(245 days)
The SA-20 Series recorder combines ambulatory ECG Holter and BP monitor. It is intended to acquire, store and display ambulatory ECG signals from adult and pediatric patient. It is capable of measuring systolic and diastolic blood pressures of adults and pediatrics (> 12 years) over a preprogrammed period of time. These measurements are displayed and stored in the recorder. It is intended to be used by trained personnel under the direction of doctors.
Holter ECG and ABP System (Model: SA-20, SA-19, SA-18, SA-15, SA-16) is composed of the recorder, NIBP cuff, lead wire. The ambulatory blood pressure adopts the principle of the oscillometric method for non-invasive blood pressure measurement. ECG signals are obtained by placing electrodes on the patient's surface to record the potential change signal of the human heart and then processing the data to form an ECG waveform and store it in the Recorder to monitor the ECG signal.
The provided text describes the Holter ECG and ABP System and its performance data to establish substantial equivalence to predicate devices. However, the document does not contain an acceptance criteria table or specific details of a study directly proving the device meets acceptance criteria in the format often associated with AI/ML algorithm validation (e.g., sensitivity, specificity, AUC).
Instead, the document focuses on non-clinical performance testing to demonstrate the device's adherence to relevant industry standards and functional specifications, ensuring its safety and effectiveness are comparable to the predicate devices.
Here's a breakdown of the information that can be extracted or inferred based on common medical device submission practices, acknowledging that explicit details on some points are missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal "acceptance criteria" table in terms of diagnostic performance metrics (e.g., sensitivity, specificity for disease detection). Instead, the performance evaluations are based on compliance with established medical device standards. The "reported device performance" is the successful compliance with these standards.
| Acceptance Criteria (Compliance with Standard) | Reported Device Performance (Status) |
|---|---|
| Electrical Safety and Electromagnetic Compatibility (EMC) | |
| ANSI AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009(R) 2012 and A2:2010(R) 2012 (Medical electrical equipment - General requirements for basic safety and essential performance) | Complies |
| IEC 60601-1-2:2014 (Fourth Edition) (Medical electrical equipment – Electromagnetic disturbances - Requirements and tests) | Complies |
| Performance Testing - Bench | |
| IEC 60601-2-47 Edition 2.0 2012-02 (Medical electrical equipment - Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems) | Meets accuracy specifications, complies |
| IEC 80601-2-30: Edition 2.0 2018-03 (Medical electrical equipment - Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers) | Meets accuracy specifications, complies |
| ANSI AAMI EC53:2013/(R) 2020 (ECG trunk cables and patient leadwires) | Meets accuracy specifications, complies |
| IEC 60601-1-11 Edition 2.1 2020-07 (Medical electrical equipment - General requirements for basic safety and essential performance - Home healthcare environment) | Meets accuracy specifications, complies |
| Software Verification and Validation | Documentation provided as recommended by FDA guidance. |
2. Sample size used for the test set and the data provenance
The document states, "Clinical data: Not applicable," implying that the assessment for this 510(k) submission did not involve a clinical trial or a test set derived from patient data in the typical sense of evaluating diagnostic accuracy. The testing was primarily bench-based and software verification. Therefore, there's no "sample size for a test set" or "data provenance" related to patient data for diagnostic performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set for diagnostic performance was used. The "ground truth" for the non-clinical testing was defined by the specifications and requirements of the referenced industry standards.
4. Adjudication method for the test set
Not applicable, as no clinical test set for diagnostic performance 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. This device is a Holter ECG and ABP system (hardware for acquisition, storage, and display of physiological signals), not an AI/ML diagnostic algorithm designed to assist human readers or perform automated interpretations beyond basic parameter measurements.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm in the context of diagnostic interpretation. It is a device for signal acquisition and measurement. The "algorithm" for NIBP (oscillometric method) and ECG signal processing is inherent to the device's function, but it's not described as a standalone diagnostic algorithm requiring performance evaluation against a specific ground truth like an AI model would be.
7. The type of ground truth used
For the performance testing, the "ground truth" was the specifications and requirements defined by the referenced international and national consensus standards (e.g., IEC 60601 series, ANSI AAMI standards). The device's measurements (ECG signals, blood pressure) are verified against the expected outputs and accuracy tolerances dictated by these standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML algorithm that requires a training set of patient data.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML algorithm that requires a training set.
Summary of the Study that Proves the Device Meets Acceptance Criteria (based on the document):
The "study" proving the device meets its "acceptance criteria" is a series of non-clinical performance tests and software verification and validation activities designed to demonstrate compliance with recognized medical device standards.
- Electrical Safety and EMC Testing: The device was tested against ANSI AAMI ES 60601-1 and IEC 60601-1-2 to ensure it is electrically safe and does not cause or succumb to electromagnetic interference.
- Performance Testing (Bench): Functional and system-level bench testing was conducted to validate the device's performance against the accuracy specifications and requirements outlined in:
- IEC 60601-2-47: For ambulatory electrocardiographic systems (ECG Holter functionality).
- IEC 80601-2-30: For automated non-invasive sphygmomanometers (ABP functionality).
- ANSI AAMI EC53: For ECG trunk cables and patient leadwires.
- IEC 60601-1-11: For devices used in the home healthcare environment.
These tests would involve simulating physiological signals or using calibrated equipment to ensure the device accurately acquires, processes, and displays ECG and ABP data within acceptable error margins defined by these standards.
- Software Verification and Validation: This involved rigorous testing of the device's embedded software to ensure it functions as intended, is free from critical bugs, and meets specified requirements, following FDA guidance for software in medical devices.
The conclusion drawn from these "non-clinical data" is that the "subject devices are as safe and as effective as the predicate device," thus establishing substantial equivalence for market clearance.
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September 25, 2023
Edan Instruments, Inc. Lavender Wang Regulatory Engineer #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen, Guangdong 518122 China
Re: K230184
Trade/Device Name: Holter ECG and ABP System Regulation Number: 21 CFR 870.2800 Regulation Name: Medical magnetic tape recorder Regulatory Class: Class II Product Code: DSH, MWJ, DXN Dated: August 25, 2023 Received: August 25, 2023
Dear Lavender Wang:
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.
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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 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).
Sincerely,
Jennifer W.Shih -S
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices
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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) K230184
Device Name
Holter ECG and ABP SystemModel: SA-20, SA-19, SA-18, SA-15, SA-16
Indications for Use (Describe)
The SA-20 Series recorder combines ambulatory ECG Holter and BP monitor.
It is intended to acquire, store and display ambulatory ECG signals from adult and pediatric patient. It is capable of measuring systolic and diastolic blood pressures of adults and pediatrics (> 12 years) over a preprogrammed period of time. These measurements are displayed and stored in the recorder.
It is intended to be used by trained personnel under the direction of doctors.
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 Prepared in accordance with the content and format regulatory Requirements of 21 CFR Part 807.92
| 1. Submitter: | Edan Instruments, Inc.#15 Jinhui Road, Jinsha Community,Kengzi Sub-District, Pingshan District,Shenzhen, 518122 P.R.China.Tel: +86(0755) 26858736Fax: +86(0755) 26882223 |
|---|---|
| Contact person: | Liu Yongying |
| Preparing date: | January 16, 2023 |
| 2. Device name andclassification: | Trade Name: Holter ECG and ABP SystemCommon/Usual Name: SA-20 SeriesModel: SA-20, SA-19, SA-18, SA-15, SA-16 |
| Classification Name | Product code |
|---|---|
| 21 CFR 870.2800 Recorder, Magnetic Tape,Medical | DSH |
| 21 CFR 870.2800 Electrocardiograph,Ambulatory (Without Analysis) | MWJ |
| 21 CFR 870.1130 System, Measurement,Blood-Pressure, Non-Invasive | DXN |
| Regulatory Class: | Class II |
|---|---|
| 3. Predicate Device(s): | 1) Vasomedical, Inc., Combined 12 Channel Ambulatory EGG and BloodPressure Recorder, Model 2302, cleared under K111096 (Primary).2) Vasomedical, Inc., Combined Ambulatory EGG and Blood PressureRecorder, cleared under K092785 (Reference).3) Edan Instruments, Inc., Holter System, cleared under K151787 (Reference).4) Edan Instruments, Inc., Ambulatory Blood Pressure Monitor, cleared underK210139 (Reference). |
| 4. Device Description: | Holter ECG and ABP System (Model: SA-20, SA-19, SA-18, SA-15, SA-16) iscomposed of the recorder, NIBP cuff, lead wire. The ambulatory blood pressureadopts the principle of the oscillometric method for non-invasive blood pressuremeasurement. ECG signals are obtained by placing electrodes on the patient'ssurface to record the potential change signal of the human heart and thenprocessing the data to form an ECG waveform and store it in the Recorder tomonitor the ECG signal. |
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Contraindications :
| Do not use it on patients with erratic, accelerated, or mechanically controlledirregular heart rhythms, including the patient with arrhythmias. | |
|---|---|
| Due to the strangulation risk posed by the cuff and hose, the SA-20 Series mustnot be within reach of unsupervised children. It must not be used onunsupervised patients with limited cognitive abilities. | |
| The SA-20 Series is not intended for alarm triggering monitoring purposes inintensive care units. It must not be used for blood pressure monitoring purposesin intensive care units or during surgery.ABP is not intended for pregnant, including pre-eclamptic patients. | |
| 5. Indication for Use | The SA-20 Series recorder combines ambulatory ECG Holter and BP monitor.It is intended to acquire, store and display ambulatory ECG signals from adultand pediatric patient. It is capable of measuring systolic and diastolic bloodpressures of adults and pediatrics (> 12 years) over a preprogrammed period oftime. These measurements are displayed and stored in the recorder.It is intended to be used by trained personnel under the direction of doctors. |
6. Predicate Device Comparison
Comparison to the predicate devices, the subject device has the same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following tables:
| Item | Subject Device (Model: SA-20 Series ) | Predicate Device ( Model : 2302 ) | Comparison Result |
|---|---|---|---|
| Manufacturer | Edan Instruments, Inc | Vasomedical, Inc | -- |
| K# | K230184 | K111096 | -- |
| Indications for Use | |||
| Indications for Use | The SA-20 Series recorder combines ambulatory ECG Holter and BP monitor.It is intended to acquire, store and display ambulatory ECG signals | Vasomedical-Biox Combined 12 Channel Ambulatory ECG and Blood Pressure Recorder, Model 2302 is a Non-Invasive device intended to acquire ambulatory 12 channel ECG | Similiar |
Table 1: Comparison between SA-20 Series and 2302 (primary predicate device)
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| from adult and pediatric patient. It is | signals and non-invasive oscillometric | ||
|---|---|---|---|
| capable of measuring systolic and | blood pressure signals from the upper | ||
| diastolic blood pressures of adults | body surfaces. Cardiac rhythm is | ||
| and pediatrics (> 12 years) over a | acquired via ECG signals. | ||
| preprogrammed period of time. | Vasomedical-Biox Model 1804 | ||
| These measurements are displayed | Ambulatory BP Recorder is a | ||
| and stored in the recorder. | noninvasive device intended to acquire | ||
| It is intended to be used by trained | ambulatory non-invasive oscillometric | ||
| personnel under the direction of | Blood Pressure signals from the upper | ||
| doctors. | body surfaces. This ABP Recorder | ||
| functions exactly the same as Model | |||
| 2301/2302 for measurement and | |||
| recording of Blood Pressure signals. | |||
| The Recorders are intended for adults | |||
| and children who are over the age of | |||
| six years. | |||
| Physical properties | |||
| SystemComponents | Recorder, blood pressure cuff, leadwire. | Recorder, blood pressure cuff, leadwire, and analysis software. | Different |
| Energy Usedand/orDelivered | Two AA alkaline batteries | four AA alkaline batteries | Different |
| Interface | USB Interface CableSD card | USB Interface CableSD card | same |
| PatientConnections | Blood pressure cuffPatient cable | Blood pressure cuffPatient cable | same |
| Performance Specifications | |||
| Channels | 12 channels | 12 channels | same |
| Electrodes | 10 | 10 | same |
| A/D SamplingFrequency | 25.6 ksps | 10000Hz | Different |
Table 2: Comparison between SA-20 Series and 2301 (reference device)
| Item | Subject Device(Model: SA-20Series ) | Reference Device (Model: 2301) | ComparisonResult |
|---|---|---|---|
| Manufacturer | Edan Instruments, Inc | Vasomedical, Inc | -- |
| K# | K230184 | K092785 | -- |
| Indications for Use | |||
| Vasomedical-Biox Combined AmbulatoryECG and Blood Pressure Recorder is aNon-Invasive device intended to acquireAmbulatory 3 Channel ECG signals andnon-invasive oscillometric Blood Pressuresignals from the upper body surfaces.Cardiac rhythm is acquired via 3 ChannelECG signals. The Recorders are intendedfor adults and children who are over theage of six years.Vasomedical-Biox Ambulatory ECG CBSeries Analysis System Software allowstransfer of ECG and Blood Pressure datafrom the Recorder to a Windows based PCprogram via a removable and large capacitystorage card (SD) for the purpose ofcreating reports and printouts. The softwaredoes not perform diagnostics. Physicianscarry out diagnostic evaluations of thisdata.The system is only for measurement,recording and display. It makes nodiagnosis. | Similiar | ||
| Indications forUse | The SA-20 Series recordercombines ambulatory ECG Holterand BP monitor.It is intended to acquire, store anddisplay ambulatory ECG signalsfrom adult and pediatric patient. Itis capable of measuring systolic anddiastolic blood pressures of adultsand pediatrics (> 12 years) over apreprogrammed period of time.These measurements are displayedand stored in the recorder.It is intended to be used by trainedpersonnel under the direction ofdoctors. | ||
| Physical properties | |||
| SystemComponents | Recorder, blood pressure cuff, leadwire. | Recorder, blood pressure cuff, lead wire,and analysis software. | Different |
| Energy Usedand/orDelivered | Two AA alkaline batteries | four AA alkaline batteries | Different |
| Interface | USB Interface Cable/SD card | USB Interface Cable/SD card | same |
| PatientConnections | Blood pressure cuff; Patient cable | Blood pressure cuff; Patient cable | same |
| Performance Specifications | |||
| Channels | 3 channels | 3 channels | same |
| Electrodes | 5 or 7 | 5 or 7 | same |
| A/D SamplingFrequency | 25.6 ksps | 10000Hz | Different |
| A/D | 24 bits | 10 bits | Different |
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As seen in the comparison tables, the subject device and predicate devices have similar design features and performance specifications. The technological differences between the subject device and predicate
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devices do not raise different questions of safety or effectiveness.
7. Performance Data:
Non-clinical data:
Electrical safety and electromagnetic compatibility (EMC)
The Holter ECG and ABP System was assessed for conformity with the relevant requirements of the following standards and complys:
- ANSI AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009(R) 2012 and A2:2010(R) 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2:2014 (Fourth Edition) Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: electromagnetic disturbances - Requirements and tests.
Performance testing-Bench
Edan has conducted functional and system level testing to validate the performance of the results of the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards.
- IEC 60601-2-47 Edition 2.0 2012-02 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performanceof ambulatory electrocardiographic systems
- IEC 80601-2-30: Edition 2.0 2018-03 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
- ANSI AAMI EC53:2013/(R) 2020 ECG trunk cables and patient leadwires
- IEC 60601-1-11 Edition 2.1 2020-07, 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
Software Verification and Validation Testing
Software verification and validation testing was conducted and documentation was 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".
Clinical data: Not applicable.
Summary
The non-clinical performance testing showed that the subject devices are as safe and as effective as the predicate device.
8. Conclusion
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The bench testing data and software verification and validation demonstrate that Holter ECG and ABP System is substantially equivalent to the predicate devices.
§ 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).