(216 days)
No
The summary describes a standard automatic blood pressure monitor with memory and classification functions based on established guidelines, with no mention of AI or ML technologies.
No
A therapeutic device is used for treatment. This device is for measuring blood pressure and pulse rate, which is a diagnostic or monitoring function, not a therapeutic one.
Yes
The device measures blood pressure and pulse rate, providing information that can be used to monitor a user's health status and identify deviations from normal ranges (e.g., blood pressure classification), which are features of a diagnostic device.
No
The device description explicitly states it is an "automatic noninvasive Blood Pressure Monitor which can be driven by dry batteries" and "consists of the main body and the arm belt," indicating it is a hardware device with software components, not a software-only device.
No, 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 body (in vitro).
- Device Function: The described device is an Arm Blood Pressure Monitor. It measures blood pressure and pulse rate by applying a cuff to the upper arm and using non-invasive methods. This is a physical measurement taken on the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is for "measuring blood pressure and pulse rate" for home use. This aligns with the function of a non-invasive blood pressure monitor, not an IVD.
The information provided clearly describes a device that performs a physical measurement on the patient's body, which is the opposite of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Arm blood pressure monitor is for home use for measuring blood pressure and pulse rate. It is suitable for adult, not for neonate or pregnancy.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The proposed device, Arm Blood Pressure Monitor, is an automatic noninvasive Blood Pressure Monitor which can be driven by dry batteries. It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult, not for neonate or pregnancy.
The proposed device consists of the main body and the arm belt, suitable for home use for measuring blood pressure and pulse rate. It is suitable for adult, not for neonate or pregnancy.
This blood pressure monitor has the memory function of 60 groups of measuring data of two people, which can save the data separately. It can display the average reading of the latest 3 groups of measurement results.
This blood pressure monitor has the function of blood pressure classification, which is convenient for you to judge whether your blood pressure is normal or not according to the World Health Organization/ International Society for hypertension(WHO/ISH) guidelines on the treatment of hypertension dated in 1999.
This blood pressure monitor has voice broadcast function (optional). During measurement and recall the memory, there will be voice operation tips.
Cuff supporting the use of Arm Blood Pressure Monitor is M5303(small adult)/M5304(adult)/ M5305(big adult) provided by Xuzhou Maikang Science and Technology Ltd., and cleared by the CE(Declaration of Conformity for Class I)/ISO and FDA(K151290).
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, not for neonate or pregnancy.
Intended User / Care Setting
Home use
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
The clinical trials for the Arm Blood Pressure Monitor were performed according to the standard of ISO 81060-2:2018, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type, and relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement.
There were 150 subjects been selected to participate in the trial, and Auscultation was applied as gold standard with the qualified calibrated mercurial sphygmomanometer used as control group for comparison with the proposed device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The clinical trials for the Arm Blood Pressure Monitor were performed according to the standard of ISO 81060-2:2018, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type, and relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement.
There were 150 subjects been selected to participate in the trial, and Auscultation was applied as gold standard with the qualified calibrated mercurial sphygmomanometer used as control group for comparison with the proposed device.
The results shown that the accuracy of proposed device meet the requirements of ISO 81060-2:2018 within the ±3mmHg.And the proposed device comply with the standard requirements and the accuracy the manufacture declared.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: ±3mmHg for BP
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Ningbo Ranor Medical Science & Technology Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, 200120 CN
July 16, 2020
Re: K193456
Trade/Device Name: Arm Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: October 25, 2019 Received: December 13, 2019
Dear Boyle Wang:
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.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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 LT Stephen Browning Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K193456
Device Name Arm Blood Pressure Monitor
Indications for Use (Describe)
The Arm blood pressure monitor is for home use for measuring blood pressure and pulse rate. It is suitable for adult, not for neonate or pregnancy.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
1.0 Submitter's Information
Name: Ningbo Ranor Medical Science & Technology Co., Ltd. Address: No. 127 Fenghui Road, Wangchun Industrial Park, Haishu District, Ningbo, China Tel: 86-574-89258788 Fax: 86- 574-88219485 Contact: Emma Hu Date of Preparation: Jul.14.2020
Designated Submission Correspondent
Mr. Boyle Wanq Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Arm Blood Pressure Monitor Common name: Noninvasive Blood Pressure Measurement System Classification name: Noninvasive Blood Pressure Measurement System Model(s): RN-032A,RN-032C
3.0 Classification
Production code: DXN Requlation number: 21 CFR 870.1130 Classification: Class II Panel: Cardiovascular
4.0 Predicate Device Information
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd Manufacturer: Device: Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D,
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YE660B, YE670A and YE670D 510(k) number: K170605
5.0 Indication for Use Statement
The Arm blood pressure monitor is for home use for measuring blood pressure and pulse rate. It is suitable for adult, not for neonate or pregnancy.
6.0 Device Description
The proposed device, Arm Blood Pressure Monitor, is an automatic noninvasive Blood Pressure Monitor which can be driven by dry batteries. It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult, not for neonate or pregnancy.
The proposed device consists of the main body and the arm belt, suitable for home use for measuring blood pressure and pulse rate. It is suitable for adult, not for neonate or pregnancy.
This blood pressure monitor has the memory function of 60 groups of measuring data of two people, which can save the data separately. It can display the average reading of the latest 3 groups of measurement results.
This blood pressure monitor has the function of blood pressure classification, which is convenient for you to judge whether your blood pressure is normal or not according to the World Health Organization/ International Society for hypertension(WHO/ISH) guidelines on the treatment of hypertension dated in 1999.
This blood pressure monitor has voice broadcast function (optional). During measurement and recall the memory, there will be voice operation tips.
Cuff supporting the use of Arm Blood Pressure Monitor is M5303(small adult)/M5304(adult)/ M5305(big adult) provided by Xuzhou Maikang Science and Technology Ltd., and cleared by the CE(Declaration of Conformity for Class I)/ISO and FDA(K151290).
7.0 Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
IEC 60601-1:2012, Medical electrical equipment-Part 1: General requirements
5
for basic safety, and essential performance.
IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
IEC 60601-1-11:2015, 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 80601-2-30:2013, Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers.
IEC 62304:2015 standard and FDA Guidance for the Content of Pre-Market Submission for Software Contained in Medical Devices standard.
8.0 Clinical Test Conclusion
Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intend use.
The clinical trials for the Arm Blood Pressure Monitor were performed the standard of of of lSO 81060-2:2018, Non-Invasive according a Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type, and relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement.
There were 150 subjects been selected to participate in the trial, and Auscultation was applied as gold standard with the qualified calibrated mercurial sphygmomanometer used as control group for comparison with the proposed device.
The results shown that the accuracy of proposed device meet the requirements of ISO 81060-2:2018 within the ±3mmHg.And the proposed device comply with the standard requirements and the accuracy the manufacture declared.
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9.0 Technological Characteristic Comparison Table
| Table2-General Comparison | |||
|---|---|---|---|
| Item | Proposed device | ||
| K193456 | Predicated device | ||
| K170605 | Remark | ||
| Product Code | DXN | DXN | SE |
| Regulation No. | 21 CFR 870.1130 | 21 CFR 870.1130 | SE |
| Class | II | II | SE |
| Intended Use | The Arm blood pressure | ||
| monitor is for home use | |||
| for measuring blood | |||
| pressure and pulse rate. | |||
| It is suitable for adult, not | |||
| for neonate or | |||
| pregnancy. | Electronic blood pressure | ||
| monitor is intended to | |||
| measure the blood | |||
| pressure and pulse rate | |||
| of adult at household or | |||
| medical center. (Not | |||
| suitable for neonate, | |||
| pregnancy or | |||
| pre-eclampsia). | SE | ||
| Application | |||
| Site | Upper Arm | Upper Arm | SE |
| Cuff | |||
| Circumference | $220mm \sim 320mm$ | $220mm \sim 320mm$ | SE |
| Patients | |||
| Contacting | |||
| Materials | Arm Cuff -M5303(small | ||
| adult)/M5304(adult)/ | |||
| M5305(big adult) | |||
| provided by Xuzhou | |||
| Maikang Science and | |||
| Technology Ltd., and | |||
| cleared by FDA | |||
| (K151290). | Patient contact materials | ||
| of the cuff have been | |||
| tested in accordance with | |||
| ISO10993 and FDA | |||
| guidance. | SE | ||
| Patient | |||
| Population | Adult | Adult | SE |
| Measurements | |||
| Item | SYS,DYS,Pulse | SYS,DYS,Pulse | SE |
| Display | LCD Digital Display | LCD Digital Display | SE |
| Design | |||
| Method | Oscillometric | ||
| Method | Oscillometric | ||
| Method | SE | ||
| Main | |||
| Component | LCD / Key / Cuff / MCU / | ||
| Pump / Batteries | LCD / Key / Cuff / MCU / | ||
| Pump / Batteries | SE |
Table2-General Comparison
Table3 Performance Comparison
| Item | Proposed Device | Predicate Device
K170605 | Remark |
|----------|-----------------|-----------------------------|----------|
| BP Range | 0-299 mmHg | 0-280 mmHg | Analysis |
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| BP Accuracy | ±3 mmHg | ±3 mmHg | SE |
|---|---|---|---|
| PR Range | 40-180 beats/min | 40 ~ 200 beats/min | Analysis |
| Pulse | |||
| Accuracy | ±5% of reading | ||
| value | ±5% of reading | ||
| value | SE | ||
| Inflation | |||
| Method | Automatic by | ||
| electronic pump | Automatic by | ||
| electronic pump | SE | ||
| Deflation | |||
| Method | Automatic Pressure | ||
| Release Valve | Automatic Pressure | ||
| Release Valve | SE | ||
| Memory Size | 2x60 set of data | Up to 60sets of data | Analysis |
| Operation | |||
| Condition | 5-40 °C | ||
| 15%-80% RH | |||
| 80kPa~106kPa | 10-40 °C | ||
| 15%-90% RH (no | |||
| condensation) | Analysis | ||
| Storage | |||
| Condition | -20-55 °C | ||
| ≤95% RH | |||
| 50kPa~105kPa | -20-55 °C | ||
| 15%-90% RH (no | |||
| condensation) | Analysis | ||
| Data Storage | SYS, DIA, PR, | ||
| Measurement Time, No. | SYS, DIA, PR, | ||
| Measurement Time, No. | SE | ||
| Performance | |||
| Standard | Comply with IEC | ||
| 80601-2-30 | Comply with IEC | ||
| 80601-2-30 | SE | ||
| Power Supply | 4 AAA batteries | 4 AA batteries | Analysis |
Analysis:
The proposed device is substantially equivalent to the predicate device. The differences between both devices are insignificant in terms of safety and effectiveness. Based on the nonclinical and clinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.
Table4 Safety Comparison
| Item | Proposed Device | Predicate Device
K170605 | Remark |
|-------------------|---------------------------------------------|------------------------------------------------------------------------------------------------------------------|--------|
| Electrical Safety | Comply with IEC
60601-1 | Comply with IEC 60601-1 | SE |
| Home Use | Comply with IEC
60601-1-11 | Comply with IEC
60601-1-11 | SE |
| EMC | Comply with IEC
60601-1-2 | Comply with IEC
60601-1-2 | SE |
| Biocompatibility | Comply with ISO
10993-1, FDA
Guidance | Comply with ISO
10993-1, FDA Guidance,
Tests included
Cytotoxicity, Sensitization
and Intracutaneous | SE |
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| Reactivity | |||
|---|---|---|---|
| Label and | |||
| Labeling | Conforms to FDA | ||
| Regulatory | |||
| Requirements | Conforms to FDA | ||
| Regulatory Requirements | SE | ||
| Level of | |||
| Concern of the | |||
| Software | Moderate | Moderate | SE |
10.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicated device and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.