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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the HX-461 Auto Blood Pressure Meter. This type of regulatory document typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed study results against specific, quantitatively defined acceptance criteria for a novel device.

Based on the provided text, here's an analysis of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a table format. Instead, it relies on a comparison to predicate devices, asserting that the HX-461's specifications and performance are "same as functional and effective as the legally marketed predicate device."

2. Sample Size Used for the Test Set and Data Provenance:

The document does not provide information on the sample size used for a test set or the data provenance (e.g., country of origin, retrospective/prospective). The assessment appears to be based on "investigation for function and effectiveness" by comparing the new device directly to the predicate device.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not mention the use of experts to establish ground truth.

4. Adjudication Method:

The document does not describe any adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention an MRMC study. The comparison is between the HX-461 and predicate blood pressure monitors, not a comparison of human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance:

The document does not provide standalone performance data for an algorithm. The HX-461 is a blood pressure measurement device, not an AI-driven diagnostic algorithm in the context typically associated with standalone performance studies.

7. Type of Ground Truth Used:

The document does not explicitly mention a specific type of ground truth beyond the "comparison results" demonstrating functional and effective equivalence to the predicate devices. For blood pressure monitors, ground truth typically involves a reference measurement method (e.g., auscultation with a manometer) against which the automated device is validated. However, such details are not in this summary.

8. Sample Size for the Training Set:

The document does not mention a training set or its sample size. This is expected as the HX-461 is a hardware device, not an AI model that typically requires a training set.

9. How Ground Truth for the Training Set Was Established:

As there is no mention of a training set, the document does not describe how ground truth for a training set was established.

Summary based on the provided text:

The 510(k) summary for the HX-461 Auto Blood Pressure Meter primarily focuses on demonstrating substantial equivalence to existing predicate devices (UA-789 & UA-767PBT). The "study" referenced is a qualitative comparison of the device's function and effectiveness against these predicates. It does not provide detailed quantitative acceptance criteria, performance metrics, sample sizes for testing or training, or information about expert ground truth establishment commonly found in studies evaluating novel diagnostic algorithms.

The key statement regarding performance is: "Comparison results demonstrate that the specifications and performance of the device are same as functional and effective as the legally marketed predicate device." This implies that the HX-461's performance is acceptable because it matches that of already cleared devices.

Summary

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K120545

5. 510(k) Summary

See 510(k) Summary, below.

1. 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.
1. The legally marketed device to which we are claiming equivalence: UA-789 & UA-767PBT(K043217)
1. Description of device:

1. 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
1. 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:

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)

Concurrence of CDRH, Office of Device Evaluation (DE)
Page (Quision Sign-On)
- Division of Cardiovascular Devices

510(k) Number.

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).