(269 days)
No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML capabilities. The "NIBP algorithm" is a standard part of such devices and does not imply AI/ML.
No.
The device is strictly for measurement and monitoring of blood pressure and pulse rate; it does not provide therapy or treatment for any condition.
Yes
Explanation: The device is an "Electronic Blood Pressure Monitor" intended to "measure the systolic and diastolic blood pressure as well as the pulse rate." Measuring these physiological parameters to assess a person's health status constitutes a diagnostic function. The description also mentions that it can indicate "the WHO (World Health Organization) Blood Pressure Classification," further supporting its role in assessing a medical condition.
No
The device description explicitly states it is a "battery driven automatic non-invasive blood pressure monitor" that performs inflation and measurement via an inflatable cuff wrapped around the upper arm. This indicates the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device Function: The Electronic Blood Pressure Monitor measures blood pressure and pulse rate by applying a cuff to the upper arm and using an oscillometric technique. This is a non-invasive measurement performed on the body, not on a sample taken from the body.
- Intended Use: The intended use clearly states it measures blood pressure and pulse rate of an adult person via a non-invasive technique.
- Device Description: The description reinforces that it's a non-invasive blood pressure monitor.
Therefore, since the device does not perform tests on samples taken from the body, it does not fit the definition of an In Vitro Diagnostic.
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 wrapper arm. It can be used at medical facilities or at home. The intended arm circumference includes 22 cm32 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 WHO (World Health Organization) 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 12 models, including PG-800B22, PG-800B23, PG-800B26, PG-800B27, PG-800B31, PG-800B32, PG-800B33, PG-800B35, PG-800B36, PG-800B37, PG-800B42 and PG-800B43. All models follow the same software, measurement principle and NIBP algorithm. The main differences are product appearance and key numbers.
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 60601-1-11:2010, 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.
IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility
IEC 80601-2-30:2009, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers
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 for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine. The caduceus is depicted with a staff entwined by two snakes and topped with wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 13, 2017
Shenzhen Pango Electronic Co., Ltd. % Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CN
Re: K170151
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: September 14, 2017 Received: September 15, 2017
Dear Ms. 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply 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 (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
M.A. Wilhelm
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170151
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 wrapper arm. It can be used at medical facilities or at home. The intended arm circumference includes 22 cm32 cm42 cm.
Type of Use (Select one or both, as applicable)
| For use in a HUD-held or FHA-held Single Family Residence | |
|---|---|
| Loan Type Conversion of a HUD-held Single Family Mortgage |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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: K170151
-
- Date of Preparation: 03/9/2017
-
- Sponsor Identification
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: Ms. 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: 240-238-7587 Email: info@mid-link.net
4
Identification of Proposed Device 4.
Trade Name: Electronic Blood Pressure Monitor; Common Name: Arm Blood Pressure Monitor; Models: PG-800B22, PG-800B26, PG-800B26, PG-800B31, PG-800B32, PG-800B33, PG-800B35. PG-800B36. PG-800B37. PG-800B42 and PG-800B43
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 WHO (World Health Organization) 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 12 models, including PG-800B22, PG-800B23, PG-800B26, PG-800B27, PG-800B31, PG-800B32, PG-800B33, PG-800B35, PG-800B36, PG-800B37, PG-800B42 and PG-800B43. All models follow the same software, measurement principle and NIBP algorithm. The main differences are product appearance and key numbers.
The proposed device is intended to be used in medical facilities or at home.
5
The product is provided non-sterile, and not to be sterilized by the user prior to use.
-
న్. Identification of Predicate Device
510(k) Number: K131558 Product Name: Electronic Blood Pressure Monitor 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.
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.
IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility
IEC 80601-2-30:2009, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers
-
- Substantially Equivalent
| ITEM | Proposed Device, Electronic Blood Pressure
Monitor | Predicate Device, PG-800B series
Electronic Blood Pressure Monitor,
K131558 |
|----------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Product Code | DXN | DXN |
| Regulation No. | 21 CFR 870.1130 | 21 CFR 870.1130 |
| Class | II | II |
| Intended Use | The Electronic Blood Pressure Monitor is
intended to measure the systolic and diastolic | PG-800B Electronic Blood Pressure Monitor
is intended to measure the systolic and |
Table 1 Substantially Equivalent Comparison
6
| | 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. | diastolic blood pressure as well as the pulse
32 cm
rate of adult person via non-invasive
oscillometric technique in which an
inflatable cuff is wrapped around the arm. It
can be used at medical facilities or at home.
The intended arm circumference is 22-32
cm. |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Measurement Type | Upper arm | Upper arm |
| Patient Population | Adult | Adult |
| Measurement Item | Systolic Pressure, Diastolic Pressure, Pulse
Rate | Systolic Pressure, Diastolic Pressure, Pulse
Rate |
| Principle | Oscillometric | Oscillometric |
| Component | LCD / Key / Cuff / MCU / Pump / Batteries | LCD / Key / Cuff / MCU / Pump / Batteries |
| arm circumference | 2232cm and 3242cm | 22~32cm |
| Blood Pressure
Range | 30 ~ 280 mmHg | 30 ~ 280 mmHg |
| Pulse Rate
Range | 40-199 bpm | 40-199 bpm |
| Patient Contact | Cuff – Nylon | Cuff – Nylon |
| Material | Enclosure – ABS
Key - ABS | Enclosure – ABS
Key – ABS |
| 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
Performance | Comply with IEC
80601-2-30:2009 and ISO 81060-2:2013 | ANSI/AAMI SP10 |
| Software Level
Concern | Moderate | Moderate |
The propoed device and its predicate devices have the identical indented use, components, principle and performance. The difference between the proposed device and the predicate device do not raise any question regarding its safety and effectiveness.
The proposed device, Electronic Blood Pressure Monitor PG-800B22, PG-800B23, PG-800B26, PG-800B27, PG-800B31, PG-800B32, PG-800B33, PG-800B36, PG-800B36, PG-800B37, PG-800B42 and PG-800B43, is determined to be Substantially Equivalent (SE) to the predicate device, PG-800B series Electronic Blood Pressure Monitor, (K131558), in respect of safety and effectiveness.