K Number
K173248
Device Name
CARDIOSKIN
Manufacturer
Date Cleared
2018-08-11

(305 days)

Product Code
Regulation Number
870.2920
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cardioskin is intended to aid the diagnostic evaluation for cardiac disorders by recording patient's ECG signals allowing to condition and monitor these signals. ECG data is stored, transferred and displayed for a review by a physician. Cardioskin is designed to be used by a patient to transmit multiple-lead ECG signal to enable review at a physician's office, hospital or other remote locations under medical supervision. Cardioskin target population is adults.
Device Description
Cardioskin is a wireless and wearable medical device. It enables acquisition, recording, storage, transmission and display of 3-12 leads electrocardiogram (ECG) to analyze potential cardiac pathological abnormalities from adult patients in healthcare facility, at home or clinical research environment. It is intended to be used by trained patients and healthcare professionals only. Cardioskin is composed of a garment, Cardioskin Textile, which is a T-Shirt where textilebased electrodes made of silver yarns are knitted and only functions on Cardioskin Battery and in association with a Cardioskin Recorder. Cardioskin functioning is coupled with a smartphone/tablet compatible with an iOS or Android system, and a mobile application, the Cardioskin App. A web-based information system, the Cardioskin Cloud, receives the ECG signals from the Cardioskin Recorder through a paired Wi-Fi connection for its long-term storage and display the signals in the web interface. The medical expert specialist, who prescribes the use of this device, should monitor its use and confirm the proper functioning of signal recording thanks to Cardioskin Cloud.
More Information

Not Found

No
The document describes a system for acquiring, storing, transmitting, and displaying ECG signals. It mentions signal conditioning and monitoring but does not mention any analysis or interpretation of the signals using AI or ML. The focus is on data acquisition and presentation for physician review.

No.
The device is intended for diagnostic evaluation of cardiac disorders by recording and monitoring ECG signals; it does not provide therapy.

Yes

The intended use clearly states that Cardioskin is "intended to aid the diagnostic evaluation for cardiac disorders." While it doesn't make the diagnosis itself, it provides the necessary ECG signals for a physician to review and make a diagnostic evaluation.

No

The device description explicitly states it is composed of a garment (Cardioskin Textile), a battery (Cardioskin Battery), and a recorder (Cardioskin Recorder), in addition to the software components (Cardioskin App and Cardioskin Cloud). This indicates it is a hardware and software system, not software-only.

Based on the provided information, Cardioskin 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 in order to provide information for diagnostic purposes. This typically involves analyzing biological samples like blood, urine, tissue, etc.
  • Cardioskin's Function: Cardioskin directly records and monitors physiological signals (ECG) from the patient's body. It does not analyze biological specimens.
  • Intended Use: The intended use clearly states it records and monitors ECG signals to aid in the diagnostic evaluation of cardiac disorders. This is a direct measurement of a physiological function, not an analysis of a biological sample.

Therefore, Cardioskin falls under the category of a physiological monitoring device rather than an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

Cardioskin is intended to aid the diagnostic evaluation for cardiac disorders by recording patient's ECG signals allowing to condition and monitor these signals. ECG data is stored, transferred and displayed for a review by a physician. Cardioskin is designed to be used by a patient to transmit multiple-lead ECG signal to enable review at a physician's office, hospital or other remote locations under medical supervision. Cardioskin target population is adults.

Product codes

DXH

Device Description

Cardioskin is a wireless and wearable medical device.

It enables acquisition, recording, storage, transmission and display of 3-12 leads electrocardiogram (ECG) to analyze potential cardiac pathological abnormalities from adult patients in healthcare facility, at home or clinical research environment. It is intended to be used by trained patients and healthcare professionals only.

Cardioskin is composed of a garment, Cardioskin Textile, which is a T-Shirt where textilebased electrodes made of silver yarns are knitted and only functions on Cardioskin Battery and in association with a Cardioskin Recorder.

Cardioskin functioning is coupled with a smartphone/tablet compatible with an iOS or Android system, and a mobile application, the Cardioskin App.

A web-based information system, the Cardioskin Cloud, receives the ECG signals from the Cardioskin Recorder through a paired Wi-Fi connection for its long-term storage and display the signals in the web interface. The medical expert specialist, who prescribes the use of this device, should monitor its use and confirm the proper functioning of signal recording thanks to Cardioskin Cloud.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adults.

Intended User / Care Setting

used by trained patients and healthcare professionals only.
healthcare facility (hospital, rehab centre) or at home

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

Support for the substantial equivalence of Cardioskin was provided as a result of risk management and testing which included electrical and biological safety, performance and software tests. Testing has provided reasonable assurance of safety and effectiveness for the intended use and supports the substantial equivalence demonstration.

The cleaning and disinfection procedures must be applied depending on the components. Procedures are provided in the User Manual.

The textile materials used in Cardioskin are widely used in the textile industry.

Biocompatibility was assessed following ISO 10993 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The skin contact of Cardioskin device is limited to 12 hours. Hence, per ISO 10993, Part 1, and the FDA-modified Matrix ("Use of International Standard ISO-10993 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing") the following tests are conducted to determine biocompatibility of Cardioskin: Irritation and Sensitization.

The firmware in Cardioskin, the mobile app and the Cloud have been tested through verification and validation according to the IEC 62304:2006 standard and as per the FDA Guidance "General Principles for Software Validation". The results of the verification and validation activities demonstrate that the software meets the requirements for safety, function and intended use.

Electromagnetic compatibility and electrical safety testing of Cardioskin was conducted following recognized standards for electro-medical equipment. Compliance to the specific standard IEC 60601-2-47:2012 Part 2: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems regarding the operational and mechanical performance has been demonstrated.

Key Metrics

Not Found

Predicate Device(s)

K161431, K142476

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 870.2920 Telephone electrocardiograph transmitter and receiver.

(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Bioserenity SAS % Esin Yesilalan Senior Regulatory Scientist Voisin Consulting Inc. Life Sciences 222 Third Street, Suite 3121 Cambridge, Massachusetts 02142

Re: K173248

Trade/Device Name: Cardioskin Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II Product Code: DXH Dated: July 23, 2018 Received: July 24, 2018

Dear Esin Yesilalan:

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

1

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

Jessica E. Paulsen -S

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) K173248

Device Name Cardioskin

Indications for Use (Describe)

Cardioskin is intended to aid the diagnostic evaluation for cardiac disorders by recording patient's ECG signals allowing to condition and monitor these signals. ECG data is stored, transferred and displayed for a review by a physician. Cardioskin is designed to be used by a patient to transmit multiple-lead ECG signal to enable review at a physician's office, hospital or other remote locations under medical supervision. Cardioskin target population is adults.

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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Image /page/3/Picture/0 description: The image shows the logo for BIOSERENITY. The logo features a stylized globe with interconnected lines, suggesting a network or global connection. Below the globe, the word "BIOSERENITY" is written in a simple, sans-serif font.

5. 510 (k) Summary

Submitter Information 5.1

Company Name:BioSerenity SAS
Company Address:47 boulevard de l'Hôpital
75013 Paris, France
Company Phone:+33 157 274 456
Company Fax:+33 186 953 093
Contact Person:Mr. Quang Tran
COO

Date the summary was prepared: August 10, 2018

5.2 Device Identification

Trade Name:Cardioskin
Common Name:Cardioskin
Classification Name:Telephone Electrocardiograph Transmitter and Receiver
Product Code:DXH
Regulation Number:21 CFR 870.2920
Device Class:II

5.3 Identification of Predicate Devices

Device NameSimplECG (Primary Predicate)Master Caution Device (MCDTM)
(Secondary Predicate)
ManufacturerNanowear Inc.Healthwatch Ltd.
510(k) NumberK161431K142476
Regulatory ClassIIII
Clearance DateNovember 30, 2016February 17, 2015
Device NameSimplECG (Primary Predicate)Master Caution Device (MCDTM)
(Secondary Predicate)
ManufacturerNanowear Inc.Healthwatch Ltd.
510(k) NumberK161431K142476
Regulatory ClassIIII
Clearance DateNovember 30, 2016February 17, 2015

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Image /page/4/Picture/0 description: The image shows a logo for "BIOSERENITY". The logo features a stylized globe made of interconnected lines, with a star-like shape at one of the intersections. The text "BIOSERENITY" is written in a simple, sans-serif font below the globe.

5.4 Device Description

Cardioskin is a wireless and wearable medical device.

It enables acquisition, recording, storage, transmission and display of 3-12 leads electrocardiogram (ECG) to analyze potential cardiac pathological abnormalities from adult patients in healthcare facility, at home or clinical research environment. It is intended to be used by trained patients and healthcare professionals only.

Cardioskin is composed of a garment, Cardioskin Textile, which is a T-Shirt where textilebased electrodes made of silver yarns are knitted and only functions on Cardioskin Battery and in association with a Cardioskin Recorder.

Cardioskin functioning is coupled with a smartphone/tablet compatible with an iOS or Android system, and a mobile application, the Cardioskin App.

A web-based information system, the Cardioskin Cloud, receives the ECG signals from the Cardioskin Recorder through a paired Wi-Fi connection for its long-term storage and display the signals in the web interface. The medical expert specialist, who prescribes the use of this device, should monitor its use and confirm the proper functioning of signal recording thanks to Cardioskin Cloud.

ર્સ રાજ્યના સાથે તેમની સાથે તે જેવા છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેરી જેવી Indications for Use

Cardioskin is intended to aid in the diagnostic evaluation for cardiac disorders by recording patient's ECG signals allowing to condition and monitor these signals. ECG data is stored, transferred and displayed for a review by a physician.

Cardioskin is designed to be used by a patient to transmit multiple-lead ECG signal to enable review at a physician's office, hospital or other remote locations under medical supervision.

Cardioskin target population is adults.

ર્સ્વ Comparison to Predicate Devices

The Cardioskin device combines the functionality of the two predicate devices into a single device. Both predicate devices along with the subject device have the same intended use, and any differences in technological characteristics do not impact safety and effectiveness.

Table 5-1 provides the comparison to the predicate devices.

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Image /page/5/Picture/0 description: The image shows the logo for BIOSERENITY. The logo features a light blue globe-like design with interconnected lines, suggesting a network or global connection. Below the globe, the word "BIOSERENITY" is written in a simple, sans-serif font, with the letters in a darker shade of blue.

FeatureCardioskinSimplECGMaster Caution Device
Indication for
Use
StatementCardioskin is intended to
aid the diagnostic
evaluation for cardiac
disorders by recording
patient's ECG signals
allowing to condition and
monitor these signals. ECG
data is stored, transferred
and displayed for a review
by a physician.
Cardioskin is designed to
be used by a patient to
transmit multiple-lead ECG
signal to
enable review at a
physician's office, hospital
or other remote locations
under medical supervision.
Cardioskin target
population is adults.The SimplECG is intended to
aid in the diagnostic
evaluation of patients, 21
years of age and above, on
the order of a physician, who
experience transient
symptoms which may suggest
the need for monitoring to
manually assess their cardiac
rhythm disturbance. ECG
data is recorded, stored,
transferred and displayed
wirelessly for review by a
physician who is skilled in
rhythm interpretation.Master Caution Device
(MCD) is intended to
condition an
electrocardiographic signal,
so that it can be transmitted
digitally via Bluetooth
technology and cell-phone or
communication device to a
remote location. The Master
Caution Device (MCD) is
designed to be used by a
patient to transmit a 12 lead
ECG, posture and motion,
respiration and skin
temperature (IR) signals, in
near real-time to enable
review at a physician's office,
hospital or other remote
medical receiving center.
Master Caution Device
(MCD) target population is
adults above the age of 21.
Intended useAcquisition, record,
storage, transmission and
displaying of 3-12 lead
ECGsCapturing and displaying
electrocardiogram signalsAcquisition, record, storage,
transmission and displaying
of 3-12 (3, 5, 12 leads) lead
ECGs, posture and motion,
respiration and skin
temperature (IR) signals
Patient
populationAdults above the age of 21
UserHealthcare professional/technicians, patients
Environment
of UseHealthcare facility (hospital, rehab centre) or at home
Number of
elementsCARDIOSKIN TEXTILE;
CARDIOSKIN
RECORDER:The SimplECG Garment
The SimplECG
Communication ModuleT-Shirt (h-Wear) and
analysis and control processor
(MasterCaution)
Report an
event
manuallyOnly for researchPatient logging of symptomsYes
ECG
measuresYes
ECG
electrodes10 electrodes (+3 electrodes
for research)Nanosensor electrodes10 electrodes
Acceleration
sensorOnly for researchNoYes
Respiration
sensorNoNoYes
Skin
temperature
sensorNoNoYes
Sampling
frequencylow resolution: ~ 250 Hz
standard: 1000Hz250 Hz1 000Hz
Power
Supply3.7V1 AA Lithium battery
(Energizer Ultimate Lithium
AA)3.7V
Physiological
parameters
transferBluetooth
CompatibilityAndroid, iOSiOSAndroid, iOS
Data depth16 bits24 bits≥12 bits
Connectivity2G/3G/4G/GPRS
WiFi
Data
transmissionCARDIOSKIN APP;
CARDIOSKIN CLOUD:SimplECG Mobile
Application
Nanowear Web ApplicationMobile health app:
MasterCaution Mobile
cloud solution: Master
Caution Cloud
StandardsIEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for
Safety. Collateral Standard: Safety Requirements for Medical Electrical Systems.
IEC 60601-1-2 Medical Electrical Equipment Part 1-2: Collateral Standard:
Electromagnetic Compatibility - Requirements and Tests.
ISO 14971 Medical Devices- Application of risk management to medical devices

Table 5-1 Comparison to Predicate Devices

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Image /page/6/Picture/0 description: The image shows a logo for a company called "BIOSERENITY". The logo features a stylized globe made of interconnected lines in a light blue color. The company name is written in a sans-serif font below the globe, also in a light blue color.

Performance Data 5.7

Support for the substantial equivalence of Cardioskin was provided as a result of risk management and testing which included electrical and biological safety, performance and software tests. Testing has provided reasonable assurance of safety and effectiveness for the intended use and supports the substantial equivalence demonstration.

The cleaning and disinfection procedures must be applied depending on the components. Procedures are provided in the User Manual.

The textile materials used in Cardioskin are widely used in the textile industry.

Biocompatibility was assessed following ISO 10993 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The skin contact of Cardioskin device is limited to 12 hours. Hence, per ISO 10993, Part 1, and the FDA-modified Matrix ("Use of International Standard ISO-10993 "Biological Evaluation of Medical Devices Part 1: Evaluation and

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Image /page/7/Picture/0 description: The image shows a logo for a company called BIOSERENITY. The logo features a stylized globe with interconnected lines, suggesting a network or global connection. The word "BIOSERENITY" is written in a sans-serif font below the globe, with the letters in a bold, blue color.

Testing") the following tests are conducted to determine biocompatibility of Cardioskin: Irritation and Sensitization.

The firmware in Cardioskin, the mobile app and the Cloud have been tested through verification and validation according to the IEC 62304:2006 standard and as per the FDA Guidance "General Principles for Software Validation". The results of the verification and validation activities demonstrate that the software meets the requirements for safety, function and intended use.

Electromagnetic compatibility and electrical safety testing of Cardioskin was conducted following recognized standards for electro-medical equipment. Compliance to the specific standard IEC 60601-2-47:2012 Part 2: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems regarding the operational and mechanical performance has been demonstrated.

5.8 Conclusion

Cardioskin is similar in intended use to the predicate. The technological differences were evaluated by non-clinical and limited clinical testing which support the safety and effectiveness of Cardioskin for its intended purposes. Therefore, Cardioskin is substantially equivalent to its legally marketed predicate.