(68 days)
No
The description focuses on basic temperature measurement, storage, and display, with no mention of AI or ML algorithms for analysis or interpretation.
No.
The device is described as a continuous temperature monitor used to measure and display human body temperature, and store data. Its function is diagnostic and monitoring, not therapeutic.
No
The device is described as a continuous temperature monitor used to measure and monitor human body temperature, which is a measurement function, not a diagnostic one. It provides data but does not interpret that data to identify a disease or condition.
No
The device description explicitly lists multiple hardware components, including a control/display assembly, a temperature probe, and a USB interface cable, in addition to the software.
Based on the provided information, the DataTherm® II Continuous Temperature Monitor 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.
- DataTherm II Function: The DataTherm II directly measures and monitors human body temperature in vivo (within the living body) using a temperature probe. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "continuously measure, display and monitor human body temperature." This is a direct physiological measurement, not an in vitro test.
Therefore, the DataTherm II falls under the category of a medical device, but not specifically an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DataTherm II Continuous Temperature Monitor is intended to continuously measure, display and monitor human body temperature updating every 4 seconds. Additionally, it stores up to 140 temperature/time/day data sets that may be stored at a user-selected frequency range from once per minute to once every 24 hours in one minute intervals. The current temperature and stored information may be viewed on the LCD screen that is integrated into the instrument or, from a PC computer screen after installation of the DataTherm software to a PC. The DataTherm II is intended to be used on patients of all ages.
The DataTherm® II Continuous Temperature Monitor is used to measure and monitor human body temperature and for storing temperature data at adjustable, preset time intervals.
Product codes
FLL
Device Description
The DataTherm II Continuous Temperature Monitor (model HD-2300) consists of four components.
-
- A control / display assembly measuring 3.16'' X 2.37' X 0.71" with an LCD screen and 5 control keys (On/Off, Mode Selection, &(increase), (decrease) and keyboard Lock). The interior electronic components consist of a circuit board, a battery compartment housing 2 - AAA batteries, a buzzer and LED alert light.
-
- A disposable flexible temperature probe having a plug-in connector at one end and thermistor sensor at the other.
-
- A USB interface connector cable that permits the transfer of stored and real-time temperature/time/day information to a PC computer screen.
-
- Proprietary software that permits an individual patient's current temperature to be viewed and temperature/time/date information to be displayed and archived, if desired.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human body
Indicated Patient Age Range
all ages.
Intended User / Care Setting
Not Found
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.
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Image /page/0/Picture/0 description: The image shows a logo with the letters 'RG' stacked on top of each other in a bold, sans-serif font. Below the letters is a zig-zag line. Underneath the zig-zag line, the word 'DIAGNOSTICS' is printed in a smaller, sans-serif font. The logo appears to be for a diagnostics company.
RG Medical Diagnostics
Pa 1 of 3
JUN - 5 2007
Premarket 510(k) Summary
DataTherm® II
Submitter information:
Sponsor:
RG Medical Diagnostics 21130 Bridge Street Southfield, MI 48034 1-248-750-0181 ph 1-248-750-0187 fax Contact Person: Ronald G. Le Tourneau Date Prepared: 26 February, 2007
Device Name:
| 1. Classification: | General Hospital |
|---|---|
| 2. Common Name: | Clinical Electronic Thermometer |
| 3. Proprietary Name: | DataTherm® II Continuous Temperature |
| Monitor | |
| 4. Classification: | FLL - CFR 880.2910 |
| 5. Performance Standards: | ASTM E1112-00 (2006), |
| EN60601-1-2 (harmonized) |
6. Predicate Device Information:
K001281, Geratherm Babywatch Temperature Monitor
Manufactured by: Geratherm Medical AG Fahrenheitstrasse 1 D-98716 Geschwenda, Germany
- Device Description: 21130 Bridge Street • Southfield, MI 48034 1 of 4 Phone: 888-596-9498 • Fax: 248-750-0187 • Website: www.rgmd.com
1
The DataTherm II Continuous Temperature Monitor (model HD-2300) consists of four components.
-
- A control / display assembly measuring 3.16'' X 2.37' X 0.71" with an LCD screen and 5 control keys (On/Off, Mode Selection, &(increase), (decrease) and keyboard Lock). The interior electronic components consist of a circuit board, a battery compartment housing 2 - AAA batteries, a buzzer and LED alert light.
-
- A disposable flexible temperature probe having a plug-in connector at one end and thermistor sensor at the other.
-
- A USB interface connector cable that permits the transfer of stored and real-time temperature/time/day information to a PC computer screen.
-
- Proprietary software that permits an individual patient's current temperature to be viewed and temperature/time/date information to be displayed and archived, if desired.
5. Intended Use:
The DataTherm II Continuous Temperature Monitor is intended to continuously measure, display and monitor human body temperature updating every 4 seconds. Additionally, it stores up to 140 temperature/time/day data sets that may be stored at a user-selected frequency range from once per minute to once every 24 hours in one minute intervals. The current temperature and stored information may be viewed on the LCD screen that is integrated into the instrument or, from a PC computer screen after installation of the DataTherm software to a PC. The DataTherm II is intended to be used on patients of all ages.
6. Comparison to Predicate Device
The subject device is substantially equivalent to the predicate device, the Babywatch (marketed as DataTherm®) K001281. Both the subject and predicate devices are designed and engineered by the same company, Geratherm AG. The two devices employ the same technology, display information, and use the same controls. The subject device differences include disposable temperature probes, larger batteries, added visual temperature alert LED, improved water repellency, expanded memory, expanded storage interval alternatives and the ability to view and archive time/temperature/date data on a PC computer in user named files.
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Ko708 78
Py 3 of B
7. Discussion of Non-clinical Tests Performed for Determination of Substantial Equivalence are as follows:
The DataTherm II (model KD-2300) complies with EN 60601-1-2 "Electromagnetic Compatibility" and ASTM E1112-00 " Electronic Thermometer for Intermittent Determination of Patient Temperature" standards. In addition, the DataTherm II conforms to the harmonized standard for electronic safety established by the US FCC Part 15.
8. Discussion of Clinical Tests Performed:
Not Applicable
9. Conclusions:
The subject device and predicate devices provide the same functions and controls through employment of the same technology. Moreover, bench testing contained in this submission demonstrate that any differences in their characteristics do not present any new questions of safety or effectiveness. Thus, the DataTherm® II Continuous Temperature Monitor is substantially equivalent to the predicate device.
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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services - USA. The logo features a stylized image of a human figure, with three overlapping profiles facing to the right. The profiles are simple and abstract, with no facial details. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ronald G. Le Tourneau President RG Medical Diagnostics 21130 Bridge Street Southfield, Michigan 48034
JUN -5 2007
Re: K070878
Trade/Device Name: DataTherm® II Continuous Temperature Monitor Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: May 04, 2007 Received: May 07, 2007
Dear Mr. Le Tourneau:
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.
4
Page 2 – Mr. Le Tourneau
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 (QS) 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K070878
Device Name: _ DataTherm® II Continuous Temperature Monitor
Indications For Use:
The DataTherm® II Continuous Temperature Monitor is used to measure and monitor human body temperature and for storing temperature data at adjustable, preset time intervals.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Sion Sign-Off) | |
|---|---|
| vision of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | Page 1 of |
| 510(k) Number: | K470878 |