CENTRA VIEW DEVICE LINK SYSTEM

K033283 · Icu Datasystems, Inc. · MWI · Oct 27, 2003 · Cardiovascular

Device Facts

• Record ID: K033283
• Device Name: CENTRA VIEW DEVICE LINK SYSTEM
• Applicant: Icu Datasystems, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Oct 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric, 3rd-Party Reviewed

Intended Use

The Centra View patient monitor is intended for monitoring, and recording of multiple physiological parameters. The device is indicated for use in health care facilities by health care professionals whenever there is a need for monitoring of physiological parameters of adult, neonatal, and pediatric patients. CentraView is indicated for use in data collection and clinical information management through cable connections with independent bedside devices. Centra View is not intended for monitoring purposes, nor is it intended to control any of the independent bedside devices it is connected to. The CentraView System: Is intended for use on neonatal, pediatric and adult patients. Is intended for use in critical care environments by trained healthcare providers. Does not require direct patient contact. Is a prescription device which restricts its sale and/or use except by the order of a physician.

Device Story

Centra View Device Link System acts as a data aggregator; receives digital physiological data from bedside devices via specific cables; displays and stores information for clinical review. Used in critical care environments by trained healthcare professionals. Device is not patient-connected; does not remotely control source devices. Provides centralized view of data from multiple sources (e.g., blood pressure monitors, cardiac monitors, ventilators, oximeters, CO2 analyzers, infusion pumps) to assist clinical information management. Benefits include consolidated data access for healthcare providers.

Clinical Evidence

Bench testing only. Includes Device Drive Unit Test and Integration Test Analysis. No clinical data provided.

Technological Characteristics

Data management system; connects to bedside devices via cables; digital data input; display and storage functionality. Complies with UL and IEEE safety standards. Not patient-contacting.

Indications for Use

Indicated for neonatal, pediatric, and adult patients in healthcare facilities requiring physiological parameter monitoring and clinical data management. Prescription use only.

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.

Submission Summary (Full Text)

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## OCT 2 7 2003

K033283

## 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR § 807.92.

- 1. The submitter of this premarket notification is:
Samuel W. Coons III CEO ICU DataSystems, Inc. 2153 SE Hawthorne Rd. Suite 220 Gainesville, FL 32641

This summary was prepared on August 19, 2003.

- 2. The name of this device is Centra View™ Device Link System. The common name is Device Link. Current Classification is (74) Cardiovascular, Procode MWI, classification names for an example of the externally connected devices are as follows:

| Regulation<br>Number | Classification Name | Panel | Procode |
|----------------------|--------------------------------|----------------|---------|
| 870.1110 | Computer, blood pressure | Cardiovascular | 74 DSK |
| 870.1130 | System blood pressure | Cardiovascular | 74 DSJ |
| 870.2300 | Monitor, cardiac | Cardiovascular | 74 DRT |
| 868.5895 | Continuous ventilator | Anesthesiology | 73 CBK |
| 870.2700 | Oximeter | Cardiovascular | 74 QGL |
| 868.1400 | Carbon Dioxide Gas<br>Analyzer | Anesthesiology | 73 CCK |
| 868.2375 | Breathing Frequency<br>Monitor | Anesthesiology | 73 BZQ |
| 880.5725 | IV Infusion Pump | Cardiovascular | 80 DWK |

- The Centra View ™ Device Link System receives digital data produced by 3. external devices through device specific cables, and displays and stores this information for review by health care professionals.
- 4. When connected to a bedside device, the Centra View™ Device Link System is intended for electronic data collection and clinical information management. Centra View ™ Device Link System is neither patient connected, nor does it remotely control the attached source device.
- 5. The CentraView uses the same technology as the predicate device.
- The Centra View has been tested and complies with UL and IEEE Safety 6. Standards.
- 7. Additional testing and validation studies were performed.
- a. Device Drive Unit Test
- b. Integration Test Analysis

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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with three wing-like shapes extending from its body.

OCT 27 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ICU DataSystems, Inc. c/o Ms. Chantel Carson Engineering Group Leader Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, IL 60062-2096

Re: K033283

Trade Name: CentraViewTM Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: October 10, 2003 Received: October 14, 2003

Dear Ms. Carson:

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. Iisting 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 - Ms. Chantel Carson

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.

Dng. Heiseku for

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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## INDICATIONS FOR USE

510(k) Number

Device Name: CentraViewTM

Indications for Use:

The Centra View patient monitor is intended for monitoring, and recording of multiple physiological parameters. The device is indicated for use in health care facilities by health care professionals whenever there is a need for monitoring of physiological parameters of adult, neonatal, and pediatric patients. CentraView is indicated for use in data collection and clinical information management through cable connections with independent bedside devices. Centra View is not intended for monitoring purposes, nor is it intended to control any of the independent bedside devices it is connected to.

The CentraView System:

- Is intended for use on neonatal, pediatric and adult patients. ●
- Is intended for use in critical care environments by trained healthcare providers.
- Does not require direct patient contact. ●
- Is a prescription device which restricts its sale and/or use except by the order of ● a physician.

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K033283

Prescription Use
21 CFR 801.109
OR
Over the counter use