(173 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.
JPD-HA120 and JPD-HA121 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 JPD-HA120 and JPD-HA121 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 document is a 510(k) premarket notification for an Electronic Blood Pressure Monitor (models JPD-HA120 and JPD-HA121). The primary goal of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves showing that the new device has the same intended use and the same technological characteristics as the predicate, or, if there are differences, that these differences do not raise new questions of safety and effectiveness.
The document focuses on comparing the new device to a predicate device and detailing the non-clinical and clinical testing performed to support substantial equivalence.
Here's an analysis addressing your specific questions, based on the provided text:
Acceptance Criteria and Device Performance
The document doesn't explicitly present a pre-defined table of acceptance criteria with corresponding performance results in the way you might expect for a typical scientific study's results section. Instead, for blood pressure monitors, accuracy is defined by industry standards like ISO 81060-2. The acceptance criteria are implicitly met if the device complies with the accuracy requirements of this standard.
The general acceptance criteria for a non-invasive blood pressure monitor would be its accuracy in measuring systolic and diastolic blood pressure, and pulse rate. The document states the device's accuracy specifications:
1. A table of acceptance criteria and the reported device performance
| Parameter | Acceptance Criteria (Standard Compliance) | Reported Device Performance (Claimed Accuracy) |
|---|---|---|
| Static Pressure | Per ISO 81060-2:2013 (implicit) | ± 3 mmHg |
| Pulse Rate | Per ISO 81060-2:2013 (implicit) | ± 5% |
It is explicitly stated that the system complies with ISO 80601-2-30:2009 (for performance effectiveness) and ISO 81060-2:2013 (for clinical validation), meaning it met the requirements set forth in those standards. The accuracy stated in the "Comparison" table (Page 4) reflects the accuracy specifications of the device, which are the same as the predicate device and are presumed to meet the standard's requirements.
Study Details
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "Clinical testing is conducted per ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type."
- Sample Size: The ISO 81060-2 standard specifies the minimum number of subjects required for clinical validation (typically 85 subjects with specific age/sex/BP distribution). While the document does not explicitly state the sample size used in this specific study, it implies compliance with the standard's requirements.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Clinical validation studies for medical devices are almost always prospective.
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)
For blood pressure monitor validation studies adhering to ISO 81060-2:2013, ground truth (reference blood pressure) is established using auscultation by trained observers. The standard typically requires two or three independent trained observers:
- Number of experts: ISO 81060-2:2013 requires measurements from two trained observers simultaneously using a mercury sphygmomanometer or validated alternative. A third observer might be used for adjudication if the first two differ significantly.
- Qualifications of experts: These are typically medical professionals or trained technicians who are specifically trained and certified in the auscultation method for blood pressure measurement, following strict protocols outlined in the standard. The document doesn't specify their direct qualifications, but compliance with the standard implies they met these criteria.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
For clinical validation following ISO 81060-2:2013, the ground truth is established by simultaneous auscultatory measurements often by two observers. If their readings differ by more than a specified amount, a third observer might be involved or the measurement discarded. The standard itself outlines the specific methodology for comparing automated device readings to reference readings. The document does not explicitly state the adjudication method beyond "Clinical testing is conducted per ISO 81060-2: 2013".
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
- No, an MRMC study was not done. This type of study (MRMC) is typically performed for diagnostic imaging AI algorithms where AI is assisting human interpretation. Blood pressure monitors are automated devices that provide a direct measurement; there's no human "reader" whose performance needs to be improved by AI assistance in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in effect, a standalone performance evaluation was done. The device itself is an automated measurement system. When it undergoes clinical validation per ISO 81060-2, its performance is evaluated as a standalone system against a reference standard (auscultation). There isn't a "human-in-the-loop" once the device is initiated for a measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for blood pressure measurement in clinical validation studies for oscillometric devices is typically established by simultaneous, independent auscultatory measurements performed by trained human observers using a standardized reference method (e.g., mercury sphygmomanometer). This can be considered a form of "expert consensus," specifically expert measurement.
8. The sample size for the training set
- The document does not specify a training set size. For blood pressure monitors, the "algorithm" is the oscillometric method itself, which is well-established. While the device's internal algorithm might have been tuned or developed using performance data, this is not typically disclosed as a distinct "training set" in a 510(k) unless a novel, data-driven AI algorithm is at its core. This device likely relies on a standard oscillometric algorithm.
9. How the ground truth for the training set was established
- As a training set is not explicitly mentioned or suggested for a novel AI algorithm, the method for establishing ground truth for a training set is not applicable/provided in this 510(k) submission. The underlying principles of oscillometry are based on established physiological responses, not on training a machine learning model on a specific dataset.
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March 3, 2019
Shenzhen Jumper Medical Equipment Co., Ltd. Jinhui Tang Regulatory Manager D Building, No. 71, Xintian Road, Fuyong Street, Baoan District, Shenzhen, 518103, CHINA
Re: K182495
Trade/Device Name: Electronic Blood Pressure Monitor, models JPD-HA120 and JPD-HA121 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: January 23, 2019 Received: January 28, 2019
Dear Jinhui Tang:
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/cfpmp/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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 C. Browning -S5
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182495
Device Name
Electronic Blood Pressure Monitor, models JPD-HA120 and JPD-HA121
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 Jumper Medical Equipment Co., Ltd. | ||||
|---|---|---|---|---|---|
| D Building, No.71, Xintian Road, Fuyong Street, Baoan District, 518103,Shenzhen, P.R. China | |||||
| Tel.: +86 -755- 2669 2192Fax: +86 -755- 2685 2025 | |||||
| Contact Person: | Jinhui Tang | ||||
| Prepare date: | 2018-09-04 | ||||
| 2. Device nameand classification: | Device Name: Electronic Blood Pressure Monitor | ||||
| Models: JPD-HA120 and JPD-HA121 | |||||
| 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 Pango Electronic Co., Ltd., PG-800B36 Electronic Blood PressureMonitor / K170151 | ||||
| 5. DeviceDescription: | JPD-HA120 and JPD-HA121 Electronic Blood Pressure Monitor is a batterypowered automatic non-invasive blood pressure monitor. It can automaticallycomplete the inflation, deflation and measurement, which can measure systolic anddiastolic blood pressure and pulse rate of the adult person at upper arm within itsclaimed range and accuracy via the oscillometric technique. User can select the unitof the measurement: mmHg or kPa.The device has the data storage function in order for data reviewing, including thesystolic pressure, diastolic pressure, pulse rate and measurement time. The proposedJPD-HA120 and JPD-HA121 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 | Proposed DeviceJPD-HA120 and JPD-HA121 | Predicate DevicePG-800B36/ K170151 | ComparisonResult |
|---|---|---|---|
| Manufacture | Shenzhen Jumper MedicalEquipment Co., Ltd. | Shenzhen Pango Electronic Co.,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. It can be used atmedical facilities or at home. Theintended arm circumferenceincludes 22 cm | Different |
| 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: 140 mm(W)x100mm(H)x50 mm(D) | Different |
| Weight | Approx: 483.8 g, excluding battery | Approx: 420 g, excluding battery | Different |
| MeasurementRange | BloodPressure30~255 mmHgPulse Rate40-199 bpm | BloodPressure30~280 mmHgPulseRate40-199 bpm | Different |
| Accuracy | StaticPressure$\pm$ 3 mmHgPulse$\pm$ 5% | StaticPressure$\pm$ 3 mmHgPulse$\pm$ 5% | Same |
| ArmCircumference | 22 cm~36 cm | 22 cm~32 cm | Different |
| Patient ContactMaterial | Cuff – TeryleneEnclosure - ABSKey - PMMA | Cuff – NylonEnclosure - ABSKey - ABS | Different |
| 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°C~ + 40°C, 15%RH | + 5°C~ + 40°C, 15%RH | Different |
| StorageEnvironments | - 20°C~ + 55°C, 10%RH | - 20°C~ + 55°C, 0%RH |
Table 1 Comparison between the predicate PG-800B36 and the subject device
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As seen in the comparison tables, the subject and predicate devices have almost the same design features and performance specifications. The main technological differences between the subject and predicate devices are minor differences, including the Physical Dimensions, Arm Circumference and Operation & Storage Environments, which do not raise different questions of safety or effectiveness. Moreover, as demonstrated in the non-clinical and 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 JPD-HA120&JPD-HA121 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 considered tissue contacting for duration of less than 24 hours. And the battery of testing included the following tests:
- □ Cytotoxicity
- □ Skin Sensitization
- □ Skin Irritation
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the JPD-HA120 and JPD-HA121 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 JPD-HA120 and JPD-HA121 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
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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
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 type.
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).