AMLUCK, YA HORNG

K042581 · Ya Horng Electronic Co., Ltd. · DXN · Oct 13, 2004 · Cardiovascular

Device Facts

• Record ID: K042581
• Device Name: AMLUCK, YA HORNG
• Applicant: Ya Horng Electronic Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Oct 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

KD-575 Memory Automatic Electronic Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on anyone each time, except infants and unconscious people, with the air cuff around the left upper arm according to the instruction in the user's guide manual.

Device Story

KD-575 is an automatic electronic blood pressure monitor; utilizes oscillometric technology with silicon integrated pressure sensor; measures systolic/diastolic blood pressure and pulse rate. Device features internal pump for automatic cuff inflation/deflation; LCD interface displays results; memory function stores 120 measurements with date/time stamps. Used by medical professionals or patients at home; cuff applied to left upper arm 1-2cm above elbow. Output allows patients to track physical condition over time. Benefits include convenient, non-invasive self-monitoring of cardiovascular metrics.

Clinical Evidence

Clinical testing performed to verify accuracy against ANSI/AAMI SP10-1992 standards. Results met or exceeded accuracy requirements for non-invasive blood pressure measurement systems.

Technological Characteristics

Oscillometric measurement principle; silicon integrated pressure sensor; internal pump for cuff inflation; LCD display; memory storage for 120 readings with date/time. Complies with IEC601-1 (1988) safety standards, IEC 60602-2-30: 1995 for automatic cycling, and electromagnetic compatibility requirements.

Indications for Use

Indicated for adults, excluding infants and unconscious individuals, for non-invasive monitoring of systolic/diastolic blood pressure and pulse rate at home or in clinical settings via an upper arm cuff.

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

• KD-559 (K030358)

Submission Summary (Full Text)

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K042581
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# 510(k) Summary

OCT 1 3 2004

#### Identification of the submitter:

Kodon (Tianjin) Electronic & Electrical Apparatus Submitter: Co., LTD No 31, Changjiang Road, Nankai District, Tianjin, P.R. China, 300193 86-22-60526082 Telephone number: Fax number: 86-22-60526162 Liu Yi Contact: 08/25/04 Date of Application:

#### Identification of the product:

| Device proprietary Name: | KD-575 Memory Automatic Electronic Blood<br>Pressure Monitor |
|--------------------------|-------------------------------------------------------------------------------|
| Common name: | Noninvasive blood pressure measurement<br>systems |
| Classification name: | Noninvasive blood pressure measurement system<br>Class II per 21 CFR 870.1130 |

#### Marketed Devices to which equivalence is claimed:

| Device | manufacture | 510(k) number |
|--------|------------------------------------------------------------------|---------------|
| KD-559 | Kodon (Tianjin) Electronic and Electrical<br>Apparatus Co., Ltd. | K030358 |

#### Device description:

KD-575 Fully Automatic Electronic Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this devise is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Swathing the air cuff around the left upper arm 1-2cm above elbow joint automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results. It can storage and show 120 times measuring result with the month, day, time of measuring.

#### Intended use:

i

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KD-575 Memory Automatic Electronic Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on anyone each time, except infants and unconscious people, with the air cuff around the left upper arm according to the instruction in the user's guide manual.

## Comparison of technological characteristics of new device to predicate devices:

KD-575 Memory Automatic Electronic Blood Pressure Monitor can storage and show 120 times measuring results with the month, day, time of measuring. It can help patients to memorize the measuring data of their measuring results. Therefore the patients can analyze the measuring data and inspect their physical conditions. The time and the date are the advantages of KD-575 compare with the predicate device.

## Clinical Tests:

Clinical tests were performed and complied the accuracy requirements of ANSI/AAMISP10-1992. The results meet or exceed the accuracy requirements of ANSI/AAMISP10-1992.

## Non-clinical Tests:

standards, including tests coincide the following non-clinical All Electromagnetic Compatibility test.

## IEC601-1 (1988)

Medical electrical equipment-----Part 1:General requirements for safety IEC601-1 (1988)

Amendment 2

IEC 60602-2-30: 1995

Medical electrical equipment-part2: Particular requirements for the safety of automatic cycling indirect blood pressure monitoring equipment. GB9706.1-1995 ISO 1833-1977

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

OCT 1 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ya Horng Electronic Co., Ltd. c/o Dr Ke-Min Jen Cro Dr No Ninese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, TAIWAN 300 CHINA

Re: K042581

K042581
Trade Name: YA HORNG Automatic Digital Wrist Blood Pressure Monitor, AK-3000T
Trade Name: YA HORNG Automatic Case Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: September 18, 2004 Received: September 22, 2004

Dear Dr. Jen:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premainter in the the may are created in interests a referenced above and nave decemblied the arrised predicate devices marketed in interstate for use stated in the encrosule for legally manatos people of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food Trug commerce prior to May 28, 1976, the enastinone with the provisions of the Federal Food. Drug, devices that have been reclassified in accordance while approval applications of the Act. The and Cosment Act (Act) that do not require app to the general controls provisions of the Act. The You may, merelore, market the devree, seejeer of use annual registration, listing of general controls provisions of the free herstand company.
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 If your device is classified (see above) mis existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controls. Extrangemage of the 21, Parts 800 to 898. In addition, FDA may be found in the Code of I sacra. Its gas ...
publish further announcements concerning your device in the Federal Register.

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Page 2 -- Dr Ke-Min Jen

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a substition with other requirements of the Act
that FDA has made a determination that your device of a forelocares . You must that FDA has made a decertification that your as res by other Federal agencies. You must a or any Federal statules and regulations daministed or registration and listing (21 little (21 l comply with all the Act S requirements, moradial was and one and security of the sent of CFR Part 807); labeling (21 CFR Part 001); good manager (200); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Pat (2); 1000 1050 forth in the quality systems (Q5) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000product radiation control provisions (becalons of to vice as described in your Section 5 10(k)
This letter will allow you to begin marketing your device as described in your I his letter will anow you to ocgin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivale there permi premarket nother in TDA miding of basemation 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 If you desire specific advice for your ac not one one one one one the regulation entitled, and Colliact the Office of Complanes at (301) 317 - 17 - 17 - 10 may obtain Misoranuiling of Icrerchee to premaintentibilities under the Act from the Division of Small other general Information on your respended its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Blinxlma 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/4/Picture/0 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 that, in smaller letters, are the words "Ya Horng CO. LTD.". The logo is simple and easy to read.

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

Applicant: _ YA HORNG CO., LTD. 510(k) Number ( if known): ___________________________________________________________________________________________________________________________________________________

YA HORNG Automatic Digital Wrist Blood Pressure Monitor, Device Name: AK-3000T

Indications for use: .

The YA HORNG Automatic Digital Wrist Blood Pressure Monitor, Model AK-3000T, 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".

. Note:

Data Transmission: Connection to PC using RS232 cable.

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)

Division Sign-Off)
vision of Cardiovascular Devices
10(k) Number K042581