Electronic Blood Pressure Monitor

K191180 · Shenzhen AOJ Medical Technology Co., Ltd. · DXN · Aug 23, 2019 · Cardiovascular

Device Facts

• Record ID: K191180
• Device Name: Electronic Blood Pressure Monitor
• Applicant: Shenzhen AOJ Medical Technology Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 23, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home.

Device Story

Battery-powered automatic non-invasive blood pressure monitor; uses oscillometric technique to measure systolic/diastolic blood pressure and pulse rate via upper arm cuff. Device performs automated inflation, deflation, and measurement. Features data storage for reviewing pressure and pulse readings with timestamps. Used in medical facilities or home settings by patients or clinicians. Output displayed on LCD; informs clinical decision-making regarding blood pressure management. Benefits include convenient, non-invasive monitoring of cardiovascular parameters.

Clinical Evidence

Clinical validation conducted per ISO 81060-2:2013. Testing confirmed performance effectiveness and safety profile similar to the predicate device. All verification and validation testing passed pre-specified criteria.

Technological Characteristics

Oscillometric measurement principle. Materials: Terylene (cuff), ABS (enclosure), PMMA (key). Power: 4x1.5V batteries. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 80601-2-30, ISO 81060-2. Non-sterile. Software-controlled.

Indications for Use

Indicated for adult patients for non-invasive measurement of systolic/diastolic blood pressure and pulse rate via oscillometric technique at medical facilities or home. Effectiveness not established in pregnant or pre-eclamptic patients.

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

• JPD-HA120 and JPD-HA121 Electronic Blood Pressure Monitor (K182495)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 23, 2019

Shenzhen AOJ Medical Technology Co., Ltd. Qihuan Zhao General Manager 601, 6th floor, B2 Building, An'le Industrial Park #172 Hangcheng Avenue Shenzhen, 518126, China

Re: K191180

Trade/Device Name: Electronic Blood Pressure Monitor: Models AOJ-30A and AOJ-30B Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: July 20, 2019 Received: July 26, 2019

Dear Qihuan Zhao:

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.

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

{1}------------------------------------------------

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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K191180

#### Device Name

Electronic Blood Pressure Monitor: Models AOJ-30A and AOJ-30B

Indications for Use (Describe)

The Electronic Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

## 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 [e-mail]

"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}------------------------------------------------

# 510(k) Summary

# Prepared in accordance with the requirements of 21 CFR Part 807.92

| 1. Submitter: | Shenzhen AOJ Medical Technology Co., Ltd. |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 601, 6th floor, B2 Building, An'le Industrial Park,#172 Hangcheng Avenue,<br>Hangcheng Street, Bao'an, 518126, Shenzhen, P.R. China |
| | [phone] |
| Contact Person: | Qihuan Zhao |
| Prepare date: | 2019-04-17 |
| 2. Device name<br>and classification: | Device Name: Electronic Blood Pressure Monitor |
| | Models: AOJ-30A and AOJ-30B |
| | Classification Name: |
| | 21 CFR 870.1130 |
| | Noninvasive Blood Pressure Measurement System |
| | Product code: DXN |
| | Regulatory Class: Class II |
| 3. Reason for<br>Submission | New Application. |
| 4. Predicate<br>Device(s): | Shenzhen Jumper Medical Equipment Co., Ltd.., JPD-HA120 and JPD-HA121<br>Electronic Blood Pressure Monitor cleared under K182495 |
| 5. Device<br>Description: | The Electronic Blood Pressure Monitor is a battery powered automatic non-invasive<br>blood pressure monitor. It can automatically complete the inflation, deflation and<br>measurement, which can measure systolic and diastolic blood pressure and pulse<br>rate of the adult person at upper arm within its claimed range and accuracy via the<br>oscillometric technique. User can select the unit of the measurement: mmHg or kPa<br>The device has the data storage function in order for data reviewing, including the<br>systolic pressure, diastolic pressure, pulse rate and measurement time. The proposed<br>AOJ-30A and AOJ-30B Electronic Blood Pressure Monitor share the same<br>software, measurement principle and NIBP algorithm. The main differences are<br>product appearance.<br>The proposed device is intended to be used in medical facilities or at home. And the<br>effectiveness of this sphygmomanometer has not been established in pregnant<br>(including pre-eclamptic) patients. |
| | The product is provided non-sterile, and not to be sterilized by the user prior to use. |

{4}------------------------------------------------

The Electronic Blood Pressure Monitor is intended to measure the systolic and 6. Indications for diastolic blood pressure as well as the pulse rate of adult person via non-invasive Use: oscillometric technique at medical facilities or at home.

## 7. Predicate Device Comparison

Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device.

Please refer to following table to find differences between the subject device and predicate device. All the differences do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no new question is raised regarding the product's effectiveness and safety.

| ITEM | Predicate Device<br>JPD-HA120 and JPD-HA121/<br>K182495 | Proposed Device<br>AOJ-30A and AOJ-30B | Comparison<br>Result |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Manufacture | Shenzhen Jumper Medical<br>Equipment Co., Ltd. | Shenzhen AOJ Medical Technology<br>Co., Ltd. | --- |
| Intended Use | The Electronic Blood Pressure<br>Monitor is intended to measure the<br>systolic and diastolic blood pressure<br>as well as the pulse rate of adult<br>person via non-invasive<br>oscillometric technique at medical<br>facilities or at home. | The Electronic Blood Pressure<br>Monitor is intended to measure the<br>systolic and diastolic blood<br>pressure as well as the pulse rate of<br>adult person via non-invasive<br>oscillometric technique in which an<br>inflatable CUFF is wrapped around<br>the upper arm at medical facilities<br>or at home. | Similar |
| Contraindications | Not Known | Not Known | Same |
| Clinical Use | Medical Facilities and Home Use | Medical Facilities and Home Use | Same |
| Patient<br>Population | Adult | Adult | Same |
| Measurement<br>Type | Upper arm | Upper arm | Same |
| Measurement<br>Principle | Oscillometric | Oscillometric | Same |
| Components | LCD / Key / Cuff / MCU / Pump /<br>Batteries | LCD / Key / Cuff / MCU / Pump /<br>Batteries | Same |
| Power Source | 4x1.5V | 4x1.5V | Same |
| Physical<br>Dimensions | Approx: 138 mm(Length)x120<br>mm(Width)x59 mm(Height) | Approx: 138 mm(Length)x120<br>mm(Width)x59 mm(Height) | Same |
| Weight | Approx: 483.8 g, excluding battery | Approx: 483.8 g, excluding battery | Same |
| Measurement<br>Range | Blood<br>Pressure<br>30~255 mmHg<br>Pulse Rate<br>40-199 bpm | Blood<br>Pressure<br>30~255 mmHg<br>Pulse<br>Rate<br>40-199 bpm | Same |
| Accuracy | Static<br>Pressure<br>$\pm$ 3 mmHg<br>Pulse<br>$\pm$ 5% | Static<br>Pressure<br>$\pm$ 3 mmHg<br>Pulse<br>$\pm$ 5% | Same |
| Arm<br>Circumference | 22 cm~36 cm | 22 cm~36 cm | Same |

Table 1 Comparison between the predicate and the subject device

{5}------------------------------------------------

| Patient Contact<br>Material | Cuff –Terylene<br>Enclosure - ABS<br>Key - PMMA | Cuff –Terylene<br>Enclosure - ABS<br>Key - PMMA | Same |
|-----------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------|
| Applied<br>Standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>80601-2-30:2009<br>81060-2:2013 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>80601-2-30:2009<br>81060-2:2013 | Same |
| Operation<br>Environments | + 5℃~ + 40℃, 15%RH~90%RH<br>Atmospheric Pressure: 70 kPa~106<br>kPa | + 5℃~ + 40℃, 15%RH~90%RH<br>Atmospheric Pressure: 70 kPa~106<br>kPa | Same |
| Storage<br>Environments | - 20°C~ + 55°C, 10%RH~93%RH<br>Atmospheric Pressure: 70 kPa~106<br>kPa | - 20°C~ + 55°C, 10%RH~93%RH<br>Atmospheric Pressure: 70 kPa~106<br>kPa | |

As seen in the comparison tables, the subject and predicate devices have exactly the same design features and performance specifications. Moreover, as demonstrated in the non-clinical testing, the different technological characteristics do not affect the safety and effectiveness of the system.

## 8. Performance Testing:

Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below.

## Non-Clinical Data:

The following performance data were provided in support of the substantial equivalence determination.

## Biocompatibility testing

The biocompatibility evaluation for the AOJ-30A and AOJ-30B Electronic Blood Pressure Monitor and the NIBP CUFF were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is contacting for duration of less than 24 hours. And the battery of testing included the following tests:

- Cytotoxicity V
- > Skin Sensitization
- V Skin Irritation

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the AOJ-30A and AOJ-30B Electronic Blood Pressure Monitor, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-1: 2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety and the IEC 60601-1-2: 2014 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances - Requirements and tests standard for EMC.

## Bench Testing

Bench testing was conducted on the AOJ-30A and AOJ-30B Electronic Blood Pressure Monitor, consisting of all the accessories in the system. The system complies with the IEC 60601-1-11: 2010 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. ISO 80601-2-30: 2009 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers standards for performance effectiveness.

Software Verification and Validation Testing

{6}------------------------------------------------

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." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.

#### Clinical data:

Clinical testing is conducted per ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement tvpe.

## Summary

Based on the non-clinical and clinical performance as documented in the device development, the subject devices were found to have a safety and effectiveness profile that is similar to the predicate device.

## 9. Conclusion:

Verification and validation testing was conducted on the subject device and all testing passed pre-specified criteria. This premarket notification submission demonstrates that the Jumper Electronic Blood Pressure Monitor is substantially equivalent to the predicate devices.