(228 days)
Not Found
No
The summary does not mention AI, ML, or any related terms like deep learning or neural networks. The device description focuses on data capture, processing, and tracking, and the performance studies listed are standard for medical devices, not specifically related to AI/ML model validation.
No.
The device is described as a monitoring system that captures and tracks health data, not as a device that provides therapy or treatment.
No
The "Intended Use / Indications for Use" section explicitly states, "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."
No
The device description explicitly states that the system is comprised of four components, including a "Medical Health Tag (MHT)" which is a physical component designed to be affixed to clothing. This indicates the system includes hardware in addition to software.
Based on the provided information, the Spire Health Remote Patient Monitoring System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Spire System Function: The Spire Health Remote Patient Monitoring System monitors physiological parameters directly from the patient's body (pulse rate, respiratory rate, sleep/wake behavior, activity) using a wearable device. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "physiologic patient monitoring" and "longitudinal monitoring of the following parameters in adults." This aligns with patient monitoring, not in vitro testing.
- Device Description: The device description details a wearable tag and associated software, not equipment for analyzing biological samples.
Therefore, the Spire Health Remote Patient Monitoring System falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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, 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.
Product codes
MSX, BZQ, DRG, LEL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult
Intended User / Care Setting
trained healthcare professionals / professional healthcare facilities or their own home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Spire Health Remote Patient Monitoring System was evaluated using the following testing:
- Electrical Safety: The RPM was tested to demonstrate compliance to the standards for basic safety and essential performance for Medical Electrical Equipment (IEC 60601-1). Result: PASS.
- EMC: The RPM was tested to demonstrate compliance to the applicable standards for electromagnetic compatibility (IEC 60601-1-2). Result: PASS.
- Biocompatibility: The RPM was tested to demonstrate biocompatibility per ISO 10993-1. Result: PASS.
- Usability/Human Factors: The RPM was assessed per IEC 62366 to demonstrate usability. Result: PASS.
- Alarms: The RPM was assessed to demonstrate compliance to IEC 60601-1-8. Result: PASS.
- Ship/Transport: The RPM and its packaging was tested to demonstrate compliance to ISTA 3A. Result: PASS.
- 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. Result: PASS.
- Respiratory Rate Validation: The RPM was clinically tested in comparison to end-tidal CO2 to confirm the accuracy respiration rate measurement. Result: PASS.
- Activity associated with Movement Validation: The RPM was clinically tested to confirm the accuracy of the activity tracking. Result: PASS.
- Environment: The RPM was tested to confirm the storage and operating temperature ranges. Result: PASS.
- Wash/Dry: The MHT was tested to confirm performance after wash/dry cycles. Result: PASS.
- Shelf Life: The MHT was tested utilizing accelerated aging to support shelf life claims. Result: PASS.
- Battery: The battery life of the MHT was tested while operating in various modes. Result: 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. Result: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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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3
5 510(k) Summary
| Submitter's Name: | Spire, Inc. |
|---|---|
| Address: | 2030 Harrison St |
| 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 |
| 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 |
| Manufacturer: Current Health | |
| Playfair House, 12A Broughton Street Lane | |
| Edinburgh, EH1 3LY Gb | |
| Regulation Number: 21 CFR 870.2300 | |
| Regulation Description: Cardiac Monitor | |
| Device Class: Class II | |
| Product Code: MSX | |
| Subsequent Product Codes: DQA, FLL, BZQ, DRG | |
| 510(k) Number: K190073 | |
| Secondary Predicate Device | Trade name: ActiGraph Gt9x-Link (originally cleared |
| under trade name ActiTrainer) | |
| Manufacturer: ActiGraph | |
| Regulatory Number: 21 CFR 890.5360 | |
| Regulation Description: Measuring exercise equipment | |
| Product Code: ISD | |
| 510(k) Number: K080545 |
Table 5-1. Subject Device Overview.
4
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.
5
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
Device | Comment |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common
Name | System, Network and
Communication,
Physiological Monitors | System, Network and
Communication,
Physiological Monitors | Exerciser, Measuring | N/A |
| Device
Manufacturer | Spire, Inc. | Current Health Ltd. | ActiGraph LLC | N/A |
| Device
Classification | 2 | 2 | 2 | N/A |
| 510(k) Number | N/A | K190073 | K080545 | N/A |
| Primary
Product Code | MSX | MSX | ISD | Though the ActiGraph Gt9x-
Link (K080545) was cleared
under product code ISD,
regulation 21 CFR 890.5360,
Spire proposes that the Spire
RPM's secondary product
code be LEL, regulation 21
CFR 882.5050, as the
regulation description and
product code better match the
functionality of both the
ActiGraph product and the
Spire product. The latest
version of the ActiGraph
product, the CentrePoint |
| Topic | Subject Device | Primary Predicate Device | Secondary Predicate
Device | Comment |
| | | | | Insight Watch (K181077),
similarly made this transition.
Though it is substantially
equivalent to the ActiGraph
Gt9x-Link (K080545), it is
cleared under a different
product code & regulation
(i.e. LEL instead of ISD). |
| Secondary
Product Code | BZQ, LEL | FLL, DQA, BZQ, DRG | N/A | N/A |
| Target
Population | Adult | Adult | Adult | Subject and Predicates are
identical |
| Environment | Professional Health Care
Facilities and Home | Professional Health Care
Facilities and Home | Professional Health Care
Facilities and Home | Subject and Predicates are
identical |
| Intended Use/
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 | The Current Wearable Health
Monitoring System is
intended for reusable bedside,
mobile and central multi-
parameter, physiologic patient
monitoring of adult patients
in professional healthcare
facilities, such as hospitals or
skilled nursing facilities, or
their own home. It is intended
for monitoring of patients by
trained healthcare
professionals.
The Current Wearable Health
Monitoring System is
intended to provide visual and | The ActiTrainer is a small
worn activity monitor
designed for documenting
physical movement
associated with applications
in physiological monitoring.
The device is intended to
monitor the activity
associated with movement
during sleep. The ActiTrainer
can be used to analyze
circadian rhythms and assess
activity in any instance where
quantifiable analysis of
physical motion is desirable. | Subject and Predicates differ
only in that:
- the Subject Device
measures a subset of the
parameters that the Primary
Predicate Device does, while
additionally measuring
additionally measuring an
additional parameter: hours
asleep and hours awake,
referenced herein simply as
"Sleep/Wake". This
parameter is measured by the
Secondary Predicate Device. - the Subject device is |
| Topic | Subject Device | Primary Predicate Device | Secondary Predicate
Device | Comment |
| | 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. | audible physiologic multi-
parameter alarms. The
Current Wearable Health
Monitoring System is
intended for temperature
monitoring where monitoring
temperature at the upper arm
is clinically indicated.
The Current Wearable Health
Monitoring System is
intended for continuous
monitoring of the following
parameters in adults: • Pulse
rate • Oxygen saturation •
Temperature • Movement
The Current Wearable Health
Monitoring System is
intended for intermittent or
spot-check monitoring of
respiration rate, non-invasive
blood pressure and weight in
adults. | | intended for longitudinal
monitoring, i.e. ongoing
monitoring at discrete time
intervals (i.e. every hour,
every day, every week, every
month), while the Primary
Predicate device is intended
for continuous monitoring of
some physiological
parameters and intermittent
monitoring of others. |
| | 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, | The Current Wearable Health
Monitoring System is not
intended for use in high-
acuity environments, such as
ICU or operating rooms.
The Current Wearable Health
Monitoring System is not
intended for use on acutely ill | | |
| Topic | Subject Device | Primary Predicate Device | Secondary Predicate
Device | Comment |
| | 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. | 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 Current Wearable Health
Monitoring System is not a
substitute for an ECG
monitor. The Current
Wearable Health Monitoring
System is not intended for
SpO2 monitoring in
conditions of high motion or
low perfusion. | | |
| Sensor Types | Pulse Rate:
Photoplethysmography (PPG)
Respiratory Rate:
Force sensor
Activity associated with
Movement: Accelerometer
Sleep/Wake: Accelerometer +
Force sensor | Pulse Rate: PPG
Respiratory Rate: PPG
Movement: Accelerometer | Activity associated with
Movement: Accelerometer
Sleep/Wake: Accelerometer | Subject and Primary Predicate
Device use identical methods
to sense Pulse Rate and
Movement. Subject and
Primary Predicate Device use
different methods for
Respiratory Rate. However,
both Subject and Primary
Predicate device validate
Respiratory Rate accuracy in
the same manner.
The Subject Device measures
an additional parameter,
Sleep/Wake Behavior, using a
sensor that is common to both |
| Topic | Subject Device | Primary Predicate Device | Secondary Predicate
Device | Comment |
| | | | | Subject and Primary
Predicate, a triaxial
accelerometer. Secondary
Predicate and Subject Device
both use an Accelerometer to
measure activity and
sleep/wake behavior. Subject
Device additionally utilizes a
force sensor as input to
analysis of sleep/wake
behavior. |
Table 5-2. Subject and Predicate Devices Comparison.
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8
9
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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 safety | |
| and essential performance for Medical | ||
| Electrical Equipment (IEC 60601-1) | PASS | |
| EMC | The RPM was tested to demonstrate compliance to the applicable standards for | |
| electromagnetic compatibility (IEC 60601-1-2) | PASS | |
| Biocompatibility | The RPM was tested to demonstrate | |
| biocompatibility 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 in | |
| accordance with ISO 80601-2-61 | PASS | |
| Respiratory Rate Validation | The RPM was clinically tested in comparison to end-tidal CO2 to confirm the accuracy | |
| respiration rate measurement | PASS | |
| Activity associated with | ||
| Movement 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 performance | |
| 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.