CENTRA VIEW DEVICE LINK SYSTEM by ICU DATASYSTEMS, INC.

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 Description

The Centra View ™ Device Link System receives digital data produced by external devices through device specific cables, and displays and stores this information for review by health care professionals. 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.

AI/ML Overview

The provided text focuses on regulatory approval (510(k)) for the Centra View™ Device Link System, a device for electronic data collection and clinical information management. It details the device's purpose, classification, and substantial equivalence to a predicate device, as well as general safety standards and validation studies performed.

However, the document does not contain the specific information requested regarding detailed acceptance criteria, reported device performance metrics against those criteria, or the methodology of a study that would demonstrate such performance. The "validation studies" mentioned ("Device Drive Unit Test" and "Integration Test Analysis") are indicated as performed but no results or specifics about these tests are provided.

Therefore, I cannot populate the requested tables and sections with data from the given text. The information required for a performance study (like sample sizes, ground truth establishment, expert qualifications, etc.) is not present in this 510(k) summary and FDA clearance letter.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what is missing:

1. A table of acceptance criteria and the reported device performance:

Missing: The document mentions "Additional testing and validation studies were performed" (Device Drive Unit Test, Integration Test Analysis) but does not provide any specific acceptance criteria or the performance metrics achieved by the device in these tests.

2. Sample sized used for the test set and the data provenance:

Missing: The text does not specify any sample sizes for test sets or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Missing: No information regarding experts or ground truth establishment is provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Missing: No adjudication method is mentioned.

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 / Missing: This device is a data collection and management system, not described as an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study as typically understood for AI in diagnostics would not be relevant, and no such study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Clarification Needed: The device's function is to collect and display data for health care professionals, not to perform independent diagnostic decisions. Its "performance" would likely relate to data accuracy, integrity, and reliable transmission, not standalone diagnostic performance. No specific details on standalone performance testing are provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Missing: No "ground truth" for clinical performance is mentioned, as the device's primary function is data handling, not diagnosis.

8. The sample size for the training set:

Missing: No training set or machine learning aspects are described for this device.

9. How the ground truth for the training set was established:

Missing: No training set is mentioned.

Summary of Device and its Intended Use (from the text):

Device Name: CentraView™ Device Link System
Manufacturer: ICU DataSystems, Inc.
Purpose: Receives digital data from external bedside devices (e.g., blood pressure monitors, cardiac monitors, ventilators, oximeters, CO2 gas analyzers, IV infusion pumps), displays, and stores this information for review by healthcare professionals.
Indications for Use: Intended for electronic data collection and clinical information management in healthcare facilities. It monitors and records multiple physiological parameters for adult, neonatal, and pediatric patients. It is not intended for monitoring purposes directly, nor does it control connected devices.
Patient Contact: Does not require direct patient contact.
Regulatory Status: Cleared under 510(k) as substantially equivalent to a predicate device (Cardiac Monitor, 21 CFR 870.2300, Product Code MWI).
Standards: Complies with UL and IEEE Safety Standards.
Validation Studies Mentioned:
- Device Drive Unit Test
- Integration Test Analysis
  (Details, acceptance criteria, and results of these tests are not provided in the given text.)

Summary

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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.

1. 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:

RegulationNumber	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 GasAnalyzer	Anesthesiology	73 CCK
868.2375	Breathing FrequencyMonitor	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.
1. 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.
1. 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.
1. 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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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 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

Regulation Number and Section

§ 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).