AlertWatch:OB is intended for use by clinicians for secondary monitoring of maternal patients in the labor and delivery unit. AlertWatch:OB is a maternal surveillance system that combines data from validated electronic medical record systems, and displays them in one place. Once alerted by AlertWatch:OB, the clinician must refer to the primary monitor, device, or data source before making a clinical decision.

Device Description

AlertWatch:OB is a secondary monitoring system used by OB nurses, obstetricians, and OB anesthesiologists to monitor women in the Labor and Delivery (L&D) unit. The purpose of the program is to synthesize a wide range of maternal patient data and inform clinicians of potential problems. Once alerted, the clinician is instructed to refer to the primary monitoring device or EMR before making a clinical decision. AlertWatch:OB should only be connected to EMR systems that have been validated for use with AlertWatch:OB. AlertWatch, LLC performs the validation for each installation site.

AI/ML Overview

Here's an analysis of the provided text regarding the AlertWatch:OB device, addressing the requested information:

Key Takeaway: The provided document is a 510(k) summary for AlertWatch:OB, which is primarily demonstrating substantial equivalence to a predicate device (AlertWatch:OR) based on similar intended use and technological characteristics. As such, it does not contain typical acceptance criteria and a study proving the device meets those criteria in the way one might expect for a de novo device or an AI/ML product with novel performance claims. Instead, the focus is on verification and validation of the software and human factors.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) and corresponding reported device performance values in the context of clinical accuracy for the AlertWatch:OB's core function of identifying patient issues. This is because its claim is for "secondary monitoring" and not for primary diagnostic capabilities or automated decision-making.

However, the document does describe performance activities related to usability, software functionality, and the establishment of "default limits and thresholds."

Acceptance Criteria Category	Reported Device Performance
Software Functionality (V&V)	"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. Validation was conducted to check the design and performance of the product." (Implies successful completion against internal specifications).
Wireless Co-existence	"Wireless Co-existence testing was performed to establish that the wireless components work effectively in the hospital environment." (Implies effective operation in the intended environment).
Usability / Human Factors	Formative Study: Conducted to identify and fix usability problems. Summative Study (17 users): "The results of the study showed that users with minimal training were able to successfully perform critical tasks and use the device for its intended purpose – to clarify clinical information and support information access." (Implies successful usability).
Clinical Validity of Default Limits	Phase 1 (References): "AlertWatch sought out definitive published studies that highlighted appropriate limits for certain patient conditions."Phase 2 (Expert Committee): "Obstetricians and OB anesthesia physicians at the University of Michigan Health System...reviewed the limits, provided feedback, and reviewed the final results."Phase 3 (External Experts): "External group of four anesthesiology and OB anesthesia experts...All approved the clinical limits." (Implies clinical consensus and validity of the set limits).

2. Sample Size Used for the Test Set and Data Provenance

Software Verification & Validation: The document mentions "constructed data and data from the EMR" for testing but does not specify sample sizes for these test sets or their provenance (e.g., country of origin, retrospective/prospective).
Human Factors Study: 17 users were recruited for the summative usability study. The provenance of these users (e.g., hospital staff, general population) is not specified, nor is the origin of the data used in the usability testing (likely simulated or de-identified data).
Clinical Data (main performance study): "Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device." This implies no specific clinical test set was used to establish performance metrics like sensitivity/specificity for identifying patient issues for the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Given the "Not applicable" for clinical data, there isn't a "ground truth" establishment in the traditional sense of a diagnostic or predictive AI device for a clinical test set.

However, for the establishment of default limits and thresholds:

An "Expert Committee" of Obstetricians and OB anesthesia physicians from the University of Michigan Health System were involved. Their specific number is not given, but their roles are.
An "External Experts" group of four anesthesiology and OB anesthesia experts provided final review. Their specific qualifications (e.g., years of experience) are not detailed beyond their specialty.

4. Adjudication Method for the Test Set

Not applicable, as no formal clinical "test set" with a need for adjudicated ground truth (e.g., for disease presence/absence) was used for direct device performance evaluation in the supplied document. For the "default limits and thresholds," the process involved multiple stages of expert review and approval, implying a consensus-based approach rather than formal adjudication of individual cases.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done or reported in the document. The device is not making claims about improving human reader performance but rather providing secondary monitoring and information synthesis.

6. Standalone Performance Study (Algorithm Only)

The document primarily focuses on the software's functionality and its role as a "secondary monitoring system" that synthesizes existing EMR data and alerts clinicians. While "Software Verification and Validation Testing" was conducted to ensure it "works as designed" and "performed a series of calculations," it does not present a standalone performance study in terms of quantifiable clinical metrics (e.g., sensitivity, specificity for detecting specific conditions) for the algorithm itself. The device is intended to be used by clinicians who then refer to primary sources.

7. Type of Ground Truth Used

For Software Verification & Validation: Likely internal functional specifications and expected outputs based on "constructed data and data from the EMR."
For Default Limits and Thresholds:
- Published medical literature/references.
- Expert consensus among obstetricians, OB anesthesia physicians (University of Michigan Health System), and an external group of four anesthesiology and OB anesthesia experts. This is the closest to a "ground truth" described, but it pertains to the establishment of the parameters the device uses, not the evaluation of the device's output against a diagnostic truth.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of an AI/ML algorithm that learns from data to make predictions or categorizations. The AlertWatch:OB appears to be a rule-based or threshold-based system that processes data according to predefined clinical limits.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set or machine learning algorithm that requires a "ground truth" for learning in this 510(k) summary. The "ground truth" for the device's operational parameters (default limits) was established via literature review and expert consensus.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 23, 2018

AlertWatch, Inc. % Donna-Bea Tillman Senior Consultant Biologics Consulting Group, Inc. 1555 King Street Suite 300 Alexandria, Virginia 22314

Re: K173715

Trade/Device Name: AlertWatch:OB Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: March 21, 2018 Received: March 22, 2018

Dear 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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

MA Hillemann

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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Indications for Use

510(k) Number (if known) K173715

Device Name AlertWatch:OB

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
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☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for AlertWatch:OB is provided below.

1. SUBMITTER

Applicant:	AlertWatch, Inc330 East Liberty St.Fourth FloorAnn Arbor, MI 48104Tel:Fax:
Contact:	Justin AdamsCEOPhone: 734-998-8344E-mail: Justin.adams@alertwatch.com
Submission Correspondent:	Donna-Bea Tillman, Ph.D.Senior ConsultantBiologics Consultant Group, Inc.Phone: 410-531-6542E-mail: dtillman@biologicsconsulting.com
Date Prepared:	December 1, 2017

2. DEVICE

Device Trade Name:	AlertWatch:OB
Device Common Name:	Physiological Patient Monitor without arrhythmiadetection or alarms
Classification Name	21 CFR 870.2300 - Cardiac monitor (includingcardiotachometer and rate alarm)
Regulatory Class:	II
Product Code:	MWI

PREDICATE DEVICE 3.

Predicate Device: AlertWatch:OR (K153335)

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4. DEVICE DESCRIPTION

AlertWatch:OB should only be connected to EMR systems that have been validated for use with AlertWatch:OB. AlertWatch, LLC performs the validation for each installation site.

INTENDED USE/INDICATIONS FOR USE ട്.

SUBSTANTIAL EQUIVALENCE 6.

Comparison of Indications

Both the subject AlertWatch:OB and the predicate AlertWatch:OR are intended for secondary monitoring of patients in the hospital. With both devices, the user is directed to refer to the primary monitor or device before making a clinical decision. The data collected, the analysis and display technology, and the alerting and paging process for both products is essentially the same. Therefore, this difference in indications for use does not constitute a new intended use, and AlertWatch:OR can be used as a primary predicate for the subject AlertWatch:OB.

Technological Comparisons

The table below compares the key technological feature of the subject devices to the predicate device (AlertWatch:OR, K153335).

	Predicate Device	Proposed Device
510(k) Number	K153335	-
Applicant	AlertWatch, Inc.	AlertWatch, Inc.
Device Name	AlertWatch:OR	AlertWatch:OB
Classification Regulation	21 CFR 870.2300 - Cardiacmonitor (includingcardiotachometer and rate alarm)	21 CFR 870.2300 - Cardiacmonitor (includingcardiotachometer and rate alarm)
Product Code	MWI	MWI
	Predicate Device	Proposed Device
Intended Use environment	OR	Labor and Delivery Unit
Intended Users	Anesthesiologist, Resident,CRNA	OB Anesthesiologist, OBPhysician, OB Nurse, Resident
Intended for primarymonitoring?	No - only for secondarymonitoring	Identical
Data server	AlertWatch:OR accesses datafrom the AIMS database server.	AlertWatch:OB accesses datafrom the EMR system.
Supported AIMS / EMRsystems	Centricity, version 7.6.3 SEPPicis / Optum, version 421 SEPiMDsoft / Metavision, version5.46.44	Epic 2015 UI 2
Supported physiologicmonitors	GE Solar 9500GE Carespan B850	None directly.
Organs Monitored	Brain, lungs, heart, liver,kidneys, skin temperature	Identical
Hardware platforms supported	PC, iPad, iPhone	Identical
Generates clinical advisories	AlertWatch:OR Analyzes datafrom patient monitors and othersources and alerts when valuesexceed preset limits.	Identical
Re-display of vital sign datafrom primary monitors	Yes	Identical
Intended to replace primarymonitors	No	Identical
Paging	Yes. For clinicians to page eachother and for AlertWatch:OR totransmit alerts using the hospital-established paging system.	Yes. For clinicians to page eachother and for AlertWatch:OB totransmit alerts using the hospital-established paging system.
Uses color to display clinicalinformation	Image: Predicate Device Clinical Information	Image: Proposed Device Clinical Information

Table 1: Technological Comparison

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There are slight differences in technological characteristics that reflect the different clinical needs of the user populations, but the general approach of retrieving data from the EMR system, integrating this data, and performing a series of calculations to assess potential patient clinical

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issues is the same. The differences in technological characteristics do not raise different questions of safety and effectiveness.

7. PERFORMANCE DATA

Biocompatibility Testing

There are no direct or indirect patient-contacting components of the subject device. Therefore, patient contact information is not needed for this device.

Electrical safety and electromagnetic compatibility (EMC)

Not applicable. The subject device is a software-only device. It contains no electric components, generates no electrical emissions, and uses no electrical energy of any type.

However, because AlertWatch:OB includes wireless communication, the system was evaluated in accordance with the FDA guidance document: Radio Frequency Wireless Technology in Medical Devices: Guidance for Industry and Food and Drug Administration Staff (August 14, 2013). Wireless Co-existence testing was performed to establish that the wireless components work effectively in the hospital environment.

Software Verification and Validation Testing

Software verification and validation testing was 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." 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. Validation was conducted to check the design and performance of the product.

Bench Testing

. Human Factors Study: To better understand any potential usability issues that could interfere with the intended use of the product. AlertWatch performed a comprehensive human factors study. AlertWatch first conducted a formative to identify and fix any problems with the usability study plan and AlertWatch:OB product. AlertWatch then recruited 17 users and conducted a summative usability study. The results of the study showed that users with minimal training were able to successfully perform critical tasks and use the device for its intended purpose – to clarify clinical information and support information access.
. Default Limits and Thresholds: AlertWatch, Inc. used a three-phased approach to ensure that the default limits were clinically valid:
- 1. Review of References. AlertWatch sought out definitive published studies that highlighted appropriate limits for certain patient conditions. This includes limits and thresholds for the green/yellow/red organ schema, as well as the alerts and formulae.

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1. Expert Committee. When references were not available, AlertWatch sought out the opinion and confirmation of obstetricians and OB anesthesia physicians at the University of Michigan Health System. Each of these clinicians reviewed the limits, provided feedback, and reviewed the final results.
1. External Experts. AlertWatch obtained final review of the default limits from an external group of four anesthesiology and OB anesthesia experts. All approved the clinical limits.
IEC 60601-1-8: A summary of how AlertWatch:OR addresses the primary issues ● identified in IEC 60601-1-8 is provided in the submission.

Animal Testing

Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.

Clinical Data

Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device.

CONCLUSION 8.

The subject AlertWatch:OB and the predicate AlertWatch:OR have the same intended use, namely to provide secondary monitoring of patients in the hospital environment. There are slight differences in technological characteristics that reflect the different clinical needs of the user populations, but the general approach of retrieving data from the EMR system, integrating this data, and performing a series of calculations to assess potential patient clinical issues is the same. The differences in technological characteristics do not raise different questions of safety and effectiveness, and the results of performance testing demonstrate that the subject device performs in accordance with specifications and meets user needs and intended uses. Therefore, AlertWatch:OB has been demonstrated to be substantially equivalent to the predicate AlertWatch:OR.

Regulation Number and Section

§ 884.2740 Perinatal monitoring system and accessories.

(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).