(102 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.
This submission is a 510(k) premarket notification for the DataCaptor™ Data Acquisition and Distribution Software. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive studies with acceptance criteria and performance metrics typically seen for novel or higher-risk devices.
Therefore, the provided text does not contain the acceptance criteria or a study directly proving the device meets acceptance criteria in the format requested. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
However, I can extract the relevant information regarding the equivalence comparison, which serves as the basis for the FDA's decision to allow the device to market.
Summary of Device Equivalence and FDA Determination:
The DataCaptor™ Data Acquisition and Distribution Software's acceptance is based on its substantial equivalence to a legally marketed predicate device, the Hewlett-Packard M2376A DeviceLink System (K000635). The FDA determined that the device is substantially equivalent for the stated indications for use.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) based on substantial equivalence, there are no explicit "acceptance criteria" in the sense of quantitative performance thresholds that the device had to meet through a specific study. Instead, the "acceptance criteria" can be inferred from the comparison areas used to demonstrate equivalence to the predicate device. The device "performance" is implicitly deemed acceptable because it is "substantially equivalent" to a device already deemed safe and effective.
| Comparison Area | Predicate Device Performance / Characteristic (Hewlett-Packard M2376A DeviceLink System, K000635) | DataCaptor™ Reported Device Performance / Characteristic | Equivalence Conclusion (Implied Acceptance) |
|---|---|---|---|
| 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. | 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. | SAME (Substantially Equivalent) |
| Interfaces | Serial or network | SAME (Serial or network) | SAME (Substantially Equivalent) |
| Where used | Hospitals | SAME (Hospitals) | SAME (Substantially Equivalent) |
| Computer | Windows PC | SAME (Windows PC) | SAME (Substantially Equivalent) |
| Hardware | DeviceLink System (implies hardware component in the system) | Software only; no interconnection hardware is supplied. | Main Difference: Software Only. Still deemed substantially equivalent in safety and effectiveness. |
| Design | Not explicitly detailed, but implied to be effective for its function | Open-architecture design, uses ActiveX and Distributed Component Object Model for data acquisition and distribution. | Implied substantial equivalence, despite potential implementation differences. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This submission does not describe a test set or data provenance in the context of performance testing for acceptance criteria. The equivalence demonstration relies on a comparison of intended use, technological characteristics, and operational environment with a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. There was no "ground truth" to establish for a test set in this type of submission. The ground truth for regulatory acceptance is the established safety and effectiveness of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or expert adjudication process is described in this submission.
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 is not an AI/CAD device. It is data collection software. No MRMC study was conducted or described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is data collection software, not an algorithm with performance metrics measured in a standalone fashion. Its function is to acquire and distribute data, not to make diagnostic or prognostic predictions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the purpose of this 510(k) submission, the "ground truth" is the established safety and effectiveness of the predicate device, the Hewlett-Packard M2376A DeviceLink System, K000635, as accepted by the FDA. The new device demonstrates substantial equivalence to this established "truth."
8. The sample size for the training set:
- Not Applicable. This submission does not describe a training set as it is not a machine learning or AI-driven device requiring model training.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set, there is no ground truth established for it.
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DEC 1 8 2001
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 September 6, 2001 510(k) Summary of Safety and Effectiveness
-
- Identification of the Device: Proprietary-Trade Name: DataCaptor™ Classification Name: MWI Common/Usual Name: Data collection Software
-
- Equivalent legally marketed device: This product is similar in design and identical in function to the Hewlett-Packard M2376A DeviceLink System, K000635.
-
- 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.
-
- 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.
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| Comparison Areas | Hewlett-Packard M2376ADeviceLink System, K000635 | Capsule TechnologieDataCaptor™ |
|---|---|---|
| Indications for use | Indicated for use in data collectionand clinical informationmanagement either directly orthrough 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 |
-
- 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 Hewlett-Packard M2376A DeviceLink System. The main difference between the two is that "DataCaptor™" is software only, and no interconnection hardware is supplied.
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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 stylized eagle with three stripes forming its body and head. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 82001
Capsule Technologie c/o Mr. Daniel Kamm, P.E. Kamm & Associates P.O. Box 7007 Deerfield, IL 60015
Re: K013019
Trade Device 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: December 6, 2001 Received: December 11, 2001
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, P.E.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I load of action and 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 or uny 1 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 Of It 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4645. Additionally, for questions on the promotion and advertising of Compliance at (301) 594 - 1 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oivision 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,
V. Dala Telle
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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j) Indications for Use
510(k) Number_K013019
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)
Prescription Use
(Per 21 CFR 801.109) OR
Over the Counter Use
Division of Cardiovascular & Respiratory Devices
510(k) Number K013019
7
§ 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).