(45 days)
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".
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, AK-4000T:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document primarily focuses on establishing substantial equivalence to a predicate device and fulfilling electrical safety and EMC standards. It makes a general statement about clinical performance but does not explicitly lay out detailed numerical acceptance criteria for blood pressure measurement accuracy. However, it does refer to a recognized standard.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Electrical Safety (EN 60601-1:1990+A1+A2+A11+A12+A13) | PASS |
| EMC Conformity (EN 60601-1-2: 1993) | PASS |
| Performance & Clinical Test (AAMI / ANSI SP10) | Implicitly claimed to meet this standard, no specific numerical results presented in the summary. |
| Substantial Equivalence to Predicate Device (AMLUCK AK-3000 / AK-4000) | Claimed: "The technological characteristics of AMLUCK AK-4000T is substantially equivalent to AMLUCK AK-3000 / AK-4000." Adds PC connection, passed EMC/Safety. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state a sample size for any clinical test set. It only mentions "PERFORMANCE & CLINICAL TEST AAMI / ANSI SP10" without providing details of such a study.
Similarly, the data provenance is not specified. We do not know if the clinical data (if any was collected) was retrospective or prospective, or the country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. As no detailed clinical test results are presented, there's no mention of how ground truth (e.g., reference blood pressure measurements) would have been established or by whom.
4. Adjudication Method for the Test Set
This information is not provided. Without details of a clinical test, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in these documents. This type of study is more relevant for diagnostic imaging or interpretation tasks, not typically for an automated blood pressure monitor.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone device in that it automatically measures blood pressure without direct human intervention in the measurement process. The document describes it as using the "Oscillometric method" where it "utilizes the microcomputer to automatically sense the characteristics of the pulse signal." However, the document does not report on a specific standalone performance study in isolation from the complete device functioning. It refers to the AAMI / ANSI SP10 standard, which would entail performance testing of the device as a whole.
7. The Type of Ground Truth Used
The document refers to the AAMI / ANSI SP10 standard for "PERFORMANCE & CLINICAL TEST." For blood pressure monitors, this standard typically requires simultaneous or near-simultaneous measurements using a recognized reference standard, such as a mercury sphygmomanometer with auscultation, often performed by trained observers. While the document doesn't explicitly state the ground truth used for its testing, adherence to AAMI/ANSI SP10 implies such a reference method would be used.
8. The Sample Size for the Training Set
The provided text mentions an "Oscillometric method" that "utilizes the microcomputer to automatically sense the characteristics of the pulse signal." This implies some internal algorithm or model. However, the document does not provide any information regarding a "training set" sample size for this algorithm, nor does it detail any machine learning components that would necessitate such a set. It's likely that the device's algorithms were developed through traditional signal processing and control rather than contemporary machine learning that requires distinct training sets.
9. How the Ground Truth for the Training Set Was Established
Since no training set is described, information on how its ground truth was established is not provided.
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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: 886-6-5932201 Fax: 886-6-5935870 http:// www.vahorng.com E-mail: lab@yahorng.com
"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: 886-6-5932201 www.vahomg.com E-mail: lab@yahorng.com
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: 886-6-5932201 6-5935870 E-mail: lab@yahorng.com 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 (301) 594-4648. 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 (800) 638-2041 or (301) 443-6597 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 886-6-59358 Tel: 886-6-5932201 E-mail: lab@yahorng.com 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
§ 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).