(113 days)
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No
The document describes a standard oscillometric blood pressure monitor and its algorithm, with no mention of AI or ML technologies.
No
A therapeutic device is used to treat or cure a disease or condition. This device is an Electronic Blood Pressure Monitor, which is used for measurement (diagnosis/monitoring), not for therapy.
Yes
Explanation: The device measures the systolic and diastolic blood pressure and pulse rate, which are physiological parameters used to assess a patient's health status and aid in the diagnosis of conditions like hypertension.
No
The device description explicitly states it is a "battery powered automatic non-invasive blood pressure monitor" and mentions hardware components like inflation and deflation mechanisms, and data storage function. It also includes non-clinical performance data related to hardware (Biocompatibility, Electrical safety, Bench Testing).
No, 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 Electronic Blood Pressure Monitor measures blood pressure and pulse rate non-invasively on the upper arm. It does not analyze any samples taken from the body.
- Intended Use: The intended use is to measure physiological parameters (blood pressure and pulse rate) directly from the patient's body.
Therefore, based on the provided information, the Electronic Blood Pressure Monitor is a non-invasive medical device used for monitoring vital signs, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The Electronic Blood Pressure Monitor is a battery powered automatic non-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The proposed AOJ-30A and AOJ-30B Electronic Blood Pressure Monitor share the same software, measurement principle and NIBP algorithm. The main differences are product appearance. The proposed device is intended to be used in medical facilities or at home. And the effectiveness of this sphygmomanometer has not been established in pregnant (including pre-eclamptic) patients. The product is provided non-sterile, and not to be sterilized by the user prior to use.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
upper arm
Indicated Patient Age Range
Adult
Intended User / Care Setting
Medical facilities or at home.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data includes "Non-Clinical Data" and "Clinical Data".
Non-Clinical Data:
- Biocompatibility testing: evaluated for AOJ-30A and AOJ-30B Electronic Blood Pressure Monitor and the NIBP CUFF in accordance with ISO 10993-1. Testing included Cytotoxicity V, Skin Sensitization, and Skin Irritation.
- Electrical safety and electromagnetic compatibility (EMC): conducted on AOJ-30A and AOJ-30B Electronic Blood Pressure Monitor. Complies with IEC 60601-1: 2012 and IEC 60601-1-2: 2014.
- Bench Testing: conducted on AOJ-30A and AOJ-30B Electronic Blood Pressure Monitor. Complies with IEC 60601-1-11: 2010 and ISO 80601-2-30: 2009.
- Software Verification and Validation Testing: conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered "major" level of concern.
Clinical data:
- Clinical testing is conducted per ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement tvpe.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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).
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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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)
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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, | |
| Hangcheng Street, Bao'an, 518126, Shenzhen, P.R. China | |
| +86 18603031299 | |
| Contact Person: | Qihuan Zhao |
| Prepare date: | 2019-04-17 |
| 2. Device name | |
| 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 | |
| Submission | New Application. |
| 4. Predicate | |
| Device(s): | Shenzhen Jumper Medical Equipment Co., Ltd.., JPD-HA120 and JPD-HA121 |
| Electronic Blood Pressure Monitor cleared under K182495 | |
| 5. Device | |
| Description: | The Electronic Blood Pressure Monitor is a battery powered automatic non-invasive |
| blood pressure monitor. It can automatically complete the inflation, deflation and | |
| measurement, which can measure systolic and diastolic blood pressure and pulse | |
| rate of the adult person at upper arm within its claimed range and accuracy via the | |
| oscillometric technique. User can select the unit of the measurement: mmHg or kPa | |
| The device has the data storage function in order for data reviewing, including the | |
| systolic pressure, diastolic pressure, pulse rate and measurement time. The proposed | |
| AOJ-30A and AOJ-30B Electronic Blood Pressure Monitor share the same | |
| software, measurement principle and NIBP algorithm. The main differences are | |
| product appearance. | |
| The proposed device is intended to be used in medical facilities or at home. And the | |
| effectiveness of this sphygmomanometer has not been established in pregnant | |
| (including pre-eclamptic) patients. | |
| The product is provided non-sterile, and not to be sterilized by the user prior to use. |
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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
JPD-HA120 and JPD-HA121/
K182495 | Proposed Device
AOJ-30A and AOJ-30B | Comparison
Result |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Manufacture | Shenzhen Jumper Medical
Equipment Co., Ltd. | Shenzhen AOJ Medical Technology
Co., Ltd. | --- |
| 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. | 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 in which an
inflatable CUFF is wrapped around
the upper arm at medical facilities
or at home. | Similar |
| Contraindications | Not Known | Not Known | Same |
| Clinical Use | Medical Facilities and Home Use | Medical Facilities and Home Use | Same |
| Patient
Population | Adult | Adult | Same |
| Measurement
Type | Upper arm | Upper arm | Same |
| Measurement
Principle | Oscillometric | Oscillometric | Same |
| Components | LCD / Key / Cuff / MCU / Pump /
Batteries | LCD / Key / Cuff / MCU / Pump /
Batteries | Same |
| Power Source | 4x1.5V | 4x1.5V | Same |
| Physical
Dimensions | Approx: 138 mm(Length)x120
mm(Width)x59 mm(Height) | Approx: 138 mm(Length)x120
mm(Width)x59 mm(Height) | Same |
| Weight | Approx: 483.8 g, excluding battery | Approx: 483.8 g, excluding battery | Same |
| Measurement
Range | Blood
Pressure
30255 mmHg255 mmHg
Pulse Rate
40-199 bpm | Blood
Pressure
30
Pulse
Rate
40-199 bpm | Same |
| Accuracy | Static
Pressure
$\pm$ 3 mmHg
Pulse
$\pm$ 5% | Static
Pressure
$\pm$ 3 mmHg
Pulse
$\pm$ 5% | Same |
| Arm
Circumference | 22 cm36 cm | 22 cm36 cm | Same |
Table 1 Comparison between the predicate and the subject device
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| Patient Contact
Material | Cuff –Terylene
Enclosure - ABS
Key - PMMA | Cuff –Terylene
Enclosure - ABS
Key - PMMA | Same |
|-----------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------|
| Applied
Standards | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
80601-2-30:2009
81060-2:2013 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
80601-2-30:2009
81060-2:2013 | Same |
| Operation
Environments | + 5℃~ + 40℃, 15%RH90%RH106
Atmospheric Pressure: 70 kPa
kPa | + 5℃~ + 40℃, 15%RH90%RH106
Atmospheric Pressure: 70 kPa
kPa | Same |
| Storage
Environments | - 20°C~ + 55°C, 10%RH93%RH106
Atmospheric Pressure: 70 kPa
kPa | - 20°C~ + 55°C, 10%RH93%RH106
Atmospheric Pressure: 70 kPa
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
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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.