(42 days)
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".
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 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 information to describe the acceptance criteria and study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details regulatory compliance and mentions performance standards but does not explicitly list specific numerical acceptance criteria for blood pressure accuracy (e.g., mean difference, standard deviation) or present a table of reported device performance in those terms.
Instead, it refers to:
- AAMI/ANSI SP10: This is the primary standard governing automated sphygmomanometers. Meeting this standard means the device's accuracy falls within internationally recognized benchmarks for blood pressure measurement.
- General Safety (EN 60601-1:1990+A1+A2+A11+A12+A13): This ensures electrical and mechanical safety.
- Performance (EN 1060-1:1995, EN 1060-3:1997): These are European standards specific to non-invasive sphygmomanometers, covering both general requirements and specific requirements for electro-mechanical blood pressure measuring systems.
- EMC Conformity (EN 60601-1-2: 1993): Ensures electromagnetic compatibility.
Given the available information, a table would look like this:
| Acceptance Criteria Category | Specific Standard/Requirement | Device Performance (Reported) |
|---|---|---|
| Blood Pressure Accuracy | AAMI / ANSI SP10 | PASSED |
| EN 1060-1:1995, EN 1060-3:1997 | PASSED | |
| Electrical Safety | EN 60601-1:1990+A1+A2+A11+A12+A13 | PASSED |
| EMC Conformity | EN 60601-1-2: 1993 | PASSED |
| Cuff Sizing | Limited to 5.3" - 8.5" (Wrist Circumference) | Intended Design Limitation |
| Intended Use Population | Adult individual, over age 18 | Intended Use Limitation |
2. Sample Size for the Test Set and Data Provenance
The document states: "PERFORMANCE & CLINICAL TEST 3. AAMI / ANSI SP10". While it indicates that a clinical test was performed to meet the AAMI/ANSI SP10 standard, it does not specify the sample size used for this test.
- Sample Size for Test Set: Not specified in the provided documents. (AAMI SP10 typically requires a minimum of 85 subjects with specific blood pressure ranges).
- Data Provenance: Not specified. The company is based in Taiwan, so it is possible the study was conducted there, but this is not confirmed. It is also not specified if the data was retrospective or prospective, though clinical trials for AAMI SP10 are typically prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications for establishing ground truth.
For AAMI SP10 testing, ground truth for blood pressure is established by trained observers (often nurses or physicians) using a mercury sphygmomanometer or auscultatory method, typically following a specific protocol to minimize bias (e.g., sequential simultaneous measurements).
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used. In AAMI SP10, blood pressure measurements are taken by two trained observers blinded to each other's readings, and the average or difference between their readings is typically used as the reference. Discrepancies beyond a certain point might require a third observer, but this specific method is not detailed here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done.
The document describes a standalone clinical performance test against a standard (AAMI/ANSI SP10) to determine accuracy, rather than a study comparing human readers with and without AI assistance for interpretation. The device is an automatic blood pressure monitor, which directly provides readings, not an imaging or diagnostic AI tool that assists human interpretation.
6. Standalone (Algorithm Only) Performance Study
- Yes, a standalone performance study was done.
The "PERFORMANCE & CLINICAL TEST 3. AAMI / ANSI SP10" and compliance with "EN 1060-1:1995, EN 1060-3:1997" refer to studies performed on the device itself (the algorithm and hardware working together) to measure its accuracy against reference measurements. This is a standalone performance assessment of the device's ability to measure blood pressure without human interpretation beyond reading the displayed values.
7. Type of Ground Truth Used
The ground truth used for performance testing to AAMI/ANSI SP10 and EN 1060 standards is typically expert auscultatory measurements (manual blood pressure readings taken by trained clinicians using a reference device like a mercury sphygmomanometer). This could be considered a form of "expert consensus" in how multiple readings by experts are handled.
8. Sample Size for the Training Set
The document does not provide any information about a training set or its sample size. This is typical for a traditional medical device (like a blood pressure monitor) that relies on fixed algorithms derived from physiological principles and extensive validation rather than machine learning models that require a distinct training phase.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned or implied for this type of device, this information is not applicable and not provided. The device's algorithm would have been developed based on established oscillometric principles and then validated through testing against human reference measurements.
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Image /page/0/Picture/0 description: The image shows handwritten text. The text at the top reads "K05/863". Below that, the text reads "p. 1/3". The handwriting is somewhat cursive and the text is in black ink.
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: 886-6-5932201 Fax: 886-6-5935870 E-mail: lab@yahorng.com 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: 886-6-5932201 E-mail: lab@yahorng.com 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: 886-6-5932201 Fax: 886-6-5935870 http:// www.yahorng.com E-mail: lab@yahorng.com
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 (800) 638-2041 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: 886-6-5935870 Tel: 886-6-5932201 http:// www.yahorng.com E-mail: lab@yahorng.com
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)
Sign-Off
§ 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).