(353 days)
K082583, Phillips MP90
No
The description focuses on data synthesis, display, and rule-based alerting, without mentioning AI/ML algorithms or training/test data sets.
No
The device combines and displays data from other monitors and alerts clinicians to potential problems, but it explicitly states that clinicians must refer to the primary monitor or device for making clinical decisions, indicating it is not primarily for treatment or diagnosis itself. Its function is secondary monitoring.
No
The device is described as a "display and secondary alert system" that synthesizes patient data and informs clinicians of potential problems. However, it explicitly states, "Once alerted, you must refer to the primary monitor or device before making a clinical decision." This indicates that the device does not provide a definitive diagnosis but rather flags potential issues, requiring further consultation of primary diagnostic tools.
Yes
The device description explicitly states it is a "display and secondary alert system" that "synthesizes a wide range of patient data". The verification and validation activities focus on software functionality (analysis output, data display, data collectors) and clinical utility, not hardware performance. While it connects to external hardware (physiologic monitors, AIMS), the device itself is described as software that processes and displays data from these sources.
Based on the provided information, AlertWatch:OR is NOT an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of disease.
- AlertWatch:OR's Function: AlertWatch:OR's intended use and description clearly state that it combines and displays data from existing networked physiologic monitors and anesthesia information management medical records. It does not collect, prepare, or examine specimens from the human body. It acts as a secondary monitoring and alert system based on data already acquired by other devices.
- Data Source: The input data for AlertWatch:OR comes from other medical devices (physiologic monitors and AIMS), not directly from patient specimens.
Therefore, AlertWatch:OR falls under the category of a medical device but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes
MHX
Device Description
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 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.
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
Not Found
Intended User / Care Setting
Intended Users: Anesthesiologist, CRNA
Intended Use environment: OR
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
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:
- 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.
- 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.
- Verify the collectors: Determine that the Live Collector and the Data Collector return the correct data from the EMR.
- 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.
- Review the software requirements specification for clinical accuracy.
- Validate the clinical utility of the product by analyzing case outcomes.
- Conduct a summative Human Factors study to demonstrate that the device meets user needs.
Key Metrics
Not Found
Predicate Device(s)
K082583, Phillips MP90
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
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.(b)
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.
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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
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638 2041 or (301) 796-7100 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
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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.
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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 PRAStaff@fda.hhs.gov
"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."
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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 |
| 1600 Huron Pkwy, Bldg. 520, Ste. 2326 | |
| Ann Arbor, MI 48109 | |
| Contact: | Donna-Bea Tillman |
| Senior Consultant | |
| Biologics Consulting Group, Inc. | |
| Phone: 410-531-6542 | |
| Fax: 720-293-0014 | |
| Email: dtillman@bcg-usa.com | |
| Date Prepared: | January 30, 2014 |
| Classification | |
| 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.
-
- 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.
-
- Verify the collectors: Determine that the Live Collector and the Data Collector return the correct data from the EMR.
-
- 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.
-
- Review the software requirements specification for clinical accuracy.
-
- Validate the clinical utility of the product by analyzing case outcomes.
-
- 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 | ||
| Use | AlertWatch: OR is intended for use | |
| by clinicians for secondary | Indicated for use by health care | |
| professionals whenever there is a | ||
| monitoring of patients within | ||
| operating rooms. | ||
| AlertWatch:OR accomplishes this | ||
| by aggregating data from networked | ||
| physiologic monitors, anesthesia | ||
| information management systems | ||
| and patient medical records and | ||
| displaying them at a central location. | ||
| Once alerted, the clinician must refer | ||
| to the primary monitoring device | ||
| before making a clinical decision. | need for monitoring the | |
| physiological parameters of | ||
| patients. Intended for monitoring | ||
| and recording of and to generate | ||
| alarms for multiple physiological | ||
| parameters of adults, pediatrics and | ||
| neonates in hospital environments. | ||
| The MP2, X2, MPS, MP20, MP30, | ||
| MP40, and MPSO are additionally | ||
| intended for use in transport | ||
| situations within hospital | ||
| environments. The MP2, X2 and | ||
| MPS are also intended for use | ||
| during patient transport outside of a | ||
| hospital environment. | ||
| Intended Use | ||
| environment | OR | OR, Bedside |
| Intended Users | Anesthesiologist, CRNA | Anesthesiologist, Surgeon, |
| Perfusionist | ||
| Data server | AlertWatch:OR accesses | |
| physiologic data from the hospital | ||
| network, and all other data from the | ||
| AIMS database server. | Philips IntelliVue Application | |
| Server accesses information from | ||
| the hospital network, including | ||
| radiology, pharmacy, laboratory and | ||
| Hospital Information System data. | ||
| Re-display of | ||
| vital sign data | ||
| from primary | ||
| monitors | Yes | Yes |
| Generates | ||
| clinical | ||
| advisories | AlertWatch:OR Alerts analyzes data | |
| from patient monitors and other | ||
| sources and alerts when values | ||
| exceed preset limits. | Advanced Event Surveillance | |
| feature analyzes data from patient | ||
| monitors and alerts when values | ||
| exceed preset limits. | ||
| Uses color to | ||
| display clinical | ||
| information | Image: Diagram of a body with different colored regions | Image: Screenshot of a monitor displaying vital signs |
| Intended to | ||
| replace | ||
| primary | ||
| monitors | No | No |
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K130401 AlertWatch: OR
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