WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS

K973474 · Witt Biomedical Corporation · MHX · Mar 13, 1998 · Cardiovascular

Device Facts

• Record ID: K973474
• Device Name: WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS
• Applicant: Witt Biomedical Corporation
• Product Code: MHX · Cardiovascular
• Decision Date: Mar 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Witt Biomedical Central Station Monitor and Advanced Patient Care Monitoring Units are designed to monitor physiological parameters and provide 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 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 Advanced Patient Care Monitoring Unit offers a thorough monitoring parameters which use proven algorithms. Patient information is displayed in a logical, easily understood format that requires only minimal familiarity to the users of any Witt Biomedical system. The Witt Biomedical Central Station Monitor and Advanced Patient Care Monitoring Units are intended for use by trained hospital personnel with training on the operation of this equipment.

Device Story

The Witt Biomedical Central Station and Advanced Patient Care Monitoring System functions as a centralized hub for patient physiological data. It receives inputs from bedside monitoring units, processes these signals using established algorithms to detect anomalous physiological events, and generates visual and audible alarms for clinical staff. Used in hospital settings—including ORs, ICUs, and recovery areas—the system displays patient data in a standardized, intuitive format to facilitate rapid clinical assessment. By providing continuous monitoring and timely alerts, the device assists healthcare providers in identifying patient deterioration, enabling prompt intervention and improved patient management. The system is designed for operation by trained hospital personnel familiar with Witt Biomedical equipment.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Centralized patient monitoring system; utilizes proven algorithms for physiological parameter analysis; visual and audible alarm interface; designed for hospital-based clinical environments; compatible with existing Witt Biomedical system interfaces.

Indications for Use

Indicated for use in hospital environments including surgical, respiratory, coronary, post-anesthesia recovery, operating rooms, medical, and pediatric intensive care units for monitoring physiological parameters in patients requiring clinical observation.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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## 510(k) Number (if known): k973474

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

Indications For Use:

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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

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