K Number
K973474
Device Name
WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS
Date Cleared
1998-03-13

(182 days)

Product Code
Regulation Number
870.1025
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Witt Biomedical Central Station Monitor and Advanced Patient Care Monitoring Units are designed to provide continuous monitoring of patient physiological parameters, generate alarms (both visual and audible), alerting operator to anomalous occurrences and facilitate timely responses. The Witt Biomedical Central Station Monitor and/or Advanced Patient Care Monitoring unit are intended for use in hospital environments including surgical intensive care, respiratory intensive care, coronary care, post anesthesia recovery, operating room, medical intensive care, pediatrics intensive care and patient holding areas of health care facilities. The Witt Biomedical Central Station Monitor and Advanced Patient Care Monitoring Unit offers a thorough display of monitoring parameters which use proven algorithms and are displayed in a logical, easily understood format that requires only familiarity to the users of any Witt Biomedical system. The Witt Biomedical Central Station Monitor and Advanced Patient Care Monitoring Units are intended to be used by trained hospital personnel with training on the operation of this equipment.
Device Description
Witt Biomedical Corporation Central Station with Advanced Patient Care Monitoring System.
More Information

Not Found

Not Found

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the algorithms used as "proven algorithms," which typically refers to established, non-ML methods for physiological parameter monitoring.

No.
The device is described as a monitor that provides continuous monitoring of physiological parameters and generates alarms, indicating it is for diagnostic or monitoring purposes, not for treating a condition.

No

The device is described as a monitor that provides continuous monitoring of physiological parameters and generates alarms. Its purpose is to alert operators to anomalous occurrences and facilitate timely responses, not to diagnose a particular condition or disease.

No

The device description explicitly mentions "Central Station Monitor and Advanced Patient Care Monitoring Units," which are hardware components used for patient monitoring. The summary does not indicate that the submission is solely for software controlling existing hardware.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
  • Device Function: The description clearly states the device is a "Central Station Monitor and Advanced Patient Care Monitoring Unit" that provides "continuous monitoring of patient physiological parameters." This involves monitoring parameters within the patient's body (in vivo), not testing samples taken from the body.
  • Intended Use: The intended use is for monitoring patients in various hospital settings and generating alarms based on these physiological parameters. This is a direct patient monitoring function, not a diagnostic test performed on a specimen.

The description focuses on monitoring vital signs and physiological data directly from the patient, which is characteristic of patient monitoring devices, not IVDs.

N/A

Intended Use / Indications for Use

The Witt Biomedical Central Station Monitor and Advanced Patient Care Monitoring Units are designed to provide both visual and audible alarms, alerting the operator to anomalous occurrences and facilitate timely responses. The Witt Biomedical Central Station Monitor and/or Advanced Patient Care Monitoring unit are intended for use in hospital environments including surgical intensive care, respiratory coronary care, post anesthesia recovery, operating room, intensive care and patient holding, intensive care, medical intensive care, pediatric intensive care, and advanced patient care areas of health care facilities. The Witt Biomedical Central Station Monitor and/or Advanced Patient Care Monitoring Unit offers a thorough analysis of all monitoring parameters which use proven algorithms and is displayed in a logical, easily understood format that requires only minimal familiarity for the users of any Witt Biomedical system. The Witt Biomedical Central Station Monitor and Advanced Patient Care Monitoring Units are intended to be used by trained hospital personnel with training on the operation of this equipment.

Product codes

74 MHX

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained hospital personnel in hospital environments including surgical intensive care, respiratory coronary care, post anesthesia recovery, operating room, intensive care and patient holding, intensive care, medical intensive care, pediatric intensive care, and advanced patient care areas of health care facilities.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Not Found

Key Metrics

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

0

Image /page/0/Picture/2 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 design featuring three human profiles facing to the right, with flowing lines beneath them.

MAR 13 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lorraine R. Fredes Witt Biomedical Corporation 295 North Drive, Suite H Melbourne, FL 32934

Re: K973474 Central Station with Advanced Patient Care Monitoring Systems Regulatory Class: II (two) Product Code: 74 MHX February 24, 1998 Dated: February 26, 1998 Received:

Dear Ms. Fredes:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) == inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

1

Page 2 - Ms. Lorraine R. Fredes

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial en your ore (1) pour 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

510(k) Number (if known): K973474

Device Name: Witt Biomedical Corporation Central Station with Advanced Patient Care Monitoring System.

Indications For Use:

The Witt Biomedical Central Station Monitor and Advanced Patient Care Monitoring Units are designed to I he Witt Biomedical Cellural Station Monton and Horns (both visual and audible), alertine operator to anomalous occurrences and facilitate timely responses. The Witt Biomedical Central Station Monitor and/or Advanced Patient Care Monitoring unit are intended for use in hospital environments including and of Advanced Pattent Care Montoning and are are are singgical intensive care, respiratory coronary care, post anesmesia recovery, operating room, antensive care and patient holding intensive care, medical intensive care, pediance incolaries and Advanced Patient Care areas of neath care lacinies. The with Dionitoring parameters which use proven algorithed format that requires Monitoring Unit offers a inorough is displayed in a logical, easily understool format that requires of ony. With Biomedical Series TV. Patlem mornation is displayed in a regions familiarity to the users of any Witt Biomedical system.

The Witt Biomedical Central Station Monitor and Advanced Patient Care Monitoring Units are intended The Witt Biometical Central Station Monton and Trevalises cassisted hospital personnel with training on the operation of this equipment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mn. Puzl.

(Division Sign-Off)
Division of Cardiovascular, Respiratory.
and Neurological Devices
510(k) Number. K973474

Prescription Use (Per 21 CFR 801.109)

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Over - The-Counter Use

(Optional Format 1-2-96)