(169 days)
K#94527
Not Found
No
The device description details a standard digital thermometer using a thermistor and microprocessor to measure and display temperature. There is no mention of AI, ML, or any algorithms beyond basic temperature conversion and display.
No
The device is described as a thermometer for measuring basal body temperature to aid in ovulation prediction for conception, not for treating or curing a medical condition.
No
The device is intended for measuring and aiding in the monitoring and tracking of basal body temperature (BBT) as an aid in ovulation prediction to aid in conception. While it measures a physiological parameter, its primary purpose is not to diagnose a disease, condition, or state of health directly. Instead, it provides data for monitoring and fertility planning.
No
The device description explicitly mentions hardware components like a thermistor, LCD, microprocessor, and IC, indicating it is a physical device, not software-only.
Based on the provided information, the Microlife Digital Basal Thermometer 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 Microlife Digital Basal Thermometer measures basal body temperature (BBT) directly from the body (in vivo), not from a sample taken from the body (in vitro).
- Intended Use: The intended use is to measure and track BBT as an aid in ovulation prediction for conception, which is a physiological measurement, not a diagnostic test performed on a sample.
Therefore, while it's a medical device used for health monitoring, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Microlife Digital Basal Thermometer is a device intended for measuring, and aiding in the monitoring and tracking of basal body temperature (BBT) as an aid in ovulation prediction to aid in conception (not to be used for contraception).
Product codes (comma separated list FDA assigned to the subject device)
85 LHD
Device Description
The Microlife Digital Basal Thermometer, which uses the Basal Temperature method can be used for helping in family planning in healthy adults by understanding their menstrual cycle and ovulation and interpreting basal temperature changes. This Thermometer provides easy, quick and highly accurate readings over the body temperature range. The body temperature is measured by the thermistor (inside the probe tip) and displayed as numbers on the LCD (liquid crystal diplay) through microprocessor of IC.
The basic principle of this thermometer is that change of thermistor resistance, caused by changes of temperature, are converted to changes of frequency of R-C oscillator circuit. Therefore, temperature can be given by measuring the frequency of oscillator.
For a given time period by applying to R-C oscillator circuit, changes of temperature will correspond to changes of pulse number.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
healthy adults
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)
Controlled human clinical studies were conducted using the Microlife Digital Basal Thermometer MT1921 for measurement and accuracy.
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.
K#94527
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
N/A
0
K030961
Attachment #2b
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is:
1. Submitter's Identification:
Microlife Intellectual Property GmbH, Switzerland Max Schmidheiny-Strasse 201 9435 Heerbrugg / Switzerland
Date Summary Prepared: March 24, 2003
2. Name of the Device:
Microlife Digital Basal Thermometer
3. Predicate Device Information:
B-D Digital Basal Thermometer, Model 524560 K#94527
4. Device Description:
The Microlife Digital Basal Thermometer, which uses the Basal Temperature method can be used for helping in family planning in healthy adults by understanding their menstrual cycle and ovulation and interpreting basal temperature changes. This Thermometer provides easy, quick and highly accurate readings over the body temperature range. The body temperature is measured by the thermistor (inside the probe tip) and displayed as numbers on the LCD (liquid crystal diplay) through microprocessor of IC.
The basic principle of this thermometer is that change of thermistor resistance, caused by changes of temperature, are converted to changes of frequency of R-C oscillator circuit. Therefore, temperature can be given by measuring the frequency of oscillator.
For a given time period by applying to R-C oscillator circuit, changes of temperature will correspond to changes of pulse number.
1
5. Intended Use:
The Microlife Digital Basal Thermometer is a device intended for measuring, and aiding in the monitoring and tracking of basal body temperature (BBT) as an aid in ovulation prediction to aid in conception (not to be used for contraception).
6. Comparison to Predicate Devices:
The Microlife Digital Basal Thermometer, Model MT1921 is substantially equivalent to B-D Digital Basal Thermometer, Model 524560 K#94527 which have the same intended use and are similar in design to the predicate device.
The Microlife Digital Basal Thermometer MT1921 and the predicate device are identical in functionality and performance with the difference being the external shape of the devices, PCB layout of the devices, ergonomics of the user interface, dimensional specifications, probe tip connection to probe wire for temperature measuring and housing material used.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Compliance to applicable voluntary standards includes ASTM E1112, as well as IEC60601-1 and IEC60601-1-2 requirements.
Guidance documents included the "FDA Guidance on the Content of Premarket Notification 510(K) Submissions for Clinical Electronic Thermometers.
8. Discussion of Clinical Tests Performed:
Controlled human clinical studies were conducted using the Microlife Digital Basal Thermometer MT1921 for measurement and accuracy.
9. Conclusions:
The Microlife Digital Basal Thermometer has the same intended use and similar technological characteristics as the B-D Digital Basal thermometer Model 524560,.Moreover, bench testing contained in this submission supplied demonstrates that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus, the Microlife Digital Basal Thermometer is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows a logo with a stylized bird in flight, composed of three curved lines that suggest movement and feathers. The bird is encircled by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a circular arrangement. The logo is rendered in black and white, giving it a simple and clean appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 2003
Microlife Intellectual Property Ms. Susan D. Goldstein-Falk Official Correspondent mdi Consultants. Inc. 55 Northern Blvd. GREAT NECK NY 11021
Re: K030961
Trade/Device Name: Microlife Digital Basal Thermometer Model MT 1921 Regulation Number: None Regulatory Class: I Product Code: 85 LHD Dated: July 24, 2003 Received: July 25, 2003
Dear Ms. Goldstein-Falk:
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 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.
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.
3
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 one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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) you may obtain. 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
. Attachment #2a
Page -1 of 1
510(k) Number (if known): _ Ko3 09 b l
Device Name Microlife Digital Basal Thermometer MT 1921
Indications For Use:
The Microlife Digital Basal Thermometer is a device intended for measuring, and aiding in the monitoring and tracking of basal body temperature (BBT) as an aid in ovulation prediction to aid in conception (not to be used for contraception).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Over-The-Counter Use
(Division Sign-Off) Division of Reproductive and Radiological De 510(k) Number