(133 days)
The Electronic Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of adults via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended arm circumference includes 22 ~32 cm.
The electronic blood pressure monitor uses fuzzy logic intelligence to detect both upper and lower pressure value simultaneously. The personalized optimal inflation level determines the result of each measurement. It is effective to reduce the discomfort by wrongly inflating the CUFF and also to reduce the wrong measurement value, thus, it improves the accuracy of the measurement. The device would store 99 groups of measurement values for 2 users and display the average reading of the latest 3 groups of measurement results. The device is composed of a main body and a cuff. The main body is composed of a central processing unit, a pressure sensor, an air pump, a solenoid valve, a uniform speed vent valve, a PCB board, and a LCD liquid crystal display.
The provided text is a 510(k) summary for an Electronic Blood Pressure Monitor. It does not contain specific acceptance criteria or detailed study results in a format that lends itself to a direct table of acceptance criteria and reported device performance with numerical values for metrics like sensitivity, specificity, or accuracy (beyond general $\pm 3$ mmHg for static pressure and $\pm 5%$ for pulse rate).
However, I can extract the relevant information regarding the study and ground truth methodologies used to demonstrate substantial equivalence.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document broadly states compliance with international standards, which implicitly define the acceptance criteria. Specific numerical performance data beyond accuracy statements for static pressure and pulse rate are not provided in this summary.
| Acceptance Criterion (implicitly by standard compliance) | Reported Device Performance |
|---|---|
| Accuracy (Static Pressure) (ISO 80601-2-30) | $\pm 3$ mmHg |
| Accuracy (Pulse Rate) (ISO 80601-2-30) | $\pm 5%$ |
| Biocompatibility (ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-23) | No cytotoxicity, no skin irritation |
| Electrical Safety (IEC 60601-1: 2012) | Complies with standard |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2: 2014) | Complies with standard |
| Home Healthcare Environment (IEC 60601-1-11: 2010) | Complies with standard |
| Automated Non-invasive Sphygmomanometer Requirements (ISO 80601-2-30: 2009) | Complies with standard; capable of indicating systolic BP over 60-230 mmHg |
| Software Verification and Validation (FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices") | All testing passed pre-specified criteria. |
| Clinical Validation (ISO 81060-2: 2013) | Conducted as per standard |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions clinical testing was conducted per ISO 81060-2: 2013. However, it does not specify the sample size used for this clinical test set, nor the data provenance (e.g., country of origin of the data, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide any information regarding the number of experts, their qualifications, or their role in establishing ground truth for the clinical validation. For blood pressure monitors, the "ground truth" during clinical validation typically involves simultaneous or sequential measurements by trained observers using mercury sphygmomanometers (or other validated reference devices), rather than "experts" in the sense of radiologists reviewing images.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method. In the context of blood pressure monitor validation, this wouldn't typically involve adjudication among multiple human readers as seen in imaging studies, but rather statistical comparison of device measurements against reference measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a blood pressure monitor, not an imaging device. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study of human readers with vs. without AI assistance is not applicable and was not performed.
6. Standalone (Algorithm Only) Performance Study
Yes, implicitly. The clinical validation per ISO 81060-2: 2013 is a standalone performance study. This standard outlines procedures for validating automated non-invasive sphygmomanometers, meaning the device's measurements are directly compared against reference measurements without human interpretation or in-the-loop assistance for the primary measurement function. The device's "algorithm" is the core oscillometric technique it employs to derive blood pressure.
7. Type of Ground Truth Used
The clinical validation per ISO 81060-2: 2013 standard typically uses reference measurements obtained from auscultation by trained observers using mercury sphygmomanometers or other validated reference devices as the "ground truth." The document implies that the standard was followed for clinical testing, suggesting this type of ground truth was used.
8. Sample Size for the Training Set
This device is an Electronic Blood Pressure Monitor based on an oscillometric technique with "fuzzy logic intelligence" for inflation. While it uses "intelligence" (fuzzy logic), it's not described as a deep learning or AI model that requires a "training set" in the conventional sense of machine learning for image classification or complex pattern recognition. The "fuzzy logic" likely refers to rule-based or empirically derived algorithms rather than data-driven machine learning models. Therefore, the concept of a "training set" in the context of large datasets for deep learning is not applicable or mentioned for this device.
9. How the Ground Truth for the Training Set Was Established
As explained above, a "training set" in the machine learning sense is not applicable to the description of this device. The "fuzzy logic" would have been developed and refined through engineering and empirical testing against reference measurements, but not through a formal "training set" with established ground truth as seen in AI/ML applications.
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October 16, 2024
Shenzhen HBcare Technology Co.,Ltd Xuyu Lee Quality Manager A208, Block A and B, No.1 ChuangJin, District 28, Dalang community, Xin'an street, Baoan Shenzhen. 516000 China
Re: K241613
Trade/Device Name: Elecrtronic Blood Pressure Monitor, Models: BP-201, BP-202, BP-203, BP-204, BP-205, BP-206 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: June 5, 2024 Received: June 5, 2024
Dear Xuyu Lee:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
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assistance/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 C. Browning -S
LCDR 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) K241613
Device Name
Electronic Blood Pressure Monitor. Models: BP-201, BP-202, BP-204, BP-205 and BP-206
Indications for Use (Describe)
The Electronic Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of adults via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended arm circumference includes 22 ~32 cm.
| Type of Use (Select one or both, as applicable) | Registration Use (Part 21 CFR 201.326, Subpart D) Sample The Start-Up (21 CFR 201.326, Subpart G) |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------- |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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K241613 510(k) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
| 1. Applicant | shenzhen HBcare Technologies co., LtdA208, Block A and B, No.1 ChuangJin, District 28, Dalang community,Xin'an street, Baoan, Shenzhen, P.R.China. |
|---|---|
| Contact Person | KAI WANG |
| Prepare date | 2024-02-01 |
| 2. Device nameand classification | Device Name: Electronic Blood Pressure MonitorModels: BP-201, BP-202, BP-203, BP-204, BP-205 and BP-206Classification Name:21 CFR 870.1130Noninvasive Blood Pressure Measurement SystemProduct code: DXNRegulatory Class: Class II |
| 3. PredicateDevice(s) | Shenzhen Pango Electronic Co., Ltd., PG-800B36 Electronic BloodPressure Monitor cleared under K170151. |
| 4. DeviceDescription | The electronic blood pressure monitor uses fuzzy logic intelligence to detectboth upper and lower pressure value simultaneously. The personalizedoptimal inflation level determines the result of each measurement. It iseffective to reduce the discomfort by wrongly inflating the CUFF and also toreduce the wrong measurement value, thus, it improves the accuracy of themeasurement. The device would store 99 groups of measurement valuesfor 2 users and display the average reading of the latest 3 groups ofmeasurement results. The device is composed of a main body and a cuff.The main body is composed of a central processing unit, a pressuresensor, an air pump, a solenoid valve, a uniform speed vent valve, a PCBboard, and a LCD liquid crystal display. |
| 5. IndicationsforUse | The Electronic Blood Pressure Monitor is intended to measure the systolicand diastolic blood pressure as well as the pulse rate of adults via non-invasive oscillometric technique in which an inflatable cuff is wrappedaround the upper arm. It can be used at medical facilities or at home. Theintended arm circumference includes 22 ~32 cm. |
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6. 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.
| ITEM | Proposed DeviceBP-201, BP-202, BP-203,BP-204, BP-205 and BP-206 | Predicate DevicePG-800B36 Electronic BloodPressure Monitor cleared underK170151. | Comparison Result |
|---|---|---|---|
| Indications for Use | The Electronic Blood PressureMonitor is intended to measurethe systolic and diastolic bloodpressure as well as the pulserate of adults via non-invasiveoscillometric technique in whichan inflatable cuff is wrappedaround the upper arm. It can beused at medical facilities or athome. The intended armcircumference includes 22~32cm. | The Electronic Blood PressureMonitor is intended to measure thesystolic and diastolic bloodpressure as well as the pulse rateof adult 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 22cm | Different¹ |
| Contraindications | Not Known | Not Known | Same |
| Clinical Use | Medical Facilities and Home Use | Medical Facilities and Home Use | Same |
| Patient Population | 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 Dry Battery | 4x1.5V AAA Alkaline Battery | Different² |
| PhysicalDimensions(mm)(LengthWidthHeight) | Approx:14710060mm | Approx: 140 x100 x50mm | Different3 |
| Weight | About 270 g (not includingbattery and cuff) | Approx: 420 g, excluding battery |
Table 1 Comparison between the predicate PG-800B36 and the subject device
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| K241613 | |||||
|---|---|---|---|---|---|
| MeasurementRange | BloodPressure | 0 ~ 299 mmHg | BloodPressure | 30 ~ 280 mmHg | Different4 |
| Pulse Rate | 40 -199bpm | PulseRate | 40-199 bpm | ||
| Accuracy | StaticPressure | $\pm$ 3 mmHg | StaticPressure | $\pm$ 3 mmHg | Same |
| Pulse rate | $\pm$ 5% | Pulse | $\pm$ 5% | ||
| Arm Circumference | 22 cm~32 cm | 22 cm~42 cm | Different4 | ||
| Patient ContactMaterial | Cuff - Polyester, Nylon, PVC, Iron | Cuff -Nylon | Different5 | ||
| Applied Standards | IEC 60601-1IEC 60601-1-2IEC 60601-1-11ISO 80601-2-30ISO 81060-2 | IEC 60601-1IEC 60601-1-2IEC 60601-1-11ISO 80601-2-30ISO 81060-2 | Same | ||
| OperationEnvironments | + 5°C~ + 40°C, 15%RH | + 5℃~ + 40℃, 15%RH | |||
| StorageEnvironments | - 20℃~ + 50℃, 15%RH | - 20℃~ + 55℃, 0%RH | Different6 |
Justification for the differences:
-
- Different Indications for Use
As indicated in the comparison table, the application scenario of the subject device and the predicate device can be used both in hospital and home on the adults' upper arm, they have same indications for use, they are just some language description difference and different circumference range.
- Different Indications for Use
-
- Different Power Source
BP-201, BP-202, BP-203, BP-204, BP-205 and BP-206 are powered by 4x1.5V Dry Battery, which is different from the predicate. Such difference is verified per the international standard ISO 60601-1, and results show PASS, so no safety problems will be raised.
- Different Power Source
-
- Different Physical Specifications
The subject and the predicate are of different size but proximity. Moreover, such engineering design has been verified during the international standards, so such minor different will not raise any safety and effectiveness questions.
- Different Physical Specifications
-
- Different Measurement Range& Arm Circumference
Different systems show different measurement range, both the subject are verified to meet the internal standard's requirements in Clause 201.12.1.103 of ISO 80601-2-30, which is indicated that the Automated Sphygmomanometer shall be capable of indicating systolic blood pressure over at least the range of 60 mmHg (8,0 kPa) to 230 mmHg (30,7 kPa) in Non-neonate mode.
- Different Measurement Range& Arm Circumference
As for the different Arm Circumference, it depends on the cuff equipped with the system, which were taken into consideration during the systematic verification. So, such difference will not raise any safety and effectiveness questions.
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K241613
5) Different Patient Contact Material
The standards ISO 10993-5, ISO 10993-10 and ISO 10993-23 are quoted to evaluate the biocompatibility of the applied parts of the system, and the results indicated in the corresponding reports show no cytotoxicity, no skin irritation, so different patient contact materials will not raise new questions on safety and effectiveness.
-
- Different Operation & Storage Environments
Existing difference on the operation and storage environments (including Temperature and Relative Humidity) between the subject device and the predicate, but the system has been proved to be safe and effective since the safety testing was conducted under the suggested environment; Moreover, environment testing data shows the device can work as declared under the suggested conditions. So those changes will not cause any safety andeffectiveness problem.
- Different Operation & Storage Environments
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, which do not raise different questions of safety or effectiveness. Moreover, as demonstrated in the non-clinical testing, the different technological characteristics do not affect the safety and effectiveness of the system.
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 Arm-type 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 Electronic Blood Pressure Monitor, consisting of all the modules and accessories in 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 Arm-type Electronic Blood Pressure Monitor, consisting of all the accessories in the system. The system complies with the IEC 60601-1-11: 2010 MEDICAL
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K241613
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 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers.
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 seriousinjury 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 proposed devices were found to have a safety and effectiveness profile that the same to the predicate device.
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 proposed Electronic Blood Pressure Monitor is substantially equivalent to the predicate device.
§ 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).