(137 days)
Not Found
Not Found
No
The summary describes a standard oscillometric blood pressure monitor with data storage and low voltage indication. There is no mention of AI, ML, or any advanced algorithms beyond the standard oscillometric technique for blood pressure measurement. The performance studies focus on standard clinical validation against ISO standards, not on the performance of any AI/ML model.
No
The device is strictly for measurement and monitoring of blood pressure and pulse rate. It does not provide any treatment or therapeutic intervention.
No
The device measures physiological parameters (blood pressure and pulse rate) but does not interpret these measurements to diagnose a condition. It provides data for a healthcare professional to use in diagnosis.
No
The device description explicitly states it is a "battery driven automatic non-invasive blood pressure monitor" and mentions hardware components like inflation, deflation, and a display. It also includes testing for electrical safety, EMC, and biocompatibility, which are relevant to hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The Blood Pressure Monitor measures blood pressure and pulse rate directly from the patient's upper arm using a non-invasive technique (oscillometric). It does not analyze samples taken from the body.
- Intended Use: The intended use is to measure physiological parameters (blood pressure and pulse rate) of a living person, not to analyze biological samples.
Therefore, based on the provided information, the Blood Pressure Monitor is a medical device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Blood Pressure Monitor is intended to measure the systolic pressure and diastolic pressure, as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home.
Product codes
DXN
Device Description
The Blood Pressure Monitor is designed as a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at upper arm within its claimed range and accuracy via the oscillometric technique. The result will be displayed in the international unit 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 device also has low voltage indication, which will be triggered when the battery is low.
The proposed device is intended to be used in medical facilities or at home. And the effectiveness of this sphygmomanometer has not been established in pregnant (including pre-eclamptic) patients.
The product is provided non-sterile, and not to be sterilized by the user prior to use.
Mentions image processing
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)
Non-Clinical Testing:
- Biocompatibility testing: Conducted in accordance with ISO 10993-1. Included Cytotoxicity, Skin Sensitization, Skin Irritation tests. Results demonstrate biocompatibility.
- Electrical safety and electromagnetic compatibility (EMC): Complies with IEC 60601-1: 2005+AMD1 (2012) +AMD2 (2020) and IEC 60601-1-2: 2014/AMD1:2020.
- Bench Testing: Complies with IEC 80601-2-30. Blood pressure Accuracy meets the requirements.
- Usability Testing: Complies with IEC 60601-1-6:2010+A1:2013+A2:2020.
- Home-used medical equipment requirements and environmental test: Complies with IEC 60601-1-11:2015 +A1:2020.
- Software Verification and Validation Testing: Provided in accordance with FDA Guidance for software with a moderate level of concern.
Clinical data:
- Clinical test performed in accordance with ISO 81060-2:2018.
- Sample size: 100 adult subjects.
- Key results: All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018. No adverse effect and/or complication is found in the study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Shenzhen AOJ Medical Technology Co., Ltd. , AOJ-30B
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
January 10, 2025
Shenzhen Ruiankang Technology Co., Ltd. Xinhua Zhao General Manager Floor1 and 2. No.8. Zhugushi Chunyang Industrial Park Wulian Community, Longgang Street, Longgang District Shenzhen, Guangdong 518117 China
Re: K242528
Trade/Device Name: Blood Pressure Monitor (RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: December 12, 2024 Received: December 12, 2024
Dear Xinhua 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 (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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 (QS) 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-devices/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
2
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,
Robert T. Kazmierski -S
for
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
Submission Number (if known)
Device Name
Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298)
Indications for Use (Describe)
The Blood Pressure Monitor is intended to measure the systolic pressure and diastolic 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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Page 1 of 1
4
510(k) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
| 1. Submitter: | Shenzhen Ruiankang Technology Co.,Ltd
Floor1 and 2, No.8, Zhugushi Chunyang Industrial Park, Wulian Community,
Longgang Street, Longgang District, Shenzhen City, Guangdong, China.
TEL: (086)1590941123 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Zhao Xinhua |
| Prepare date: | 2024-10-14 |
| 2. Device name and
classification | Device Name: Blood Pressure Monitor |
| | Models: RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283,
RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297,
RAK298 |
| | Classification Name: 21 CFR 870.1130 Cardiovascular Diagnostic Devices |
| | Product code: DXN |
| | Regulatory Class: Class II |
| 3. Reason for
Submission | Submission for the 510(k) clearance. |
| 4. Predicate
Device(s) | Shenzhen AOJ Medical Technology Co., Ltd. , AOJ-30B |
| 5. Device Description | The Blood Pressure Monitor is designed as a battery driven automatic non-invasive
blood pressure monitor. It can automatically complete the inflation, deflation and
measurement, which can measure systolic and diastolic blood pressure as well as
the pulse rate of adult person at upper arm within its claimed range and accuracy
via the oscillometric technique. The result will be displayed in the international unit
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 device
also has low voltage indication, which will be triggered when the battery is low.
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. |
| 6. Indications for Use | The Blood Pressure Monitor is intended to measure the systolic pressure and diastolic pressure, as well as the pulse rate of adult person via non-invasive |
oscillometric technique at medical facilities or at home.
5
7. Predicate Device Comparison
Please refer to following table to find differences between the subject device and predicate device.
| ITEM | Proposed Device | Predicate Device | Comparison
Result |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Manufacture | Shenzhen Ruiankang
Technology Co.,Ltd. | Shenzhen AOJ Medical
Technology Co., Ltd. | Same |
| Indications for Use | The Blood Pressure Monitor is
intended to measure the
systolic pressure and diastolic
pressure, as well as the pulse
rate of adult person via
non-invasive oscillometric
technique at medical facilities
or at home. | The Electronic Blood Pressure
Monitor is intended to measure
the systolic and diastolic blood
pressure as well as the pulse
rate of adult person via
non-invasive oscillometric
technique in which an inflatable
CUFF is wrapped around the
upper arm at medical facilities
or at home. | Different¹ |
| Contraindications | Not Known | Not Known | Same |
| Application
scenario | Medical Facilities and Home
Use | Medical Facilities and Home
Use | Same |
| Operational Specifications | | | |
| Principle | Oscillometric | Oscillometric | Same |
| Measurement Item | SYS, DYS, Pulse Rate | SYS, DYS, Pulse Rate | Same |
| Intended patient
population | Adult | Adult | Same |
| Intended
application site | Upper arm | Upper arm | Same |
| Blood pressure
measurement
range | 25255 mmHg | 30 - 255 mmHg | Different² |32 cm | 22
| Accuracy | $\pm$ 3 mmHg | $\pm$ 3 mmHg | Same |
| Heart rate
measurement
range | 40-199 bpm | 40-199 bpm | Same |
| Accuracy | $\pm$ 5% | $\pm$ 5% | Same |
| Cuff circumference | 2236 cm | Different³ | 40°C
| Components | LCD/Key/Cuff/MCU/Pump/Bat
teries | LCD/Key/Cuff/MCU/Pump/Batt
eries | Same |
| Auto shutdown | YES | YES | Same |
| Operating
environment | Temperature: 5°C
Humidity: 15%-80% RH,
Atmospheric pressure:
70 kPa - 106 kPa | Temperature: 5°C~ 40°C
Humidity: 15%-90% RH,
Atmospheric pressure:
70 kPa - 106 kPa | Same |
| Storage
environment | Ambient Temperature:
20°C to 55°C | Ambient Temperature:
20°C to 55°C | Same |
| Table 1 Comparison between the predicate and the subject device | ||
|---|---|---|
6
| | Relative Humidity: 10-93% RH,
Atmospheric pressure:
70 kPa - 106 kPa | Relative Humidity: 10-93% RH,
Atmospheric pressure:
70 kPa - 106 kPa | |
|----------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|------------|
| Power supply | USB DV 5V or 6V DC (4 1.5V AAA batteries) | 6V DC (4 1.5 V AAA batteries) | Different4 |
| Memory | 299 | 299 | Same |
| Compliance Standards | | | |
| Bio-compatibility | ISO 10993-1
ISO 10993-5
ISO 10993-10 | ISO 10993-1
ISO 10993-5
ISO 10993-10 | Same |
| Electrical Safety | IEC 60601-1
IEC 60601-1-11 | IEC 60601-1
IEC 60601-1-11 | |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | |
| Performance | IEC 80601-2-30 | IEC 80601-2-30 | |
Justification for the differences:
-
- Different Indications for Use
The subject device shares a similar intended use with the predicate device, and the substantial difference between the subject device and the predicate device regarding the intended use lies in the arm circumference range. However, the subject device with matched cuffs has been validated according to IEC 80601-2-30. As demonstrated in relevant test reports, the difference here does not raise any issues concerning safety and effective.
- Different Indications for Use
-
- Different Blood pressure measurement range
The Blood pressure measurement range of the subject device is different form the predicate device, but the measurement range of the subject device has been verified by IEC 60601-1 and IEC 80601-2-30, so the different range will be acceptable for the subject device.
- Different Blood pressure measurement range
-
- Different Cuff circumference
The range of pressure is wider than the predicate device while the cuff circumference is narrower than predicate device. They have the same accuracy. The differences are very slightly and they both contain the blood pressure range of most people, and the measurement range of proposed device is fully verified according to IEC 80601-2-30, so the different range and accuracy will be acceptable for the subject device.
- Different Cuff circumference
-
- Different Power supply
The difference between subject device and predicate device is the batteries, the predicate device use 4 *1.5V AAA batteries while the subject device use USB DV5V or 4pcs AAA batteries, but the power supply safety of subject device is justified by the IEC60601-1 test reports. Thus this difference will not affect the safety and effectiveness.
- Different Power supply
As seen in the comparison tables, the subject and predicate devices have same design principle, similar design features and performance specifications. The different technological characteristics between the subject and predicate devices will not raise different questions of safety or effectiveness as demonstrated in the non-clinical and clinical evidence.
8. Performance Testing
7
Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below.
Non-Clinical Testing:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the Blood pressure monitor was 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 testing included the following tests, results of which demonstrate the biocompatibility of the subject device:
- Cytotoxicity
- Skin Sensitization
- Skin Irritation
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted, and the results show that the subject device complies with the IEC 60601-1: 2005+AMD1 (2012) +AMD2 (2020) Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety and the IEC 60601-1-2: 2014/AMD1:2020 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 and the results show that the subject device complies with the IEC 80601-2-30: Medical electrical equipment – Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers. And blood pressure Accuracy meets the requirements defined in IEC 80601-2-30.
Usability Testing
Usability testing was conducted and the results show that the subject device complies with the IEC 60601-1-6:2010+A1:2013+A2:2020 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
Home-used medical equipment requirements and environmental test:
Environmental testing was conducted and the test results show that the subject device complies with the IEC 60601-1-11:2015 +A1:2020 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.
Software Verification and Validation Testing
Software documentation including verification & validation was provided in accordance with FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for software with a moderate level of concern.
8
Clinical data:
Clinical test has been performed in accordance with ISO 81060-2:2018 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. The clinical test included 100 adult subjects. All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018. No adverse effect and/or complication is found in the study.
9. Conclusion
Verification and validation testing was conducted on the subject device Blood pressure monitor and all testing passed pre-specified criteria. The subject device and the predicate device have very similar intended use and the differences in technological features do not raise different questions of safety and effectiveness. This premarket notification submission demonstrates that the subject device is substantially equivalent to the predicate device.