AMLUCK, YA HORNG

K051863 · Ya Horng Electronic Co., Ltd. · DXN · Aug 19, 2005 · Cardiovascular

Device Facts

• Record ID: K051863
• Device Name: AMLUCK, YA HORNG
• Applicant: Ya Horng Electronic Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The YA HORNG Automatic Digital Wrist Blood Pressure Monitor, Model BP-410 and BP-420, are noninvasive blood pressure measurement systems 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

Device uses oscillometric method to measure blood pressure and pulse rate; replaces traditional stethoscope/Korotkoff sound monitoring. System consists of inflatable wrist cuff and microcomputer; senses pulse signal vibrations via closed air pipe system. Systolic pressure defined as cuff pressure amplitude increase; diastolic as amplitude stop-decreasing. Used at home by adult patients. Output displayed for user to monitor blood pressure. Benefits include automated, non-invasive, simple blood pressure tracking without clinical assistance.

Clinical Evidence

Bench testing only. Compliance with EN 60601-1 (general safety), EN 1060-1/3 (non-invasive sphygmomanometers), and EN 60601-1-2 (EMC). Performance testing conducted per AAMI/ANSI SP10 standards.

Technological Characteristics

Oscillometric measurement principle; microcomputer-based signal processing. Wrist-worn inflatable cuff (5.3"-8.5"). Complies with EN 60601-1, EN 1060-1, EN 1060-3, and EN 60601-1-2. Standalone device.

Indications for Use

Indicated for non-invasive 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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Image /page/0/Picture/1 description: The image shows the logo for Ya Horng CO., LTD. The logo is in black and features a bold, sans-serif font. The words "Ya Horng" are stacked on top of "CO., LTD."

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

AUG 1 9 2005

# "510(k) Summary"

YA HORNG Electronic Co., Ltd. Submitter's Name:

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

886-6-5932201 Telephone:

> 886-6-5935870 FAX:

Dr. Jen, Ke-Min Contact Person:

Date Summary July 2, 2005 Prepared:

Automatic Digital Wrist Blood Pressure Monitor Proprietary Name: BP-410, BP-420

BLOOD PRESSURE MONITOR Common Name:

BLOOD-PRESSURE Classification Name: NON-INVASIVE MEASUREMENT SYSTEM

( per 21CFR section 870.1130)

Device Class: Class II (performance standards)

Specialty: CARDIOVASCULAR

DXN Product code:

AMLUCK AUTOMATIC DIGITAL WRIST Legally Marketed BLOOD PRESSURE MONITOR AK-3000 / ( Predicate ) AK-4000 Device :

510(k) No: K012796

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KC51863
p.2/3

Image /page/1/Picture/1 description: The image shows the word "YAHORNG" in large, bold, black letters. Below this, in smaller letters, is the text "Ya Horng CO., LTD.". The text is centered and appears to be a company name or logo.

No 35 7sha Lun Antin Shiang, Tainan, Ta Tel: [phone] E-mail: [e-mail] http:// www.yahomg.com

## Description of the new device:

YA HORNG BP-410 and BP-420 use the Oscillometric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure It is not needed to use the stethoscope, as in the traditional measuring method, recently. 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 YA HORNG BP-410 and BP-420 are substantially equivalent to AMLUCK AK-3000 / AK-4000. There is the same Owner, AMLUNK Inc., Especially, there are the same design which FDA owner number is 9040892. specifications, the same form and intended to be used in the same manner that mean the new device BP-410 is same as the predicate device AK-4000, and the new device BP-420 is same as the predicate device AK-3000.

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Image /page/2/Picture/1 description: The image shows the logo for Ya Horng CO., LTD. The logo is in black and white, with the words "YA HORNG" in large, bold letters. Below the main title, the words "Ya Horng CO., LTD." are written in a smaller font. The logo appears to be for a company, but further details about the company are not available from the image.

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

The mainly different of the two devices are only vision appearance and all of the devices were passed the relevant EMC and Safety standards. Thus there are substantially equivalent.

### Test Summary:

#### ELECTRIC SAFETY and EMC test reports, 1.

| General safety | EN 60601-1:1990+A1+A2+A11+A12+A13 | PASS |
|----------------|-----------------------------------|------|
| | EN 1060-1:1995, EN 1060-3:1997 | PASS |
| EMC conformity | EN 60601-1-2: 1993 | PASS |

#### WOVEN COTTON SHEETING 2.

Uses the 510K Blood-Pressure Cuff

- PERFORMANCE & CLINICAL TEST 3. 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, July 2, 2005 General Maneger YA HORNG Electronic Co., Ltd.

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Image /page/3/Picture/14 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the HHS emblem, which consists of a stylized caduceus with three intertwined snakes and a staff. The emblem is accompanied by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular pattern around the emblem. The text is in uppercase letters and is evenly spaced around the emblem.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 9 2005

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Ya Horng Electronics Co., Ltd. c/o Mr. Jen Ke-Min ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City China, (Taiwan) 300

Re: K051863

Trade Name: Automatic Digital Wrist Blood Pressure Monitor, Model BP-410 and BP-420 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: July 2, 2005 Received: July 8, 2005

Dear Mr. Ke-Min:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Jen Ke-Min

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dr 3 issualites arour device complies with other requirements of the Act that I DA has made a actor regulations administered by other Federal agencies. You must of ally redural statures and regulatents, including, but not limited to: registration and listing Comply with an the Net Net 3 requirements , x 801); good manufacturing practice requirements as set (21 CFR Part 807), lacemis (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product laulation control pro herens (seting your device as described in your Section 510(k) This letter will anow you to oegin mainers of your device of your device to a legally premarket notication: "The PDF intembers on the sour 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 If you desire specific advice for your ac now of the regulation entitled fregulation entitled, Connact the Office or Courter notification" (21CFR Part 807.97). You may obtain Misoraliums by reference to presences withing the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Octess http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Blymmmer for

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 text "YAHORNG Ya Horng CO., LTD." in a bold, sans-serif font. The word "YAHORNG" is in a larger font size than the rest of the text. The text is black and the background is white. The text appears to be a company name.

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

Indications for Use

510(k) Number:

K05/1863

Device Name:

YA HORNG ELECTRONIC CO., LTD.

YA HORNG Automatic Digital Wrist Blood Pressure Monitor BP-410, BP-420

● Indications for use:

The YA HORNG Automatic Digital Wrist Blood Pressure Monitor, Model BP-410 and BP-420, are noninvasive blood pressure measurement systems 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".

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(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)

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