OSTAR USB Blood Pressure Monitor Upper Arm Type : P200 and Wrist Type : M100, are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressure 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 or upper arm.

The cuff circumference is limited to be 5.5'~7.8'(14 cm ~20 cm) for wrist type, and 9'~13'(24cm ~32cm) for Upper Arm Type.

Device Description

Basically the measuring system were composite of blood pressure measuring circuit via Oscillometric method, pressure sensor, measuring cuff at arm, pneumatic pump, inflation and deflation system, housing, display LCD, and measuring software ... and so on.

OSTAR USB Blood Pressure Monitor Upper Arm Type : P200 and Wrist Type : M100 use the Oscillometric method to measure blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to ise the stethoscope, as in the traditional measuring method, to monitor the Korothkov sound when deciding the systolic and 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 stop decreasing. In addition, the heart beat rate will be also measured and displayed on LCD as part of measurement result.

For P200 Upper Arm Type, all the measuring circuit, measuring devices, measuring and display software are all mounted on the device housing. It can be operated individually or be operated by the PC installed with measurement software through USB connection port to control and transfer the measuring records, and then stored the records in device.

For M100 Wrist Type. all the measuring circuit, measuring devices, software are all mounted on the device housing except for the measurement control keys and display. It can be operated only by the PC installed with measurement software through USB connection port to control and transfer the measuring records, and then stored the records in device.

AI/ML Overview

The provided text describes the Ostar USB Blood Pressure Monitor and details its classification, intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to predicate devices. However, it does not explicitly state acceptance criteria or provide a study with detailed performance metrics against those criteria. The document states that the device is compliant with certain standards, including ANSI/AAMI, SP 10-2002/A 1:2003, for blood pressure monitors. These standards typically contain detailed accuracy requirements that would serve as acceptance criteria. Without explicit mention of those criteria in the document or the results against them, I can only indicate general compliance.

Here's the information based on the provided text, with limitations noted due to the absence of specific acceptance criteria and detailed study results:

1. Table of Acceptance Criteria and Reported Device Performance

The document states compliance with ANSI/AAMI SP 10-2002/A 1:2003. This standard dictates accuracy requirements for automated sphygmomanometers.

Acceptance Criteria (Based on ANSI/AAMI SP 10-2002/A 1:2003 for automated sphygmomanometers) - Inferred, not explicitly stated in the document:
- Mean difference between device and reference standard: ≤ ±5 mmHg
- Standard deviation of the difference: ≤ 8 mmHg
Reported Device Performance:
The document states: "verification and validation tests contained in this submission demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device."
This broadly confirms that the device meets the necessary performance standards, including those for accuracy as defined by ANSI/AAMI SP 10-2002/A 1:2003, but specific numerical results are not provided in this summary.

Acceptance Criteria (Inferred from ANSI/AAMI SP 10-2002/A 1:2003)	Reported Device Performance (Summary Statement)
Mean difference between device and reference standard ≤ ±5 mmHg; Standard deviation of the difference ≤ 8 mmHg	"Verification and validation tests contained in this submission demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device." (Indicates compliance with relevant standards)

2. Sample size used for the test set and the data provenance

The document does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "verification and validation tests."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not provide information on the number of experts or their qualifications for establishing ground truth. For blood pressure measurements, ground truth would typically come from auscultatory measurements by trained observers using a reference sphygmomanometer, often with mercury.

4. Adjudication method for the test set

The document does not describe any adjudication method used for the test set.

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 as the device is a blood pressure monitor, not an AI-assisted diagnostic imaging device that involves human readers.

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

Yes, the blood pressure monitor is a standalone device that measures blood pressure using an oscillometric method. Its performance is inherent to the device's algorithms and hardware, without requiring human interpretation for the measurement itself.

7. The type of ground truth used

The type of ground truth for blood pressure monitors, while not explicitly stated in the document, is universally established by comparison to a reference standard, typically auscultatory measurements performed by trained clinicians using a mercury sphygmomanometer or an equivalent validated non-invasive method.

8. The sample size for the training set

The document does not provide information about a "training set." This term is usually associated with machine learning or AI models, which is not directly applicable to the functional description of this blood pressure monitor. The oscillometric method is an established physiological measurement technique.

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

As there is no mention of a "training set" in the context of an AI/ML model, this question is not applicable. The device relies on established oscillometric principles and internal calculations.

Summary

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Ostar Meditech Corp.

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10(K) SUMMARY

OCT 2 0 2011

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 on June 20, 2011.

The assigned 510(k) number is:

1. Submitter's Identifications: Ostar Meditech Corp. 5F, No. 46-4, Min-Chiuan Rd., Shing-Tien Dist., New Taipei City 231, Taiwan, R.O.C.
  Contact: Mr. Steven Chang/President & OC TEL No : +886-2-2918-2390 FAX No.: +886-2-2918-2683

Name of the Device & Classification: Ostar USB Blood Pressure Monitor / Models P200, and Mini-M100. Requlation Number 870.1130 .. Medical Specialty Neurology

Product Code DXN Device Class 11

Information of the 510(k) Cleared Device (Predicate Device):

HOSMAN model HM500 (K103046) for P200 upper arm model
HOSMAN model HM100(K103046) for M100 wrist model

4. Device Description:

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Ostar Meditech Corp.

USB connection port to control and transfer the measuring records, and then stored the records in device.

1. Intended Use:
  OSTAR USB Blood Pressure Monitor Upper Arm Type : P200 and Wrist Type :M100, are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressure 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 or upper arm.

The cuff circumference is limited to be 5.5'~7.8'(14 cm ~20 cm) for wrist type, and 9'~13'(24cm ~32cm) for Upper Arm Type.

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

Compliance to applicable voluntary standards includes ANSI/AAMI, SP 10-2002/A 1:2003, as well as EN 60601-1, and EN 60601-1-2 requirement.

For the cuff of blood pressure monitor, the skin contact materials are in compliance with ISO 10993-1, ISO-10993-5, and ISO 10993-10.

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

7. Conclusions

The Ostar USB Blood Pressure Monitor / Models P200 for blood pressure measurement at upper arm, and M100 for blood pressure measurement at wrist have the same intended use and technological characteristics as the cleared device of HOSMAN model HM500 (K103046) for P200 upper arm model and HOSMAN model HM100(K103046) for M100 wrist model. 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 device.

In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wing. The eagle faces right and appears to be in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 2 0 2011

Ostar Meditech Corp. c/o Mr. Steven Chang Official Correspondent 5F, No. 46-4, Min-Chiuan Road Shing-Tien Dist. New Taipei City CHINA (TAIWAN) 231

Re: K112269

Trade/Device Name: Ostar USB Blood Pressure Monitor, Models P200 and Regulatory Number: 21 CFR 870.1130 M100 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: 74 DXN Dated: June 20, 2011 Received: August 8, 2011

Dear Mr. Steven Chang:

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 r ou may are servicions 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 your device is elassified (000 act 1) . 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. Steven Chang

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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Ostar Meditech Corp.

Indications For Use

510(k) Number (if known):

112269

Device Name: Ostar USB Blood Pressure Monitor / Models P200, and M100.

Indications For Use:

The cuff circumference is limited to be 5.5'~7.8'(14 cm ~20 cm) for wrist type, and 9'~13'(24cm ~32cm) for Upper Arm Type.

Prescription Use (Part 21 CFR 801 Subpart D)

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)

Division Sign Off

Page 1 of

(Bivision Sign-Off) Division of Cardiovascular Devices

510(k) Number K112265

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).