ZSBP-003/004/005/006/007/008 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-102/103/104/105/106/107 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 the measuring system were composite of blood pressure measuring circuit via Oscillometric method, pressure sensor, measuring cuff at wrist or upper arm, pneumatic pump, inflation and deflation system, housing, display LCD, and measuring software... and so on.

The main operation for the blood pressure measurement is carried out in such a way that the measuring cuff at wrist or upper arm is inflated to the estimated pressure level, then deflated to zero automatically. During the inflation, the pressure change with respective of time were recorded as the data base of measurement. Then the following measuring results will be calculated against the measurement data base:

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

AI/ML Overview

The provided text describes a 510(k) submission for a blood pressure monitor and does not contain detailed information about a specific study proving the device meets acceptance criteria. Instead, it refers to compliance with voluntary standards and verification/validation tests.

Here's a breakdown of what can be inferred and what is not present in the provided document, based on the requested categories:

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

The document states "Compliance to applicable voluntary standards includes ANSI/AAMI, SP 10," which is the standard for non-invasive sphygmomanometers. This standard dictates specific accuracy requirements for blood pressure measurements.

Acceptance Criteria (Based on ANSI/AAMI SP 10, inferred)	Reported Device Performance
Blood Pressure Measurement Accuracy
Mean difference between device and reference measurement: ≤ ±5 mmHg	Not explicitly stated. The submission states that V&V tests demonstrate the device "maintain the same safety and effectiveness as that of cleared devices" which comply with ANSI/AAMI SP 10.
Standard deviation of difference between device and reference measurement: ≤ 8 mmHg	Not explicitly stated.
Heart Rate Measurement Accuracy	Not explicitly stated.

2. 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 document. The submission mentions "verification and validation tests" but does not detail the methodology, sample size, or data provenance of these tests.

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)

This information is not provided in the document. For blood pressure monitors, ground truth is typically established by trained technicians using a reference sphygmomanometer (e.g., mercurial manometer) in a clinical setting.

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

This information is not provided in the document.

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

This is not applicable to this device. Blood pressure monitors are standalone measurement devices and do not involve "human readers" or AI assistance in their primary function of measuring blood pressure from a patient.

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

Yes, this is the primary mode of operation for a blood pressure monitor. The device is intended to automatically measure blood pressure and heart rate using an oscillometric method. The "verification and validation tests" would assess this standalone performance against reference measurements. However, the details of these tests (e.g., specific metrics, results) are not provided.

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

The document implicitly refers to reference blood pressure measurements as the ground truth. For accuracy testing of blood pressure monitors, the established practice (as per ANSI/AAMI SP 10) involves comparing the device's readings to those obtained simultaneously from a validated reference method (e.g., a mercury sphygmomanometer) by trained observers.

8. The sample size for the training set

This information is not provided in the document. Blood pressure monitors using the oscillometric method rely on algorithms that are typically developed and refined using extensive physiological data. The size of this underlying development/training data set is not specified.

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

This information is not provided in the document. For an oscillometric blood pressure monitor, the ground truth for algorithm development would generally involve simultaneous recordings of cuff oscillations and invasive arterial pressure (or highly accurate non-invasive reference measurements) across a diverse population.

Summary of what the document does indicate regarding acceptance criteria and study:

The submission implies that the device meets acceptance criteria by:

Stating "Compliance to applicable voluntary standards includes ANSI/AAMI, SP 10." This standard itself contains detailed acceptance criteria for non-invasive sphygmomanometers.
Reporting that "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 [ZSBP-001, ZSBP-002, and ZSBP-101 (K070473)]."
The FDA's clearance (K090027) indicates that these tests were sufficient to demonstrate substantial equivalence to predicate devices, which were themselves compliant with relevant standards.

However, the document does not provide the specific numerical results of the performance tests, the sample sizes, expert qualifications, or detailed methodology of the studies conducted for this specific device (ZSBP-003/004/005/006/007/008 and ZSBP-102/103/104/105/106/107). It relies on the assertion of compliance with standards and equivalence to previously cleared devices.

Summary

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Zen Strong Medical Technology Co., Ltd.

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:

1. 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: December 31, 2008
1. Name of the Device: Blood Pressure Monitor, models ZSBP-003/004/005/006/007/008 for wrist type and ZSBP-102/103/104/105/106/107 for upper arm type.
1. Classification information: Regulation Number 870.1130 Medical Specialty Cardiovascular Product Code DXN Device Class Tier

Device Description: 4.

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

5. Intended Use:

ZSBP-003/004/005/006/007/008 blood pressure monitors measure automatically human being svstolic, diastolic blood pressure and heart beat rate from wrist by using the oscillometric method for all ages of person.

ZSBP-102/103/104/105/106/107 blood pressure monitors measure automatically human being systolic, diastolic blood pressure and heart beat rate from upper arm by using the Oscillometric method for all ages of person.

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

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Zen Strong Medical Technology Co., Ltd.

1. Comparison to the 510(k) Cleared Device (Predicate Device): ZSBP-001, ZSBP-002, and ZSBP-101 (K070473).
1. Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:

Compliance to applicable voluntary standards includes ANSI/AAMI, SP 10, as well as EN 60601-1, and EN 60601-1-2 requirement.

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 model ZSBP-003/004/005/006/007/008blood pressure monitors (measurement at wrist) have the same intended use and technical characteristics as the cleared model ZSBP-001 and ZSBP-002 (K070473), and ZSBP-102/103/104/105/106/107 blood pressure monitors (measured at upper arm) have the same intended use and technical characteristics as the cleared model ZSBP-101 (K070473).

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

FEB - 2 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zen Strong Medical Technology Co., Ltd. c/o Ms. Cheng Roie-Sheng 6F, No. 88, Ning Jin Street, Nuannuan District, Keelung City, Taiwan, R.O.C.

Re: K090027

Trade/Device Name: Blood Pressure Monitor, Models ZSBP-003/004/005/006/007/008 for wrist type and ZSBP-102/103/104/105/106/107 for upper arm type Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: December 31, 2008 Received: January 5, 2009

Dear Ms. Roie-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 - Ms. Cheng Roie-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 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.

Dina R. Valenci

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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Indications For Use

510(k) Number (if known):

`Device Name: Blood Pressure Monitor, models ZSBP-003/004/005/006/007/008 for wrist type, and ZSBP-102/103/104/105/106/107 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) OR

Over-The-Counter Use (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)

proma & Valumes

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K090027

Page 1 of

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).