CARDIOSKIN

K173248 · Bioserenity Sas · DXH · Aug 11, 2018 · Cardiovascular

Device Facts

• Record ID: K173248
• Device Name: CARDIOSKIN
• Applicant: Bioserenity Sas
• Product Code: DXH · Cardiovascular
• Decision Date: Aug 11, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

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 Story

Cardioskin is a wearable ECG monitoring system comprising a textile garment (T-shirt) with silver-yarn electrodes, a battery-powered recorder, a mobile application (iOS/Android), and a cloud-based information system. The device acquires 3-12 lead ECG signals from adult patients in clinical or home settings. Signals are transmitted via Bluetooth to the mobile app and then to the Cardioskin Cloud for long-term storage and physician review. The system enables remote monitoring by healthcare professionals to analyze potential cardiac pathological abnormalities. Physicians access the cloud interface to confirm signal recording and review data to inform clinical decision-making. The device benefits patients by facilitating ambulatory cardiac monitoring outside of traditional clinical environments.

Clinical Evidence

No clinical trial data provided. Substantial equivalence supported by bench testing, including electrical safety, electromagnetic compatibility (IEC 60601-1, IEC 60601-1-2), and performance testing per IEC 60601-2-47:2012. Biocompatibility assessed per ISO 10993 for limited skin contact (<12 hours). Software verification and validation performed per IEC 62304 and FDA guidance.

Technological Characteristics

Wearable garment with silver-yarn textile electrodes; 3-12 lead ECG acquisition; 3.7V battery; 16-bit data depth; sampling frequency 250Hz-1000Hz; Bluetooth connectivity to mobile app; Wi-Fi/cellular transmission to cloud. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-47, ISO 14971, ISO 10993. Software: IEC 62304 compliant.

Indications for Use

Indicated for adult patients requiring diagnostic evaluation of cardiac disorders via ECG signal recording, conditioning, and monitoring under medical supervision in healthcare facilities, homes, or clinical research environments.

Regulatory Classification

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.

Predicate Devices

• SimplECG (K161431)
• Master Caution Device (MCDTM) (K142476)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|----------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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<br>75013 Paris, France |
| Company Phone: | [phone] |
| Company Fax: | [phone] |
| Contact Person: | Mr. Quang Tran<br>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 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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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.

| Feature | Cardioskin | SimplECG | Master Caution Device |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for<br>Use<br>Statement | Cardioskin is intended to<br>aid the diagnostic<br>evaluation for cardiac<br>disorders by recording<br>patient's ECG signals<br>allowing to condition and<br>monitor these signals. ECG<br>data is stored, transferred<br>and displayed for a review<br>by a physician.<br>Cardioskin is designed to<br>be used by a patient to<br>transmit multiple-lead ECG<br>signal to<br>enable review at a<br>physician's office, hospital<br>or other remote locations<br>under medical supervision.<br>Cardioskin target<br>population is adults. | The SimplECG is intended to<br>aid in the diagnostic<br>evaluation of patients, 21<br>years of age and above, on<br>the order of a physician, who<br>experience transient<br>symptoms which may suggest<br>the need for monitoring to<br>manually assess their cardiac<br>rhythm disturbance. ECG<br>data is recorded, stored,<br>transferred and displayed<br>wirelessly for review by a<br>physician who is skilled in<br>rhythm interpretation. | Master Caution Device<br>(MCD) is intended to<br>condition an<br>electrocardiographic signal,<br>so that it can be transmitted<br>digitally via Bluetooth<br>technology and cell-phone or<br>communication device to a<br>remote location. The Master<br>Caution Device (MCD) is<br>designed to be used by a<br>patient to transmit a 12 lead<br>ECG, posture and motion,<br>respiration and skin<br>temperature (IR) signals, in<br>near real-time to enable<br>review at a physician's office,<br>hospital or other remote<br>medical receiving center.<br>Master Caution Device<br>(MCD) target population is<br>adults above the age of 21. |
| Intended use | Acquisition, record,<br>storage, transmission and<br>displaying of 3-12 lead<br>ECGs | Capturing and displaying<br>electrocardiogram signals | Acquisition, record, storage,<br>transmission and displaying<br>of 3-12 (3, 5, 12 leads) lead<br>ECGs, posture and motion,<br>respiration and skin<br>temperature (IR) signals |
| Patient<br>population | Adults above the age of 21 | | |
| User | Healthcare professional/technicians, patients | | |
| Environment<br>of Use | Healthcare facility (hospital, rehab centre) or at home | | |
| Number of<br>elements | CARDIOSKIN TEXTILE;<br>CARDIOSKIN<br>RECORDER: | The SimplECG Garment<br>The SimplECG<br>Communication Module | T-Shirt (h-Wear) and<br>analysis and control processor<br>(MasterCaution) |
| Report an<br>event<br>manually | Only for research | Patient logging of symptoms | Yes |
| ECG<br>measures | Yes | | |
| ECG<br>electrodes | 10 electrodes (+3 electrodes<br>for research) | Nanosensor electrodes | 10 electrodes |
| Acceleration<br>sensor | Only for research | No | Yes |
| Respiration<br>sensor | No | No | Yes |
| Skin<br>temperature<br>sensor | No | No | Yes |
| Sampling<br>frequency | low resolution: ~ 250 Hz<br>standard: 1000Hz | 250 Hz | 1 000Hz |
| Power<br>Supply | 3.7V | 1 AA Lithium battery<br>(Energizer Ultimate Lithium<br>AA) | 3.7V |
| | | | |
| Physiological<br>parameters<br>transfer | Bluetooth | | |
| Compatibility | Android, iOS | iOS | Android, iOS |
| Data depth | 16 bits | 24 bits | ≥12 bits |
| Connectivity | 2G/3G/4G/GPRS<br>WiFi | | |
| Data<br>transmission | CARDIOSKIN APP;<br>CARDIOSKIN CLOUD: | SimplECG Mobile<br>Application<br>Nanowear Web Application | Mobile health app:<br>MasterCaution Mobile<br>cloud solution: Master<br>Caution Cloud |
| Standards | IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for<br>Safety. Collateral Standard: Safety Requirements for Medical Electrical Systems.<br>IEC 60601-1-2 Medical Electrical Equipment Part 1-2: Collateral Standard:<br>Electromagnetic Compatibility - Requirements and Tests.<br>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.