(57 days)
Not Found
No
The description details a standard oscillometric blood pressure monitor and does not mention any AI or ML components or capabilities.
No
The device is described as an "Arm Blood Pressure Monitor" intended to "measure the blood pressure and pulse rate." Its function is diagnostic (measurement), not therapeutic (treatment).
Yes
The device is described as an "Arm Blood Pressure Monitor" intended to "measure the blood pressure and pulse rate." Measuring vital signs like blood pressure is a common diagnostic function, providing information about a person's health status.
No
The device description explicitly lists hardware components such as PCBA, crystal oscillator, pump, valve, enclose, LCD, and cuffs, indicating it is a physical device with integrated software, not a software-only medical device.
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. This is a physiological measurement taken directly from the body, not a test performed on a sample (like blood, urine, or tissue) in vitro (outside the body).
- Device Description: The description details a noninvasive blood pressure measurement system that uses an arm cuff and oscillation mensuration. This is consistent with a device that interacts directly with the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This blood pressure monitor does not fit that definition.
N/A
Intended Use / Indications for Use
Arm Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of person older than twelve (12) years in household or medical facilities.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
Arm Blood Pressure Monitor, model: BPM-A7VL is a Noninvasive Blood Pressure Measurement System that is intended to measuring blood pressure through oscillation mensuration. The subject device will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; The record maybe revisited.
lt measures blood pressure and pulse rate through inflating cuff which rounding the upper arm of patients. The BPM-A7VL is small, portable and used in home or medical facilities environment. The Arm Blood Pressure Monitor consists of two parts: main unit and cuffs. The BPM-A7VL is composed of PCBA, crystal oscillator, pump, valve, enclose, and LCD. Cuffs including cuff of size 23cm33cm and cuff of size 33cm47cm.
Principle of operation: This product uses the Oscillometric Measuring method to detect blood pressure. When the cuff is fully inflated to reach a pressure above systolic pressure, no blood flow occurs through the artery. As the cuff is deflated below the systolic pressure, the reducing pressure exerted on the artery allows blood to flow through it and sets up a detectable vibration in the arterial wall. When the cuff pressure falls below the patient's diastolic pressure, blood flows smoothly through the artery in the usual pulses, without any vibration being set up in the wall. Vibrations occur at any point where the cuff pressure is sufficiently high that the blood has to push the arterial wall open in order to flow through the artery. The vibrations are transferred from the arterial wall, through the air inside the cuff, into a transducer in the monitor that converts the measurements into electrical signals. Hence when it starts inflating the arm cuff, meanwhile, the unit detects pressure oscillations generated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure, and pulse rate.
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
person older than twelve (12) years
Intended User / Care Setting
household or medical facilities
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 accuracy test report and data analysis followed the requirements of the ISO 81060-2 Third edition 2018-11 Amendment 1 2020-01.
Subjects requirement:
Total: A minimum of 85 people, Actual number: 85
Male: At least 26 people, Actual number: 39
Female: At least 26 people, Actual number: 46
Age > 12: 100%, Actual number: 100%
Arm circumference range: 23-33 cm; At least 18 people, Actual number: 44
Arm circumference range: 33-47 cm; At least 25 people, Actual number: 41
The clinical accuracy testing evaluated 85 of subjects, division of all subjects:
23 = 20%, 28, 32.94%
29 = 20%, 20, 23.53%
35 = 20%, 20, 23.53%
41 = 20%, 17, 20.00%
44 =10%, 10, 11.76%
23 =10%, 14, 16.47%
Systolic BP: Systolic BP =5%, 117, 17.21%
Systolic BP: Systolic BP >= 160mmHg: >=5%, 68, 10.00%
Systolic BP: Systolic BP >=140mmHg: >=20%, 196, 28.82%
Diastolic BP: Diastolic BP =5%, 49, 7.21%
Diastolic BP: Diastolic BP >= 100mmHg: >=5%, 134, 19.71%
Diastolic BP: Diastolic BP >= 85mmHg: >=20%, 303, 44.56%
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The clinical accuracy test report and data analysis followed the requirements of the ISO 81060-2 Third edition 2018-11 Amendment 1 2020-01.
The test data showed the clinical accuracy of the subject device complied with the requirements of ISO 81060-2 Third edition 2018-11 Amendment 1 2020-01.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 26, 2024
Shenzhen IMDK Medical Technology Co., Ltd. % Yiiie You Manager Oimmig Medical Consulting Service Co., Ltd RM.406, Building C, Run Science Park No.18 Shenzhou Road, Huangpu Guangzhou, Guangdong 510663 China
Re: K243118
Trade/Device Name: Arm Blood Pressure Monitor (model: BPM-A7VL) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: September 30, 2024 Received: September 30, 2024
Dear Yijie You:
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.
2
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,
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
Submission Number (if known)
Device Name
Arm Blood Pressure Monitor (model: BPM-A7VL)
Indications for Use (Describe)
Arm Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of person older than twelve (12) years in household or medical facilities.
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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4
510(k) Summary
[As required by section 807.92(c)]
1. 510(k) owner (Applicant)
| Establishment
Registration
| number: | 3015007456 | |
|---|---|---|
| Name: | Shenzhen IMDK Medical Technology Co., Ltd. | |
| Address: | 904, 9F, Guangming Tianan Cloud Park Building, 255 | |
| Zhenmei Road, Zhenmei Community, Xinhu Street, | ||
| Guangming District, Shenzhen, 518107, PEOPLE'S | ||
| REPUBLIC OF CHINA | ||
| Contact | ||
| Person | Name: | Xia yuan |
| Address: | 904, 9F, Guangming Tianan Cloud Park Building, 255 | |
| Zhenmei Road, Zhenmei Community, Xinhu Street, | ||
| Guangming District, Shenzhen, 518107, PEOPLE'S | ||
| REPUBLIC OF CHINA | ||
| TEL: | +86-13662694320 | |
| Email: | vicky-xia@imdker.com |
2. Submission Correspondent (Authorized representative)
| Name: | You Yijie |
|---|---|
| Company Name | Qimmiq Medical Consulting Service Co., Ltd |
| Address: | RM.406, Building C, Run Science Park, No.18 |
| Shenzhou Road, Huangpu, Guangzhou, Guangdong | |
| 510663 P.R. China | |
| TEL: | (+86)020-82245821 |
| FAX: | (+86)020-82245821 |
| Email: | jet.you@qimmiq-med.com |
3. Device Information
| Purpose of the application: | 510(K) submission |
|---|---|
| Submission Type: | Traditional 510(K) |
| The reason for the 510(k): | It is a new device |
| Trade Name: | Arm Blood Pressure Monitor |
| Model: | BPM-A7VL |
| Common name of the device: | Arm Blood Pressure Monitor |
| Classification name: | System, Measurement, Blood-Pressure, Non-Inva |
5
| Review panel: | Cardiovascular |
|---|---|
| Product code: | DXN |
| Regulation Class: | II |
| Regulation Number: | 21 CFR 870.1130 |
4. Predicate Device Information
| 510(k) submitter/holder: | ShenZhen GoodlyMed Technology Co., Ltd. |
|---|---|
| 510(K) Number: | K241129 |
| Trade name: | Upper Arm Electronic Blood Pressure Monitor |
| Model: | A02-SE4 |
| Review Panel: | Cardiovascular |
| Product Code: | DXN |
| Regulation Class: | II |
| Regulation Number: | 21 CFR 870.1130 |
5. Device description
Arm Blood Pressure Monitor, model: BPM-A7VL is a Noninvasive Blood Pressure Measurement System that is intended to measuring blood pressure through oscillation mensuration. The subject device will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; The record maybe revisited.
lt measures blood pressure and pulse rate through inflating cuff which rounding the upper arm of patients. The BPM-A7VL is small, portable and used in home or medical facilities environment. The Arm Blood Pressure Monitor consists of two parts: main unit and cuffs. The BPM-A7VL is composed of PCBA, crystal oscillator, pump, valve, enclose, and LCD. Cuffs including cuff of size 23cm33cm and cuff of size 33cm47cm.
Principle of operation:
This product uses the Oscillometric Measuring method to detect blood pressure. When the cuff is fully inflated to reach a pressure above systolic pressure, no blood flow occurs through the artery. As the cuff is deflated below the systolic pressure, the reducing pressure exerted on the artery allows blood to flow through it and sets up a detectable vibration in the arterial wall. When the cuff pressure falls below the patient's diastolic pressure, blood flows smoothly through the artery in the usual pulses, without any vibration being set up in the wall. Vibrations occur at any point where the cuff pressure is sufficiently high that the blood has to push the arterial wall open in order to flow through the artery. The vibrations are transferred from the arterial wall, through the air inside the cuff, into a transducer in the monitor that converts the measurements into electrical signals. Hence when it starts inflating the arm cuff, meanwhile, the unit detects pressure oscillations generated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure, and pulse rate.
6
6. Indications for Use
Arm Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of person older than twelve (12) years in household or medical facilities.
7. Summary of technological characteristics of device compared to the
| SE
Comparisons | Subject device
(Arm Blood Pressure Monitor,
model: BPM-A7VL) | Predicate device
(Upper Arm Electronic Blood Pressure
Monitor, Model: A02-SE4) | Discussion of
difference |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| 510K Number | / | K241129 | / |
| Model | BPM-A7VL | A02-SE4 | / |
| Classification | 21CFR 870.1130 | 21CFR 870.1130 | Same |
| Product Code | DXN | DXN | Same |
| FDA Class | II | II | Same |
| Indications for
Use | Arm Blood Pressure Monitor is intended to
measure the blood pressure and pulse rate of
person older than twelve (12) years in household
or medical facilities. | Upper Arm Electronic Blood Pressure
Monitor is intended for used by a
person older than twelve (12) years to
measure the systolic and diastolic
blood pressure and pulse rate. | Same |
| Patient
Population | person older than twelve (12) years | person older than twelve (12) years | Same |
| Design | table type | table type | Same |
| Design Method | Oscillometric | Oscillometric | Same |
| Measurement
Site | Upper Arm | Upper Arm | Same |
| Cuff
Circumference | 23cm33cm;47cm. | 22cm
33cm42cm;52cm. | Different
32cm
(Discussion is
indicated in
D1) |
| Deflation Method | Automatic Pressure Release Valve | Automatic Pressure Release Valve | Same |
| Display | Backlight LCD
Digital Display | Backlight LCD
Digital Display | Same |
| Memory Size | 99 groups | Not public | Different
(Discussion is
indicated in
D2) |
| Blood Pressure
Measurement
Range | Measurement blood pressure range:
SYS:60mmHg230mmHg130mmHg | BP Range: 0 ~ 299 mmHg | Different
DIA: 40mmHg
(Discussion is
indicated in
D3) |
| Blood Pressure
Measurement
Accuracy | ±3 mmHg | ±3 mmHg | Same |
| Pulse
Measurement
Range | 40200 beats/min | 40 ~ 199 beats/min | Different +40°C
(Discussion is
indicated in
D4) |
| Pressurization
Source | Automatic Internal Pump | Automatic Internal Pump | Same |
| Operating
Environment | Ambient temperature: +5°C
Relative humidity (RH): 15%85%106kPa | Not public | Different
Atmospheric pressure: 80 kPa
(Discussion is
indicated in
D5) |
| Storage
Environment | Ambient temperature: -20 °C ~+50 °C
Relative humidity (RH): 15%85%106kPa | Not public | Different
Atmospheric pressure: 80 kPa
(Discussion is
indicated in
D6) |
| Energy Source | Internal power supply DC 6V (4X1.5V (AA)
batteries;
External power supply: USB interface DC 5V 1A | 4 X AA batteries or AC adapter | Different
(Discussion is
indicated in
D7) |
| Measurement
Item | SYS, DYS, Pulse Rate | SYS, DYS, Pulse Rate | Same |
| Software Level
Concern | Moderate | Moderate | Same |
| Wireless | NA | 4G | Different
(Discussion is
indicated in
D8) |
| Performance | ISO 81060-2 Third edition 2018-11 Amendment 1
2020-01 | ISO 81060-2:2020 | Same |
| Performance | IEC 80601-2-30: Edition 2.0 2018-03 | IEC 80601-2-30 | Same |
| Biocompatibility | ISO 10993-1, FDA Guidance, Tests included
Cytotoxicity, Sensitization and Intracutaneous
Reactivity | ISO 10993-1, FDA Guidance, Tests
included Cytotoxicity, Sensitization and
Intracutaneous Reactivity | Same |
| Electrical
Safety | ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012
C1:2009/(R)2012 & A2:2010/(R)2012 (Cons.
Text) [Incl. AMD2:2021] | IEC60601-1 | Same |
| EMC | IEC 60601-1-2: 2014+AMD1:2020 | IEC 60601-1-2 | Same |
| Home Use | IEC 60601-1-11:2015/2020 | IEC 60601-1-11 | Same |
| Material of
Patient contact
components | Shell: ABS757
Display cover: PMMA
M button and ON/Off button: ABS757 | Not public | Different
(Discussion is
indicated in
D9) |
| Dimensions | 110mm x 103mm x 103 (mm)
(Length $\times$ Width $\times$ Height) | Not public | Different
(Discussion is
indicated in
D10) |
| Weight | Approximate 280g. (Without battery) | Not public | Different
(Discussion is
indicated in
D11) |
| Principle of
operation | Oscillometric Measuring method | Oscillometric Measuring method | Same |
| User Interface | Cuff, button | Cuff, button | Same |
| Software | Embedded | Embedded | Same |
predicate devices (K241129)
7
8
The discussion of differences exist between the subject and predicate devices is listed in following:
- D1: The difference of Cuff Circumference between subject device is that the intended Cuff Circumference range of subject device is 23-33 cm & 33-47cm and predicate device is 22~42cm&32-52cm, the Cuff Circumference range of subject device is in the range of predicate device, and this difference is also addressed through clinical trial conducted with subject device according to ISO 81060-2 Third edition 2018-11 Amendment 1 2020-01, the results of clinical trial meet the requirements of ISO 81060-2 Third edition 2018-11 Amendment 1 2020-01, therefore, the difference of subject device with predicate device A02-SE4 (K241129) will not affect the safety and effectiveness.
- D2: The Memory Size of subject device is different with predicate device predicate device A02-SE4 (K241129) which will not affect the safety and effectiveness.
- D3: The difference of Blood Pressure Measurement Range between subject device and predicate device is that the Blood Pressure Indication Range of subject device is DIA: 40 mmHg
130mmHg & SYS: 60 mmHg230mmHg and predicate device is BP Range: 0 ~ 299 mmHg, the Blood Pressure Indication Range of subject device is in the range of predicate device and meets the requirements of IEC 80601-2-30: Edition 2.0 2018-03, and this difference is also addressed through clinical trial conducted with subject device according to ISO 81060-2 Third edition 2018-11 Amendment 1 2020-01, the results of clinical trial meet the requirements of ISO 81060-2 Third edition 2018-11 Amendment 1 2020-01, therefore, the difference of subject device with predicate device A02-SE4 (K241129) will not affect the safety and effectiveness. - D4: The Measurement Pulse Range of subject device is tiny different with predicate device, and this difference is also addressed through clinical trial conducted with subject device according to ISO 81060-2 Third edition 2018-11 Amendment 1 2020-01, therefore, the difference of subject device with predicate device A02-SE4 (K241129) will not affect the safety and effectiveness.
- D5: The operating Environment of subject device are different with predicate device A02-SE4 (K24129), the difference introduces risks mitigated by testing in accordance with IEC 60601-1-11 and ANSI AAMI ES60601-1 provided in this submission, therefore the difference does not raise new questions of safety and effectiveness.
- D6: The Storage Environment of subject device is different with predicate device A02-SE4 (K241129), the difference introduces risks mitigated by testing in accordance with IEC 60601-1-11 and ANSI AAMI
9
ES60601-1 provided in this submission, therefore the difference does not raise new questions of safety and effectiveness.
- D7: The Energy Source of subject device are different with predicate devices, the difference introduces risks mitigated by the electromagnetic compatibility and electrical safety testing in accordance with IEC 60601-1-2 and ANSI AAMI ES60601-1 provided in this submission, therefore the difference does not raise new questions of safety and effectiveness.
- D8: The subject device does not have wireless function which will not affect the safety and effectiveness.
- D9: The Material of Patient contact components of subject device has been validated for Cytotoxicity though testing against ISO 10993- 5, for Sensitization though testing against ISO 10993-10 and ISO 10993-23 tested and all test results are positive, the difference of subject device with predicate device A02-SE4 (K241129) do not raise new questions of safety and effectiveness.
- D10: The Dimensions of subject device is different with predicate device predicate device A02-SE4 (K241129) will not affect the safety and effectiveness.
- D11: The Weight of subject device is tiny different with predicate device A02-SE4 (K241129) will not affect the safety and effectiveness.
8. Discussion of Non-Clinical Tests Performed for Safety and
effectiveness are as follows
The recognized consensus standards for safety of medical electrical equipment: ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021], IEC 60601-1-11:2015/2020, IEC 60601-1-2: 2014+AMD1:2020 for electromagnetic compatibility, IEC 80601-2-30: Edition 2.0 2018-03, ISO 81060-2 Third edition 2018-11 Amendment 1 2020-01 for performance, IEC 62304 Edition 1.1 2015-06 for software verification and ISO 10993-5:2009 for Cytotoxicity endpoints, ISO 10993-10:2021 and ISO 10993-23:2021 for Sensitization and Irritation endpoints are complied. See below table for details:
| Standards | Standards Name |
|---|---|
| ANSI AAMI ES60601-1:2005/(R)2012 & | |
| A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 | |
| (Cons. Text) [Incl. AMD2:2021] | Medical Electrical Equipment - Part 1: General |
| Requirements For Basic Safety And Essential Performance | |
| 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 | |
| IEC 60601-1-11:2015/2020 | 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 | |
| IEC 80601-2-30: Edition 2.0 2018-03 | Medical electrical equipment - Part 2-30: Particular |
| requirements for the basic safety and essential performance | |
| of automated non-invasive sphygmomanometers |
10
| ISO 81060-2 Third edition 2018-11
Amendment 1 2020-01 | Non-invasive sphygmomanometers - Part 2: Clinical
investigation of intermittent automated measurement type |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for in
vitro cytotoxicity |
| ISO 10993-10:2021 | Biological evaluation of medical devices - Part 10: Tests for
skin sensitization |
| ISO 10993-23:2021 | Biological evaluation of medical devices - Part 23: Tests for
irritation |
| IEC 62304 Edition 1.1 2015-06 | Medical device software - Software life cycle processes |
● Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the subject device BPM-A7VL. The system complies with the AAMI ANSI ES60601-1, IEC 60601-1-11 for electrical safety, the IEC 60601-1-2 standard for EMC, IEC 80601-2-30 and ISO 81060-2 for performance.
● Software Verification and Validation Testing
Software verification and validation was performed for the subject device in accordance with Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff, May 2005.
Software Description:
The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could result in Minor Injury, either to a patient or to a user of the device. The software of the system, on the whole, is accountable for the system scheduler of the device, including Pressure and pulse signal acquisition, calculation and display, the button presses of end user, display the result of the measurement data storage and average calculation, memory data query, prompt of error message, low battery voltage detection and prompt, measurement Unit conversion.
9. Discussion of Clinical Accuracy Testing Performed
The clinical accuracy test report and data analysis followed the requirements of the ISO 81060-2 Third edition 2018-11 Amendment 1 2020-01.
| Subjects requirement | Number specified in ISO 81060-2
Third edition 2018-11 Amendment 1
2020-01 | Actual number |
|-------------------------|---------------------------------------------------------------------------------|---------------|
| Total | A minimum of 85 people | 85 |
| Male | At least 26 people | 39 |
| Female | At least 26 people | 46 |
| Age > 12 | 100% | 100% |
| Arm circumference range | 23-33 cm;
At least 18 people | 44 |
| | 33-47 cm;
At least 25 people | 41 |
The clinical accuracy testing evaluated 85 of subjects, division of all subjects:
11
| | 23 ≤ x