The Blood pressure monitor with stethoscope, Model HBPK-A is a non-automated, aneroid blood pressure monitor that is used for the indirect measurement (noninvasive) and display of arterial blood pressure. It can be used by professionals as well as trained individual users at hospital or at home to monitor both systolic and diastolic pressure. This device is sold with an adult D-ring cuff and suitable for use on adult.

Device Description

Blood pressure monitor with stethoscope, Model HBPK-A is a non-invasive blood pressure measurement system for monitoring blood pressure levels. This Non-automated Sphygmomanometer uses an occluding cuff, an aneroid manometer to measure pressure, and a stethoscope for detecting Korotkoff sounds.

The Aneroid Sphygmomanometer with Stethoscope contains:

1. Adjustable D-ring Cuff (Adult Size)
1. Stethoscope (Attaches to the cuff)
1. Non-stop rotary pin. 300 mmHq gauge
1. Instruction booklet and record
1. Carrying case

-The Blood pressure monitor with stethoscope enables the user to monitor the pressure of flowing blood that is exerted against the arteries at highest (systolic or contraction) and lowest (diastolic or relaxation) pressure. To operate, the user places the attached stethoscope on the inner arm above the bend in the elbow, to detect the pulse of the brachial artery. After inflation of the cuff, the user does auditory monitoring with the stethoscope to evaluate systolic and diastolic pressure. The two values are usually recorded as a ratio of the two measurements: systolic over diastolic.

AI/ML Overview

The provided text refers to a traditional, non-automated aneroid blood pressure monitor with a stethoscope. As such, the concept of "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of software-driven AI/ML devices, as typically asked for in these questions, does not directly apply here.

However, I can extract information related to the device's performance validation based on the standards it claims to meet.

Acceptance Criteria and Device Performance (Interpreted from Compliance to Standards)

Acceptance Criteria Category	Specific Criteria (from standards)	Reported Device Performance
Blood Pressure Accuracy	Compliance with ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003 (Manual, electronic or automated sphygmomanometers)	"The device successfully passed all the requirements within these standards." (Implies meeting accuracy requirements, though specific accuracy values are not provided)
Biocompatibility	Compliance with ISO 10993-5 (Tests for in vitro cytotoxicity) and ISO 10993-10 (Tests for irritation and skin sensitization)	"The device successfully passed all the requirements within these standards." (Implies the externally contacting components are biocompatible)
General Safety & Effectiveness	Compliance with other general controls and applicable parts of the Federal Food, Drug, and Cosmetic Act	"Blood pressure monitor with stethoscope, Model HBPK-A is safe and effective as proven by compliance to consensus standards."

Study Details (Not applicable in the AI/ML sense, but interpreted from regulatory submission)

Sample size used for the test set and the data provenance: Not applicable. For a manual aneroid sphygmomanometer, "test set" in the context of AI/ML data is not relevant. The "testing" refers to physical and performance testing against the cited standards. The provenance of subjects used in any clinical validation for the ANSI/AAMI SP10 standard is not detailed in this summary.
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): Not applicable. "Ground truth" in the AI/ML sense is not relevant here. The ground truth for blood pressure measurement against which the device would be compared (if direct clinical validation data were presented, which it is not) would typically involve a reference standard measurement method performed by trained clinicians.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept is for AI/ML model output disagreements, which doesn't apply to this device.
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 is not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a manual device requiring human operation. There is no standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for evaluating blood pressure monitors against standards like ANSI/AAMI SP10 typically involves comparison to a highly accurate reference method (e.g., intra-arterial measurement or another validated sphygmomanometer) performed by trained personnel. This document only states "compliance to consensus standards" and does not detail the specific ground truth used in the underlying studies for those standards or for this specific device's validation.
The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set."
How the ground truth for the training set was established: Not applicable.

Summary

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510(k) Summary

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

Date: July 14, 2012

Company and Correspondent making the submission:

	Company	Correspondent
Name	Hangzhou Reli-On Co., Ltd	IRC/ Charles Mack
Address	#204, 3Xin Chang Road,Gongshu District, HangzhouCity, Zhejiang Province, CHINA	77325 Joyce WayEcho, Oregon 97826
Phone	+86-571-28036398	931-625-4938
FAX	+86-571-28036400	541-376-5063
Contact	Ms. Yu Manhua / GeneralManager	Charles Mack/PrincipalEngineer
Internet	charliemack@irc-us.com	charliemack@irc-us.com

2. Device :

Trade/proprietary name: Blood pressure monitor with stethoscope, Model HBPK-A

Common Name	: Blood Pressure Cuff
Classification Name	: Blood Pressure Cuff

1. Predicate Device :
  The predicate device is:

Wenzhou Kindcare Import & Export Co., Ltd K081951 Aneroid Sphygmomanometer, Model KT-A01

Recognized Consensus Standards:

The following standard was used to demonstrate compliance to FDA recognized consensus standards:

SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/( Manual, electronic or . automated sphygmomanometers

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1. Classifications Names & Citations :
  21CFR 870.1120, DXQ, Blood Pressure Cuff, Class 2

5. Description :

The Aneroid Sphygmomanometer with Stethoscope contains:

1. Adjustable D-ring Cuff (Adult Size)
1. Stethoscope (Attaches to the cuff)
1. Non-stop rotary pin. 300 mmHq gauge
1. Instruction booklet and record
1. Carrying case

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Indications for use :

7. Technical Characteristics:

The submitted Hangzhou Rei-On device is exactly like the predicate. This is a simple manually operated aneroid blood pressure monitor with a bulb for inflation of a bladder which fits around the user or patient's arm. A stethoscope is used to hear the Korotkoff sounds.

8. Safety and Performance Data Summary:

Testing was performed in accordance with the Recognized Consensus standards, noted under Item 3, and also testing to Biological Compatibility Standards (ISO 10993-5, ISO 10993-10). The device successfully passed all the requirements within these standards.

9. Conclusions:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Hangzhou Reli-On Co., Ltd, concludes that Blood pressure monitor with stethoscope, Model HBPK-A is safe and effective as proven by compliance to consensus standards.

END

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP
2 4
2012

Hangzhou Reli-On Co., Ltd. c/o Mr. Charlie Mack Principal Engineer IRC 77325 Joyce Way Echo, OR 97826

Re: K122259

Trade/Device Name: Blood Pressure Monitor with Stethoscope, Model HBPK-A Regulatory Number: 21 CFR 870.1120 Regulation Name: Blood-Pressure Cuff Regulatory Class: II (two) Product Code: 74 DXO Dated: September 13, 2012 Received: September 18, 2012

Dear Mr. Mack:

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. Iisting 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

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Page 2 - Mr. Charlie Mack

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/CDRH0ffices/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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Indications for Use

510(k) Number (if known):

Device Name: Blood pressure monitor with stethoscope, Model HBPK-A

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use × (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

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510(k) Number K122259

Regulation Number and Section

§ 870.1120 Blood pressure cuff.

(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).