(15 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement and does not mention AI or ML.
No.
The device is intended to measure blood pressure and pulse rate, not to treat or cure any medical condition.
No
The device measures blood pressure and pulse rate, which are physiological parameters, not a diagnosis for a disease or condition. While the measurements can be used for monitoring health, the device itself doesn't provide a diagnosis.
No
The device description explicitly states it is a "battery driven automatic on-invasive blood pressure monitor" with an "inflatable cuff," indicating it is a hardware device with integrated software, not a software-only device.
No, 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 PG-800A Series Electronic Blood Pressure Monitor measures blood pressure and pulse rate non-invasively by wrapping a cuff around the wrist. It does not analyze any samples 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.
Therefore, based on the provided information, the device is a non-invasive medical device for measuring physiological parameters, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
PG-800A 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 wrist. It can be used at medical facilities or at home. The intended wrist circumference is 13.5-19.5 cm.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The proposed device, PG-800A Series Electronic Blood Pressure Monitor, is a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at wrist 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 and data storage. These two 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
wrist
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)
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.
AAMI SP10:2002/(R) 2008 & A1:2003, Manual, electronic or automated sphygmomanometers.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
BP Accuracy: +/- 3 mmHg
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
JUN 1 4 2013
11 - 11 - 11
K131569
P 1/4
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: December 20, 2012
-
- Sponsor
Shenzhen Pango Electronic Co., Ltd No.25, 156 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
Submission Correspondent 3. Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
- Proposed Device Identification 4.
..
Proposed Device Name: Electronic Blood Pressure Monitor;
1
Proposed Device Model: PG-800A Series, including: PG-800AD, PG-800A-1, PG-800AD-1,
K131569 P 2/4
. 2
. .
PG-800A3, PG-800A4, PG-800A4D, PG-800A5, PG-800A5D, PG-800A6, PG-800A6D, PG-800A6-1, PG-800A6-2, PG-800A7, PG-800A7D, PG-800A9, PG-800A8, PG-800A11, PG-800A12, PG-800A15
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:
PG-800A 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 wrist. It can be used at medical facilities or at home. The intended wrist circum ference is 13.5-19.5 cm.
- Predicate Device Identification 5.
510(k) Number: K102920
Product Name: Electronic Blood Pressure Monitor, PG-800A Manufacturer: Shenzhen Pango Electronic Co., Ltd
- Device Description 6.
The proposed device, PG-800A Series Electronic Blood Pressure Monitor, is a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at wrist 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 and data storage. These two differences will not affect the safety and effectiveness of the device.
-
- Non-Clinical Test Conclusion
.
- 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
2
device complies with the following standards:
| K131569 | ||
|---|---|---|
| P 3/4 |
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.
AAMI SP10:2002/(R) 2008 & A1:2003, Manual, electronic or automated sphygmomanometers.
- Substantially Equivalent 8.
| ITEM | PG-800A Series
Electronic Blood Pressure Monitor | Electronic Blood Pressure
Monitor PG-800A, K102920 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Product Code | DXN | Same |
| Regulation No. | 21 CFR 870.1130 | Same |
| Class | II | Same |
| Intended Use | PG-800A 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 wrist. It can be used at medical
facilities or at home. The intended wrist
circumference is 13.5-19.5 cm. | Same |
| Measurement
Type | Wrist | Same |
| Patient
Population | Adult | Same |
| Measurement
Item | SYS, DYS, Pulse Rate | Same |
| Principle | Oscillometric | Same |
| BP Range | 30~280 mmHg | Same |
| BP Accuracy | $\pm$ 3 mmHg | Same |
| PR Range | 40-199 bpm | Same |
| Cuff Size | 30.8 cm (length) x 8 cm (width) | Same |
| Power Supply | two AAA or LR03 batteries | Same |
| Software Level
Concern | Moderate | Same |
Table III-1 Substantially Equivalent Comparison
3
3
.
.
.
K 1 3 1 569 .
The proposed device, PG-800A Series Electronic Blood Pressure Monitor, is determined to be Substantially Equivalent (SE) to the predicate device, Electronic Blood Pressure Monitor PG-800A (K102920), in respect of safety and effectiveness.
. . : :
. : : .
: . . . . 1 .
. .
. . . . . . . . 4
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: the department's name arranged in a circular fashion around the left side and a stylized symbol on the right. The symbol is a stylized representation of an eagle or bird in flight, with three curved lines forming the wings and body. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 14, 2013
Shenzhen Pango Electronic Co., Ltd. c/o Mr. Jeff D. Rongero Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709
Re: K131569
Trade/Device Name: Electronic Blood Pressure Monitor, PG-800A Series Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: May 24, 2013 Received: May 30, 2013
Dear Mr. Rongero:
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. Iisting 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
5
Page 2 - Mr. Jeff D. Rongero
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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours,
Owen P Earis -S
for Bram D. Zuckerman, M.D.
Director_ Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
K131569
Indications for Use
510(k) Number:
Device Name: Electronic Blood Pressure Monitor
Models: PG-800A Series, including: PG-800AD, PG-800A-1, PG-800AD-1, PG-800A3, PG-800A4, PG-800A4D, PG-800A5, PG-800A5D, PG-800A6, PG-800A6-1, PG-800A6-1, PG-800A6-2, PG-800A7, PG-800A7D, PG-800A9, PG-800A8, PG-800A11, PG-800A12, PG-800A15
Indications for Use:
The PG-800A 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 wrist.
It can be used at medical facilities or at home.
The intended wrist circumference is 13.5-19.5 cm.
OPRESCRIPTION USE (Part 21 CFR 801 Subpart D)
ZOVER-THE-COUNTER USE (21 CFR 801. Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Owen P. Faris -S
2013.06.14 10:03:03
-04'00'
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