(25 days)
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.
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
The provided text describes a 510(k) premarket notification for a medical device called DataCaptor™. This submission is for an upgrade to an existing product, K013019 and K020197, adding compatibility with additional medical devices and upgrading basic capabilities.
However, the 510(k) summary does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device. This type of submission generally relies on demonstrating that changes made to the device do not alter its fundamental functionality, safety, or effectiveness, thus not requiring new clinical performance studies.
Therefore, many of the requested sections regarding acceptance criteria and study details cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific performance acceptance criteria for a new study. | Not provided. As there are no specific performance acceptance criteria, there are no corresponding reported performance metrics. The claim is that the modified device performs "identically in function" to the predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document does not describe any specific test set or data used to evaluate the upgraded DataCaptor™ system's performance beyond internal verification that the new interfaces function as intended.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No expert review or ground truth establishment is described in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is mentioned as there is no specific test set of data presented.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is data collection software and is explicitly stated not to be for "monitoring purposes" or for "controlling any of the clinical devices." It is not an AI-assisted diagnostic or interpretive tool that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of diagnostic performance. While the software operates without human-in-the-loop for data collection, a standalone performance study in the sense of diagnostic accuracy (which is often what this question implies) was not conducted or reported. Its performance is related to its ability to acquire and distribute data, not to make clinical interpretations.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No ground truth in the context of clinical or diagnostic performance is mentioned. The "truth" here would likely be the accurate and reliable transfer of data from medical devices, which is verified through engineering tests rather than clinical expert consensus or pathology.
8. The sample size for the training set
- Not applicable. This software is described as data acquisition and distribution software using ActiveX and Distributed Component Object Model. It does not appear to be an AI/ML device that requires a training set in the conventional sense for learning patterns from data.
9. How the ground truth for the training set was established
- Not applicable. As no training set is described (see point 8), no method for establishing its ground truth is provided.
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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
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| Comparison Areas | DataCaptor Software, K013019and K020197 | Capsule TechnologieDataCaptor™ added devicesupport (modification) |
|---|---|---|
| Indications for use | Indicated for use in datacollection and clinicalinformation management eitherdirectly or through networks withindependent bedside devices. Notintended for monitoring purposes,nor is the software intended tocontrol any of the clinical devices(independent bedside devices /information systems) it isconnected 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..
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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.
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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
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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
§ 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).