(195 days)
Mercury Sphygmomanometer
No
The description explicitly states the device uses the "oscillometric method," a well-known and established technique for blood pressure measurement that does not inherently involve AI or ML. The data transmission function is also described as having "without any control feature," further indicating a lack of advanced processing or learning capabilities.
No
The device is designed to measure blood pressure and pulse rate, which is a diagnostic function, not a therapeutic one. It provides information for monitoring health, but does not directly treat or alleviate a medical condition.
Yes
The device is described as an "Upper Arm Electronic Blood Pressure Monitor" intended to "Measure blood pressure (systolic and diastolic) and pulse rate." This involves collecting physiological data (blood pressure and pulse rate) to assess a patient's health status, which is the definition of a diagnostic device.
No
The device description clearly states the device consists of a main unit and a cuff unit, which are hardware components. While it includes software for data analysis and transmission, it is not solely software.
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 (systolic and diastolic) and pulse rate." This is a physiological measurement taken directly from the body, not a test performed on a sample of biological material in vitro (outside the body).
- Device Description: The description details a non-invasive technique using an inflatable cuff on the upper arm and an electronic pressure sensor. This is a physical measurement process.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are designed 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 description.
N/A
Intended Use / Indications for Use
Measure blood pressure(systolic and diastolic) and pulse rate.
Product codes
DXN
Device Description
Upper Arm Electronic Blood Pressure Monitor, Model U86E and TelliBP01 are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a wellknown technique in the market called the "oscillometric method".
The main components of the Upper Arm Electronic Blood Pressure Monitor are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately 22 cm to 42 cm, includes the inflatable bladder and fabric. The device consists of the main unit and cuff.
The product is provided non-sterile, and not to be sterilized by the user prior to use.
Model U86E and TelliBP01 in this submission follow the similar software, same measurement principle and similar specifications. The differences existed between different models included in this submission will not affect the safety and effectiveness of the device.
The model U86E embed an Bluetooth Wireless network connections module that allows it to send data(systolic blood pressure, diastolic blood pressure, pulse rate) from blood pressure monitor to the Application in the external instruments. The TelliBP01 embed a SIM card, which can send data(systolic blood pressure, diastolic blood pressure, pulse rate) from blood pressure monitor to the Application in the external instruments through 4G network. The wireless functions of U86E and TelliBP01 only have data transmission function, without any control feature.
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
Medical Facilities and 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 study population consisted of 93 qualified participants with an average age of 54.81 years, 39 males and 54 females. A Mercury Sphygmomanometer was used as a reference device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Test: The clinical testing has been conducted per ISO 81060-2:2018/A1:2020 Non-Invasive Sphygmomanometers -- Part 2: Clinical Validation of Automated Measurement Type on the Electronic Sphygmomanometer. The clinical accuracy testing was performed on the U80EH Upper Arm Electronic Blood Pressure Monitor, which is also manufactured by the sponsor. The key factors affecting clinical trials, such as the intended use, measurement site, cuff size, working principle, and the core algorithms, are the same in U80EH, U86E and TelliBP01. Therefore, the clinical accuracy testing for the model for U80EH is applicable for U86E and TelliBP01.
The study population consisted of 93 qualified participants with an average age of 54.81 years, 39 males and 54 females. A Mercury Sphygmomanometer was used as a reference device.
Key results from clinical testing:
According to Criterion 1, the mean difference of systolic blood pressure measured by deviceunder-test and the reference device was 0.17mmHg, with a standard deviation of 7.52mmHg; the mean difference of diastolic blood pressure was 0.29mmHg, with a standard deviation of 5.35mmHg. The mean differences of both systolic blood pressure and diastolic blood pressure were less than 5mmHg, and the standard deviations were less than 8mmHg.
According to Criterion 2, the mean difference of systolic blood pressure measured by deviceunder-test and the reference device was 0.33mmHg, with a standard deviation of 6.84mmHg; The mean difference of diastolic blood pressure was 0.37mmHg, with a standard deviation of 4.77mmHg.
All the subjects completed the clinical study without adverse event. The device-under-test fulfilled both validation criteria 1 and 2 of ISO 81060-2:2018/A1:2020.
Non-clinical testing: A series of safety and performance tests were conducted on the subject device:
- Product service life
- Software validation
- Electromagnetic compatibility and electrical safety
- Bench Testing
- Biocompatibility test
All the test results demonstrate Upper Arm Electronic Blood Pressure Monitor meets the requirements of its pre-defined acceptance criteria and intended use, and it is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
According to Criterion 1:
- Mean difference of systolic blood pressure: 0.17mmHg (standard deviation: 7.52mmHg)
- Mean difference of diastolic blood pressure: 0.29mmHg (standard deviation: 5.35mmHg)
According to Criterion 2:
- Mean difference of systolic blood pressure: 0.33mmHg (standard deviation: 6.84mmHg)
- Mean difference of diastolic blood pressure: 0.37mmHg (standard deviation: 4.77mmHg)
Accuracy:
- Pressure: ±3mmHg
- Pulse value: ±5% of reading
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 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 24, 2024
Shenzhen Urion Technology Co.,Ltd. % Wang Reanny General Manager Shenzhen Reanny Medical Devices Management Consulting Co.,Lt Room 1407, Jingting Building, Dongzhou Community, Guangming Street, Guangming District Shenzhen, Guangdong 518107 China
Re: K241007
Trade/Device Name: Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) 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 Wang Reanny:
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 (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-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
Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)
Indications for Use (Describe)
| Measure blood pressure (systolic and diastolic) and pulse rate. |
|---|
| ----------------------------------------------------------------- |
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
Traditional 510(k) Summary
510(k) number: K241007
1. Information of Submitter and Correspondent
Submitter's information:
| Company Name: | Shenzhen Urion Technology Co.,Ltd. |
|---|---|
| Street Address: | Floor 4th-6th of Building D, Jiale Science&Technology Industrial |
| Zone, No.3, ChuangWei Road, Heshuikou Community, MaTian | |
| St., GuangMing New District | |
| City: | Shenzhen |
| State/ Province: | Guangdong |
| Country: | China |
| Telephone: | +86-755-29231308 |
| Fax: | / |
| Contact Person: | Zhu Changming |
| Contact Title: | General Manager |
| Contact Email: | urion@urion.com.cn |
Date Prepared: Aug. 05, 2024
Submission correspondent's information:
Shenzhen Reanny Medical Devices Management Consulting Co., Ltd
Address: Room 1407, Jingting Building, Dongzhou Community, Guangming Street, Guangming District, Shenzhen 518107, China
Contact Person: Reanny Wang
E-mail: reanny@reanny.com
Phone: +86(755) 27391220
2. Device Information
5
| Trade Name: | Upper Arm Electronic Blood Pressure Monitor |
|---|---|
| Model: | U86E and TelliBP01 |
| Common Name: | Electronic Upper Arm Electronic Blood Pressure Monitor |
| Classification Name: | System, measurement, blood-pressure, non-invasive; |
| Regulation: | 21 CFR 870.1130 |
| Device Class: | Class 2 |
| Product Code: | DXN |
3. Identification of Predicate Device(s)
| Manufacturer | Zhuhai Linte Medical Instrument
Co., Ltd. | Shenzhen AOJ Medical
Technology Co., Ltd. |
|-------------------------|----------------------------------------------|----------------------------------------------|
| Legally Marketed Device | Electronic Sphygmomanometer | Arm Blood Pressure Monitor |
| 510(K) Number | K220220 | K222125 |
4. Description of Device
Upper Arm Electronic Blood Pressure Monitor, Model U86E and TelliBP01 are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a wellknown technique in the market called the "oscillometric method".
The main components of the Upper Arm Electronic Blood Pressure Monitor are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately 22 cm to 42 cm, includes the inflatable bladder and fabric. The device consists of the main unit and cuff.
The product is provided non-sterile, and not to be sterilized by the user prior to use.
Model U86E and TelliBP01 in this submission follow the similar software, same measurement principle and similar specifications. The differences existed between different models included in this submission will not affect the safety and effectiveness of the device.
The model U86E embed an Bluetooth Wireless network connections module that allows it to send data(systolic blood pressure, diastolic blood pressure, pulse rate) from blood pressure monitor to the Application in the external instruments. The TelliBP01 embed a SIM card, which
6
can send data(systolic blood pressure, diastolic blood pressure, pulse rate) from blood pressure monitor to the Application in the external instruments through 4G network. The wireless functions of U86E and TelliBP01 only have data transmission function, without any control feature.
5. Intended use
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.
6. Indications for Use
Measure blood pressure(systolic and diastolic) and pulse rate.
7. Discussion of Non-Clinical Tests and clinical test Performed for Determination of Substantial Equivalence are as follows:
7.1 Non-clinical testing
A series of safety and performance tests were conducted on the subject device.
- Product service life
- Software validation
- Electromagnetic compatibility and electrical safety
- Bench Testing
- Biocompatibility test
All the test results demonstrate Upper Arm Electronic Blood Pressure Monitor meets the requirements of its pre-defined acceptance criteria and intended use, and it is substantially equivalent to the predicate device.
7.2 Clinical Testing
The clinical testing has been conducted per ISO 81060-2:2018/A1:2020 Non-Invasiv Sphygmomanometers -- Part 2: Clinical Validation of Automated Measurement Type on the Electronic Sphygmomanometer.
The clinical accuracy testing was performed on the U80EH Upper Arm Electronic Blood Pressure Monitor, which is also manufactured by the sponsor. The key factors affecting clinical trials, such as the intended use, measurement site, cuff size, working principle, and the core algorithms, are the same in U80EH, U86E and TelliBP01. Therefore, the clinical clinical accuracy testing for the model for U80EH is applicable for U86E and TelliBP01.
7
The study population consisted of 93 qualified participants with an average age of 54.81 years, 39 males and 54 females. A Mercury Sphygmomanometer was used as a reference device.
According to Criterion 1, the mean difference of systolic blood pressure measured by deviceunder-test and the reference device was 0.17mmHg, with a standard deviation of 7.52mmHg; the mean difference of diastolic blood pressure was 0.29mmHg, with a standard deviation of 5.35mmHg. The mean differences of both systolic blood pressure and diastolic blood pressure were less than 5mmHg, and the standard deviations were less than 8mmHg.
According to Criterion 2, the mean difference of systolic blood pressure measured by deviceunder-test and the reference device was 0.33mmHg, with a standard deviation of 6.84mmHg; The mean difference of diastolic blood pressure was 0.37mmHg, with a standard deviation of 4.77mmHg.
All the subjects completed the clinical study without adverse event.
The device-under-test fulfilled both validation criteria 1 and 2 of ISO 81060-2:2018/A1:2020.
8. Performance Summary
The devices conform to applicable standards as follow table:
| Test Type | Standard Designation Number | FDA
Recogniti
on Status | Outcome
for Device |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------|-------------------------------|-----------------------|
| Safety | ANSI AAMI ES60601-1:2005/(R)2012
& A1:2012, C1:2009/(R)2012 &
A2:2010/(R)2012 (Cons. Text) [Incl.
AMD2:2021] | Yes | Conforms |
| EMC | IEC 60601-1-2:2020
IEC TS 60601-4-2: 2016 | Yes | Conforms |
| Software | ANSI AAMI IEC 62304:2006/A1:2016 | Yes | Conforms |
| Home healthcare
environment | IEC 60601-1-11:2020 | Yes | Conforms |
| Biocompatibility | ISO 10993-1:2018;
ISO 10993-5:2009;
ISO 10993-10:2010. | Yes | Conforms |
| Safety of Lithium
battery | IEC 62133-2:2017 | Yes | Conforms |
| Bench test | IEC 80601-2-30:2018 | Yes | Conforms |
| Clinical test | ISO 81060-2:2018/A1:2020 | Yes | Conforms |
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9. Discussion of Comparison to Predicate Devices.
The Upper Arm Electronic Blood Pressure Monitor submitted in this 510(k) submission is substantially equivalent in intended use, technological characteristics/ principles of operation and performance to the cleared Electronic Sphygmomanometer K220220, and Arm Blood Pressure Monitor K222125. Differences between the subject and predicate devices do not raise new questions of safety and effectiveness.
9
| Elements of Comparison | Subject Device | Primary Predicate Device (K220220) | Secondary Predicate Device (K222125) | Judgment |
|---|---|---|---|---|
| Trade name | Upper Arm Electronic Blood Pressure Monitor | Electronic Sphygmomanometer | Arm Blood Pressure Monitor | Same |
| Model | TelliBP01, U86E | LT-P30 | AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G | Same |
| Company | Shenzhen Urion Technology Co.,Ltd. | Zhuhai Linte Medical Instrument Co., Ltd. | Shenzhen AOJ Medical Technology Co., Ltd. | Same |
| Product code | DXN | DXN | DXN | Same |
| Classification | Class II | Class II | Class II | Same |
| Regulation # | 21CFR870.1130 | 21CFR870.1130 | 21CFR870.1130 | Same |
| Type of Use | OTC | OTC | OTC | Same |
| Application scenario | Medical Facilities and Home Use | Not publicly available | Medical Facilities and Home Use | Same |
| Indications for use | Measure blood pressure (systolic and diastolic) and pulse rate. | Measure blood pressure (systolic and diastolic) and pulse rate. | The Arm 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. | The same as the primary Predicate Device |
| Intended use | 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. | The Electronic Sphygmomanometer is intended for used by a person older than twelve (12) years to measure the systolic and diastolic blood pressure and pulse rate. | The same as the primary Predicate Device | |
| Intended patient | Person older than 12 years | Person older than 12 years | adult | The same as the primary Predicate Device |
| Application sites | Upper arm | Upper arm | Upper arm | Same |
| Operation principle | Oscillometric | Oscillometric | Oscillometric | Same |
| Measurement Item | SYS, DYS, Pulse Rate | SYS, DYS, Pulse Rate | SYS, DYS, Pulse Rate | Same |
| Blood pressure measurement range | SYS: 50mmHg~255mmHg | |||
| DIA: 30mmHg~ 200mmHg | 20-280mmHg | 30-255 mmHg | Different, refer to Remark 1 | |
| Elements of | ||||
| Comparison | Subject Device | Primary Predicate Device | ||
| (K220220) | Secondary Predicate | |||
| Device (K222125) | Judgment | |||
| Pulse rate | ||||
| measurement range | 40-199 beat/minute | 30-200bpm | 40-199 beat/minute | The same as the |
| secondary | ||||
| predicate device | ||||
| Accuracy | Pressure: ±3mmHg | |||
| Pulse value: ±5% of reading | Pressure: ±3mmHg or | |||
| ±2% of measured value, | ||||
| whichever is greater; | ||||
| Pulse Rate: ±5% | Pressure: ± 3 mmHg | |||
| Pulse value: ± 5% of | ||||
| reading | Same | |||
| Display type | LCD | LCD | LCD | Same |
| Pressurization | ||||
| source | Automatic internal pump | Automatic internal pump | Not publicly available | The same as the |
| primary Predicate | ||||
| Device | ||||
| Cuff deflation | ||||
| method | Standard exhaust valve | Standard exhaust valve | Not publicly available | The same as the |
| primary Predicate | ||||
| Device | ||||
| Cuff attachment | ||||
| method | By plastic hose connected | |||
| to monitor | By plastic hose connected | |||
| to monitor | Not publicly available | The same as the | ||
| primary Predicate | ||||
| Device | ||||
| Cuff design | D-ring cuffs | D-ring cuffs | Not publicly available | The same as the |
| primary Predicate | ||||
| Device | ||||
| Cuff | ||||
| Circumference | 22 cm to 42 cm | Small cuff: 17 ~ 22 cm | ||
| Medium cuff: 22 ~ 32cm | ||||
| Large cuff: 22 ~ 42 cm | 22~42 cm | Same | ||
| Memory | 90 measurements for each user (a | |||
| total of 180 for two users) | 45×3 recording of | |||
| measurement data for | ||||
| multiple person | Not publicly available | Different, refer to | ||
| Remark 2 | ||||
| Power source | TelliBP01: Rechargeable18650 | |||
| lithium battery, 2000mAh. | ||||
| Charging input: DC 5V 1A. | 4 AA size batteries and USB | |||
| type-C cable as an | ||||
| option | 6Vdc (4 *1.5V AAA | |||
| batteries) | Different, refer to | |||
| Remark 3 | ||||
| Operating | ||||
| Environment | U86E: DC 6V, 4xAA batteries | |||
| Temperature range: +5°C to | ||||
| +40°C, | ||||
| Relative humidity range: 15% to | Temperature: +5°C~+40℃; | |||
| Humidity: 15~80%RH | Temperature: 5°C~40°C; | |||
| Humidity: 15%-90% RH | Different, refer to | |||
| Remark 4 | ||||
| Elements of Comparison | Subject Device | Primary Predicate Device (K220220) | Secondary Predicate Device (K222125) | Judgment |
| 93% | ||||
| Storage Environment | Temperature: -20°C to +55°C, | |||
| Relative humidity range: 10% to 93% | Temperature: | |||
| -40°C~+55°C; | ||||
| Humidity: | ||||
| $\le$ 93%RH | Ambient Temperature: | |||
| -20°C to 55°C | ||||
| Relative Humidity: 10-93% | ||||
| RH | The same as the secondary predicate device | |||
| Compliance with voluntary standards | IEC 60601-1 | |||
| IEC 60601-1-11 | ||||
| ISO 80601-2-30 | ||||
| IEC 60601-1-2 | ||||
| ISO 10993-1 | ||||
| ISO 10993-5 | ||||
| ISO 10993-10 | IEC 60601-1; | |||
| IEC 60601-1-2; | ||||
| IEC 60601-1-11; | ||||
| IEC 80601-2-30; | ||||
| ISO 10993-1,-5,-10 | ||||
| ISO 81060-2 | IEC 60601-1 | |||
| IEC 60601-1-11 | ||||
| ISO 80601-2-30 | ||||
| IEC 60601-1-2 | ||||
| ISO 10993-1 | ||||
| ISO 10993-5 | ||||
| ISO 10993-10 | Same | |||
| Patient Contacting | Surface-contacting, | |||
| Less than 24 h | Not publicly available | Surface-contacting, | ||
| Less than 24 h | Same | |||
| Biocompatibility evaluation | Cytotoxicity, skin sensitization and irritation | Cytotoxicity, skin sensitization | Cytotoxicity, skin sensitization | Same |
| WHO BP classification Indicator | Yes | Not publicly available | Yes | Same |
| Irregular heart beat prompt function | Yes | Not publicly available | Not publicly available | Different, refer to Remark 5 |
| Speaking function and Clock reminder | U86E: no | |||
| TelliBP01: yes | Not publicly available | Not publicly available | Different, refer to Remark 6 | |
| Weight | TelliBP01: Approx.273 g (without battery and cuff) | |||
| U86E: Approx. 345g (without the battery and cuff) | Not publicly available | AOJ-30A/AOJ-30B/AOJ-30G: (262±5) g without battery | ||
| AOJ-30C: (316±5) g without battery | ||||
| AOJ-30D: (349±5) g without battery | ||||
| AOJ-30E: About 220 g without battery | ||||
| AOJ-30F: About 220 g without battery | Different, refer to Remark 7 | |||
| Dimensions | TelliBP01: Approx.130 mm×95 mm×52.5mm | |||
| U86E: Approx 135mm x | Not publicly available | AOJ-30A/AOJ-30B/AOJ-30G:127 mm * 93 mm * 73 mm | ||
| AOJ-30C:108 mm * 139 | Different, refer to Remark 7 | |||
| Elements of | ||||
| Comparison | Subject Device | Primary Predicate Device | ||
| (K220220) | Secondary Predicate | |||
| Device (K222125) | Judgment | |||
| W100mm x H53mm | mm * 62 mm | |||
| AOJ-30D:136 mm * 113 | ||||
| mm * 68 mm | ||||
| AOJ-30E/AOJ-30F:118 mm * 98 mm * 61mm | ||||
| Data | ||||
| transmission | U86E: Has wireless function with | |||
| Bluetooth | ||||
| TelliBP01: Has wireless function | ||||
| with 4G | Not publicly available | Has wireless function with | ||
| Bluetooth and available for | ||||
| AOJ-30A and AOJ-30B | ||||
| only | U86E is the same | |||
| as the secondary | ||||
| predicate device; | ||||
| TelliBP01 is | ||||
| Different, refer to | ||||
| Remark 8 |
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Comparison discussion:
Remark 1: The Blood pressure measurement range of subject device is different from that of predicate devices, but the blood pressure measurement range of subject device is within the range of predicate devices. In additional, the subject device had passed the testing of IEC 80601-2-30 and ISO 81060-2 standards.So the difference will not raise any safety or effectiveness issue.
Remark 2: Although the memory groups between the predicate devices are different, they both comply with the IEC 80601-2-30 and ISO 81060-2 standards, so the difference will not raise safety or effectiveness issue.
Remark 3: Although the device power sources among the predicate devices and subject device are different, they are all complied with IEC 60601-1-2, IEC 60601-1-2, IEC 60601-1-11 and IEC 80601-2-30. So the minor difference do not affect the safety and effectiveness.
Remark 4: Although the Operating Environments of predicate devices and subject device are different, they are all complied with IEC 60601-1-2, IEC 60601-1-2, IEC 60601-1-11 and IEC 80601-2-30. So the minor differences do not affect the safety and effectiveness.
Remark 5: Irregular heart beat prompt does not influence the accuracy, and the Irregular heart beat prompt function have been verified by software test. so the difference will not raise safety or effectiveness issue.
Remark 6: Speaking function and Clock reminder do not influence the accuracy, and the Speaking function and Clock reminder function of TelliBP01 have been verified by software test. so the difference will not raise safety or effectiveness issue.
Remark 7: Although the "Dimension" and "Weight" between the predicate devices and subject device are different, they all comply with IEC 60601-1 and IEC 60601-1-2, so the differences do not affect the safety and effectiveness.
Remark 8: Although the data transmission between the TelliBP01 subject device and the secondary predicate device is different. the software validation and performance testing, as well as FCC testing, indicate that this difference will not cause any new performance and safety issues.
10. Conclusions
Verification and validation testing were conducted on the subject device and all testing passed prespecified criteria. This premarket notification submission demonstrates that the Upper Arm Electronic Blood Pressure Monitor is substantially equivalent to the predicate devices.