Who is the manufacturer of Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09?

Edan Instruments, Inc. filed the 510(k) submission for Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 (K210139).

What is the FDA product code for Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09?

DXN. It is classified under 21 CFR 870.1130 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09?

Suntech Medical, Inc., Oscar 2 NIBP Monitor (K151520).

Who can help prepare an FDA 510(k) submission like Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09

K210139 · Edan Instruments, Inc. · DXN · Oct 1, 2021 · Cardiovascular

Device Facts

Record ID	K210139
Device Name	Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09
Applicant	Edan Instruments, Inc.
Product Code	DXN · Cardiovascular
Decision Date	Oct 1, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1130
Device Class	Class 2
Attributes	Pediatric

Intended 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.

Device Story

The SA Series Ambulatory Blood Pressure Monitor (ABPM) consists of an electronics module, cuff, and 'Smart ABPM View' analysis software. The device is worn by patients in home or clinical settings to measure systolic/diastolic blood pressure and pulse via the oscillometric method with step deflation. Measurements are stored on the device and transferred to a PC via USB or Bluetooth for clinician review. The software allows clinicians to edit, display, and analyze the recorded data. By providing longitudinal blood pressure data, the device assists physicians in diagnosing and managing hypertension or other cardiovascular conditions, potentially improving patient outcomes through better-informed treatment decisions.

Clinical Evidence

Clinical investigation conducted in accordance with ISO 81060-2:2018+A1:2020. The study validated the safety and effectiveness of the SA series ABPM in both resting and ambulatory states. Results confirmed the device meets clinical accuracy requirements for its intended population.

Technological Characteristics

Oscillometric measurement with step deflation. Connectivity via USB or Bluetooth. Software-based analysis on Windows (XP/7/8/10). Biocompatibility per ISO 10993-1, -5, -10. Safety compliance with ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 80601-2-30.

Indications for Use

Indicated for measuring systolic/diastolic blood pressure and pulse in adults and pediatric patients (>12 years) over a preprogrammed period. Intended as an aid/adjunct to diagnosis and treatment.

Regulatory Classification

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.

Predicate Devices

Suntech Medical, Inc., Oscar 2 NIBP Monitor (K151520)

Reference Devices

A&D MEDICAL DIV, TM-2430 Ambulatory Blood Pressure Monitors (K992808)

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Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text. 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) | <div style="display:inline-block;">☒</div> | | Over-The-Counter Use (21 CFR 801 Subpart C) | <div style="display:inline-block;">☐</div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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 | <Subject Device> | <Predicate Device> | 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%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 | | {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.