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

HOCA EZ-CARE BP108 and TENDER-CARE BP109 use 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, clinically proven, 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 HOCA EZ-CARE BP108 and TENDER-CARE BP109 are noninvasive blood pressure measurement systems. The provided documentation does not include explicit acceptance criteria with numerical targets for device performance or a detailed study description with specific results. However, it does reference compliance with a standard related to electronic or automated sphygmomanometers, which implicitly defines performance criteria.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the HOCA EZ-CARE BP108 and TENDER-CARE BP109 are implicitly based on compliance with the ANSI/AAMI SP10-1992 Electronic or Automated Sphygmomanometers standard. This standard typically defines accuracy requirements for blood pressure monitors.

However, the document does not explicitly state the numerical acceptance criteria or the reported device performance against these criteria in the form of specific accuracy (e.g., mean difference and standard deviation compared to a reference method). It only states that the device was tested against this standard and that its "accuracy" is a characteristic it shares with the predicate device.

Acceptance Criteria (Implied by ANSI/AAMI SP10-1992)	Reported Device Performance (Not explicitly quantified in the document)
Blood pressure accuracy within specified limits	Stated as "accuracy" and "reflect the accurate real blood pressure"

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

The document does not specify the sample size used for any performance testing, nor does it detail the data provenance (e.g., country of origin or whether it was retrospective or prospective). It only mentions "Performance Testing" which includes adherence to ANSI/AAMI SP10-1992. Performance testing for blood pressure monitors typically involves clinical validation studies, but the details of such a study are not present in this document.

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

The document does not provide any information regarding the number of experts or their qualifications used to establish ground truth for any test set. For blood pressure devices, ground truth for clinical validation is typically established by trained observers using auscultation (Korotkoff sounds) with a mercury sphygmomanometer, often with double-blinded readings.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improving with AI vs. without AI assistance

The device is a blood pressure monitor, not an AI-assisted diagnostic imaging or classification system that typically involves human readers interpreting cases. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study of human readers with vs. without AI assistance is not applicable to this type of device and was not mentioned.

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

The device itself is a standalone (algorithm only) blood pressure monitor that provides a direct reading. Its performance is evaluated as a standalone system. The document refers to "Performance Testing" with respect to relevant electrical safety and EMC standards, and the ANSI/AAMI SP10-1992 standard for electronic or automated sphygmomanometers, which addresses the standalone performance of such devices. The statement "Through simple calculation, clinically proven, the reading can reflect the accurate real blood pressure" implies a standalone performance evaluation.

7. The Type of Ground Truth Used

While not explicitly stated for a specific study in the document, for blood pressure monitors, the type of ground truth used in clinical validation studies conforming to standards like ANSI/AAMI SP10-1992 is typically expert consensus derived from auscultation using a calibrated mercury sphygmomanometer.

8. The Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. Modern oscillometric blood pressure devices are developed using algorithms that are calibrated and validated, but the specifics of a "training set" in the context of machine learning (as often implied by this question) are not detailed here. The "simple calculation, clinically proven" phrase suggests a validated algorithm rather than a continuously "trained" AI model.

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

As no training set is mentioned, there is no information on how its ground truth was established.

Summary of Study Information:

The document primarily focuses on establishing substantial equivalence to a predicate device (Automatic Digital Blood Pressure Monitor, APM BP108A - K040159) based on shared characteristics including "intended use, technological characteristics, power supply, display, measuring range, accuracy, operating and storage environments."

The "Performance Testing" mentioned refers to compliance with:

Electric Safety Requirement Test Report of EN 60601-1:1990
EMC test report of EN 60601-1-2 (EN 55011:1991 and EN 61000-4-2:1995)
ANSI/AAMI SP10-1992 Electronic or Automated Sphygmomanometers

The ANSI/AAMI SP10-1992 standard is the key reference for the accuracy performance of such devices. While the document confirms testing against this standard, it does not provide the specific numerical results of those tests or the details of the clinical study (e.g., subject count, methodology, statistical analysis). It relies on the predicate device's existing clearance which would have been based on such studies.

Summary

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FEB S 2006

K052671
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HOCA Medical Microsystem, Inc.

No.336-2, Chien Kuo Road, Chu Nan Chen, Miaoli Shien, 35045, Taiwan Telephone (886) 37-481909 (886) 37- 484906 Fax # e-mail: neo@smarthoca.com Website : www.smarthoca.com

510(k) SUMMARY " દા

HOCA Medical Microsystem, Inc. Submitter's Name:

No.336-2, Chien Kuo Road, Miaoli Shien, 350, Taiwan Fax: 886-37-484906 Telephone: 886-37-481909 e-mail : neo@smarthoca.com

Date summary prepared:

Proprietary Name:

Device Name:

HOCA EZ-CARE BP108, TENDER-CARE BP109 NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM Common or Usual Name: Blood Pressure Monitor, Class II, Classification Name: 21 CFR 870.1130

September 19, 2005

Indications for Use:

Description of the device:

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K052471

F2/2

Image /page/1/Picture/1 description: The image shows a logo with a stylized leaf shape in black and white. Inside the leaf, there is a white square with a black plus sign in the center. To the right of the leaf, there is a cursive word that appears to be "foca".

HOCA Medical Microsystem, Inc.

No.336-2, Chien Kuo Road, Chu Nan Chen, Miaoli Shien, 35045, Taiwan (886) 37- 484906 Telephone (886) 37- 481909 Fax # e-mail: neo@smarthoca.com Website : www.smarthoca.com

Performance Testing:

Electric Safety Requirement Test Report of EN 60601-1:1990 and EMC test report of EN 60601-1-2 ( EN 55011:1991 and EN 61000-4-2:1995) ANSI/AAMI SP10-1992 Electronic or Automated Sphygmomanometers

Legally marketed device for substantial equivalence comparison:

Automatic Digital Blood Pressure Monitor, APM BP108A (K040159)

Summary for substantial equivalence comparison:

Same characteristics: intended use, technological characteristics, power supply, display, measuring range, accuracy, operating and storage environments. The new device HOCA BP108 are all the same as the predicate device APM BP108A.

Different characteristics: the new device HOCA BP109 has the different appearance for the "start key".

They are decided to be substantially equivalent.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 3 2006

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

Re: K052671

Trade Name: HOCA Ez-Care BP108 and Tender-Care BP109 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: January 12, 2006 Received: January 18, 2006

Dear Dr. Ke-Min.

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 - Dr. Jen Ke-Min

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 (240) 276-0210. 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/industry/support/index.html.

Sincerely yours,

Bhimimor 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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Image /page/4/Picture/1 description: The image shows a logo with a leaf-like shape on the left and the word "Coca" on the right. Inside the leaf shape, there is a plus sign. The leaf is shaded in black, and the word "Coca" is written in a cursive font.

HOCA Medical Microsystem, Inc.

No.336-2, Chien Kuo Road, Chu Nan Chen, Miaoli Shien, 35045, Taiwan Telephone (886) 37-481909 (886) 37- 484906 Fax # e-mail: neo@smarthoca.com Website : www.smarthoca.com

Indications for Use

510(k) Number:

K052671

Device Name: HOCA Medical Microsystem, Inc. HOCA EZ-CARE BP108 and TENDER-CARE BP109

. Indications for use:

Prescription Use

AND/OR

Over-The-Counter Use __

(Part 21 CFR 801 Subpart D)

(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)

Blummmmas
(Division Sign-Off)

Division of Cardiovascular Devices
510(k) Number K052671

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).