MS-700 by ALAN S. LEE | FDA 510(k) Summary

The MARS MS-700 Automatic Digital Blood Pressure Monitor is designed to provide signals from which systolic and diastolic pressures can be derived the use of the oscillometric method, The device also measures the heart rate.

Device Description

MS-700 Automatic Digital Blood Pressure Monitor

AI/ML Overview

The provided text is related to a 510(k) submission for the "MS-700 Automatic Digital Blood Pressure Monitor." It discusses safety and effectiveness. However, it does not contain the detailed clinical study information needed to fill out all aspects of your request.

Specifically, the document states:

"Effectiveness information on the MS-700 can be found in Section C (Clinical Studies) of this submission."
"Mars Metal Company, Ltd. will provide safety and effectiveness information on the MS-700 to interested persons upon request. This information will include adverse safety and effectiveness information that is relevant to a assessment of substantial equivalence. The information provided on request will also include clinical testing information."

Therefore, based only on the provided text, I can only partially address your request.

Here's what can be inferred or stated based on the given document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in the provided text. For blood pressure monitors, acceptance criteria typically involve accuracy standards (e.g., AAMI, ISO 81060-2).
Reported Device Performance: The document only generically states the device "measures the heart rate" and provides "signals from which systolic and diastolic pressures can be derived the use of the oscillometric method." No specific performance metrics (e.g., mean difference, standard deviation compared to a reference method) are provided.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Information Not Provided: The document states clinical study information is in Section C and available upon request, but it does not detail sample size or data 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)

Information Not Provided: This detail is not present in the given text. For blood pressure, ground truth is usually established by a highly accurate reference device and/or trained operators following specific protocols, not typically "experts" in the sense of image interpretation.

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

Information Not Provided: The document does not discuss clinical study methodology in this level of detail.

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

Not Applicable / Not Provided: This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool requiring human reader studies like those for image interpretation. The concept of "human readers improve with AI" does not apply here.

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

Likely Yes (Implied): The device is described as an "Automatic Digital Blood Pressure Monitor" that uses the oscillometric method to derive pressures. This strongly implies it functions as a standalone algorithm without human interpretation of raw signals to determine the primary output (systolic, diastolic, heart rate). However, the specific study of its standalone performance is not detailed.

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

Information Not Provided: While typical ground truth for blood pressure monitors involves comparison to a gold standard (e.g., auscultation by trained observers with a mercury sphygmomanometer, or a highly accurate invasive measurement), the document does not specify how ground truth was established for the MS-700's clinical study.

8. The sample size for the training set

Not Applicable / Not Provided: For a device based on the oscillometric method, it's unlikely there's a "training set" in the machine learning sense. The oscillometric algorithm is typically a pre-defined engineering solution based on physiological principles and signal processing, rather than a machine learning model that requires training data in the same way. If any calibration or tuning data was used, it's not mentioned.

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

Not Applicable / Not Provided: See explanation for #8.

Summary of what is present:

Device Type: Automatic Digital Blood Pressure Monitor
Method: Oscillometric method for deriving systolic and diastolic pressures, and measuring heart rate.
Intended Use: For adult use only.
Safety: Stated to operate similarly to other standard oscillometric devices, with emergency deflation valves for patient and power safety.
Effectiveness: Stated to be covered in Section C of the submission, but details are not provided in the extracted text.

To fully answer your request, the "Section C (Clinical Studies)" document would be required.

Summary

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K972213

MAR 1 3 1998

Statement on the Safety and Effectiveness of the MS-700

Safety

A) For the Subject

Since this device operates in exactly the same manner as any other standard oscillometric blood pressure measure device, it presents no special safety concerns for the patient. The device is equipped with an emergency deflation valve which can be opened immediately with the pressing of a single function key if the patient should feel any discomfort during the test. Any rapid change in electric power also causes the emergency valve to be opened immediately. No electrical components come in direct contact with the subject.

B) For the Operator

This device can be operate by the subject. If it is operated by someone other than the subject, the operator faces the same safety concern as the subject.

C) Additional Safety Information

Additional safety information on the MS-700 can be found in Section D (Physical and Environmental Testing Results) and Section E (Software Development Standards and Quality Assurance) of the 510(k) submission.

2. Effectiveness

Effectiveness information on the MS-700 can be found in Section C (Clinical Studies) of this submission. Additionally, per the Safe Medical Devices Act of 1990, Mars Metal Company, Ltd. will provide safety and effectiveness information on the MS-700 to interested persons upon request. This information will include adverse safety and effectiveness information that is relevant to a assessment of substantial equivalence. The information provided on request will also include clinical testing information.

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Image /page/1/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Alan S. Lee US Representative Mars Metal Co., Ltd. 2121 W. Beacon Avenue Anaheim, CA 92804

K972213 Re: MS-700 Regulatory Class: II (Two) 74 DPW Product Code: Dated: December 12, 1997 December 15, 1997 Received:

Dear Mr. Lee:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

MAR 13 1998

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CER Part 220) and that through periodic QS --inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Alan S. Lee

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html. "

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K972213 510(k) Number (if known):

Device Name:MS-700 Automatic Digital Blood Pressure Monitor

Classification Panel: Class II 74 DXN 870.1130

Indications for Use:

The device is for adult use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the-Counter Use

D.A. Singh f. DLL

(Division Sign-Off) ------ 0 ------(Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number _

Regulation Number and Section

§ 870.2100 Cardiovascular blood flowmeter.

(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).