(113 days)
BP5S Wireless Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.
BP5S Wireless Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30.
The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LED. The measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user.
The provided text describes the 510(k) submission for the BP5S Wireless Blood Pressure Monitor. Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (Reference) |
|---|---|
| IEC 60601-1-2 (Electromagnetic compatibility) | Confirms compliance, "Non-clinical Tests have been done as follows: a. Electromagnetic compatibility test according to IEC 60601-1-2;" |
| IEC 60601-1 (Electrical safety) | Confirms compliance, "b. Electrical safety according test to IEC 60601-1;" |
| IEC 80601-2-30 (Safety and performance characteristics of automated non-invasive sphygmomanometers) | Confirms compliance, "c. Safety and performance characteristics of the test according to IEC 80601-2-30" and "Performance summary: BP5S Wireless Blood Pressure Monitor conforms to the following standards: ... IEC 80601-2-30:2009 & A1:2013" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for any specific clinical performance studies. It mentions that non-clinical tests were performed according to specified IEC standards. For the performance characteristics related to blood pressure accuracy (IEC 80601-2-30), these standards typically require clinical validation with a certain number of subjects, but the details of this specific study are not provided in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided. The summary focuses on standard compliance and technology comparisons, not details of clinical study design regarding ground truth establishment by experts.
4. Adjudication Method for the Test Set
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. This device is a blood pressure monitor, not an imaging or diagnostic AI system that would typically involve human reader interpretation.
6. Standalone (Algorithm Only) Performance Study
The information provided describes the device's performance in terms of adherence to international standards for blood pressure monitors. The device itself performs the measurement and calculation of blood pressure. Therefore, the "standalone" performance is inherent in its design and its ability to meet the specified performance standards. The Non-clinical Tests and Performance Summary paragraphs implicitly refer to the standalone performance of the device in measuring blood pressure and pulse rate according to the specified standards.
7. Type of Ground Truth Used
For the specific performance related to blood pressure measurement, the ground truth would be established by reference measurements taken simultaneously with a validated method (e.g., by trained observers using a mercury sphygmomanometer or an equivalent reference device) as prescribed by the IEC 80601-2-30 standard. However, the document does not explicitly detail the ground truth method used in the validation study.
8. Sample Size for the Training Set
This information is not applicable and not provided. The BP5S is a traditional blood pressure monitor based on oscillometric technology, not an AI/machine learning device that requires a training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reason as above.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 3, 2017
Andon Health Co., Ltd. Ms. Liu Yi President No.3 Jin Ping Street Ya An Road, Nankai District Tianjin, 300190 CN
Re: K171062
Trade/Device Name: BP5S Wireless Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: June 8, 2017 Received: July 3, 2017
Dear Ms. Liu Yi:
This letter corrects our substantially equivalent letter of August 1, 2017.
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. 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
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Page 2 - Ms. Liu Yi
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
M.A. Hilleman
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171062
Device Name
BP5S Wireless Blood Pressure Monitor
Indications for Use (Describe)
BP5S Wireless Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
ne-Counter Use (21 CFR 801 Subbart Ci
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K171062
Page 1 of 3
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92.
1.0 submitter's information
| Name: | Andon Health Co., Ltd. |
|---|---|
| Address: | No 3, Jinping Street Ya An Road, Nankai District, Tianjin,P.R. China |
| Phone number: | 86-22-6052 6161 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Liu Yi |
| Date of Preparation: | 3/31/2017 |
2.0 Device information
Trade name: BP5S Wireless Blood Pressure Monitor
Common name: Noninvasive blood pressure measurement system
Classification name: Noninvasive blood pressure measurement system
3.0 Classification
Production code: DXN- Noninvasive blood pressure measurement system. Regulation number: 870.1130 Classification: II Panel: Cardiovascular
4.0 Predicate device information
Manufacturer: Andon Health Co., Ltd. Device: KD-936 Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K120672
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K171062 Page 2 of 3
5.0 Intended use
BP5S Wireless Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.
The intended use and the indication for use of BP5S, as described in its labeling are the same as the predicate device KD-936 (K120672).
6.0 Device description
BP5S Wireless Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30.
The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LED. The measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user.
7.0 Summary comparing technological characteristics with predicate device
| Technological Characteristics | Comparison result |
|---|---|
| Design principle | Identical |
| Appearance | Similar |
| Patients contact Materials | Similar |
| Performance | Similar |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Standards met | Identical |
| Electrical safety | Identical |
| EMC | Identical |
| Function | Similar |
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K171062 Page 3 of 3
8.0 Discussion of non-clinical and clinical test performed
Non-clinical Tests have been done as follows:
a. Electromagnetic compatibility test according to IEC 60601-1-2;
b. Electrical safety according test to IEC 60601-1;
c. Safety and performance characteristics of the test according to IEC 80601-2-30
None of the test demonstrates that BP5S Blood Pressure Monitor bring new questions of safety and effectiveness.
9.0 Performance summary
BP5S Wireless Blood Pressure Monitor conforms to the following standards:
- 60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And ● IEC A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
- · 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
- IEC 80601-2-30:2009 & A1:2013,Medical Electrical Equipment Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Noninvasive Sphygmomanometers
10.0 Comparison to the predicate device and the conclusion
Our device BP5S is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-936 whose 510(k) number is K120672.
BP5S is very similar with its predicate device in the intended use, the design principle, the memory capacity, the material, the performance and the applicable standards. Only their appearance is changed, and BP5S can display test results itself.
However, the test in this submission provides demonstrates that these small differences do not raise any new questions of safety and effectiveness.
§ 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).