The Multiple Brand, with model number KTJ-50, aneroid sphygmomanometer is an instrument intended to be used for the indirect (noninvasive) measurement of human's Systolic, Diastolic blood pressure using the auscultatory method by detecting Korotkoff Sound. This device is to be used by trained medical and health care personnel or trained general users.

Device Description

The aneroid sphygmomanometer with stethoscope is a non-invasive blood pressure measurement system for monitoring blood pressure levels which can be performed by trained individuals. The sphygmomanometer Model KTJ-50 consists of 5 parts. They are aneroid manometer, latex bulb, cuff, valve and stethoscope set. The aneroid sphygmomanometer with stethoscope enables the user places the attached stethoscope on the inner arm above the bend in the elbow, to detect the Korotkoff sound. After inflation of the user does auditory monitor with the stethoscope to evaluate systolic and diastolic pressure. The two values are recorded as: systolic over diastolic.

AI/ML Overview

The provided text describes a 510(k) submission for an aneroid sphygmomanometer, the Multiple Brand KTJ-50. This document focuses on the regulatory clearance process rather than a detailed scientific study proving the device's performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, and ground truth establishment is not available in the provided text.

However, based on the information provided, we can infer some details related to its intended use and general performance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred)	Reported Device Performance
Intended Use	Non-invasive measurement of arterial blood pressure using auscultatory method.	Device is an aneroid sphygmomanometer intended for indirect (non-invasive) measurement of arterial blood pressure by detecting Korotkoff Sound. Allows trained individuals to evaluate systolic and diastolic pressure.
User	Used by trained medical and healthcare personnel or trained general users.	Device is for trained medical and healthcare personnel or trained general users.
Methodology	Utilize Korotkoff sound detection for systolic and diastolic pressure.	Users place the attached stethoscope on the inner arm above the bend in the elbow to detect Korotkoff sound for auditory monitoring and evaluation of systolic and diastolic pressure.
Safety and Effectiveness	(Implied) Substantial equivalence to a legally marketed predicate device (Mabis brand, K942072) demonstrating similar performance, safety, and effectiveness.	The FDA determined the device is "substantially equivalent" to the predicate device, K942072. This implies its safety and effectiveness are comparable under its intended use.

Explanation of Inference:
The provided document is a 510(k) summary, which largely focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance data from a specific clinical study with predefined acceptance criteria. The "Predicate Device" section and the FDA's letter confirming "substantial equivalence" are key here. For devices like this, the acceptance criteria are generally aligned with established standards for sphygmomanometers (e.g., ANSI/AAMI SP10 or ISO 81060-1 or -2), which would cover accuracy and reproducibility. However, these specific standards or detailed performance figures are not provided in this document.

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

Sample Size for Test Set: Not specified in the provided document.
Data Provenance: Not specified in the provided document. The manufacturer is Golden Horse Medical Equipment (Wuxi) Co., Ltd. in P. R. China, but whether any testing data originated from China or retrospectively/prospectively is not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not specified in the provided document.
Qualifications of Experts: Not specified in the provided document.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified in the provided document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

MRMC Study: Not applicable/not performed for this type of device (aneroid sphygmomanometer) in the context of this 510(k) summary. These studies are typically relevant for imaging or diagnostic algorithms where human readers interpret results.
Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: Not applicable for this device. An aneroid sphygmomanometer relies on a human operator to perform the auscultatory method (listening for Korotkoff sounds with a stethoscope) to determine BP values. There is no "algorithm only" performance for this manual device.

7. The Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated. For a traditional aneroid sphygmomanometer, the "ground truth" for comparative accuracy studies usually involves simultaneous or near-simultaneous measurements by highly trained observers using a reference standard (e.g., mercury sphygmomanometer) or an invasive arterial line. However, the methodology used to establish this for the KTJ-50 is not detailed in the provided submission. The "substantial equivalence" claim implies that its performance would be expected to align with its predicate device when proper technique is used.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is a mechanical instrument, not an AI/ML algorithm that requires a "training set" in the computational sense. The document does not describe any such training process.

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

How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" in the context of this mechanical device.

Summary

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FEB & 2 2005

K04344
P 1/2

510(K) Summary

Submitter

George Su Crosslinks International 1800 Century Park East, Suite 600 Los Angeles, CA 90067 USA

Tel: 310-229-5748 Fax: 310-388-1067 Email: crosslinks2000@aol.com

Manufacturer:

Golden Horse Medical Equipment (Wuxi) Co., Ltd. 42 Xi Xin Road, Zhang Jing Town, Wuxi City, P. R. China 214194

Tel: +86 510 3791303 Fax: +86 510 3791680 Email: ghmed(@)publicl.wx.js.cn

Device Name:

Proprietary Name: Multiple Common/Usual Name: Aneroid Sphygmomanometer Device Name: Non-invasive Blood-pressure Measurement System Product Code: DXN Classification: Class II

Predicate Device:

Mabis brand and Mabis customers private label brand Establishment: MABIS HEALTHCARE, INC. Regulation Number : 890.5500 Product Code : DXN 510(k) Number: K942072 Registration Number: 1422443 Owner/Operator Number: 9005245

Description of the Multiple Brand KTJ-50:

The aneroid sphygmomanometer with stethoscope is a non-invasive blood pressure measurement system for

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monitoring blood pressure levels which can be performed by trained individuals. The sphygmomanometer Model KTJ-50 consists of 5 parts. They are aneroid manometer, latex bulb, cuff, valve and stethoscope set. The aneroid sphygmomanometer with stethoscope enables the user places the attached stethoscope on the inner arm above the bend in the elbow, to detect the Korotkoff sound. After inflation of the user does auditory monitor with the stethoscope to evaluate systolic and diastolic pressure. The two values are recorded as: systolic over diastolic.

Intended Use

The Multiple Brand KTJ-50 is an aneroid sphygmomanometer intended to be used for the indirect (noninvasive) measurement of the arterial blood pressure by trained medical and health care personnel or trained general users.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 7 - 2005

Golden Horse Medical Equipment (Wuxi) Co., Ltd. c/o Mr. George Su Crosslinks International, Inc. 1800 Century Park East, Suite 600 Los Angeles, CA 90067

Re: K043444

Trade Name: Multiple, Model KTJ-50 Regulation Number: 21 CFR 870.1120 Regulation Name: Blood-Pressure Cuff Regulatory Class: Class II Product Code: DXQ Dated: February 09,2005 Received: February 10,2005

Dear Mr. Su:

This letter corrects our substantially equivalent letter of February 22,2005, regarding the regulation number, regulation name, and product code.

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 (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. If your device is classified (see above) into either class 11 (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.

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Page 2 - Mr. George Su

Please be advised that FDA's issuance of a substantial equivalence determination doks 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Complianceat (240) 276-0293. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

B bimuma for
Bram D. Zuckerman, M.D.

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): K043444

Device Name : Non-invasive Blood Pressure Measurement System

Indications for Use:

Prescription Use X (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)

Blumensone

IDWslon Sign-Off) Division of Cordiovascular Deyices 510(k) Numbor_

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(Posted November 13, 2003)

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).