(112 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any features or functionalities that would typically involve AI/ML for ECG interpretation or analysis. The focus is on recording, displaying, storing, and transferring the ECG signal for rhythm interpretation by qualified healthcare providers.
No.
The device is used for recording and monitoring ECG signals for rhythm interpretation, which is a diagnostic function, not a therapeutic one. It does not provide treatment or intervene in a disease process.
Yes
Explanation: The device is indicated for "rhythm interpretation" and transfers ECG data for qualified healthcare providers to access, which are diagnostic activities.
No
The device description explicitly states the system consists of three components: a wrist-worn CardioBand, a smart-phone application, and a secure cloud. The CardioBand is a hardware component that records ECG signals.
Based on the provided information, the CardioBand Event Recorder is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This examination is performed outside of the living body (in vitro).
- CardioBand Function: The CardioBand Event Recorder directly measures electrical activity of the heart from the patient's body (in vivo) to record ECG signals. It does not analyze specimens derived from the body.
- Intended Use: The intended use is to "record, display, store and transfer single-channel electrocardiogram (ECG) for rhythm interpretation." This is a physiological measurement taken directly from the patient.
Therefore, the CardioBand Event Recorder falls under the category of a medical device that performs physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
DPS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Left hand fingers to right wrist or vice versa
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Mobile/active users at rest (ambulatory)
when prescribed by a physician
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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) |
|---|---|
| ------------------------------------------------------------ | ----------------------------------------------------------- |
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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)] | |