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

K040528 · Ya Horng Electronic Co., Ltd. · DXN · Apr 15, 2004 · Cardiovascular

Device Facts

• Record ID: K040528
• Device Name: AMLUCK YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, MODEL AK-4000T
• Applicant: Ya Horng Electronic Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Apr 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

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 Story

Wrist-worn blood pressure monitor; uses oscillometric method to sense pulse signal via closed air pipe system; microcomputer calculates systolic/diastolic pressure based on cuff oscillation amplitude; systolic defined as start of amplitude increase, diastolic as end of amplitude decrease. Device intended for home use by adult patients. Features PC connectivity via RS232 cable for data transmission. Provides digital display of blood pressure and pulse rate; enables patient self-monitoring of cardiovascular health.

Clinical Evidence

Bench testing only. Device performance evaluated against AAMI/ANSI SP10 standards. Electrical safety and EMC compliance verified per EN 60601-1 and EN 60601-1-2.

Technological Characteristics

Oscillometric measurement principle; microcomputer-based signal processing; wrist cuff (5.3"-8.5"); RS232 PC interface. Complies with EN 60601-1 (safety) and EN 60601-1-2 (EMC).

Indications for Use

Indicated for noninvasive measurement of systolic/diastolic blood pressure and pulse rate in adults over age 18. For home use. Cuff circumference 5.3"-8.5".

Regulatory Classification

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.

Predicate Devices

• AMLUCK AUTOMATIC DIGITAL WRIST BLOOD PRESSURE MONITOR AK-3000 / AK-4000 (K012796)

Submission Summary (Full Text)

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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
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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 < 0 405