The CardioBand Event Recorder is indicated for use by adult patients, when prescribed by a physician, to record, display, store and transfer single-channel electrocardiogram (ECG) for rhythm interpretation.

Device Description

The CardioBand Event Recorder is intended to be used by a single patient to record, display, store and transfer single-channel electrocardiogram (ECG) for rhythm interpretation. The system consists of three components: a wrist-worn CardioBand, a smart-phone application, and a secure cloud. The CardioBand records ECG signals from the patient and sends them to the smart-phone application. The smart-phone application then sends the data to the cloud, where it can be accessed by qualified healthcare providers.

AI/ML Overview

The CardioBand Event Recorder underwent clinical testing to validate the signal quality of its ECG signal.

Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in the text. The document states that the CardioBand demonstrated substantial equivalence to the predicate device in quantitative ECG measurement analysis when compared to a gel-electrode reference ECG device given a margin of clinically acceptable measurement error. However, the specific acceptance criteria and the reported performance values are not detailed.
Sample Size used for the test set and data provenance:
- Sample Size: Not explicitly stated.
- Data Provenance: The study was a "single-center" study. The country of origin is not specified, but the applicant's address is in San Jose, California, USA. The study was "non-randomized," and it is implied to be prospective as it's a validation study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated.
Adjudication method for the test set: Not explicitly stated.
If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study was a "comparative" study of signal quality comparing the CardioBand to a predicate device and a reference device. It does not mention human readers or and AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The provided text focuses on the device's signal quality and comparison to other ECG devices. It does not mention a specific algorithm for interpretation or its standalone performance in isolation from the hardware. The device is intended for "rhythm interpretation," implying either human interpretation from the displayed ECG or a subsequent algorithmic analysis (which is not detailed here).
The type of ground truth used: The ground truth for the test set was established by a "reference gel-electrode 12-lead ECG device."
The sample size for the training set: Not applicable, as this study describes a validation of signal quality, not the training of an AI algorithm.
How the ground truth for the training set was established: Not applicable.

Summary

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November 15, 2018

Samsung Strategy and Innovation Center (SSIC) Matthew Wiggins, Ph.D. Acting Mgr QA/RA & Senior Mgr Algorithms 3655 North First Street San Jose. California 95134

Re: K181998

Trade/Device Name: CardioBand Event Recorder Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: July 25, 2018 Received: July 26, 2018

Dear Matthew Wiggins:

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 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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 medical devices and radiation-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,

Jessica E. Paulsen -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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Indications for Use

510(k) Number (if known) K181998

Device Name CardioBand Event Recorder

Indications for Use (Describe)

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)
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CardioBand 510(k) Submission Section 5 510(K) Summary

510(k) Summary

[As Required by 21 CFR 807.92(c)]

OwnerInformation[As requiredby807.92(a)(1)]	Eunsung Park, SSIC-DH VP, EngineeringSAMSUNG STRATEGY & INNOVATION CENTER3655 North First StreetSan Jose, CA 95134(408) 544 - 5310es001.park@samsung.comContact: Matthew Wiggins, SSIC-DH Quality Assurance and Regulatory AffairsContact phone number: (770) 596-1765Contact email: m.wiggins@samsung.comSummary was prepared on 29-JUN-2018 and revised on 15-NOV-2018
DeviceInformation[As requiredby807.92(a)(2)]	Trade name - CARDIOBAND© EVENT RECORDERCommon name - CardioBandClassification name – Quantitative Electrocardiographic Detector (21 CFR 870.2340, ProductCode DPS)
ClaimingEquivalence[As requiredby807.92(a)(3)]	K171816 KardiaBand System

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Image /page/4/Figure/2 description: The image shows a diagram of the Samsung CardioBand Event Recorder system. The system consists of three components: a wrist-worn CardioBand, a smart-phone application, and a secure cloud. The CardioBand records ECG signals from the patient and sends them to the smart-phone application. The smart-phone application then sends the data to the cloud, where it can be accessed by qualified healthcare providers. The CardioBand Event Recorder is intended to be used by a single patient to record, display, store and transfer single-channel electrocardiogram (ECG) for rhythm interpretation.

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AMSUN SAMSUNG STRATEGY & INNOVATION CENTER 3655 North First Street San Jose, CA 95134 (408) 544 - 4000 www.samsung.com/ssic

	Characteristicor Specification	D1: AliveCorKardiaBand SystemK171816	D2: SSI CardioBandECG Event Recorder
PredicateDevice[As requiredby807.92(a)(6)]	Indications forUse	The KardiaBand Systemis intended to record, storeand transfer single-channel electrocardiogram(ECG) rhythms. TheKardiaBand System alsodisplays ECG rhythmsand detects the presenceof atrial fibrillation andnormal sinus rhythm(when prescribed or usedunder the care of aphysician). TheKardiaBand system isintended for use byhealthcare professionals,adult patients with knownor suspected heartconditions and healthconscious individuals.	The CardioBand EventRecorder is indicated foruse by adult patients,when prescribed by aphysician, to record,display, store and transfersingle-channelelectrocardiogram (ECG)for rhythm interpretation.
	Product code	DXH, DPS	DPS
	Mechanism ofAction	Users completes circuitwith skin contact andhardware transmits audiosignal to MCP to convertand display ECG	Same, except transmissionto MCP is via BluetoothLE
	Anatomical Sites	Left hand fingers to rightwrist or vice versa	Same
	Where used(intended use)	Mobile/active users at rest(ambulatory)	Same

DataAcquisition:FrequencyResponse	0.5 Hz - 40 Hz	Same
ECG channels	Single Channel	Same
ECG Resolution	16 bit	24 bit
Sample Rate	300 Samples/ Second	500 Samples/ Second
MemoryCapacity	Essentially unlimited dueto real-time transmissionto MCP memory	Same
Number of ECGLeads	Single Lead, 2 electrodes	Same
Energy Source:Battery	Replaceable LithiumManganese Dioxide coincells	Internal LithiumIon battery
Battery Life	100 hours operation	7 days operation
User Interface:Primary Lead	Lead 1: Left to Right	Same
Hardwareplatforms	Apple iPhone and AppleWatch Band Sensor	Samsung Galaxy S6 or S7Phone and CardioBandSensor
Softwareplatforms	Apple iOS andApple Watch OS	Android OS (versionsMarshmallow to Nougat)
PhysicalSpecifications:Dimensions	24.5 x 24.5 x 6.5 mm	35.6 x 25.5 x 11.8 mm
Weight	9 grams	14.2 grams
Prescribed/Over-the-Counter	Prescription and OTC	Prescription only
Environmental:Operating Temp	10 to 40 degrees C	-5 to 50 degrees C
Storage Temp	-20 to 60 degrees C	-20 to 30 degrees C
Communications	Ultrasonic Acoustics	Bluetooth LE
Conformance toRecognizedStandards:	(From FDA Database)	(From Certification Labs)
Medicalelectricalequipment - Part1: Generalrequirements forbasic safety andessentialperformance	IEC 60601-1	IEC 60601-1:2005/(R)2012 and A1:2012
Medicalelectricalequipment -Part1-2: Generalrequirements forbasic safety andessentialperformance –CollateralStandard:Electromagneticdisturbances –Requirementsand tests	60601-1-2	60601-1-2:2014
	Particularrequirements forthe basic safetyand essentialperformance ofambulatoryelectrocardiographic systems	60601-2-47	60601-2-47
	Biologicalevaluation ofmedical devices- Part 1:Evaluation andtesting within arisk managementprocess	ISO 10993-1	ISO 10993-1
	Biologicalevaluation ofmedical devices-- Part 5: Testsfor in vitrocytotoxicity	ISO 10993-5	ISO 10993-5
	Biologicalevaluation ofmedical devices-- Part 10: Testsfor irritation andskin sensitization	ISO 10993-10	ISO 10993-10
Non-ClinicalPerformance[As requiredby807.92(b)(1)]	The CardioBand Event Recorder was tested in accordance with international recognizedstandards for EMC and electrical safety, and for biocompatibility. Further, the device underwentverification and validation testing for wireless coexistence and for various data integrity, andsignal sufficiency.

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SAMSUNG STRATEGY & INNOVATION CENTER 3655 North First Street San Jose, CA 95134 (408) 544 - 4000 www.samsung.com/ssic

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MINSTIN SAMSUNG STRATEGY & INNOVATION CENTER 3655 North First Street San Jose, CA 95134 (408) 544 - 4000 www.samsung.com/ssic

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AMSUI

SAMSUNG STRATEGY & INNOVATION CENTER 3655 North First Street San Jose, CA 95134 (408) 544 - 4000 www.samsung.com/ssic

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SAMSUNG SAMSUNG STRATEGY & INNOVATION CENTER 3655 North First Street San Jose, CA 95134 (408) 544 - 4000 www.samsung.com/ssic

ClinicalPerformance[As requiredby807.92(b)(2)]	The CardioBand development team elected to validate the signal quality of the CardioBand ECGsignal in a comparative, single-center, non-randomized study. The CardioBand was compared tothe predicate device and to a reference gel-electrode 12-lead ECG device.
Conclusionon Clinicaland Non-clinical Tests[As requiredby807.92(b)(3)]	The CardioBand Event Recorder is substantially equivalent to the KardiaBand System(K171816). The devices have nearly identical intended use. The devices have the same keytechnological characteristics. The devices have the same mechanism of action, and they aresimilar in dimensional and other characteristics. The devices conform to the same recognizedstandards. In clinical testing, the CardioBand demonstrated that for quantitative ECGmeasurement analysis it was substantially equivalent to the predicate when compared to a gel-electrode reference ECG device given a margin of clinically acceptable measurement error.
OtherInformationAs requiredby 807.92(d)]

ClinicalPerformance[As requiredby807.92(b)(2)]

The CardioBand development team elected to validate the signal quality of the CardioBand ECGsignal in a comparative, single-center, non-randomized study. The CardioBand was compared tothe predicate device and to a reference gel-electrode 12-lead ECG device.

Conclusionon Clinicaland Non-clinical Tests[As requiredby807.92(b)(3)]

The CardioBand Event Recorder is substantially equivalent to the KardiaBand System(K171816). The devices have nearly identical intended use. The devices have the same keytechnological characteristics. The devices have the same mechanism of action, and they aresimilar in dimensional and other characteristics. The devices conform to the same recognizedstandards. In clinical testing, the CardioBand demonstrated that for quantitative ECGmeasurement analysis it was substantially equivalent to the predicate when compared to a gel-electrode reference ECG device given a margin of clinically acceptable measurement error.

OtherInformationAs requiredby 807.92(d)]

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).