(30 days)
Not Found
No
The description focuses on data acquisition and distribution using standard software components and communication protocols, with no mention of AI/ML algorithms or capabilities.
No.
The device is described as a data acquisition and distribution software for clinical information management, not for direct therapeutic intervention or treatment.
No
The device description indicates it is a "data acquisition and distribution software" that retrieves data from other devices and makes it available for use in software applications. Its intended use is "data collection and clinical information management." It is not described as analyzing or interpreting data to diagnose a condition, but rather as a tool for managing information.
Yes
The device description explicitly states "We do not supply any hardware" and describes the device as "a data acquisition and distribution software". While it interacts with hardware, the device itself is presented as a software product.
Based on the provided information, the DataCaptor™ System is not an IVD (In Vitro Diagnostic).
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." IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment. DataCaptor™ does not perform this function.
- Device Description: The description focuses on data acquisition and distribution from various devices. It does not mention any interaction with biological specimens or laboratory testing.
- Lack of IVD-related information: The document lacks any information typically associated with IVDs, such as:
- Analysis of biological samples.
- Measurement of analytes.
- Performance characteristics related to diagnostic accuracy (sensitivity, specificity, etc.).
- Information about reagents or test procedures.
The DataCaptor™ System appears to be a software tool for managing data from clinical devices, not for performing diagnostic tests on patient 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 (comma separated list FDA assigned to the subject device)
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.
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): 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
§ 870.2300 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
FEB 2 1 2002
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 January 15, 2002 510(k) Summary of Safety and Effectiveness
-
- Identification of the Device: Proprietary-Trade Name: DataCaptor™ Classification Name: MWI Common/Usual Name: Data Collection Software
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- Equivalent legally marketed device: This product is similar in design and identical in function to the DataCaptor Software, K013019. This premarket notification adds compatibility with additional medical devices.
- Indications for Use (intended use) The DataCaptor™ System is indicated for use in 3. 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.
-
- 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.
1
| Comparison Areas | DataCaptor Software, K013019 | Capsule Technologie
DataCaptor™ added device
support (modification) |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Indications for use | Indicated for use in data collection
and clinical information
and 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 |
-
- 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. The main difference between the two is that modified "DataCaptor™" supports more connected devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 1 2002
Capsule Technologie c/o Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, IL 60015
Re: K020197
Trade Name: Capsule Technologie DataCaptor™ Data Acquisition and Distribution Software Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: January 18, 2002 Received: January 22, 2002
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, P.E.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that IDA's issualled of a building with other requirements of the Act that I DA has made a decemination administered by other Federal agencies. You must or any Federal statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Part 807), rabeing (21 CFR Part 820); good marked if applicable, the electronic forul in the quality systems (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) I his letter will anow you to begin manoting your evence of your device to a legally premaired notification. The PDF micing 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 and IT you desire specific acrise for your switted diagnostic devices), please contact the Office of additionally 21 CFC Fart 007.10 for m. The promotion and advertising of Compliance at (301) 594-4640. Thankshany to expliance at (301) 594-4639. Also, please note the your do to the some withing by reference to premarket notification" (21CFR Part 807.97). It guilation entitied, "Misoranang of responsibilities under the Act may be obtained from the Other general information on your respectional 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,
Katy Tell
Bram D. Zuckerman, M.D Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
j) Indications for Use
KO20197 510(k) Number
Device Name: Capsule Technologie : "DataCaptor™" Data Acquisition and 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)
OR
Prescription Use (Per 21 CFR 801.109)
Over the Counter Use
Division of Cardiovascular & Respiratory Devices
510(k) Number R020697