(108 days)
Not Found
No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML capabilities. The technology described is a well-established non-invasive technique.
No.
The device is used for measurement and monitoring (blood pressure and pulse rate), not for treating or rehabilitating a condition, which are characteristic functions of a therapeutic device.
Yes
Explanation: The device measures blood pressure and pulse rate, which are physiological parameters used to assess a patient's health status, making it a diagnostic tool.
No
The device description explicitly states it is a "battery driven automatic on-invasive blood pressure monitor" and uses an "inflatable cuff wrapped around the upper arm," indicating it is a hardware 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:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The U80 Series Upper Arm Electronic Blood Pressure Monitor measures blood pressure and pulse rate non-invasively by wrapping a cuff around the upper arm. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it measures blood pressure and pulse rate via a non-invasive technique.
Therefore, this device falls under the category of a non-invasive medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The U80 Series Upper Arm Electronic 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. It can be used at medical facilities or at home. The intended upper arm circumference is 22-36cm.Suitable for adults who over the age of 12.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The proposed device, U80 Series Electronic Blood Pressure Monitor, is a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa.
All the models included in this submission follow the same measurement principle and same specifications. The main differences are appearance, data storage and time display. These three differences will not affect the safety and effectiveness of the device.
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
Adults who over the age of 12.
Intended User / Care Setting
It can be used at medical facilities or at home.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench 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 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety, and essential performance.
IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
ANSI/AAMI/IEC 80601-2-30:2009 Medical electrical equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers.
ANSI/AAMI/ISO 81060-2:2009 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
BP Accuracy: +/-3 mmHg
PR Range: 40-199 bpm
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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 22, 2016
Shenzhen Urion Technology Co., Ltd. Ms. Autumn Liu Sales Manager 4th Building, Hi-tech Industrial Zone, Heping Community, Fuyong Street, Baoan Shenzhen, 518103 CN
Re: K160019
Trade/Device Name: Upper Arm Electronic Blood Pressure Monitor U80 Series, including: U80A, U80AH, U80B, U80BH Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: December 28, 2015 Received: January 15, 2016
Dear Ms. Autumn Liu,
We have reviewed vour 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
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 yours,
Mitchell Stei
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K160019
Device Name
Upper Arm Electronic Blood Pressure Monitor U80 Series, including: U80A, U80AH, U80B, U80BH
Indications for Use (Describe)
The U80 Series Upper Arm Electronic 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. It can be used at medical facilities or at home. The intended upper arm circumference is 22-36cm.Suitable for adults who over the age of 12.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
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4
K160019 Page 1 of 4
Section III 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number:
-
- Date of Submission: Dec 28, 2015
-
- Sponsor
Shenzhen Urion Technology Co., Ltd 4th building, Hi-tech Industrial Zone, Heping Community,Fuyong street, Baoan District, Shenzhen, Guangdong, China 518103
Establishment Registration Number: not yet;
Contact Person: MS. Autumn Liu Position: Sales Manager Tel: +86-755-29231308 Fax: +86-755-27493959 Email: autumn@urion.com.cn
- Submission Correspondent 3. MS. Autumn Liu Shenzhen Urion Technology Co., Ltd. 4th building, Hi-tech Industrial Zone, Heping Community, Fuyong street, Baoan District, Shenzhen, Guangdong, China 518103 Tel: (86 755) 29231308 Fax: (86 755) 27493959 Email: autumn@urion.com.cn
-
- Proposed Device Identification
Proposed Device Name: Electronic Blood Pressure Monitor;
5
K160019 Page 2 of 4
Proposed Device Model: U80 Series, including: U80A, U80AH, U80B, U80BH
Classification Name: System, measurement, blood-pressure, non-invasive; Common Name: Electronic Blood Pressure Monitor; Classification: 2 Product Code: DXN; Regulation Number: 21 CFR 870.1130; Review Panel: Cardiovascular;
Intended Use Statement:
The U80 Series Upper Arm Electronic 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. It can be used at medical facilities or at home. The intended upper arm circumference is 22-36 cm. Suitable for persons who over the age of 12.
-
- Predicate Device Identification
510(k) Number: K001670 Product Name: Electronic Blood Pressure Monitor, HEM-757 Manufacturer: Omron Healthcare, Inc
- Predicate Device Identification
-
- Device Description
The proposed device, U80 Series Electronic Blood Pressure Monitor, is a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa.
- Device Description
All the models included in this submission follow the same measurement principle and same specifications. The main differences are appearance, data storage and time display. These three differences will not affect the safety and effectiveness of the device.
-
- Non-Clinical Test Conclusion
Bench 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:
- Non-Clinical Test Conclusion
IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety, and essential performance.
IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
6
K160019 Page 3 of 4
ANSI/AAMI/IEC 80601-2-30:2009 Medical electrical equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers.
ANSI/AAMI/ISO 81060-2:2009 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type.
-
- Substantially Equivalent
| ITEM | U80 Series
Electronic Blood Pressure Monitor | Electronic Blood
Pressure Monitor
HEM-757, K001670 | Comparison |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Product Code | DXN | DXN | Same |
| Regulation No. | 21 CFR 870.1130 | 21 CFR 870.1130 | Same |
| Class | II | II | Same |
| Intended Use | U80 Series Electronic 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. It can
be used at medical facilities or at
home. The intended upper arm
circumference is 22-36 cm. | Measure the systolic and
diastolic blood pressure
and pulse rate in adult
patients with arm
circumference between
7inches to 15 inches. | SE
Analysis 1 |
| Measurement
Type | Upper arm | Upper arm | Same |
| Patient
Population | Adults
Person
over
12 | Adult | Same |
| Measurement
Item | SYS, DYS, Pulse Rate | SYS, DYS, Pulse Rate | Same |
| Principle | Oscillometric | Oscillometric | Same |
| BP Range | 0 ~ 299 mmHg | 0 ~ 280mmHg | SE
Analysis 2 |
| BP Accuracy | $\u00b13$ mmHg | $\u00b13$ mmHg or 2% of reading | SE
Analysis 3 |
| PR Range | 40-199 bpm | 40-180 bpm | SE
Analysis 4 |
Table III-1 Substantially Equivalent Comparison
7
| Premarket Notification 510(k) Submission | Section III 510(k) Summary | Project #: 201401K |
|---|---|---|
| Cuff Size | 63 cm (length) x 14.4 cm (width) | 48 cm (length) x 14 cm (width) |
| SE | ||
| Analysis 1 | ||
| Power Supply | Four AA batteries or AC adapter | Four AA batteries or AC adapter |
| Same | ||
| Software Level | ||
| Concern | Moderate | Moderate |
| Same |
SE Analysis 1
The intended arm circumferences (22-36 cm VS about 17.8-38 cm) and cuff size (63 X 14.4cm VS 48 X 14 cm) of the proposed and predicate device are difference are very slight, and the cuff size is appropriate to the claimed intended arm circumference per ANSI/AAMI/IEC 80601-2-30. Therefore, this point is considered as substantially equivalent.
SE Analysis 2
The blood pressure measurement range of the proposed is a little larger than that of the predicate device. (0-299 mmHg VS 0-280 mmHg). But the difference parts of the range 280-299 mmHg are happened very rare and abnormal, and the range is clearly stated on the label of the container and instructions manual, the operator can select whether to use this product per the actual conditions. Therefore, this difference is considered to be not affect the substantially equivalent conclusion.
SE Analysis 3
The blood pressure measurement accuracy of the proposed is a little different compared with that of the predicate device. (±3 mmHg VS ±3 mmHg or 2% of reading). For the predicate device's measurement accuracy with ±3 mmHg or 2% of reading, the larger shall be taken, that is, for the actual measurement range 0-300mmHg, the accuracy is more than ±3 mmHg. Therefore, this point is considered as substantially equivalent.
SE Analysis 4
The pulse rate measurement range of the proposed is a little different compared with that of the predicate device. (40 - 199 bpm VS 40 - 180 bpm). The difference parts, 180-199 bpm, is very rare and abnormal, and the the range is clearly stated on the label of the container and instructions manual, the operator can select whether to use this product per the actual conditions. Therefore, this difference is considered to be not affect the substantially equivalent conclusion.
The proposed device, U80 Series Upper Arm Electronic Blood Pressure Monitor, is determined to be Substantially Equivalent (SE) to the predicate device, Electronic Blood Pressure Monitor HEM-757 (K001670), in respect of safety and effectiveness.