(14 days)
Not Found
No
The document describes a standard oscillometric blood pressure monitor and does not mention any AI or ML capabilities. The "Not Found" entries for AI/ML mentions and training/test sets further support this.
No
The device is described as a monitor used to measure blood pressure and pulse rate, providing information for diagnosis or monitoring but not for treating a condition.
No
The device measures physical parameters (blood pressure and pulse rate) but does not interpret these measurements to diagnose a specific disease or condition. Its function is to provide data, which may then be used by a healthcare professional for diagnosis. The WHO classification feature also refers to a general classification and does not explicitly state it is for diagnosis.
No
The device description explicitly states it is a "battery driven automatic non-invasive blood pressure monitor" and mentions an "inflatable cuff," indicating it is a hardware device with software components, not a software-only medical device.
Based on the provided information, the PG-800A Electronic Blood Pressure Monitor 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 PG-800A measures blood pressure and pulse rate using a non-invasive oscillometric technique applied to the wrist. It does not analyze any samples taken from the body.
- Intended Use: The intended use describes measuring physiological parameters directly from the patient's body.
Therefore, the PG-800A falls under the category of a non-invasive medical device used for monitoring physiological signs, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
PG-800A 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 Electronic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It 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. The device has the data storage function. It has an 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.
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 person
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)
Performance and Clinical Verification Test per ANSI/AAMI SP10:2002+A1:2003+A2:2006.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
KD-795 Blood Pressure Monitor as cleared in K070826
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
K102920
OCT 1 5 2010
PANGAO®
·
Premarket Notification promission Promission
Traditional Sec. 510(L) Submission
PG-800A Ellectronic Blood Pressure Monitor
Sec. III 510(k) Summary
OCT 15 2016
IH-1
Sec. III 510(k) Summary
| This 510(k) Summary is prepared per the request of 21 CFR 807.92. The Assigned 510(k) Number is: | |
|---|---|
| Date | 20 JUL 2010 |
| Sponsor | Shenzhen Pango Electronic Co., Ltd |
| No.25, 1st Industrial Park, Fenghuang Road, Xikeng Village, Henggang Town, | |
| Longgang District, Shenzhen, Guangdong, 518115, China | |
| Contact Person: Ms. Xiaoyun Yang, Vice General Manager | |
| T: +86-755-33825988 F: +86-755-33825989 E: sales@pan-go.com | |
| Submission | MS. Diana Hong / MR. Lee Fu |
| Correspondent | Shanghai Mid-Link Consulting Co., Ltd |
| P.O.BOX 237-023, Shanghai, 200237, China | |
| Proposed Device | Electronic Blood Pressure Monitor, PG-800A |
| Classification | System, Measurement, Blood-pressure, Non-invasive DXN 21 CFR 870.1130 Class II |
| Intended Use | PG-800A 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. | |
| Device Description | The proposed device, PG-800A Electronic Blood Pressure Monitor, is a battery driven automatic |
| non-invasive blood pressure monitor. It 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. The device has the data storage function. It has an 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. | |
| Testing | Electric Safety per IEC 60601-1:1988+A1:1991+A2:1995 / EMC per IEC 60601-1-2:2001+A1:2004 |
| Performance and Clinical Verification Test per ANSI/AAMI SP10:2002+A1:2003+A2:2006 | |
| Biocompatibility per ISO 10993-5:2006 / ISO 10993-10:2002+AMD:2006 | |
| Predicate Device | KD-795 Blood Pressure Monitor as cleared in K070826 |
| SE Conclusion | The proposed device, PG-800A Electronic Blood Pressure Monitor, measures the blood pressure via |
| same principle, oscillometric, at the same site, wrist, as the predicate device. Both of them are | |
| driven by batteries. The patient contact materials of both are Nylon and ABS. Therefore, the | |
| proposed device, PG-800A Electronic Blood Pressure Monitor, is claimed to be Substantially | |
| Equivalent (SE) to the predicate device, KD795 Blood Pressure Monitor as cleared in K070826, in | |
| aspect of safety and effectiveness |
Shenzhen Pango Electronic Co., Ltd
Report SN: SHA01420100715-01
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes above a wavy line, representing water. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Shenzhen Pango Electronic Co., Ltd. c/o Mr. Ned Devine Underwriters Laboratories Inc. 333 Pfingsten Road Northbrook, IL 60062
OCT 1 5 2010
Re: K102920
Trade/Device Name: Electronic Blood Pressure Monitor, Model PG-800A Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: 74 DXN Dated: September 20, 2010 Received: October 1, 2010
Mr. Devine:
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.
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.
2
Page 2 - Mr. Ned Devine
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-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/CDRH/CDRHOffices/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 yours,
Bram D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
PANGAO®
Premarket Notification Traditional Sec. 510(k) Submission PG-800A Electronic Blood Pressure Monitor Sec. II Indication for Use
1 5 2010 OCT
:
Sec. II Indication for Use Statement
510(k) Number:
Device Name: PG-800A Electronic Blood Pressure Monitor
Indications for Use:
PG-800A Electronic Blood Pressure Monitor is intended to measure the systelic 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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (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)
(Division Sign-Off)
Division of Cardiovascular Devices
Page _ I_ of
510(k) Number K102920
Shenzhen Pango Electronic Co., Ltd Report SN: SHA01420100715-01
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