The probe cover is used as a sanitary barrier between the infra red thermometer and the ear canal. The probe cover is provided non-sterile and for single use only.

Device Description

The Disposable Ear Thermometer Probe Cover is a disposable plastic cover made of a biocompatible polypropylene material that is dimensionally manufactured to set tolerances so that it can be fitted on the probe tip of the thermometer. The probe cover is used as a sanitary barrier between the infra red thermometer and the ear canal to prevent any ear secretions or particulates from being transferred between different people. The subject device is used as barriers between Braun Thermoscan® PRO3000 series/PRO4000 series/PRO6000 series ear thermometer, and also compatible with Braun Thermoscan® IRT1020/IRT2020/IRT2520/IRT3020/ IRT3520/IRT4020/IRT4520/IRT6020/IRT6520 ear thermometer and users' auditory canal measuring sites to avoid possible contamination and infection during temperature measuring. The probe covers are transparent, colorless and odorless, non-sterile and intended for single use only.

AI/ML Overview

The provided document relates to a 510(k) premarket notification for a Disposable Ear Thermometer Probe Cover. It details the device's characteristics, its intended use, and a comparison to a predicate device. The core of the submission focuses on proving "substantial equivalence" to a previously cleared device.

However, the document does not contain the kind of information requested in the prompt, which is typical for the evaluation of AI/ML-driven medical devices that require robust performance studies to establish accuracy, sensitivity, specificity, or improvement in human reader performance.

Here's why the prompt's questions cannot be answered based on the provided text, followed by an explanation of what the document does provide:

No AI/ML Component: The "Disposable Ear Thermometer Probe Cover" is a passive, mechanical device (a plastic cover). It does not involve any algorithm, artificial intelligence, machine learning, image analysis, or diagnostic capabilities that would necessitate the types of criteria and studies outlined in the prompt (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts, training set sample sizes).
Substantial Equivalence, Not Performance Metrics: The FDA's 510(k) process for this type of device (Class II, general hospital, FLL product code) primarily relies on demonstrating "substantial equivalence" to a legally marketed predicate device. This is done by showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise different questions of safety or effectiveness. This is fundamentally different from proving the diagnostic performance of an AI model.

Based on the provided document, here's what can be extracted, and where the requested information is absent:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance / Evaluation Method (from document)
Material Biocompatibility	ISO 10993-5:2009 (Tests for in vitro cytotoxicity)	Non-clinical tests demonstrated compliance.
	ISO 10993-10:2010 (Tests for irritation and skin sensitization)	Non-clinical tests demonstrated compliance.
Physical Design/Performance	ASTM E1104-98 (Reapproved 2016) Standard Specification for Clinical Thermometer Probe Covers and Sheaths (Dimension, fit, sanitary barrier function)	Non-clinical tests demonstrated compliance that "met all design specifications" and were "Substantially Equivalent to the predicate".
Intended Use Equivalence	Used as a sanitary barrier between infrared thermometer and ear canal; non-sterile, single use.	Same as predicate device's probe cover component.
Technological Characteristics Equivalence	Made of biocompatible polypropylene; transparent, colorless, odorless.	Same as predicate in terms of material, design, OTC/non-sterile status. Minor differences did not raise new safety/effectiveness questions.

2. Sample sizes used for the test set and the data provenance

Not Applicable / Not Mentioned: This device did not undergo a "test set" evaluation in the sense of an algorithm performance study. The evaluation was primarily through non-clinical bench testing to confirm compliance with standards and physical properties. No human patient data (retrospective or prospective) was used for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable: There was no "ground truth" to establish for a probe cover's performance in a diagnostic sense. Compliance with standards was assessed through laboratory testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable: No test set requiring expert adjudication was conducted.

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: No MRMC study was conducted as the device is not an AI/ML diagnostic tool and does not involve human readers interpreting data or images.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable: The device is a physical, passive accessory. There is no algorithm or standalone performance to evaluate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable: The "ground truth" equivalent for this device is compliance with engineering and material standards (e.g., ASTM E1104, ISO 10993).

8. The sample size for the training set

Not Applicable: There is no "training set" for this type of device.

9. How the ground truth for the training set was established

Not Applicable: As there is no training set, there's no ground truth establishment process to describe.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

July 28, 2021

Huaian Zhongxin Packing Material Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM. 608, No. 738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China

Re: K203431

Trade/Device Name: Disposable Ear Thermometer Probe Cover Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: July 1, 2021 Received: July 9, 2021

Dear Boyle Wang:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

CAPT Alan M. Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203431

Device Name Disposable Ear Thermometer Probe Cover

Indications for Use (Describe)

The probe cover is used as a sanitary barrier between the infra red thermometer and the ear canal. The probe cover is provided non-sterile and for single use only.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary (K203431)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.

1.0 Submitter's Information

Name: Huaian Zhongxin Packing Material Co.,Ltd. Address: No.128-5,West Meigao Road,Qingpu Industrial Park, Huaian, Jiangsu Province,223022 China Tel: +86 -15751384913 Fax: +86- 517-83852820 Contact: Fenq Zuo Date of Preparation: July.24,2021

Designated Submission Correspondent

Mr. Boyle Wanq Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn

2.0 Device Information

Trade name: Disposable Ear Thermometer Probe Cover Common name: Thermometer Probe Covers and Sheaths Classification name: Clinical electronic thermometer Model(s): 4#.6#

3.0 Classification

Production code: FLL Requlation number: 21CFR 880.2910 Classification: Class II Panel: General Hospital

4.0 Predicate Device Information

Manufacturer: Kaz, USA Inc. Device: Braun Thermoscan® Pro 4000 Series/IRT 4000 Series

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Thermometers 510(k) number: K101747

5.0 Device Description

The subject device is used as barriers between Braun Thermoscan® PRO3000 series/PRO4000 series/PRO6000 series ear thermometer, and also compatible with Braun Thermoscan® IRT1020/IRT2020/IRT2520/IRT3020/ IRT3520/IRT4020/IRT4520/IRT6020/IRT6520 ear thermometer and users' auditory canal measuring sites to avoid possible contamination and infection during temperature measuring.

The probe covers are transparent, colorless and odorless, non-sterile and intended for single use only.

6.0 Indication for Use Statement

The probe cover is used as a sanitary barrier between the infra red thermometer and the ear canal. The probe cover is provided non-sterile and for single use only.

Item	Subject DeviceK203431	Predicate DeviceK101747	Remark
Type ofThermometer	Disposable Ear ThermometerProbe Cover	Probe Cover	--
Product Code	FLL	FLL	Same
Regulation No.	21 CFR 880.2910	21 CFR 880.2910	Same
Class	II	II	Same
Indications foruse	The probe cover is used as asanitary barrier between theinfra red thermometer and theear canal. The probe cover isprovided non-sterile and forsingle use only.	The BraunThermoscan®IRT 4000series and BraunThermoscan® PRO 4000series Clinical Infrared EarThermometers is indicated	Same*

7.0 Comparison to the Predicate Device

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		for the intermittentmeasurement andmonitoring of human bodytemperature by consumersof all ages in a homeuse/professional useenvironment.The probe cover is used asa sanitary barrier betweenthe infra red thermometerand the ear canal.
Prescription/over-the-counteruse	Over-the-counter use	Over-the-counter use	Same
Design Features	Conforms to ASTM StandardE1104	Conforms to ASTMStandard E1104	Same
DesignConfigurations	One size	One size	Same
PerformanceSpecifications	Conforms to ASTM StandardE1104	Conforms to ASTMStandard E1104	Same
Prescription vs.OTC	OTC	OTC	Same
Sterile vs.Non-Sterile	Non-sterile	Non-sterile	Same
Patient contactmaterials	Polypropylene	Polypropylene	Same
Biocompatibility	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10	Same

*The predicate's thermometer probe covers are accessories to the thermometer itself, and were included in its 510(k) clearance under K101747.Only the probe covers are included in this current 510(k),as there is no thermometer or any accessory marked with the current subject device. The subject device's indications are only applicable to the probe covers. The proposed device's Indications for Use are, therefore, more narrow than the Indications for Use stated in K101747, which applied to both the thermometer and the probe covers, as the subject device's indications are only applicable to the probe covers.

8.0 Summary of Non-Clinical Testing

Non clinical tests were conducted to verify that the subject devices met all design specifications as were Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

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● ASTM E1104-98 (Reapproved 2016) Standard Specification for Clinical Thermometer Probe Covers and Sheaths.

● ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity

● ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests

for irritation and skin sensitization

9.0 Summary of Clinical Testing

Clinical testing was not required for this submission.

10.0 Conclusion

Performance testing contained in this submission demonstrates the minor differences in technological characteristics between the subject device and the predicate do not raise different questions of safety and effectiveness. Based on the performance testing and compliance with acceptable voluntary standards, the subject device is substantially equivalent to its predicate device in K101747.

Regulation Number and Section

§ 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.