(133 days)
Not Found
Yes
The device description explicitly states the use of "fuzzy logic intelligence," which is a form of artificial intelligence used for decision-making based on imprecise or uncertain data.
No
Monitors measure a physiological parameter, but do not treat or mitigate a disease or condition. This device measures blood pressure and pulse rate, which is a monitoring function, not a therapeutic one.
Yes
The device measures systolic blood pressure and pulse rate, which are physiological parameters used to assess a patient's health status and can indicate medical conditions.
No
The device description explicitly lists hardware components such as a main body, cuff, pressure sensor, air pump, solenoid valve, PCB board, and LCD display. While it uses "fuzzy logic intelligence" (a form of AI), it is integrated into a physical device that performs the measurement.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device Function: The description clearly states that this device "measure[s] 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." This is a measurement taken on the living body (in vivo) and does not involve analyzing samples taken from the body.
- Intended Use: The intended use is for measuring blood pressure and pulse rate, which are physiological parameters measured directly from the patient.
Therefore, this electronic blood pressure monitor falls under the category of a non-invasive medical device used for physiological monitoring, not an In Vitro Diagnostic.
No
The input clearly states "Control Plan Authorized (PCCP) and relevant text: Not Found", meaning the letter does not mention that the FDA has reviewed or cleared a PCCP for this device.
Intended Use / Indications for Use
The Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic 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.
Product codes
DXN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: Static Pressure: ± 3 mmHg; Pulse rate: ± 5%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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
3
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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4
K241613 510(k) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
| 1. Applicant | shenzhen HBcare Technologies co., Ltd
A208, 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 name
and classification | Device Name: Electronic Blood Pressure Monitor
Models: BP-201, BP-202, BP-203, BP-204, BP-205 and BP-206
Classification Name:
21 CFR 870.1130
Noninvasive Blood Pressure Measurement System
Product code: DXN
Regulatory Class: Class II |
| 3. Predicate
Device(s) | Shenzhen Pango Electronic Co., Ltd., PG-800B36 Electronic Blood
Pressure Monitor cleared under K170151. |
| 4. Device
Description | 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. |
| 5. Indications
for
Use | The Electronic Blood Pressure Monitor is intended to measure the systolic
and diastolic 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. |
5
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 Device
BP-201, BP-202, BP-203,
BP-204, BP-205 and BP-
206 | Predicate Device
PG-800B36 Electronic Blood
Pressure Monitor cleared under
K170151. | Comparis
on Result |
|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Indications for Use | The Electronic Blood Pressure
Monitor is intended to measure
the systolic and diastolic 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 223232 cm and 32
cm. | 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. It can be used at
medical facilities or at home. The
intended arm circumference
includes 22cm
cm~42 cm. | 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 |
| 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 Dry Battery | 4x1.5V AAA Alkaline Battery | Different² |
| Physical
Dimensions(mm)(
LengthWidthHe
ight) | Approx:14710060mm | Approx: 140 x100 x50mm | Different3 |
| Weight | About 270 g (not including
battery and cuff) | Approx: 420 g, excluding battery | |
Table 1 Comparison between the predicate PG-800B36 and the subject device
6
| K241613 | |||||
|---|---|---|---|---|---|
| Measurement | |||||
| Range | Bloo | ||||
| d | |||||
| Pressure | 0 ~ 299 mmHg | Bloo | |||
| d | |||||
| Pressure | 30 ~ 280 mmHg | Different4 | |||
| Pulse Rate | 40 -199bpm | Pulse | |||
| Rate | 40-199 bpm | ||||
| Accuracy | Static | ||||
| Pressure | $\pm$ 3 mmHg | Static | |||
| Pressure | $\pm$ 3 mmHg | Same | |||
| Pulse rate | $\pm$ 5% | Pulse | $\pm$ 5% | ||
| Arm Circumference | 22 cm~32 cm | 22 cm~42 cm | Different4 | ||
| Patient Contact | |||||
| Material | Cuff - Polyester, Nylon, PVC, Iron | Cuff -Nylon | Different5 | ||
| Applied Standards | IEC 60601-1 | ||||
| IEC 60601-1-2 | |||||
| IEC 60601-1-11 | |||||
| ISO 80601-2-30 | |||||
| ISO 81060-2 | IEC 60601-1 | ||||
| IEC 60601-1-2 | |||||
| IEC 60601-1-11 | |||||
| ISO 80601-2-30 | |||||
| ISO 81060-2 | Same | ||||
| Operation | |||||
| Environments | + 5°C~ + 40°C, 15%RH~85%RH | ||||
| Atmospheric Pressure: 70 | |||||
| kPa~105 kPa | + 5℃~ + 40℃, 15%RH~93%RH | ||||
| Atmospheric Pressure: 50 kPa~106 | |||||
| kPa | |||||
| Storage | |||||
| Environments | - 20℃~ + 50℃, 15%RH~85%RH | ||||
| Atmospheric Pressure: 70 | |||||
| kPa~106 kPa | - 20℃~ + 55℃, 0%RH~93%RH | ||||
| Atmospheric Pressure: 50 kPa~106 | |||||
| kPa | 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.
7
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
8
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.