BLOOD PRESSURE MONITOR WITH SPECTRUM/P2, X2, A2, AND K7 by OSTAR MEDITECH CORP.

The Ostar A2, and K7 are indicated for trained medical professionals to operate on the patient at clinical settings to collect and measure blood pressure, pulse rate noise index and pressure waveform diagram (including heartbeat waveform and noise waveform). In addition, the Ostar P2 and X2 are indicated for patients at home who are capable and willing to self-administrate this device upon prescription of their healthcare provider. P2 and X2 do not display the measuring waveform.

The devices do not send any real-time alarms. Clinical judgment and experience are required to check and interpret the information delivered.

Device Description

Basically the measuring system were composite of blood pressure measuring circuit via Dacillometric method, pressure sensor, measuring cuff at 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 arm is inflated to the estimated pressure level, then deflated to zero measuring our at unfine inflation and deflation, 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.
Heart beat noise calculated via FFT ( Fast Fourier Transformation).

For the display of measuring results and operation interface, the following difference were provided for the following different models :

For model A2, RS 232 is provided for the connection with PC for the measurement operation and display of the whole measuring pressure waveform, noise waveform, systolic and diastolic pressure, heat beat rate, and noise index.
For model K7, the operation and display details are completely identical to that of model A2.
For model X2 and P2, all the measurement components are mounted within a compact housing with operation key and display LCD. These two models do not display the measurement waveform and noise waveform, but they could display the measurement results of systolic and diastolic pressure, heat beat rate, and noise index.

AI/ML Overview

The provided text is a 510(k) summary for a blood pressure monitor. It includes information about the device's intended use, comparison to a predicate device, and non-clinical tests performed. However, it does not contain detailed information about specific acceptance criteria for performance metrics (like accuracy, precision, sensitivity, specificity, etc.) nor does it report the results of a specific study proving the device meets said criteria in the format requested.

The document states that the substantial equivalence determination is based on the device having the "same intended use and technological characteristics" as the predicate device (DynaPulse 500G) and that "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."

It mentions compliance with voluntary standards:

ANSI/AAMI SP 10-1992: "American National Standard, Manual, electronic, or automated sphygmomanometers" - This standard sets accuracy requirements for blood pressure monitors.
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"

It also mentions that "software verification has been carried out according to the FDA software guidance."

Since the document does not provide the specific "acceptance criteria" and "reported device performance" in a quantitative manner, nor does it detail a specific study with sample sizes, expert qualifications, and ground truth methodologies, I cannot fill in the table or the other requested points directly from the provided text.

Therefore, many of the requested fields will be marked as "Not provided in the text."

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

Acceptance Criteria (Metric)	Value (If provided)	Reported Device Performance (Value)
Compliance with ANSI/AAMI SP 10-1992 (Accuracy, etc.)	Met	Not explicitly detailed
Compliance with EN 60601-1 (Basic safety & essential performance)	Met	Not explicitly detailed
Compliance with EN 60601-1-2 (Electromagnetic compatibility)	Met	Not explicitly detailed
Software verification according to FDA software guidance	Performed	Not explicitly detailed
Same safety and effectiveness as predicate device (DynaPulse 500G)	Verified by "verification and validation tests contained in this submission"	Not explicitly detailed

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not provided in the text.
Data provenance: Not provided in the text. The manufacturer is from Taiwan, R.O.C., but the location of the clinical data (if any) is not mentioned.
Retrospective or prospective: Not provided in the text.

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)

Not provided in the text. The document refers to "verification and validation tests" but does not detail the methodology for establishing ground truth or the involvement of experts for a test set. Blood pressure monitors are typically validated against a reference standard (like a mercury sphygmomanometer) during device testing, observing agreement within specified limits rather than relying on expert consensus for "ground truth" in the same way an imaging algorithm might.

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

Not provided in the text.

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

Not applicable. This is a blood pressure monitor, not an AI-assisted diagnostic imaging device requiring human reader interpretation or MRMC studies.

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

The device itself is a standalone blood pressure monitor. The document implies its performance was evaluated against standards and compared to a predicate device, which would inherently be a "standalone" evaluation of the device's measurement capabilities. However, specific performance metrics are not given.

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

While not explicitly stated, for blood pressure monitors, the "ground truth" for accuracy testing is typically established by simultaneously measuring blood pressure using a validated reference method (e.g., a trained observer using a mercury sphygmomanometer following a standardized protocol) on the same subjects, and comparing the device's readings to these reference measurements. The document mentions compliance with ANSI/AAMI SP 10-1992, which specifies such comparison methods.

8. The sample size for the training set

Not applicable/Not provided. This device is a traditional medical device (oscillometric blood pressure monitor), not explicitly an AI/ML algorithm that requires a "training set" in the common sense. Its "algorithm" is fixed and based on oscillometric principles.

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

Not applicable/Not provided, as there is no mention of a "training set" for an AI/ML algorithm.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY2 B 520205

Ostar Meditech Corporation c/o Mr. Steven Chang 5F, No. 46-4, Min Chiuan Road Shing -Tien City Taipei Hsien, CHINA 231

Re: K050680

Trade Name: Blood Pressure Monitor with Spectrum/P2, X2, A2 and K7 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: March 14,2005 Received: March 16,2005

Dear Mr. Chang:

This letter corrects our substantially equivalent letter of May 13,2005. regarding the contact's name and address.

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.

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Page 2 - Mr. Steven Chang

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 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 may be obtained 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/dsma/dsmamain.html

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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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:

Image /page/2/Picture/4 description: The image shows the text "KOSO680" in a bold, sans-serif font. The text is black and appears to be handwritten or stylized. The text is underlined with a thin black line.

1. Submitter's Identifications: Ostar Technology Corp. 5F, No. 46-4, Min-Chiuan Rd., Shing-Tien City, Taipei Hsien 231, Taiwan, R.O.C.
  Contact: Mr. Steven Chang President

Date of Summary Preparation: February 25, 2005.

1. Name of the Device: Blood Pressure Monitor with Spectrum /Models P2, X2, A2 and K7..
Information of the 510(k) Cleared Device (Predicate Device): ဒေ DynaPulse 500G, (k number : K012498).
1. Device Description:

Blood pressure information including systolic and diastolic pressure (calculated via Oscillometric method)
Heart beat rate.
Heart beat noise calculated via FFT ( Fast Fourier Transformation).

For the display of measuring results and operation interface, the following difference were provided for the following different models :

provided tot the following different model PX-31X-46-XXX/FLYTECH was integrated with r of model to , the porcess so as to provide the operation interface and display of the whole mouding pressure waveform, noise waveform, systolic and diastolic pressure, heat beat rate, and noise index.
For model A2, RS 232 is provided for the connection with PC for the measurement operation r of model xx, NO 20218 provided is the operation and display details are completely identical to that of model K7.

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For model X2 and P2, all the measurement components are mounted within a compact housing with operation key and display LCD. These two models do not display the measurement waveform and noise waveform, but they could display the measurement results of systolic and diastolic pressure, heat beat rate, and noise index.
In general the models A2 and K7 are the device used by trained medical professionals to operate on patient at clinical setting to collect and measure blood pressure. Whilst the two models X2 and P2 . are indicated for patients at home who are capable and willing to self-administrate this device for the blood pressure monitor upon prescription of their healthcare provider.
1. Intended Use:
  The Ostar A2, and K7 are indicated for trained medical professionals to operate on patient at clinical settings to collect and measure blood pressure, pulse rate noise index and pressure waveform diagram (including heartbeat waveform and noise waveform). In addition, the Ostar P2 and X2 are indicated for patients at home who are capable and willing to self-administrate this device upon prescription of their healthcare provider. P2 and X2 do not display the measuring waveform.

The devices do not send any real-time alarms. Clinical judgment and experience are required to check and interpret the information delivered.

1. Comparison to the 510(k) Cleared Device (Predicate Device):
  The cleared device for the specification comparison of A2,K7,X2, and P2 is DynaPulse 500G (K012498).
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.

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

1. Conclusions
  The Ostar Blood Pressure Monitor with Spectrum and/or Index, including model A2, K7, X2, and P2, have the same intended use and technological characteristics as the cleared device of DynaPulse model 500G. 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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Indications For Use

KOSB680

510(k) Number (if known):

Device Name: Blood Pressure Monitor with Spectrum/P2, X2, A2 and K7.

Indications For Use:

The Ostar A2, and K7 are indicated for trained medical professionals to operate on the The Ostal A2, and N1 are Indicatou for trainsa for trainsure blood pressure, pulse rate noise patient at cillical settings to oblioorana mound theattbeat waveform and noise index and pressure wavelom diagram (from and the matients of home who
waveform). In addition, the Ostar P2 and X2 are indicated for patients of their waverom), In addition, the Ostar PL and AD at and AD and on prescription of their are capable and willing to self administrate within the measuring waveform.

The devices do not send any real-time alarms. Clinical judgment and experience are The devious and interpret the information delivered.

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)

Bhumima

Division Sign-Off
Division of Cardiovascular Devices
510(k) Number K050680

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).