(66 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as a data collection and transmission system for analysis by qualified medical professionals on a 3rd-party platform. There is no mention of AI/ML being used within the device itself or the described workflow.
No
The device is described as an ECG data collection device that acquires and transmits ECG signals for analysis and interpretation, but it does not provide any treatment or therapy.
Yes
The device is described as continuously acquiring ECG signals and transmitting them for further analysis and interpretation by qualified medical professionals, indicating its role in providing data for diagnosis.
No
The device description explicitly states "The S-Patch ExL ECG Patch System... is a light-weight electrocardiogram ("ECG") data collection device." and mentions it "continuously acquires ECG signals and wirelessly transmits the data". This indicates a physical hardware component is involved in data acquisition, not just software processing.
Based on the provided information, the S-Patch ExL wearable ECG patch is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- S-Patch ExL Function: The S-Patch ExL is a device that collects electrical signals from the body (ECG). It does not analyze samples taken from the body. It is a wearable device that directly interacts with the patient's skin to acquire physiological data.
- Intended Use: The intended use describes the device's purpose as collecting ECG data for analysis and interpretation by medical professionals to help diagnose or monitor cardiac conditions based on the electrical activity of the heart. This is a direct measurement of a physiological process, not an analysis of a biological sample.
Therefore, the S-Patch ExL falls under the category of a medical device that measures physiological parameters, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
S-Patch ExL 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 ExL wearable ECG patch is intended for use by patients 18 years or older.
Product codes
MWJ
Device Description
The S-Patch ExL ECG Patch System ("S-Patch ExL") is a light-weight electrocardiogram ("ECG") data collection device.
The S-Patch ExL operates wirelessly, and due to its compact size, it is unobtrusive during daily activity. The S-Patch ExL 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 ExL does not include but works with 3rd-party lithium coin batteries and 3rd-party ECG electrodes.
The S-Patch ExL is intended to be used by medical professionals in accordance with the User Manual. The S-Patch ExL 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.
The S-Patch ExL should be worn continuously with the same electrodes for no more than 72 hours. At 72 hours, the existing electrodes should be removed and exchanged for new electrodes before continuing to collect ECG data.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
18 years or older
Intended User / Care Setting
Intended Use: The S-Patch ExL 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.
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)
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 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 ExL 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 ExL. The subject device complies with the electrical safety and electromagnetic compatibility requirements established by the following standards: ES60601-1-2005(R)2012 and A1:2012 (AAMI/ANSI 60601-1), 60601-1-2 Edition 4.0 2014-02 (IEC 60601-1-2), and 60601-1-11 Edition 2.0 2015-01 (IEC 60601-1-11).
Firmware/Software Verification and Validation Testing:
The S-Patch ExL contains "moderate" level of concern firmware 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. However, the subject device uses the same firmware as the predicate device (K231289). Therefore, no additional firmware/software verification and validation testing was required for this device.
Integration and System Performance Testing:
The subject device uses the same firmware as the predicate device (K231289). Therefore, no additional Integration and System Performance Testing was required for this device.
Cybersecurity Assessment and Testing:
The subject device uses the same firmware as the predicate device (K231289). Therefore, no additional cybersecurity assessment and Testing were required for this device.
Animal Study:
Animal performance testing was not required for this device.
Human Factors Usability Validation Study:
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. The subject device has the same usage method and similar design as the predicate device (K231289), differing primarily in the size of the battery side. The change in battery size does not affect the critical tasks of the predicate device and does not introduce new critical tasks.
Clinical Study:
Clinical study was not required for demonstrating safety, effectiveness of the subject device and significant equivalence to the predicate device.
Conclusion:
The subject device S-Patch ExL ECG Patch System is substantially equivalent in indications for use, functions, and performance to the predicate device. The minor difference in battery type between the subject and predicate device was adequately evaluated and did not raise any new or different questions regarding the safety and effectiveness of the device 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2800 Medical magnetic tape recorder.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 16, 2024
Wellysis Corp. Sam Engelman Senior Manager, Digital Health Regulatory Affairs 8F, 425 Teheran-ro, Gangnam-gu Seoul, 06159 South Korea
Re: K233906
Trade/Device Name: S-Patch (S-Patch ExL) Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: MWJ Dated: January 19, 2024 Received: January 19, 2024
Dear Sam Engelman:
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.
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"
1
(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 OS 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 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-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 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.
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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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).
2
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
3
Indications for Use
510(k) Number (if known) K233906
Device Name S-Patch (S-Patch ExL)
Indications for Use (Describe)
S-Patch ExL 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 ExL wearable ECG patch is intended for use by patients 18 years or older.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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."
4
510(k) Summary
1. Date Prepared
November 17, 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.: +82 10-9140-8475
- Email Address: Ian.Im@wellysis.com
3. Trade Name, Common Name, Classification
| 510(k) Number | K233906 |
|---|---|
| Trade/Device/Model Name | S-Patch ExL |
| Product Name | S-Patch ExL ECG Patch System |
| Device Classification Name | Electrocardiograph, Ambulatory (Without Analysis) |
| Regulation Number | 21 CFR 870.2800 |
| Classification Product Code | MWJ |
| 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 | K231289 |
|---|---|
| Trade/Device/Model Name | S-Patch Ex |
| Device Classification Name | Medical magnetic tape recorder |
| Regulation Number | 21 CFR 870.2800 |
5
| Classification Product Code | DSH |
|---|---|
| Device Class | II |
| 510(k) Review Panel | Cardiovascular |
5. Description of the Device
The S-Patch ExL ECG Patch System ("S-Patch ExL") is a light-weight electrocardiogram ("ECG") data collection device.
The S-Patch ExL operates wirelessly, and due to its compact size, it is unobtrusive during daily activity. The S-Patch ExL 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 ExL does not include but works with 3rd-party lithium coin batteries and 3rd-party ECG electrodes.
The S-Patch ExL is intended to be used by medical professionals in accordance with the User Manual. The S-Patch ExL 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.
The S-Patch ExL should be worn continuously with the same electrodes for no more than 72 hours. At 72 hours, the existing electrodes should be removed and exchanged for new electrodes before continuing to collect ECG data.
6. Indications for use
S-Patch ExL 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 ExL wearable ECG patch is intended for use by patients 18 years or older.
7. Intended use
The S-Patch ExL 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.
6
The data recorded by the S-Patch ExL 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.
The S-Patch ExL wearable ECG Patch does not include automated ECG analysis and is not intended to be used with 3rd party automated ECG analysis software.
-
- 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 ExL ECG Patch System is substantially equivalent to its predicate device.
- Comparison of the Technological Characteristics with the Predicate Devices
| Predicate Device | Subject Device | |
|---|---|---|
| K Number | K231289 | K233906 |
| Manufacturer | Wellysis Corp. | Wellysis Corp. |
| Product Name | S-Patch Ex ECG Patch | |
| System | S-Patch ExL ECG Patch | |
| System | ||
| Review Panel | Cardiovascular | Cardiovascular |
| Regulation Number | 21 CFR 870.2800 | 21 CFR 870.2800 |
| Product Code | DSH | MWJ |
| 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, | ||
| syncope, fatigue, chest pain | ||
| and/or anxiety. S-Patch Ex | ||
| wearable ECG patch is | ||
| intended for use by patients | ||
| 18 years or older. | S-Patch ExL 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, | ||
| syncope, fatigue, chest pain | ||
| and/or anxiety. S-Patch ExL | ||
| wearable ECG patch is | ||
| intended for use by patients | ||
| 18 years or older. | ||
| Intended Patient | ||
| Population | General care patients who | |
| are 18 years or older | General care patients who | |
| are 18 years or older | ||
| Single Use | S-Patch Ex is multi-patient, | |
| multi-use; compatible 3rd- | ||
| party ECG electrode is single | ||
| use | S-Patch ExL is multi-patient, | |
| multi-use; compatible 3rd- | ||
| party ECG electrode is single | ||
| use |
7
| Predicate Device | Subject Device | ||
|---|---|---|---|
| Intended Use | |||
| Environment | Home & Healthcare settings | Home & Healthcare settings | |
| Measured | |||
| Parameters | ECG | × | × |
| ECG Dynamic Range | -10mV to + 10mV | -10mV to + 10mV | |
| Applied Part Category | Type CF (cardiac floating) | Type CF (cardiac floating) | |
| Battery | DC 3V, Coin Battery | ||
| (CR2032) - 100 hours | DC 3V, Coin Battery | ||
| (CR2450) - 216 hours | |||
| Data Storage and | |||
| Transfer | × | × | |
| Communication | |||
| Protocol | Bluetooth Low Energy (2402 – 2480 MHz) | Bluetooth Low Energy (2402 – 2480 MHz) | |
| Viewing Software | |||
| Platform | A compatible 3rd-party ECG | ||
| viewing software | A compatible 3rd-party ECG | ||
| viewing software | |||
| Data Encryption | Advanced Encryption | ||
| Standard-CCM mode | Advanced Encryption | ||
| Standard-CCM mode | |||
| Battery Side | |||
| Enclosure Size | 30mm × 6mm | 35.6mm × 8.7 mm | |
| Weight | 9 g | 11 g |
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 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 ExL 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)
8
Electrical safety and EMC testing were conducted on the S-Patch ExL. The subject device complies with the electrical safety and electromagnetic compatibility requirements established by the following standards.
| Standards
No. | Standards
Organization | Standard Title | Version |
|------------------|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| 60601-1 | AAMI/ANSI | Medical Electrical Equipment - Part 1:
General Requirements for Basic Safety
and Essential Performance (IEC 60601-
1:2005, MOD) | ES60601-1-
2005(R)201
2 and
A1:2012 |
| 60601-1-2 | IEC | Medical Electrical Equipment - Part 1-2:
General Requirements for Safety –
Collateral Standard: Electromagnetic
Compatibility - Requirements and Tests | 60601-1-2
Edition 4.0
2014-02 |
| 60601-1-11 | IEC | Medical electrical equipment - Part 1-11:
General requirements for basic safety and
essential performance - Collateral
Standard: Requirements for medical
electrical equipment and medical
electrical systems used in the home
healthcare environment | 60601-1-11
Edition 2.0
2015-01 |
Firmware/Software Verification and Validation Testing
The S-Patch ExL contains "moderate" level of concern firmware 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. However, the subject device uses the same firmware as the predicate device (K231289). Therefore, no additional firmware/software verification and validation testing was required for this device.
Integration and System Performance Testing
The subject device uses the same firmware as the predicate device (K231289). Therefore, no additional Integration and System Performance Testing was required for this device.
Cybersecurity Assessment and Testing
The subject device uses the same firmware as the predicate device (K231289). Therefore, no additional cybersecurity assessment and Testing were required for this device.
Animal Study
Animal performance testing was not required for this device.
Human Factors Usability Validation Study
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. The subject device has the same usage method and similar design as the predicate device (K231289), differing primarily in the
9
size of the battery side. The change in battery size does not affect the critical tasks of the predicate device and does not introduce new critical tasks.
Clinical Study
Clinical study was not required for demonstrating safety, effectiveness of the subject device and significant equivalence to the predicate device.
10
10. Conclusion
The subject device S-Patch ExL ECG Patch System is substantially equivalent in indications for use, functions, and performance to the predicate device. The minor difference in battery type between the subject and predicate device was adequately evaluated and did not raise any new or different questions regarding the safety and effectiveness of the device 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 ExL ECG Patch System is substantially equivalent to the predicate device.