Spire Health Remote Patient Monitoring System
Device Facts
| Record ID | K192952 |
|---|---|
| Device Name | Spire Health Remote Patient Monitoring System |
| Applicant | Spire, Inc. D/B/A Spire Health |
| Product Code | MSX · Cardiovascular |
| Decision Date | Jun 5, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2300 |
| Device Class | Class 2 |
Intended 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, 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.
Device Story
System captures, processes, and tracks physiologic data for longitudinal monitoring. Components: Medical Health Tag (MHT) affixed to clothing, Mobile App, Cloud Platform, and Healthcare Professional Dashboard. MHT uses photoplethysmography (PPG) for pulse rate, force sensor for respiratory rate, and accelerometer/force sensor for activity and sleep/wake behavior. Data transmitted to cloud for provider review via dashboard. Used in professional facilities or home by trained healthcare professionals. Provides longitudinal tracking to improve patient outcomes. Not a substitute for ECG; not for high-acuity monitoring.
Clinical Evidence
Bench testing included electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), biocompatibility (ISO 10993-1), usability (IEC 62366), and alarm compliance (IEC 60601-1-8). Performance validation included pulse rate accuracy (ISO 80601-2-61), respiratory rate accuracy (compared to end-tidal CO2), and activity tracking accuracy. MHT durability tested via wash/dry cycles and accelerated aging. All tests passed.
Technological Characteristics
System includes MHT (wearable tag), mobile app, cloud platform, and dashboard. Sensors: PPG (pulse), force sensor (respiration), triaxial accelerometer (activity/sleep). Connectivity: Wireless data transmission to cloud. Software: Moderate level of concern. Biocompatibility per ISO 10993-1. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2.
Indications for Use
Indicated for longitudinal monitoring of pulse rate, respiratory rate, sleep/wake behavior, and activity in adult patients in professional healthcare facilities or home settings. Not for high-acuity environments (ICU/OR) or patients with potential for life-threatening arrhythmias (e.g., fast atrial fibrillation). Not for sleep staging or sleep disorder diagnosis.
Regulatory Classification
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.
Predicate Devices
Related Devices
- K212957 — BioButton System · Biolntellisense, Inc. · Dec 12, 2022
- K241101 — BioButton System · Biointellisense, Inc. · Sep 26, 2024
- K173510 — BioStamp nPoint · Mc10, Inc. · May 8, 2018
- K212160 — SimpleSENSE Platform · Nanowear, Inc. · Sep 22, 2021
- K210133 — Current Health Monitoring System Gen 2 (G2) · Current Health · Sep 3, 2021
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
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) | |
|-------------------------------------------------|--------------|
| <div></div> | |
| Prescription Use (Part 21 CFR 801 Subpart D) | <div> </div> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> </div> |
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# 5 510(k) Summary
| Submitter's Name: | Spire, Inc. |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 2030 Harrison St<br>San 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, Physiological<br>Monitors |
| 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 System<br>Manufacturer: Current Health<br>Playfair House, 12A Broughton Street Lane<br>Edinburgh, EH1 3LY Gb<br>Regulation Number: 21 CFR 870.2300<br>Regulation Description: Cardiac Monitor<br>Device Class: Class II<br>Product Code: MSX<br>Subsequent Product Codes: DQA, FLL, BZQ, DRG<br>510(k) Number: K190073 |
| Secondary Predicate Device | Trade name: ActiGraph Gt9x-Link (originally cleared<br>under trade name ActiTrainer)<br>Manufacturer: ActiGraph<br>Regulatory Number: 21 CFR 890.5360<br>Regulation Description: Measuring exercise equipment<br>Product Code: ISD<br>510(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 Predicate<br>Device | Comment |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common<br>Name | System, Network and<br>Communication,<br>Physiological Monitors | System, Network and<br>Communication,<br>Physiological Monitors | Exerciser, Measuring | N/A |
| Device<br>Manufacturer | Spire, Inc. | Current Health Ltd. | ActiGraph LLC | N/A |
| Device<br>Classification | 2 | 2 | 2 | N/A |
| 510(k) Number | N/A | K190073 | K080545 | N/A |
| Primary<br>Product Code | MSX | MSX | ISD | Though the ActiGraph Gt9x-<br>Link (K080545) was cleared<br>under product code ISD,<br>regulation 21 CFR 890.5360,<br>Spire proposes that the Spire<br>RPM's secondary product<br>code be LEL, regulation 21<br>CFR 882.5050, as the<br>regulation description and<br>product code better match the<br>functionality of both the<br>ActiGraph product and the<br>Spire product. The latest<br>version of the ActiGraph<br>product, the CentrePoint |
| Topic | Subject Device | Primary Predicate Device | Secondary Predicate<br>Device | Comment |
| | | | | Insight Watch (K181077),<br>similarly made this transition.<br>Though it is substantially<br>equivalent to the ActiGraph<br>Gt9x-Link (K080545), it is<br>cleared under a different<br>product code & regulation<br>(i.e. LEL instead of ISD). |
| Secondary<br>Product Code | BZQ, LEL | FLL, DQA, BZQ, DRG | N/A | N/A |
| Target<br>Population | Adult | Adult | Adult | Subject and Predicates are<br>identical |
| Environment | Professional Health Care<br>Facilities and Home | Professional Health Care<br>Facilities and Home | Professional Health Care<br>Facilities and Home | Subject and Predicates are<br>identical |
| Intended Use/<br>Indications for<br>Use | The Spire Health Remote<br>Patient Monitoring System is<br>intended for reusable bedside<br>and mobile multi-parameter,<br>physiologic patient<br>monitoring of adult patients<br>in professional healthcare<br>facilities or their own home.<br>It is intended for monitoring<br>of patients by trained<br>healthcare professionals.<br>The Spire Health Remote<br>Patient Monitoring System is<br>intended for longitudinal | The Current Wearable Health<br>Monitoring System is<br>intended for reusable bedside,<br>mobile and central multi-<br>parameter, physiologic patient<br>monitoring of adult patients<br>in professional healthcare<br>facilities, such as hospitals or<br>skilled nursing facilities, or<br>their own home. It is intended<br>for monitoring of patients by<br>trained healthcare<br>professionals.<br>The Current Wearable Health<br>Monitoring System is<br>intended to provide visual and | The ActiTrainer is a small<br>worn activity monitor<br>designed for documenting<br>physical movement<br>associated with applications<br>in physiological monitoring.<br>The device is intended to<br>monitor the activity<br>associated with movement<br>during sleep. The ActiTrainer<br>can be used to analyze<br>circadian rhythms and assess<br>activity in any instance where<br>quantifiable analysis of<br>physical motion is desirable. | Subject and Predicates differ<br>only in that:<br>1) the Subject Device<br>measures a subset of the<br>parameters that the Primary<br>Predicate Device does, while<br>additionally measuring<br>additionally measuring an<br>additional parameter: hours<br>asleep and hours awake,<br>referenced herein simply as<br>"Sleep/Wake". This<br>parameter is measured by the<br>Secondary Predicate Device.<br>2) the Subject device is |
| Topic | Subject Device | Primary Predicate Device | Secondary Predicate<br>Device | Comment |
| | monitoring of the following<br>parameters in adults:<br>• Pulse Rate<br>• Respiratory Rate<br>• Sleep/Wake Behavior<br>• Activity associated<br>with Movement<br>The Spire Health Remote<br>Patient Monitoring System is<br>intended only for general,<br>non-diagnostic sleep and<br>wake behavioral monitoring.<br>It is not intended to assess<br>sleep staging nor diagnose<br>sleep disorders.<br>The Spire Health Remote<br>Patient Monitoring System is<br>not intended for use in high-<br>acuity environments, such as<br>ICU or operating rooms. | audible physiologic multi-<br>parameter alarms. The<br>Current Wearable Health<br>Monitoring System is<br>intended for temperature<br>monitoring where monitoring<br>temperature at the upper arm<br>is clinically indicated.<br>The Current Wearable Health<br>Monitoring System is<br>intended for continuous<br>monitoring of the following<br>parameters in adults: • Pulse<br>rate • Oxygen saturation •<br>Temperature • Movement<br>The Current Wearable Health<br>Monitoring System is<br>intended for intermittent or<br>spot-check monitoring of<br>respiration rate, non-invasive<br>blood pressure and weight in<br>adults. | | intended for longitudinal<br>monitoring, i.e. ongoing<br>monitoring at discrete time<br>intervals (i.e. every hour,<br>every day, every week, every<br>month), while the Primary<br>Predicate device is intended<br>for continuous monitoring of<br>some physiological<br>parameters and intermittent<br>monitoring of others. |
| | The Spire Health Remote<br>Patient Monitoring System is<br>not intended for use on<br>acutely ill cardiac patients<br>with the potential to develop<br>life threatening arrhythmias<br>e.g. very fast atrial<br>fibrillation. For these patients, | The Current Wearable Health<br>Monitoring System is not<br>intended for use in high-<br>acuity environments, such as<br>ICU or operating rooms.<br>The Current Wearable Health<br>Monitoring System is not<br>intended for use on acutely ill | | |
| Topic | Subject Device | Primary Predicate Device | Secondary Predicate<br>Device | Comment |
| | they should be monitored<br>using a device with<br>continuous ECG.<br>The Spire Health Remote<br>Patient Monitoring System is<br>not a substitute for an ECG<br>monitor. | cardiac patients with the<br>potential to develop life<br>threatening arrhythmias e.g.<br>very fast atrial fibrillation.<br>For these patients, they<br>should be monitored using a<br>device with continuous ECG.<br>The Current Wearable Health<br>Monitoring System is not a<br>substitute for an ECG<br>monitor. The Current<br>Wearable Health Monitoring<br>System is not intended for<br>SpO2 monitoring in<br>conditions of high motion or<br>low perfusion. | | |
| Sensor Types | Pulse Rate:<br>Photoplethysmography (PPG)<br>Respiratory Rate:<br>Force sensor<br>Activity associated with<br>Movement: Accelerometer<br>Sleep/Wake: Accelerometer +<br>Force sensor | Pulse Rate: PPG<br>Respiratory Rate: PPG<br>Movement: Accelerometer | Activity associated with<br>Movement: Accelerometer<br>Sleep/Wake: Accelerometer | Subject and Primary Predicate<br>Device use identical methods<br>to sense Pulse Rate and<br>Movement. Subject and<br>Primary Predicate Device use<br>different methods for<br>Respiratory Rate. However,<br>both Subject and Primary<br>Predicate device validate<br>Respiratory Rate accuracy in<br>the same manner.<br>The Subject Device measures<br>an additional parameter,<br>Sleep/Wake Behavior, using a<br>sensor that is common to both |
| Topic | Subject Device | Primary Predicate Device | Secondary Predicate<br>Device | Comment |
| | | | | Subject and Primary<br>Predicate, a triaxial<br>accelerometer. Secondary<br>Predicate and Subject Device<br>both use an Accelerometer to<br>measure activity and<br>sleep/wake behavior. Subject<br>Device additionally utilizes a<br>force sensor as input to<br>analysis of sleep/wake<br>behavior. |
Table 5-2. Subject and Predicate Devices Comparison.
K192952
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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 |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| <b>Electrical Safety</b> | The RPM was tested to demonstrate compliance to the standards for basic safety<br>and essential performance for Medical<br>Electrical Equipment (IEC 60601-1) | PASS |
| <b>EMC</b> | The RPM was tested to demonstrate compliance to the applicable standards for<br>electromagnetic compatibility (IEC 60601-1-2) | PASS |
| <b>Biocompatibility</b> | The RPM was tested to demonstrate<br>biocompatibility per ISO 10993-1 | PASS |
| <b>Usability/Human Factors</b> | The RPM was assessed per IEC 62366 to demonstrate usability | PASS |
| <b>Alarms</b> | The RPM was assessed to demonstrate compliance to IEC 60601-1-8 | PASS |
| <b>Ship/Transport</b> | The RPM and its packaging was tested to demonstrate compliance to ISTA 3A | PASS |
| <b>Pulse Rate Validation</b> | The RPM was tested to confirm the accuracy of pulse rate monitoring of the system in<br>accordance with ISO 80601-2-61 | PASS |
| <b>Respiratory Rate Validation</b> | The RPM was clinically tested in comparison to end-tidal CO2 to confirm the accuracy<br>respiration rate measurement | PASS |
| <b>Activity associated with<br/>Movement Validation</b> | The RPM was clinically tested to confirm the accuracy of the activity tracking. | PASS |
| <b>Environment</b> | The RPM was tested to confirm the storage and operating temperature ranges. | PASS |
| <b>Wash/Dry</b> | The MHT was tested to confirm performance<br>after 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.
