ALERTWATCH: OR

K130401 · Alertwatch, LLC · MHX · Feb 7, 2014 · Cardiovascular

Device Facts

• Record ID: K130401
• Device Name: ALERTWATCH: OR
• Applicant: Alertwatch, LLC
• Product Code: MHX · Cardiovascular
• Decision Date: Feb 7, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Software as a Medical Device, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K130401 · Feb 7, 2014	ALERTWATCH: OR	Alertwatch, LLC	Historical patient cases from EMR	Historical patient data from the EMR was used as part of the verification process to confirm that the device's data collectors and analysis components functioned as designed.	Verification; Historical data; EMR

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Verification with historical data; Retrospective analysis of historical patient cases	Actual patients from the EMR	Not applicable for this study	Verification of product design and data collection functionality

Indications for Use

AlertWatch:OR is intended for use by clinicians for secondary monitoring of patients within operating rooms. AlertWatch:OR combines data from networked physiologic monitors, anesthesia information management medical records and displays them in one place. AlertWatch:OR can only be used with both physiological monitors and AIMS versions that have been validated by AlertWatch. Once alerted, you must refer to the primary monitor or device before making a clinical decision.

Device Story

AlertWatch:OR is a secondary monitoring display system for operating rooms; operated by anesthesiology staff (residents, CRNAs, attending anesthesiologists). Inputs include real-time physiologic data from networked monitors and patient data from anesthesia information management systems (AIMS). The device synthesizes these inputs to identify potential clinical problems; alerts clinicians when values exceed preset limits. Output is a visual display (including a body diagram with color-coded regions) providing a synthesized view of patient status. The device is intended to support clinical awareness; it does not replace primary monitoring. Clinicians must verify alerts against primary monitoring devices before making clinical decisions. Benefits include improved synthesis of patient data to inform clinicians of potential immediate or long-term complications.

Clinical Evidence

No clinical trials were conducted. Evidence consists of bench testing and validation: 1) Verification of analysis output using constructed data; 2) Verification of data display via web client; 3) Verification of data collectors (Live/Data Collector) from EMR; 4) Verification using historical patient data; 5) Validation of software requirements for clinical accuracy; 6) Validation of clinical utility via case outcome analysis; 7) Summative human factors study to confirm user needs.

Technological Characteristics

Software-based secondary monitoring system. Operates via network connectivity to hospital physiologic monitors and AIMS databases. Employs rule-based algorithms to analyze aggregated data against preset limits. Web-based client interface. Validated for specific monitor/AIMS versions at each installation site.

Indications for Use

Indicated for secondary monitoring of patients in operating rooms by clinicians (anesthesiologists, CRNAs). Used to aggregate and display data from networked physiologic monitors, anesthesia information management systems (AIMS), and medical records. Contraindicated for use as a primary monitor; clinicians must refer to primary devices before making clinical decisions.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Predicate Devices

• Phillips MP90 (K082583)

Submission Summary (Full Text)

{0}------------------------------------------------

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

February 7, 2014

AlertWatch LLC c/o Donna-Bea Tillman 400 N. Washington Street Suite 100 Alexandria, VA 22314 US

K130401 Re:

> Trade/Device Name: Alertwatch: OR Regulation Number: 21 CFR 870.1025 Regulation Name: Physiological Patient Monitor (with Arrhythmia Detection or Alarms) Regulatory Class: Class II Product Code: MHX Dated: November 6, 2013 Received: November 8, 2013

Dear Ms. Donna-Bea Tillman:

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. 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 requirements, including, but not limited to: registration and listing (2 I CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

{1}------------------------------------------------

Page 2 - Ms. Donna-Bea Tillman

. •

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.zov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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), piease go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Owen P. Faris -S

for

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

Enclosure

{2}------------------------------------------------

### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K130401

### Device Name

AlertWatch:OR

### Indications for Use (Describe)

AlertWatch:OR is intended for use by clinicians for secondary monitoring of patients within operating rooms. AlertWatch:OR combines data from networked physiologic monitors, anesthesia information management medical records and displays them in one place. AlertWatch:OR can only be used with both physiological monitors and AIMS versions that have been validated by AlertWatch. Once alerted, you must refer to the primary monitor or device before making a clinical decision.

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)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

{3}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

K130401 AlertWatch: OR

# 510(k) Summary

In accordance with 21 CFR 807.87(h) and (2) CFR 807.92) the 510(k) Summary for the AlertWatch:OR device is provided below.

| Device Common Name: | Physiological Patient Monitor with arrhythmia detection or alarms |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Proprietary Name: | AlertWatch:OR |
| Submitter: | AlertWatch<br>1600 Huron Pkwy, Bldg. 520, Ste. 2326<br>Ann Arbor, MI 48109 |
| Contact: | Donna-Bea Tillman<br>Senior Consultant<br>Biologics Consulting Group, Inc.<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | January 30, 2014 |
| Classification<br>Regulation: | 21 CFR 870.1025 |
| Panel: | Cardiovascular |
| Product Code: | MHX |
| Predicate Device: | K082583, Phillips MP90 |

#### Indication for Use:

Alert Watch:OR is intended for use by clinicians for secondary monitoring of patients within operating rooms. AlertWatch:OR combines data from networked physiologic monitors, anesthesia information management systems and patient medical records and displays them in one place. AlertWatch:OR can only be used with both physiological monitors and AIMS versions that have been validated by AlertWatch. Once alerted, you must refer to the primary monitor or device before making a clinical decision.

#### Device Description:

Device Deseription.
AlertWatch:OR is a display and secondary alert system used by the anesthesiology staff - residents, CRNA's, and attending anesthesiologists - to monitor patients in operating rooms. The purpose of the program is to synthesize a wide range of patient data and inform clinicians of potential problems that

{5}------------------------------------------------

#### K130401 AlertWatch: OR

might lead to immediate or long-term complications. Once alerted, the clinician is instructed to refer to the primary monitoring device before making a clinical decision. AlertWatch:OR should only be connected to AIMS systems and physiologic monitors that have been validated for use with Alert Watch:OR. Alert Watch, Inc. performs the validation for each installation site.

#### Performance Testing:

Verification of AlertWatch:OR was conducted to ensure that the product works as designed, and was tested with both constructed data and data from the EMR. There were four parts to the verification process:

- I. Verify the analysis output: Using constructed data, each of the rules/algorithms in the Software Requirements Specification were passed to the product's analysis component to determine that it produced the desired output.
- 2. Verify the data display: Similar to step 1. Using constructed data, verify that the web client produced the desired display for each of the test cases.
- 3. Verify the collectors: Determine that the Live Collector and the Data Collector return the correct data from the EMR.
- 4. Verify the product with historical data: Using a set of cases from actual patients, determine that the product works as designed.

Validation was conducted to check the design and performance of the product, and included these steps:

- Review the process and various inputs for creating the product design the software requirements specification.
- 2. Review the software requirements specification for clinical accuracy.
- 3. Validate the clinical utility of the product by analyzing case outcomes.
- 4. Conduct a summative Human Factors study to demonstrate that the device meets user needs.

#### Substantial Equivalence:

The results of the verification and validation activities demonstrate that the AlertWatch:OR complies with its stated requirements and meets user needs and intended uses. Therefore, it can be found substantially equivalent to the MP90.

#### Table 1: Device Comparison Table

| | Proposed Device | Predicate Device |
|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | AlertWatch:OR | Philips MP90 |
| 510(k) number | Not Yet Assigned | K082583 |
| Classification | MHX | MHX |
| Regulation | 870.1025 | 870.1025 |
| Indications for<br>Use | AlertWatch: OR is intended for use<br>by clinicians for secondary | Indicated for use by health care<br>professionals whenever there is a |
| | monitoring of patients within<br>operating rooms.<br>AlertWatch:OR accomplishes this<br>by aggregating data from networked<br>physiologic monitors, anesthesia<br>information management systems<br>and patient medical records and<br>displaying them at a central location.<br>Once alerted, the clinician must refer<br>to the primary monitoring device<br>before making a clinical decision. | need for monitoring the<br>physiological parameters of<br>patients. Intended for monitoring<br>and recording of and to generate<br>alarms for multiple physiological<br>parameters of adults, pediatrics and<br>neonates in hospital environments.<br>The MP2, X2, MPS, MP20, MP30,<br>MP40, and MPSO are additionally<br>intended for use in transport<br>situations within hospital<br>environments. The MP2, X2 and<br>MPS are also intended for use<br>during patient transport outside of a<br>hospital environment. |
| Intended Use<br>environment | OR | OR, Bedside |
| Intended Users | Anesthesiologist, CRNA | Anesthesiologist, Surgeon,<br>Perfusionist |
| Data server | AlertWatch:OR accesses<br>physiologic data from the hospital<br>network, and all other data from the<br>AIMS database server. | Philips IntelliVue Application<br>Server accesses information from<br>the hospital network, including<br>radiology, pharmacy, laboratory and<br>Hospital Information System data. |
| Re-display of<br>vital sign data<br>from primary<br>monitors | Yes | Yes |
| Generates<br>clinical<br>advisories | AlertWatch:OR Alerts analyzes data<br>from patient monitors and other<br>sources and alerts when values<br>exceed preset limits. | Advanced Event Surveillance<br>feature analyzes data from patient<br>monitors and alerts when values<br>exceed preset limits. |
| Uses color to<br>display clinical<br>information | Image: Diagram of a body with different colored regions | Image: Screenshot of a monitor displaying vital signs |
| Intended to<br>replace<br>primary<br>monitors | No | No |

{6}------------------------------------------------

### K130401 AlertWatch: OR

3 of 3