(321 days)
J & J Engineering, Inc. Thermistor Thermometer, Exergen Corporation DermaTemp DT 1001
Not Found
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or training/test sets for algorithms. The device description is consistent with a standard infrared thermometer.
No
The device is an infrared thermometer used for measuring and monitoring skin temperature, not for providing therapy.
Yes
No
The device description explicitly states it is a "hand held instrument" that measures infrared radiation, indicating it is a physical hardware device, not software only.
No, 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.
- Device Function: The Prizm Medical, Inc. ThermoTrace™ Infrared Thermometer measures surface skin temperature by detecting infrared radiation emitted from the body. It does not analyze samples taken from the body.
- Intended Use: The intended use is for the "intermittent measurement and monitoring of surface skin temperature on people of all ages." This is a direct measurement of a physical parameter of the body, not an analysis of a biological sample.
Therefore, based on the provided information, this device falls under the category of a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Prizm Medical, Inc. ThermoTrace™ Infrared Thermometer Models 15004 and 15007 are intended for use in clinical settings for the intermittent measurement and monitoring of surface skin temperature on people of all ages.
The Prizm Medical, Inc. ThermoTrace™ Infrared Thermometer Models 15004 and 15007 are a hand held instrument intended for use in clinical settings for the intermittent measurement and monitoring of skin temperature variations of the wml and a son people of all ages.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The Prizm Medical, Inc. ThermoTrace™ Infrared Thermometer Models 15004 and 15007 are a hand held instrument that measures skin temperature based on measuring infrared radiation. It is designed for ease of patient use with clearly marked patient intensity buttons. The indications for use are to measure and monitor the patient's skin temperature. It is intended for use on people of all ages.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared radiation
Anatomical Site
surface skin
Indicated Patient Age Range
people of all ages
Intended User / Care Setting
clinical settings
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): 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.
J & J Engineering, Inc. Thermistor Thermometer, Exergen Corporation DermaTemp DT 1001
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.
Not Found
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
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.
0
510(k) SUMMARY of SAFETY and EFFECTIVENESS
I. GENERAL INFORMATION
| Trade or (Proprietary) Name: | Prizm Medical, Inc. ThermoTrace™ Infrared
Thermometer Models 15004 and 15007 |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Common or usual name: | Thermometer, electronic, clinical |
| Classification Name: | FDA has classified thermometer, electronic, clinical as
Class II devices. (21 C.F.R. § 880.2910) |
| Submitter's Name
And Address: | Cathryn N. Cambria
for Prizm Medical, Inc.
Regulatory Resources Group
5536 Trowbridge Drive
Dunwoody, GA 30338 |
| Submission Date: | September 4, 2001 |
| Legally Marketed Device | |
To Which Claim Substantial
J & J Engineering, Inc. Thermistor Thermometer Equivalence: Exergen Corporation DermaTemp DT 1001
II. INDICATIONS FOR USE
The Prizm Medical, Inc. ThermoTrace™ Infrared Thermometer Models 15004 and 15007 are intended for use in clinical settings for the intermittent measurement and monitoring of surface skin temperature on people of all ages.
III. DEVICE DESCRIPTION
The Prizm Medical, Inc. ThermoTrace™ Infrared Thermometer Models 15004 and 15007 are a hand held instrument that measures skin temperature based on measuring infrared radiation. It is designed for ease of patient use with clearly marked patient intensity buttons. The indications for use are to measure and monitor the patient's skin temperature. It is intended for use on people of all ages.
Please refer to the Operations Manual (Exhibit A) for photographs and a more thorough description of the device.
The Prizm Medical, Inc. ThermoTrace™ Infrared Thermometer Models 15004 and 15007 are intended for use in clinical settings for the intermittent measurement and monitoring of surface skin temperature on people of all ages. The primary function of
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the ThermoTrace™ Infrared Thermometer Models 15004 and 15007 are the same as the J & J Engineering, Inc. Thermistor Thermometer and the Exergen Corporation DermaTemp DT 1001 and raises no new questions of safety and effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human profiles or faces, stacked one behind the other, with the foremost profile being the most distinct.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 3 2002
Prizm Medical, Incorporated C/O Ms. Cathryn N. Cambria Regulatory Resources Group, Incorporated 5536 Trowbridge Drive Dunwoody. Georgia 30338
Re: K012974
Trade/Device Name: Prizm Medical Inc. Thermotrace™ Infrared Thermometer. Models 15004 and 15007 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: July 3, 2002 Received: July 10, 2002
Dear Ms. Cambria:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Cambria
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements" of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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.
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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M II MICHINUN
Prizm Medical, Inc.
Page 1 of 1.
510(k) Number (if known):
Device Name:
Prizm Medical, Inc. ThermoTrace™ Infrared Thermometer Models 15004 and 15007
Indications for Use:
The Prizm Medical, Inc. ThermoTrace™ Infrared Thermometer Models 15004 and 15007 are a hand held instrument intended for use in clinical settings for the intermittent measurement and monitoring of skin temperature variations of the wml and a son people of all ages.
1012974
wint
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
er Use
Patucia Cucero
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _
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