Stasis Monitoring System

K183634 · Stasis Labs, Inc. · MWI · Apr 17, 2019 · Cardiovascular

Device Facts

• Record ID: K183634
• Device Name: Stasis Monitoring System
• Applicant: Stasis Labs, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Apr 17, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended Use

The Stasis Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients (≥21 years of age). It is indicated for 3 lead ECG, respiration rate (RESP), heart rate (HR), noninvasive blood pressure (NIBP), noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and skin temperature (TEMP) in hospital-based facilities; including, general medical-surgical floors, intermediate care floors, and emergency departments. The Stasis Monitoring System includes bedside patient monitors that communicate with mobile tablets through wireless Bluetooth Low Energy (BLE) communication. The Stasis Monitoring System can generate alerts when rate-based cardiac arrhythmias such as asystole are detected, and when physiological vital signs fall outside of selected parameters. The Stasis Monitoring System has a notification system that communicates data and alarms to a Stasis Tablet. It is intended to supplement the primary alarms which originate at the Stasis Monitor device.

Device Story

Stasis Monitoring System provides bedside vital signs monitoring for adult patients in hospital settings. System comprises a bedside monitor and a mobile Android tablet. Monitor connects to patient via wired, off-the-shelf sensors (ECG, SpO2, NIBP, TEMP, RESP). Monitor processes physiological signals and transmits data via Bluetooth Low Energy (BLE) to the tablet. Tablet serves as primary user interface for viewing live/recorded data, configuring alarm settings, and managing alerts. System generates rate-based cardiac arrhythmia alerts (e.g., asystole) and physiological parameter alarms. Clinicians use tablet to monitor patient status and respond to alarms. System supplements primary alarms originating at the bedside monitor. Benefits include continuous, mobile-accessible patient monitoring to support clinical decision-making.

Clinical Evidence

Bench testing only. No clinical data. Verification and validation testing performed using simulators to confirm functional requirements, accuracy, and software performance. Coexistence testing performed per ANSI C63.27 (2017) using the radiated open environment (ROE) method. All testing passed within specifications.

Technological Characteristics

Six-parameter vital signs monitor; bedside form factor with custom stand. Uses off-the-shelf sensors/cables (GE Critikon, Edan, 3M, Unimed, Shenzen Med-Link). Connectivity: Bluetooth Low Energy (BLE) to Android tablet. Power: DC supply with backup batteries. Software: Custom monitor and tablet applications. Standards: IEC 60601-1, 60601-1-2, 60601-1-8, 60601-2-27, 60601-2-49, 80601-2-30, 80601-2-61, 80601-2-56, 62304, ANSI C63.27. Software Safety Class C.

Indications for Use

Indicated for single or multi-parameter vital signs monitoring of adult patients (≥21 years) in hospital settings (general medical-surgical, intermediate care, emergency departments). Parameters: 3-lead ECG, RESP, HR, NIBP, SpO2, PR, and TEMP.

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

• Sotera Wireless ViSi Mobile Monitoring System (K152341)

Submission Summary (Full Text)

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Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 17, 2019

Stasis Labs, Inc. % Eric Eggers Principal 510konsult LLC 754 NW Broadway, Suite 206 Bend, Oregon 97703

Re: K183634

Trade/Device Name: Stasis Monitoring System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI, DRT, DXN, DQA, FLL Dated: March 6, 2019 Received: March 7, 2019

Dear Eric Eggers:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) SUMMARY

# Stasis Labs, Inc. Stasis Monitoring System

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Stasis Labs, Inc.

10100 Venice Blvd, Ste. 418, Culver City, CA 90232

Phone: [phone] Facsimile: [phone]

Contact Person: Eric A. Eqgers.

Date Prepared: February 27, 2019

Name of Device and Name/Address of Sponsor

Stasis Labs, Inc. Stasis Monitoring System

Stasis Labs, Inc.

10100 Venice Blvd. Ste. 418

Culver City, CA 90232

Common or Usual Name: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Regulation Number: 21 CFR 870.2300

Classification Product Code: MWI

Subsequent Product Codes: DRT, DXN, DQA, FLL

Device Class: Class II

## Predicate Device: Sotera Wireless ViSi Mobile Monitoring System (K152341)

## Intended Use / Indications for Use:

The Stasis Monitoring System is intended for use by clinicians and medically qualified personnel for sinqle or multi-parameter vital signs monitoring of adult patients (≥21 years of age). It is indicated for 3 lead ECG, respiration rate (RESP), heart rate (HR), noninvasive blood pressure (NIBP), noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpOz), pulse rate (PR), and skin temperature (TEMP) in hospital-based facilities; including, general medical-surgical floors, intermediate care floors, and emergency departments. The Stasis Monitoring System includes bedside patient monitors that communicate with mobile tablets through wireless Bluetooth Low Energy (BLE) communication. The Stasis Monitoring System can generate alerts when rate-based cardiac

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K183634 Page 2 of 8

arrhythmias such as asystole are detected, and when physiological vital signs fall outside of selected parameters.

The Stasis Monitoring System has a notification system that communicates data and alarms to a Stasis Tablet. It is intended to supplement the primary alarms which originate at the Stasis Monitor device.

#### Technological Characteristics

The Stasis Monitoring System consists of:

- the Stasis Monitor .
- the Stasis Tablet

The Stasis Monitoring System consists of a compact six-parameter vital signs monitor that sits at the patient's bedside and communicates via Bluetooth with off the shelf Android tablets running a custom Stasis application. The parameters measured include the following: 3 lead ECG, respiration rate (RESP), heart rate (HR), noninvasive blood pressure (NIBP), noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and skin temperature (TEMP). The System uses traditional wired sensor technology (i.e., sensors cables are connected to back of Monitor with sensors applied to patient) to acquire the vital signs. All sensors and cables used are off-the-shelf and are already 510(k) cleared as identified in the bulleted list on the following page below. The primary data display and control for the monitoring system is on the Android tablet (see Fig 1 below).

Image /page/4/Figure/8 description: The image shows a Stasis Monitor and a Stasis Tablet. The Stasis Monitor receives patient vitals data from sensors and outputs it to the user via a display and speaker. The Stasis Tablet receives user input via touchscreen and outputs it to the user via a display, and the two devices communicate via Bluetooth Low Energy.

## Figure 1-Stasis Monitor and Tablet

The Stasis Monitor is mounted near a patient's bed on a custom stand, and sensors collect vital signs data from the patient. The Stasis Monitor has a color-coded display to convey vitals sensor and alarm status to clinical staff. It also has a speaker used for audible alarming, a touch sensor on the top to pair a monitor with a Tablet, as well as unique connectors for the various sensor cable connections (see Fig 2 below). The Stasis Monitor program interacts with the Stasis Tablet program through wireless communication over Bluetooth Smart (also called Bluetooth Low Energy).

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Image /page/5/Picture/1 description: The image shows a Stasis Monitor device. The device has a black casing and a touch sensor on the top. The front of the device has a screen with icons for heart rate, oxygen saturation, ECG, and other vital signs. The back of the device has ports for connecting sensors and a power switch.

Figure 2-Stasis Monitor (back of Monitor and Touch sensor location)

The Stasis Tablet works as a digital patient chart, allowing clinical staff to view patient data, both live vital signs data and recorded vital signs, as well as change settings. It is the primary interface for interacting with the Stasis Monitoring System. It also allows clinical staff to set alarm settings on a per-vital sign basis, and view and pause those alarms when they occur. It is the primary interface for interacting with the Stasis Monitoring System. The Android tablets running the Stasis Tablet application are available off the shelf, but will be provided to users by Stasis Labs with the Stasis Tablet application installed.

The Stasis Monitoring System requires the following:

## · Stasis Monitor

- custom Monitor (containing off-the-shelf batteries for backup power) .
- custom software application that runs Monitor
- . custom Stand (for holding Monitor)
- off-the-shelf DC power supply (to power Monitor and charge Monitor batteries)
- off-the shelf sensors/cables that connect to Monitor .
- GE Critikon blood pressure Dura-Cuf cleared by K120125, reusable O
- Edan Instruments blood pressure extension tube cleared by O K120144, reusable
- 3M Red Dot ECG electrode cleared by K970796, single use O disposable
- Unimed Medical Supplies SpO2 sensor and cable cleared by O K082546, reusable
- Unimed Medical Supplies temperature sensor and cable cleared by O K121427, reusable
- O Shenzen Med-Link ECG cable cleared by K120010, reusable

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#### · Stasis Tablet (connected to Monitor via Bluetooth)

- . Off-the-shelf Android Tablet
- custom software application that runs Stasis software on Tablet .

Pursuant to 807.92(a)(6), basically, both the applicant's device (Stasis Monitoring System) and the predicate device (Sotera Wireless ViSi Mobile Monitoring System), allow for measurement of 3 lead ECG, respiration rate (RESP), heart rate (HR), noninvasive blood pressure (NIBP), noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and skin temperature (TEMP) utilizing wireless communication. The only difference in indications for use is the generation of alerts when rate-based cardiac arrhythmias such as asystole are detected, and when physiological vital signs fall outside of selected parameters. which does not constitute a substantive change, as this is simply rate based detection and not specific waveform triggered alerts. The only technological differences between the applicant's device (Stasis Monitoring System) and the predicate device (Sotera Wireless ViSi Mobile Monitoring System) are the Stasis Monitoring System uses Bluetooth communication to Tablet instead of 802.11 wireless communication to a computer, the Stasis Monitoring System utilizes off-the-shelf previously 510(k) cleared sensors for vitals monitoring while the predicate measures vitals either at the custom wrist control unit (measuring temperature and NIBP) or with custom sensors that are connected by wires that deploy from the wrist unit to finger (measuring pulse and SpO2) or chest (measuring ECG and respiratory rate) and the Stasis Monitoring System displays vitals at the Tablet connected by wireless Bluetooth only while the predicate displays vitals at wrist unit and computer connected by 802.11 wireless communication. Both the applicant's device (Stasis Monitoring System) and the predicate device (Sotera Wireless ViSi Mobile Monitoring System) have a product code of MWI for Monitor. Physiological, Patient (Without Arrhythmia Detection Or Alarms), as well as share subsequent product codes of DRT, DXN, DQA and FLL.

The Stasis Monitoring System software is Safety Class C according to ANSI/AAMI/IEC 62304:2006. Determination of the LOC and Safety Class is the result of risk assessment activities per ISO 14971.

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# STASIS LABS INC.

# STASIS MONITORING SYSTEM SUBSTANTIAL EQUIVALENCE CHART

| | [Stasis Monitoring System, k183634] | [Sotera Wireless ViSi Mobile Monitoring System, k152341] |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Stasis Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients (≥21 years of age). It is indicated for 3 lead ECG, respiration rate (RESP), heart rate (HR), noninvasive blood pressure (NIBP), noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and skin temperature (TEMP) in hospital-based facilities; including, general medical-surgical floors, intermediate care floors, and emergency departments. The Stasis Monitoring System includes bedside patient monitors that communicate with mobile tablets through wireless Bluetooth Low Energy (BLE) communication. The Stasis Monitoring System can generate alerts when rate-based cardiac arrhythmias such as asystole are detected, and when physiological vital signs fall outside of selected parameters<br><br>The Stasis Monitoring System has a notification system that communicates data and alarms to a Stasis Tablet. It is intended to supplement the primary alarms which originate at the Stasis Monitor device. | The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients (18 years or older). It is indicated for ECG (3 or 5 lead-wire), respiration rate (RESP), heart rate (HR), noninvasive blood pressure (NIBP), continuous noninvasive blood pressure (cNIBP), noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and skin temperature (TEMP) in hospital- based facilities; including, general medical- surgical floors, intermediate care floors, and emergency departments.<br><br>The ViSi Mobile Monitoring System may be used as standalone devices or networked to ViSi Mobile Remote Viewers through wireless 802.11 communication.<br><br>The ViSi Mobile InSight is an optional secondary notification system that communicates alarms directly to an assigned caregiver. It is intended to supplement the primary alarming devices which originate in the ViSi Mobile patient worn device. |
| Intended use | Same as above | Same as above |
| User Population | Healthcare professionals | Healthcare professionals |
| Classification Product Code | MWI--Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI--Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| Subsequent Product<br>Code(s) | DRT, DXN, DQA and FLL | DRT, DXN, DQA, FLL, MSX |
| Primary<br>component(s) | Software: Custom monitor<br>software, custom tablet<br>application<br>Hardware: Custom monitor (with<br>batteries and power supply), custom<br>monitor stand, off-the-shelf vitals<br>monitoring sensors, off-the-shelf<br>tablet | Software: Custom monitor software,<br>custom computer software<br>Hardware: Custom wrist monitor,<br>custom finger and chest sensors,<br>off-the-shelf computer |
| Wireless<br>communication | Bluetooth | 802.11 (Wifi) |
| Safety Features | Risk analysis developed in<br>accordance with ISO 14971 | Not available in 510(k), assumed in<br>accordance with ISO 14971 |
| Software level of<br>concern | Major level of concern | Not available in 510(k), assumed to<br>be major per IEC 62304:2006 |
| Standards used and<br>testing performed | IEC 60601-1, IEC 60601-1-2, IEC<br>60601-1-8, IEC 60601-2-27, IEC<br>60601-2-49, IEC 80601-2-30, IEC<br>80601-2-61, IEC 80601-2-56, IEC<br>62304, ANSI C63.27 (2017) | Not available in 510(k) |
| Respiratory rate (RR)<br>operating principle | Impedance Pneumography measuring<br>in respirations per minute (or RPM) | Impedance Pneumography in breaths<br>per minute (same as RPM) |
| Default RR Alarms<br>Settings | 10 RPM lower, 25 RPM higher | 4 RPM lower, 35-40 RPM higher |
| RR Alarms<br>Settings Tunable<br>for User? | Yes | Yes |
| RR Min/Max Alarm<br>settings | 6 RPM lower, 50 RPM higher | Not specified |
| RR Display Range | 0-50 RPM | 0-50 RPM |
| RR Accuracy Range | 7-45 RPM | 3-50 RPM |
| RR Resolution | 1 RPM | 1 RPM |
| RR Accuracy | ±3 RPM | ± 3 BR/MIN or 10% of reading,<br>whichever is greater |
| Respiration Drive<br>Signal Applied to<br>Patient | Voltage: 0.8 V P-P Frequency: 32.5<br>KHz | Voltage: 1.0 V P-P ± 5%<br>Frequency: 32 KHz ± 2% |

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#### Electrical Testing

EMC testing per IEC 60601-1-2 and leakage current testing per IEC 60601-1-1 were performed for the Stasis Monitoring System. All test results were acceptable for the Stasis Monitoring System.

#### Coexistence Testina

Pursuant to 807.92(b)(1), coexistence testing was performed on the Stasis Monitoring System per ANSI C63.27 (2017) using the radiated open environment (ROE) method. The Stasis Monitoring System was tested as Tier 1 device per ANSI C63.27 (2017). The Stasis Monitoring System passed testing and pursuant to 807.92(b)(3), the results of coexistence testing demonstrate that the Stasis Monitoring System is as safe and effective as the predicate devices and is substantially equivalent to the legally marketed predicate device Sotera Wireless ViSi Mobile Monitoring System per k152341, and that Stasis Monitoring System performs as well as legally marketed predicate device Sotera Wireless ViSi Mobile Monitoring System per k152341.

#### Performance Data

Pursuant to 807.92(b)(1), testing for Stasis Monitoring System was performed to ensure that all functional requirements have been met, and that core functions execute as expected. Testing was conducted in-house by trained personnel using simulators to obtain the functional and accuracy test

results. Testing was also conducted by 3rd party trained personnel using simulators to obtain the functional and accuracy test results. Verification testing was performed on code and the tests performed passed with all required results. Validation testing was performed on software, which confirmed that software met all requirements and operated as intended. All test steps from the validation protocol passed.

Pursuant to 807.92(b)(3), the results of these performance tests demonstrate that the Stasis Monitoring System validation and non-clinical testing, coexistence testing) is within specification. As such, pursuant to 807.92(b)(3) the Stasis Monitoring System is as safe and effective as the predicate devices and is substantially equivalent to Sotera Wireless ViSi Mobile Monitoring System per k152341. The software performs as well as legally marketed predicate device Sotera Wireless ViSi Mobile Monitoring System per k152341.

Stasis Monitoring System indications for use are drawn from the indications for use of a legally marketed predicate device: Sotera Wireless ViSi Mobile Monitoring System. Stasis Monitoring System draws from features of this predicate device and does not provide novel functionality. As such, the features provided by Stasis Monitoring System do not in themselves raise new concerns of safety or effectiveness.

In all instances, the Stasis Monitoring System functioned as intended and the operation observed was as expected.

#### Substantial Equivalence

The Stasis Monitoring System is as safe and effective as the Sotera Wireless ViSi Mobile Monitoring System. The Stasis Monitoring System has similar intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. A minor difference in indications for use is the generation of alerts when rate-based cardiac arrhythmias such as asystole are detected, and when physiological vital signs fall outside of selected parameters, which

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does not constitute a substantive change, as this is simply rate based detection and not specific waveform triggered alerts. The minor technological differences between the Stasis Monitoring System and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the Stasis Monitoring System is as safe and effective as the Sotera Wireless ViSi Mobile Monitoring System. Thus, the Stasis Monitoring System is substantially equivalent.