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.

AI/ML Overview

The provided text describes the Cardioskin device, its indications for use, and a comparison to predicate devices, but it primarily focuses on regulatory approval (510(k) summary) and does not contain detailed acceptance criteria or a specific study demonstrating direct performance against those criteria.

Instead, the document mentions that "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." It also states, "Testing has provided reasonable assurance of safety and effectiveness for the intended use and supports the substantial equivalence demonstration." However, it does not elaborate on what these performance tests entailed, what the acceptance criteria were, or the specific results of those tests.

Therefore, many of the requested items cannot be definitively answered from the provided text.

Here is an attempt to answer the questions based only on the information available:

A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document. The document refers to "requirements for safety, function and intended use" and compliance with specific IEC and ISO standards (IEC 60601-1, IEC 60601-1-2, ISO 14971, IEC 62304, IEC 60601-2-47). These standards imply certain performance criteria, but the specific thresholds or metrics for "acceptance" of the Cardioskin's ECG performance (e.g., accuracy of heart rate detection, signal-to-noise ratio) are not detailed.
- Reported Device Performance: The document only makes a general statement: "The results of the verification and validation activities demonstrate that the software meets the requirements for safety, function and intended use." No specific performance metrics or quantitative results for ECG signal acquisition and analysis are provided.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document refers to "non-clinical and limited clinical testing" but does not specify the sample size for any test set or the data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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
- Not specified, and it's unlikely given the nature of an ECG recording device where the primary output is the raw data for physician review, rather than an AI interpretation tool being evaluated for reader improvement.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device "records patient's ECG signals allowing to condition and monitor these signals. ECG data is stored, transferred and displayed for a review by a physician." This indicates a human-in-the-loop system, as the physician performs the review. There is no mention of a standalone algorithm for diagnosis.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified.
The sample size for the training set
- Not specified. This device is primarily for data acquisition and display, and while it has a "Cardioskin Cloud" that stores and displays signals, the document doesn't indicate extensive AI model training in the diagnostic sense that would require a large training set for a "ground truth" establishment.
How the ground truth for the training set was established
- Not specified.

Summary of what can be inferred or directly stated from the text regarding performance and testing:

Type of tests conducted: Electrical and biological safety, performance (general statement), software verification and validation, electromagnetic compatibility, and compliance with specific medical device standards (IEC 60601-1, IEC 60601-1-2, ISO 14971, IEC 62304, IEC 60601-2-47).
Biocompatibility tests: Irritation and Sensitization, based on ISO 10993 for skin contact limited to 12 hours.
Software tests: Verification and validation according to IEC 62304:2006 and FDA Guidance "General Principles for Software Validation."
Outcome of tests: The tests provide "reasonable assurance of safety and effectiveness for the intended use" and demonstrate that "the software meets the requirements for safety, function and intended use." Compliance with recognized standards was demonstrated.

The document primarily serves as a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices and meeting general regulatory safety and effectiveness requirements, rather than providing detailed performance study results against specific, quantified acceptance criteria for diagnostic performance.

Summary

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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

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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)

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'Hôpital75013 Paris, France
Company Phone:	+33 157 274 456
Company Fax:	+33 186 953 093
Contact Person:	Mr. Quang TranCOO

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 Name	SimplECG (Primary Predicate)	Master Caution Device (MCDTM)
		(Secondary Predicate)
Manufacturer	Nanowear Inc.	Healthwatch Ltd.
510(k) Number	K161431	K142476
Regulatory Class	II	II
Clearance Date	November 30, 2016	February 17, 2015
Device Name	SimplECG (Primary Predicate)	Master Caution Device (MCDTM)
		(Secondary Predicate)
Manufacturer	Nanowear Inc.	Healthwatch Ltd.
510(k) Number	K161431	K142476
Regulatory Class	II	II
Clearance Date	November 30, 2016	February 17, 2015

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5.4 Device Description

Cardioskin is a wireless and wearable medical device.

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

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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Feature	Cardioskin	SimplECG	Master Caution Device
Indication forUseStatement	Cardioskin is intended toaid the diagnosticevaluation for cardiacdisorders by recordingpatient's ECG signalsallowing to condition andmonitor these signals. ECGdata is stored, transferredand displayed for a reviewby a physician.Cardioskin is designed tobe used by a patient totransmit multiple-lead ECGsignal toenable review at aphysician's office, hospitalor other remote locationsunder medical supervision.Cardioskin targetpopulation is adults.	The SimplECG is intended toaid in the diagnosticevaluation of patients, 21years of age and above, onthe order of a physician, whoexperience transientsymptoms which may suggestthe need for monitoring tomanually assess their cardiacrhythm disturbance. ECGdata is recorded, stored,transferred and displayedwirelessly for review by aphysician who is skilled inrhythm interpretation.	Master Caution Device(MCD) is intended tocondition anelectrocardiographic signal,so that it can be transmitteddigitally via Bluetoothtechnology and cell-phone orcommunication device to aremote location. The MasterCaution Device (MCD) isdesigned to be used by apatient to transmit a 12 leadECG, posture and motion,respiration and skintemperature (IR) signals, innear real-time to enablereview at a physician's office,hospital or other remotemedical receiving center.Master Caution Device(MCD) target population isadults above the age of 21.
Intended use	Acquisition, record,storage, transmission anddisplaying of 3-12 leadECGs	Capturing and displayingelectrocardiogram signals	Acquisition, record, storage,transmission and displayingof 3-12 (3, 5, 12 leads) leadECGs, posture and motion,respiration and skintemperature (IR) signals
Patientpopulation	Adults above the age of 21
User	Healthcare professional/technicians, patients
Environmentof Use	Healthcare facility (hospital, rehab centre) or at home
Number ofelements	CARDIOSKIN TEXTILE;CARDIOSKINRECORDER:	The SimplECG GarmentThe SimplECGCommunication Module	T-Shirt (h-Wear) andanalysis and control processor(MasterCaution)
Report aneventmanually	Only for research	Patient logging of symptoms	Yes
ECGmeasures	Yes
ECGelectrodes	10 electrodes (+3 electrodesfor research)	Nanosensor electrodes	10 electrodes
Accelerationsensor	Only for research	No	Yes
Respirationsensor	No	No	Yes
Skintemperaturesensor	No	No	Yes
Samplingfrequency	low resolution: ~ 250 Hzstandard: 1000Hz	250 Hz	1 000Hz
PowerSupply	3.7V	1 AA Lithium battery(Energizer Ultimate LithiumAA)	3.7V

Physiologicalparameterstransfer	Bluetooth
Compatibility	Android, iOS	iOS	Android, iOS
Data depth	16 bits	24 bits	≥12 bits
Connectivity	2G/3G/4G/GPRSWiFi
Datatransmission	CARDIOSKIN APP;CARDIOSKIN CLOUD:	SimplECG MobileApplicationNanowear Web Application	Mobile health app:MasterCaution Mobilecloud solution: MasterCaution Cloud
Standards	IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements forSafety. 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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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.

Regulation Number and Section

§ 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).