(118 days)
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, 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.
The S-Patch Ex ECG Patch System ("S-Patch Ex") is a light-weight electrocardiogram ("ECG") data collection device. The S-Patch Ex operates wirelessly, and due to its compact size, it is unobtrusive during daily activity. The S-Patch Ex 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 Ex does not include but works with 3rd-party lithium coin batteries and 3rd-party ECG electrodes.
The provided text is a 510(k) summary for the S-Patch Ex Wearable ECG Patch. It describes the device, its intended use, and how it was determined to be substantially equivalent to a predicate device. However, the document does not contain details about specific acceptance criteria for a performance study or the results of such a study in terms of quantifiable metrics like accuracy, sensitivity, or specificity against established ground truth.
The document states that "Multiple system performance testing was successfully performed, demonstrating comparative performance against traditional multi-leads ECG monitors and acceptable electrode placement performance. An integration testing was also conducted, demonstrating good ECG signal quality and compatibility with 3rd-party ECG viewing platforms." but it does not provide the actual data or specific acceptance criteria for these tests.
Therefore, I cannot populate the table or answer most of your detailed questions directly from the provided text. The document focuses on demonstrating substantial equivalence through similar indications for use, technological characteristics, and conformance to general device standards (biocompatibility, electrical safety, software V&V, cybersecurity, human factors). It explicitly states: "Clinical study was not required for demonstrating substantial equivalence to the predicate device." This means a formal comparative effectiveness study against human readers or a standalone algorithm performance study with a defined ground truth and statistical metrics was not performed for this 510(k) submission.
Here's what can be inferred or stated as not available based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ECG Signal Quality (comparative to traditional multi-leads ECG monitors) | Not specified (implied to be "acceptable") | "demonstrating comparative performance against traditional multi-leads ECG monitors" |
| Electrode Placement Performance | Not specified (implied to be "acceptable") | "acceptable electrode placement performance" |
| Integration with 3rd-party ECG viewing platforms | Not specified (implied to be "good compatibility") | "demonstrating good ECG signal quality and compatibility with 3rd-party ECG viewing platforms" |
| Biocompatibility | Conformance to ISO 10993-1:2009 | Testing conducted and complied satisfactorily. |
| Device Reuse and Cleaning Validation | Disinfection method satisfactorily evaluated, no new questions of safety/effectiveness raised. | "low-level disinfection method was satisfactorily evaluated and did not raise any new or different questions of safety or effectiveness." |
| Electrical Safety & EMC | Compliance with specified standards (ES60601-1:2005(R)2012, IEC 60601-1-2 Ed 4.0, IEC 60601-1-11 Ed 2.0) | "The subject device complies with the electrical safety and electromagnetic compatibility requirements." |
| Firmware/Software V&V | Conformance to FDA Guidance (May 11, 2005) for "moderate" level of concern software. | "Software verification and validation testing was conducted, and documentation is provided as recommended." |
| Cybersecurity | Conformance to FDA Guidance (October 2, 2014) | "Cybersecurity assessment and testing were conducted, according to FDA's Guidance." |
| Human Factors/Usability | Conformance to FDA Guidance (February 3, 2016) | "A human factors summative usability validation study was conducted, according to FDA's Guidance." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any performance testing.
- Data Provenance: Not specified. (The document mentions the manufacturer is in the Republic of Korea, but no information on data origin is provided).
- Retrospective/Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not available as the document does not describe a clinical study with ground truth established by experts for performance evaluation. The device does not include automated ECG analysis and relies on "further analysis and interpretation by qualified medical professionals" using 3rd-party platforms.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/Not available. No clinical study with expert adjudication is described for performance evaluation.
5. 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. The document explicitly states: "Clinical study was not required for demonstrating substantial equivalence to the predicate device." Furthermore, the S-Patch Ex "does not include automated ECG analysis and is not intended to be used with 3rd party automated ECG analysis software." Therefore, no MRMC study involving AI assistance would have been conducted or reported here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. The device itself does not perform automated ECG analysis. Its function is to collect and transmit ECG data.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable/Not available. As no clinical performance study requiring ground truth was presented, this information is not provided. The performance testing appears to be primarily technical (signal quality, electrical safety, software functionality), not diagnostic accuracy against a clinical ground truth.
8. The sample size for the training set:
Not applicable/Not available. This device is a data collection device and does not inherently involve an AI algorithm that would require a "training set" for diagnostic performance.
9. How the ground truth for the training set was established:
Not applicable/Not available. (See point 8).
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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 on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
August 30, 2023
Wellysis Corp. % Nikki Batista Vice President MCRA, LLC 803 7th Street NW Washington, District of Columbia 20001
Re: K231289
Trade/Device Name: S-Patch Ex Wearable ECG Patch Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: DSH Dated: August 2, 2023 Received: August 3, 2023
Dear Nikki Batista:
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,
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
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Indications for Use
510(k) Number (if known) K231289
Device Name S-Patch Ex Wearable ECG Patch
Indications for Use (Describe)
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, 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.
| 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
1. Date Prepared
August 02, 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 | K231289 |
|---|---|
| Trade/Device/Model Name | S-Patch Ex |
| Product Name | S-Patch Ex ECG Patch System |
| Device Classification Name | Medical magnetic tape recorder |
| Regulation Number | 21 CFR 870.2800 |
| Classification Product Code | DSH |
| 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 | K171410 |
|---|---|
| Trade/Device/Model Name | ePatch® |
| Device Classification Name | Medical magnetic tape recorder |
| Regulation Number | 21 CFR 870.2800 |
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| Classification Product Code | DSH |
|---|---|
| Device Class | II |
| 510(k) Review Panel | Cardiovascular |
5. Description of the Device
The S-Patch Ex ECG Patch System ("S-Patch Ex") is a light-weight electrocardiogram ("ECG") data collection device.
The S-Patch Ex operates wirelessly, and due to its compact size, it is unobtrusive during daily activity. The S-Patch Ex 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 Ex does not include but works with 3rd-party lithium coin batteries and 3rd-party ECG electrodes.
The S-Patch Ex is intended to be used by medical professionals in accordance with the User Manual. The S-Patch Ex 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.
6. 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, fatigue, chest pain and/or anxiety. S-Patch Ex wearable ECG patch is intended for use by patients 18 years or older.
7. Intended use
The S-Patch Ex 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.
The data recorded by the S-Patch Ex 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.
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The S-Patch Ex wearable ECG Patch does not include automated ECG analysis and is not intended to be used with 3rd party automated ECG analysis software.
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- 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 Ex ECG Patch System is substantially equivalent to its predicate device.
| Predicate Device | Subject Device | ||
|---|---|---|---|
| K Number | K171410 | K231289 | |
| Manufacturer | Braemar Manufacturing, LLC | Wellysis Corp. | |
| Product Name | ePatch® | S-Patch Ex ECG PatchSystem | |
| Review Panel | Cardiovascular | Cardiovascular | |
| Regulation Number | 21 CFR 870.2800 | 21 CFR 870.2800 | |
| Product Code | DSH | DSH | |
| Indications for Use | The ePatch® is indicated foruse on patients who may beasymptomatic or who maysuffer from transientsymptoms such aspalpitations, shortness ofbreath, dizziness, lightheadedness, pre-syncope,syncope, fatigue, chest painand/or anxiety. The Patch®is intended for use byadolescents 18-21 andadults. | S-Patch Ex wearable ECGpatch is indicated for use onpatients who may beasymptomatic or who maysuffer from transientsymptoms such aspalpitations, shortness ofbreath, dizziness, lightheadedness, pre-syncope,syncope, fatigue, chest painand/or anxiety. S-Patch Exwearable ECG patch isintended for use by patients18 years or older. | |
| Intended PatientPopulation | The ePatch® is intended foruse by adolescents 18-21and adults. | General care patients whoare 18 years or older | |
| Single Use | Reusable / RechargeableMonitor, Single UseElectrodes | S-Patch Ex is multi-patient,multi-use; compatible 3rd-party ECG electrode issingle use | |
| Intended UseEnvironment | Home & Healthcare settings | Home & Healthcare settings | |
| Measured | ECG | X | X |
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| Parameters | ||
|---|---|---|
| ECG Dynamic Range | -10mV to + 10mV | -10mV to + 10mV |
| Applied Part Category | Type BF (body floating) | Type CF (cardiac floating) |
| Battery | DC3.7V, rechargeablelithium-ion polymer battery –48 hours | DC 3V, Coin Battery(CR2032) - 100 hours |
| Data Storage andTransfer | X | X |
| CommunicationProtocol | USB 2.0 | Bluetooth Low Energy(2402 – 2480 MHz) |
| Viewing SoftwarePlatform | Compatible 3rd party ECGviewing software includingCardiologs | A compatible 3rd-party ECGviewing software |
| Data Encryption | No related information | Advanced EncryptionStandard-CCM mode |
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 the 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 Ex 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 Ex. The subject device complies with the electrical safety and electromagnetic compatibility requirements established by the following standards.
| StandardsNo. | StandardsOrganization | Standard Title | Version |
|---|---|---|---|
| 60601-1 | AAMI/ANSI | Medical Electrical Equipment - Part 1:General Requirements for Basic Safety | ES60601-1:2005(R)2012 |
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| StandardsNo. | StandardsOrganization | Standard Title | Version |
|---|---|---|---|
| and Essential Performance (IEC 60601-1:2005, MOD) | 2 andA1:2012 | ||
| 60601-1-2 | IEC | Medical Electrical Equipment - Part 1-2:General Requirements for Safety -Collateral Standard: ElectromagneticCompatibility - Requirements and Tests | 60601-1-2Edition 4.02014-02 |
| 60601-1-11 | IEC | Medical electrical equipment - Part 1-11:General requirements for basic safety andessential performance - CollateralStandard: Requirements for medicalelectrical equipment and medicalelectrical systems used in the homehealthcare environment | 60601-1-11Edition 2.02015-01 |
Firmware/Software Verification and Validation Testing
The S-Patch Ex contains "moderate" level of concern firmware/software 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. Software verification and validation testing was conducted, and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005.
Integration and System Performance Testing
Multiple system performance testing was successfully performed, demonstrating comparative performance against traditional multi-leads ECG monitors and acceptable electrode placement performance. An integration testing was also conducted, demonstrating good ECG signal quality and compatibility with 3rd-party ECG viewing platforms.
Cybersecurity Assessment and Testing
Cybersecurity assessment and testing were conducted, according to FDA's Guidance for Industry and FDA Staff, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued on October 2, 2014.
Animal Study
Animal performance testing was not required for this device.
Human Factors Usability Validation Study
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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.
Clinical Study
Clinical study was not required for demonstrating substantial equivalence to the predicate device.
10. Conclusion
The subject device S-Patch Ex ECG Patch System is substantially equivalent in indications for use, functions, and performance to the predicate device. The minor difference between subject and predicate device in single versus multiple patient usage was adequately evaluated and did not raise any new or different questions regarding its performance 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 Ex ECG Patch System is substantially equivalent to the predicate device.
§ 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).