(266 days)
EZYPRO ECG Recorder (Model: UG02) is a prescription-only, single-patient-use, continuously recording single-lead cardiac thythm recorder that can be worn up to 14 days each time through recharge. It is indicated for use on patients who are older than 21 years old. At the end of the recorded ECG data can be transferred in an available file on PC via the USB connection.
During wearing, EZYPRO ECG Recorder (Model: UG02) can digitally transmit ECG data to the mobile device with the APP (EZY iSee) embedded through Bluetooth technology, supporting spot checks on signals. EZY iSee does not contain diagnostic interpretation.
UG02 setting tool is a program executed on the Windows OS platform and to provide an interface for setting up operational parameters of EZYPRO ECG Recorder (Model: UG02) and downloading the recorded ECG data.
EZYPRO ECG Recorder (Model: UG02) can record cardiac rhythm up to 14 days. Wearing duration is adjustable based on different needs of the physicians.
The recorder is lightweight, wire free, and easy to carry around; Will not interfere patient's daily routine or any activities.
Patient's symptomatic episodes can be marked by proactive pressing the blue button on the recorder; Physicians could later look back at the data and use it in the diagnosis.
EZYPRO ECG Recorder is solely intended for manual interpretation of the recorded ECG and heart rate detection using the integrated software. The ECG signal recorded by this device is not intended for automated analysis.
The provided text describes the regulatory clearance of the EZYPRO ECG Recorder (Model: UG02) and its substantial equivalence to a predicate device. It details non-clinical testing performed but does not include information about acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) based on clinical data or a study describing how these criteria were met.
The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." This means that a study proving the device meets performance-based acceptance criteria (as typically understood in terms of diagnostic accuracy or reader improvement for AI devices) was not conducted or submitted for this 510(k) clearance.
Therefore, many of the requested items cannot be answered from the provided text.
Based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific performance-based acceptance criteria for diagnostic accuracy metrics (e.g., sensitivity, specificity for arrhythmia detection) as no clinical trials were conducted to assess these aspects. The "acceptance criteria" referred to in the document relate to the successful completion of various non-clinical engineering and safety tests.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Reliability Test | Met requirements |
| Reliability Evaluation (ME) | Met requirements |
| Reliability (500 cycles reusable) | Met requirements |
| Shelf Life Test | Met requirements |
| Biocompatibility | Met requirements |
| In Vitro Cytotoxicity Test (Agar Diffusion) | Met requirements |
| Intracutaneous Irritation Study in Rabbits | Met requirements |
| Skin Sensitization Study in Guinea Pigs (Maximization Test) | Met requirements |
| Software Validation | Met requirements |
| Recorder Firmware Validation | Met requirements |
| EZY iSee Software Validation | Met requirements |
| UG02 Setting Tool Software Validation | Met requirements |
| Cybersecurity Management | Met requirements |
| EMC and Electrical Safety | Met requirements |
| IEC 60601-1 Test | Met requirements |
| EMC Test | Met requirements |
| Radio Spectrum Test | Met requirements |
| SAR Evaluation | Met requirements |
| Safety Requirements for Portable Sealed Secondary Cells | Met requirements |
| Lithium Polymer Battery Safety Test | Met requirements |
| IEC 60601-1-11 Test | Met requirements |
| Energy Reduction Test | Met requirements |
| Medical Electrical Equipment Performance | Met requirements |
| IEC 60601-2-47 Test | Met requirements |
| Product Function Test (EE) | Met requirements |
| Disposable ECG electrodes Test | Met requirements |
| QRS and Heart Rate Accuracy | Met requirements |
| HFE/UE | Met requirements |
| MR Unsafe Evaluation | Met requirements |
| RF Wireless Evaluation | Met requirements |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no clinical test data was used for a test set. The non-clinical tests were performed on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical test data requiring expert review for ground truth was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test data requiring adjudication was used.
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
Not applicable. The device is for recording and manual interpretation of ECG; there is no mention of AI assistance or a comparative effectiveness study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device explicitly states: "EZYPRO ECG Recorder is solely intended for manual interpretation of the recorded ECG and heart rate detection using the integrated software. The ECG signal recorded by this device is not intended for automated analysis." Therefore, a standalone algorithm performance evaluation would not be relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical data requiring ground truth for performance evaluation was used. The "ground truth" for non-clinical tests would be defined according to the specific test standards (e.g., electrical safety standards, biocompatibility standards).
8. The sample size for the training set
Not applicable, as there is no mention of a training set for an algorithm. The device is not intended for automated analysis.
9. How the ground truth for the training set was established
Not applicable.
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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 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.
June 23, 2022
Sigknow Biomedical Co.,Ltd. Hsiao-Fan Liu Regulatory Affairs 6F., No. 760, Sec. 4, Bade Rd., Songshan Dist, Taipei City, 105412 Taiwan
Re: K213233
Trade/Device Name: EZYPRO ECG Recorder (Model: UG02) Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II Product Code: DRG Dated: May 16, 2022 Received: May 26, 2022
Dear Hsiao-Fan Liu:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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 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).
Sincerely,
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
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Indications for Use
510(k) Number (if known) K213233
Device Name EZYPRO ECG Recorder (Model: UG02)
EZYPRO ECG Recorder (Model: UG02) is a prescription-only, single-patient-use, continuously recording single-lead cardiac thythm recorder that can be worn up to 14 days each time through recharge. It is indicated for use on patients who are older than 21 years old. At the end of the recorded ECG data can be transferred in an available file on PC via the USB connection.
During wearing, EZYPRO ECG Recorder (Model: UG02) can digitally transmit ECG data to the mobile device with the APP (EZY iSee) embedded through Bluetooth technology, supporting spot checks on signals. EZY iSee does not contain diagnostic interpretation.
UG02 setting tool is a program executed on the Windows OS platform and to provide an interface for setting up operational parameters of EZYPRO ECG Recorder (Model: UG02) and downloading the recorded ECG data.
| 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)
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510(k) SUMMARY
| 5.1 | Type of Submission | Traditional |
|---|---|---|
| 5.2 | Date of Summary | 06/17/2022 |
| 5.3 | Submitter | Sigknow Biomedical Co., Ltd.Address: 6F., No.760, Sec. 4, Bade Rd., Songshan Dist.,Taipei City 105, Taiwan (R.O.C.)Phone: +886-2-2761-2577Contact: Hsiao-Fan Liuvera.liu@sigknow.com.tw |
5.4 Identification of the Device
| Proprietary/Trade Name: | EZYPRO ECG Recorder (Model:UG02) |
|---|---|
| Model Number: | UG02 |
| Regulation Description: | Radiofrequency physiological signaltransmitter and receiver. |
| Review Panel: | Cardiovascular |
| Regulation Number: | 870.2910 |
| Product Code: | DRG |
| Device Class: | II |
રત્ત Identification of the Predicate Device
| Predicate Device Name: | Rooti Rx System ECG EventRecorder, Rooti Link APP Software |
|---|---|
| Model Number: | — |
| 510(k) Number: | K163694 |
| Manufacturer: | Rooti Labs Ltd. |
| Regulation Number: | 870.2910 |
| Product Code: | DRG |
| Device Class: | II |
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5.6 Identification of the Reference Device
| Reference Device Name: | ZIO® Patch |
|---|---|
| Model Number: | — |
| 510(k) Number: | K121319 |
| Manufacturer: | iRhythm Technologies, Inc. |
| Regulation Number: | 870.2800 |
| Product Code: | DSH |
| Device Class: | II |
Intended Use/Indications for Use of the Device 5.7
EZYPRO ECG Recorder (Model: UG02) is a prescription-only, single-patient-use, continuously recording single-lead cardiac rhythm recorder that can be worn up to 14 days each time through recharge. It is indicated for use on patients who are older than 21 years old. At the end of the recording, the recorded ECG data can be transferred in an available file on PC via the USB connection.
During wearing, EZYPRO ECG recorder (model: UG02) can digitally transmit ECG data to the mobile device with the APP (EZY iSee) embedded through Bluetooth technology, supporting spot checks on signals. EZY iSee does not contain diagnostic interpretation.
UG02 setting tool is a program executed on the Windows OS platform and to provide an interface for setting up operational parameters of EZYPRO ECG Recorder (Model: UG02) and downloading the recorded ECG data.
5.8 Device Description
EZYPRO ECG Recorder (Model: UG02) can record cardiac rhythm up to 14 days. Wearing duration is adjustable based on different needs of the physicians.
The recorder is lightweight, wire free, and easy to carry around; Will not interfere patient's daily routine or any activities.
Patient's symptomatic episodes can be marked by proactive pressing the blue button on the recorder; Physicians could later look back at the data and use it in the
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diagnosis.
EZYPRO ECG Recorder is solely intended for manual interpretation of the recorded ECG and heart rate detection using the integrated software. The ECG signal recorded by this device is not intended for automated analysis.
5.9 Non-clinical Testing
A series of safety and performance tests were conducted on the subject device, EZYPRO ECG Recorder (Model: UG02).
- . Reliability Test
- Reliability Test (ME)
- Reliability Evaluation (500 cycles reusable) -
- Shelf Life Test .
- . Biocompatibility
- Biological evaluation of medical device ।
- In Vitro Cytotoxicity Test (Agar Diffusion)
- Intracutaneous Irritation Study in Rabbits
- Skin Sensitization Study in Guinea Pigs (Maximization Test) ।
- . Software
- Recorder Firmware Validation ।
- EZY iSee Software Validation
- UG02 Setting Tool Software Validation
- Cybersecurity Cybersecurity Management
- Electromagnetic compatibility and electrical safety test ●
- IEC 60601-1 Test
- EMC Test
- Radio Spectrum Test ।
- SAR Evaluation ।
- Safety Requirements for Portable Sealed Secondary Cells ।
- Lithium Polymer Battery Safety Test
- IEC 60601-1-11 Test
- Energy Reduction Test ।
- Performance test .
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- IEC 60601-2-47 Test
- Product Function Test (EE)
- Disposable ECG electrodes Test
- QRS and Heart Rate Accuracy
- HFE/UE .
- . MR Unsafe Evaluation
- RF Wireless Evaluation
All the test results demonstrate EZYPRO ECG Recorder (Model: UG02) meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device.
5.10 Clinical Testing
No clinical test data was used to support the decision of substantial equivalence.
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5.11 Substantial Equivalence Determination
EZYPRO ECG Recorder (Model: UG02) submitted in this 510(k) file is substantially equivalent in intended use, safety and performance to the cleared Rooti Rx System (K163694). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.
| Item | Subject device | Predicate device | Substantialequivalencedetermination |
|---|---|---|---|
| 510(k) No. | K213233 | K163694 | N/A |
| ProprietaryName | EZYPRO ECG Recorder (Model: UG02) | Rooti Rx System ECG EventRecorder, Rooti Link APP Software | N/A |
| Manufacturer | Sigknow Biomedical Co., Ltd. | Rooti Labs Limited | N/A |
| RegulationNumber | 21 CFR 870.2910 | 21 CFR 870.2910 | Same |
| Classification | Class II | Class II | Same |
| Product Code | DRG | DRG | Same |
| Intended Use | EZYPRO ECG Recorder (Model: UG02)is a prescription-only, single-patient-use,continuously recording single-lead cardiacrhythm recorder that can be worn up to 14days each time through recharge. It is | The intended use of the Rooti RxSystem is to allow a patient at homeor in the workplace to recordsingle-lead electrocardiography(ECG) data for post-analysis by | SimilarThe subject device is to recordsingle-lead cardiac rhythm frompatients who are older than 21years old; its medical indication is |
| Item | Subject device | Predicate device | Substantialequivalencedetermination |
| indicated for use on patients who are olderthan 21 years old. At the end of therecording, the recorded ECG data can betransferred in an available file on PC viathe USB connection.During wearing, EZYPRO ECG recorder(model: UG02) can digitally transmit ECGdata to the mobile device with the APP(EZY iSee) embedded through Bluetoothtechnology, supporting spot checks onsignals. EZY iSee does not containdiagnostic interpretation.UG02 setting tool is a program executedon the Windows OS platform and toprovide an interface for setting upoperational parameters of EZYPRO ECGRecorder (Model: UG02) and downloadingthe recorded ECG data. | medical professionals. The Rooti Rxdevice stores the ECG data, and therecorded data is transmitted to amedical professional's iOS devicevia Wi-Fi at a later time.The device is not intended to be usedon critical care patients.The Rooti Rx System is indicated foruse on general care patients and onpatients who are 21 years of age orolder. | same as the predicate device.The recorded data could betransmitted wireless to a medicalprofessional's equipment.The subject device has additionalcomponent, UG02 setting tool thatcan set up the operationalparameters and download the data. | |
| Item | Subject device | Predicate device | Substantialequivalencedetermination |
| Data StorageCapacity | 14 days | 7 days | DifferentThe subject device has morecapacity. And the softwarevalidation and performance testscould demonstrate that it would notaffect the safety and effectiveness. |
| Method ofApplication | Designed adhesive electrode | Off the shelf adhesive electrode | DifferentThe subject device has exclusiveelectrode, and the function ofexclusive electrode has been tested.It could demonstrate the substantialequivalence of devices. |
| ECG channel | Channel 1, Single lead | Channel 1, Single lead | Same |
| ElectrodePosition | Left Sternum, inclined(Self-defined position called"ECG Channel A") | Left Sternum, horizontal | DifferentA reference device (ZIO Patch,K121319) which are applied to thesimilar position as the subjectdevice was used to support the |
| Item | Subject device | Predicate device | Substantialequivalencedetermination |
| technological characteristic. Therelevant evaluation and testscould demonstrate the subjectdevice is substantially equivalentto the predicate. | |||
| ECG resolution | 18 bits, ±5mV | 24 bits, 6mVp-v, offset ±300mV | DifferentThe subject device has lower ECGresolution.Performance tests shown that itmeets the requirements and thedevice is substantially equivalentto the predicate. |
| ECG samplingrate (Hz) | 256 | 500 | DifferentBoth are more than double thehighest useful frequencycomponent (40Hz).Performance tests shown that itmeets the requirements and the |
| Item | Subject device | Predicate device | Substantialequivalencedetermination |
| device is substantially equivalent tothe predicate. | |||
| Water resistant | Yes | Yes | Same |
| Datatransmission | Bluetooth | Wifi | DifferentAlthough they are different in datatransmission, it doesn't affect thedevice function.Software validation demonstratedthat it meets the requirements. |
| Power source | 360 mAh lithium battery(Rechargeable battery) | 240 mAh lithium battery(Rechargeable battery) | SimilarThe subject device has morequantity of electricity.The relevant electric safety testsshown that it meets therequirements. |
| Weight (g) | 20 | 14 | SimilarAlthough the subject device isheavier due to the battery, it |
| Item | Subject device | Predicate device | Substantialequivalencedetermination |
| doesn't affect the device function. | |||
| Dimensions(mm) | 47 (L) x 32 (W) x 12 (H) mm | 62 x 22.5 x 8.45 mm | SimilarAlthough the subject device islarger due to the battery, it doesn'taffect the device function. |
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5.12 Similarity and Difference
In terms of the intended use, the subject device and the predicate device are much similar.
The subject device can be worn up to 14 days to record ECG data. During wearing, it can digitally transmit ECG data to the mobile device with the APP (EZY iSee) embedded through Bluetooth technology, supporting spot checks on signals just for making sure the device are working normally. At the end of the recording, the recorded ECG data can be downloaded from recorder for post-analysis by medical professionals.
The predicate device can be worn up to 7 days to record ECG data. During wearing, the recorded data is transmitted to a medical professional's iOS device via Wi-Fi at a later time for post-analysis.
Both of them are used on general care patients and on patients who are 21 years of age or older. They are both used at home or in the workplace, and the recorded data is finally received to medical professionals.
Therefore, the intended use and the indication for use for the subject device are substantially equivalent to the predicate device.
In the terms of electrode position, the subject device adopts a specific position named "ECG Channel A", which is different from the predicate. Therefore, a reference device (ZIO Patch, K121319) applied to a similar position was added to support the technological characteristic.
In terms of the specification, because of the larger battery, the subject device has bigger data storage capacity, power source, weight and dimension so that it can record ECG data up to 14 days.
On the other hand, although there are some differences on data transmission technology, ECG resolution, and ECG sampling rate, they do not affect the safety and performance of the subject device based on the provided test reports.
In terms of the ECG patch, the subject device has exclusive electrode, and the
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function of exclusive electrode has been tested to demonstrate substantial equivalence
5.13 Conclusion
In conclusion, according to the substantial equivalence discussion, the EZYPRO ECG Recorder (Model: UG02) is substantially equivalent to the predicate device in all respects. The intended use for the EZYPRO ECG Recorder (Model: UG02) are substantially equivalent to the predicate device. The performance testing results demonstrate that any differences in the technological characteristics between the devices are incidental and not significant which do not raise any new issues of safety or efficacy as compared to the predicate. Therefore, the EZYPRO ECG Recorder (Model: UG02) is substantially equivalent to the predicate device.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).