(155 days)
K925411/A
K925411/A
No
The document describes a standard ST segment analysis system based on deviations from a reference beat, which is a traditional signal processing technique, not AI/ML. There are no mentions of AI, ML, deep learning, training sets, or performance metrics typically associated with AI/ML devices.
No
The device is described as a monitor intended to provide real-time monitoring and alarms for ST segment deviations. It assists clinicians in determining clinical significance but does not directly implement therapy.
Yes
The device is described as providing "real-time monitoring and alarms for ST segment deviations... for patients with suspected heart disease or anomalies," which indicates its use in identifying or characterizing a medical condition.
No
The device description explicitly states "Acuity Central Station, Cardiac ECG ST Analysis Central Station Monitor," indicating it is a hardware device with integrated software for ST analysis. The intended use also describes it as part of a "network system within the hospital environment or clinical setting," further suggesting a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside the body (in vitro).
- Device Function: The Acuity ST Analysis option is a monitoring system that analyzes real-time ECG data from a patient within the body (in vivo). It does not process samples taken from the patient.
- Intended Use: The intended use is for real-time monitoring and alarms for ST segment deviations, which is a direct measurement of electrical activity of the heart.
- Input: The input is ECG data, not a biological sample.
Therefore, the Acuity ST Analysis option falls under the category of a medical device used for patient monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
74LOS, 74MLD
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
Adult and Pediatric patients one year or older.
Intended User / Care Setting
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K925411/A
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
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: (503) 526-8500
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
1
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.
2
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 (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. 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
3
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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)