The OBSERVER Central Station with ST-segment measurement is a prescription device intended for use only by health care professionals. The device is used for the remote monitoring of physiological parameters, including non-invasive and invasive blood pressure; invasive hemodynamic and intracranial pressures; oxygen saturation via pulse oximetry; temperature; ECG ; and pulse/heart rate of adult, pediatric and neonatal patients. The device is located at a distance from the patient but within the same facility, including settings such as hospital and outpatient services, including general medical/surgical, critical care, intermediate/step-down care, emergency room, radiology, labor and delivery, operating and recovery room, cardiac catheterization lab, endoscopy and same-day surgery.

Arrhythmia detection and ST-segment measurement are optional ECG features limited to the adult population. ST-segment measurement is contraindicated in paced patients. The ST-segment feature of the OBSERVER Central Station provides for the measurement of the ST-segment level and slope of the ECG waveform, alerting the clinician to ST-segment changes. The significance of ST-segment changes must be determined by a clinician. The device is not designed, sold or intended for use except as indicated.

Device Description

The OBSERVER Central Station with ST-segment measurement is an optional feature of the OBSERVER Central Station with arrhythmia analysis. This feature allows for the measurement of the ST-segment level and slope and the issuance of alarms for ST elevations and depressions. The clinician may adjust certain waveform points and alarm priority and limits or rely on default settings for each patient to be analyzed.

The OBSERVER Central Station (K933404) is a PC-based monitoring system designed to provide remote surveillance with alarms, trending and retrieval of wave-form and numeric physiological data for up to 8 patients who are monitored via various DINAMAP* Physiological Monitors or other appropriate bedside/patient monitors.

The OBSERVER Central Station displays, records and stores physiological data including ECG, non-invasive and invasive blood pressure, heart rate, temperature and pulse oximetry. The system is designed to be used with a hardwire interface using RS 232; wireless connectivity using 900 MHz spread spectrum or fixed frequency; or VHF (174-216 MHz, TV channels 7 through 13), including patient-worn telemetry. Monitors that may be networked with the OBSERVER Central Station for ECG include members of the Johnson & Johnson Medical Inc. DINAMAP* family of monitors, such as the DINAMAP MPS* Select* Monitor (K955113) and the DINAMAP* PLUS Monitor (K943709 and K912188), and patient-worn ECG VHF telemetry (VitalCom, Inc. K942147). The OBSERVER Central Station uses a Pentium PC with an SVGA, touch or non-touch, color monitor. Recordings can be made on either the built-in two-channel thermal recorder or with an optional HP LaserJet* Printer. Also optional is full disclosure (history) of all waveforms.

AI/ML Overview

The OBSERVER* Central Station with ST-segment measurement is a continuous monitoring device. The device was found to be substantially equivalent to the currently marketed OBSERVER Central Station with arrhythmia analysis (K933404) and the ST-segment measurement feature of the VitalCom, Inc. VCOM Central Monitor (K942147).

1. Acceptance Criteria and Reported Device Performance:

The document does not explicitly state numerical acceptance criteria for each performance metric. It mentions that the software was "tested against" databases to "measure" the algorithm's performance. The conclusion states that the modified device is "safe, effective and substantially equivalent" to predicate devices.

Performance Metric	Acceptance Criteria (Not explicitly stated, assumed to meet predicate device performance)	Reported Device Performance (Summary)
QRS detection sensitivity	Implied to be acceptable for substantial equivalence	Measured against AHA and MIT databases
QRS detection positive predictivity	Implied to be acceptable for substantial equivalence	Measured against AHA and MIT databases
Ventricular beat identification sensitivity	Implied to be acceptable for substantial equivalence	Measured against AHA and MIT databases
Ventricular beat identification positive predictivity	Implied to be acceptable for substantial equivalence	Measured against AHA and MIT databases
Ventricular beat identification false positive rate	Implied to be acceptable for substantial equivalence	Measured against AHA and MIT databases
ST sensitivity	Implied to be acceptable for substantial equivalence	Measured against the European ST-T database
ST positive predictivity	Implied to be acceptable for substantial equivalence	Measured against the European ST-T database
ST peak error	Implied to be acceptable for substantial equivalence	Measured against the European ST-T database
Software validation for ST information processing	Implied to demonstrate correct processing and no adverse effect on other system parts	Performed to show correct processing and no system interference

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated, as the document refers to "AHA and MIT databases" and the "European ST-T database." These are established public databases containing numerous ECG recordings.
Data Provenance: The databases used are:
- AHA (American Heart Association) database
- MIT (Massachusetts Institute of Technology) database
- European ST-T database
  These are generally retrospective, publicly available datasets for ECG algorithm testing, often compiled from various clinical sources. The specific country of origin for each sample within these databases is not detailed in this summary, but they are recognized international benchmarks.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not specify the number of experts or their qualifications for establishing the ground truth within the AHA, MIT, or European ST-T databases. These databases are typically curated with expert-validated annotations, but the details of that validation process are external to this 510(k) summary.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method for the test set as part of this submission. The ground truth for the databases is assumed to be established by the curators of those databases.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study is mentioned for this device. The regulatory submission focuses on the algorithm's performance against standard databases and its substantial equivalence to predicate devices, not on human-in-the-loop performance improvement.

6. Standalone (Algorithm Only) Performance:

Yes, a standalone performance evaluation was done. The "Performance" section explicitly states that "The ST-enabled arrhythmia analysis software was tested against the AHA and MIT databases" and "The algorithm was also tested against the European ST-T database." This indicates an algorithm-only performance evaluation.

7. Type of Ground Truth Used:

The ground truth used is implied to be expert-annotated ECG waveforms from established public databases (AHA, MIT, European ST-T). These databases typically provide reference annotations for QRS complexes, arrhythmias, and ST-segment changes, which are considered the ground truth for evaluating such algorithms.

8. Sample Size for the Training Set:

The document does not specify the sample size for the training set. It focuses on the validation of the algorithm against known test databases.

9. How the Ground Truth for the Training Set Was Established:

The document does not describe how the ground truth for any training set was established. Given that the software was developed by VitalCom, Inc. (who also developed the ST-segment software for a predicate device), it's likely they used proprietary or established datasets for training, with ground truth established through expert review, but this is not detailed in the 510(k) summary.

Summary

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K972498

510(k) Summary

(

FEB | 7 1998

Date	November 18, 1997
Contact	Darlene T. Korab
	Sr. Project Manager
	Regulatory Affairs
	Johnson & Johnson Medical, Inc.
	4110 George Road
	Tampa, FL 33634
	Telephone: (813) 887-2663
	Telefax: (813) 887-2263
	E Mail: dkorab@crtus.jnj.com
Device Name	• OBSERVER* Central Station
	The subject of this premarket notification is the modification of the currently marketed Johnson & Johnson Medical, Inc. OBSERVER Central Station (K933404) to include ST-segment measurement.
Common Name	• Central Station
Classification	The classification name, 21 Code of Federal Regulations (CFR) Part and Paragraph number and classification of the OBSERVER Central Station with ST-segment measurement follow. The tier categorization based on the list (January 27, 1994) distributed by the Office of Device Evaluation is also included.

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ClassificationName	21 CFR Section	Class	Tier
Monitor,Electrocardio-graphic	870.2360	II	2
Transmitters andreceivers,physiologicalsignal,radiofrequency	870.2910	II	2
Detector andalarm,Arrhythmia	870.1025	III	3

Classification name, 21 CFR section, class and tier are as follows: Classification, continued

Predicate Devices

The addition of ST-segment measurement to the currently marketed OBSERVER Central Station with arrhythmia analysis is substantially equivalent to the currently marketed OBSERVER Central Station with arrhythmia analysis which received market clearance February 9, 1994 via 510(k) K933404. Everything remains the same except for the addition of STsegment measurement. The added ST-segment measurement feature is substantially equivalent to the ST-segment measurement feature of the currently marketed VitalCom, Inc. VCOM Central Monitor which received market clearance on January 30, 1995 via VitalCom 510(k) K942147. The same firm - VitalCom, Inc. -- that is developing the ST-segment software for the OBSERVER Central Station developed the ST-segment software for the VitalCom, Inc. VCOM Central Monitor.

Predicate Devices	510(k) Number
OBSERVER Central Station	K933404
VCOM Central Monitor	K942147

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ST-segment measurement is an optional feature of the OBSERVER Central Device Description Station with arrhythmia analysis. This feature allows for the measurement of the ST-segment level and slope and the issuance of alarms for ST elevations and depressions. The clinician may adjust certain waveform points and alarm priority and limits or rely on default settings for each patient to be analyzed.

The OBSERVER Central Station (K933404) is a PC-based monitoring system designed to provide remote surveillance with alarms, trending and retrieval of wave-form and numeric physiological data for up to 8 patients who are monitored via various DINAMAP* Physiological Monitors or other appropriate bedside/patient monitors.

Continued on next page

*Trademark

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Indications

Technological Characteristics

The OBSERVER Central Station with ST-segment measurement has the same technological characteristics as the predicate devices. The modification of the device software is an enhancement of the arrhythmia analysis feature to allow for the measurement of the ST segment with corresponding alarms. The methodology for ST-measurement is virtually the same as the VitalCom, Inc. VCOM Central Monitor.

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: 上一篇: :

វ្ 1

Performance	The ST-enabled arrhythmia analysis software was tested against the AHA and MIT databases to measure the algorithm's QRS detection sensitivity and positive predictivity and ventricular beat identification sensitivity, positive predictivity and false positive rate.
	The algorithm was also tested against the European ST-T database to measure the algorithm's ST sensitivity, positive predictivity and peak error.
	Software validation was performed to show that the OBSERVER Central Station correctly processes ST information, while not affecting other portions of the system.
Conclusions	In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this premarket notification, Johnson & Johnson Medical concludes that the modified device, the OBSERVER* Central Station with ST-segment measurement is safe, effective and substantially equivalent to the predicate devices as described herein.
Other Information	Johnson & Johnson Medical, Inc. will update and include in this summary any other information deemed reasonably necessary by the FDA.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 17 1998

Ms. Darlene T. Korab Johnson & Johnson Medical Inc. 4110 George Road Tampa, FL 33634

K972498 Re : OBSERVER* Central Station Regulatory Class: III (Three) Product Code: 74 DSI Dated: November 18, 1997 Received: November 19, 1997

Dear Ms. Korab:

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 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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.

Image /page/5/Picture/9 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

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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. Callshan

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

Enclosure

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INDICATIONS FOR USE

Page 1 of 1

510(k) Number (if known): K972498

Device Name: OBSERVER* Central Station

Indications for Use:

(

Arrhythmia detection and ST-segment measurement are optional ECG features limited to the adult population. ST-segment measurement is contraindicated in paced patients. The ST-segment feature of the OBSERVER Central Station provides for the measurement of the ST-segment level and slope of the ECG waveform, alerting the clinician to STsegment changes. The significance of ST-segment changes must be determined by a clinician. The device is not designed, sold or intended for use except as indicated. _

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ﺮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ (per 21 CFR 801.109

Over-The Counter Use -------

(Optional Format 1-2-96)

*Trademark

Regulation Number and Section

§ 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.