DATACAPTOR

K013019 · Capsule Technologie · MWI · Dec 18, 2001 · Cardiovascular

Device Facts

• Record ID: K013019
• Device Name: DATACAPTOR
• Applicant: Capsule Technologie
• Product Code: MWI · Cardiovascular
• Decision Date: Dec 18, 2001
• Decision: SESE
• Submission Type: Traditional
• 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 software-only data acquisition/distribution tool; retrieves data from serial, network, or analog bedside devices; utilizes ActiveX and Distributed Component Object Model (DCOM) architecture; makes retrieved data available over networks for other software applications. Used in hospitals; operated by clinical staff. No hardware supplied; users connect devices via COM ports, multiport boxes, or RS-232 to Ethernet converters. Output facilitates clinical information management; does not perform monitoring or device control. Benefits include centralized data access from disparate bedside equipment.

Clinical Evidence

Bench testing only.

Technological Characteristics

Software-only data acquisition system; utilizes ActiveX and Distributed Component Object Model (DCOM) for data distribution; interfaces with serial, network, or analog bedside devices; runs on Windows PC; no hardware components supplied.

Indications for Use

Indicated for data collection and clinical information management via direct or network connection to independent bedside devices in clinical settings. Not for patient monitoring or control of 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

• Hewlett-Packard M2376A DeviceLink System (K000635)

Submission Summary (Full Text)

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DEC 1 8 2001

## EXHIBIT 2 Capsule Technologie 79, rue du Faubourg Poissonnière 75009 Paris FRANCE Phone: [phone] Fax : [phone] Contact: Nicolas Choussat, President September 6, 2001 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 Hewlett-Packard M2376A DeviceLink System, K000635.
- 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.

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| Comparison Areas | Hewlett-Packard M2376A<br>DeviceLink System, K000635 | Capsule Technologie<br>DataCaptor™ |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Indications for use | Indicated for use in data collection<br>and clinical information<br>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 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 [phone]. Additionally, for questions on the promotion and advertising of Compliance at (301) 594 - 1 the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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