The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.

Device Description

The device comprises tubing attached to a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure . The device tubing is connected to a non-invasive sphygmomanometer.

AI/ML Overview

The acceptance criteria for the SUZHOU JJ METER CO., LTD's Sphygmomanometer (models JHT-1110, JHT-1500, JHT-1611) are based on conformance to the international standard ISO 81060-1:2007 "Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type". Additionally, the device was tested for biocompatibility according to ISO 10993-5 and ISO 10993-10.

However, the provided text does not contain a table of specific acceptance criteria values with corresponding reported device performance, nor does it detail a standalone study with quantitative results against specific thresholds. Instead, it broadly states that the device "have been tested conform to" these standards. The conclusion is that the device is "safe and effective, and substantially equivalent to the predicate device" based on this conformance.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that the device conforms to ISO 81060-1:2007. This standard outlines requirements for accuracy of blood pressure measurements. Typically, for non-automated sphygmomanometers, key aspects include:

Accuracy of Pressure Indication: The error of the pressure indicator should be within specified limits (e.g., ±3 mmHg).
Measurement Accuracy: The device's measurement performance when compared to a reference standard (e.g., intra-arterial measurement) should meet defined criteria (e.g., mean difference and standard deviation of differences).

The document states: "The JJ METER's Sphygmomanometer(model: JHT-1110, JHT-1500, JHT-1611) have been tested conform to the ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type, and ISO 10993-5 and ISO 10993-10."

Without the full test report or detailed results from the submission, specific numerical acceptance criteria and reported performance cannot be extracted into a table. The statement of conformance implies that the device met all the required specifications within this standard, but the exact values are not provided in this summary.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size for the test set (number of subjects/measurements) or the data provenance (e.g., country of origin, retrospective/prospective) for the testing against ISO 81060-1:2007.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. For blood pressure measurement device testing per ISO 81060-1, ground truth is typically established by trained observers taking reference measurements (e.g., using auscultation by multiple observers or intra-arterial pressure monitoring). The specifics of who performed this, their number, or qualifications are not detailed.

4. Adjudication method for the test set

This information is not provided in the document. For blood pressure studies using multiple observers, adjudication methods (e.g., averaging readings, using a consensus) are common but not mentioned here.

5. 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

This is not applicable as the device is a manual sphygmomanometer, not an AI-assisted diagnostic tool for interpretation by human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not explicitly described as a distinct "standalone" study in the context of an algorithm. The testing against ISO 81060-1:2007 is essentially a standalone performance evaluation of the device itself, as it assesses the device's ability to accurately measure blood pressure. However, it's a hardware device, not an algorithm. Therefore, the "standalone" phrasing typically used for AI/software is not directly applicable.

7. The type of ground truth used

For the ISO 81060-1:2007 testing, the ground truth would typically be established by:

Reference standard measurements: This often involves highly accurate invasive (intra-arterial) blood pressure measurements or auscultatory measurements by trained observers using a calibrated mercury sphygmomanometer (or other validated reference method), against which the device under test is compared.

The document does not explicitly state which method was used, only that the device conformed to the standard.

8. The sample size for the training set

This is not applicable. The device is a hardware medical device (manual sphygmomanometer) and does not involve AI/machine learning models that require a training set.

9. How the ground truth for the training set was established

This is not applicable, as there is no training set for this device type.

Summary

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K141392; page 1 of 3

510(k) Summary

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

Date: May 27, 2014

Submitter:

Name: SUZHOU JJ METER CO., LTD.

Add: No.156 Xuqing Rd, Xushuguan Town, Suzhou New District, P.R. China

Tel: 0086-512-66168979

Fax: 0086-512-66168979

Contact Person:

Long Yang (COO.)

Shenzhen Hlongmed Biotech Co., Ltd.

R1508, East Building, Yihai Plaza, Chuangye Road, Nanshan District,Shenzhen, P.R. China

Tel: 0086-755-86664986

Fax: 0086-755-86664933

E-mail: yanglong@hlongmed.com

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K141392

3. Device Information:

Trade name:	Sphygmomanometer
Model:	JHT-1110, JHT-1500, JHT-16
Common name:	Blood Pressure Cuff
Classification name:	Blood Pressure Cuff
Review Panel:	Cardiovascular
Product Code:	DXQ
Regulation Class:	II
Regulation Number:	870.1120

4. Predicate Device Information:

Company Name: Wenzhou Bokang instruments Co., Ltd.

Device Name: Aneroid Sphygmomanometer BK2002

510(k) number: K043286.

5. Device Description:

6. Indication For Use:

The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on adults. The device is intended to be

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K141392

Page 3 of 3

manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.

7. Technological Characteristics:

The JJ METER's Sphygmomanometer(model: JHT-1110, JHT-1500, JHT-1611) are virtually the same as Bokang's Aneroid Sphygmomanometer BK2002.

8. Safety and Performance Data:

The JJ METER's Sphygmomanometer(model: JHT-1110, JHT-1500, JHT-1611) have been tested conform to the ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type, and ISO 10993-5 and ISO 10993-10.

9. Conclusions:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this pre-market notification. SUZHOU JJ METER CO., LTD concludes that the Sphygmomanometer( models JHT-1110, JHT-1500, JHT-1611) are safe and effective, and substantially equivalent to the predicate device described herein.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

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

July 2, 2014

Suzhou Jj Meter Co., Ltd. c/o Ms. Long Yang Official Correspondent R1508, East Bldg, Yihai Plaza Chuangye Rd. Nanshan District Shenzhen, Guangdong, 518054 CH

K141392 Re:

Trade/Device Name: Sphygmomanometer (Models JHT-1110, JHT-1500, JHT-1611) Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ Dated: May 20, 2014 Received: May 27, 2014

Dear Ms. Yang:

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.

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 IVD and Part 809); medical device reporting (reporting of

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Page 2 - Ms. Long Yang

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 IVD and Part 809), please contact 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportalProblem/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/dcfault.htm.

Sincerely yours,

Image /page/4/Picture/6 description: The image shows a logo with the letters FDA in a stylized font. The letters are interconnected and have a textured appearance. There is a signature or some other form of writing across the letters.

forbram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K141392

Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): K141392

Device Name: __ Sphygmomanometer (Model: JHT-1110, JHT-1500, JHT-1611) _______________________________________________________________________________________________________

Indications For Use:

The device is intended to be used by medical professionals
or in the home for the measurement of systolic and diastolic
pressure on adults. The device is intended to be manua attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.

(BLEASE DO NOT WRITE BETON THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Image /page/5/Picture/7 description: The image shows a document with the title "Concurrence of CDRH, Office of Device Evaluation (ODE)". There is a signature and the date "2014.07.02 14:34:45-04'00'". The document indicates "Over-The-Counter Use" with an "X" marked, and also mentions "Prescription Use (Per 21 CFR 801.109)" along with an "OR" separator.

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).