(58 days)
Not Found
No
The description details standard signal processing techniques (Oscillometric method, FFT) for calculating blood pressure and heart rate, with no mention of AI or ML algorithms.
No.
The device is indicated for collecting and measuring blood pressure, pulse rate, noise index, and pressure waveform diagrams, which are diagnostic measurements, not therapeutic interventions.
Yes
The device is designed to collect and measure physiological data such as blood pressure, pulse rate, noise index, and pressure waveform diagrams, which are then used to calculate parameters like systolic and diastolic pressure, heart beat rate, and heart beat noise. This information is used for interpretation and checking by medical professionals, indicating its role in diagnosis rather than just treatment.
No
The device description explicitly lists hardware components such as a pressure sensor, measuring cuff, pneumatic pump, inflation and deflation system, housing, and display LCD, in addition to the measuring software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description clearly states that this device measures blood pressure, pulse rate, noise index, and pressure waveform directly from the patient's arm using a cuff. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The intended use and device description focus on physiological measurements. The device utilizes the oscillometric method to measure blood pressure and heart rate, and FFT to analyze noise. These are all in-vivo measurements taken directly from the patient.
Therefore, this device falls under the category of a medical device used for physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DXN
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.
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:
- 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.
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
arm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
- A2 and K7: trained medical professionals at clinical setting.
- X2 and P2: patients at home who are capable and willing to self-administrate this device upon prescription of their healthcare provider.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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
2
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.
-
- 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
- Submitter's Identifications: Ostar Technology Corp. 5F, No. 46-4, Min-Chiuan Rd., Shing-Tien City, Taipei Hsien 231, Taiwan, R.O.C.
Date of Summary Preparation: February 25, 2005.
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- 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).
-
- 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 :
- 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.
3
-
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. -
- 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.
- Intended Use:
The devices do not send any real-time alarms. Clinical judgment and experience are required to check and interpret the information delivered.
-
- 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).
- Comparison to the 510(k) Cleared Device (Predicate Device):
-
- 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.
- Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:
In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance.
-
- 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.
- Conclusions
In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.
4
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
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