(84 days)
No
The device description explicitly states it is a "simple electronic thermometer which is a thermistor to measure temperature" and mentions the calculation method is the same as a predicate device from 1988. There is no mention of AI, ML, or any complex algorithms beyond basic temperature measurement.
No
The device is an electronic thermometer intended to measure body temperature, not to treat any medical condition.
No
Explanation: A diagnostic device is used to identify or determine the nature of a disease or condition. This device is an electronic thermometer, which measures body temperature, a physiological parameter, but does not by itself diagnose a disease or condition. While temperature measurement can be an input to a diagnostic process, the thermometer itself is a measurement device.
No
The device description explicitly states it is a "simple electronic thermometer which is a thermistor to measure temperature," indicating it is a hardware device with a physical component (thermistor) for measurement.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Omron electronic thermometer measures body temperature directly from the body (oral, axillary, rectal). It does not analyze specimens taken from the body.
Therefore, based on the provided information, this device falls under the category of a general medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Omron electronic thermometer Models MC-245, MC-341, MC-341, MC-343, and MC-344 are intended to measure the body temperature either oral, axillaries (under arm) and rectal and Model - MC-247 measure the body temperature oral (basal) and to be used by medical professionals in clinical and hospital environments and consumers in a home environment. It is intended for use on people of all ages.
Product codes
FLL
Device Description
These are simple electronic thermometer which is a thermistor to measure temperature. . All the functions, except posture symbol, are the same as the predicate device, MC-3B, K881446. Power source battery operated . Calculation method (system) is the same and identical to the predicate, K881449 The differences between the various models are: Some models have a flexible or rigid or rigid / flexible tip . Offered with a probe cover . Temperature scale offered in C° & F° or F° only . Readout time is different .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral, axillaries (under arm), rectal
Indicated Patient Age Range
all ages
Intended User / Care Setting
medical professionals in clinical and hospital environments and consumers in a home environment.
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
Premarket Notification 510(k) Section 5 - 510(k) Summary
Omron Thermometers
KC916676
| Omron Healthcare, Inc.
1200 Lakeside Dr.
Bannockburn, IL 60015 | Tel - 847-247-5678
Fax - 847-680-6269 | SEP - 1 2009 |
|----------------------------------------------------------------------|------------------------------------------------------------|--------------|
| Official Contact: | Ronald Dudek - Director of Quality | |
| Proprietary or Trade Name: | Models – MC-245, MC-246, MC-247, MC-341, MC-343,
MC-344 | |
| Common/Usual Name: | Clinical electronic thermometer | |
| Classification Name/Code: | FLL – clinical electronic thermometer
21 CFR 880.2910 | |
| Device: | Models – MC-245, MC-246, MC-247, MC-341, MC-343,
MC-344 | |
Device Description:
These are simple electronic thermometer which is a thermistor to measure temperature.
- . All the functions, except posture symbol, are the same as the predicate device, MC-3B, K881446.
- Power source battery operated .
- Calculation method (system) is the same and identical to the predicate, K881449 �
The differences between the various models are:
- Some models have a flexible or rigid or rigid / flexible tip .
- Offered with a probe cover .
- Temperature scale offered in C° & F° or F° only .
- Readout time is different .
Indications for Use:
The Omron electronic thermometer Models MC-245, MC-341, MC-341, MC-343, and MC-344 are intended to measure the body temperature either oral, axillaries (under arm) and rectal and Model - MC-247 measure the body temperature oral (basal) and to be used by medical professionals in clinical and hospital environments and consumers in a home environment. It is intended for use on people of all ages.
Environment of Use: Clinics, hospital and home environments
Contraindications: None
1
510(k) Summary Page 2 of 3 5-Jun-09
Summary of substantial equivalence .
| | MC-3B
K881446 | MC-245/246/247
MC-341/343/344 |
|-----------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|
| Measurement
Method | Human temperature is detected by
thermistor and calculated | Human temperature is detected by
thermistor and calculated |
| Display | Reading value is displayed on LCD
with 4 digits.(0.1 increments) | Reading value is displayed on LCD
with 4 digits.(0.1 increments) |
| Buzzer | Beeper sound at peak temperature | Beeper sound at peak temperature |
| Power Source | Battery(LR41 type) | Battery(LR41 type) |
| SPECIFICATION | MC-3B
K881446 | MC-245, MC-246, MC-247
MC-341, MC-343, MC-344 |
|---------------------------------------|----------------------------------------|-------------------------------------------------------------------------------------------------------|
| Display | LCD Digital Display | LCD Digital Display |
| Measurement
Range | 89.6 °F to 107.6 °F | 89.6 °F to 107.6 °F, 32.0 °C to 42.0 °C
These models switch the display unit (°F, °C) alternately. |
| Measurement area | Oral, rectum, under arm | Oral, rectum, under arm, except Model MC-247 is for oral (basal) only |
| Accuracy | ±0.2 °F | ±0.2 °F, ±0.1 °C |
| Display Resolution | 4 Digits
(0.1 °F increments) | 4 Digits
(0.1 °F / 0.1 °C increments) |
| Weight | Approx. 1/3 oz /(11g) | Approx. 1/3 oz / (11g) |
| Length | Approx. 130mm | Approx. 130mm |
| Battery | 1 each LR41 Alkali
1.5V D.C | 1 each LR41 Alkali 1.5V D.C |
| Battery Life | Approx. 300 hours.
(Continuous use) | Approx. 2 years (3 times measurements / day ) |
| Ambient
Temperature for
use | 50 °F to 104 °F
(10 °C to 40 °C) | 50 °F to 104 °F
(10 °C to 40 °C) |
| Ambient
Temperature for
use | (10 ° C to 40 ° C) | (10 ° C to 40 ° C) |
| Ambient
Temperature for
storage | 4 °F to 140 °F
(-20 °C to 60 °C) | 4 °F to 140 °F
(-20 °C to 60 °C) |
| Ambient
Temperature for
storage | (-20 ° C to 60 ° C) | (-20 ° C to 60 ° C) |
| Ambient Humidity
for use | 30 to 85%RH | 30 to 85%RH |
| Ambient Humidity
for storage | 30 to 95%RH | 10 to 95%RH |
.
2
510(k) Summary Page 3 of 3
5-Jun-09
Differences Between Other Legally Marketed Predicate Devices
The Omron thermometer models MC-245, MC-247, MC-341, MC-341, MC-343, and MC-344 are viewed as substantially equivalent to the predicate device because:
Indications -
- . Identical to predicate - K881446
Technology -
- . Identical algorithms and means of measuring temperature to predicate - K881446
Operating specifications -
- Identical to predicate K881446 .
Materials -
The materials have been tested in accordance to ISO 10993.
Environment of Use -
- Identical to predicate K881446 �
Patient Population -
- Identical to predicate K881446 .
3
Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of four abstract shapes that resemble a stylized human figure or a flame-like design. The logo is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Omron Healthcare, Incorporated C/O Mr. Paul Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134
Re: K091676
Trade/Device Name: Omron Thermometer Models MC-245, MC-246, MC-247,
MC-341, MD-343, MC-344 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: July 25, 2009 Received: July 29, 2009
Dear Mr. Dryden:
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.
4
Page 2- Mr. Dryden
Enclosure
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH /CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Anthony L., Amato Jr.
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use Statement
Page 1 of 1
510(k) Number:
- 0 91676 (To be assigned)
Device Name:
Omron Thermometers Models MC-245, MC-246, MC-247, MC-341, MC-343, MC-344
Indications for Use:
The Omron electronic thermometer Models MC-245, MC-341, MC-341, MC-343, and MC-344 are intended to measure the body temperature either oral, axillaries (under arm) and rectal and Model - MC-247 measure the body temperature oral (basal) and to be used by medical professionals in clinical and hospital environments and consumers in a home environment. It is intended for use on people of all ages.
| Prescription Use | or | Over-the-counter use XX |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Y. Schacter
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091676