|
| Address: | 2030 Harrison StSan Francisco, CA 94110 |
| Contact Person: | Jared Seehafer |
| Title: | Regulatory Consultant |
| Telephone Number: | 415-638-9554 |
| Fax Number: | 415-367-1279 |
| Email: | jared@enzyme.com |
| Date Summary Prepared: | 4-JUN-2020 |
| Device Proprietary Name: | Spire Health Remote Patient Monitoring System |
| Common Name: | System, Network and Communication, PhysiologicalMonitors |
| Regulation Number: | 21 CFR 870.2300 |
| Regulation Name: | Cardiac Monitor |
| Product Code: | MSX |
| Subsequent Product Codes: | BZQ, LEL |
| Device Class: | Class II |
| Primary Predicate Device | Trade name: Current Wearable Health Monitoring SystemManufacturer: Current HealthPlayfair House, 12A Broughton Street LaneEdinburgh, EH1 3LY GbRegulation Number: 21 CFR 870.2300Regulation Description: Cardiac MonitorDevice Class: Class IIProduct Code: MSXSubsequent Product Codes: DQA, FLL, BZQ, DRG510(k) Number: K190073 |
| Secondary Predicate Device | Trade name: ActiGraph Gt9x-Link (originally clearedunder trade name ActiTrainer)Manufacturer: ActiGraphRegulatory Number: 21 CFR 890.5360Regulation Description: Measuring exercise equipmentProduct Code: ISD510(k) Number: K080545 |
Table 5-1. Subject Device Overview.
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5.1 Device Description
The Spire Health Remote Patient Monitoring System (RPM) is designed to capture, process, and longitudinally track clinically relevant patient health data and share this data with healthcare providers with a view to improving patient health and outcomes. The RPM is intended for longitudinal monitoring of pulse rate, respiratory rate, sleep/wake behavior, and activity associated with movement.
The RPM solution is comprised of four components - a Medical Health Tag (MHT), a Spire Mobile Application (Mobile App), a Cloud Platform (Platform) and a Healthcare Professional Dashboard (HPD). The patient facing components of the MHT and Mobile App) are intended for daily use in professional healthcare facilities or in the home. The MHT is a component designed to be affixed semi-permanently via an adhesive backing to the patient's first layer of clothing (e.g. underwear, bras, or pajamas), passing through laundry cycles without detaching. It does not require charging by the user.
5.2 Indications for Use
The Spire Health Remote Patient Monitoring System is intended for reusable bedside and mobile multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities or their own home. It is intended for monitoring of patients by trained healthcare professionals.
The Spire Health Remote Patient Monitoring System is intended for longitudinal monitoring of the following parameters in adults:
- Pulse Rate
- Respiratory Rate ●
- Sleep/Wake Behavior
- Activity associated with Movement ●
The Spire Health Remote Patient Monitoring System is intended only for general, nondiagnostic sleep and wake behavioral monitoring. It is not intended to assess sleep staging nor diagnose sleep disorders.
The Spire Health Remote Patient Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms.
The Spire Health Remote Patient Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG.
The Spire Health Remote Patient Monitoring System is not a substitute for an ECG monitor.
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5.3 Summary of Substantial Equivalence
The following table demonstrates equivalence between the Subject and Predicate Devices.
| Topic | Subject Device | Primary Predicate Device | Secondary PredicateDevice | Comment |
|---|---|---|---|---|
| CommonName | System, Network andCommunication,Physiological Monitors | System, Network andCommunication,Physiological Monitors | Exerciser, Measuring | N/A |
| DeviceManufacturer | Spire, Inc. | Current Health Ltd. | ActiGraph LLC | N/A |
| DeviceClassification | 2 | 2 | 2 | N/A |
| 510(k) Number | N/A | K190073 | K080545 | N/A |
| PrimaryProduct Code | MSX | MSX | ISD | Though the ActiGraph Gt9x-Link (K080545) was clearedunder product code ISD,regulation 21 CFR 890.5360,Spire proposes that the SpireRPM's secondary productcode be LEL, regulation 21CFR 882.5050, as theregulation description andproduct code better match thefunctionality of both theActiGraph product and theSpire product. The latestversion of the ActiGraphproduct, the CentrePoint |
| Topic | Subject Device | Primary Predicate Device | Secondary PredicateDevice | Comment |
| Insight Watch (K181077),similarly made this transition.Though it is substantiallyequivalent to the ActiGraphGt9x-Link (K080545), it iscleared under a differentproduct code & regulation(i.e. LEL instead of ISD). | ||||
| SecondaryProduct Code | BZQ, LEL | FLL, DQA, BZQ, DRG | N/A | N/A |
| TargetPopulation | Adult | Adult | Adult | Subject and Predicates areidentical |
| Environment | Professional Health CareFacilities and Home | Professional Health CareFacilities and Home | Professional Health CareFacilities and Home | Subject and Predicates areidentical |
| Intended Use/Indications forUse | The Spire Health RemotePatient Monitoring System isintended for reusable bedsideand mobile multi-parameter,physiologic patientmonitoring of adult patientsin professional healthcarefacilities or their own home.It is intended for monitoringof patients by trainedhealthcare professionals.The Spire Health RemotePatient Monitoring System isintended for longitudinal | The Current Wearable HealthMonitoring System isintended for reusable bedside,mobile and central multi-parameter, physiologic patientmonitoring of adult patientsin professional healthcarefacilities, such as hospitals orskilled nursing facilities, ortheir own home. It is intendedfor monitoring of patients bytrained healthcareprofessionals.The Current Wearable HealthMonitoring System isintended to provide visual and | The ActiTrainer is a smallworn activity monitordesigned for documentingphysical movementassociated with applicationsin physiological monitoring.The device is intended tomonitor the activityassociated with movementduring sleep. The ActiTrainercan be used to analyzecircadian rhythms and assessactivity in any instance wherequantifiable analysis ofphysical motion is desirable. | Subject and Predicates differonly in that:1) the Subject Devicemeasures a subset of theparameters that the PrimaryPredicate Device does, whileadditionally measuringadditionally measuring anadditional parameter: hoursasleep and hours awake,referenced herein simply as"Sleep/Wake". Thisparameter is measured by theSecondary Predicate Device.2) the Subject device is |
| Topic | Subject Device | Primary Predicate Device | Secondary PredicateDevice | Comment |
| monitoring of the followingparameters in adults:• Pulse Rate• Respiratory Rate• Sleep/Wake Behavior• Activity associatedwith MovementThe Spire Health RemotePatient Monitoring System isintended only for general,non-diagnostic sleep andwake behavioral monitoring.It is not intended to assesssleep staging nor diagnosesleep disorders.The Spire Health RemotePatient Monitoring System isnot intended for use in high-acuity environments, such asICU or operating rooms. | audible physiologic multi-parameter alarms. TheCurrent Wearable HealthMonitoring System isintended for temperaturemonitoring where monitoringtemperature at the upper armis clinically indicated.The Current Wearable HealthMonitoring System isintended for continuousmonitoring of the followingparameters in adults: • Pulserate • Oxygen saturation •Temperature • MovementThe Current Wearable HealthMonitoring System isintended for intermittent orspot-check monitoring ofrespiration rate, non-invasiveblood pressure and weight inadults. | intended for longitudinalmonitoring, i.e. ongoingmonitoring at discrete timeintervals (i.e. every hour,every day, every week, everymonth), while the PrimaryPredicate device is intendedfor continuous monitoring ofsome physiologicalparameters and intermittentmonitoring of others. | ||
| The Spire Health RemotePatient Monitoring System isnot intended for use onacutely ill cardiac patientswith the potential to developlife threatening arrhythmiase.g. very fast atrialfibrillation. For these patients, | The Current Wearable HealthMonitoring System is notintended for use in high-acuity environments, such asICU or operating rooms.The Current Wearable HealthMonitoring System is notintended for use on acutely ill | |||
| Topic | Subject Device | Primary Predicate Device | Secondary PredicateDevice | Comment |
| they should be monitoredusing a device withcontinuous ECG.The Spire Health RemotePatient Monitoring System isnot a substitute for an ECGmonitor. | cardiac patients with thepotential to develop lifethreatening arrhythmias e.g.very fast atrial fibrillation.For these patients, theyshould be monitored using adevice with continuous ECG.The Current Wearable HealthMonitoring System is not asubstitute for an ECGmonitor. The CurrentWearable Health MonitoringSystem is not intended forSpO2 monitoring inconditions of high motion orlow perfusion. | |||
| Sensor Types | Pulse Rate:Photoplethysmography (PPG)Respiratory Rate:Force sensorActivity associated withMovement: AccelerometerSleep/Wake: Accelerometer +Force sensor | Pulse Rate: PPGRespiratory Rate: PPGMovement: Accelerometer | Activity associated withMovement: AccelerometerSleep/Wake: Accelerometer | Subject and Primary PredicateDevice use identical methodsto sense Pulse Rate andMovement. Subject andPrimary Predicate Device usedifferent methods forRespiratory Rate. However,both Subject and PrimaryPredicate device validateRespiratory Rate accuracy inthe same manner.The Subject Device measuresan additional parameter,Sleep/Wake Behavior, using asensor that is common to both |
| Topic | Subject Device | Primary Predicate Device | Secondary PredicateDevice | Comment |
| Subject and PrimaryPredicate, a triaxialaccelerometer. SecondaryPredicate and Subject Deviceboth use an Accelerometer tomeasure activity andsleep/wake behavior. SubjectDevice additionally utilizes aforce sensor as input toanalysis of sleep/wakebehavior. |
Table 5-2. Subject and Predicate Devices Comparison.
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5.3 Technological Characteristics
A review of the Spire Health Remote Patient Monitoring System with the predicate devices found that the technology, mode of operation, and general principles for treatment with this device were substantially equivalent as the predicate devices. See Table 5-2 for a comparison of technological characteristics between the three devices.
5.4 Performance Data
The Spire Health Remote Patient Monitoring System was evaluated using the following testing:
| Test Name | Test Description | Results |
|---|---|---|
| Electrical Safety | The RPM was tested to demonstrate compliance to the standards for basic safetyand essential performance for MedicalElectrical Equipment (IEC 60601-1) | PASS |
| EMC | The RPM was tested to demonstrate compliance to the applicable standards forelectromagnetic compatibility (IEC 60601-1-2) | PASS |
| Biocompatibility | The RPM was tested to demonstratebiocompatibility per ISO 10993-1 | PASS |
| Usability/Human Factors | The RPM was assessed per IEC 62366 to demonstrate usability | PASS |
| Alarms | The RPM was assessed to demonstrate compliance to IEC 60601-1-8 | PASS |
| Ship/Transport | The RPM and its packaging was tested to demonstrate compliance to ISTA 3A | PASS |
| Pulse Rate Validation | The RPM was tested to confirm the accuracy of pulse rate monitoring of the system inaccordance with ISO 80601-2-61 | PASS |
| Respiratory Rate Validation | The RPM was clinically tested in comparison to end-tidal CO2 to confirm the accuracyrespiration rate measurement | PASS |
| Activity associated withMovement Validation | The RPM was clinically tested to confirm the accuracy of the activity tracking. | PASS |
| Environment | The RPM was tested to confirm the storage and operating temperature ranges. | PASS |
| Wash/Dry | The MHT was tested to confirm performanceafter wash/dry cycles | PASS |
Table 5-3. Summary of Testing.
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| Shelf Life | The MHT was tested utilizing accelerated aging to support shelf life claims | PASS |
|---|---|---|
| Battery | The battery life of the MHT was tested while operating in various modes | PASS |
| Software Verification and Validation | Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a “moderate” level of concern, since a failure or latent design flaw could directly result in minor injury to the patient or operator or a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider. | PASS |
Based upon the results of this testing, the Spire Health Remote Patient Monitoring System performance was determined to be substantially equivalent to the predicate devices.
5.5 Substantial Equivalence Conclusion
Spire Health Remote Patient Monitoring System is substantially equivalent to the legally marketed primary predicate device, Current Wearable Health Monitoring System (K190073). The two devices have similar intended uses. The technological differences between the devices do not raise any new questions of safety or effectiveness.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).