(321 days)
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 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.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided 510(k) summary does not contain a specific table of acceptance criteria or detailed device performance metrics beyond stating that the device is "substantially equivalent" to predicate devices. The document explicitly states: "The primary function of 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." This implies that the acceptance criteria for this device are met by demonstrating equivalence to the legally marketed predicate devices, which would have themselves met their respective performance standards.
Without specific performance data, it's impossible to create a table. However, if performance data were present, it would typically look something like this (hypothetical example):
| Performance Metric | Acceptance Criteria (from predicate/standards) | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| Accuracy Range | ±0.2°C from 36°C-39°C | ±0.15°C from 36.5°C-38.5°C | Yes |
| Response Time | < 2 seconds | 1.5 seconds | Yes |
| Repeatability | Standard Deviation < 0.1°C | Standard Deviation 0.08°C | Yes |
| Temperature Range | 32°C - 42°C | 32°C - 42°C | Yes |
2. Sample size used for the test set and the data provenance:
The provided 510(k) summary does not contain any information about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective or prospective). The submission relies on demonstrating substantial equivalence to predicate devices rather than reporting new clinical study data that would typically involve a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The provided 510(k) summary does not contain any information about experts used to establish ground truth. As mentioned, the submission relies on substantial equivalence.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
The provided 510(k) summary does not contain any information about an adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
The device described is an infrared thermometer and not an AI-powered diagnostic tool requiring human interpretation. Therefore, no MRMC comparative effectiveness study was done or is applicable in this context.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The provided 510(k) summary does not contain any information about standalone performance studies in the context of an algorithm. The device is a direct measurement tool. The "standalone performance" of the thermometer would be its inherent accuracy, reproducibility, etc., which is implied to be equivalent to the predicate devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The provided 510(k) summary does not explicitly state the type of ground truth used, as it relies on substantial equivalence to existing devices. For a thermometer, "ground truth" for performance would typically be established by comparing its readings to a highly accurate reference thermometer or a known standard temperature source within a controlled laboratory environment. The submission assumes that the predicate devices had already established their accuracy characteristics through such ground truth methods.
8. The sample size for the training set:
The provided 510(k) summary does not contain any information about a "training set." This type of terminology is relevant for machine learning or AI-based devices. The ThermoTrace™ Infrared Thermometer is a direct measurement device; it does not "learn" from a training set.
9. How the ground truth for the training set was established:
As no training set is applicable to this type of device, the question of how its ground truth was established is not relevant to this 510(k) summary.
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510(k) SUMMARY of SAFETY and EFFECTIVENESS
I. GENERAL INFORMATION
| Trade or (Proprietary) Name: | Prizm Medical, Inc. ThermoTrace™ InfraredThermometer Models 15004 and 15007 |
|---|---|
| Common or usual name: | Thermometer, electronic, clinical |
| Classification Name: | FDA has classified thermometer, electronic, clinical asClass II devices. (21 C.F.R. § 880.2910) |
| Submitter's NameAnd Address: | Cathryn N. Cambriafor Prizm Medical, Inc.Regulatory Resources Group5536 Trowbridge DriveDunwoody, 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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
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(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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§ 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.