The M100 of blood pressure monitor is an electronic device that provides a signal from which the systolic, diastolic and rate of heart beats can be derived through the use of transducers placed on the surface of the body. The signals of measurement can be stored in the memory of device, and then can be displayed on the screen of device and/or be transmitted out of device by using the standard signal transmission cable.

Device Description

The Meditek Blood Pressure Monitor, model M100, is the non-invasive electronic medical device intended for the measuring of blood pressure (including systolic pressure and diastolic pressure) and the number of heart beats of patient by using the oscillometric method. According to the general principle of the oscillometric method, the cuff was placed on patient's wrist or arm. The cuff was inflated by using pneumatic pump to the estimated pressure and then was deflated at a certain deflation rate. During the deflation of pressure, the pressure and it's oscillation was measured. The measuring pressure and its oscillation are calculated and analysed by the software of the microprocessor according to the algorithm of oscillometric method.

After completing the measuring cycle, the systolic pressure, diastolic pressure, and heart beat rate are displayed on the LCD of device. All the measuring information and the time of measuring may be stored in the memories of device. Those stored memories may be transmitted out of device through the signal transmission cable.

Basically the blood pressure monitor M100 is the device measuring blood pressure at wrist.

AI/ML Overview

The provided document is a 510(k) summary for the Meditek Blood Pressure Monitor, model M100. It focuses on establishing substantial equivalence to a predicate device (HL-168, K990807) rather than presenting a detailed de novo clinical study with specific acceptance criteria and performance metrics for the M100 itself.

Therefore, many of the requested details regarding acceptance criteria, study design, and performance against those criteria are not explicitly provided in this type of regulatory document. This summary primarily outlines the device's description, intended use, and comparison to a predicate device to demonstrate safety and effectiveness.

Here's a breakdown of what can be extracted and what information is missing based on your request:

1. Table of acceptance criteria and the reported device performance

This information is not explicitly stated in the provided 510(k) summary. For blood pressure monitors, acceptance criteria typically involve accuracy standards (e.g., within certain mmHg limits compared to a reference standard) and often refer to voluntary standards like ANSI/AAMI SP10. The summary mentions compliance with ANSI/AAMI SP 10-1992, but it does not list specific numerical acceptance criteria or the M100's performance against them.

2. 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. The document states that "verification and validation tests contained in this submission demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device," but it does not detail the size or nature of these test sets or their provenance.

3. 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 available. Given that this is a blood pressure monitor, the "ground truth" would likely come from a reference standard blood pressure measurement (e.g., auscultation by trained observers), not typically "experts" in the sense of image readers. However, the details of how ground truth was established for any internal testing are not disclosed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided.

5. 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

This is not applicable to this device. An MRMC study is relevant for diagnostic imaging devices where human readers interpret results, possibly assisted by AI. This device is a non-invasive blood pressure monitor; it doesn't involve human "readers" interpreting complex medical images, nor does it incorporate "AI" in the sense of a machine learning algorithm providing diagnostic assistance to a human.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a "standalone" blood pressure monitor in that it automatically measures and displays readings. However, the document does not describe a formal "standalone performance study" in the context of an algorithm being evaluated independently of human interaction for a diagnostic task. It operates by an "oscillometric method" according to an "algorithm of oscillometric method," but its performance evaluation as described here is focused on meeting existing standards as part of a substantial equivalence claim.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document does not specify the type of ground truth used for any internal validation. For blood pressure monitors, "ground truth" would typically refer to simultaneously acquired reference standard measurements, often from a sphygmomanometer used by trained personnel using auscultation.

8. The sample size for the training set

This information is not applicable or not provided. This summary does not suggest a machine learning model that would require a "training set" in the common sense for a diagnostic AI. The device uses an "algorithm of oscillometric method," which is a well-established physiological principle, not typically a learned model.

9. How the ground truth for the training set was established

This information is not applicable or not provided for the reasons stated in point 8.

Summary of available information:

The 510(k) summary for the Meditek Blood Pressure Monitor, model M100, aims to demonstrate substantial equivalence to a predicate device (HL-168, K990807). Key points regarding its testing and regulatory compliance are:

Acceptance Criteria: Not explicitly stated as numerical values, but the device claims "Compliance to applicable voluntary standards includes ANSI/AAMI, SP 10-1992." This standard provides the framework for blood pressure monitor accuracy and performance.
Study Proving Acceptance: The document mentions "verification and validation tests contained in this submission demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device." However, no details on the study design, sample size, or specific performance results are provided in this public summary.
Regulatory Basis: The FDA's clearance (K032308) is based on a finding of "substantial equivalence" to a legally marketed predicate device, rather than a de novo clinical trial demonstrating novel performance against defined acceptance criteria.
Device Function: The M100 uses the "oscillometric method" to measure systolic pressure, diastolic pressure, and heart rate.

In conclusion, this 510(k) summary provides a high-level overview for regulatory clearance based on substantial equivalence, and therefore lacks the detailed clinical study information and specific performance metrics often found in PMA applications or de novo submissions for novel devices.

Summary

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K032308

NOV 1 0 2003

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: ____________________

1. Submitter's Identifications: Meditek Technology Inc. 1F, No. 11, Lane 223, Sec. 3, Chung Ching N. Rd., Taipei, Taiwan, R.O.C.
  Contact: Mr. Rodin Chang President

Date of Summary Preparation: September 25, 2002.

1. Name of the Device: Meditek Blood pressure Monitor, model M100.
1. Information of the 510(k) Cleared Device (Predicate Device): Health care: HL-168(K990807).

4. Device Description:

Basically the blood pressure monitor M100 is the device measuring blood pressure at wrist.

5. Intended Use:

The M100 Blood Pressure Monitor is an electric device that provides a signal from which the systolic, diastolic, and rate of heart beats can be derived through the use of transducers placed on the surface of body. The signals of measurement can be stored in the memory of device, and then can be displayed on the screen of device and/or be transmitted out of device by using the standard signal transmission cable.

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mediek technology mc.

1. Comparison to the 510(k) Cleared Device (Predicate Device):
  The cleared device for the specification comparison of M100 is HL-168 (K990807).
1. Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:
  Compliance to applicable voluntary standards includes ANSI/AAMI, SP 10-1992, as well as EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirement.

In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance.

1. Conclusions
  The Meditek Blood Pressure Monitor, including model M100, has the same intended use and technological characteristics as the cleared device of HL-168. Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device.

In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 0 2003

Meditek Technology, Inc. c/o Mr. Tony C. S. Chang Official Correspondent 1F, No. 11, Lane 223, Sec. 3 Chung Ching N. Road Taipei Taiwan, R.O.C.

Re: K032308

Trade Name: Blood Pressure Monitor, Model M100 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Monitor Regulatory Class: Class II (two) Product Code: DXN Dated: November 3, 2003 Received: November 3, 2003

Dear Mr. Chang:

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. Tony C. S. Chang

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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with 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 forth 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 contact the Office of Compliance at (301) 594-4646. 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 Manufacturers, International 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 vours.

Uffaxmy
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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510(k) Number (if known):

Device Name: Blood Pressure Monitor / M100 .

Indications For Use:

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)
K032308
(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number
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Prescription Use (Per 21 CFR 801.109)		OR	Over-The-Counter Use	✓
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K03230

And All and

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).