(269 days)
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.
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.
The provided document is a 510(k) summary for the "Electronic Blood Pressure Monitor" by Shenzhen Pango Electronic Co., Ltd. It declares substantial equivalence to a predicate device. However, this document primarily focuses on regulatory compliance, outlining intended use, device description, comparison to a predicate, and non-clinical test conclusions based on various IEC standards.
Crucially, this document does NOT contain information about a clinical study involving a test set, expert readers, ground truth establishment, or any data related to diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) that would be relevant for a typical AI/ML medical device submission.
Instead, the performance of this blood pressure monitor is assessed against standards for accuracy defined by organizations like ISO and IEC for non-invasive sphygmomanometers. Therefore, the "acceptance criteria" and "proof of meeting criteria" here refer to the device's ability to measure blood pressure within the specified accuracy limits of these standards, not against a human expert consensus.
Given this, I will interpret the requested information in the context of a blood pressure monitor's accuracy testing, as implied by the reference to IEC 80601-2-30:2009 and ISO 81060-2:2013 (which generally address accuracy requirements for automated sphygmomanometers).
Based on the provided document, here's an attempt to answer your questions, with the understanding that the "study" is likely a performance verification against a standard, not a clinical trial with human readers assisting AI.
1. A table of acceptance criteria and the reported device performance
The document states that the device "Comply with IEC 80601-2-30:2009 and ISO 81060-2:2013" for "Particular Performance." These standards define the accuracy requirements for automated non-invasive sphygmomanometers.
Acceptance Criteria (as per ISO 81060-2:2013 for clinical validation for blood pressure devices):
The ISO 81060-2:2013 standard typically requires two main criteria for accuracy:
- Mean difference: The mean difference between the device's measurement and the reference standard (e.g., mercury sphygmomanometer) should be $\le \pm 5$ mmHg.
- Standard deviation: The standard deviation of the difference between the device's measurement and the reference standard should be $\le 8$ mmHg.
- Individual differences (AAMI/BHS protocols often append this): A high percentage of measurements (e.g., >60% for AAMI, or various grades for BHS) must fall within certain error margins (e.g., $\pm 5, \pm 10, \pm 15$ mmHg).
Reported Device Performance:
The document states: "The test results demonstrated that the proposed device complies with the following standards: ... IEC 80601-2-30:2009, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers" and "Comply with IEC 80601-2-30:2009 and ISO 81060-2:2013".
Therefore, the reported device performance is that it met the accuracy requirements outlined in these standards. The specific numerical values (mean difference and standard deviation) are not provided in this 510(k) summary, but the declaration of compliance serves as the proof.
| Acceptance Criteria (from ISO 81060-2:2013) | Reported Device Performance |
|---|---|
| Mean difference $\le \pm 5$ mmHg | Complies with ISO 81060-2:2013 (indicating these criteria were met) |
| Standard deviation $\le 8$ mmHg | Complies with ISO 81060-2:2013 (indicating these criteria were met) |
| (Additional criteria for individual differences vary by protocol, but compliance with the standard implies these were also met) | Complies with ISO 81060-2:2013 (indicating these criteria were met) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the accuracy testing. ISO 81060-2:2013 typically recommends a minimum of 85 participants for a clinical validation study to assess accuracy. The data provenance (country of origin, retrospective/prospective) is also not disclosed in this summary. Such details would usually be found in the full test report, not the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable in the context of a blood pressure monitor's accuracy testing. The "ground truth" for blood pressure measurements is typically established by simultaneous measurements using a reference standard device, often a double-headed mercury sphygmomanometer, read by trained observers, not "experts" in the sense of medical specialists adjudicating an image.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Blood pressure accuracy testing does not involve adjudication of readings in the typical sense of expert consensus on an image or medical condition. Instead, it involves comparison to standard reference measurements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an automatic blood pressure monitor, not an AI-assisted diagnostic tool that human readers would use. There is no human-in-the-loop component or AI assistance for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the fundamental performance assessment of an automated blood pressure monitor is a standalone performance evaluation. The device (algorithm and hardware) measures blood pressure and provides a reading without human intervention in the measurement process. The "standalone" performance here refers to its accuracy against a reference standard. The document confirms that "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."
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For blood pressure monitor accuracy, the ground truth is established by simultaneous, direct comparison to a validated reference measurement method, typically a mercury sphygmomanometer or an equivalent standard, performed by two trained observers. It is a live physiological measurement, not an static image or pathology result.
8. The sample size for the training set
This device does not appear to be an AI/ML model that undergoes "training" in the conventional sense of deep learning. It uses an "oscillometric technique" and an "NIBP algorithm" (Non-Invasive Blood Pressure algorithm). While such algorithms might be refined and calibrated, the concept of a "training set" as understood in modern AI/ML development (with vast amounts of labeled data) is not explicitly stated or implied by the document for this device. It's more of a calibration and validation process against physical principles and existing data.
9. How the ground truth for the training set was established
As there's no explicitly mentioned "training set" in the AI/ML sense, this question isn't directly applicable. The underlying algorithm would have been developed based on general principles of oscillometry and vast amounts of existing physiological data, where the "ground truth" would originate from reference blood pressure measurements across diverse populations.
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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
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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
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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)
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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
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- 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
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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.
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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
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- Substantially Equivalent
| ITEM | Proposed Device, Electronic Blood PressureMonitor | Predicate Device, PG-800B seriesElectronic 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 isintended to measure the systolic and diastolic | PG-800B Electronic Blood Pressure Monitoris intended to measure the systolic and |
Table 1 Substantially Equivalent Comparison
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| blood pressure as well as the pulse rate of adultperson via non-invasive oscillometrictechnique in which an inflatable cuff iswrapped around the upper arm. It can be usedat medical facilities or at home. The intendedarm circumference includes: 22 cm | diastolic blood pressure as well as the pulserate of adult person via non-invasiveoscillometric technique in which aninflatable cuff is wrapped around the arm. Itcan be used at medical facilities or at home.The intended arm circumference is 22-32cm. | |
|---|---|---|
| Measurement Type | Upper arm | Upper arm |
| Patient Population | Adult | Adult |
| Measurement Item | Systolic Pressure, Diastolic Pressure, PulseRate | Systolic Pressure, Diastolic Pressure, PulseRate |
| Principle | Oscillometric | Oscillometric |
| Component | LCD / Key / Cuff / MCU / Pump / Batteries | LCD / Key / Cuff / MCU / Pump / Batteries |
| arm circumference | 22 | 22~32cm |
| Blood PressureRange | 30 ~ 280 mmHg | 30 ~ 280 mmHg |
| Pulse RateRange | 40-199 bpm | 40-199 bpm |
| Patient Contact | Cuff – Nylon | Cuff – Nylon |
| Material | Enclosure – ABSKey - ABS | Enclosure – ABSKey – 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 |
| ParticularPerformance | Comply with IEC80601-2-30:2009 and ISO 81060-2:2013 | ANSI/AAMI SP10 |
| Software LevelConcern | 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.
§ 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).