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.
The intended arm circumference includes 22 cm~32 cm.

Device Description

The proposed device, Electronic Blood Pressure Monitor, is a battery driven non-invasive blood pressure monitor. It can complete the inflation, deflation 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: mmHq 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 13 models, including PG-800B30, PG-800B39, PG-800B45, PG-800B46, PG-800B48, PG-800B48, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61. All models follow the same software, measurement principle and NIBP algorithm. The main differences are product appearance and key numbers.
The product is provided non-sterile, and not to be sterilized by the user prior to use.

AI/ML Overview

The provided document is a 510(k) summary for an Electronic Blood Pressure Monitor (Model: PG-800B30, etc.) from Shenzhen Pango Medical Electronics Co., Ltd. This document does not contain information about software algorithms for intelligent analysis or AI assistance. Therefore, it does not provide the details requested for acceptance criteria and study proving device performance for such AI-based systems.

The document discusses the substantial equivalence of the new device to a predicate device (K170151), focusing on non-clinical tests (electrical safety, EMC, software verification/validation, human factors/usability) and stating that no clinical measurement performance test was needed because the blood pressure measurement function, principle, and NIBP algorithm are identical to the legally marketed predicate device.

Specifically, the document lacks the following:

Acceptance criteria table and reported device performance for an AI/ML algorithm. The "Accuracy" row in the comparison table refers to the device's accuracy for blood pressure measurement (3mmHg), not an AI algorithm's performance metrics.
Sample size and data provenance for an AI test set.
Number of experts and their qualifications used for ground truth establishment for an AI algorithm.
Adjudication method for an AI test set.
Multi-reader multi-case (MRMC) comparative effectiveness study details.
Standalone (algorithm-only) performance data.
Type of ground truth used for an AI algorithm.
Training set sample size for an AI algorithm.
Method for establishing ground truth for an AI training set.

The document states that the device's software was considered a "Moderate" level of concern, and software verification and validation testing were conducted as per FDA guidance. However, this is for the device's core functionality (non-invasive blood pressure measurement using an oscillometric technique), not an AI-driven diagnostic or analytical tool.

In summary, this document is for a standard electronic blood pressure monitor, not a device incorporating a novel AI/ML algorithm that would require the detailed performance study and acceptance criteria you've asked for.

Summary

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June 14, 2024

Shenzhen Pango Medical Electronics Co., Ltd. % Cassie Lee Official Correspondent Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road Huangpu District Guangzhou, Guangdong 510700 China

Re: K240729

Trade/Device Name: Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39. PG-800B45. PG-800B46. PG-800B47. PG-800B48. PG-800B53. PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: March 15, 2024 Received: March 18, 2024

Dear Cassie Lee:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Robert T. Kazmierski -S

for

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K240729

Device Name

Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B39, PG-800B39, PG-800B45, PG-800B46, PG-800B47, PG-800B48, PG-800B53, PG-800B56, PG-800B57, PG-800B58, PG-800B61)

Indications for Use (Describe)

The intended arm circumference includes 22 cm~32 cm.

Type of Use (Select one or both, as applicable)

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 of K240729

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Date of the summary prepared: June 10, 2024

2. Submitter's Information

Company Name: Shenzhen Pango Medical Electronics Co., Ltd. Address: No.25, the 1st industrial park, Fenghuang Road, Xikeng,Henggang Town, Longgang district, Shenzhen, 518115, Guangdong, China Contact name: Xiaoyun Yanq Title: Deputy General Manager Tel: 755-33825988 Fax: / E-mail: sales@pan-go.com

Application Correspondent

Contact Person: Ms. Cassie Lee Company: Guangzhou GLOMED Biological Technology Co., Ltd. Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Title: Manager Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com

3. Subject Device Information

Company Name: Shenzhen Pango Medical Electronics Co., Ltd. Trade Name: Electronic Blood Pressure Monitor Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46, PG-800B47, PG-800B48, PG-800B53, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61 Medical Specialty: Cardiovascular Common Name: Noninvasive blood pressure measurement system Classification Name: System, Measurement, Blood-Pressure, Non-Invasive Requlation Number: 21 CFR 870.1130 Product Code: DXN Regulation Class: Class II

4. Predicate Device Information

510(k) Number: K170151 Company Name: Shenzhen Pango Medical Electronics Co., Ltd. Trade Name: Electronic Blood Pressure Monitor

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K240729

Model: 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 Medical Specialty: Cardiovascular Common Name: Noninvasive blood pressure measurement system Classification Name: System, Measurement, Blood-Pressure, Non-Invasive Regulation Number: 21 CFR 870.1130 Product Code: DXN Requlation Class: Class II

5. Device Description

The product is provided non-sterile, and not to be sterilized by the user prior to use.

6. Intended Use / Indications for Use

The intended arm circumference includes 22 cm~32 cm.

7. Comparison to predicate devices

Compare with the predicate devices, the subject device is very similar in technical design, intended use/indications for use, functions, etc. And the differences between the subject device and predicate devices do not raise new questions of safety or effectiveness. Please refer to the detailed Substantial Equivalence Comparison of the subject device and predicate devices in the following table.

Elements ofComparison	Subject Device	Predicate Device	Verdict
Company	Shenzhen Pango ElectronicCo.,Ltd.	Shenzhen Pango Electronic Co.,Ltd.	--
Trade Name	Electronic Blood Pressure Monitor	Electronic Blood Pressure Monitor	--
Model	PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46,PG-800B47, PG-800B48, PG-	PG-800B22, PG-800B23, PG-800B26,PG-800B27, PG-800B31, PG-800B32,PG-800B33, PG-800B35, PG-800B36,	--
Elements ofComparison	Subject Device	Predicate Device	Verdict
	800B53, PG-800B55, PG-800B56,PG-800B57, PG-800B58, PG-800B61	PG-800B37, PG-800B42 and PG-800B43
510(k) Number	K240729	K170151	--
MedicalSpecialty	Cardiovascular	Cardiovascular	Same
Regulation	Noninvasive blood pressuremeasurement system	Noninvasive blood pressuremeasurement system	Same
Product Code	DXN	DXN	Same
RegulationClass	Class II	Class II	Same
Intended Use /Indications forUse	The Electronic Blood PressureMonitor is intended to measure thesystolic and diastolic bloodpressure as well as the pulse rateof adult person via non-invasiveoscillometric technique in which aninflatable cuff is wrapped aroundthe upper arm.The intended arm circumferenceincludes 22 cm~32 cm.	The Electronic Blood Pressure Monitoris intended to measure the systolic anddiastolic blood pressure as well as thepulse rate of adult person via non-invasive oscillometric technique inwhich an inflatable cuff is wrappedaround the upper arm. It can be usedat medical facilities or at home.The intended arm circumferenceincludes 22 cm~~32 cm and 32 cm~~42cm.	SimilarNote 1
Type for use	OTC	OTC	Same
MeasurementSite	Upper arm	Upper arm	Same
PatientPopulation	Adult	Adult	Same
Measurementltem	Systolic Pressure, DiastolicPressure, Pulse Rate	Systolic Pressure, Diastolic Pressure,Pulse Rate	Same
MeasurementMethod	Oscillometric	Oscillometric	Same
Component	LCD / Key / Cuff / MCU / Pump /Batteries	LCD / Key / Cuff / MCU / Pump /Batteries	Same
Power Source	PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46,PG-800B47, PG-800B48, PG-800B53, PG-800B55, PG-800B56,PG-800B57, PG-800B58: 4x1.5VAAA or LR03 batteriesPG-800B61: 4x1.5V AA or LR06batteries	4x 1.5V Battery (AA or LR6 batteries)	Same
Blood PressureRange	30~280 mmHg	30~280 mmHg	Same
Blood Pressure	3mmHg	3mmHg	Same
Elements of	Subject Device	Predicate Device	Verdict
Comparison
Accuracy
Pulse RateRange	40-199bpm	40-199bpm	Same
CuffCircumference	22-32cm	22-32cm and 32-42cm	SimilarNote1
Patient ContactMaterial	Cuff -Silk ClothEnclosure - ABSKey - ABS	Cuff - NylonEnclosure - ABSKey - ABS	SimilarNote 2
Electrical Safety	Comply with IEC 60601-1	Comply with IEC 60601-1	Same
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	Same
ParticularPerformance	Comply with IEC 80601-2-30	Comply with IEC 80601-2-30	Same
Clinicalmeasurementperformance	Comply with ISO 80601-2	Comply with ISO 80601-2	SameNote 3
Software LevelConcern	Moderate	Moderate	Same

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Comparison in Detail(s):

Note 1:

Though the cuff circumference in "Intended Use / Indications for Use" and "Cuff Circumference" of the subject device is only one cuff type with a circumference of 22-32cm, and the predicate device has 2 cuff types with a circumference of 22-32cm. The cuff type with a 22-32cm circumference is the same as the predicate device's 22-32cm cuff type. So the difference between the subject device and the predicate device will not raise any safety or effectiveness issues.

Note 2:

Although the cuff material of the subject device is different from the predicate device, we conducted the biocompatibility tests according to ISO 10993-10 on the cuff of subject device, and all test results are in compliance with standards' requirements. So the difference between the subject device and the predicate device will not raise any safety or effectiveness issues.

Note 3:

No Clinical measurement performance test is included in this submission, because the blood pressure measurement function including the measurement principle and NIBP algorithm of the proposed device is identical with that of the legally marketed Electronic Blood Pressure Monitor (predicate device, K170151), which is also manufactured by the sponsor. In addition, the cuff size of the proposed device is also same as that of the legally marketed Electronic Blood Pressure Monitor (predicate device, K170151). So, there is no necessary to conduct the additional clinical measurement performance on our subject device.

8. Test Summary

8.1 Summary of Non-clinical tests

Non-clinical tests were performed on the subject device in order to validate the design and to assure

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conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility:

Electrical safety and electromagnetic compatibility (EMC) -Electrical safety and EMC testing were conducted on the Electronic Blood Pressure Monitor. The subject device complies with the IEC 60601-1-11 and IEC 80601-2-30 standards for safety and the IEC 60601-1-2 standard for EMC.
-Software Verification and Validation Testing Software verification and validation testing were conducted and documented which provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" The software for this device was considered as a "Moderate" level of concern, since a failure in the software could result in minor injury to the patient or operator.
Human Factor and Usability Testing -Usability test were conducted and documented according to the recognized consensus standards of IEC 62366-1. The result of the usability demonstrated all the users in testing did not show any critical errors and represented the performance of using can be smoother by extra practices without specific usability problems. The Electronic Blood Pressure Monitor has been found to be reasonably safe and effective for the intended users, uses and use environments.

8.2 Summary of Clinical Testing

9. Final conclusion

The subject device is as safe, as effective, and performs as well as the legally marketed predicated devices K170151.

Regulation Number and Section

§ 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).