(245 days)
No
The summary describes a standard ambulatory ECG and BP monitor using established methods (oscillometric for BP, electrode placement for ECG) and does not mention any AI/ML terms or capabilities.
No.
The device is intended to acquire, store, and display ambulatory ECG signals and measure blood pressure, which are diagnostic or monitoring functions, not therapeutic.
Yes
The device is intended to acquire, store, and display ambulatory ECG signals and blood pressure measurements, which are diagnostic indicators. It is used to monitor ECG signals and measure blood pressure, and the results are displayed and stored, which are standard practices in diagnostic procedures to look for abnormal conditions.
No
The device description explicitly states it is composed of a recorder, NIBP cuff, and lead wire, which are hardware components.
Based on the provided information, this device 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.
- Device function: The SA-20 Series recorder acquires and stores in vivo data – ECG signals from the patient's body surface and blood pressure measurements taken directly from the patient. It does not analyze samples taken from the body.
- Intended Use: The intended use describes acquiring, storing, and displaying physiological signals and measurements from the patient, not analyzing biological samples.
Therefore, the device falls under the category of in vivo diagnostic or monitoring equipment, not in vitro diagnostics.
N/A
Intended 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 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.
Product codes (comma separated list FDA assigned to the subject device)
DSH, MWJ, DXN
Device Description
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.
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
adult and pediatric patient. For blood pressure, pediatrics (> 12 years).
Intended User / Care Setting
trained personnel under the direction of doctors.
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)
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 complies:
- 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 performance of 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a recognizable symbol of the agency's role in regulating and overseeing food and drug products in the United States.
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.
1
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
2
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) 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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4
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) 26858736
Fax: +86(0755) 26882223 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Liu Yongying |
| Preparing date: | January 16, 2023 |
| 2. Device name and
classification: | Trade Name: Holter ECG and ABP System
Common/Usual Name: SA-20 Series
Model: 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 Blood |
| Pressure Recorder, Model 2302, cleared under K111096 (Primary). |
- Vasomedical, Inc., Combined Ambulatory EGG and Blood Pressure
Recorder, cleared under K092785 (Reference). - Edan Instruments, Inc., Holter System, cleared under K151787 (Reference).
- Edan Instruments, Inc., Ambulatory Blood Pressure Monitor, cleared under
K210139 (Reference). |
| 4. Device Description: | 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. |
5
Contraindications :
| | Do not use it on patients with erratic, accelerated, or mechanically controlled
irregular heart rhythms, including the patient with arrhythmias. |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Due to the strangulation risk posed by the cuff and hose, the SA-20 Series must
not be within reach of unsupervised children. It must not be used on
unsupervised patients with limited cognitive abilities. |
| | The SA-20 Series is not intended for alarm triggering monitoring purposes in
intensive care units. It must not be used for blood pressure monitoring purposes
in 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 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. |
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)
6
| 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 | |||
| System | |||
| Components | Recorder, blood pressure cuff, lead | ||
| wire. | Recorder, blood pressure cuff, lead | ||
| wire, and analysis software. | Different | ||
| Energy Used | |||
| and/or | |||
| Delivered | Two AA alkaline batteries | four AA alkaline batteries | Different |
| Interface | USB Interface Cable | ||
| SD card | USB Interface Cable | ||
| SD card | same | ||
| Patient | |||
| Connections | Blood pressure cuff | ||
| Patient cable | Blood pressure cuff | ||
| Patient cable | same | ||
| Performance Specifications | |||
| Channels | 12 channels | 12 channels | same |
| Electrodes | 10 | 10 | same |
| A/D Sampling | |||
| Frequency | 25.6 ksps | 10000Hz | Different |
Table 2: Comparison between SA-20 Series and 2301 (reference device)
| Item | Subject Device(Model: SA-20
Series ) | Reference Device (Model: 2301) | Comparison
Result |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Manufacturer | Edan Instruments, Inc | Vasomedical, Inc | -- |
| K# | K230184 | K092785 | -- |
| Indications for Use | | | |
| | | | |
| | | Vasomedical-Biox Combined Ambulatory
ECG and Blood Pressure Recorder is a
Non-Invasive device intended to acquire
Ambulatory 3 Channel ECG signals and
non-invasive oscillometric Blood Pressure
signals from the upper body surfaces.
Cardiac rhythm is acquired via 3 Channel
ECG signals. The Recorders are intended
for adults and children who are over the
age of six years.
Vasomedical-Biox Ambulatory ECG CB
Series Analysis System Software allows
transfer of ECG and Blood Pressure data
from the Recorder to a Windows based PC
program via a removable and large capacity
storage card (SD) for the purpose of
creating reports and printouts. The software
does not perform diagnostics. Physicians
carry out diagnostic evaluations of this
data.
The system is only for measurement,
recording and display. It makes no
diagnosis. | Similiar |
| 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
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. | | |
| Physical properties | | | |
| System
Components | Recorder, blood pressure cuff, lead
wire. | Recorder, blood pressure cuff, lead wire,
and analysis software. | Different |
| Energy Used
and/or
Delivered | Two AA alkaline batteries | four AA alkaline batteries | Different |
| Interface | USB Interface Cable/SD card | USB Interface Cable/SD card | same |
| Patient
Connections | 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 Sampling
Frequency | 25.6 ksps | 10000Hz | Different |
| A/D | 24 bits | 10 bits | Different |
7
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
8
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
9
The bench testing data and software verification and validation demonstrate that Holter ECG and ABP System is substantially equivalent to the predicate devices.