(229 days)
No
The document describes standard signal processing and analysis techniques for ECG data (ST-segment measurement, arrhythmia detection) and does not mention AI or ML. The testing against standard databases (AHA, MIT, European ST-T) is typical for traditional signal processing algorithms.
No
The device is described as a monitoring system that displays, records, and stores physiological data and alerts healthcare professionals to changes in parameters. It does not actively treat or intervene in the patient's condition.
Yes
This device monitors physiological parameters, performs arrhythmia detection, and measures ST-segment changes, all of which are activities associated with diagnosing a patient's medical condition.
No
The device description explicitly states it is a PC-based monitoring system that uses a Pentium PC with a monitor and can connect to various hardware components like patient monitors, printers, and recorders via hardwire or wireless interfaces. While it includes software features, it is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The OBSERVER Central Station monitors physiological parameters directly from the patient (non-invasive and invasive blood pressure, oxygen saturation, temperature, ECG, pulse/heart rate). It does not analyze samples taken from the patient.
- Intended Use: The intended use describes remote monitoring of physiological parameters, not the analysis of biological samples.
Therefore, the device falls under the category of a patient monitoring system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
74 DSI
Device Description
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.
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, pediatric and neonatal
Intended User / Care Setting
prescription device intended for use only by health care professionals. 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.
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software validation was performed to show that the OBSERVER Central Station correctly processes ST information, while not affecting other portions of the system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
QRS detection sensitivity and positive predictivity
ventricular beat identification sensitivity, positive predictivity and false positive rate
ST sensitivity, positive predictivity and peak error
Predicate Device(s)
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
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. |
Continued on next pagel
... ...
.
1
| Classification
| Name | 21 CFR Section | Class | Tier |
|---|---|---|---|
| Monitor, | |||
| Electrocardio- | |||
| graphic | 870.2360 | II | 2 |
| Transmitters and | |||
| receivers, | |||
| physiological | |||
| signal, | |||
| radiofrequency | 870.2910 | II | 2 |
| Detector and | |||
| alarm, | |||
| 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 |
Continued on next page
2
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.
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.
Continued on next page
*Trademark
3
Indications
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.
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.
Continued on next page
4
: 上一篇: :
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| 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.
6
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
7
INDICATIONS FOR USE
Page 1 of 1
510(k) Number (if known): K972498
Device Name: OBSERVER* Central Station
Indications for Use:
(
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 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)
==============================================================================================================================================================================
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
OR
Over-The Counter Use -------
(Optional Format 1-2-96)
*Trademark