(62 days)
No
The document describes a basic digital thermometer with a stopwatch function for heart rate, and there is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.
No
The device is a thermometer used for measurement, not for treating or curing a medical condition.
Yes
The device measures temperature and estimates heart rate, which are used to assess a patient's health status, thus aiding in diagnosis.
No
The device description explicitly states it is a "hand-held, battery powered thermometer," indicating it is a physical hardware device.
Based on the provided information, the EntraCare Thermometer, Model 1000, is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro (outside the body) for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes.
- EntraCare Thermometer Function: The EntraCare Thermometer measures temperature directly within the human body (orally or rectally). It does not analyze specimens taken from the body.
Therefore, the device's function and intended use clearly place it outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The EntraCare Thermometer, Model 1000, is intended to be used under a physicians orders when an accurate temperature measurement is required. The device is intended to be used orally or rectally in the human body temperature range of 92°F to 108°F. It may be used with infants, children, or adults in all settings under the order of a physcian. The heart rate timer is also provided to aid in establishing a patients approximate heart rate.
Product codes
FLL
Device Description
The EntraCare Thermometer, Model 1000, is a hand-held, battery powered thermometer. This thermometer is capable of measuring and displaying temperatures over the entire human body temperature range (92.0° to 108.0° F or 33.0° to 42.0° C). This device also is capable of calculating a persons approximate heart rate through the use of a stopwatch type function and will display the rate simultaneously with temperature. This feature acts like a stop watch and does not attempt to directly measure a patients pulse.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
orally or rectally
Indicated Patient Age Range
infants, children, or adults
Intended User / Care Setting
used under a physicians orders / all settings under the order of a physcian
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
EntraCare Corp.
510(k) SUMMAR Y
Page 1 of 3
FEB - 3 1997
510(k) SUMMARY OF SAFETY AND EFFICACY
DATE PREPARED:
November 22, 1996
SUBMITTER:
EntraCare, Inc. 14400 College Blvd. Suite 101 Lenexa, KS 66215 Tel: 913-327-7700 Fax: 913-327-7705
CONTACT PERSON: Al Boedeker, Director of Regulatory Affairs
TRADE (PROPRIETARY) NAME:
EntraCare 1000 Thermometer
COMMON NAME: Thermometer
CLASSIFICATION NAME: Thermometer, Electronic, Clinical
DEVICE CLASSIFICATION: Class II
PREDICATE DEVICES: 1. Ivac Corp., Temp-Plus Vital Signs Measurement System, Model 2080 (K860436).
- Diatek, Thermometer System, Model 600 (K833568).
1
DESCRIPTION OF DEVICE: The EntraCare Thermometer, Model 1000, is a hand-held, battery powered thermometer. This thermometer is capable of measuring and displaying temperatures over the entire human body temperature range (92.0° to 108.0° F or 33.0° to 42.0° C). This device also is capable of calculating a persons approximate heart rate through the
use of a stopwatch type function and will display the rate simultaneously with temperature. This feature acts like a stop watch and does not attempt to directly measure a patients pulse.
STATEMENT OF INTENDED USE:
The EntraCare Thermometer, Model 1000, is intended to be used under a physicians orders when an accurate temperature measurement is required. The device is intended to be used orally or rectally in the human body temperature range of 92°F to 108°F. It may be used with infants, children, or adults in all settings under the order of a physcian. The heart rate timer is also provided to aid in establishing a patients approximate heart rate.
TECHNOLOGICAL CHARACTERISTICS:
The new device has the same technological characteristics (i.e., design, material, energy source) as the predicate devices. The specifications are illustrated in the substantial Equivalence Matrix on the following page.
2
SUBSTANTIAL EQUIVALENCE MATRIX
| | Candidate
EntraCare
Model 1000 | Predicate
Ivac Corp.
Model 2080 | Predicate
Diatek
Model 60 |
|------------------------|--------------------------------------|---------------------------------------|---------------------------------|
| FEATURES | | | |
| MONITOR MODE | YES | YES | YES |
| PREDICTIVE MODE | NO | YES | YES |
| NIGHT-VIEW DISPLAY | YES | YES | YES |
| °F / °C | YES | YES | YES |
| PULSE TIMER | YES | YES | YES |
| DISPOSABLE PROBE COVER | YES | YES | YES |
| BATTERY POWERED | YES | YES | YES |
| HAND HELD - PORTABLE | YES | YES | YES |
| REPLACEMENT PROBES | YES | YES | YES |
| DIAGNOSTIC SELF-TEST | YES | YES | YES |