(34 days)
PG-800B 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 is 22-32 cm.
The proposed device, PG-800B 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 arm 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.
Here's a breakdown of the acceptance criteria and the study details for the PANGAO® PG-800B Electronic Blood Pressure Monitor, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary references performance and clinical verification testing per ANSI/AAMI SP10:2002+A1:2003+A2:2006. This standard outlines the accuracy requirements for automated sphygmomanometers. While the exact numerical acceptance criteria and reported performance are not explicitly detailed in the provided text, the fact that the device was cleared implies it met these standards.
Based on the ANSI/AAMI SP10 standard, the general acceptance criteria for blood pressure monitors typically require:
- Mean difference: The average difference between the device's readings and a reference standard (e.g., auscultatory measurements by trained observers) should be within a specific range (e.g., ±5 mmHg).
- Standard deviation (or overall accuracy within a range): The standard deviation of these differences should also be within a specified limit (e.g., 8 mmHg).
- These criteria usually apply independently to both systolic and diastolic blood pressure measurements.
Without the specific test report, I cannot provide the exact reported device performance values. Therefore, the table below reflects the implied acceptance criteria from the referenced standard, noting that the reported performance would have met these.
| Measurement Parameter | Acceptance Criteria (Implied by ANSI/AAMI SP10) | Reported Device Performance (Not explicitly stated in provided document) |
|---|---|---|
| Systolic BP | Mean difference ≤ ±5 mmHg, Standard deviation ≤ 8 mmHg (typically) | Met the ANSI/AAMI SP10 standard requirements (implied by 510(k) clearance) |
| Diastolic BP | Mean difference ≤ ±5 mmHg, Standard deviation ≤ 8 mmHg (typically) | Met the ANSI/AAMI SP10 standard requirements (implied by 510(k) clearance) |
| Pulse Rate | Accuracy within a specified range (e.g., ±5% or ±5 beats/min) (varies by standard) | Met the ANSI/AAMI SP10 standard requirements (implied by 510(k) clearance) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The provided document does not explicitly state the sample size used for the clinical verification test.
- Data Provenance: The document states the sponsor is "Shenzhen Pango Electronic Co., Ltd" in Guangdong, China. The submission correspondent is "Shanghai Mid-Link Consulting Co., Ltd" also in China. This strongly suggests the data was collected in China. The study type is a clinical verification test, which typically implies prospective data collection for accuracy validation against a reference method.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not specify the number of experts or their qualifications.
- In the context of ANSI/AAMI SP10 testing, ground truth for blood pressure measurements is typically established by at least two, and often three, trained observers using a standardized auscultatory method, calibrated sphygmomanometers, and following strict protocols. These observers are usually medical professionals (e.g., nurses, physicians, or trained technicians).
4. Adjudication Method for the Test Set
- The document does not explicitly state the adjudication method.
- For ANSI/AAMI SP10 standards, if multiple observers are used, discrepancies are often handled by:
- Averaging: Taking the average of the observers' readings if they are within a pre-defined acceptable range.
- Third observer: If the initial two observers disagree beyond the acceptable range, a third independent observer's reading might be taken, or the average of the two closest readings might be used. The 2+1 or 3+1 methods are common.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI devices, where the AI assists human readers. For a blood pressure monitor, the primary effectiveness is its standalone accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Yes, a standalone study was done. The clinical verification test per ANSI/AAMI SP10 is designed to assess the accuracy of the device (algorithm and hardware combined) against a reference standard without human intervention influencing the device's measurement. The device itself is the "algorithm only" in this context of a blood pressure monitor.
7. The Type of Ground Truth Used
- The ground truth used would be "expert consensus" or "reference measurement." Specifically, it would involve auscultatory blood pressure measurements taken by trained human observers using a mercury or aneroid sphygmomanometer as the gold standard, against which the automated oscillometric readings from the PG-800B device are compared.
8. The Sample Size for the Training Set
- The document does not provide any information regarding a training set sample size. For a physically-based device like a blood pressure monitor using an oscillometric technique, while calibration and internal algorithm development involve data, it's not typically a "machine learning" training set in the same way an image recognition AI would have. The "training" here would be part of the device's engineering and calibration processes.
9. How the Ground Truth for the Training Set was Established
- As above, the document does not provide details on a specific training set or its ground truth establishment. The development of oscillometric algorithms involves extensive engineering and physiological modeling. While large datasets of oscillometric waveforms and corresponding auscultatory readings might be used during the development and calibration phases, these are generally not described as "training sets" in regulatory documents for such devices in the same vein as AI/ML applications. The underlying physics and signal processing are the "ground truth" for the algorithm itself, validated against clinical standards like ANSI/AAMI SP10.
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PANGAO®
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Premarket Notification
Traditional Sec. 510(k) Submission
PG-800B Electronic Blood Pressure Monitor
Sec. III 510(k) Summary
NOV - 9 2010
次;
・・・・・
Sec. III 510(k) Summary
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| 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-800B |
| Classification | System, Measurement, Blood-pressure, Non-invasive DXN 21 CFR 870.1130 Class II |
| Intended Use | PG-800B 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 is 22-32 cm. | |
| Device Description | The proposed device, PG-800B 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 arm 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-595 Blood Pressure Monitor as cleared in K070828. |
| SE Conclusion | The proposed device, PG-800A Electronic Blood Pressure Monitor, measures the blood pressure via |
| same principle, oscillometric, at the same site, upper arm, as the predicate device, Both of | |
| them are driven by batteries. The proposed device, PG-800B Electronic Blood Pressure Monitor, is | |
| claimed to be Substantially Equivalent (SE) to the predicate device, KD595 Blood Pressure Monitor as | |
| cleared in K070828, in aspect of safety and effectiveness. |
Shenzhen Pango Electronic Co., Ltd
Report SN: SHA01420100715-02
III-I
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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 features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. The logo is simple and recognizable, representing the department's role in promoting health and well-being.
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 Third Party reviewer Underwriters Laboratories, Inc. 333 Pfingsten Rd. Northbrook, IL 60062
NOV - 9 2010
Re: K102988
Trade/Device Name: Electronic Blood Pressure Monitor, PG-800B Regulation Number: 21 CFR 870.1130 Regulation Name: Non invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: October 22, 2010 Received: October 28, 2010
Dear 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.
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Page 2 - 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Dime R.V. Ines
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1610
PANGAO®
Premarket Notification Traditional Sec. 510(k) Submission PG-800B Electronic Blood Pressure Monitor Sec. II Indication for Use Statement
Indication for Use Statement Sec. II
510(k) Number: K102988 Device Name: PG-800B Electronic Blood Pressure Monitor
2010
Indications for Use:
PG-800B 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 is 22-32 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)
Duma b. V. Limes
Page 1 of _
(novascular Devices
510(k) Number K10 2
Shenzhen Pango Electronic Co., Ltd Report SN: SHA01420100715-02
II-1
§ 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).