Who is the manufacturer of CardioBand ECG Event Recorder?

Samsung Strategy and Innovation Center (Ssic) filed the 510(k) submission for CardioBand ECG Event Recorder (K181998).

What is the FDA product code for CardioBand ECG Event Recorder?

DPS. It is classified under 21 CFR 870.2340 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for CardioBand ECG Event Recorder?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CardioBand ECG Event Recorder?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CardioBand ECG Event Recorder

K181998 · Samsung Strategy and Innovation Center (Ssic) · DPS · Nov 15, 2018 · Cardiovascular

Device Facts

Record ID	K181998
Device Name	CardioBand ECG Event Recorder
Applicant	Samsung Strategy and Innovation Center (Ssic)
Product Code	DPS · Cardiovascular
Decision Date	Nov 15, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2340
Device Class	Class 2

Intended Use

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 Story

CardioBand Event Recorder is a wrist-worn device that records single-channel ECG signals; patient completes circuit via skin contact between fingers and wrist. Device transmits ECG data via Bluetooth LE to a smartphone application; data is then stored and transferred to a secure cloud for access by healthcare providers. Used by adult patients in ambulatory settings to assist in rhythm interpretation. Healthcare providers review the ECG output to inform clinical decision-making regarding heart conditions. Benefits include convenient, patient-initiated ECG monitoring.

Clinical Evidence

Single-center, non-randomized comparative study. CardioBand signal quality compared against the KardiaBand predicate and a reference gel-electrode 12-lead ECG device. Results demonstrated that for quantitative ECG measurement analysis, the CardioBand is substantially equivalent to the predicate within a margin of clinically acceptable measurement error.

Technological Characteristics

Wrist-worn sensor; Bluetooth LE connectivity; 24-bit resolution; 500 Hz sampling rate; internal Lithium-Ion battery. Conforms to IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-47 (ambulatory ECG), and ISO 10993-1, -5, -10 (biocompatibility).

Indications for Use

Indicated for adult patients, when prescribed by a physician, to record, display, store, and transfer single-channel ECG for rhythm interpretation.

Regulatory Classification

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.

Predicate Devices

KardiaBand System (K171816)

Related Devices

K201644 — QardioCore · Qardio, Inc. · Feb 28, 2021
K181310 — HeartCheck Cardi Beat ECG Monitor with GEMS Mobile · Cardiocomm Solutions, Inc. · Feb 22, 2019
K210753 — KardiaMobile 6L · AliveCor, Inc. · Jun 30, 2021
K130409 — ALIVECOR HEART MONITOR · AliveCor, Inc. · Sep 6, 2013
K213233 — EZYPRO ECG Recorder (Model: UG02) · Sigknow Biomedical Co., Ltd. · Jun 23, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ 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 & 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. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K181998 Device Name CardioBand Event Recorder Indications for Use (Describe) 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. 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) | |------------------------------------------------------------|-----------------------------------------------------------| |------------------------------------------------------------|-----------------------------------------------------------| ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {3}------------------------------------------------ ### CardioBand 510(k) Submission Section 5 510(K) Summary ### 510(k) Summary ### [As Required by 21 CFR 807.92(c)] | Owner Information [As required by 807.92(a)(1)] | Eunsung Park, SSIC-DH VP, Engineering SAMSUNG STRATEGY & INNOVATION CENTER 3655 North First Street San Jose, CA 95134 (408) 544 - 5310 es001.park@samsung.com Contact: Matthew Wiggins, SSIC-DH Quality Assurance and Regulatory Affairs Contact phone number: (770) 596-1765 Contact email: m.wiggins@samsung.com Summary was prepared on 29-JUN-2018 and revised on 15-NOV-2018 | |----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Information [As required by 807.92(a)(2)] | Trade name - CARDIOBAND© EVENT RECORDER Common name - CardioBand Classification name – Quantitative Electrocardiographic Detector (21 CFR 870.2340, Product Code DPS) | | Claiming Equivalence [As required by 807.92(a)(3)] | K171816 KardiaBand System | {4}------------------------------------------------ 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. {5}------------------------------------------------ AMSUN SAMSUNG STRATEGY & INNOVATION CENTER 3655 North First Street San Jose, CA 95134 (408) 544 - 4000 www.samsung.com/ssic | | Characteristic or Specification | D1: AliveCor KardiaBand System K171816 | D2: SSI CardioBand ECG Event Recorder | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Predicate Device [As required by 807.92(a)(6)] | Indications for Use | The KardiaBand System is intended to record, store and transfer single- channel electrocardiogram (ECG) rhythms. The KardiaBand System alsodisplays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician). The KardiaBand system is intended for use by healthcare professionals, adult patients with known or suspected heart conditions and health conscious individuals. | 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. | | | Product code | DXH, DPS | DPS | | | Mechanism of Action | Users completes circuit with skin contact and hardware transmits audio signal to MCP to convert and display ECG | Same, except transmission to MCP is via Bluetooth LE | | | Anatomical Sites | Left hand fingers to right wrist or vice versa | Same | | | Where used (intended use) | Mobile/active users at rest (ambulatory) | Same | | | | | | | Data Acquisition: Frequency Response | 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 | | | Memory Capacity | Essentially unlimited due to real-time transmission to MCP memory | Same | | | Number of ECG Leads | Single Lead, 2 electrodes | Same | | | Energy Source: Battery | Replaceable Lithium Manganese Dioxide coin cells | Internal Lithium Ion battery | | | Battery Life | 100 hours operation | 7 days operation | | | User Interface: Primary Lead | Lead 1: Left to Right | Same | | | Hardware platforms | Apple iPhone and Apple Watch Band Sensor | Samsung Galaxy S6 or S7 Phone and CardioBand Sensor | | | Software platforms | Apple iOS and Apple Watch OS | Android OS (versions Marshmallow to Nougat) | | | Physical Specifications: 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 to Recognized Standards: | (From FDA Database) | (From Certification Labs) | | | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | IEC 60601-1 | IEC 60601-1:2005 /(R)2012 and A1:2012 | | | Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests | 60601-1-2 | 60601-1-2:2014 | | | | Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems | 60601-2-47 | 60601-2-47 | | | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | ISO 10993-1 | ISO 10993-1 | | | Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity | ISO 10993-5 | ISO 10993-5 | | | Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization | ISO 10993-10 | ISO 10993-10 | | Non-Clinical Performance [As required by 807.92(b)(1)] | The CardioBand Event Recorder was tested in accordance with international recognized standards for EMC and electrical safety, and for biocompatibility. Further, the device underwent verification and validation testing for wireless coexistence and for various data integrity, and signal sufficiency. | | | {6}------------------------------------------------ SAMSUNG STRATEGY & INNOVATION CENTER 3655 North First Street San Jose, CA 95134 (408) 544 - 4000 www.samsung.com/ssic {7}------------------------------------------------ ### MINSTIN SAMSUNG STRATEGY & INNOVATION CENTER 3655 North First Street San Jose, CA 95134 (408) 544 - 4000 www.samsung.com/ssic {8}------------------------------------------------ # AMSUI SAMSUNG STRATEGY & INNOVATION CENTER 3655 North First Street San Jose, CA 95134 (408) 544 - 4000 www.samsung.com/ssic {9}------------------------------------------------ SAMSUNG SAMSUNG STRATEGY & INNOVATION CENTER 3655 North First Street San Jose, CA 95134 (408) 544 - 4000 www.samsung.com/ssic | Clinical Performance [As required by 807.92(b)(2)] | The CardioBand development team elected to validate the signal quality of the CardioBand ECG signal in a comparative, single-center, non-randomized study. The CardioBand was compared to the predicate device and to a reference gel-electrode 12-lead ECG device. | |------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Conclusion on Clinical and Non- clinical Tests [As required by 807.92(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 key technological characteristics. The devices have the same mechanism of action, and they are similar in dimensional and other characteristics. The devices conform to the same recognized standards. In clinical testing, the CardioBand demonstrated that for quantitative ECG measurement 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. | | Other Information As required by 807.92(d)] | |