YLS-01 is intended for use as a barrier that is used as an accessory to oral or rectal for digital thermometers. This sheath is non-sterile and is intended for single patient use only.

Device Description

The Yu Long Sheng Disposable Thermometer Sheath(model YLS-01) is a plastic covering used for oral/rectal digital thermometer. This device is not made with natural rubber latex

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Yu Long Sheng Disposable Thermometer Sheath (Model YLS-01). This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the manner one might expect for a diagnostic or therapeutic AI medical device.

Therefore, many of the requested sections below, particularly those related to AI-specific study designs, reader studies, and ground truth establishment, cannot be directly addressed from the provided text. The device in question is a simple medical accessory, not an AI-powered system.

However, I can extract the acceptance criteria (performance tests) and the reported performance as described for this type of device, as well as information about the testing conducted.

Acceptance Criteria and Reported Device Performance

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

For the Yu Long Sheng Disposable Thermometer Sheath (Model YLS-01), the "acceptance criteria" are implied by the standards and tests performed to demonstrate safety and performance for this type of accessory. The reported performance is that the device has undergone these tests.

Acceptance Criteria (Test Standard)	Reported Device Performance
Material Safety Test	Conducted by SGS (results not detailed, but implied to be acceptable for 510(k) clearance)
Biocompatibility (ISO 10993-5)	Conducted by SUPERLAB (implied to be acceptable)
Biocompatibility (ISO 10993-10)	Conducted by SUPERLAB (implied to be acceptable)
Product Characteristics (ASTM E1104:03 / F1104-98(2003))	Conducted by Wincent Consultant (implied to be acceptable)

Note: For medical accessories like a thermometer sheath, "performance" typically refers to meeting material safety, biocompatibility, and physical characteristic standards, ensuring it functions as intended without harming the patient or altering thermometer accuracy. The document states these tests were conducted, implying successful completion.

Study Details (Limitations apply as this is not an AI study)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The provided document does not specify sample sizes for the material safety, biocompatibility, or product characteristics tests. These tests are typically conducted on a limited number of device samples according to the respective standard's requirements for characterization.

Sample Size: Not specified.
Data Provenance: The tests were conducted by SGS and SUPERLAB (for biocompatibility) and Wincent Consultant (for performance test, likely in Taiwan or China given the submitter's location). This would be considered prospective testing of manufactured samples.

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 is not applicable. The device is a thermometer sheath, not an AI diagnostic tool. Ground truth in this context refers to the chemical, biological, and physical properties of the material and device determined through standardized laboratory tests, not expert interpretation of medical images or data.

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

This is not applicable. The tests mentioned (material safety, biocompatibility, product characteristics) are objective laboratory assessments based on established quantitative and qualitative methods defined by international standards (ISO, ASTM). They do not involve expert adjudication in the clinical sense.

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

This is not applicable. The device is a disposable thermometer sheath, not an AI or imaging device requiring MRMC studies.

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

This is not applicable. The device is a physical medical accessory, not an algorithm or AI system.

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

The "ground truth" for this device's evaluation is based on objective measurements and assessments against established international standards for material safety, biocompatibility (cytotoxicity, irritation, sensitization), and physical characteristics. This includes:

Chemical analysis: To ensure material components are safe.
Biological assays: For biocompatibility (e.g., cell cultures for cytotoxicity, animal models for irritation/sensitization as per ISO 10993 standards).
Physical measurements: To confirm product dimensions and integrity as per ASTM E1104.

8. The sample size for the training set

This is not applicable. The device is a physical product, not an AI algorithm requiring a training set.

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

This is not applicable, as there is no training set for a physical device like a thermometer sheath.

Summary

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Yuläng 玉隆塑膠廠

Tel: 0755-899366

K102508

" 510(K) SUMMARY "

JAN 1 0 2011

Submitter's Name: YU LONG SHENG TECHNOLOGY CO., LTD. 1.

No. 76, Mingqiang Road, Pingshan Shabo Community, Pingshan District, Shen Zhen City, Guangdong Province, China.

Contact person: Pearl Chen Contact Information: Fax No: +86-0755-8993-6600; E-mail: vulong89@126.com

1. Date summary prepared: November 10, 2010

3. Device Name:

Classification name: Thermometer, Electronic, Clinical .
Classification number: { FLV, Class II .
880.2910 Regulation Name: .
. Proprietary name: Yu Long Sheng Disposable Thermometer Sheath
� Common Name: Disposable Thermometer Sheaths
. Model: YLS-01 for digital thermometer
Predicate Device: GOOD MEDY Disposable Thermometer Sheaths, K061007 ●

4. Indications for Use:

YLS-01 disposable thermometer sheath is intended for use as a barrier that is used as an accessory to oral or rectal for digital thermometers. This thermometer sheath is non-sterile and is intended for single patient use only.

1. Description of the device:
  The Yu Long Sheng Disposable Thermometer Sheath(model YLS-01) is a plastic covering used for oral/rectal digital thermometer. This device is not made with natural rubber latex
Summary of the non-clinical testing data included in the submission : 6.
- i. Material safety test conducted by SGS.
- 1SO10993-5 and ISO10993-10 biocompatibility test conducted by SUPERLAB. ii.
- ASTM E1104:03 product characteristics test conducted by Wincent Consultant. iii.

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Yulöng
玉隆玉隆塑料有限公司

Tel: 0755-89936600: Fox: 0755_00 E-mail:vulin89@126.com

Legally marketed device for substantial equivalence comparison: 7. GOOD MEDY Disposable Thermometer Sheaths, K061007.

8. Comparison information

As the following comparison table.

Comparison feature	Model
	Yu Long Sheng YLS-01	Good Medy (K061007)
Device Name	Yu Long Sheng DisposableThermometer Sheaths	Good Medy DisposableThermometer Sheaths
Indication for use	Use as a barriers that is usedas an accessory to oral orrectal for digital thermometer	Use as a barriers that is usedas an accessory to oral orrectal for digital thermometer
Construction	EVA film with upper andLower exterior protectionpaper.	EVA film with upper andLower exterior protectionpaper.
Use type	For single use	For single use
Size of single piece	94 x 26 mm	124 x 34 mm
Package	50 pcs in one packaging unit	1000 pcs in one packaging unit
Sterile package	Non-sterile package	Non-sterile package
Test Data	1. Material safety test.2. Biocompatibility testaccording to ISO10993-5& ISO10993-10.3. Performance testaccording to ASTMF1104-98(2003)	1. Material Safety test.2. Biocompatibility testaccording to ISO 10993-5& ISO10993-10.

9. Summary for substantial equivalence comparison:

The new devices, Yu Long Sheng Disposable Thermometer Sheath, model YLS-01 for digital thermometer is substantially equivalent to the predicate devices: GOOD MEDY Disposable Thermometer Sheaths, K061007. The intended use of the two devices is the same, and the overall dimensions are similar. The two devices also had passed the biocompatibility test by ISO10993, same non-sterile and not made with natural rubber latex. Thus the new devices are substantially equivalent to the devices.

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Image /page/2/Picture/0 description: The image shows a partial view of a logo or emblem. On the left, a portion of the text "DEPARTMENT OF HEALTH" is visible, arranged vertically along the edge. To the right of the text is a stylized graphic consisting of three curved lines stacked on top of each other, resembling a simplified human figure or abstract design. The overall impression is that of an official seal or emblem, likely associated with a health-related organization or government department.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Yu Long Sheng Technology Company, Limited C/O Mr. Tony C. Chang Wincent Consultant Company, Limited No. 15, Alley 71, Chenping 156 Beitun District Taichung China (Taiwan) 406

JAN 10 2011

Re: K102508

Trade/Device Name: Yu Long Shen Disposable Thermometer Sheath/Model YLS-01 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: December 17, 2010 Received: December 20, 2010

Dear Mr. Chang:

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. 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.

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Page 2- Mr. Chang

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Jamsd Kusoztus
for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Tel: 0755-899366

Indications For Use

JAN 1 0 2011

510(k) Number (if known): K102508

Device Name: Yu Long Sheng Disposable Thermometer Sheath / Model YLS-01

Indications For Use:

YLS-01 is intended for use as a barrier that is used as an accessory to oral or rectal for digital thermometers. This sheath is non-sterile and is intended for single patient use only.

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use V (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)

Page 1 of

ACDNG for
RICHARD CHAPMAN
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

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.