(88 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement and data storage, with no mention of AI or ML algorithms for analysis, prediction, or enhanced measurement. The algorithm is stated to be identical to the predicate device, which is a standard blood pressure monitor.
No
The device is an electronic blood pressure monitor, intended for measuring blood pressure and pulse rate, which are diagnostic functions rather than therapeutic ones. It does not actively treat or alleviate a medical condition.
Yes
Explanation: The device is intended to measure systolic and diastolic blood pressure and pulse rate, providing objective data that can be used for diagnosis or monitoring of health conditions related to blood pressure. It also includes a function to indicate WHO Blood Pressure Classification, further supporting its diagnostic utility.
No
The device description explicitly states it is a "battery driven non-invasive blood pressure monitor" that "can complete the inflation, deflation and measurement," indicating it includes hardware components beyond just software.
Based on the provided information, this device 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Electronic Blood Pressure Monitor measures blood pressure and pulse rate non-invasively by wrapping a cuff around the upper arm. It does not analyze samples taken from the body.
- Intended Use: The intended use is to measure physiological parameters (blood pressure and pulse rate) directly from the body, not to analyze biological samples.
Therefore, this device falls under the category of a non-invasive medical device for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / 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.
The intended arm circumference includes 22 cm~32 cm.
Product codes (comma separated list FDA assigned to the subject device)
DXN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper arm
Indicated Patient Age Range
adult person
Intended User / Care Setting
medical facilities or at home (inferred)
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)
Non-clinical tests:
- Electrical safety and electromagnetic compatibility (EMC): 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: Conducted and documented 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.
- Human Factor and Usability Testing: Conducted and documented according to IEC 62366-1. The result demonstrated all users did not show any critical errors and suggested performance can be smoother with extra practices without specific usability problems. The device was found to be reasonably safe and effective for intended users, uses, and use environments.
Clinical Testing:
- 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.
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.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
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
1
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.
2
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
3
Indications for Use
Submission Number (if known)
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 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.
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
5
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 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.
6. Intended Use / 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.
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 of
| Comparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Company | Shenzhen Pango Electronic | ||
| Co.,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 of | |||
| Comparison | 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 | -- |
| Medical | |||
| Specialty | Cardiovascular | Cardiovascular | Same |
| Regulation | Noninvasive blood pressure | ||
| measurement system | Noninvasive blood pressure | ||
| measurement system | Same | ||
| Product Code | DXN | DXN | Same |
| Regulation | |||
| Class | Class II | Class II | Same |
| Intended Use / | |||
| 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. | |||
| The intended arm circumference | |||
| includes 22 cm~32 cm. | 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 cm | |||
| cm. | Similar | ||
| Note 1 | |||
| Type for use | OTC | OTC | Same |
| Measurement | |||
| Site | Upper arm | Upper arm | Same |
| Patient | |||
| Population | Adult | Adult | Same |
| Measurement | |||
| ltem | Systolic Pressure, Diastolic | ||
| Pressure, Pulse Rate | Systolic Pressure, Diastolic Pressure, | ||
| Pulse Rate | Same | ||
| Measurement | |||
| Method | 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: 4x1.5V | |||
| AAA or LR03 batteries | |||
| PG-800B61: 4x1.5V AA or LR06 | |||
| batteries | 4x 1.5V Battery (AA or LR6 batteries) | Same | |
| Blood Pressure | |||
| Range | 30~280 mmHg | 30~280 mmHg | Same |
| Blood Pressure | 3mmHg | 3mmHg | Same |
| Elements of | Subject Device | Predicate Device | Verdict |
| Comparison | |||
| Accuracy | |||
| Pulse Rate | |||
| Range | 40-199bpm | 40-199bpm | Same |
| Cuff | |||
| Circumference | 22-32cm | 22-32cm and 32-42cm | Similar |
| Note1 | |||
| Patient Contact | |||
| Material | Cuff -Silk Cloth | ||
| Enclosure - ABS | |||
| Key - ABS | Cuff - Nylon | ||
| Enclosure - ABS | |||
| Key - ABS | Similar | ||
| Note 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 |
| Particular | |||
| Performance | Comply with IEC 80601-2-30 | Comply with IEC 80601-2-30 | Same |
| Clinical | |||
| measurement | |||
| performance | Comply with ISO 80601-2 | Comply with ISO 80601-2 | Same |
| Note 3 | |||
| Software Level | |||
| Concern | Moderate | Moderate | Same |
6
7
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
8
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
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.
9. Final conclusion
The subject device is as safe, as effective, and performs as well as the legally marketed predicated devices K170151.