The device 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 5.25" – 7.75".

Device Description

AI/ML Overview

The provided text describes a 510(k) summary for the MYTECH WRIST BLOOD PRESSURE MONITOR, HPL-200. This document primarily focuses on demonstrating substantial equivalence to a predicate device (MYTECH WRIST BLOOD PRESSURE MONITOR, HPL-100) and does not contain a detailed study proving the device meets specific acceptance criteria related to its performance beyond general safety and EMC.

The key points of the submission are:

Substantial Equivalence: The manufacturer asserts that the HPL-200 is substantially equivalent to the HPL-100.
Minimal Differences: The only stated difference between the two devices is the "display layout."
Testing for Equivalence: Electric safety and EMC testing was performed for the HPL-200 to ensure safety and effectiveness aspects were not compromised by the display change. The testing standards cited are EN 60601-1 and EN 60601-1-2.
Performance & Clinical Test: A "Performance & Clinical Test" to AAMI/ANSI SP10 is mentioned, but no detailed results or acceptance criteria for this test are provided in the summary.
Indications for Use: The device is intended to measure systolic and diastolic blood pressures and pulse rate of adults over 18 years old at home, using a non-invasive technique with a wrist cuff (5.25" – 7.75" circumference).

Given this information, it is not possible to fully answer the request as no specific acceptance criteria for blood pressure measurement accuracy are explicitly stated, nor are detailed study results provided to demonstrate meeting such criteria. The document focuses on demonstrating equivalence based on minimal changes and general safety/EMC standards, rather than a clinical performance study with predefined acceptance metrics.

However, based on the limited information, here's an attempt to structure the answer, highlighting what is available and what is missing:

Acceptance Criteria and Device Performance (Based on Available Information)

The provided document does not explicitly state quantitative acceptance criteria for blood pressure measurement accuracy (e.g., mean difference and standard deviation compared to a reference method) nor does it provide a detailed study report with results demonstrating compliance against such criteria. The submission relies on establishing substantial equivalence to a predicate device (MYTECH WRIST BLOOD PRESSURE MONITOR, HPL-100) based on minimal design changes and general safety/EMC testing.

The only "acceptance criteria" implied or directly mentioned are related to:

Electrical Safety: Compliance with EN 60601-1:1990+A1+A2+A11+A12+A13.
Electromagnetic Compatibility (EMC): Conformity with EN 60601-1-2: 1993.
Performance & Clinical Test: Compliance with AAMI / ANSI SP10. However, the specific criteria within AAMI/ANSI SP10 that were met, and the actual performance results, are not detailed in this summary.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Requirement (as implied or stated in document)	Reported Device Performance (as stated in document)	Notes
Electrical Safety	Conformance to EN 60601-1:1990+A1+A2+A11+A12+A13	"PASS"	This indicates the device passed general electrical safety requirements.
Electromagnetic Compatibility	Conformance to EN 60601-1-2: 1993	"PASS"	This indicates the device passed EMC requirements, ensuring it operates correctly in its electromagnetic environment and does not interfere with other devices.
Blood Pressure Measurement	"Performance & Clinical Test" according to AAMI / ANSI SP10 (No specific numeric criteria or results provided in summary)	Not specified in this document.	The summary states this test was performed and refers to a document, but the outcomes (e.g., mean differences, standard deviations) against AAMI/ANSI SP10 accuracy requirements are not presented. AAMI/ANSI SP10 typically requires a mean difference of ≤ ±5 mmHg and a standard deviation of ≤ 8 mmHg for both systolic and diastolic blood pressure compared to a reference method. The document implicitly claims these were met by stating the test was performed.
Substantial Equivalence to HPL-100	Same intended use, technological characteristics, power supply, LCD display, range, accuracy, and operating environments, memory, dimensions, weight, and storage environments.	Affirmed as "substantially equivalent."	The primary argument for market clearance is that the HPL-200 is substantially equivalent to the legally marketed predicate HPL-100, with the only noted difference being the display layout. The passing of safety/EMC tests for the HPL-200 reinforces this claim.

Since the provided document is a 510(k) summary demonstrating substantial equivalence for a non-AI medical device (blood pressure monitor), many of the requested points related to AI/algorithm studies, expert ground truth, and training data are not applicable or detailed.

Here's an analysis of the requested information based on the provided text:

Table of acceptance criteria and the reported device performance:
- See table above. Specific performance metrics for blood pressure accuracy (mean difference, standard deviation) against AAMI/ANSI SP10 are not reported in this summary, only that "Performance & Clinical Test" was done.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not provided in the summary. The summary mentions a "Performance & Clinical Test" to AAMI/ANSI SP10, which would involve a clinical study with human subjects, but details on sample size, study design (prospective/retrospective), or data provenance are absent.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not applicable as the device is a blood pressure monitor, not an imaging or diagnostic AI device requiring expert interpretation for ground truth. AAMI/ANSI SP10 studies typically use a highly accurate reference blood pressure measurement device (e.g., mercury sphygmomanometer) carefully operated by trained technicians for ground truth comparison. No details on this are provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable (see point 3).
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools and is not applicable to an automated blood pressure monitor.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The device is a standalone blood pressure monitor (an algorithm automatically measures BP). The "Performance & Clinical Test" to AAMI/ANSI SP10 can be considered a standalone performance evaluation against a reference standard. However, no specific results of this performance are detailed in the summary.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- As inferred from AAMI/ANSI SP10, the ground truth would be from a validated reference blood pressure measurement method (e.g., auscultatory method with a mercury sphygmomanometer) performed by trained observers. The summary does not explicitly state this, but it is the standard for such tests.
The sample size for the training set:
- This information is not applicable. The HPL-200 is not an AI/machine learning device that requires a "training set" in the conventional sense. Its measurement algorithm is based on established oscillometric principles.
How the ground truth for the training set was established:
- This information is not applicable (see point 8).

Summary

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MYTECH TECHNOLOGY CO., LTD

MAY 1 7 2004

5F.6, Alley 2, Lane 222, Lien Cheng Road, Chung Ho City, Taipei Hsien, 235, Taiwan, ROC Telephone: 886-2-2247 4816 Fax: 886-2-2247 7024 Email: sale@mytech.com.tw

"510(k) Summary"

Submitter's Name:	MYTECH TECHNOLOGY CO., LTD.
Address:	5F.6, Alley 2, Lane 222, Lien Cheng Road,Chung Ho City, Taipei Hsien, 235, Taiwan, ROC
Telephone:	886-2-2247 4816
FAX:	886-2-2247 7024
Contact Person:	Dr. Jen, Ke-Min
Date Summary Prepared:	5/7/2004
Proprietary Name:	MYTECH WRIST BLOOD PRESSUREMONITOR, HPL-200
Common Name:	BLOOD PRESSURE MONITOR
Classification Name:	NON-INVASIVE BLOOD-PRESSUREMEASUREMENT SYSTEM(per 21CFR section 870.1130)
Device Class:	Class II (performance standards)
Specialty:	CARDIOVASCULAR
Product code:	DXN
Legally Marketed (Predicate):	MYTECH WRIST BLOOD PRESSUREMONITOR, HPL-100
Device:	510(k) No. K030561

510(k) No: K030561

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MYTECH TECHNOLOGY CO., LTD

5F.6, Alley 2, Lane 222, Lien Cheng Road, Chung Ho City, Taipei Hsien, 235, Taiwan, ROC Telephone: 886-2-2247 4816 Fax: 886-2-2247 7024 Email: sale@mytech.com.tw

Description of the new device:

Basically, the subject device and the predicated device are the same in intended use, technological characteristics, power supply, LCD display, range, accuracy, and operating environments, memory, dimensions, weight, and storage environments. The only difference is the display layout. We present two photos for HPL-100 and HPL-200 respectively in the following page for comparison. Since we also did the relevant electric safety and EMC testing for HPL-200, the safety and effectiveness aspects are not raised.

They are decided to be substantially equivalent.

Technological Characteristics of our new device compared to the predicate device:

The technological characteristic of MYTECH HPL-100 is substantially equivalent to HPL-200. I MYTECH HPL-100 is of generally the same form and intended to be used in the same manner as the substantially equivalent product; and is passed the relevant EMC and Safety standards. Thus there are substantially equivalent.

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MYTECH TECHNOLOGY CO., LTD.

5F.6, Alley 2, Lane 222, Lien Cheng Road, Chung Ho City, Taipei Hsien, 235, Taiwan, ROC Telephone: 886-2-2247 4816 Fax: 886-2-2247 7024 Email: sale@mytech.com.tw

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

2. WOVEN COTTON SHEETING

Uses the 510K Blood-Pressure Cuff

PERFORMANCE & CLINICAL TEST 3. AAMI / ANSI SP10
MYTECH TECHNOLOGY 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.

JAMES WU

Submitter, 5/7/2004 General Manager MYTECH TECHNOLOGY CO., LTD.

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Image /page/3/Picture/1 description: The image contains the text "Public Health Service". The text is in a bold, sans-serif font. The words are stacked on top of each other, with "Public" on the top line, "Health" on the second line, and "Service" on the third line.

Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 7 2004

Mytech Technology Co., Ltd. c/o Dr. Ke-Min Jen Cro Dr. its its in mean Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300

Re: K041228

K041220
Trade Name: Mytcch/Happy Life Blood Pressure Monitor, HPL-200 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: May 07, 2004 Received: May 10, 2004

Dear Dr. Jen:

We have reviewed your Section 510(k) premarket notification of intent to market the devices in we nave reviewed your Section 910(t) premained is substantially equivalent (for the indications reletenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the encrosure to regars) at regally and the Medical Device Amendments, or to commerce prior to May 20, 1976, the encordance with the provisions of the Federal Food, Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Costlience Act (Act) that do not require appt to the general controls provisions of the Act. The You may, therefore, market the dovices, sale, of the more
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the research and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it If your device is classified (500 abs. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of the con Inay be subject to suen additional vehicler , Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease oc advised that I Dri 3 modalso wrough with other requirements of the Act

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Page 2 – Dr. Ke-Min Jen

or any Federal statutes and regulations administered by other Federal agencies. You must of any i cacal statutes and regaranents, including, but not limited to: registration and listing (21 Comply with an the Free brequirements, while and manufacturing practice requirements as set CITY art 607), adoling (21 CFR Part 820); and if applicable, the electronic forth in the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation oonal of to begin marketing your device as described in your Section 510(k) I ins icher witi anow you to begin maing of substantial equivalence of your device to a legally prematics notification: "The President on 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 acripliance at (301) 594-4648. Also, please note the regulation entitled, Contact the Office of Course 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 information on your responser Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dimna R. Vochner

Image /page/4/Picture/5 description: The image shows a close-up of a signature. The signature is illegible, but it appears to be written in cursive. The signature is made up of a series of loops and curves. The signature is written in black ink.

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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MYTECH TECHNOLOGY CO., LTD.

5F.6, Alley 2, Lane 222, Lien Cheng Road, Chung Ho City, Taipei Hsien, 235, Taiwan, ROC Fax: 886-2-2247 7024 Telephone: 886-2-2247 4816 Email: sale(@mytech.com.tw

510(k) Number ( if known): ___________________________________________________________________________________________________________________________________________________

Device Name: MYTECH / HAPPY LIFE BLOOD PRESSURE MONITOR_ HPL-200

Indications for use:

The device 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 5.25" – 7.75". the wrist.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use V (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)

Dring R. Volumes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number上04/228

Page 1 of 1 -

Regulation Number and Section

§ 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).