(261 days)
No
The description focuses on standard oscillometric blood pressure measurement and data storage. There is no mention of AI/ML terms, image processing, or any description of training/test sets which would be typical for an AI/ML device. The algorithm is described as a standard NIBP algorithm, identical to the predicate device.
No
The device is intended to measure blood pressure and pulse rate, not to treat any medical condition.
Yes
Explanation: The device is described as an "Electronic Blood Pressure Monitor" intended to "measure the systolic and diastolic blood pressure as well as the pulse rate". Measuring these physiological parameters is a form of diagnosis, as it provides information about the patient's health status. The device also has a "bar indicating function, which can indicate the World Health Organization (WHO) Blood Pressure Classification," which further supports its role in assessing a patient's condition.
No
The device description explicitly states it is a "battery driven automatic non-invasive blood pressure monitor" that "can automatically complete the inflation and measurement," indicating it includes hardware components like a pump, valve, and sensor, in addition to software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Device Function: The Electronic Blood Pressure Monitor measures blood pressure and pulse rate non-invasively by wrapping a cuff around the upper arm. It does not analyze any samples taken from the body.
- Intended Use: The intended use is to measure physiological parameters (blood pressure and pulse rate) directly from the patient's body.
Therefore, based on the provided information, the Electronic Blood Pressure Monitor is a non-invasive medical device used for monitoring physiological signs, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Electronic Blood Pressure Monitor is intended to measure the systolic 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 arm circumference includes 22 cm32 cm and 32 cm42 cm.
Product codes
DXN
Device Description
The proposed device, Electronic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the 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.
The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. It has a bar indicating function, which can indicate the World Health Organization (WHO) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2.
The proposed electronic blood pressure monitor has six models, including PG-800B18, PG-800B19, PG-800B19L. PG-800B28. PG-800B29. PG-800B51. All models follow the same software, measurement principle and NIBP algorithm.
The proposed device is intended to be used in medical facilities or at home.
The product is provided non-sterile, and not to be sterilized by the user prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
adult
Intended User / Care Setting
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012, Medical electrical equipment -Part 1: General requirements for basic safety, and essential performance
- IEC 60601-1-2:2014, -Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- IEC 80601-2-30:2009, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
- IEC 60601-1-11:2010. 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.
No Clinical study is included in this submission, because the blood pressure measurement function including the measurement principle and NIBP algorithm of the proposed device is identical with that of the legally marketed Electronic Blood Pressure Monitor (predicat device, K170151), which is also manufactured by the sponsor. In addition, the cuff size of the proposed device is also same as that of the legally marketed Electronic Blood Pressure Monitor (predicat device, K170151).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
December 4, 2020
Shenzhen Pango Electronic Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 China
Re: K200716
Trade/Device Name: Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: November 4, 2020 Received: November 5, 2020
Dear Diana Hong:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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.
LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality 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) K200716
Device Name Electronic Blood Pressure Monitor
Indications for Use (Describe)
The Electronic Blood Pressure Monitor is intended to measure the systolic 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 arm circumference includes 22 cm32 cm and 32 cm42 cm.
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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3
Tab #6 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number:
-
- Date of Preparation: 2/20/2020
- Sponsor Identification 2.
Shenzhen Pango Electronic Co.,Ltd.
No.25, 1st Industrial Park, Fenghuang Road, Xikeng, Henggang, Longgang District Shenzhen, Guangdong, 518115, China.
Establishment Registration Number: 3006792041
Contact Person: Xiaoyun Yang Position: Vice General Manager Tel: +86-755-33825988 Fax: +86-755-33825989 Email: sales@pan-go.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360 925-3199 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: Electronic Blood Pressure Monitor Common Name: Arm Blood Pressure Monitor; Models: PG-800B18, PG-800B19, PG-800B19L, PG-800B28, PG-800B29 and PG-800B51
Regulatory Information
Classification Name: Noninvasive blood pressure measurement system Classification: II; Product Code: DXN; Regulation Number: 21 CFR 870.1130; Review Panel: Cardiovascular;
Indications for Use:
The 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 arm circumference includes 22 cm32 cm and 32 cm42 cm.
Device Description
The proposed device, Electronic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the 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.
The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. It has a bar indicating function, which can indicate the World Health Organization (WHO) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2.
The proposed electronic blood pressure monitor has six models, including PG-800B18, PG-800B19, PG-800B19L. PG-800B28. PG-800B29. PG-800B51. All models follow the same software, measurement principle and NIBP algorithm.
The proposed device is intended to be used in medical facilities or at home.
The product is provided non-sterile, and not to be sterilized by the user prior to use.
5
-
ર . Identification of Predicate Device
510(k) Number: K170151 Product Name: Electronic Blood Pressure Monitor Model: PG-800B22, PG-800B23, PG-800B26, PG-800B27, PG-800B31, PG-800B32, PG-800B33, PG-800B35, PG-800B36, PG-800B37, PG-800B43 and PG-800B42 Manufacturer: Shenzhen Pango Electronic Co., Ltd. -
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
-
IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012, Medical electrical equipment -Part 1: General requirements for basic safety, and essential performance
-
A 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
-
A IEC 80601-2-30:2009, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
-
IEC 60601-1-11:2010. 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.
-
- Clinical Test Conclusion
No Clinical study is included in this submission, because the blood pressure measurement function including the measurement principle and NIBP algorithm of the proposed device is identical with that of the legally marketed Electronic Blood Pressure Monitor (predicat device, K170151), which is also manufactured by the sponsor. In addition, the cuff size of the proposed device is also same as that of the legally marketed Electronic Blood Pressure Monitor (predicat device, K170151).
6
8. Substantially Equivalent (SE) Comparison
| Item | Proposed Device, Electronic Blood Pressure
Monitor | Predicate Device, K170151
Electronic Blood Pressure Monitor |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | DXN | DXN |
| Regulation Number | 21 CFR 870.1130 | 21 CFR 870.1130 |
| Class | II | II |
| Indications for Use | The 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
arm circumference includes: 22 cm32 cm and42 cm. | The Electronic Blood Pressure Monitor is
32 cm
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 arm circumference
includes: 22 cm32 cm and 32 cm42 cm. |
| Measurement Site | Upper arm | Upper arm |
| Patient Population | Adult | Adult |
| Measurement Item | Systolic Pressure, Diastolic Pressure, Pulse
Rate | Systolic Pressure, Diastolic Pressure, Pulse
Rate |
| Measurement
Method | Oscillometric | Oscillometric |
| Component | LCD / Key / Cuff / MCU / Pump / Batteries | LCD / Key / Cuff / MCU / Pump / Batteries |
| Blood Pressure Range | 30280mmHg/ | 30 ~ 280 mmHg |32cm and 32
| Blood Pressure Accuracy | 3mmHg | 3 mmHg |
| Pulse Rate Range | 40 ~ 199 bpm | 40 ~ 199 bpm |
| Data storage | SYS, DIA, Pulse Rate, Measurement Time,
Memory Number. | SYS, DIA, Pulse Rate, Measurement Time,
Memory Number. |
| WHO BP Classification | Model PG-800B18, PG-800B19,
PG-800B19L, PG-800B28, PG 800B29 has
WHO BP Classification Per WHO
Classification
Model PG-800B51 has not WHO BP
Classification | All models provide WHO Classification |
| Power Supply | 4 x 1.5V Batteries (LR03 or AAA) for models
PG-800B18, PG-800B19,
PG-800B19L ,PG-800B28, PG-800B29
Rechargeable Li-ion Battery PL 652035HC for
model: PG-800B51 | 4x 1.5V Battery (AA or LR6 batteries) |
| Records Quantity | Single patient records quantity:90 for E)for
models PG-800B18, PG-800B19, PG-800B28,
PG-800B29, PG-800B51 | Single patient records quantity:90 for
Electronic Blood Pressure Monitor
(PG-800B42) |
| | Doulbe patient records quantity: 90/90 for r for | Doulbe patient records quantity:60/60 for |
| | model :PG PG-800B19L | Electronic Blood Pressure Monitor |
| | | (PG-800B22, PG-800B23, PG-800B26, |
| | | PG-800B27, PG-800B31, PG-800B32, |
| | | PG-800B33, PG-800B35, PG-800B36, |
| | | PG-800B37, PG-800B43) |
| Arm circumference | 2242cm | 2232cm and 32~42cm |
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
| Particular | Comply with IEC | Comply with IEC |
| Performance | 80601-2-30:2009 | 80601-2-30:2009 |
| Clinical study | Not conducted | Conducted according to ISO 81060-2 |
| Patient Contact Material | Cuff - Nylon Brush Tricot | Cuff - Nylon |
| | Enclosure - ABS | Enclosure - ABS |
| | Key - ABS | Key - ABS |
| Software Level Concern | Moderate | Moderate |
Table 1 Comparison of Technology Characteristics
7
By comparisons, there are mainly four differences between proposed device and predicated device. which are power supply, voltage, record quantities and clincial study.
SE Analysis 1-WHO BP classification
Majority models of proposed device have WHO BP classification which is identical to predicated device except model PG-800B51. Yet the WHO BP classification indicating is only for reference, it cannot be used as diagnosis criteria. This difference will not affect the safety and effectiveness, therefore this item is considered as substantial equivalence.
SE Analysis 2- Power supply
The difference between proposed device and predicated device (K170151) is the batteries , the proposed device use 4 x 1.5V Batteries (for models: PG-800B18, PG-800B19, PG-800B19L PG-800B28, PG-800B29) and Rechargeable Li-ion Battery PL 652035HC for model: PG-800B51 while the predicate device use four AA or LR6 batteries, but the power supply safety of proposed device is justified by the IEC60601-1 electricity test reports, and the rechargeable battery of the proposed device meets the requirements of IEC 62133. thus This difference will not affect the safety and effectiveness, therefore this item is considered as substantial equivalence.
SE Analysis 3 -Record quantities
For single patient model, the proposed device has the same record quantities as predicate device. For double patient model, the records quantities of proposed device is 90/90 while for predicated device is 60/60 , yet the proposed device adopt same measurement principle and NIBP algorithm as predicated device, software function is justified by the software documents. This difference will not affect the safety and effectiveness, therefore this item is considered as substantial equivalence.
8
SE Analysis 4- Clinical study
No Clinical study is included in this submission, because the blood pressure measurement function including the measurement principle and NIBP algorithm of the proposed device is identical with that of the legally marketed Electronic Blood Pressure Monitor (predicat device, K170151), which is also manufactured by the sponsor. In addition, the cuff size of the proposed device is also same as that of the legally marketed Electronic Blood Pressure Monitor (predicat device, K170151).
-
- Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.
- Substantially Equivalent (SE) Conclusion