V-Patch Cardiac Monitor

K222842 · Shandong Corecare Technology Limited · DXH · Oct 20, 2022 · Cardiovascular

Device Facts

• Record ID: K222842
• Device Name: V-Patch Cardiac Monitor
• Applicant: Shandong Corecare Technology Limited
• Product Code: DXH · Cardiovascular
• Decision Date: Oct 20, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Indications for Use

The V-Patch Cardiac Monitor is intended to record, transfer and store single-channel electrocardiogram (ECG) data via Bluetooth transmission to Bluetooth enabled devices. The monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals. The ECG data is intended to supplement other patient data and is not intended for automated analysis. The device has not been tested and it is not intended for pediatric use.

Device Story

V-Patch Cardiac Monitor is a continuous, single-channel ECG recording device for remote monitoring. Device consists of a battery-powered electronic unit used with off-the-shelf disposable medical-grade gel electrodes applied to the upper left chest. Device automatically activates upon skin contact; records ECG signals; transmits data via Class II Bluetooth to a Bluetooth-enabled computing or mobile device. Intended for use by healthcare professionals, patients, and health-conscious individuals. Output is raw ECG data for review by healthcare professionals to supplement other patient data; device provides no automated ECG analysis, alarms, or real-time viewing. Benefits include facilitating long-term ambulatory ECG monitoring for cardiac assessment.

Clinical Evidence

No clinical testing was performed. Substantial equivalence was demonstrated through non-clinical bench testing, including biocompatibility (ISO 10993-1), electromagnetic compatibility (IEC 60601-1-2), electrical safety (AAMI/ANSI ES60601-1), and ambulatory ECG performance testing (ANSI/AAMI/IEC 60601-2-47).

Technological Characteristics

Single-channel ECG monitor; 250 Hz sampling rate; Class II Bluetooth connectivity. Uses off-the-shelf disposable gel electrodes. Battery-powered, reusable electronic unit. Complies with ISO 10993-1, IEC 60601-1-2, AAMI/ANSI ES60601-1, and ANSI/AAMI/IEC 60601-2-47. Software level of concern: Moderate.

Indications for Use

Indicated for adult patients with known or suspected heart conditions and health-conscious individuals for recording, transferring, and storing single-channel ECG data. Not for pediatric use.

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

• eCordum™ Cardiac Monitor (K193296)

Submission Summary (Full Text)

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October 20, 2022

Shandong CoreCare Technology Limited % Prabhu Raghavan Principal Consultant Mdar, LLC. 1790 Montemar Way San Jose. California 95125

Re: K222842

Trade/Device Name: V-Patch™ Cardiac Monitor Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter And Receiver Regulatory Class: Class II Product Code: DXH Dated: September 20, 2022 Received: September 20, 2022

Dear Prabhu Raghavan:

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,

for

Jennifer Shih 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)

K22842

Device Name V-Patch™ Cardiac Monitor

#### Indications for Use (Describe)

The V-Patch Cardiac Monitor is intended to record, transfer and store single-channel electrocardiogram (ECG) data via Bluetooth transmission to Bluetooth enabled devices. The monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals. The ECG data is intended to supplement other patient data and is not intended for automated analysis. The device has not been tested and it is not intended for pediatric use.

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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#### 510(k) Summary for K222842

Prepared in accordance with the requirements of 21 CFR 807.92

# Submitter Information [807,92(a)(1)]

| Submitter Information [807.92(a)(1)]<br>Sponsor/Applicant | Cao Cheng<br>Chief Executive Officer<br>Shandong CoreCare Technology Limited<br>Suite 801-2, Incubator Phase I, Innovation Valley<br>Jinan High-Tech Industrial Development Zone, Jinan, Shandong<br>China |
|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: [phone]<br>Email: [e-mail] |
| Submission Correspondent | Prabhu Raghavan<br>Principal Consultant, MDQR, LLC<br>Phone: [phone]<br>Email: [e-mail] |
| Secondary Correspondent,<br>US Agent and Partner to<br>Sponsor | Darin Slack<br>Chief Executive Officer<br>Versa Cardio, Inc.<br>255 E. Rincon, Suite 210<br>Corona, CA 92879 |
| | Phone: [phone]<br>Email: [e-mail] |
| Date Prepared | September 19, 2022 |
| Device Information [807.92(a)(2)] | |
| Trade Name | V-Patch™ Cardiac Monitor |
| Common Name | Transmitters and receivers, electrocardiograph, telephone |
| Classification | 21 CFR§870.2920 |
| Device Class | II |
| Product Code<br>Classification Panel | DXH<br>Cardiovascular |

## Predicate Information [807.92(a)(3)]

K193296, eCordum™ Cardiac Monitor, eCordum Inc. Predicate(s)

#### Device Description [807.92(a)(4)]

The V-Patch Cardiac Monitor ("V-Patch CM") is a continuous electrocardiogram (ECG) recording device to record, store, and transfer single channel ECGs and is designed for remote ECG data collection and remote monitoring. The device is in the form of an ECG patch that records ECG signals and transmits directly to a Bluetooth™ enabled device. The V-Patch CM

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has Bluetooth module for transferring ECG data from V-Patch CM to a Bluetooth enabled computing or mobile devices to be accessible to healthcare professionals.

The V-Patch CM includes a battery powered electronic unit that is used with off-the-shelf (OTS) disposable medical grade gel electrodes for long term monitoring. The adhesive electrodes should be replaced by the user every 24 hours or when it no longer adheres to skin. The V-Patch CM is a prescription use device and the recorded ECG data is intended to be used with other patient data. The device does not provide any automated ECG analysis.

### Indications for use [807.92(a)(5)]

The V-Patch Cardiac Monitor is intended to record, transfer and store single-channel electrocardiogram (ECG) data via Bluetooth transmission to Bluetooth enabled devices. The monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals. The ECG data is intended to supplement other patient data and is not intended for automated analysis. The device has not been tested and it is not intended for pediatric use.

#### Substantial Equivalence

The V-Patch CM substantially equivalent to its legally marketed predicate device, eCordum Cardiac Monitor, K193296 (eCordum Inc). The subject V-Patch CM is identical in form and function to the predicate device, using the same components, materials, and software as the predicate and is manufactured by Shandong CoreCare Technology Limited using the same manufacturing process. The two devices have identical intended use, physical characteristics, and technological characteristics.

| Feature | V-Patch Cardiac Monitor<br>(K222842)<br>(Subject Device) | eCordum Cardiac Monitor<br>(K193296)<br>(Predicate Device) |
|----------------|------------------------------------------------------------------|------------------------------------------------------------|
| Intended Use | Ambulatory, long-term, continuous<br>ECG monitoring | Same |
| Product Code | DXH, Telephone<br>electrocardiograph transmitter and<br>receiver | Same |
| Regulation | 21 CFR§870.2920 | Same |
| Classification | II | Same |

| | Comparison of Technological Characteristics with the Predicate Device [807.92(a)(6)) | | | |
|--|--------------------------------------------------------------------------------------|--|--|--|
| | | | | |

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| Feature | V-Patch Cardiac Monitor<br>(K222842)<br>(Subject Device) | eCordum Cardiac Monitor<br>(K193296)<br>(Predicate Device) |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The V-Patch Cardiac Monitor is<br>intended to record, transfer and<br>store single-channel<br>electrocardiogram (ECG) data via<br>Bluetooth transmission to<br>Bluetooth enabled devices. The<br>monitor is intended for use by<br>healthcare professionals, patients<br>with known or suspected heart<br>conditions and health-conscious<br>individuals. The ECG data is<br>intended to supplement other<br>patient data and is not intended for<br>automated analysis. The device has<br>not been tested and it is not<br>intended for pediatric use. | The eCordum Cardiac Monitor is<br>intended to record, transfer and<br>store single-channel<br>electrocardiogram (ECG) data via<br>Bluetooth transmission to<br>Bluetooth enabled devices. The<br>monitor is intended for use by<br>healthcare professionals, patients<br>with known or suspected heart<br>conditions and health-conscious<br>individuals. The ECG data is<br>intended to supplement other<br>patient data and is not intended for<br>automated analysis. The device has<br>not been tested and it is not<br>intended for pediatric use. |
| Indicated Use Method | Apply patch on upper left chest | Same |
| Type of use | Rx only | Same |
| Alarms, arrhythmia<br>detection | No | Same |
| Population | Adult | Same |
| Anatomical Sites | Chest | Same |
| Electrodes | Attachable standard ambulatory<br>OTS electrodes with conductive<br>gel. | Same |
| Single Use/Reusable | Electronic unit is reusable.<br>OTS electrodes are single use | Same |
| ECG and Events Storage | Transmit ECG data to a Bluetooth<br>enabled device. | Same |
| Real time ECG View | No | Same |
| Sampling Rate | 250 Hz | Same |
| Activation | Automatic turn on upon skin<br>contact<br>Mobile app | Same |
| Feature | V-Patch Cardiac Monitor<br>(K222842)<br>(Subject Device) | eCordum Cardiac Monitor<br>(K193296)<br>(Predicate Device) |
| Transmission method | Class II Bluetooth | Same |
| Power Supply | Replaceable battery | Same |
| Software Level of<br>Concern | Moderate | Same |

# Comparison of Technological Characteristics with the Predicate Device [807.92(a)(6)]

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## Comparison of Technological Characteristics with the Predicate Device [807.92(a)(6)]

## Performance Data [807.92(b)]

All necessary testing was conducted on V-Patch Cardiac Monitor to support a determination of substantial equivalence to the predicate device.

# Nonclinical Testing Summary [807.92(b)(1)]

The V-Patch CM was successfully passed its nonclinical testing activities included:

- Biocompatibility evaluation per ISO 10993-1 Fourth edition 2009 Biological evaluation . of medical devices - Part 1: Evaluation and testing within a risk management process.
- . Electromagnetic Compatibility per IEC 60601-1-2 Edition 4.0 2014-02, Medical electrical equipment - part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - requirements and tests.
- . Electrical Safety per AAMI/ANSI ES60601-1:2005/(R) 2012 and A1:2012, c1:2009/(r) 2012 and a2:2010/(r) 2012 (consolidated text) Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
- 0 Ambulatory ECG testing per ANSI/AAMI/IEC 60601-2-47:2012 (60601-2-47); Medical electrical equipment – Part 2-47: Requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
- Software verification and validation testing .

# Clinical Testing Summary [807.92(b)(2)]

No clinical testing is required to demonstrate substantial equivalence to the predicate eCordum Cardiac Monitor (K193296).

# Conclusions [807.92(b)(3)]

The V-Patch CM has a same intended use, physical characteristics, and technological characteristics as the predicate. The minor difference between the devices do not raise different questions of safety or effectiveness. Therefore, the V-Patch CM is substantially equivalent to its predicate device, the eCordum Cardiac Monitor (K193296).