(223 days)
No
The document describes a data acquisition and distribution software system that interfaces with medical devices. There is no mention of AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML applications. The focus is on data connectivity and management.
No
The device is described as data collection and clinical information management software that retrieves and distributes data from clinical devices, but it is not intended for monitoring purposes nor to control any clinical devices. It does not provide any therapeutic function.
No
The device description clearly states "MEDLOG is a data acquisition and distribution software" and "It retrieves data from serial or network devices and makes these data available over networks or any other type of communication for us in software applications." The intended use is for "data collection and clinical information management." It explicitly states that it is "not intended for monitoring purposes, nor is the software intended to control any of the clinical devices." This indicates it handles data, but does not perform diagnostic analysis itself.
No
The device description explicitly mentions the use of cables, multiport boxes, and Serial/Ethernet converters for connecting to clinical devices. While the core of MEDLOG is software, these hardware components are integral to its function of data acquisition and distribution from physical medical devices.
Based on the provided information, the MEDLOG System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "data collection and clinical information management." It explicitly states it's not for monitoring or controlling clinical devices. IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on data acquisition and distribution from various medical devices (like blood-gas analyzers or cardiac-monitoring systems). While it interfaces with devices that might produce data used in IVD procedures (like blood-gas analyzers), the MEDLOG system itself is not performing the diagnostic test on a specimen. It's managing the data generated by those tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, performing diagnostic tests, or providing diagnostic information directly.
The MEDLOG system appears to be a data management and integration tool for clinical data, rather than a device that performs in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The MEDLOG System is indicated for the use in data collection and clinical information management. MEDLOG is connected with independent bedside or clinical devices either directly or through networks.
MEDLOG is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices, which is connected to.
Product codes
MWI
Device Description
MEDLOG is based of open-architecture design using JAVA Technology. MEDLOG is a data acquisition and distribution software. It retrieves data from serial or network devices and makes thes data available over networks or any other type of communication for us in software applications. BMC customers can buy cables and can connect the devices directly to the COM Port or they can use a multiport box. Customers also can use Serial/Ethernet converters if needed. BMC not recommends hardware suppliers. MEDLOG enables the interfacing of medical devices, which are types of blood-gas analyzers or cardiac-monitoring systems. It is a matter of principle, that MEDLOG is able to support other kind of connected devices. The basic componente of MEDLOG ist the MCS Communication server, which runs and controls MMD Device Drivers. The collected device data can stored temporarily may MCS. The MEI External Interfaces makes data available for other external systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
OCT 3 0 2006
Image /page/0/Picture/1 description: The image shows the logo for BMC IT Health Solutions. The logo features the letters "BMC" in bold, black font. Below the letters, there is a curved line that connects to the words "IT Health Solutions" in a smaller, lighter font. The logo is simple and professional, with a focus on the company's name and area of expertise.
5. Summary 510(k)
| Submitter: | BMC Gesellschaft f\u00fcr Medizintechnik mbH
Harburger Schlossstrasse 6-12
D-21079 Hamburg - Germany |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dr. Angelika Berger
Managing Director
Phone: 0049 40 76629 2712
Fax: 0049 40 76629 543
email: angelika.berger@bmc-ithealth.de |
- Identification of Device
| Proprietary-Trade Name: | MEDLOG |
|---|---|
| Classification Name: | MWI |
| Common/Usual Name: | Data Collection Software |
- Equivalent legally marketed device
This product is similar in design and identical in funtion to the DataCaptor Software, K032142. The premarket notfication adds compatibility with basic capabilities of DataCaptor.
-
- Indications of Use (intended Use)
The MEDLOG System is indicated for the use in data collection and clinical information management. MEDLOG is connected with independent bedside or clinical devices either directly or through networks.
- Indications of Use (intended Use)
MEDLOG is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices, which is connected to.
- Description of Device
MEDLOG is based of open-architecture design using JAVA Technology. MEDLOG is a data acquisition and distribution software. It retrieves data from serial or network devices and makes thes data available over networks or any other type of communication for us in software applications. BMC customers can buy cables and can connect the devices directly to the COM Port or they can use a multiport box. Customers also can use Serial/Ethernet converters if needed. BMC not recommends hardware suppliers. MEDLOG enables the interfacing of medical devices, which are types of blood-gas analyzers or cardiac-monitoring systems. It is a matter of principle, that MEDLOG is able to support other kind of connected devices. The basic componente of MEDLOG ist the MCS Communication server, which runs and controls MMD Device Drivers. The collected device data can stored temporarily may MCS. The MEI External Interfaces makes data available for other external systems.
1
Image /page/1/Picture/0 description: The image shows the logo for BMC IT Health Solutions. The logo features the letters "BMC" in bold, black font on the left side of the image. To the right of the letters is a vertical line that is broken into three segments, with a curved line running through the middle segment. Below the vertical line are the words "IT Health Solutions" in a smaller font.
| Comparion Areas | DataCaptor, K032142 | BMC
MEDLOG |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Indications of Use | The MEDLOG System is
indicated for the use in data
collection and clinical
information management.
MEDLOG is connected with
independent bedside or
clinical devices either directly
or through networks.
MEDLOG is not intended for
monitoring purposes, nor is
the software intended to
control any of the clinical
devices, which is connected
to. | SAME |
| Interfaces | Serial or network | SAME |
| Where used | Hospitals | SAME |
| Computer | Windows PC | SAME |
5. Safety and Effectiveness, comparison to predicate device
6. Conclusion
In all important respects, the MEDLOG Data Acquisition and Distribution Software is substantially equivalent to the DataCaptor Software K032142. The main difference between the two is, that MEDLOG is with JAVA Technology and DataCaptor is with Windows/DCOM Technoloy. DataCaptor supports more connected devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with outstretched arms, representing care and protection. The figure is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 0 2006
BMC Gesellschaft fur Medizintechnik mbH c/o Dr. Angelika Berger Managing Director Harburger Schlossstrasse 6-12 D-21079 Hamburg - Germany
Re: K060756
Trade Name: MEDLOG Model 1-0-10 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotarhometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: October 18, 2006 Received: October 20, 2006
Dear Dr. Berger:
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, , or g and Cosmetic Act (Act) that do not require approval of a premarket approval application (DMA), 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 misbrandijng 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.
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
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Page 2 – Dr. Angelika Berger
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 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 yours,
B/simmurofor
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K060756
Device Name: MEDLOG, MODEL 1-0-10
Indications For Use:
The MEDLOG System is indicated for the use in data collection and clinical information management. MEDLOG is connected with independent and onlinedial or clinical devices either directly of through networks.
MEDLOG is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices, which is connected to.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B/temmena
ign-Off Litylistion of Cardlovaso C (k) Number
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