(113 days)
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.
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.
The provided text describes the acceptance criteria and the study conducted for the Electronic Blood Pressure Monitor models AOJ-30A and AOJ-30B.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Accuracy (Static Pressure) (ISO 80601-2-30:2009 & 81060-2:2013) | $\pm$ 3 mmHg |
| Accuracy (Pulse) (ISO 80601-2-30:2009 & 81060-2:2013) | $\pm$ 5% |
| Electrical Safety (IEC 60601-1: 2012) | Complies |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2: 2014) | Complies |
| Home Healthcare Environment Requirements (IEC 60601-1-11: 2010) | Complies |
| Biocompatibility (ISO 10993-1) | Cytotoxicity, Skin Sensitization, Skin Irritation tests passed |
| "Major" Level of Concern Software (FDA Guidance for Software in Medical Devices) | Software verification and validation testing conducted and documentation provided. |
Study that proves the device meets the acceptance criteria:
The study proving the device meets the acceptance criteria is a combination of non-clinical and clinical performance testing, as detailed in section 8 of the 510(k) Summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text mentions "Clinical testing is conducted per ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type." However, the specific sample size used for the clinical test set is not provided in the document. The data provenance (country of origin, retrospective/prospective) is also not explicitly stated, although the submitter is based in Shenzhen, China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. For blood pressure monitors, ground truth is typically established by comparing the device's readings to reference measurements taken by trained professionals using a validated method (e.g., auscultation with a mercury sphygmomanometer). The number and qualifications of these professionals are not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication method for establishing ground truth in the clinical testing.
5. 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
The device is an "Electronic Blood Pressure Monitor" and measures physiological parameters directly. It is not an AI-assisted diagnostic device that would involve human readers or image interpretation. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the primary evaluation of this device is standalone (algorithm only) performance, as it is an automated blood pressure monitor. The clinical validation per ISO 81060-2:2013 evaluates the device's accuracy in measuring blood pressure values directly, without human intervention in the measurement process itself, beyond proper cuff placement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the clinical validation of automated non-invasive sphygmomanometers (as per ISO 81060-2:2013), the ground truth for blood pressure measurements is typically established by simultaneous measurements by trained observers using a reference method, often auscultation with a mercury sphygmomanometer, under specific protocols. This would fall under a form of "expert consensus/reference measurement."
8. The sample size for the training set
The document does not mention a training set sample size. For medical devices that rely on algorithms, training data is often used internally during development. However, the 510(k) submission focuses on the validation of the final product.
9. How the ground truth for the training set was established
Since a training set is not explicitly discussed, the method for establishing its ground truth is not provided in the document. If an algorithm was trained, it would likely use similar methods to the clinical validation for establishing ground truth, i.e., comparison to reference measurements.
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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
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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 nameand 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 forSubmission | New Application. |
| 4. PredicateDevice(s): | Shenzhen Jumper Medical Equipment Co., Ltd.., JPD-HA120 and JPD-HA121Electronic Blood Pressure Monitor cleared under K182495 |
| 5. DeviceDescription: | The Electronic Blood Pressure Monitor is a battery powered automatic non-invasiveblood pressure monitor. It can automatically complete the inflation, deflation andmeasurement, which can measure systolic and diastolic blood pressure and pulserate of the adult person at upper arm within its claimed range and accuracy via theoscillometric technique. User can select the unit of the measurement: mmHg or kPaThe device has the data storage function in order for data reviewing, including thesystolic pressure, diastolic pressure, pulse rate and measurement time. The proposedAOJ-30A and AOJ-30B Electronic Blood Pressure Monitor share the samesoftware, measurement principle and NIBP algorithm. The main differences areproduct appearance.The proposed device is intended to be used in medical facilities or at home. And theeffectiveness 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 DeviceJPD-HA120 and JPD-HA121/K182495 | Proposed DeviceAOJ-30A and AOJ-30B | ComparisonResult |
|---|---|---|---|
| Manufacture | Shenzhen Jumper MedicalEquipment Co., Ltd. | Shenzhen AOJ Medical TechnologyCo., Ltd. | --- |
| Intended Use | The Electronic Blood PressureMonitor is intended to measure thesystolic and diastolic blood pressureas well as the pulse rate of adultperson via non-invasiveoscillometric technique at medicalfacilities or at home. | The Electronic Blood PressureMonitor is intended to measure thesystolic and diastolic bloodpressure as well as the pulse rate ofadult person via non-invasiveoscillometric technique in which aninflatable CUFF is wrapped aroundthe upper arm at medical facilitiesor at home. | Similar |
| Contraindications | Not Known | Not Known | Same |
| Clinical Use | Medical Facilities and Home Use | Medical Facilities and Home Use | Same |
| PatientPopulation | Adult | Adult | Same |
| MeasurementType | Upper arm | Upper arm | Same |
| MeasurementPrinciple | Oscillometric | Oscillometric | Same |
| Components | LCD / Key / Cuff / MCU / Pump /Batteries | LCD / Key / Cuff / MCU / Pump /Batteries | Same |
| Power Source | 4x1.5V | 4x1.5V | Same |
| PhysicalDimensions | Approx: 138 mm(Length)x120mm(Width)x59 mm(Height) | Approx: 138 mm(Length)x120mm(Width)x59 mm(Height) | Same |
| Weight | Approx: 483.8 g, excluding battery | Approx: 483.8 g, excluding battery | Same |
| MeasurementRange | BloodPressure30~255 mmHgPulse Rate40-199 bpm | BloodPressure30~255 mmHgPulseRate40-199 bpm | Same |
| Accuracy | StaticPressure$\pm$ 3 mmHgPulse$\pm$ 5% | StaticPressure$\pm$ 3 mmHgPulse$\pm$ 5% | Same |
| ArmCircumference | 22 cm~36 cm | 22 cm~36 cm | Same |
Table 1 Comparison between the predicate and the subject device
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| Patient ContactMaterial | Cuff –TeryleneEnclosure - ABSKey - PMMA | Cuff –TeryleneEnclosure - ABSKey - PMMA | Same |
|---|---|---|---|
| AppliedStandards | IEC 60601-1IEC 60601-1-2IEC 60601-1-1180601-2-30:200981060-2:2013 | IEC 60601-1IEC 60601-1-2IEC 60601-1-1180601-2-30:200981060-2:2013 | Same |
| OperationEnvironments | + 5℃~ + 40℃, 15%RH | + 5℃~ + 40℃, 15%RH | Same |
| StorageEnvironments | - 20°C~ + 55°C, 10%RH | - 20°C~ + 55°C, 10%RH |
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.
§ 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).