(188 days)
Not Found
No
The description details a standard oscillometric blood pressure monitor using an electronic pressure sensor and analog-to-digital conversion, with no mention of AI or ML algorithms for data processing or interpretation.
No.
The device is a digital monitor for measuring blood pressure and pulse rate, which are diagnostic measurements, not therapeutic interventions.
No
The device is described as a monitor for measuring blood pressure and pulse rate, which are physiological parameters. While these measurements can be used in diagnosis, the device itself performs a measurement function, not a diagnostic one of identifying a disease or condition. Its intended use is to generate data, not to interpret that data into a diagnosis.
No
The device description explicitly details hardware components like an electronic pressure sensor, a circuit for signal conditioning, an analog-to-digital converter (ADC), a motor for inflation, and an LCD display. It also describes a physical cuff and the oscillometric method which relies on hardware interaction with the body.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure blood pressure and pulse rate in adult patients. This is a physiological measurement taken directly from the body, not a test performed on a sample of biological material (like blood, urine, or tissue) outside of the body.
- Device Description: The device measures blood pressure and pulse rate using an oscillometric method based on pressure variations in a cuff on the wrist. This is a physical measurement, not a diagnostic test performed on a biological sample.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or diagnostic markers, which are characteristic of IVD devices.
Therefore, this device falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is a digital monitor for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 inches to 7 1/4 inches (12.8 cm to 18.5 cm).
Product codes
DXN
Device Description
RA-T59 Wrist blood pressure monitor is designed to measure the blood pressure and pulse rate of adults within the range of the designated wrist cuff (12.8 to 18.5 cm). RA-T59 Wrist blood pressure monitor is based on an oscillometric method to measure blood pressure and pulse rate from wrist. The device uses automatic inflation mode. It starts to inflate from 0 mmHg and automatically stops the motor after 25 seconds and quickly deflates, with a steady inflation speed detecting the measurement during inflation. The device utilizes the oscillometric method whereby the electronic pressure sensor converts variation in cuff pressure to electrical signals. The signal from the electronic pressure sensor is conditioned with a circuit before data conversion by an analog-to-digital converter (ADC). The systolic pressure, diastolic pressure, and pulse rate are then calculated in the digital domain. The resulting systolic, diastolic, and pulse-rate measurements are displayed on a LCD and stored in the device's memory.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist
Indicated Patient Age Range
Adult
Intended User / Care Setting
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
The proposed device was tested to ISO 81060-2: 2018 Non-invasive sphygmomanometers- Part 2: Clinical validation of automated measurement type. The study population consisted of 85 qualified healthy adult subjects. The results of this clinical investigation show that the proposed device fulfills the requirement of ISO 81060-2:2018.
Key Metrics
Not Found
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 & 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" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
January 27, 2022
LotusNine Medical Limited % Yuhua Chen Manager PuHsu Consulting Ltd. 7F., No.272, Jiankang Rd., Zhonghe Dist. New Taipei City, 235042 Taiwan
Re: K212312/S001
Trade/Device Name: RA-T59 Wrist blood pressure monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN Dated: December 17, 2021 Received: December 29, 2021
Dear Yuhua Chen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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 and Part 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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-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,
for
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K212312
Device Name
RA-T59 Wrist blood pressure monitor
Indications for Use (Describe)
The device is a digital monitor for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 inches to 7 1/4 inches (12.8 cm to 18.5 cm).
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
3
510(k) Summary
Date prepared: July 15, 2021
1. Submitter's Information
Submission Submitter
| Company Name | LotusNine Medical Limited |
|---|---|
| Address | No. 2, Ln. 223, Sec. 1, Taiping Rd., Tsaotun |
| Township, Nantou County 542007, Taiwan | |
| Contact Person | Yating Chang |
| Phone | 886-966512879 |
| ytc@lotus9.xyz |
Submission Correspondent
| Company Name | PuHsu Consulting Ltd. |
|---|---|
| Address | 7F., No.272, Jiankang Rd., Zhonghe Dist., New |
| Taipei County 235042, Taiwan | |
| Contact Person | Yuhua Chen |
| Phone | 886-965650265 |
| yuhua@puhsuconsult.com |
2. Subject Device Information
| Proprietary/Trade Name | RA-T59 Wrist blood pressure monitor |
|---|---|
| Regulation Name | Noninvasive blood pressure measurement system |
| Regulation Number | 870.1130 |
| Product Code | DXN |
| Device Classification | II |
| Panel | Cardiovascular |
3. Predicate Device Information
| 510(k)
| Number | Trade Name | Manufacturer | Type |
|---|---|---|---|
| K131742 | Model HEM-6131 | Omron Healthcare, Inc. | Predicate |
| Device |
4
4. Device Description
RA-T59 Wrist blood pressure monitor is designed to measure the blood pressure and pulse rate of adults within the range of the designated wrist cuff (12.8 to 18.5 cm). RA-T59 Wrist blood pressure monitor is based on an oscillometric method to measure blood pressure and pulse rate from wrist. The device uses automatic inflation mode. It starts to inflate from 0 mmHg and automatically stops the motor after 25 seconds and quickly deflates, with a steady inflation speed detecting the measurement during inflation. The device utilizes the oscillometric method whereby the electronic pressure sensor converts variation in cuff pressure to electrical signals. The signal from the electronic pressure sensor is conditioned with a circuit before data conversion by an analog-to-digital converter (ADC). The systolic pressure, diastolic pressure, and pulse rate are then calculated in the digital domain. The resulting systolic, diastolic, and pulse-rate measurements are displayed on a LCD and stored in the device's memory.
5. Indications for Use
The device is a digital monitor for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 inches to 7 1/4 inches (12.8 cm to 18.5 cm).
| Proposed Device | Predicate Device | Remark | |
|---|---|---|---|
| Device | RA-T59 Wrist blood pressure monitor | Model HEM-6131 | |
| Manufacturer | LotusNine Medical Limited | Omron Healthcare, Inc. | -- |
| 510(k) Number | N/A | K131742 | -- |
| Product Code | DXN | DXN | Same |
| Regulation | |||
| Number | 870.1130 | 870.1130 | Same |
| Indications for | |||
| Use | The device is a digital monitor | ||
| for use in measuring blood | |||
| pressure and pulse rate in | |||
| adult patient population with | |||
| wrist circumference ranging | |||
| from 5 inches to 7 1/4 inches | |||
| (12.8 cm to 18.5 cm). | The device is a digital monitor | ||
| for use in measuring blood | |||
| pressure and pulse rate in | |||
| adult patient population with | |||
| wrist circumference ranging | |||
| from 5 1/4 inches to 8 1/2 | |||
| inches (13.5 cm to 21.5 cm). | Different | ||
| (Note 1) | |||
| Proposed Device | Predicate Device | Remark | |
| Device | RA-T59 Wrist blood pressure | ||
| monitor | Model HEM-6131 | ||
| Patient | |||
| Population | Adult | Adult | Same |
| Prescriptive | OTC | OTC | Same |
| Anatomical Site | Wrist | Wrist | Same |
| Environment of | |||
| Use | Home | Home | Same |
| Measuring | |||
| Method | Oscillometric | Oscillometric | Same |
| Measurement | |||
| Range | Systolic blood pressure: 60 - | ||
| 230 mmHg | |||
| Diastolic blood pressure: 40 - | |||
| 130 mmHg | |||
| Rated range of CUFF | |||
| pressure: 300 mmHg | |||
| Pulse: 40 to 180 beats | Pressure: 0-299 mmHg | ||
| Pulse rate: 40 to 80 bpm | Different | ||
| (Note 2) | |||
| Accuracy or | |||
| pressure | |||
| indicator | ±3 mmHg or 2% of reading | ±3 mmHg or 2% of reading | Same |
| Accuracy Pulse | |||
| Rate | ±5% | ±5% | Same |
| Inflation and | |||
| Deflation | Automatic | Automatic | Same |
| Display Type | LCD | LCD | Same |
| Power Source | USB type C charging | AAA batteries | Different |
| (Note 3) | |||
| Operation | |||
| Conditions | Temperature: 10°C to 40°C | ||
| Humidity: 15 to 85% RH | Temperature: 10°C to 40°C | ||
| Humidity: 15 to 85% RH | Same | ||
| Storage | |||
| Conditions | Temperature: -20°C to 70°C | ||
| Humidity: 10 to 90% RH | Temperature: -20°C to 60°C | ||
| Humidity: 10 to 95% RH | Different | ||
| (Note 4) | |||
| Memory | 25 Measurements | 60 Measurements | Different |
| (Note 5) | |||
| Device | Proposed Device | Predicate Device | Remark |
| RA-T59 Wrist blood pressure | |||
| monitor | Model HEM-6131 | ||
| Electrical safety | IEC 60601-1-2 | ||
| IEC60601-1 | IEC 60601-1-2 | ||
| IEC60601-1 | Same | ||
| Biocompatibility | ISO 10993 series | ISO 10993 series | Same |
6. Comparison to the Predicate Device
5
6
LotusNine Medical Limited 510(k) Notification
Comparison
Note 1:
The substantial difference of the intended use is the wrist circumference ranging. The proposed device is narrower than the predicate device. The proposed device was validated according to ISO 80601-2-30 and ISO 81060-2. The performance data can demonstrate this difference does not raise different questions of safety and effectiveness.
Note 2:
The proposed device's systolic and diastolic blood pressure measurement range is restricted from 40 to 230 mmHg. The measuring rang of the proposed device was validated according to ISO 80601-2-30. The different does not raise different questions of safety and effectiveness.
Note 3:
Although the power source is different, IEC 60601-1, IEC 60601-1-11 and IEC 60601-1-2, and IEC 62133-2 can demonstrate that the proposed device can maintain the safety and performance when the proposed device is charged. Thus, this difference does not raise different questions of safety and effectiveness.
Note 4:
Compared with the predicate device, the proposed device requires different storage environment. IEC 60601-1-11 test report can demonstrate that the proposed device can maintain the safety and performance within the storage environment. Thus, this difference does not raise different questions of safety and effectiveness.
Note 5:
The memory size of the proposed device is less than the predicate device. The difference is very slight and it will not affect the main function and the intended use of the proposed
7
device. Therefore, this difference will not raise any safety or effectiveness issue.
7. Performance Testing
Performance testing has been carried out to demonstrate that the proposed device meets the performance specifications for its intend use.
The proposed device was tested to ISO 81060-2: 2018 Non-invasive sphygmomanometers- Part 2: Clinical validation of automated measurement type. The study population consisted of 85 qualified healthy adult subjects. The results of this clinical investigation show that the proposed device fulfills the requirement of ISO 81060-2:2018.
8. Non-Clinical Testing
The subject device has been tested according to the following standards:
- A. Safety Test
- . IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and essential performance
- . IEC 60601-1-11, 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
- IEC 62133-2, Secondary cells and batteries containing alkaline or other nonacid electrolytes - Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
- B. EMC Test
- . IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- C. Biocompatibility testing
- ISO- 10993, Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing
- . ISO 10993-5, Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity
- 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
8
- . ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
- Performance Test D.
- IEC 80601-2-30, Medical electrical equipment Particular requirements for the . basic safety and essential performance of automated non-invasive sphygmomanometers.
- E. Software Verification and Validation
- . FDA Guidance for the Content of Pre-Market Submission for Software Contained in Medical Devices
- . IEC 62304, Medical device software - Software life cycle processes
- F. Usability
- IEC 60601-1-6, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 62366-1, Medical devices - Application of usability engineering to medical devices.
9. Conclusion
In conclusion, it shows that the proposed device and the predicate device has the same intended use, and the difference in technological features of the proposed devices and the predicate devices do not raise different questions of safety and effectiveness. The result of all testing conducted was found acceptable to support the claim of substantial equivalence.