(62 days)
Electrohome M1544/1744 High Resolution Monochrome Monitors
No
The 510(k) summary describes a general-purpose computer monitor modified for medical use, with no mention of AI or ML capabilities.
No
The device is a monitor intended for displaying data from other medical devices, not for providing therapy itself.
No
Explanation: The device is a monitor that displays data from other medical devices, but it does not perform any analysis or interpretation to generate a diagnosis itself.
No
The device description clearly states it is a "general purpose computer monitor which has been modified for use in medical settings," indicating it is a hardware device.
Based on the provided information, the Sony PGM-100P1MD Trinitron® Color Graphic Monitor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to display multi-parameter data from patient monitoring applications. This involves displaying data generated from the patient (like ECG, blood pressure, imaging), not performing tests on samples taken from the patient.
- Device Description: It's described as a general purpose computer monitor modified for medical settings to display images received from a computer system. It's a display device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing chemical or biological tests, or providing diagnostic information based on the analysis of such samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This monitor's function is to display data that has already been generated by other medical devices.
N/A
Intended Use / Indications for Use
The Sony PGM-100P1MD Trinitron® Color Graphic Monitor is intended for use in patient monitoring applications to display multi-parameter data in graphic format. The Sony. PCM-100P1MD can be used in hospital settings such as the intensive care unit, central station, and nurse station. Applications include the display of data from electrocardiographs, blood pressure and pulse measurement systems, and computed tomography and other imaging systems.
Product codes
90 JAK
Device Description
The Sony PGM-100P1MD Trinitron® Color Graphic Monitor is a general purpose computer monitor which has been modified for use in medical settings for patient monitoring applications. It will display images received from a computer system and is designed for use with PC-compatible computers.
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
Not Found
Intended User / Care Setting
hospital settings such as the intensive care unit, central station, and nurse station.
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)
Sony Trinitron Color Video Monitor PVM-1343MD K885042, Siemens Sirecust 1481T Digital Telemetry System K900319
Reference Device(s)
Electrohome M1544/1744 High Resolution Monochrome Monitors
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
K97099
ー
510(k) Summary
for
Sony PGM-100P1MD Trinitron® Color Graphic Monitor
MAY 2 0 1997
- Applicant: 1.
ﻤﺴﺘﺸﻔﺎ
Sony Medical Systems Division Sony Electronics Inc. 3 Paragon Drive Montvale, NJ 07645
| Contact Person: | Anthony John Kefalos |
|---|---|
| Telephone: | 201-358-4330 |
March 18, 1997 Date Prepared:
2. Device Name
Proprietary Name:
Sony PGM-100P1MD Trinitron® Color Graphic Monitor
Color Graphic Monitor Common/Usual Name:
Accessory to Medical Imaging, Monitoring and Classification Name: Diagnostic Devices
- Classification Status: Class II
3. Predicate Devices
- : Sony Trinitron Color Video Monitor PVM-1343MD . Sony Medical Systems Division K885042
- Electrohome M1544/1744 High Resolution Monochrome Monitors . Electrohome Limited
- Siemens Sirecust 1481T Digital Telemetry System (includes the Sony . Trinitron® Character Display CPD-1304 as the monitor component) Siemens Medical Electronics, Inc. K900319
1
Device Description 4.
The Sony PGM-100P1MD Trinitron® Color Graphic Monitor is a general purpose computer monitor which has been modified for use in medical settings for patient monitoring applications. It will display images received from a computer system and is designed for use with PC-compatible computers.
Intended Use 5.
- ﺔ ﺍﻟﻤﺘﺮﺟﻤﺔ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻮﻧﻴ
The Sony PGM-100P1MD Trinitron® Color Graphic Monitor is intended for use in patient monitoring applications to display multi-parameter data in graphic format.
Technological Characteristics Q.
The Sony PGM-100P1MD Trinitron® Color Graphic Monitor is intended as an addition to the Sony video monitor product line and has the same general purposes and function as the predicate devices identified above. All of the devices accept standard video signals produced by a wide range of equipment. The primary difference between the Sony PGM-100P1MD and the predicate devices is the higher resolution that it provides for use in graphical display.
3/18/97
2
Image /page/2/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 1997
Cynthia A. Sinclair Sony Medical Systems C/O Medical Device Consult, Inc. 49 Plain Street . ...... . ........ North Attleboro, MA 02760
Re: K970999
Sony PGM-100P1MD Trinitron® Color Graphic Monitor Dated: March 18, 1997 Received: March-19; 1997 …… Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK
Dear Ms. Sinclair:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have desermined 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, Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, ind Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and produbtions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premater 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 equivalion assemes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 does not affect any obligation you might have under sections 51 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations,
This letter will allow you to begin marketing your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed presidention for your device and this, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (2) CFR Part 801 and additionally 809.10 for in pitco diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please noted, "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,
Lillian Xia, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): _ K970999
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Sony PGM-100P1MD Trinitron® Color Graphic Monitor is intended for use in patient monitoring applications to display multi-parameter data in graphic format. The Sony. PCM-100P1MD can be used in hospital settings such as the intensive care unit, central station, and nurse station. Applications include the display of data from electrocardiographs, blood pressure and pulse measurement systems, and computed tomography and other imaging systems.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrenee of CDRH, Office of Device Evaluation (ODE)
David C. Jesson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devic 147494 510(k) Number
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
3/18/97
Sony PGM-100P1MD Monitor 510(k)