ACUITY CENTRAL STATION

K972121 · Protocol Systems, Inc. · MLD · Nov 7, 1997 · Cardiovascular

Device Facts

• Record ID: K972121
• Device Name: ACUITY CENTRAL STATION
• Applicant: Protocol Systems, Inc.
• Product Code: MLD · Cardiovascular
• Decision Date: Nov 7, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Acuity ST Analysis option is being incorporated into the Acuity central station (licensed with Arrhythmia and Full Disclosure) as part of a network system within the hospital environment or clinical setting. The ST Analysis option is intended to be used to provide real-time monitoring and alarms for ST segment deviations (from a reference beat) for patients with suspected heart disease or anomalies. It is recommended for use with Adult and Pediatric patients one year or older. ST Analysis is automatically disabled when the corresponding Propaq Encore is in the Neonatal patient mode. It is intended for use by healthcare practitioners who know to acquire and interpret patients' vital signs and are trained in the use of the Acuity System and its components. The clinician is responsible for determining the clinical significance of each alarm generated by Acuity. As with all computerized ST Analysis systems, Acuity cannot replace skilled care and proper surveillance by a clinician. A clinician should review all data obtained from Acuity before implementing therapy based on this data.

Device Story

Acuity Central Station is a hospital-based network system providing real-time ECG ST segment analysis. It processes ECG signals to detect deviations from a reference beat, triggering alarms for clinical review. Operated by trained healthcare practitioners in clinical settings, the system functions as an adjunct to patient monitoring. Clinicians interpret the generated alarms and ST data to inform clinical decision-making and therapy. The device does not replace skilled care or surveillance; it serves as a tool for monitoring cardiac anomalies in adult and pediatric populations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Networked central station monitor for ECG ST segment analysis. Integrates with Propaq Encore patient monitors. Features automated ST segment deviation detection and alarm generation. Software-based analysis of ECG signals relative to a reference beat. Designed for adult and pediatric (≥1 year) use.

Indications for Use

Indicated for adult and pediatric patients (≥1 year) with suspected heart disease or anomalies requiring real-time monitoring and alarms for ST segment deviations. Contraindicated for neonatal patients (ST analysis automatically disabled in neonatal mode).

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.

Predicate Devices

• Cardiac Central Station Monitor with ST Segment Analysis (PCI Model 2041-PC/ST, K925411/A)

Submission Summary (Full Text)

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KAN2121

## 510(k) Summary

NOV - 7 Joer

In compliance with section 21 CFR 807.92, this document comprises a 510(k) Summary for K972121.

Submitter: Protocol Systems, Inc. 8500 SW Creekside Place Beaverton, OR 97008-7107 Phone: [phone]

Contact Persons: James P. Welch, Vice President, Quality Systems (Primary)

Jim Sandberg, Director, Regulatory Affairs, (Secondary)

Date Prepared: June 4, 1997

Predicate Device: "Cardiac Central Station Monitor with ST Segment Analysis" (PCI Model 2041-PC/ST, Pacific Communications, Inc. (PCI, now VitalCom), 510(k) Number K925411/A)

Device Name: Acuity Central Station

Classification Name: System, ECG Analysis (ST), Class III under section 513 of the Federal Food, Drug and Cosmetic (FD&C) Act, Panel 74 Cardiovascular, Product Code 74LOS,

Federal Regulation Number 870.2340

Trade/Proprietary Name: Acuity Central Station

Common/Usual Name: Cardiac ECG ST Analysis Central Station Monitor

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

. . . . . .

NOV - 7 1997

Mr. James P. Welch Protocol Systems, Inc. 8500 S.W. Creekside Place Beaverton, Oregon 97008-7107

Re: к972121 Acuity Central Station Monitor Regulatory Class: III (three) Product Code: 74 MLD Dated: September 5, 1997 Received: September 8, 1997

.Dear Mr. Welch:

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 Requlation (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 Failure to comply with the GMP regulation may result in assumptions. requlatory 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 - Mr. James P. Welch

This letter will allow you to begin marketing your device as described in your 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 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. Callahan

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): K972121

Device Name: Acuity Central Station, Cardiac ECG ST Analysis Central Station Monitor

Indications For Use:

The Acuity ST Analysis option is being incorporated into the Acuity central station (licensed with Arrhythmia and Full Disclosure) as part of a network system within the hospital environment or clinical setting. The ST Analysis option is intended to be used to provide real-time monitoring and alarms for ST segment deviations (from a reference beat) for patients with suspected heart disease or anomalies.

It is recommended for use with Adult and Pediatric patients one year or older. ST Analysis is automatically disabled when the corresponding Propaq Encore is in the Neonatal patient mode.

It is intended for use by healthcare practitioners who know to acquire and interpret patients' vital signs and are trained in the use of the Acuity System and its components. The clinician is responsible for determining the clinical significance of each alarm generated by Acuity. As with all computerized ST Analysis systems, Acuity cannot replace skilled care and proper surveillance by a clinician. A clinician should review all data obtained from Acuity before implementing therapy based on this data.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | Christy Fouman for AAC |
|---------------|-------------------------------------------------------------------|
| | Division Sign-Off) |
| | Division of Cardiovascular, Respiratory, and Neurological Devices |
| 510(k) Number | K972121 |

| Prescription Use | OR | Over-The-Counter Use |
|----------------------|----|----------------------|
| (Per 21 CFR 801.109) | | |

(Optional Format 1-2-96)