S-Patch Ex Wearable ECG Patch

K231289 · Wellysis Corp. · DSH · Aug 30, 2023 · Cardiovascular

Device Facts

• Record ID: K231289
• Device Name: S-Patch Ex Wearable ECG Patch
• Applicant: Wellysis Corp.
• Product Code: DSH · Cardiovascular
• Decision Date: Aug 30, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended Use

The S-Patch Ex wearable ECG patch is an electrocardiography (ECG) data recording device for use by healthcare professionals for continuous collection of the ECG data at home and in healthcare settings. The data recorded by the S-Patch Ex wearable ECG patch can be uploaded wirelessly via a smartphone application to a compatible 3rd-party cloud-based ECG viewing platform for further analysis and interpretation by qualified clinicians.

Device Story

S-Patch Ex is a wearable, lightweight ECG data collection device; continuously acquires ECG signals; transmits data wirelessly via smartphone application to 3rd-party cloud-based ECG viewing platform. Used in healthcare settings or at home; operated by medical professionals or patients (e.g., electrode replacement) per manual. Device does not perform automated ECG analysis; output is raw ECG data for interpretation by qualified clinicians. Benefits include continuous cardiac monitoring for transient symptoms. Powered by 3V coin battery (CR2032); uses Bluetooth Low Energy for transmission.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including electrical safety (IEC 60601-1, 60601-1-2, 60601-1-11), biocompatibility (ISO 10993-1), cybersecurity assessment, and human factors usability validation.

Technological Characteristics

Wearable ECG patch; Type CF applied part; DC 3V CR2032 coin battery; Bluetooth Low Energy (2402–2480 MHz) connectivity; ECG dynamic range -10mV to +10mV. Multi-patient, multi-use device with single-use electrodes. Biocompatibility per ISO 10993-1. Cybersecurity includes AES-CCM encryption.

Indications for Use

Indicated for patients 18 years or older who may be asymptomatic or suffer from transient symptoms including palpitations, shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain, and/or anxiety.

Regulatory Classification

Identification

A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

Predicate Devices

• ePatch® (K171410)

Submission Summary (Full Text)

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August 30, 2023

Wellysis Corp. % Nikki Batista Vice President MCRA, LLC 803 7th Street NW Washington, District of Columbia 20001

Re: K231289

Trade/Device Name: S-Patch Ex Wearable ECG Patch Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: DSH Dated: August 2, 2023 Received: August 3, 2023

Dear Nikki Batista:

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

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jennifer W. Shih -S

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K231289

Device Name S-Patch Ex Wearable ECG Patch

#### Indications for Use (Describe)

S-Patch Ex wearable ECG patch is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, pre-syncope, syncope, fatigue, chest pain and/or anxiety. S-Patch Ex wearable ECG patch is intended for use by patients 18 years or older.

| Type of Use (Select one or both, as applicable) |
|---------------------------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;"><b> ☑ </b></span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span style="text-decoration: underline;"><b> ☐ </b></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

#### 1. Date Prepared

August 02, 2023

# 2. Submitter's Information

- Name of Manufacturer: Wellysis Corp.
- Address: 8F, 425 Teheran-ro, Gangnam-gu, Seoul, Republic of Korea
- Contact Name: DoGyun Im
- Telephone No.: [phone]
- Email Address: [e-mail]

#### 3. Trade Name, Common Name, Classification

| 510(k) Number | K231289 |
|-----------------------------|--------------------------------|
| Trade/Device/Model Name | S-Patch Ex |
| Product Name | S-Patch Ex ECG Patch System |
| Device Classification Name | Medical magnetic tape recorder |
| Regulation Number | 21 CFR 870.2800 |
| Classification Product Code | DSH |
| Device Class | II |
| 510(k) Review Panel | Cardiovascular |

## 4. Identification of Predicate Device(s)

The identified predicate device within this submission is shown as following:

#### Predicate Device

| 510(k) Number | K171410 |
|----------------------------|--------------------------------|
| Trade/Device/Model Name | ePatch® |
| Device Classification Name | Medical magnetic tape recorder |
| Regulation Number | 21 CFR 870.2800 |

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| Classification Product Code | DSH |
|-----------------------------|----------------|
| Device Class | II |
| 510(k) Review Panel | Cardiovascular |

#### 5. Description of the Device

The S-Patch Ex ECG Patch System ("S-Patch Ex") is a light-weight electrocardiogram ("ECG") data collection device.

The S-Patch Ex operates wirelessly, and due to its compact size, it is unobtrusive during daily activity. The S-Patch Ex continuously acquires ECG signals and wirelessly transmits the data and via a smartphone application (that meets the definition of MDDS) to a compatible 3rd-party cloud-based ECG viewing platform for further analysis and interpretation by qualified medical professionals. The S-Patch Ex does not include but works with 3rd-party lithium coin batteries and 3rd-party ECG electrodes.

The S-Patch Ex is intended to be used by medical professionals in accordance with the User Manual. The S-Patch Ex can be worn by a patient in either a healthcare setting or at home. Certain actions (such as replacement of the electrodes) can be performed by the patient at the direction of a medical professional and in accordance with the User Manual.

## 6. Indications for use

S-Patch Ex wearable ECG patch is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, fatigue, chest pain and/or anxiety. S-Patch Ex wearable ECG patch is intended for use by patients 18 years or older.

## 7. Intended use

The S-Patch Ex wearable ECG patch is an electrocardiography (ECG) data recording device for use by healthcare professionals for continuous collection of the ECG data at home and in healthcare settings.

The data recorded by the S-Patch Ex wearable ECG patch can be uploaded wirelessly via a smartphone application to a compatible 3rd-party cloud-based ECG viewing platform for further analysis and interpretation by qualified clinicians.

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K231289

The S-Patch Ex wearable ECG Patch does not include automated ECG analysis and is not intended to be used with 3rd party automated ECG analysis software.

- 8. Comparison of the Technological Characteristics with the Predicate Devices In comparison to the predicate device, the subject device provides similar indications for use, functions and technological characteristics and device performance. A tabular highlevel comparison of the subject device and the predicate device is provided in table below. The S-Patch Ex ECG Patch System is substantially equivalent to its predicate device.

| | | Predicate Device | Subject Device |
|----------|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K Number | K171410 | K231289 |
| | Manufacturer | Braemar Manufacturing, LLC | Wellysis Corp. |
| | Product Name | ePatch® | S-Patch Ex ECG Patch<br>System |
| | Review Panel | Cardiovascular | Cardiovascular |
| | Regulation Number | 21 CFR 870.2800 | 21 CFR 870.2800 |
| | Product Code | DSH | DSH |
| | Indications for Use | The ePatch® is indicated for<br>use on patients who may be<br>asymptomatic or who may<br>suffer from transient<br>symptoms such as<br>palpitations, shortness of<br>breath, dizziness, light<br>headedness, pre-syncope,<br>syncope, fatigue, chest pain<br>and/or anxiety. The Patch®<br>is intended for use by<br>adolescents 18-21 and<br>adults. | S-Patch Ex wearable ECG<br>patch is indicated for use on<br>patients who may be<br>asymptomatic or who may<br>suffer from transient<br>symptoms such as<br>palpitations, shortness of<br>breath, dizziness, light<br>headedness, pre-syncope,<br>syncope, fatigue, chest pain<br>and/or anxiety. S-Patch Ex<br>wearable ECG patch is<br>intended for use by patients<br>18 years or older. |
| | Intended Patient<br>Population | The ePatch® is intended for<br>use by adolescents 18-21<br>and adults. | General care patients who<br>are 18 years or older |
| | Single Use | Reusable / Rechargeable<br>Monitor, Single Use<br>Electrodes | S-Patch Ex is multi-patient,<br>multi-use; compatible 3rd-<br>party ECG electrode is<br>single use |
| | Intended Use<br>Environment | Home & Healthcare settings | Home & Healthcare settings |
| Measured | ECG | X | X |

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| Parameters | | |
|------------------------------|----------------------------------------------------------------------|------------------------------------------------|
| ECG Dynamic Range | -10mV to + 10mV | -10mV to + 10mV |
| Applied Part Category | Type BF (body floating) | Type CF (cardiac floating) |
| Battery | DC3.7V, rechargeable<br>lithium-ion polymer battery –<br>48 hours | DC 3V, Coin Battery<br>(CR2032) - 100 hours |
| Data Storage and<br>Transfer | X | X |
| Communication<br>Protocol | USB 2.0 | Bluetooth Low Energy<br>(2402 – 2480 MHz) |
| Viewing Software<br>Platform | Compatible 3rd party ECG<br>viewing software including<br>Cardiologs | A compatible 3rd-party ECG<br>viewing software |
| Data Encryption | No related information | Advanced Encryption<br>Standard-CCM mode |

## 9. Performance Data

Verification and validation activities established the safety and performance characteristics of the proposed subject device with respect to the predicate device. The following performance data demonstrated conformance with special controls and substantial equivalence to the predicate device's performance.

## Biocompatibility Testing

Biocompatibility testing was conducted, included in-vitro cytotoxicity, irritation and sensitization, according to the recommendations of ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing.

## Device Reuse and Cleaning Validation

The S-Patch Ex can be used on multiple patients. Low-level disinfection is required between patient usage and the low-level disinfection method was satisfactorily evaluated and did not raise any new or different questions of safety or effectiveness.

## Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the S-Patch Ex. The subject device complies with the electrical safety and electromagnetic compatibility requirements established by the following standards.

| Standards<br>No. | Standards<br>Organization | Standard Title | Version |
|------------------|---------------------------|---------------------------------------------------------------------------------|---------------------------|
| 60601-1 | AAMI/ANSI | Medical Electrical Equipment - Part 1:<br>General Requirements for Basic Safety | ES60601-1:<br>2005(R)2012 |

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| Standards<br>No. | Standards<br>Organization | Standard Title | Version |
|------------------|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| | | and Essential Performance (IEC 60601-<br>1:2005, MOD) | 2 and<br>A1:2012 |
| 60601-1-2 | IEC | Medical Electrical Equipment - Part 1-2:<br>General Requirements for Safety -<br>Collateral Standard: Electromagnetic<br>Compatibility - Requirements and Tests | 60601-1-2<br>Edition 4.0<br>2014-02 |
| 60601-1-11 | IEC | Medical electrical equipment - Part 1-11:<br>General requirements for basic safety and<br>essential performance - Collateral<br>Standard: Requirements for medical<br>electrical equipment and medical<br>electrical systems used in the home<br>healthcare environment | 60601-1-11<br>Edition 2.0<br>2015-01 |

#### Firmware/Software Verification and Validation Testing

The S-Patch Ex contains "moderate" level of concern firmware/software because a failure or latent flaw could lead to a minor injury to the patient through incorrect information or through the action of the healthcare providers. Software verification and validation testing was conducted, and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005.

## Integration and System Performance Testing

Multiple system performance testing was successfully performed, demonstrating comparative performance against traditional multi-leads ECG monitors and acceptable electrode placement performance. An integration testing was also conducted, demonstrating good ECG signal quality and compatibility with 3rd-party ECG viewing platforms.

#### Cybersecurity Assessment and Testing

Cybersecurity assessment and testing were conducted, according to FDA's Guidance for Industry and FDA Staff, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued on October 2, 2014.

#### Animal Study

Animal performance testing was not required for this device.

#### Human Factors Usability Validation Study

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A human factors summative usability validation study was conducted, according to FDA's Guidance for Industry and FDA Staff, Applying Human Factors and Usability Engineering to Medical Devices, issued on February 3, 2016.

#### Clinical Study

Clinical study was not required for demonstrating substantial equivalence to the predicate device.

#### 10. Conclusion

The subject device S-Patch Ex ECG Patch System is substantially equivalent in indications for use, functions, and performance to the predicate device. The minor difference between subject and predicate device in single versus multiple patient usage was adequately evaluated and did not raise any new or different questions regarding its performance when used as labeled.

The verification and validation testing data supported the substantial equivalence and demonstrated that the subject device performs as intended in the specified use conditions.

Therefore, the S-Patch Ex ECG Patch System is substantially equivalent to the predicate device.