(25 days)
Not Found
No
The description focuses on data acquisition, distribution, and basic processing (averaging, filtering) using standard software components and communication protocols. There is no mention of AI, ML, or related concepts like training data, algorithms, or performance metrics typically associated with AI/ML devices.
No.
The device is described as data acquisition and distribution software for collecting and managing clinical information, not for providing therapy or treatment.
No
The DataCaptor™ System is described as a "data collection and clinical information management" system, "not intended for monitoring purposes" and not for controlling clinical devices. Its function is to retrieve and distribute data for software applications, and to process (average, suppress, streamline) data. This functionality does not involve diagnosing conditions or providing diagnostic insights.
Yes
The device description explicitly states, "We do not supply any hardware." The system is described as "data acquisition and distribution software" and its components (DMM Server, DataPortal) are also described as software modules. While it interacts with hardware devices, the device itself is presented as a software solution.
Based on the provided information, the DataCaptor™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "data collection and clinical information management." It explicitly states it is "not intended for monitoring purposes, nor is the software intended to control any of the clinical devices." This focus on data management and not on analyzing biological samples or providing diagnostic information is a key differentiator from IVDs.
- Device Description: The description details a software system that retrieves data from various medical devices and makes it available for other software applications. It processes and manages data streams but does not perform any analysis or interpretation of biological samples.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Use in a laboratory setting for diagnostic testing
The DataCaptor™ System appears to be a medical device software that facilitates the flow and management of data from other medical devices within a hospital setting. Its function is to acquire and distribute data, not to perform diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The DataCaptor™ System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. DataCaptor™ 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.
Product codes
MWI
Device Description
Based on an open-architecture design, DataCaptor is a data acquisition and distribution software, using ActiveX and the Distributed Component Object Model. This tool retrieves data from serial, network or analog devices and, via an ActiveX control, makes this data available over network or any other type of communication for use in software applications. We do not supply any hardware - our customers can buy cable and connect the devices directly to the COM port (we provide a wiring diagram that shows them pin configurations) or they can use a multiport box or card, an RS-232 to Ethernet converter is used if several devices need to be connected to the network and there are not necessarily computers next to each one. We don't recommend hardware suppliers. The change enables interface to additional models of connected medical devices. Also the DataCaptor Solution now includes the DMM Server module and the DataPortal module. The DMM Server module allows one to process the data originating from the devices and decoded by DataCaptor, i-e, it allows users to create averages, to suppress some data, to streamline the frequency of data that come out of DataCaptor. The DataPortal module converts a dataflow from a Microsoft COM (Component Object Model) container into a TCP/IP Sockets container
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
Hospitals
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
AUG - 8 2003
EXHIBIT 2 Capsule Technologie 79, rue du Faubourg Poissonnière 75009 Paris FRANCE Phone: +33 1 53 34 14 00 Fax : +33 1 53 34 14 09 Contact: Nicolas Choussat, President July 10, 2003 510(k) Summary
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- Identification of the Device: Proprietary-Trade Name: DataCaptor™ Classification Name: MWI Common/Usual Name: Data Collection Software
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- Indications for Use (intended use) The DataCaptor™ System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. DataCaptor™ 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.
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- Description of the Device: Based on an open-architecture design, DataCaptor is a data acquisition and distribution software, using ActiveX and the Distributed Component Object Model. This tool retrieves data from serial, network or analog devices and, via an ActiveX control, makes this data available over network or any other type of communication for use in software applications. We do not supply any hardware - our customers can buy cable and connect the devices directly to the COM port (we provide a wiring diagram that shows them pin configurations) or they can use a multiport box or card, an RS-232 to Ethernet converter is used if several devices need to be connected to the network and there are not necessarily computers next to each one. We don't recommend hardware suppliers. The change enables interface to additional models of connected medical devices. Also the DataCaptor Solution now includes the DMM Server module and the DataPortal module. The DMM Server module allows one to process the data originating from the devices and decoded by DataCaptor, i-e, it allows users to create averages, to suppress some data, to streamline the frequency of data that come out of DataCaptor. The DataPortal module converts a dataflow from a Microsoft COM (Component Object Model) container into a TCP/IP Sockets container
1
| Comparison Areas | DataCaptor Software, K013019
and K020197 | Capsule Technologie
DataCaptor™ added device
support (modification) |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Indications for use | Indicated for use in data
collection and clinical
information management either
directly or through networks with
independent bedside devices. 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. | SAME |
| Interfaces | Serial or network | SAME |
| Where used | Hospitals | SAME |
| Computer | Windows PC | SAME |
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- Safety and Effectiveness, comparison to predicate device:
6. Conclusion
In all important respects, the "DataCaptor™" Data Acquisition and Distribution Software is substantially equivalent to the DataCaptor Software, K013019 and K020197. The main difference between the two is that modified "DataCaptor™" supports more connected devices and the basic capabilities of DataCaptor have been upgraded..
2
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol of three abstract human figures, represented by flowing lines, positioned to the right of the text.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 8 2003
Kamm and Associates c/o Mr. Daniel Kamm Regulatory Engineer P.O. Box 7007 Deerfield, IL 60015
Re: K032142
Trade Name: DataCaptor™ Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm). Regulatory Class: Class II (two) Product Code: MWI Dated: July 11, 2003 Received: July 14, 2003
Dear Mr. Kamm:
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.
3
Page 2 – Mr. Daniel kamm
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 (301) 594-4646. 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 (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
4
j) Indications for Use
0-2214 510(k) Number
: "DataCaptor™" Data Acquisition and Device Name: Capsule Technologie Distribution Software.
Indications for Use: The DataCaptor™ System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. DataCaptor™ 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.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR (Per 21 CFR 801.109)
Over the Counter Use
510(k) Numb