(79 days)
The device is an electronic clinical thermometer using an infrared thermopile sensor to detect body temperature of the radiation from the tympanic part of the human of all ages at home.
AVITA TS0/TS1 Infrared Ear Thermometer is a hand-held, non-sterile, reusable clinical thermometer intended for the determination of human temperature by radiation emitted via the human ear (Tympanic Temperature).
Here's the analysis of the provided text regarding the AVITA TS0/TS1 Infrared Ear Thermometer (referred to as HIVOX Cover-Free Ear Thermometer TS-510 in the FDA letter, though the 510(k) summary lists AVITA as the submitter and manufacturer, suggesting a potential rebranding or distribution relationship).
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary for the AVITA TS0/TS1 Infrared Ear Thermometer (K020471) is very sparse on specific performance data and acceptance criteria for temperature accuracy. It primarily states compliance with general standards.
| Acceptance Criteria Category | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Temperature Accuracy | N/A (Specific numerical accuracy criteria not stated explicitly) | "conforms to applicable standards included ASTM E1965-98" (implies meeting accuracy requirements of this standard) |
| Operating Specifications | "In terms of operating specification" | "the device conforms to applicable standards" |
| Safety | N/A (General safety criteria not stated explicitly) | "conforms to applicable standards included IEC 60601-1" |
| EMC Requirements | N/A (General EMC criteria not stated explicitly) | "conforms to applicable standards included IEC 60601-1-2 requirements" |
Study Proving Device Meets Acceptance Criteria:
The document states: "Moreover, bench technological characteristics do not raise and new questions of safety or effectiveness." This implies that bench testing was performed to demonstrate conformity. However, no detailed information about this bench study (e.g., specific protocols, results, sample sizes for the "test set" in this context) is provided in the summary. For a thermometer, "bench technological characteristics" would typically refer to tests for accuracy against a reference temperature source in a controlled environment. The primary evidence presented for substantial equivalence is conformity to recognized standards (ASTM E1965-98, IEC 60601-1, IEC 60601-1-2).
Missing Information (Not Available in the Provided Text):
The provided documents are a 510(k) summary and the FDA's clearance letter. These types of documents typically summarize the manufacturer's findings rather than providing exhaustive detail on the underlying studies. Therefore, many of the specific questions you asked are not answered by this limited information.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The manufacturer is based in Taiwan (AVITA International Corp).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is more relevant for diagnostic AI/imaging devices. For an infrared ear thermometer, the "ground truth" for temperature measurement would typically be established by a calibrated reference thermometer in a controlled laboratory setting, not by human experts. No information on human experts is provided, nor would it be expected for this type of device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically used when there are multiple human readers or interpretations of diagnostic data. For a thermometer's performance testing, measurement against a standard reference would be the method.
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
- Not applicable. This is not an AI-assisted diagnostic device, but a standalone measurement device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The device is an infrared ear thermometer, designed to provide a temperature reading directly. Its performance would be evaluated as a standalone device, with its readings compared to a known reference (ground truth). The document states "bench technological characteristics," which points to standalone testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For an infrared ear thermometer, the ground truth would be established by a calibrated reference thermometer in a controlled environment, likely using a black body or other stable heat source, as per the ASTM E1965-98 standard it claims to conform to.
8. The sample size for the training set
- Not applicable. Infrared ear thermometers are typically hardware devices with firmware, not machine learning algorithms that require "training sets" in the conventional sense. The "training" in this context would be the calibration process during manufacturing.
9. How the ground truth for the training set was established
- Not applicable for the reason stated in point 8.
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MAY 022002
KO20471
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the .equirements of SMDA and 21 CFR §807.92
| 1.0 | Submitter's Name: | AVITA International Corp |
|---|---|---|
| Address: | 9F, No. 78, Sec. 1, Kwang-Fu Rd., San-Chung, Taipei County, Taiwan, R.O.C. | |
| Phone: | 001-886-2-85121568 | |
| Fax: | 001-886-2-85121347 | |
| Contact: | Mr. Geo Lin, General Manager | |
| 2.0 | Device Name: | AVITA TS0/TS1 Infrared Ear Thermometer |
| Models TS-001,TS-002,TS-003 and TS-101,TS-102,TS-103 | ||
| 3.0 | Classification: | Class II |
| 4.0 | Predicate Device: | 1. Braun ThermoScan IRT 3020 One Seconds Ear Thermometer (K983295) |
| 2. K-Jump Health Co., Ltd.'s Infrared Ear Thermometer, | ||
| Model KI-8120 (K984551) | ||
| 5.0 | Device Description: | AVITA TS0/TS1 Infrared Ear Thermometer is a hand-held, non-sterile, |
| reusable clinical thermometer intended for the determination of human | ||
| temperature by radiation emitted via the human ear (Tympanic Temperature). | ||
| 6.0 | Intended Use: | The AVITA TS0/TS1 Infrared Ear Thermometer is intended for the |
| intermittent measurement and monitoring of human body temperature, through | ||
| the opening of auditory canal, by consumers in the home. | ||
| 7.0 | PerformanceSummary: | In terms of operating specification, Safety & EMC requirements, the deviceconforms to applicable standards included ASTM E1965-98, IEC 60601-1 andIEC 60601-1-2 requirements. |
8. Conclusions:
The AVITA TS0/TS1 Infrared Ear Thermometer have the same intended use and similar technological characteristics as the Braun ThermoScan IRT 3020 One Seconds Ear Thermometer (K983295) and
- Jump Health Co., Ltd.'s Infrared Ear Thermometer, Model KI-8120 (K984551). Moreover, bench ( > . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . technological characteristics do not raise and new questions of safety or effectiveness. Thus, the AVTA TS0/TS1 Infrared Ear Thermometer, Models TS-001,TS-002,TS-003 and 1S-101,TS-102,TS-102,TS-103 is substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 2 2002
Mr. Ke-Min Jen Official Correspondent Hivox Biotek, Incorporated 12 F, No. 156, Chien Kuo North Road Taipei. CHINA ( TAIWAN )
Re: K020471
Trade/Device Name: HIVOX Cover-Free Ear Thermometer TS-510 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer ( IR Ear ) Regulatory Class: II Product Code: FLL Dated: February 6, 2002 Received: February 12, 2002
Dear Mr. Jen:
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.
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Page 2 - Mr. Ke-Min Jen
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618 . 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). 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timo A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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- Duruse 10 : I bar
HIVOX BIOTEK II
12F, No. 156, Scc. 1 Chien Kuo N. Rd., Taipei 104, Taiwan, ROC FAX: 886-2-2516-6995 TEL: 886-2-2516-8488 E-MAIL: hivox@ms58.hinet.net
Page
510 (K) NUMBER ( IF KNOW ): _ K020471
DEVICE NAME: _________________________________________________________________________________________________________________________________________________________________ INDICATIONS FOR USE:
The device is an electronic clinical thermometer using an infrared thermopile sensor to detect body temperature of the radiation from the tympanic part of the human of all ages at home.
( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE 1
Concurrence of CDRH, office of Device Evaluation (ODE )
Prescription Use
OR
Over-The-Counter-Use √
( Per 21 CFR 801.109 )
( Optional Format 1-2-96 )
Laluna Cassevitz
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 4021 . Con Number _________________________________________________________________________________________________________________________________________________________________
J-
§ 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.