(264 days)
The VSH101 is designed to record, transmit, and store single channel electrocardiogram (ECG) data via Bluetooth communication to compatible Bluetooth enabled devices. The device is intended for use by healthcare professionals, individuals with known or suspected cardiac conditions, and health-conscious users. The ECG data serves as a supplementary source of patient information and is not intended for automated analysis.
VitalSigns 1-Lead Holter is an ambulatory and Bluetooth-based wireless communication ECG measurement solution designed to allow users to record, store, transmit, and display single-channel ECG data.
VitalSigns 1-Lead Holter consists of the following three components:
- VS Electrode Patch "VSP101"
- ECG Recorder Host "VSH101"
- iOS APP "VSHealth"
When the ECG Recorder Host "VSH101" is fully charged and connected wirelessly via Bluetooth to the iOS app "VSHealth", it can instantly obtain the user's ECG data. VSHealth assists in transmitting, displaying, recording, and storing ECG data.
After the "VSH101" is fully charged, the device, through the VSHealth app, allows users to continuously use and record ECG data for 24 hours in their daily routines, whether at home or in a work environment.
The provided FDA 510(k) clearance letter and summary for the VitalSigns 1-Lead Holter (VSH101) primarily focus on demonstrating substantial equivalence to a predicate device through comparison of features and adherence to various safety and performance standards. However, it does not include explicit acceptance criteria tables or detailed study results for specific device performance metrics that would be typically found in a clinical or performance validation report.
The document states that "software validation, performance test and usability test have been completed to demonstrate that the differences between these parameters would not impact the safety and effectiveness of the subject device. The subject device has also undergone all safety and performance tests, and the results complied with the test requirements." It also mentions "Performance testing - IEC 60601-2-47 test" and "Disposable ECG electrode test."
Given the information provided in the 510(k) summary, I will infer the acceptance criteria based on the mentioned compliance standards and the general nature of an ECG Holter device, and then describe what is stated about the testing.
Inferred Acceptance Criteria and Reported Device Performance
The 510(k) summary for the VitalSigns 1-Lead Holter (VSH101) does not provide a specific table of acceptance criteria with corresponding performance metrics. Instead, it relies on demonstrating compliance with relevant international standards and equivalence to a predicate device. Based on the mentioned standards (e.g., IEC 60601-2-47 for ambulatory ECG recorders, ANSI/AAMI EC12 for disposable ECG electrodes), the general acceptance criteria for such a device would relate to the accuracy, signal quality, and reliability of ECG signal acquisition.
Here's a table based on the inferred acceptance criteria from the context of ECG device standards and the information stated in the document:
| Acceptance Criteria Category | Specific Metric (Inferred) | Acceptance Threshold (Inferred from Standards & Equivalence) | Reported Device Performance (as stated in document) |
|---|---|---|---|
| ECG Signal Quality | Artifact/Noise Levels, Baseline Wander, Frequency Response | Compliance with IEC 60601-2-47 (e.g., specific limits for noise, linearity, gain accuracy) | "The patch provides stable conductivity, low impedance" (for electrodes). "Performance is equivalent to IEC 60601-2-47 for all devices." "The results complied with the test requirements." |
| ECG Electrode Performance | Impedance, Biocompatibility, Adhesion | Compliance with ANSI/AAMI EC12 (e.g., biocompatibility (cytotoxicity, irritation, sensitization), acceptable impedance range, adhesion properties over time) | "The VS Electrode Patch has been tested in accordance with ANSI/AAMI EC12, confirming compliance with established safety and performance standards." "The patch provides stable conductivity, low impedance, and biocompatibility." |
| Data Acquisition & Storage | Continuous Recording Duration | At least 24 hours (explicitly stated function) | "Allows users to continuously use and record ECG data for 24 hours." "Data storage: 24 hours." |
| Device Functionality & Reliability | Wireless Communication Reliability, Battery Life, Software Functionality | Reliable Bluetooth communication, adequate battery life for intended use, proper software operation (no critical errors) | "Connected wirelessly via Bluetooth." "Allows users to continuously use and record ECG data for 24 hours." "Software validation... has been completed." |
| Safety | Electrical Safety, Electromagnetic Compatibility (EMC), Biocompatibility | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 10993-1 | "Meet all requirements for all design, biocompatibility, electrical, EMC safety and cybersecurity protection." "VSH101 has been tested and complies with the requirements of Clause 8.5.5.2 – Energy reduction test." "Pass all testing." |
Study Proving Device Meets Acceptance Criteria
The provided 510(k) summary describes that comprehensive testing was conducted, primarily focusing on compliance with recognized consensus standards and demonstrating substantial equivalence to a predicate device, rather than a single large-scale clinical/performance study with detailed outcome metrics.
Here's an analysis based on the information provided:
-
A table of acceptance criteria and the reported device performance:
- As detailed above, a direct table is not provided in the 510(k) summary. The acceptance criteria are inferred from the listed compliance standards (e.g., IEC 60601-2-47, ANSI/AAMI EC12). The reported performance is generally stated as "complied with the test requirements," "met its pre-defined criteria," or "confirmed compliance."
-
Sample sizes used for the test set and the data provenance:
- Sample Size: Not explicitly stated for performance testing. For compliance with standards like IEC 60601-2-47 or ANSI/AAMI EC12, testing typically involves a sufficient number of device units or electrodes to statistically demonstrate compliance with the standard's requirements (e.g., a batch of electrodes, multiple device samples). The document does not specify if patient data was used for performance testing beyond what is implied by the "24 hours" recording capability.
- Data Provenance (Country of Origin, Retrospective/Prospective): Not specified. Standard compliance testing is typically done in a lab setting rather than involving patient data in a "retrospective" or "prospective" clinical study design for 510(k) submissions unless a specific clinical performance claim needs to be proven. The focus here is on engineering verification and validation against standards.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the 510(k) summary. The nature of the testing described (compliance with standards like IEC 60601-2-47 for signal quality, ANSI/AAMI EC12 for electrodes, and general electrical safety) suggests controlled laboratory testing and engineering validation, which typically does not involve human expert adjudication of ECG readings as a "ground truth" for device performance in this context. The device's indication for use explicitly states, "The ECG data serves as a supplementary source of patient information and is not intended for automated analysis," implying that human interpretation remains key. Therefore, ground truth establishment by experts for automated analysis is not applicable.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None is explicitly described. Based on the content, there was no clinical study described that would require a ground truth panel or adjudication method for ECG event interpretation. The testing focuses on technical performance compliance.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done or described. The device is a "1-Lead Holter" that records ECG data; it does not perform "automated analysis" or include AI assistance. Its purpose is to provide raw ECG data for supplementation of patient information, not for diagnostic interpretation by an algorithm. Therefore, an MRMC study assessing AI assistance is not relevant to this device's claims or function.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Based on the indication for use, "The ECG data serves as a supplementary source of patient information and is not intended for automated analysis," there is no algorithm for diagnostic interpretation. Therefore, no standalone algorithm performance study was done or described.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- As noted above, for the type of device and the presented summary, complex ground truth derived from expert consensus, pathology, or outcomes data is not applicable for the performance testing described. The "ground truth" for compliance testing is largely defined by the technical specifications and requirements within the IEC/AAMI standards themselves (e.g., known input signals for signal quality, chemical assays for biocompatibility).
-
The sample size for the training set:
- Not applicable / Not provided. The device records raw ECG data and does not perform automated analysis using a trained algorithm. Therefore, no "training set" for AI/ML model development is mentioned or required for this type of device based on its intended use.
-
How the ground truth for the training set was established:
- Not applicable. As there is no AI/ML model for automated analysis that requires a training set, the establishment of ground truth for such a set is not discussed.
FDA 510(k) Clearance Letter - VitalSigns 1-Lead Holter (VSH101)
Page 1
June 17, 2025
VitalSigns Technology Co., Ltd.
Leon Chuang
Chief of Technology Officer
3F., No. 153, Ziqiang S. Rd., Zhubei City
Hsinchu County, 302042
Taiwan
Re: K243003
Trade/Device Name: VitalSigns 1-Lead Holter (VSH101)
Regulation Number: 21 CFR 870.2920
Regulation Name: Telephone electrocardiograph transmitter and receiver
Regulatory Class: Class II
Product Code: DXH
Dated: May 23, 2025
Received: May 23, 2025
Dear Leon Chuang:
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 (the 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 available 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.
Page 2
K243003 - Leon Chuang Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K243003 - Leon Chuang Page 3
assistance/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,
Jennifer W. Shih -S
Jennifer 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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K243003
Device Name
VitalSigns 1-Lead Holter (VSH101)
Indications for Use (Describe)
The VSH101 is designed to record, transmit, and store single channel electrocardiogram (ECG) data via Bluetooth communication to compatible Bluetooth enabled devices. The device is intended for use by healthcare professionals, individuals with known or suspected cardiac conditions, and health-conscious users. The ECG data serves as a supplementary source of patient information and is not intended for automated analysis.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
510(K) Summary
1. Submitter
| 510(K) Sponsor | VitalSigns Technology Co., Ltd |
|---|---|
| Address | 3F., No. 153, Ziqiang S. Rd., Zhubei City, Hsinchu County 302042, Taiwan (R.O.C.) |
| Applicant | JIH-LIANG, JUANG |
| Contact Information | TEL: +886-3-6682091Mail: jl_juang@vsigntek.com |
| Correspondent Person | JIH-LIANG, JUANG |
| Contact Information | TEL: +886-3-6682091Mail: jl_juang@vsigntek.com |
| Date | 2025/05/23 |
2. Subject device
| Device Name | VitalSigns 1-Lead Holter |
|---|---|
| Regulation Name | Telephone electrocardiograph transmitter and receiver |
| Regulation Number | 21 CFR870.2920 |
| Product Code | DXH |
| 510(k) review | Cardiovascular |
| Regulatory Class | Class II |
3. Predicate device
| Device Name | eCordum™ Cardiac Monitor |
|---|---|
| Regulation Name | Telephone electrocardiograph transmitter and receiver |
| Regulation Number | 21 CFR870.2920 |
| Product Code | DXH |
| 510(k) review | Cardiovascular |
| Regulatory Class | Class II |
| 510(k) number | K193296 |
K243003
Page 1 of 8
Page 6
4. Device Description
VitalSigns 1-Lead Holter is an ambulatory and Bluetooth-based wireless communication ECG measurement solution designed to allow users to record, store, transmit, and display single-channel ECG data.
VitalSigns 1-Lead Holter consists of the following three components:
- VS Electrode Patch "VSP101"
- ECG Recorder Host "VSH101"
- iOS APP "VSHealth"
When the ECG Recorder Host "VSH101" is fully charged and connected wirelessly via Bluetooth to the iOS app "VSHealth", it can instantly obtain the user's ECG data. VSHealth assists in transmitting, displaying, recording, and storing ECG data.
After the "VSH101" is fully charged, the device, through the VSHealth app, allows users to continuously use and record ECG data for 24 hours in their daily routines, whether at home or in a work environment.
5. Intended Use/ Indication for Use
The VSH101 is designed to record, transmit, and store single channel electrocardiogram (ECG) data via Bluetooth communication to compatible Bluetooth enabled devices. The device is intended for use by healthcare professionals, individuals with known or suspected cardiac conditions, and health-conscious users. The ECG data serves as a supplementary source of patient information and is not intended for automated analysis.
K243003
Page 2 of 8
Page 7
6. Contraindications
VSH101 is contraindicated for those patients with the following conditions:
- Chronic Disease patients
- Allergic to polyester patient
- Pregnant women, breastfeeding women, infants or children
- Patients with implanted pacemakers or implantable cardioverter defibrillators (ICDs). The device should not be used in the presence of these implants.
- Patients during defibrillation or AED rescue. The device must be removed prior to such procedures.
Caution: The ECG data acquired by the subject device is a non-traditional lead intended only for manual interpretation.
7. Target Population
This product is intended for use in patients 21 years of age or older.
K243003
Page 3 of 8
Page 8
8. Safety and Effectiveness Substantial Equivalence Comparison
| Device Name | VitalSigns 1-Lead Holter | eCordum™ Cardiac Monitor | Substantial equivalence of difference determination |
|---|---|---|---|
| Applicant | VitalSigns Technology Co., Ltd | eCordum, Inc. | -- |
| 510(k) Number | K243003 | K193296 | -- |
| Regulation Number | 21 CFR 870.2920 | 21 CFR 870.2920 | SE |
| Product Code | DXH | DXH | SE |
| Classification | Class II | Class II | SE |
| Indication for use | The VSH101 is designed to record, transmit, and store single- channel electrocardiogram (ECG) data via Bluetooth communication to compatible Bluetooth enabled devices. The device is intended for use by healthcare professionals, individuals with known or suspected cardiac conditions, and health-conscious users. The ECG data serves as a supplementary source of patient information and is not intended for automated analysis. | 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. | SE |
| Number of ECG | 1 channel | 1 channel | SE |
| Power source | Rechargeable Lithium battery pack 3.7V/ 160mAh/ 0.59Wh | Replaceable Coin Battery (CR2032) | DifferentThe battery has been tested and met its pre- defined criteria, and it does not raise new issues of safety and effectiveness. |
K243003
Page 4 of 8
Page 9
| Intended use environment | Healthcare and home environments | Healthcare | SimilarPredicate device allows ambulatory use and by healthcare professionals. Although home use is not explicitly stated, the functional environment overlap supports similar use conditions |
|---|---|---|---|
| Communication Protocol | Bluetooth Low Energy (2402 – 2480 MHz) | Class II Bluetooth | Similar transmission type |
| Data storage | 24 hours | Not provided | DifferentThere is no change in the safety and effectiveness of the device. Performance is equivalent to IEC 60601-2-47 for all devices. |
| Viewing software platform | Mobile app | Mobile app | SE |
| Application/ wear region | Chest-based, single channel | Chest for ambulatory OTS electrodes | Similar |
| Electrodes | The VS Electrode Patch is composed of 3M™ Single-Coated Medical Tan Elastic Nonwoven Tape on Line and AmGel AG600 Series Sensing Hydrogels. Both materials are widely utilized in electrode applications. | Attachable standard ambulatory OTS electrodes with conductive gel. | DifferentThe VS Electrode Patch has been tested in accordance with ANSI/AAMI EC12, confirming compliance with established safety and performance standards. The patch provides stable conductivity, low impedance, and biocompatibility. |
K243003
Page 5 of 8
Page 10
| Compliance standard | IEC 60601-1IEC 60601-1-2IEC 60601-2-47IEC 60601-1-11IEC 10993-1ANSI/AAMI EC12FCC testing per part 15 | IEC 60601-1IEC 60601-1-2IEC 60601-2-47IEC 10993-1FCC testing per part 15 | SimilarThe predicate device does not reference ANSI/AAMI EC12 and IEC 60601-1-11. To address the required signal quality, evidence will be generated through the proposed performance verification protocol in this submission. |
|---|
The VitalSigns 1-Lead Holter has been compared with a predicate device. The subject device has the same indications for use, similar technology/mechanism of action, and similar safety and performance as the predicate device.
Although there are some different specifications between two devices, the software validation, performance test and usability test have been completed to demonstrate that the differences between these parameters would not impact the safety and effectiveness of the subject device. The subject device has also undergone all safety and performance tests, and the results complied with the test requirements.
Therefore, the difference between the subject device and the predicate device did not raise any problem of substantial equivalence. The subject device is substantially equivalent to the predicate device in intended use, safety and performance claims.
Continued on the next page
K243003
Page 6 of 8
Page 11
9. Summary of Non-Clinical Testing
The VitalSigns 1-Lead Holter meet all requirements for all design, biocompatibility, electrical, EMC safety and cybersecurity protection. The VitalSigns 1-Lead Holter pass all testing and supports the claims of substantial equivalence and safe operation.
The VitalSigns 1-Lead Holter was designed and tested for compliance with the applicable clauses of the following standards and USFDA guidance:
- ISO 10993-1
- IEC 60601-1
Note: VSH101 has been tested and complies with the requirements of Clause 8.5.5.2 – Energy reduction test.
- IEC 60601-1-2
- IEC 60601-2-47
- IEC 60601-1-11
- IEC 62304
- ISO 14971
- IEC 62366-1
- ANSI/AAMI EC 12
- IEEE/ANSI C63.27
- USFDA Guidance, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
- USFDA Guidance, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.
- USFDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Device.
Biocompatibility test
- Biological evaluation of medical device
- In vitro cytotoxicity
- Skin irritation
- Skin sensitization were conducted.
Electromagnetic compatibility and electrical safety test
- IEC 60601-1 test
- IEC 60601-1-11 test
- Lithium battery safety test
- IEC 60601-1-2 test
Performance testing
- IEC 60601-2-47 test
- Disposable ECG electrode test
Software
- Recorder-VSH101 validation
- APP-VSHealth validation
- Cybersecurity-Cybersecurity management
HFE/UE
RF Wireless test
K243003
Page 7 of 8
Page 12
10. Conclusion
The VitalSigns 1-Lead Holter is substantially equivalent with respect to safety and effectiveness to the legally marketed predicate device for its intended use. Minor differences between the VitalSigns 1-Lead Holter and the predicate device have no effect on safety or effectiveness, as established through various performance tests.
Page 8 of 8
§ 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).