DATACAPTOR

K032142 · Capsule Technologie · MWI · Aug 8, 2003 · Cardiovascular

Device Facts

• Record ID: K032142
• Device Name: DATACAPTOR
• Applicant: Capsule Technologie
• Product Code: MWI · Cardiovascular
• Decision Date: Aug 8, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

DataCaptor is data acquisition and distribution software; retrieves data from serial, network, or analog bedside medical devices; uses ActiveX and Distributed Component Object Model (DCOM) architecture. Software runs on Windows PCs in hospital environments. Includes DMM Server module for data processing (averaging, filtering, frequency streamlining) and DataPortal module for converting Microsoft COM dataflow to TCP/IP Sockets. Does not include hardware; interfaces via COM ports, multiport boxes, or RS-232 to Ethernet converters. Output is distributed over networks to other software applications for clinical information management. Does not monitor patients or control connected devices; serves as a data conduit for healthcare providers.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Open-architecture software using ActiveX and DCOM. Operates on Windows PC. Interfaces with serial, network, or analog medical devices via COM ports or RS-232 to Ethernet converters. Includes DMM Server for data processing and DataPortal for TCP/IP conversion.

Indications for Use

Indicated for use in data collection and clinical information management from independent bedside medical devices in a hospital setting. Not intended for patient monitoring or controlling connected clinical devices.

Regulatory Classification

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.

Predicate Devices

• DataCaptor Software (K013019)
• DataCaptor Software (K020197)

Submission Summary (Full Text)

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K032142

## AUG - 8 2003

## EXHIBIT 2 Capsule Technologie 79, rue du Faubourg Poissonnière 75009 Paris FRANCE Phone: [phone] Fax : [phone] Contact: Nicolas Choussat, President July 10, 2003 510(k) Summary

- 1. Identification of the Device: Proprietary-Trade Name: DataCaptor™ Classification Name: MWI Common/Usual Name: Data Collection Software
- 2. Equivalent legally marketed device: This product is similar in design and identical in function to the DataCaptor Software, K013019 and K020197. This premarket notification adds compatibility with additional medical devices and upgrades the basic capabilities of DataCaptor.
- 3. 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.
- 4. 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, K013019<br>and K020197 | Capsule Technologie<br>DataCaptor™ added device<br>support (modification) |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Indications for use | Indicated for use in data<br>collection and clinical<br>information management either<br>directly or through networks with<br>independent bedside devices. Not<br>intended for monitoring purposes,<br>nor is the software intended to<br>control any of the clinical devices<br>(independent bedside devices /<br>information systems) it is<br>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 "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 [phone]. 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 [phone] or [phone] 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