CardeaScreen records and measures a resting ECG from the adult and pediatric (age ≥ 14) body surface. It provides automatic ECG interpretations which are identified as "Unconfirmed" by the product until they have been overread and confirmed by a clinician.

CardeaScreen is intended for use on apparently healthy individuals and on symptomatically stable patients with known or potential cardiac conditions.

This device is intended for use under the direct supervision of a licensed health care clinician.

Device Description

The CardeaScreen™, developed by Cardea Associates, Inc. (Cardea), is small, lightweight, portable electrocardiograph, designed for collection of resting (nonambulatory) electrocardiographic (ECG) data.

The CardeaScreen device system is composed of 2 main components:

. ECG Transmitter - this type of device is also referred to in the medical community as a "ECG recorder", or "ECG data acquisition unit". The CardeaScreen ECG transmitter is about the size of a small paperback book (~6" x 4" x 1.5") and ~11 ounces. The transmitter is battery powered or it can also be powered via AC mains power by using the medical grade power supply supplied as part of the CardeaScreen system.
A patient cable with 10 lead wires is attached to the transmitter. The lead wires terminate in connectors that are attached to commercially available ECG electrodes selected by the clinician for use. The electrodes (not part of the CardeaScreen system) adhere to the patient's skin in the chest region and are used for detecting a patient's ECG.
. CardeaScreen Software - the software is installed by the clinician on the clinician's personal computer (PC). The software controls the ECG transmitter's use. The transmitter cannot function in any manner to collect ECG, without the software.
Collected ECG data is transferred from the ECG transmitter to the PC using wireless (Bluetooth) transmission. The software can be used for subsequent analysis of the patient's ECG data.

AI/ML Overview

Here's an analysis of the provided text regarding the CardeaScreen™ device's acceptance criteria and the supporting study, structured according to your request:

Acceptance Criteria and Device Performance

The provided document, a 510(k) Summary of Safety and Effectiveness, focuses primarily on establishing substantial equivalence to predicate devices rather than defining specific performance-based acceptance criteria with quantitative thresholds. The "Testing" section broadly describes verification and validation activities.

Therefore, the table below will reflect the types of testing performed, implying that acceptable results from these tests constitute the criteria for regulatory acceptance. There are no specific quantitative performance metrics reported in this document that can be directly mapped to the common acceptance criteria for diagnostic devices (e.g., sensitivity, specificity, accuracy).

Criteria Description (Implied Acceptance)	Reported Device Performance
Electrical Safety (IEC 60601-1)	Demonstrated acceptable results post-testing
Electromagnetic Compatibility (EMC) (IEC 60601-1-2)	Demonstrated acceptable results post-testing
Patient Cable Compliance (ANSI/AAMI EC53)	Demonstrated acceptable results post-testing
21 CFR 898 Compliance	Demonstrated acceptable results post-assessment
Additional Design Verification	Demonstrated acceptable results post-testing
Firmware/Software Verification/Validation (including ECG analysis algorithm)	Demonstrated acceptable results post-verification/validation
Biocompatibility (ISO 10993-1)	Demonstrated acceptable results post-assessment
Maintenance of Substantial Equivalence	Device does not raise any new safety or effectiveness issues compared to predicates.

Study Details

Based on the provided K123217 510(k) summary, the "study" conducted for the CardeaScreen™ is a series of verification and validation (V&V) tests to demonstrate compliance with recognized standards and to establish substantial equivalence, rather than a clinical performance study with detailed metrics like sensitivity/specificity.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for any of the tests. The document broadly refers to "testing" and "assessments." For the "Firmware/Software (including ECG analysis algorithm) verification/validation testing," it can be inferred that a set of ECG data was used, but the size is not specified.
- Data Provenance: Not specified. It is not clear if it was prospective or retrospective data, or its country of origin.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The document does not describe a process where experts established ground truth for a test set in the context of diagnostic performance (e.g., labeling ECGs for rhythm abnormalities). The "ECG analysis algorithm" is mentioned, and its interpretations are "Unconfirmed" until overread by a clinician, implying a human confirmation step in clinical use, but not for establishing ground truth during the described V&V.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. As no expert-derived ground truth process is detailed, an adjudication method is not mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study is mentioned in this document. The device provides "automatic ECG interpretations which are identified as 'Unconfirmed' by the product until they have been overread and confirmed by a clinician," suggesting it's intended to assist, but no study on the impact of this assistance on human reader performance is provided.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies that the "ECG analysis algorithm" was part of the firmware/software verification/validation testing. However, no specific standalone performance metrics (like sensitivity, specificity, accuracy) for this algorithm are reported. The "automatic ECG interpretations" are explicitly stated to be "Unconfirmed" until overread, suggesting the standalone interpretation is not intended as a final diagnosis.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated for the "ECG analysis algorithm" testing. For the physical and technical tests (electrical safety, EMC, etc.), the "ground truth" would be compliance with the respective standards, confirmed by test results meeting predefined thresholds.
The sample size for the training set:
- Not specified. The document does not detail the development or training of the ECG analysis algorithm.
How the ground truth for the training set was established:
- Not specified. No information is provided regarding the training set or its ground truth establishment.

Summary

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510(k) Summary of Safety and Effectiveness ll.

FEB 0 5 2013

CardeaScreen™

General Information

Criteria	Information
Trade Name	CardeaScreen™
Model Number	CS-2020
Common Name	Electrocardiograph (ECG)
Classification	21 CFR 870.2340 - ElectrocardiographClass II; product code: DPS
510(k) Submitter	Cardea Associates, Inc.13720 220th Place NEWoodinville, WA 98077 USA
Contact Person	David M. Hadley, Ph.D.PresidentCardea Associates, Inc.dave@cardeascreen.com(855) 800-0760 extension 801 (phone)(855) 800-0760 (fax)

Device Description

The CardeaScreen device system is composed of 2 main components:

. ECG Transmitter - this type of device is also referred to in the medical community as a "ECG recorder", or "ECG data acquisition unit". The CardeaScreen ECG transmitter is about the size of a small paperback book (~6" x 4" x 1.5") and ~11 ounces. The transmitter is battery powered or it can also be powered via AC mains power by using the medical grade power supply supplied as part of the CardeaScreen system.
A patient cable with 10 lead wires is attached to the transmitter. The lead wires terminate in connectors that are attached to commercially available ECG electrodes selected by the clinician for use. The electrodes (not part of the CardeaScreen system) adhere to the

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patient's skin in the chest region and are used for detecting a patient's ECG.

. CardeaScreen Software - the software is installed by the clinician on the clinician's personal computer (PC). The software controls the ECG transmitter's use. The transmitter cannot function in any manner to collect ECG, without the software.
Collected ECG data is transferred from the ECG transmitter to the PC using wireless (Bluetooth) transmission. The software can be used for subsequent analysis of the patient's ECG data.

Indications for Use

CardeaScreen is intended for use on apparently healthy individuals and on symptomatically stable patients with known or potential cardiac conditions.

This device is intended for use under the direct supervision of a licensed health care clinician.

Manufacturer	Substantiallyequivalent devices	510(k)
Cardiac Science CorporationBothell, WA	CareCenter MD	K093211
Brentwood Medical TechnologyCorporation,Midmark Diagnostics GroupVersailles, Ohio	IQecg	K103640

Substantially Equivalent Devices

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Substantial Equivalence Comparison

The CardeaScreen has in many instances identical or nearly identical technological characteristics to the substantially equivalent (predicate) ECG devices. The following many similarities are noted:

. All devices are electrocardiographs.
Devices are all classified by FDA as Class II medical devices under . regulation 21 CFR 870.2340; code DPS.
Devices have a common system configuration (e.g., an ECG transmitter . (data acquisition unit) and software installed on a clinician's personal computer (PC) for ECG processing/analysis.
Devices have an identical intended use all are electrocardiographs used . in the collection and analysis of ECG data.
The devices have very similar wording in terms of indications for use. .
All devices are used for resting ECG data collection. .
All are prescription use devices; no over-the-counter use. .
Devices are used by the same personnel (e.q., healthcare clinicians). .
All devices are used in the same use environment in hospital/medical settings. .
All devices have the same intended patient population use in adults and/or ● pediatrics.
All devices are not for ambulatory use. .
The CardeaScreen and predicates are all have a common device . configuration and the same use mode in that the patient cables (leads) are integrated into the ECG transmitter and the cables terminate in clip/snap connectors that attach to ECG electrodes (applied to the patient's chest by a clinician).
The CardeaScreen and CareCenter MD predicate ECG have wireless ECG . data transfer (via Bluetooth) of the collected ECG data to the clinician's PC. The IQecq is a wired transfer.
All devices transfer collected ECG data continuously. .
All devices require/are compatible with Microsoft Windows Operating . Systems and require a Windows-compatible PC.
. Devices are all capable of interfacing with other equipment (such as servers, electronic medical records, etc.).
All devices are similarly sized small and lightweight. .
. Devices are all portable.
Devices are all supplied nonsterile and are reusable. ●
Devices are all a standard 12 lead configuration. .
. Devices have identical or nearly identical ECG data acquisition characteristics (e.q., frequency response, filters, sensitivity, input impedance, common mode rejection, sample rate for ECG interpretation and analysis, ECG amplifier presence, simultaneous data acquisition from all leads and displayed data of resting ECGs).

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All devices have software that is installed on the user's PC and performs . ECG analysis for arrhythmia detection. Such analysis is available to the clinician for use, however the labeling of all the devices notes that device interpretations/analyses are to be confirmed by a clinician.
All devices have comparable environmental ranges (e.g., temperature . and humidity).
Lastly, the devices all have common safety attributes (e.g., pacemaker . and leads off detection features, technical standard conformance, input protection against defibrillation shocks, type CF applied part rating and patient isolation).

Therefore, due to the identical or nearly identical nature of the CardeaScreen, as noted in the numerous similarities itemized above, Cardea believes the CardeaScreen is substantially equivalent to the predicate ECG devices.

Testing

The CardeaScreen underwent extensive testing and related assessments, as listed below. All testing demonstrated acceptable results.

Design Verification (Safety) testing, including:
- IEC 60601-1 testing (electrical safety)
- IEC 60601-1-2 testing (EMC)
- ANSI/AAMI EC53 testing (patient cable)
21 CFR 898 Compliance assessment
Additional design verification testing
Firmware/Software (including ECG analysis algorithm) verification/ validation testing
ISO 10993-1 (biocompatibility and equivalent usage in predicate devices)

Summary of Substantial Equivalence

Based on the information provided in this 510(k) and testing completed, the CardeaScreen does not raise any new safety or effectiveness issues and is substantially equivalent to legally marketed electrocardiographs that are in commercial distribution, and have been determined to be substantially equivalent to devices in commercial distribution, prior to May 28, 1976.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

FEB 0 5 2013

Cardea Associates, Inc. c/o Mr. Jeff D. Rongero Senior Project Engineer UL LLC 12 Laboratory Drive, Research Triangle Park, NC 27709-3995

Re: K123217

Trade/Device Name: CardeaScreen™ Regulatory Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (Two) Product Code: DPS Dated: January 14, 2013 Received: January 15, 2013

Dear Mr. Rongero:

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.

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Page 2 - Mr. Jeff D. Rongero

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 (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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm] 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

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/ResourcesforYou/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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K123217 510(k) Number:

Device Name:

CardeaScreen™

Indications for Use:

CardeaScreen is intended for use on apparently healthy individuals and on symptomatically stable patients with known or potential cardiac conditions.

This device is intended for use under the direct supervision of a licensed health care clinician.

Prescription Use	C
	(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

page 1 of 1

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Notification - CardeaScree	510(k) Number: K2321
-----------------------------------	----------------------

Cardea Associates, Inc.

page 1 of 1

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).