(130 days)
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No
The device description focuses on physical design features for comfort and ease of use, with no mention of AI or ML algorithms for data processing or interpretation.
No
The device is an electronic thermometer, which is used for measurement and diagnosis, not for treating a condition or disease.
Yes
Explanation: The device is a thermometer, which is used to measure body temperature, a key vital sign that helps diagnose various medical conditions like fever, hypothermia, and infections.
No
The device description clearly describes a physical electronic thermometer with a flexible probe and insertion guide, indicating it is a hardware device.
Based on the provided information, 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 Description: The description clearly states that the Pro-Flex is an electronic thermometer used for measuring body temperature. It describes features related to comfort and proper insertion for rectal and underarm use.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting substances in samples, or any other activity typically associated with in vitro diagnostics.
Therefore, the Pro-Flex thermometer is a medical device, but it falls under the category of a non-IVD device.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
Pro-Flex is a redesign of the traditional electronic thermometer with more convenient and comfortable features. It has flexible and soft probe make user comfortable in using. It also has insertion guide to prevent over insertion when use in rectal. The funnel shape of the probe is also fit the contour of baby's underarm so the tip of the probe will be in the same middle position of the armpit every time it is used.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
rectal, armpit
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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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.
0
AUG 1 6 1996
463 North Orcm Orem, UT 84057 Tel/Fax: (801) 221-9996
510(K) Summary
| Submitter: | Intelligent Product L. C. |
|---|---|
| Contact Person: | Matthew Kho |
| Address: | 463 North Orem Blvd., Orem, Utah 84057 |
| Telephone: | (801) 221-9996 |
| Date of Submission: | Jan 10, 1996 |
| Classification Name: | Electronic Clinical Thermometer |
|---|---|
| Common/Usual Name: | Pro-Flex |
| Proprietary Name: | Pro-Flex, Digital Pacifier Thermometer |
Legally Marketed Device to which Substantial Equivalence is claimed: Digital Thermometer manufactured by Micro-Ideas Instruments Co. Ltd. (K844273)
Pro-Flex is a redesign of the traditional electronic thermometer with more convenient and comfortable features. It has flexible and soft probe make user comfortable in using. It also has insertion guide to prevent over insertion when use in rectal. The funnel shape of the probe is also fit the contour of baby's underarm so the tip of the probe will be in the same middle position of the armpit every time it is used.
The Pro-Flex is a safe device. It is contracted to be manufactured by ISO 9001 certified manufacturer, Micro Idea Instruments Co. Ltd. who also has some FDA registered Clinical Electronic Thermometer that are legally marketed in USA (Owner ID # 8020605). It is made to meet the ASTM 1112-86, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature". The materials that used on Pro-Flex include ABS plastic and the metal cap on the probe are the same materials on Micro Idea's thermometer which are legally marketed in US for a period of time already. The PVC flexible probe is also medical graded and certified by AlphaGary Corporation.
In conclusion, I believe that Pro-Flex is a well designed, quality and safe device. It is also substantially equivalent to the legally marketed device listed above. I hereby submit Pro-Flex for the 510(K) approval.
Sincerely,
Matthew Kho
President