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.

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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Edan Instruments, Inc. Ambulatory Blood Pressure Monitor (Models: SA-10, SA-05, SA-06, SA-08 and SA-09). The device measures systolic and diastolic blood pressure and pulse using the oscillometric method.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against the international standard for non-invasive sphygmomanometers, ISO 81060-2.

Acceptance Criteria (ISO 81060-2:2018+A1:2020)	Reported Device Performance (SA series ABPM)
Mean error: ±5 mmHg	Mean error: ±5 mmHg
Standard deviation: Max. 8 mmHg	Standard deviation: Max. 8 mmHg
Heart Rate Acuracy: Not explicitly stated but the predicate device criteria was used
Heart Rate accurate within ±3 bpm or ±3.5%, whichever is greater.

Note: The document explicitly states that the "Blood Pressure results meet or exceed ANSI/AAMI/ISO 81060-2:2013 standards for non-invasive accuracy: ±5 mmHg mean error & 8 mmHg standard deviation" in the predicate comparison table, and later confirms compliance with the updated ISO 81060-2:2018+A1:2020 standard. For heart rate accuracy, the subject device's performance criterion is listed as "Heart Rate accurate within ±3 bpm or ±3.5%, whichever is greater," which is also the reported performance.

Study Information

Here's a breakdown of the study details based on the provided text:

Sample size used for the test set and the data provenance:
- Sample Size: The document mentions "investigation with qualified subject distribution" for the clinical test but does not specify the exact sample size.
- Data Provenance: The document implies the data is prospective, as it describes a "clinical investigation" undertaken specifically to validate the device. The country of origin of the data is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not provide details on the number or qualifications of experts used to establish ground truth. For blood pressure monitors, ground truth typically involves simultaneous measurements by a trained professional using a reference standard (e.g., auscultation with a mercury sphygmomanometer) as part of the ISO 81060-2 standard protocol.
Adjudication method for the test set:
- The document does not describe a specific adjudication method. For validation against ISO 81060-2, the comparison is typically direct against the reference standard.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for interpretation by human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance study was done for the device. The "Clinical test" section states, "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." This standard is for the performance of automated non-invasive sphygmomanometers themselves.
The type of ground truth used:
- The ground truth would be established through simultaneous or closely timed measurements by a "reference standard" as defined by ISO 81060-2, typically involving trained observers using a mercury or other validated sphygmomanometer performing auscultatory measurements. This is inherent to the ISO 81060-2 clinical validation protocol.
The sample size for the training set:
- The document does not mention a training set sample size. Ambulatory Blood Pressure Monitors typically use proprietary algorithms for oscillometric measurements, which are developed and validated during the product's R&D phase; however, details of an algorithm's training data are not usually part of a 510(k) summary for this type of device. The ISO 81060-2 study is a validation, not a training activity.
How the ground truth for the training set was established:
- The document does not provide information about how ground truth was established for any training set, as it does not discuss a training set for the NIBP algorithm.

Summary

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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.

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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

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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)

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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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 andclassification:	Trade name: Ambulatory Blood Pressure Monitor, Model: SA-10, SA-05,SA-06, SA-08 and SA-09Common/Usual Name: Noninvasive blood pressure measurement system Classification Name Product code 21 CFR 870.1130System, 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.

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Traditional 510K for SA Series Ambulatory Blood Pressure Monitor

5. Indication for Use

6. Predicate Device Comparison

Item			Comparisonon Result
Manufacturer/K#	Current Submission	K151520	---
Indications for Use
Indication foruse	The Ambulatory Blood PressureMonitor is capable of measuringsystolic and diastolic bloodpressures, and pulse of adults andpediatrics (> 12 years) over apreprogrammed period of time.These measurements are stored inthe monitor and can be transferredto analysis system via wire orwireless transmission. It isintended for use as an aid oradjunct to diagnosis and treatment.	The Oscar 2, Model 250 system is a non-invasiveoscillometric ambulatory blood pressure monitorthat is intended to be used with AccuWin Pro, aPC-based computer program for the recordingand displaying of up to 250 measurements ofsystolic and diastolic blood pressure and heartrate. It is intended for use as an aid or adjunct todiagnosis and treatment when it is necessary tomeasure an adult and pediatric (> 3yrs.) patient'ssystolic and diastolic blood pressures over anextended period of time. The system is only formeasurement, recording, and display. It makes nodiagnoses.Optionally, The Model 250 will provide a derivedascending aortic blood pressure waveform and arange of central arterial indices. Thesemeasurements are provided noninvasivelythrough the use of a brachial cuff.It is to be used on those patients whereinformation related to ascending aortic bloodpressure is desired but the risks of cardiaccatheterization procedure or other invasivemonitoring may outweigh the benefits (excludespediatric subjects).Bluetooth, wireless connectivity will be offeredas an option.	Different

IntendedPatientPopulation	adults and pediatrics (>12yrs.)	adult and pediatric (>3yrs.) patients	Different
IntendedApplicationEnvironment	Physician's office, clinic, researchcenter(under supervision ofphysician) and patient homeenvironment	Physician's office, clinic, research center(undersupervision of physician) and patient homeenvironment	Same
Measurement	Systolic and Diastolic BloodPressureHeart Rate	Systolic and Diastolic Blood PressureHeart RateCentral Blood Pressure (Sp/Dp/MAP/Pp)Central Augmentation Index & Pressure, andIndex at HR 75	Different
		Physical properties
SystemComponents	Electronics Module (EDAN SASeries)EDAN NIBP Cuff sleeveSoftware DiscOperator's ManualCablesCarrying pouch	Electronics Module (Oscar 2, Model 250)SunTech BP CuffSoftware downloadOperator's ManualCablesPouch	Same
Interface	USB Interface CableWireless-Bluetooth	USB Interface CableWireless-Bluetooth	Same
		Software Section
SoftwareOperatingPlatform	Windows XP, Windows 7,Windows 8, or Windows 10	Microsoft Windows® 7, 8	Different
PC Software	Smart ABPM View	AccuWin Pro	Different
NIBPAlgorithm	NIBP iCUFS	SunTeck Oscar 2	Different
CBPAlgorithm	N/A	SphygmoCor® XCEL	Different
Performance Specifications
OperationPrinciple	Oscillometric with step deflation	Oscillometric with step deflation	Same
Blood PressureRange	Systolic: 25 to 290 mmHg (3.3 to38.6 kPa)Diastolic: 10 to 250 mmHg (1.3 to33.2 kPa)	Systolic: 40-260 mmHgDiastolic: 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 fornon-invasive accuracy: ±5 mmHg mean error & 8 mmHg standard deviation.
Heart RateRange	40-240 bpm	40-200 bpm	Different
Error of HeartRate	Heart Rate accurate within ±3 bpmor ±3.5%, whichever is greater.	Heart Rate accurate within ±2% or ±3 bpm,whichever is greater.	ClearedunderK992808
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%RH~95%RH Non-Condensing	20%RH~95%RH Non-Condensing
Transport/Storage	15%RH~95%RH Non-Condensing	15%RH~95%RH Non-Condensing

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Traditional 510K for SA Series Ambulatory Blood Pressure Monitor

006_6.0_510(k)_Summary

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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

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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.

Regulation Number and Section

§ 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).