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 Probe Cover is a disposable plastic cover made of a biocompatible clarified 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 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 text is a 510(k) summary for Probe Covers (YF-001, YF-002). The acceptance criteria for this device are based on its equivalence to a predicate device and compliance with established standards, primarily ASTM E1104-98 for Clinical Thermometer Probe Covers and Sheaths.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Standard	Required Performance	Reported Device Performance
Physical Properties	Conforms to ASTM E1104-98 (Reapproved 2016) Standard Specification for Clinical Thermometer Probe Covers and Sheaths	Conforms to ASTM Standard E1104. "The stability validation of the probe cover after accelerated aging condition meet the ASTM E1104 requirement for physical properties."
Material	Biocompatible Polypropylene	Polypropylene
Biocompatibility	ISO 10993-5 (Cytotoxicity)	Complies with ISO 10993-5:2009
	ISO 10993-10 (Skin Sensitization)	Complies with ISO10993-10:2021
	ISO 10993-23 (Irritation)	Complies with ISO10993-23:2021
Shelf Life	5 years (demonstrated through accelerated aging)	5 years. "An accelerated aging test was conducted per ASTM F1980."

Study Proving Acceptance Criteria:

A non-clinical study was conducted to verify that the subject devices met all design specifications and were substantially equivalent to the predicate device. The study involved testing against the mentioned standards.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample size for the test set used for the non-clinical tests. The tests were likely conducted on a representative sample of the manufactured probe covers.

Data Provenance: Not explicitly stated, however, the manufacturer is Shenzhen Yi Fang Blister Packaging Co., Ltd. in China, implying the testing was likely conducted in China or by organizations partnered with the manufacturer. The tests are non-clinical (laboratory-based).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The "ground truth" for the performance of this device (probe covers) is established through adherence to technical standards (e.g., ASTM E1104, ISO 10993 series) and direct physical/chemical testing, not through expert human assessment of diagnostic output.

4. Adjudication Method for the Test Set

Not applicable as the testing involves objective measurement against engineering and biocompatibility standards, not interpretive human assessment.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a passive medical device (probe cover), not an AI-assisted diagnostic tool or an imaging device that would typically involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device does not involve an algorithm. The testing is for the physical and biological characteristics of a disposable product.

7. Type of Ground Truth Used

The ground truth used for this type of device is compliance with established international and national standards (e.g., ASTM E1104 for physical properties, ISO 10993 for biocompatibility). This involves objective measurements and scientific testing against predefined criteria, rather than expert consensus, pathology, or outcomes data, which are more relevant for diagnostic or therapeutic devices.

8. Sample Size for the Training Set

Not applicable. This device is a physical product and does not involve AI or machine learning, which would require a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable as there is no training set for this device.

Summary

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March 1, 2024

Shenzhen Yi Fang Blister Packaging Co., Ltd. Xu Junwen Manager 4/F, Bldg BC, Weixinda Industrial Park, Longteng Community Xixiang, Bao'an District Shenzhen, 518126 China

Re: K240023

Trade/Device Name: Probe Covers (YF-001, YF-002) Regulation Number: 21 CFR 880.2910 Regulation Name: 880.2910 Regulatory Class: Class II Product Code: FLL Dated: January 3, 2024 Received: January 3, 2024

Dear Xu Junwen:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

David Walloschek

David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices,

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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) K240023

Device Name Probe Covers (YF-001, YF-002)

Indications for Use (Describe)

The probe cover is used as a sanitary barrier between the infra red 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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K240023 - 510(k) Summary

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:	Shenzhen Yi Fang Blister Packaging Co., Ltd.
Address:	4/F, Bldg BC, Weixinda Industrial Park, Longteng CommunityXixiang, Bao'an District, Shenzhen, 518126 China
Tel:	+86 - 13631618130
Fax:	+86- 755-23406821
Contact:	Junwen Xu

Designated Submission Correspondent

Contact:	Mr. Boyle Wang
Name:	Shanghai Truthful Information Technology Co., Ltd.
Address:	Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai,200120 China
Tel:	+86-21-50313932
Email:	Info@truthful.com.cn

Date of Preparation: March 1, 2024

2.0 Device Information

Trade name:	Probe Covers (YF-001, YF-002)
Common name:	Thermometer Probe Covers and Sheaths
Regulation name:	Clinical electronic thermometer
Model(s):	YF-001, YF-002

3.0 Classification

Product code:	FLL
Regulation number:	21CFR 880.2910
Classification:	Class II
Panel:	General Hospital

4.0 Predicate Device Information

Manufacturer: Kaz, USA Inc.

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Braun Thermoscan®V IRT 4000 Series/Pro 4000 Series Infra-Red Device: Ear Thermometers with Probe Cover 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 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 Device	Predicate DeviceK101747	Remark
Device Name	Probe Covers	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.	TheThermoscan®IRT 4000series and BraunThermoscan® PRO 4000series Clinical Infrared EarThermometers is indicatedfor the intermittentmeasurement and	Same*

7.0 Comparison to the Predicate Device

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		monitoring 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.
Compatiblethermometermodels	Braun Thermoscan®PRO3000 series/PRO4000series/PRO6000 series earthermometer	Braun Thermoscan® Pro4000 Series/IRT 4000Serie Thermometers	Same
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
Shelf Life	5 years	Not publicly available	Different

*The predicate's thermometer probe covers are accessories to the thermometer itself, and were included in its 510(k) clearance under K101747. Only probe covers are included in this current 510(k). The subject device's indications are compared 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.

The shelf life of the predicate device is not publicly available. An accelerated aging test was conducted per ASTM F1980. And the stability validation of the probe cover after accelerated aging condition meet the ASTM E1104

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requirement for physical properties, the desired shelf life can be guaranteed. So the subject device is as safe and as effective as the predicate.

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:

· 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
· ISO10993-10:2021 Biological evaluation of medical devices Part 10: Tests for skin sensitization
· ISO10993-23:2021 Biological evaluation of medical devices Part 23: Tests for irritation

9.0 _Summary of Clinical Testing

Clinical testing were not conducted for this submission.

Conclusion 10.0

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

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.