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 Description

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 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.

AI/ML Overview

The provided document does not contain information about specific acceptance criteria, device performance, sample sizes used, data provenance, expert involvement, adjudication methods, MRMC studies, or standalone performance for the V-Patch™ Cardiac Monitor.

The document is a 510(k) summary for the V-Patch™ Cardiac Monitor (K222842) and focuses on establishing substantial equivalence to a predicate device (eCordum™ Cardiac Monitor, K193296). It outlines the device description, indications for use, and a comparison of technological characteristics, stating that the two devices are "identical in form and function..., using the same components, materials, and software... and the same manufacturing process."

Instead of presenting performance data against specific acceptance criteria, it lists nonclinical testing activities that were successfully passed, indicating compliance with relevant standards. These tests confirm the device's electrical safety, electromagnetic compatibility, biocompatibility, and functionality for ambulatory ECG recording, but they do not provide quantitative performance metrics against pre-defined acceptance criteria.

The document explicitly states: "No clinical testing is required to demonstrate substantial equivalence to the predicate eCordum Cardiac Monitor (K193296)." This implies that no specific clinical study was conducted to prove primary performance criteria for the V-Patch™ Cardiac Monitor itself.

Therefore, I cannot provide the requested information based on the given text.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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)]Sponsor/Applicant	Cao ChengChief Executive OfficerShandong CoreCare Technology LimitedSuite 801-2, Incubator Phase I, Innovation ValleyJinan High-Tech Industrial Development Zone, Jinan, ShandongChina
	Phone: +86-18610294350Email: cao.cheng@ecordum.cn
Submission Correspondent	Prabhu RaghavanPrincipal Consultant, MDQR, LLCPhone: 408-316-5707Email: prabhu@mdqr.solutions
Secondary Correspondent,US Agent and Partner toSponsor	Darin SlackChief Executive OfficerVersa Cardio, Inc.255 E. Rincon, Suite 210Corona, CA 92879
	Phone: 855-329-5794Email: darin@versacardio.com
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 CodeClassification Panel	DXHCardiovascular

Predicate Information [807.92(a)(3)]

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

Device Description [807.92(a)(4)]

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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)]

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(K222842)(Subject Device)	eCordum Cardiac Monitor(K193296)(Predicate Device)
Intended Use	Ambulatory, long-term, continuousECG monitoring	Same
Product Code	DXH, Telephoneelectrocardiograph transmitter andreceiver	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(K222842)(Subject Device)	eCordum Cardiac Monitor(K193296)(Predicate Device)
Indications for Use	The V-Patch Cardiac Monitor isintended to record, transfer andstore single-channelelectrocardiogram (ECG) data viaBluetooth transmission toBluetooth enabled devices. Themonitor is intended for use byhealthcare professionals, patientswith known or suspected heartconditions and health-consciousindividuals. The ECG data isintended to supplement otherpatient data and is not intended forautomated analysis. The device hasnot been tested and it is notintended for pediatric use.	The eCordum Cardiac Monitor isintended to record, transfer andstore single-channelelectrocardiogram (ECG) data viaBluetooth transmission toBluetooth enabled devices. Themonitor is intended for use byhealthcare professionals, patientswith known or suspected heartconditions and health-consciousindividuals. The ECG data isintended to supplement otherpatient data and is not intended forautomated analysis. The device hasnot been tested and it is notintended for pediatric use.
Indicated Use Method	Apply patch on upper left chest	Same
Type of use	Rx only	Same
Alarms, arrhythmiadetection	No	Same
Population	Adult	Same
Anatomical Sites	Chest	Same
Electrodes	Attachable standard ambulatoryOTS electrodes with conductivegel.	Same
Single Use/Reusable	Electronic unit is reusable.OTS electrodes are single use	Same
ECG and Events Storage	Transmit ECG data to a Bluetoothenabled device.	Same
Real time ECG View	No	Same
Sampling Rate	250 Hz	Same
Activation	Automatic turn on upon skincontactMobile app	Same
Feature	V-Patch Cardiac Monitor(K222842)(Subject Device)	eCordum Cardiac Monitor(K193296)(Predicate Device)
Transmission method	Class II Bluetooth	Same
Power Supply	Replaceable battery	Same
Software Level ofConcern	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).

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).