(30 days)
Not Found
No
The device description explicitly states that it "does not provide any automated ECG analysis" and the intended use states the data is "not intended for automated analysis." There is no mention of AI or ML in the document.
No.
The device is described as an ECG recording device used to capture and transmit ECG data, not to deliver any form of therapy. Its primary functions are monitoring and data collection to supplement other patient data, without providing automated analysis or therapeutic intervention.
No.
Explanation: The device records, transfers, and stores ECG data but explicitly states, "The ECG data is intended to supplement other patient data and is not intended for automated analysis" and "The device does not provide any automated ECG analysis." This indicates it is a data acquisition and recording device, not a diagnostic device that performs analysis leading to a diagnosis.
No
The device description explicitly states it is a "continuous electrocardiogram (ECG) recording device" in the form of an "ECG patch" that includes a "battery powered electronic unit" and uses "disposable medical grade gel electrodes." These are all hardware components.
Based on the provided information, the V-Patch Cardiac Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body (in vitro).
- V-Patch Function: The V-Patch Cardiac Monitor records electrocardiogram (ECG) data directly from the patient's chest. This is a measurement of electrical activity within the body (in vivo).
- Intended Use: The intended use clearly states it records, transfers, and stores ECG data. It does not mention analyzing samples taken from the body.
- Device Description: The description focuses on the device's ability to record and transmit electrical signals from the skin.
Therefore, the V-Patch Cardiac Monitor falls under the category of a medical device that performs a physiological measurement, but it is not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DXH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Chest
Indicated Patient Age Range
Adult
Intended User / Care Setting
healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Testing Summary: 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
- 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: No clinical testing is required to demonstrate substantial equivalence to the predicate eCordum Cardiac Monitor (K193296).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
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
1
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
2
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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3
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 Cheng
Chief Executive Officer
Shandong CoreCare Technology Limited
Suite 801-2, Incubator Phase I, Innovation Valley
Jinan High-Tech Industrial Development Zone, Jinan, Shandong
China |
|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: +86-18610294350
Email: cao.cheng@ecordum.cn |
| Submission Correspondent | Prabhu Raghavan
Principal Consultant, MDQR, LLC
Phone: 408-316-5707
Email: prabhu@mdqr.solutions |
| Secondary Correspondent,
US Agent and Partner to
Sponsor | Darin Slack
Chief Executive Officer
Versa Cardio, Inc.
255 E. Rincon, Suite 210
Corona, CA 92879 |
| | Phone: 855-329-5794
Email: 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 Code
Classification Panel | DXH
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
4
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
(K222842)
(Subject Device) | eCordum Cardiac Monitor
(K193296)
(Predicate Device) |
|----------------|------------------------------------------------------------------|------------------------------------------------------------|
| Intended Use | Ambulatory, long-term, continuous
ECG monitoring | Same |
| Product Code | DXH, Telephone
electrocardiograph transmitter and
receiver | Same |
| Regulation | 21 CFR§870.2920 | Same |
| Classification | II | Same |
| Comparison of Technological Characteristics with the Predicate Device [807.92(a)(6)) | ||||
|---|---|---|---|---|
5
| Feature | V-Patch Cardiac Monitor
(K222842)
(Subject Device) | eCordum Cardiac Monitor
(K193296)
(Predicate Device) |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | The eCordum 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. |
| Indicated Use Method | Apply patch on upper left chest | Same |
| Type of use | Rx only | Same |
| Alarms, arrhythmia
detection | No | Same |
| Population | Adult | Same |
| Anatomical Sites | Chest | Same |
| Electrodes | Attachable standard ambulatory
OTS electrodes with conductive
gel. | Same |
| Single Use/Reusable | Electronic unit is reusable.
OTS electrodes are single use | Same |
| ECG and Events Storage | Transmit ECG data to a Bluetooth
enabled device. | Same |
| Real time ECG View | No | Same |
| Sampling Rate | 250 Hz | Same |
| Activation | Automatic turn on upon skin
contact
Mobile 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 of
Concern | Moderate | Same |
Comparison of Technological Characteristics with the Predicate Device [807.92(a)(6)]
6
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).