(243 days)
Not Found
No
The description focuses on standard blood pressure measurement technology (oscillometric method), data transfer, and communication features. There is no mention of AI, ML, or any algorithms that would suggest learning or adaptive capabilities. The performance study compares functionality to predicate devices, not AI/ML performance metrics.
No
The device is intended to measure blood pressure and pulse rate, and transfer data. It does not perform any therapeutic function.
Yes
The device measures physiological parameters like systolic and diastolic blood pressure and pulse rate, which are used to assess a patient's health status. While it also has communication features, its core function of measuring these vital signs qualifies it as a diagnostic device.
No
The device description explicitly states it is composed of hardware components including a blood pressure module, cuff, LCD touch pad control panel, and CPU processor.
Based on the provided text, the HX-461 device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is to measure blood pressure and pulse rate, and to transfer this data electronically. It also facilitates the reception of data from other measurement instruments (blood glucose, body fat), but it does not perform the diagnostic testing itself.
- Device Description: The device description focuses on the oscillometric method for blood pressure measurement and its communication capabilities. It describes how it receives data from other devices, not how it performs in vitro diagnostic tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device is a measurement and data management tool for physiological parameters.
While it can receive data from a blood glucose meter (which is an IVD), the HX-461 itself is not performing the blood glucose test. It's acting as a data hub and communication device for various health parameters.
N/A
Intended Use / Indications for Use
HX-461 is intended for used by adults to measure the systolic and diastolic blood pressure and pulse rate and transfer medical device data electronically to the designated health care center through internet website. HX-461 enables user reqistration for user-specific data management, and provides blood pressure measurement function. It can receive blood pressure, blood qlucose and body fat measurement values by connecting with respective measurement instruments supporting Bluetooth connection, or by docking a blood glucose meter on its back. In addition, HX-461 supports wired/wireless communication with a designated person including video communication.. It has three size of cuff for blood pressure measurement. User chooses the cuff depending on their arm circumference.
Product codes (comma separated list FDA assigned to the subject device)
DXN, OUG
Device Description
HX-461 applies the oscillometric method to measure patient blood pressure. It is composed of blood pressure module, cuff, LCD touch pad control panel and CPU processer based on Window CE to operate the blood pressure module. Patient can easily operate the device with the touch pad using the cuff installed in the device. Operator can control by touch screen based on SEERSTECHNOLOGY CO., LTD.'s software. It has unique communication function that can get the medical information from other blood pressure meter, blood glucose meter and body fat measurement device using bluetooth module and wire connector. HX-461 has a wire and wireless internet function.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults
Intended User / Care Setting
Not Found
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)
The Device is investigated for function and effectiveness to compare the operation of function between HX-461 and the UA-789 & UA-767PBT.
Comparison results demonstrate that the specifications and performance of the device are same as functional and effective as the legally marketed predicate device.
Therefore, it is concluded that HX-461 is substantially equivalent to the legally marketed predicate device
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
UA-789 & UA-767PBT(K043217)
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
5. 510(k) Summary
See 510(k) Summary, below.
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- Trade Name: HX-461 Common Name: Auto Blood Pressure Meter Product Code: DXN (Blood pressure measurement monitor), OUG (Medical Device Data System) Regulation: 21 CFR 870.1130 & 21 CFR880.6310 Class of device : ClassII.
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- The legally marketed device to which we are claiming equivalence: UA-789 & UA-767PBT(K043217)
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- Description of device:
HX-461 applies the oscillometric method to measure patient blood pressure. It is composed of blood pressure module, cuff, LCD touch pad control panel and CPU processer based on Window CE to operate the blood pressure module. Patient can easily operate the device with the touch pad using the cuff installed in the device. Operator can control by touch screen based on SEERSTECHNOLOGY CO., LTD.'s software. It has unique communication function that can get the medical information from other blood pressure meter, blood glucose meter and body fat measurement device using bluetooth module and wire connector. HX-461 has a wire and wireless internet function.
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- Intended Use: HX-461 is intended for used by adults to measure the systolic and diastolic blood pressure and pulse rate and transfer medical device data electronically
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- Technological Characteristics:
The Device is investigated for function and effectiveness to compare the operation of function between HX-461 and the UA-789 & UA-767PBT.
Comparison results demonstrate that the specifications and performance of the device are same as functional and effective as the legally marketed predicate device.
Therefore, it is concluded that HX-461 is substantially equivalent to the legally marketed predicate device
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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 eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 23 2012
SEERS Technology Co., Ltd. c/o Mr. Peter Chung 300 Atwood Street Pittsburgh, PA 15213
Re: K120545
Trade name: HX-461 Auto Blood Pressure Meter Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: July 23, 2012 Received: October 19, 2012
Dear Mr. Chung:
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.
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Page 2 - Mr. Peter Chung
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-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.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indications for Use Statement
Indications for Use
510(k) Number (if known): K12
Device Name: HX-461
Indications For Use:
HX-461 is intended for used by adults to measure the systolic and diastolic blood pressure and pulse rate and transfer medical device data electronically to the designated health care center through internet website. HX-461 enables user reqistration for user-specific data management, and provides blood pressure measurement function. It can receive blood pressure, blood qlucose and body fat measurement values by connecting with respective measurement instruments supporting Bluetooth connection, or by docking a blood glucose meter on its back. In addition, HX-461 supports wired/wireless communication with a designated person including video communication.. It has three size of cuff for blood pressure measurement. User chooses the cuff depending on their arm circumference.
| Cuff size | Arm Circumference |
|---|---|
| D-cuff Small | : 18-22cm |
| D-cuff Adult | : 22-32cm |
| D-cuff Large | : 32-45cm |
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
120545
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| NEEDED) |
| Concurrence of CDRH, Office of Device Evaluation (DE) |
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| Page (Quision Sign-On) |
| - Division of Cardiovascular Devices |
510(k) Number.