The CalHealth Finger Blood Pressure Monitor, MDMouse is 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 left index finger. The cuff circumference is designed for Left Index Finger circumference: 1.5' ~ 3.5' (3.7~8.8 cm) for finger type.

Device Description

CalHealth Finger Blood Pressure Monitor, MDMouse uses 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.

AI/ML Overview

The provided 510(k) summary for the CalHealth, Inc. Finger Blood Pressure Monitor, MDMouse, focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a standalone study proving the device meets those criteria.

However, based on the information provided, we can infer some aspects and identify what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions adherence to several standards related to safety, EMC, and performance. The "PASS" designation indicates the device met the requirements of these standards. While specific numerical acceptance criteria (e.g., accuracy ranges for blood pressure measurements) are not explicitly stated in the summary, they would be inherent to the AAMI / ANSI SP10 standard mentioned.

Standard/Test	Acceptance Criteria (Inferred from Standard)	Reported Device Performance
IEC/EN 60601-1:1990+A1+A2+A11+A12+A13	General Medical Electrical Equipment Safety	PASS
EN 1060-1:1995, EN 1060-3:1997	Non-Invasive Sphygmomanometers	PASS
IEC/EN 60601-1-2: 1993	Electromagnetic Compatibility (EMC)	PASS
FCC conformity / ANSI C63.4: 2003	Radio Frequency Device Emissions	PASS
AAMI / ANSI SP10	Non-Automated Sphygmomanometer Performance	PASS

Missing Information: Specific acceptance criteria for blood pressure accuracy (e.g., mean difference and standard deviation between device and reference method) as defined by AAMI / ANSI SP10 were not detailed in the summary. The summary only states "PASS" for AAMI / ANSI SP10.

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

The document mentions "PERFORMANCE & CLINICAL TEST 3. AAMI / ANSI SP10," implying a clinical validation study was conducted. However, it does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

The document does not provide any information on the number of experts used or their qualifications for establishing ground truth, as is common in AI/ML device studies. This is expected since this device predates the widespread use of advanced AI in medical devices and its submission is based on traditional medical device validation. For blood pressure monitors, the "ground truth" is typically established by trained technicians following a standardized protocol using a reference auscultatory method.

4. Adjudication Method for the Test Set:

This information is not applicable or provided. For traditional blood pressure monitor validation per AAMI / ANSI SP10, the comparison is typically against a standardized reference method (e.g., mercury sphygmomanometer with trained observers), not expert adjudication of images or diagnoses.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC study was not conducted or reported. This type of study is primarily relevant for AI devices that assist human readers in tasks like image interpretation, not for automated measurement devices like a blood pressure monitor.

6. Standalone (Algorithm Only) Performance Study:

A standalone study of the algorithm's performance was done in the sense that the device itself, the "CalHealth Finger Blood Pressure Monitor, MDMouse," was subjected to performance testing against established standards (AAMI/ANSI SP10). The device operates as a standalone system to measure blood pressure. The summary indicates that the device's "Oscillometric method" automatically senses pulse signals and calculates blood pressure. This implies the algorithm within the device was validated to perform these measurements.

7. Type of Ground Truth Used:

For blood pressure monitors, the ground truth is typically established by simultaneous measurements using a reference auscultatory method (e.g., using a mercury sphygmomanometer or an equivalent reference device) performed by trained observers. The AAMI / ANSI SP10 standard specifies the methodology for this.

8. Sample Size for the Training Set:

This information is not applicable or provided. Blood pressure monitors using the oscillometric method are typically based on well-established algorithms derived from physiological principles and extensive empirical data, not from machine learning models requiring a "training set" in the modern AI sense. The algorithms are usually pre-determined and validated against clinical data, rather than being "trained" iteratively.

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

This information is not applicable or provided for the same reasons as #8. The "ground truth" for developing such an algorithm would have been based on extensive physiological and clinical studies over many years by the broader scientific community, rather than a specific training set constructed for this particular device's development.

In summary, the 510(k) emphasizes compliance with recognized standards for safety and performance (AAMI/ANSI SP10) to demonstrate substantial equivalence. It does not provide the detailed breakdown of clinical study parameters (sample size, ground truth specifics, etc.) that would be expected in a pre-market submission for a novel AI/ML-based device.

Summary

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Kof 1924

45 Irsine Geotre, Drive, Suite 200 - Irvine, Cablornia 92618

CalHealth, Inc.

Home of MIMouse™

Office, bager Bare-Bain

"510(k) Summary"

JAN - 7 2009

DATE OF SUBMISSION: SUBMITTER:

. . .

...

June 30, 2008

CalHealth, Inc. 7545 Irvine Center Drive # 200, Irvine, CA 92618, USA TEL: (949) 623-8662 FAX: (949) 623-8305

ESTABLISHMENT REGISTRATION NO:

3006985801

OFFICIAL CONTACT: Dr. JEN. KE-MIN ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY NO 58. FU-CHIUN ST. HSIN-CHU CITY, CHINA (TAIWAN) 30067 FAX: 886-3-5209783 TEL: 886-3-5208829 Email: ceirs.jen@msa.hinet.net

TRADE NAME:

$\nabla$

Finger Blood Pressure Monitor, MDMouse

Blood Pressure Monitor

CARDIOVASCULAR

NAME: CLASSIFICATION NAME: PRODUCT CODE:

COMMON/USUAL

Non-Invasive Blood-Pressure Measurement System ( 21CFR 870.1130) DXN

CLASSIFICATION PANEL:

PREDICATED DEVICE:

INTENDED USE:

Omron Digital Finger Blood Pressure Monitor (K894563)

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ちな

me Conter Drive, Softe 2007 - Iteme, Cablorous - 92618

Office: (1)49) 523-8662

Fax: 1949) 083-8305

Description of the new device: (Same as the predicate devices)

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

The technological characteristics of CalHealth Finger Blood Pressure Monitor, MDMouse are substantially equivalent to Omron Digital Finger Blood Pressure Monitor (K894563). The main difference is the subject device has the functions for connects to the PC by using USB cable for data transmission.

Thus there are substantially equivalent.

Test Summary:

ELECTRIC SAFETY, EMC and FCC test reports, 1.

General safety	IEC/EN 60601-1:1990+A1+A2+A11+A12+A13	PASS
	EN 1060-1:1995, EN 1060-3:1997	PASS
EMC conformity	IEC/EN 60601-1-2: 1993	PASS
FCC conformity	ANSI C63.4: 2003	PASS

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Callery Comity Home of MUMous

15 15 Irvine Center Drove, 200 - Irvine, California - 120018

රිffice: (සුදුල) රියුං හිරුදු පිරිබිය

Fax: 4949) (123-8909

WOVEN COTTON SHEETING: 2.

Uses the 510K Blood-Pressure Cuff: YA HORNG Blood-Pressure Cuff (K051539).

PERFORMANCE & CLINICAL TEST 3.

AAMI / ANSI SP10:

Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance Version 1; Final

CalHealth, Inc. 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.

Dr. Jen, Ke-Min official correspondent for CalHealth, Inc.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 a stylized eagle symbol, with three curved lines representing the eagle's body and wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 7 2009

CalHealth, Inc. c/o Dr. Jen. Ke-Min Roc Chinese-European Industrial Research Society No. 58. Fu-Chiun St. Hsin-Chu City, 30067 Taiwan, ROC

Re: K081924

Trade/Device Name: Finger Blood Pressure Monitor, MDMouse Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: December 24, 2008 Received: January 5, 2009

Dear Dr. Jen:

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.

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

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Page 2 - Dr. Jen, Ke-Min

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 this, permitte 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 Center for Devices and Radiological Health's (CDRH) s) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Dmna R. Vuhner

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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CalHealth, Inc. Home of MIMouse

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Paz: (qaq) tipu-Xuer

Indications for Use

510(k) Number:

Kod1924

Device Name: CalHealth, Inc. Finger Blood Pressure Monitor, MDMouse

Indications for use:

. The CalHealth Finger Blood Pressure Monitor, MDMouse is 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 left index finger.

The cuff circumference is designed for Left Index Finger circumference: 1.5' ~ 3.5' (3.7~8.8 cm) for finger type.

Prescription Use (Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

Over-The-Counter Use

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

une R.de hnes
(Division Sign-Off)

Page 1 of 1

Division of Cardiovascular Devices

510(k) Number _ Ko81924

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).