(55 days)
DataEngine is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. DataEngine is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices ( independent bedside devices / information systems ) it is connected to.
DataEngine is a comprehensive solution to integrate medical device data into HIS. It is also designed to be compatible with XML and HL7. All data collected from medical device is able to transfer to readable format of XML and HL7. Caregiver or nurses will be beneficial from DataEngine, device connectivity software to collect data in real time and receive a complete electronic data for patient's record. Medical staffs do not have to spend much time on manual script. Every patient's real time data will be stored in database server for future research projects, education, and clinical study.
The provided text describes a 510(k) summary for the POISE DataEngine, a Patient Physiological Monitor. The document focuses on establishing substantial equivalence to a predicate device and does not contain information about specific acceptance criteria, a study proving device performance against such criteria, or the details typically found in a clinical validation study for an AI/ML device.
Therefore, I cannot fulfill the request for information regarding performance tables, sample sizes, expert ground truth establishment, MRMC studies, standalone performance, or training set details as that information is not present in the provided text.
Based on the information provided, here's what can be extracted:
- Device Name: POISE DataEngine
- Classification: Class II, Product Code MWI
- Intended Use: Data collection and clinical information management, either directly or through networks with independent bedside devices. Not intended for monitoring purposes or to control clinical devices.
- Predicate Device: CAPSULE TECHNOLOGIE Datacaptor, K032142
- Similarities to Predicate: Same intended use, same output mode, same technological characteristics (software server application, no contact with patients, not controlling life-sustaining devices).
- Differences from Predicate (Performance Differences): Can output formats other than just text files, supports waveform information for some devices, supports HL7 & Database, can output in Database format, easier to organize, easy to learn.
Key takeaway regarding your request: The provided document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device, rather than a detailed report of a clinical performance study. It does not contain the specific performance metrics, study designs, or ground truth methodologies that your request asks for.
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2.1
K040969
page 1 of 2
2. ADMINISTRATIVE INFORMATION
510(k) Summary
-
- Identification of the Device:
- Proprietary name: POISE DataEngine .
- Common Name : Patient Physiological Monitor .
- Classification number: MWI, Class II .
- Regulation Number: 870.2300 .
2. Equivalent legal marketed device:
- CAPSULE TECHNOLOGIE .
- Datacaptor, K032142 .
-
- Indications for Use ( intended use ) :
- DataEngine is indicated for use in data collection and clinical ● information management either directly or through networks with independent bedside devices. DataEngine is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices ( independent bedside devices / information systems ) it is connected to.
-
- Description of the Device:
- DataEngine is a comprehensive solution to integrate medical ● device data into HIS. It is also designed to be compatible with XML and HL7. All data collected from medical device is able to transfer to readable format of XML and HL7. Caregiver or nurses will be beneficial from DataEngine, device connectivity software to collect data in real time and receive a complete electronic data for patient's record. Medical staffs do not have to spend much time on manual script. Every patient's real time data will be stored in database server for future research projects, education, and clinical study.
- Safety and Effectiveness, comparison to predicate devices: Similarities
- Same intended use ●
- Same output mode ●
- Same technological characteristics software server application, ● not contact with the patients, not controlling any life sustaining devices
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<840969
page 2 of 2
Differences
- Performance differences ●
- Can output format other than just text file .
- Support wave form information for some device 그
- Support HL7 & Database ■
- Can output in Database format, easier to organize 1999
- Easy to learn 트
-
- Conclusion:
- The new device and the predicate device utilize the similar . technologies and design aspects. The subject device is very toonhologics and performs the same clinical function as the predicate olmillar arra personal distinguishing characteristics of the subject device are more convenience usage than the predicate device, and they are considered to be substantially equivalent.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 9 2004
Poise Technology Corporation c/o Ke-Min Jen, Ph.D. No. 58 . Fu-Chiun Street Hsin Chu City, 300 Taiwan, ROC
Re: K040969
Trade Name: POISE DataEngine Regulation Number: 21 CFR 870 2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: II (two) Product Code: MWI Dated: May 23, 2004 Received: May 26, 2004
Dear Dr. Jen:
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 -- Ke-Min Jen, Ph.D.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised film I DA 3 issualto of a business with other requirements of the Act
that FDA has made a determination that your device complies with other requirements of that FDA has made a decommation and Journer Federal agencies. You must or any Federal statures and regulations daminities, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 820); and 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Dections your device as described in your Section 510(k) I ms letter will anow you to ogin maneting of substantial equivalence of your device to a legally premarket notheation: "The PDF mining of casion 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 If you desire specific advice for your as 110 % 0.0 % 0.0 % 0.0 % 0.0 % 0.7 % % % % % Colliant the Office of Comphalled as (SS +) + + + + + 807.97). You may obtain "Misoranding by reference to promance notifies under the Act from the Division of Small other geleral information on your responsions is and its toll-free number (800) 638-2041 or Manufacturers, International and Consess http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Qolly P. All
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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Ko4096
2.2 FDA Indication for Use Form :
| Applicant: | POISE TECHNOLOGY CORPORATION |
|---|---|
| 510(k) Number : | TO BE ASSIGNED |
| Device Name: | POISE DataEngine |
Indications for Use :
- DataEngine is indicated for use in data collection and clinical ● information management either directly or through networks with independent bedside devices. DataEngine is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices ( independent bedside devices / information systems ) it is connected to.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/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)
Hith P. All for BDZ
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K040969
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).