(263 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on a power source modification to an existing patient monitor.
No
The device is a patient monitor, indicated for measuring and displaying physiological parameters and waves to gain information for treatment, assess treatment adequacy, or rule out symptoms. It does not directly provide therapy.
Yes
The device is described as a "patient monitor" and its "Physiological Purpose" is "to gain information for treatment, to assess adequacy of treatment, or to rule out causes of symptoms." This clearly indicates its role in diagnosing or assessing a patient's condition.
No
The device description explicitly states "Viridia 24 CT is a patient monitor" and mentions a modification to the "power source," indicating it is a hardware device. It also states it obtains signals from "accessory electrode, transducer, and sensor devices," which are hardware components.
Based on the provided information, the Viridia 24 CT is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device measures and displays multiple physiological parameters and waves from the patient. It is used for patient monitoring, assessing treatment, and ruling out causes of symptoms. This is characteristic of a patient monitoring device, not an IVD.
- Interaction with the Body: The description explicitly states that the Viridia 24 CT "does not contact the body or tissue of the patient." IVD devices typically interact with biological specimens (blood, urine, tissue, etc.) taken from the body.
- Physiological Purpose: The purpose is to gain information for treatment, assess adequacy of treatment, or rule out causes of symptoms through monitoring physiological parameters. This is distinct from analyzing biological samples to diagnose a condition.
- Device Description: It is described as a "patient monitor."
In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The Viridia 24 CT is a device that monitors physiological signals from the patient, not from a specimen.
N/A
Intended Use / Indications for Use
"Viridia 24 CT is generally indicated when the clinician decides there is a need to measure and display multiple physiological parameters and waves, to generate alarms and recordings of adult, pediatric, or neonatal patients."
"Part of Body or Type of Tissue with Which the Device Interacts: Viridia 24 CT does not contact the body or tissue of the patient. Signals are obtained from accessory electrode, transducer, and sensor devices."
"Frequency of Use: Viridia 24 CT is indicated for use when prescribed by a clinician."
"Physiological Purpose: Viridia 24 CT is indicated when the purpose is to gain information for treatment, to assess adequacy of treatment, or to rule out causes of symptoms. Viridia 24 CT is well suited for patient monitoring."
"Patient Population: Adult, pediatric, and neonatal non-ambulatory patients."
"Prescription Versus Over-the-Counter: Viridia 24 CT is a prescription device."
Product codes (comma separated list FDA assigned to the subject device)
74 DSI
Device Description
Viridia 24 CT is a patient monitor. This submission notifies the FDA that the power source was modified. No other significant changes were made to the device.
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
"Viridia 24 CT is intended to be used in a clinical environment by licensed clinicians. It is not intended for home use."
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)
Viridia 24 CT has been verified and validated to provide the test results needed to show substantial equivalence to legally marketed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K950821, K960934, K922974, K945134, K961247
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
DEC 9 1998
K981/376
CHAPTER 23: SUMMARY OF SAFETY AND EFFECTIVENESS
1.0 Manufacturer/Submitter
1.1 Name and Address
Hewlett-Packard Company Patient Monitoring Division Medical Products Group 3000 Minuteman Road Andover, MA 01810-1099
1.2 Establishment Registration Number 1218950
1.3 Hewlett-Packard Manufacturing Site Address
Hewlett-Packard Company Patient Monitoring Division Medical Products Group 3000 Minuteman Road Andover, MA 01810-1099
1.3.1 Manufacturing Site Establishment Registration Number 9680888
1.4 Sterilization Site
Does not apply.
1.5 Contact Persons
You may contact David Osborn at (978) 659-3178 or Elisabeth George at (978) 659-4663 for additional information. Or, a fax may be sent to (978) 685-5624. Alternate contact: Chas Burr at (978) 659-2529.
1.6 Date
4/14/98
2.0 Regulatory Information
2.1 References
- · K950821 and K960934, Hewlett-Packard M1205A Viridia 24 (formally OmniCare 24)
- · K922974 and K945134, Hewlett-Packard Model M1275A Component Transport System.
- · K961247, Datex AS/3 Compact Monitor
Device Name. Trade Name 2.2
Proprietary: Hewlett-Packard M1205A Viridia 24 CT
Trade: Viridia 24 CT
Products (Components) Included As Part Of 2.3 This Device:
Accessories or additional components are included as part of the Hewlett-Packard M1205A Viridia 24 CT as indicated in the technical data sheet.
2.4 Device Classification
We believe the proper classification for the device is 870.1025, Monitor, Physiological, Patient.
2.5 Performance Standard:
None established under section 514.
3.0 Description
Viridia 24 CT is a patient monitor. This submission notifies the FDA that the power source was modified. No other significant changes were made to the device.
4.0 Intended use
4.1 Purpose
"Viridia 24 CT measures and displays multiple physiological parameters and waves, and generates alarms, and recordings. It exchanges information with compatible devices. Viridia 24 CT is not a therapeutic device." on page 3-1.
4.2 Patient Population
"Viridia 24 CT is intended to be used on adult, pediatric, and neonatal patients." on page 3-1.
4.3 Environment
"Viridia 24 CT is intended to be used in a clinical environment by licensed clinicians. It is not intended for home use." on page 3-1.
"It communicates with devices such as a central station through network interface ports and a serial I/O port. It is suitable for intra facility transport." on page 3-1.
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"Viridia 24 CT is a prescription device and will carry the following label, 'United States Federal law restricts this device to sale by or on the order of a physician.'" on page 3-1.
"Viridia 24 CT is not a therapeutic device." on page 3-1.
5.0 Indications for Use
5.1 510(k) Number
The 510(k) number has not been assigned.
5.2 Device Name
The device name is Hewlett-Packard M1205A Viridia 24 CT.
5.3 Indications for Use Statement
The paragraphs below are the elements of the indications for use statement for Viridia 24 CT.
Condition 5.3.1
"Condition: Viridia 24 CT is generally indicated when the clinician decides there is a need to measure and display multiple physiological parameters and waves, to generate alarms and recordings of adult, pediatric, or neonatal patients." on page 4-1.
5.3.2 Part of Body or Type of Tissue with Which the Device Interacts
"Part of Body or Type of Tissue with Which the Device Interacts: Viridia 24 CT does not contact the body or tissue of the patient. Signals are obtained from accessory electrode, transducer, and sensor devices." on page 4-1. Viridia 24 CT does not contact the body or tissue of the patient.
Frequency of Use 5.3.3
"Frequency of Use: Viridia 24 CT is indicated for use when prescribed by a clinician." on page 4-1.
Physiological Purpose 5.3.4
"Physiological Purpose: Viridia 24 CT is indicated when the purpose is to gain information for treatment, to assess adequacy of treatment, or to rule out causes of symptoms. Viridia 24 CT is well suited for patient monitoring." on page 4-1.
5.3.5 Patient Population
"Patient Population: Adult, pediatric, and neonatal non-ambulatory patients." on page 4-1.
5.3.6 Prescription Versus Over-the-Counter
"Prescription Versus Over-the-Counter: Viridia 24 CT is a prescription device." on page 4-1.
6.0 Verification and Validation
Viridia 24 CT has been verified and validated to provide the test results needed to show substantial equivalence to legally marketed devices.
7.0 Safe and Effective When Used as Labeled
Documented test results obtained from extensive testing coupled with detailed user documentation of Viridia 24 CT and host devices produces a very high confidence level that the device is safe and effective when used as intended.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, with three profiles facing to the right, representing the department's focus on people and health.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 4 1999
Mr. David Osborn Medical Products Group Hewlett-Packard Company 3000 Minuteman Road Andover, MA 01810
K981376 Re: Hewlett-Packard M1205A Viridia 24CT Regulatory Class: III (three) Product Code: 74 DSI Dated: September 11, 1998 Received: September 14, 1998
Dear Mr. Osborn:
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 legally marketed predicate 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.
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Page 2 - Mr. David Osborn
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 requlation (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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
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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