(182 days)
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.
Witt Biomedical Corporation Central Station with Advanced Patient Care Monitoring System.
I am sorry, but the provided text does not contain the necessary information to answer your request regarding the acceptance criteria and study details for the Witt Biomedical Corporation Central Station with Advanced Patient Care Monitoring System.
The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a predicate device and can be marketed. It includes the device name, indications for use, and regulatory classification but does not detail the specific performance acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications that would be found in a clinical study report or performance evaluation.
Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes, data provenance, number of experts, adjudication methods, MRMC study results, standalone performance, type of ground truth used, or training set details based on this document.
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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 (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
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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:
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.
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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
(Optional Format 1-2-96)
§ 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.