MODIFICATION TO DATACAPTOR

K020197 · Capsule Technologie · MWI · Feb 21, 2002 · Cardiovascular

Device Facts

• Record ID: K020197
• Device Name: MODIFICATION TO DATACAPTOR
• Applicant: Capsule Technologie
• Product Code: MWI · Cardiovascular
• Decision Date: Feb 21, 2002
• 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/distribution software; retrieves data from serial, network, or analog bedside medical devices; utilizes ActiveX and Distributed Component Object Model (DCOM) for data transmission; operates on Windows PCs in hospital environments; provides data to other software applications via network; does not provide hardware; enables centralized data management; benefits clinicians by facilitating information flow from bedside devices to clinical information systems; does not perform monitoring or device control.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Open-architecture software; utilizes ActiveX and Distributed Component Object Model (DCOM); runs on Windows PC; interfaces with serial, network, or analog devices; connectivity via COM ports, multiport boxes, or RS-232 to Ethernet converters.

Indications for Use

Indicated for 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)

Submission Summary (Full Text)

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## FEB 2 1 2002

EXHIBIT 2 Capsule Technologie 79. rue du Faubourg Poissonnière 75009 Paris FRANCE Phone: [phone] Fax : [phone] Contact: Nicolas Choussat, President January 15, 2002 510(k) Summary of Safety and Effectiveness

- 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. 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.
- 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.

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| Comparison Areas | DataCaptor Software, K013019 | Capsule Technologie<br>DataCaptor™ added device<br>support (modification) |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Indications for use | Indicated for use in data collection<br>and clinical information<br>and management either directly or<br>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. The main difference between the two is that modified "DataCaptor™" supports more connected devices.

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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.

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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 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 [phone]. Thankshany to expliance at [phone]. 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 [phone] or [phone] 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

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## 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