The AMPLIFE Wrist Watch Blood Pressure Monitor, Model M600 is a device intended to measure the systolic and diastolic blood pressure and pulse rate of intendou to ividual by using a non-invasive technique in which an inflatable cuff is wrapped around the Wrist.

Device Description

The AMPLIFE Wrist Watch Automatic Blood Pressure Monitor, Model M600 is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the Wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well known technique in the market called the "oscillometric method".

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, using the requested format:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text only explicitly mentions adherence to the ANSI/AAMI - SP-10 Standard for "clinical tests." It doesn't detail specific numerical acceptance criteria (e.g., mean difference, standard deviation) for blood pressure measurements as would typically be found in such a standard. However, the conclusion states the device is "as safe and effective as the predicate" based on these tests.

Acceptance Criteria Category	Specific Criteria (from standard if named)	Reported Device Performance
Clinical Performance	Adherence to ANSI/AAMI - SP-10 Standard	Met standard; "as safe and effective as the predicate"
Electrical Safety	Adherence to FDA DCRND November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions" & IEC 60601-1 Safety Test	Met guidance and standard
Mechanical Performance	Adherence to FDA DCRND November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions" (General Functions, Drop, Vibration Tests)	Met guidance and standards
Environmental Performance	Adherence to FDA DCRND November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions" (Storage Test) & EMC Test	Met guidance and standard
Reliability	General Functions Test, Drop Testing, Storage Reliability Test, Vibrating Testing	No reported failures; met requirements

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The text mentions "the clinical test" (singular) was performed.
Data Provenance: Not explicitly stated. The submitter is from Taichung, Taiwan, R.O.C., but the location of the clinical test is not mentioned. It is a prospective clinical study, as it was "performed" for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not explicitly stated. The ANSI/AAMI SP-10 standard typically involves trained clinicians taking reference blood pressure measurements (often using a mercury sphygmomanometer) alongside the device under test. However, the document does not detail the number or specific qualifications of these clinicians.

4. Adjudication Method for the Test Set

Not explicitly stated. The ANSI/AAMI SP-10 standard outlines specific protocols for data collection and comparison, often involving multiple readings and statistical analysis, but it's not a jury-style adjudication in the sense of expert consensus described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not reported. The study focused on the performance of the device itself against a reference standard, not on how human readers' performance might improve with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the clinical test described is a standalone performance evaluation of the device's ability to measure blood pressure independently. The device's algorithm determines the systolic and diastolic blood pressure and pulse rate. Human interaction is limited to operating the device, not interpreting its output for further diagnostic decisions.

7. The Type of Ground Truth Used

The ground truth for the clinical test was established by comparison with a reference method, as dictated by the ANSI/AAMI - SP-10 Standard. This standard typically mandates comparison to auscultatory measurements performed by trained observers using a mercury sphygmomanometer or another validated reference method.

8. Sample Size for the Training Set

No information is provided regarding a separate "training set" or its sample size. The device uses an "oscillometric method" algorithm, which is described as "well known" and "identical to the predicate device." This suggests the algorithm itself was developed and validated prior to this specific device's clinical testing, likely not requiring a new training set for this submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no specific training set for this device's algorithm development is described in the context of this submission. The "oscillometric method" is a pre-existing, established technique.

Summary

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EXHIBIT # 1

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 5l0(k) number is:

Submitter's Identification: 1.

AMPLIFE Corporation 10F, No. 69, Sec. 3, Hue Jung Rd Taichung, Taiwan, R.O.C

Date Summary Prepared: January 25, 2005

Contact: Mr. Laurence Yang Tel: 0422587766 Fax: 0422587558

2. Name of the Device:

AMPLIFE Wrist Watch Blood Pressure Monitor, Model M600

Common Name or Classification Name:

Wrist Watch Blood Pressure Monitor / Auto-Inflation Oscillometric Digital Blood Pressure Monitor

3. Predicate Device Information:

The AMPLIFE Wrist Watch Automatic Blood Pressure Monitor, Model M600 is substantially equivalent to the Microlife Automatic Wrist Watch Blood Pressure Monitor, Model BP3AX1, K# 040002.

4. Device Description:

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define the systolic and diastolic blood pressure and calculating pulse rate, which is a well known technique in the market called the "oscillometric method".

Intended Use: 5.

Comparison to Predicate Devices: 6.

The AMPLIFE Wrist Watch Automatic Blood Pressure Monitor, Model M600 and the predicate device are identical in functionality and performance with the difference being the external shape of the devices, and PCB layout of the devices, performance specifications, ergonomics of the user interface, dimensional specifications, display mode and memory function, which do not make any effects on the performance of the device. The blood pressure measurements algorithm and its fundamental scientific technology are identical to the predicate device.

Both devices use the well-known oscillometric method within the software algorithm to determine the systolic and diastolic blood pressure and pulse rate. A wrist watch cuff is inflated automatically; deflate rate is controlled but a factory set bleed valve and the deflation pressures are transferred via tubing to a sensor in both units.

Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:

Testing information demonstrating safety and effectiveness of the AMPLIFE Automatic Wrist Watch Blood Pressure Monitor, Model M600 in the intended environment of use is supported by testing that was conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND, which outlines Electrical, Mechanical and Environmental Performance Requirements.

The following testing was conducted:

General Functions Test a.
Reliability Test Operation Conditions b.
Reliability Test Drop Testing C.
Reliability Test Storage ದ.

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Reliability Test Vibrating Testing e.
سن EMC Test
IEC 60601-1 Safety Test g.

None of the testing demonstrated any design characteristics that violated the None of the Reviewer Guidance or resulted in any safety hazards. It was requirements of the Reviewer OE Automatic Blood Pressure Monitor, Model our conclusion that the Allant requirements of the aforementioned tests.

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p 3/3

Discussion of Clinical Tests Performed: 8.

We have performed the clinical test on AMPLIFE Wrist Watch Blood Pressure We have performed the olinical toa and Analysis ANSI/AAMI - SP-10 Standard, Monitor according to "Gillied. In summarizes clinical testing performed.

Conclusions: 9.

We have demonstrated that the AMPLIFE Automatic Wrist Watch Blood Pressure Monitor, Model M600, is as safe and effective as the predicate, the Microlife Automatic Blood Pressure Monitor, Model BP3AX1, based on electrical, mechanical and environmental testing results as well as the FDA DCRND November 1993 Draft "Reviewer Guidance for Premarket Notification November 1900 Drame Standard, Standard, SP10-1992 testing results.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three flowing lines representing the body and head. The symbol is black, and the background is white.

Public Health Service

MAR 4 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AMPLIFE Corporation c/o Mr. Ned Devine Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548

Re: K050413

R020113
Trade Name: AMPLIFE Wrist Watch Blood Pressure Monitor, Model M600 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: February 17, 2004 Received: February 18, 2005

Dear Mr.Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device w chave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conniner co may no may 2011 de nees mat have been require approval of a premarket approval application (PMA). and cosmotic receive, market the device, subject to the general controls provisions of the Act. The r ou may, arovisions of the Act include requirements for annual registration, listing of general only is profiteturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither 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. Ned Devine

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a believe complies with other requirements of the Act
that FDA has made a determination that your device complies with of act that FDA has made a decemmanon that your as were were were would be and the said the sed ligit or any Federal statutes and regulations daminders but not limited to: registration and listing (21
comply with all the Act's requirements, including, but not limited to set comply with an the Act s requirements, merceive reading practice requirements as set CFK Part 807); labeling (21 CFR Part 607); god ations (21 CFR Part 820); and if applicable, the electronic (21 CFR) 1000 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFF 1000-1050.
product radiation control provisions (Sections 531-542 of the Action Section S product radiation control provisions (Dections on device as described in your Section 510(k)
This letter will allow you to begin marketing your device of your douice to Jegal I his letter will anow you to begin maneting your antial equivalence of your device to a legally premarket nother in the PDA midning of backanian vipen 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 device of variable of the regulation entitled, the regulation entitled, contact the Office of Comphalled as (21 mg 11 mart 807.97). You may obtain "Misbranding by relefence to premation is nother the Act from the Division of Small other geleral miormational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, machadonal and Comsailters http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Duna R. Vainer

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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K050413

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Exhibit B

of ___________________________________________________________________________________________________________________________________________________________________________ Page _ 1

KOSO413 510(k) Number (if known): __

Device Name: AMPLIFE Wrist Watch Blood Pressure Monitor, Model M600

Indications For Use:

The AMPLIFE Wrist Watch Blood Pressure Monitor, Model M600 is a device The AMPLIFE Whist Watch Diood Fressure and pulse rate and pulse rate of
intended to measure the systolic and diastolic blood pressure and pulse rate of intended to measure the systolic and diactorie brood province in which an inflatable cuff is wrapped around the wrist.

Prescription Use (Per 21 CFR 801 Subpart D)

Over-The Counter Use X (21 CFT 807 Subpart C)

(Please Do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Varner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number Ko504 13

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).