AMLUCK YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, MODEL AK-4000T

• K Number: K040528
• Device Name: AMLUCK YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, MODEL AK-4000T
• Manufacturer: YA HORNG ELECTRONIC CO., LTD.
• Date Cleared: 2004-04-15 ( 45 days)
• Product Code: DXN
• Regulation Number: 870.1130

Intended Use

The YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, Model AK-4000T, is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.3" - 8.5".

Device Description

YA HORNG AK-4000T uses the Oscillometric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to use the stethoscope, as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, the reading can reflect the accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.

Predicate Devices

K012796

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions a "microcomputer" and "simple calculation" for processing the oscillometric signal, which is a standard method for automatic blood pressure monitors and does not indicate the use of AI or ML. There are no mentions of AI, ML, or related concepts like training or test sets.

Therapeutic

No
The device is a blood pressure monitor, which measures blood pressure but does not provide therapy or treatment.

Diagnostic

Yes
The device is intended to measure systolic and diastolic blood pressure and pulse rate, which are used to assess an individual's health status, aligning with the definition of a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a hardware-based blood pressure monitor utilizing an inflatable cuff and the oscillometric method, which involves sensing physical vibrations. This is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Function: The YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, Model AK-4000T, is a non-invasive device that measures blood pressure and pulse rate by wrapping a cuff around the wrist. It uses the oscillometric method to detect pressure changes within the cuff.
• No Sample Analysis: The device does not analyze any biological samples taken from the body. It directly measures a physiological parameter (blood pressure) externally.

Therefore, this device falls under the category of a non-invasive medical device, not an in vitro diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, Model AK-4000T, is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.3" - 8.5".

Product codes

DXN

Device Description

YA HORNG AK-4000T uses the Oscillometric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. I It is not needed to use the stethoscopc, as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, the reading can reflect the accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

wrist

Indicated Patient Age Range

adult individual, over age 18

Intended User / Care Setting

at home

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)

ELECTRIC SAFETY and EMC test reports:
General safety - EN 60601-1:1990+A1+A2+A11+A12+A13 - PASS
EMC conformity - EN 60601-1-2: 1993 - PASS

WOVEN COTTON SHEETING:
Uses the 510K Blood-Pressure Cuff

PERFORMANCE & CLINICAL TEST:
AAMI / ANSI SP10

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K012796

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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APR 1 5 2004

Image /page/0/Picture/1 description: The image shows the logo for Ya Horng CO., LTD. The text is in a bold, sans-serif font and is black. The logo is simple and easy to read.

K040528
p. 1 of 3

No. 35. Zsha Lun, Jon Zsha village, Antin Shiang, Tainan, Taiwan, ROC Tel: [phone] Fax: [phone] http:// www.vahorng.com E-mail: [e-mail]

"510(k) Summary"

YA HORNG CO. LTD. Submitter's Name:

Address: No. 35, Zaha Lun, Jon Zsha Village, Antin Shiang, 745, Taiwan, ROC

886-6-5932201 Telephone:

886-6-5935870 FAX:

Dr. Jen, Ke-Min Contact Person:

2/22/2004 Date Summary Prepared:

YA HORNG PC COMPATIBLE WRIST BLOOD Proprietary Name: PRESSURE MONITOR, AK-4000T

BLOOD PRESSURE MONITOR Common Name:

NON-INVASIVE BLOOD-PRESSURE Classification Name: MEASUREMENT SYSTEM

( per 21CFR section 870.1130)

Device Class: Class II (performance standards)

CARDIOVASCULAR Specialty:

Product code: DXN

AMLUCK AUTOMATIC DIGITAL WRIST BLOOD Legally Marketed PRESSURE MONITOR AK-3000 / AK-4000 ( Predicate ) Device : 510(k) No: K012796

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K040528
p. 2 of 3

Antin Shiang, Ta Tel: [phone] www.vahomg.com E-mail: [e-mail]

Description of the new device:

YA HORNG AK-4000T uses the Oscillometric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. I It is not needed to use the stethoscopc, as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, the reading can reflect the accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.

Technological Characteristics of our new device compared to the predicate device:

The technological characteristics of AMLUCK AK-4000T is substantially equivalent to AMLUCK AK-3000 / AK-4000. AMLUCK AK-4000T is of generally the same form and intended to be used in the same manner as the substantially equivalent product; and the new device just add to connect the PC and is passed the relevant EMC and Safety standards. Thus there are substantially equivalent.

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No. 35, Zsha Antin Shiang, Tainan, Tel: [phone] E-mail: [e-mail] http:// www.yahorng.com

Test Summary:

ELECTRIC SAFETY and EMC test reports, 1.

General safety	EN 60601-1:1990+A1+A2+A11+A12+A13	PASS
EMC conformity	EN 60601-1-2: 1993	PASS

WOVEN COTTON SHEETING 2.

Uses the 510K Blood-Pressure Cuff

PERFORMANCE & CLINICAL TEST న. AAMI / ANSI SP10

YA HORNG Co. Ltd. believes this information and referred document to be sufficient for the FDA to find our proposed device substantially equivalent to the predicate product and other products currently in distribution.

HSU SHENG HSIUNG

Submitter, 2/22/2004 General Maneger YA HORNG CO., LTD.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 5 2004

Ya Horng Electronic CO., Ltd. c/o Dr. Jen Ke-Min ROC Chinese-European Industrial Research Society No.58, Fu-Chiun St. Hsin-Chu City CHINA (TAIWAN) 300

Re: K040528

: K040328
Trade Name: Ya Horng PC Compatible Wrist Blood Pressure Monitor, AK-4000T Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: February 22, 2004 Received: March 01, 2004

Dear Dr. Jen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 3 re(s) person is substantially equivalent (for the indications felerenced above and nave determined in the enclicate devices marketed in interstate for use stated in the encrosule) is tegars actment date of the Medical Device Amendments, or to commerce prior to May 20, 1976, the exacceance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). allo Cosmetic Act (71ct) that as not requent of the general controls provisions of the Act. The I ou may, therefore, manies of the Act include requirements for annual registration, listing of general controls provisions of nactice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can may be subject to subli additions, 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 -- Dr. Jen Ke-Min

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 that I Dr Has Intacted and regulations administered by other Federal agencies. You must or any I eath 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 CI It 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. product radiation of to begin marketing your device as described in your Section 510(k) This letter will and to your finding of substantial equivalence of your device to a legally premarked 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 in you t the Office of Compliance at [phone]. 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 other general sainternational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Daria D. Lochner

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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Image /page/5/Picture/0 description: The image shows the word "YAHORNG" in large, bold, black letters. Below the word, there are smaller letters that say "CO., LTD.". The text is simple and clear, with a focus on the company name.

Antin Shiang, Tainan, T Fax [phone] Tel: [phone] E-mail: [e-mail] http:// www.vahorng.com

Indications for Use

Applicant: YA HORNG CO., LTD.

510(k) Number ( if known): __ K040528

YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE Device Name: MONITOR AK-4000T

Indications for use: .

The YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, Model AK-4000T, is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around The cuff circumference is limited to be 5.3" - 8.5". the wrist.

. Note:

Data Transmission: Connection to PC using RS232 cable.

Prescription Use _______________

AND/OR

Over-The-Counter Use $\sqrt{}$

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muna R. Kachner
(Division, City, or

(Division Sign-Off)
Division of Cardiovascular Devic

C

510(k) Number