(337 days)
The B-D Assure Ear Thermometer is designed for home use to measure body temperature from the tympanic membrane.
The B-D Assure Ear Thermometer is designed for measuring body temperature in a home setting.
The Becton Dickinson Infrared Thermometer is a device that measures patient body temperature by quantifying the infrared emission from the tympanic membrane.
In clinical application the end of the infrared thermometer is placed in the outer portion of the auditory canal, where the sensor can get a good view of the tympanic membrane. Placing the probe is very similar to the maneuver used to visualize the ear drum using an otoscope. There is no risk of eardrum injury because the probe is not long enough or small enough to be inserted too deep into the ear canal.
The most advantageous feature of infrared tympanic thermometry is that it takes very little time. Readings can be taken in a few seconds.
This looks like a 510(k) submission, not a study report. 510(k) submissions demonstrate substantial equivalence to a predicate device rather than explicitly defining and meeting acceptance criteria through a standalone study.
Therefore, many of the requested fields cannot be directly extracted as they would be for a typical clinical or performance study report. The document primarily focuses on demonstrating that the B-D Assure Ear Thermometer has the "same technological characteristics" and functions "in an equivalent manner" to the predicate device, the Thermoscan® Instant Thermometer.
Here's an attempt to answer the questions based on the provided text, flagging where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalence to predicate device (Thermoscan® Instant Thermometer) in functionality and safety. | "The B-D Assure Ear Thermometer has been bench tested and has proven to function in a equivalent manner as the predicate device." "Based on the results of the bench testing the B-D Assure Ear Thermometer is considered safe and effective when used as intended." |
| Technological characteristics: measure patient body temperature by quantifying infrared emission from the tympanic membrane. | "The B-D Assure Ear Thermometer and the predicate device (the Thermoscan® Instant Thermometer) have the same technological characteristics." |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. The document only mentions "bench testing."
- Data provenance: Not specified. The nature of "bench testing" suggests it was likely internal testing by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. "Bench testing" typically refers to laboratory or engineering tests, not human expert assessment for ground truth.
4. Adjudication method for the test set
- Not applicable/Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a medical device (thermometer), not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The "bench testing" mentioned can be considered a standalone performance evaluation of the device itself. The device is not an algorithm, but a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated, but for bench testing of a thermometer, the "ground truth" would likely be a highly accurate reference thermometer or calibrated temperature source.
8. The sample size for the training set
- Not applicable. This is a traditional medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
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1 1998 MAY
SUMMARY OF SAFETY AND EFFECTIVENESS
-
1.0 Submitted By:
Peter Zurlo Manager, Regulatory Affairs BECTON DICKINSON CONSUMER PRODUCTS 1 Becton Drive Franklin Lakes, New Jersey 07417-1883 Phone: 201-847-6447 Fax: 201-848-0457 -
2.0 Device Name:
B-D Assure Ear Thermometer -
3.0 Predicate Device
Thermoscan® Instant Thermometer
4.0 Device Description:
The Becton Dickinson Infrared Thermometer is a device that measures patient body temperature by quantifying the infrared emission from the tympanic membrane.
The tympanic membrane has long been known to be an excellent spot to check body temperature because it shares the blood supply that reaches the hypothalamus, the center of core body temperature regulation.
In clinical application the end of the infrared thermometer is placed in the outer portion of the auditory canal, where the sensor can get a good view of the tympanic membrane. Placing the probe is very similar to the maneuver used to visualize the ear drum using an otoscope. There is no risk of eardrum injury because the probe is not long enough or small enough to be inserted too deep into the ear canal.
The most advantageous feature of infrared tympanic thermometry is that it takes very little time. Readings can be taken in a few seconds.
-
5.0 Intended Use:
The B-D Assure Ear Thermometer is designed for home use to measure body temperature from the tympanic membrane. -
6.0 Technological Characteristics:
The B-D Assure Ear Thermometer and the predicate device (the Thermoscan® Instant Thermometer) have the same technological characteristics.
See Item 4 above for a description.
7.0 Performance Summary:
The B-D Assure Ear Thermometer has been bench tested and has proven to function in a equivalent manner as the predicate device. Based on the results of the bench testing the B-D Assure Ear Thermometer is considered safe and effective when used as intended.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 1998 MAY
Mr. Peter Zurlo ·Manager, Regulatory Affairs BECTON DICKINSON CONSUMER PRODUCTS 1 Becton Drive Franklin Lakes, New Jersey 17417-1883
Re : K971994 B-D Assure Ear Thermometer Trade Name: Requlatory Class: II Product Code: FLL Dated: January 30, 1998 February 2, 1998 Received:
Dear Mr. Zurlo:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially-equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. În addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Zurlo
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA described in your sia in privalence of your device to a legally marketed predicate device results in a classification for your marketed produce amits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (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 one regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of of loa
K971994 510(k) Number (if known): ___
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Device Name: B-D Assure Ear Thermometer の 2007年の1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年に1000
Indications for Use:
The B-D Assure Ear Thermometer is designed for measuring body temperature in a home setting.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patuxent Crescent
Division Sign-Off) Vision of Dental, Infection Control, Ind General Hospital Devices
510(k) Number K971994
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use X
(Optional Format 1-2-96)
§ 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.