BLOOD PRESSURE MONITOR, MODELS ZSBP-OXX AND ZSBP-1XX by ZEN STRONG MEDICAL TECHNOLOGY CO., LTD

ZSBP-001 and ZSBP-002 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from wrist by using the Oscillometric method for the patient of the age over 18 years old.

ZSBP-101 series of blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from upper arm by using the Oscillometric method for the patient of the age over 18 years old.

All measurement values can be read out and keep memory on the LCD panel for home care use.

Device Description

Basically two different type of blood pressure monitors are to be included in this 510(K) submission, the wrist type and upper arm type. The main intended use for these two tvpe of blood pressure monitor is as the following description:

1> ZSBP-001 and ZSBP-002 blood pressure monitor. This series of device measures automatically the human being systolic, diastolic blood pressure and heart beat rate from wrist by using the oscillometric method for the patient of ages above 18 years old.

2> ZSBP-101 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from upper arm by using the Oscillometric method for the patient of the age above 18 tears old.
For all of these three blood pressure monitors, the measurement values can be read out and keep memory on the LCD panel for home care use( without the involvement of professional physician).

From the construction point of view, the non-invasive electronic blood pressure monitor was composite of blood pressure measuring circuit via Oscillometric method, pressure sensor, measuring cuff at upper arm or wrist, pneumatic pumping inflation and deflation system, housing, display LCD, and measuring software, and memories ....... etc.

The main operation for the non-invasive electronic blood pressure monitor is carried out in such a way that the measuring cuff at wrist or upper arm is inflated to the set pressure level, then deflated to zero automatically. During the inflation and deflation, the pressure change with respective to time were recorded as the database of measurement. Then the following measuring results will be calculated against the measurement database, and displayed on the LCD of device:

Blood pressure information including systolic and diastolic pressure (calculated via Oscillometric method)
Heart beat rate.

In addition to the main blood pressure and heart beat rate measuring function, the ZSBP series of blood pressure monitor provides also the memory function for user to store the result of measurement.

AI/ML Overview

The provided text is a 510(k) summary for a blood pressure monitor, not an AI/ML medical device. Therefore, much of the requested information, such as details about AI model training, test sets, ground truth establishment, and MRMC studies, is not applicable or present in this type of document.

However, I can extract the information that is relevant to the acceptance criteria and the study performed, based on the provided text.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on compliance with established voluntary standards. The document explicitly mentions:

ANSI/AAMI SP 10-1992: This standard specifies requirements for automated sphygmomanometers.
EN 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
EN 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.

The document states that the "representative models of ZSBP-001 and ZSBP-101 were chosen as testing samples" to demonstrate conformity with these standards.

The "reported device performance" is summarized by the conclusion that the devices "maintain the same safety and effectiveness as that of cleared devices" (the predicate devices) and that the engineering differences "do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device."

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Standard Reference)	Reported Device Performance (Compliance Statement)
ANSI/AAMI SP 10-1992	The representative models (ZSBP-001 and ZSBP-101) demonstrate compliance.
EN 60601-1	The representative models (ZSBP-001 and ZSBP-101) demonstrate compliance.
EN 60601-1-2	The representative models (ZSBP-001 and ZSBP-101) demonstrate compliance.
Software Verification (FDA Guidance)	Software verification has been carried out according to FDA software guidance.
Substantial Equivalence	Engineering differences do not: (1) affect intended use or (2) alter fundamental scientific technology. Device maintains same safety and effectiveness as predicate.

Regarding the other requested information (and why it's mostly not applicable here):

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 in the 510(k) summary. For a blood pressure monitor, testing would typically involve clinical validation studies (e.g., following AAMI protocols) to establish accuracy against a reference method (like auscultatory measurement by trained observers). The 510(k) summary only states "representative models... were chosen as testing samples" for standard compliance. It does not mention the number of subjects or the data provenance for these tests.
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):
- Not applicable in this context. Blood pressure monitor validation relies on comparison to a gold standard measurement (often auscultation by trained technicians/physicians), not expert consensus on images or other subjective data. The document does not provide details on the personnel involved in the testing process or their qualifications.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies where there's an element of human interpretation and potential disagreement (e.g., reading medical images). For a blood pressure monitor, the "ground truth" and device measurements are objective numerical values.
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. This is a blood pressure monitor, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed or is relevant to this device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This device is a standalone algorithm (an oscillometric method, though not an AI algorithm) for measuring blood pressure. Its "performance" is its accuracy in measuring blood pressure compared to a reference standard, as implicitly covered by compliance with ANSI/AAMI SP 10-1992. The document confirms that "measurement values can be read out and keep memory on the LCD panel for home care use( without the involvement of professional physician)." This indicates it's intended for standalone use.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For blood pressure monitors, the gold standard (ground truth) is typically an invasive intra-arterial measurement or, more commonly in non-invasive validation, simultaneous auscultatory measurements taken by trained observers using a mercury sphygmomanometer (or an equivalent validated device). The document itself does not explicitly state the ground truth method used beyond referencing compliance with ANSI/AAMI SP 10-1992, which dictates such validation methods.
The sample size for the training set:
- Not applicable. This device uses the "oscillometric method," which is a well-established signal processing technique for detecting blood pressure. It is not an AI/ML device that requires a "training set" in the modern sense.
How the ground truth for the training set was established:
- Not applicable, as there's no AI/ML training set in this context.

Summary

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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:

Submitter's Identifications: Zen Strong Medical Technology Co., Ltd. 6F No. 88, Ning Jin St., Keelung, Taiwan, R.O.C. Contact: Cheng Roei-Sheng Date of Summary Preparation: February 15, 2007 MAY 2 3 2007

1. Name of the Device: Blood Pressure Monitor, models ZSBP-001 and ZSBP-002 for wrist type and ZSBP-101 for upper arm type.
1. Classification information:

Regulation Number	870.1130
Medical Specialty	Neurology
Product Code	DXN
Device Class	II
Tier	II

4. Device Description:

2> ZSBP-101 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from upper arm by using the Oscillometric method for the patient of the age above 18 tears old.
For all of these three blood pressure monitors, the measurement values can be read out and keep memory on the LCD panel for home care use( without the involvement of professional physician).

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Blood pressure information including systolic and diastolic pressure (calculated via -Oscillometric method)
Heart beat rate. ।

In addition to the main blood pressure and heart beat rate measuring function, the ZSBP series of blood pressure monitor provides also the memory function for user to store the result of measurement.

1. Intended Use:
  ZSBP-001 and ZSBP-002 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from wrist by using the oscillometric method for the patient of the age over 18 years old.

ZSBP-101 series of blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heat beat rate from upper arm by using the Oscillometric method for the patient of the age over 18 years old.

All measurement values can be read out and keep memory on the LCD panel for home care use.

1. Comparison to the 510(k) Cleared Device (Predicate Device):
- 1> Health & Life model HL-168 (K050249).
- 2> Micro life model BP-3BT0-AP (K041411).
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, and EN 60601-1-2 requirement. For the conformity of standards, the representative models of ZSBP-001 and ZSBP-101 were chosen as testing samples.

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

1. Conclusions
  The Zen Strong mode! ZSBP-001 and ZSBP-002 blood pressure monitor (measurement at wrist) has the same intended use and technical characteristics as the cleared model HL-168 (K050249), and ZSBP-101 series of blood pressure monitor (measured at upper arm) has the same intended use and technical characteristics as the cleared model BP-3BT0-AP (K041411).

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 devices.

In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device, and the new models as mentioned on this submission are considered substantial equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines that curve and converge. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2007

Zen Strong Medical Technologies Co. c/o Cheng- Roei-Sheng 6F, No. 88 Ning Jing St. Keelung China (Taiwan)

Re: K070473

Trade/Device Name: Blood Pressure Monitor, models ZSBP-001 and ZSBP-002 for wrist type and ZSBP-101 for upper arm type. Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN Dated: April 16, 2007 Received: April 16, 2007

Dear Mr. Roei-Sheng:

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. Roei-Sheng

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) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Blyminuma for

Bram B. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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070473/s1

Indications For Use

510(k) Number (if known):

Device Name: Blood Pressure Monitor, models ZSBP-001and ZSBP-002 for wrist type, and ZSBP-101 for upper arm type.

Indications For Use:

All measurement values can be read out and keep memory on the LCD panel for home care use.

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use V (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)

Bllminson

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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).