(255 days)
No
The summary describes a standard oscillometric blood pressure monitor and analysis software, with no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
The device is used to measure blood pressure and pulse, which are diagnostic indicators. While it mentions being an "aid or adjunct to diagnosis and treatment," its primary function described is measurement and data storage/transfer for analysis, not directly delivering therapy.
Yes
The "Intended Use / Indications for Use" states that the device is "intended for use as an aid or adjunct to diagnosis and treatment."
No
The device description explicitly states the device is "primarily composed of Ambulatory Blood Pressure Monitor (ABPM) and ABPM Analysis software". The ABPM is a hardware component that measures blood pressure and pulse.
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 description clearly states that the device measures blood pressure and pulse by the oscillometric method using a cuff on the upper arm. This is a non-invasive measurement taken directly from the patient's body, not from a sample taken from the body.
- Intended Use: The intended use is to measure blood pressure and pulse over time as an aid or adjunct to diagnosis and treatment. This aligns with the function of a medical device used for monitoring physiological parameters, not for analyzing biological samples.
Therefore, while it is a medical device used for diagnosis and treatment, it does not meet the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Ambulatory Blood Pressure Monitor is capable of measuring systolic and diastolic blood pressures, and pulse of adults and pediatrics (> 12 years) over a preprogrammed period of time. These measurements are stored in the monitor and can be transferred to analysis system via wire or wireless transmission. It is intended for use as an aid or adjunct to diagnosis and treatment.
Product codes
DXN
Device Description
The SA Series ABPM (Ambulatory Blood Pressure Monitor), primarily composed of Ambulatory Blood Pressure Monitor (ABPM) and ABPM Analysis software (Smart ABPM View), is designed to measure systolic and diastolic blood pressures, and pulse of adults and pediatrics (> 12 years) over a preprogrammed period of time.
The monitor inflates and deflates the cuff on the upper arm to measure blood pressures and pulse by the oscillometric method and stores the measurement.
The stored measurements are transferred into analysis software installed in generally used PC via wire transfer or Bluetooth.
The monitor is carried around by patients. Patients are requested to come back to medical treatment site after recording time. The systolic and diastolic blood pressures, and pulse data recorded in monitor will be transferred into PCs and then analyzed, displayed and edited by Analysis software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
adults and pediatrics (> 12 years)
Intended User / Care Setting
Physician's office, clinic, research center (under supervision of physician) and patient home environment
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
Clinical test:
The subject devices have been undertaken clinical investigation in accordance with ISO 81060-2:2018+A1:2020 to validate the clinical safety and effectiveness within its intended use. From the investigation with qualified subject distribution, SA series ambulatory blood pressure monitor with its accessories are concluded to be safe and effective in both resting state and ambulatory monitoring within its intended use.
Non-clinical test:
The SA series Ambulatory Blood Pressure Monitor complies with:
- (1) ANSUAAMI 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
- (2) IEC 60601-1-2 Edition 4.0 2014-02, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- (3) IEC 60601-1-11 Edition 2.0 2015-01, 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
- (4) IEC 80601-2-30 Edition 1.1 2013-07 Medical electrical equipment Part 2-30 Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
- (5) ISO 81060-2 Third edition 2018-11 Non-invasive sphygmomanometers Part 2: Clinical investigation of intermittent automated measurement type [including: Amendment 1 (2020)]
- (6) ISO 14971 Second edition 2007-03-01 Medical devices Application of risk management to medical devices
The following biocompatibility standards are complied with on the subject device:
(7) ISO 10993-1: 2018. ISO 10993-5:2009 and ISO 10993-10:2010
Software Verification and Validation Testing:
Software verification and validation testing were 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".
Key Metrics
Accuracy of Blood Pressure:
Mean error: +/-5 mmHg (+/-0.67 kPa)
Standard deviation: Max. 8 mmHg (1.07 kPa)
Error of Heart Rate:
Heart Rate accurate within +/-3 bpm or +/-3.5%, whichever is greater.
Blood Pressure Range:
Systolic: 25 to 290 mmHg (3.3 to 38.6 kPa)
Diastolic: 10 to 250 mmHg (1.3 to 33.2 kPa)
Heart Rate Range:
40-240 bpm
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
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October 1, 2021
Edan Instruments, Inc. Ying Dai Regulatory Engineer #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District Shenzhen, Guangdong 518122 China
Re: K210139
Trade/Device Name: Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-08 and SA-09 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 26, 2021 Received: August 31, 2021
Dear Ying Dai:
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.
1
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 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.
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210139
Device Name
Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09
Indications for Use (Describe)
The Ambulatory Blood Pressure Monitor is capable of measuring systolic and diastolic blood pressures, and pulse of adults and pediatrics (> 12 years) over a preprogrammed period of time. These measurements are stored in the monitor and can be transferred to analysis system via wire or wireless transmission. It is intended for use as an aid or adjunct to diagnosis and treatment.
| 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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3
Traditional 510K for SA Series Ambulatory Blood Pressure Monitor
510(k) Summary
Prepared in accordance with the 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: +86-755-2685 6469 Fax: +86-755-2689 8330 | | | | | | |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|
| Contact person: | Ying DAI | | | | | | |
| Preparing date: | Jan 5th, 2021 | | | | | | |
| 2. Device name and
classification: | Trade name: Ambulatory Blood Pressure Monitor, Model: SA-10, SA-05,
SA-06, SA-08 and SA-09
Common/Usual Name: Noninvasive blood pressure measurement system Classification Name Product code 21 CFR 870.1130
System, Measurement,
Blood-Pressure, Non-Invasive/ DXN Regulatory Class: Class II | | | | | | |
| 3. Predicate Device(s): | Suntech Medical, Inc., Oscar 2 NIBP Monitor, cleared under K151520
(Primary)
A&D MEDICAL DIV, TM-2430 Ambulatory Blood Pressure Monitors, cleared under K992808 (reference) | | | | | | |
| 4. Device Description: | The SA Series ABPM (Ambulatory Blood Pressure Monitor), primarily composed of Ambulatory Blood Pressure Monitor (ABPM) and ABPM Analysis software (Smart ABPM View), is designed to measure systolic and diastolic blood pressures, and pulse of adults and pediatrics (> 12 years) over a preprogrammed period of time.
The monitor inflates and deflates the cuff on the upper arm to measure blood pressures and pulse by the oscillometric method and stores the measurement.
The stored measurements are transferred into analysis software installed in generally used PC via wire transfer or Bluetooth.
The monitor is carried around by patients. Patients are requested to come back to medical treatment site after recording time. The systolic and diastolic blood pressures, and pulse data recorded in monitor will be transferred into PCs and then analyzed, displayed and edited by Analysis software. | | | | | | |
4
Traditional 510K for SA Series Ambulatory Blood Pressure Monitor
5. Indication for Use
The Ambulatory Blood Pressure Monitor is capable of measuring systolic and diastolic blood pressures, and pulse of adults and pediatrics (> 12 years) over a preprogrammed period of time. These measurements are stored in the monitor and can be transferred to analysis system via wire or wireless transmission. It is intended for use as an aid or adjunct to diagnosis and treatment.
6. Predicate Device Comparison
| Item | | | Comparison
on Result |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Manufacturer/
K# | Current Submission | K151520 | --- |
| Indications for Use | | | |
| Indication for
use | The Ambulatory Blood Pressure
Monitor is capable of measuring
systolic and diastolic blood
pressures, and pulse of adults and
pediatrics (> 12 years) over a
preprogrammed period of time.
These measurements are stored in
the monitor and can be transferred
to analysis system via wire or
wireless transmission. It is
intended for use as an aid or
adjunct to diagnosis and treatment. | The Oscar 2, Model 250 system is a non-invasive
oscillometric ambulatory blood pressure monitor
that is intended to be used with AccuWin Pro, a
PC-based computer program for the recording
and displaying of up to 250 measurements of
systolic and diastolic blood pressure and heart
rate. It is intended for use as an aid or adjunct to
diagnosis and treatment when it is necessary to
measure an adult and pediatric (> 3yrs.) patient's
systolic and diastolic blood pressures over an
extended period of time. The system is only for
measurement, recording, and display. It makes no
diagnoses.
Optionally, The Model 250 will provide a derived
ascending aortic blood pressure waveform and a
range of central arterial indices. These
measurements are provided noninvasively
through the use of a brachial cuff.
It is to be used on those patients where
information related to ascending aortic blood
pressure is desired but the risks of cardiac
catheterization procedure or other invasive
monitoring may outweigh the benefits (excludes
pediatric subjects).
Bluetooth, wireless connectivity will be offered
as an option. | Different |
| | | | |
| Intended
Patient
Population | adults and pediatrics (>12yrs.) | adult and pediatric (>3yrs.) patients | Different |
| Intended
Application
Environment | Physician's office, clinic, research
center(under supervision of
physician) and patient home
environment | Physician's office, clinic, research center(under
supervision of physician) and patient home
environment | Same |
| Measurement | Systolic and Diastolic Blood
Pressure
Heart Rate | Systolic and Diastolic Blood Pressure
Heart Rate
Central Blood Pressure (Sp/Dp/MAP/Pp)
Central Augmentation Index & Pressure, and
Index at HR 75 | Different |
| | | Physical properties | |
| System
Components | Electronics Module (EDAN SA
Series)
EDAN NIBP Cuff sleeve
Software Disc
Operator's Manual
Cables
Carrying pouch | Electronics Module (Oscar 2, Model 250)
SunTech BP Cuff
Software download
Operator's Manual
Cables
Pouch | Same |
| Interface | USB Interface Cable
Wireless-Bluetooth | USB Interface Cable
Wireless-Bluetooth | Same |
| | | Software Section | |
| Software
Operating
Platform | Windows XP, Windows 7,
Windows 8, or Windows 10 | Microsoft Windows® 7, 8 | Different |
| PC Software | Smart ABPM View | AccuWin Pro | Different |
| NIBP
Algorithm | NIBP iCUFS | SunTeck Oscar 2 | Different |
| CBP
Algorithm | N/A | SphygmoCor® XCEL | Different |
| Performance Specifications | | | |
| Operation
Principle | Oscillometric with step deflation | Oscillometric with step deflation | Same |
| Blood Pressure
Range | Systolic: 25 to 290 mmHg (3.3 to
38.6 kPa)
Diastolic: 10 to 250 mmHg (1.3 to
33.2 kPa) | Systolic: 40-260 mmHg
Diastolic: 25-200 mmHg | Different |
| Accuracy of | Mean error: ±5 mmHg (±0.67 kPa) | Blood Pressure results meet or exceed | Same |
| Blood Pressure | Standard deviation: Max. 8 mmHg
(1.07 kPa) | ANSI/AAMI/ISO 81060-2:2013 standards for
non-invasive accuracy: ±5 mmHg mean error & 8 mmHg standard deviation. | |
| Heart Rate
Range | 40-240 bpm | 40-200 bpm | Different |
| Error of Heart
Rate | Heart Rate accurate within ±3 bpm
or ±3.5%, whichever is greater. | Heart Rate accurate within ±2% or ±3 bpm,
whichever is greater. | Cleared
under
K992808 |
| Environmental Specifications | | | |
| Temperature | | | |
| Operating | +5 ℃ (+41 F) ~ +40 ℃ (+104 F) | +10 ℃ (+50 °F) ~ +50 ℃ (+122 F) | |
| Transport/Storage | -20 ℃ (-4 F) ~ +55 ℃ (+131 F) | -20 ℃ ~ +70 ℃ | |
| Humidity | | | Different |
| Operating | 15%RH95%RH Non-Condensing | 20%RH95%RH Non-Condensing | |
| Transport/Storage | 15%RH95%RH Non-Condensing | 15%RH95%RH Non-Condensing | |
5
Traditional 510K for SA Series Ambulatory Blood Pressure Monitor
006_6.0_510(k)_Summary
6
Traditional 510K for SA Series Ambulatory Blood Pressure Monitor
The subject and predicate device have same general intended use, similar design features and performance specifications. The technological differences between the subject and predicate device do not raise different questions of safety or effectiveness.
7. Performance Data:
Clinical test:
The subject devices have been undertaken clinical investigation in accordance with ISO 81060-2:2018+A1:2020 to validate the clinical safety and effectiveness within its intended use. From the investigation with qualified subject distribution, SA series ambulatory blood pressure monitor with its accessories are concluded to be safe and effective in both resting state and ambulatory monitoring within its intended use.
Non-clinical test:
The SA series Ambulatory Blood Pressure Monitor complies with:
- (1) ANSUAAMI 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
- (2) IEC 60601-1-2 Edition 4.0 2014-02, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- (3) IEC 60601-1-11 Edition 2.0 2015-01, Medical electrical equipment Part 1-11 General requirements for basic
7
Traditional 510K for SA Series Ambulatory Blood Pressure Monitor
safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- (4) IEC 80601-2-30 Edition 1.1 2013-07 Medical electrical equipment Part 2-30 Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
- (5) ISO 81060-2 Third edition 2018-11 Non-invasive sphygmomanometers Part 2: Clinical investigation of intermittent automated measurement type [including: Amendment 1 (2020)]
- (6) ISO 14971 Second edition 2007-03-01 Medical devices Application of risk management to medical devices The following biocompatibility standards are complied with on the subject device:
The following biocompatibility standards are complied with on the subject device:
(7) ISO 10993-1: 2018. ISO 10993-5:2009 and ISO 10993-10:2010
Software Verification and Validation Testing
Software verification and validation testing were 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".
Summary
The non-clinical performance testing showed that the subject devices are as safe and as effective as the predicate devices.
8. Conclusion
Verification and validation testing has been conducted on the SA series Ambulatory Blood Pressure Monitor. This premarket notification submission demonstrates that SA series Ambulatory Blood Pressure Monitor is substantially equivalent to the predicate device.