The Disposable Thermometer Covers and Sheaths are intended for use as barriers between digital or mercury thermometers and users' rectum or oral cavities to avoid the possible contamination and infection during temperature measuring. These covers and sheaths are non-sterile and intended for single use only.

Device Description

The Disposable Thermometer Covers and Sheaths, made of PE and EVA, are used for either oral or rectal measurements for digital or mercury thermometers. The products and packaging are non-sterile and are not made with natural rubber latex. The size may vary to accommodate differences in digital and mercury thermometers. The inner packing material is paper, while the outer packing material is carton. Each outer packing contains 100 pieces of covers and sheaths.

AI/ML Overview

The provided text describes a medical device called "Disposable Thermometer Covers and Sheaths" and its 510(k) submission for market clearance. It does not contain information about a study proving the device meets acceptance criteria in the way typically associated with AI/ML-driven devices (e.g., performance metrics like sensitivity, specificity, or AUC against a ground truth dataset). Instead, the "acceptance criteria" and "study" refer to adherence to established standards and bench testing for device safety and effectiveness.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Standard	Reported Device Performance (Compliance)
Biocompatibility:
ISO 10993-5: 1999: Tests for cytotoxicity: In vitro methods	Device tested and found to meet standards.
ISO 10993-10: 2002: Tests for Irritation and Sensitization	Device tested and found to meet standards.
Physical Performance:
ASTM E1104-98(2003): Standard Specification for Clinical Thermometer Probe Covers and Sheaths	Device tested and found to meet standards.
Material Composition (Chemical Content):
IEC 62321 Ed. 1: Electrotechnical products - Determination of levels of six regulated substances (lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, polybrominated diphenyl ethers)	Device tested and found to meet standards.
EPA Method 3546 Microwave extraction	Device tested and found to meet standards.

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

Test Set Sample Size: Not explicitly stated. The document refers to "bench testing" and "safety testing" against standards, which implies samples of the device were tested, but the specific number of units or tests is not provided.
Data Provenance: The testing was conducted by KANG ZE INDUSTRIAL CO., LTD. or laboratories they commissioned. The raw data and specific locations are not detailed, but it's related to the manufacturing of the device in China. This is not a "clinical data provenance" in the sense of patient data. It's more about laboratory testing of the product itself.

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

This section is Not Applicable to this submission. The "ground truth" for this type of device (thermometer covers) is established by adherence to recognized international and national standards for material safety (biocompatibility, chemical content) and physical performance (e.g., maintaining barrier integrity). Expert consensus for diagnosing a medical condition is not relevant here.

4. Adjudication method for the test set

This section is Not Applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert interpretations of clinical data. This device's evaluation relies on objective laboratory tests against pre-defined thresholds within the specified standards.

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 section is Not Applicable. This is not an AI/ML-driven device. It's a physical medical device (thermometer covers). Therefore, no MRMC study or AI assistance evaluation was performed.

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

This section is Not Applicable. This is not an algorithm or AI device.

7. The type of ground truth used

The "ground truth" for this device's acceptance is based on validated industry standards and test methodologies for:

Biocompatibility: Absence of cytotoxicity, irritation, and sensitization as per ISO 10993.
Physical Performance: Compliance with ASTM E1104 for thermometer probe covers and sheaths.
Chemical Composition: Levels of regulated substances meeting thresholds defined by IEC 62321 and EPA Method 3546.

8. The sample size for the training set

This section is Not Applicable. This device does not involve a "training set" as it's not an AI/ML model.

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

This section is Not Applicable. No training set was used.

Summary

{0}------------------------------------------------

KANG ZE INDUSTRIAL CO., LTD.

No. 9 Venture Industry Park, Jane Sandbar, Wanjiang Area, Dongguan, Guangdong, China 523063

. Section 5

510(k) Summary

[As required by 21 CFR 807.92]

1. Submission Information:
510(k) Number:	K112289
Date:	Aug 5th, 2011
Type of 510(k) Submission:	Traditional
Basis for 510(k) Submission:	New device
Submitter/Manufacturer:	KANG ZE INDUSTRIAL CO., LTD.
	Office Add.: Room 1701, Henan Building, No. 90 Jaffe Road, Wan Chai, HK
	Factory Add.: No. 9 Venture Industry Park, Jane Sandbar, Wanjiang Area, Dongguan,
	Guangdong, China 523063
Contactor:	Doris Dong
	[Consultant, from Shanghai CV Technology Co., Ltd.]
	Add.: Room 1706 Yuesha, No. 128 Songle Rd., Songjiang, Shanghai, China 201600
	E-mail: doris_d@126.com
	Tel: 86 21-31261348
	Fax: 86 21-37824346

2. Device Description:
Proprietary Name:	Disposable Thermometer Covers and Sheaths
Common Name:	Disposable Thermometer Covers and Sheaths
Classification Name:	Clinical electronic thermometer / Clinical mercury thermometer
Regulation Number:	880.2910 / 880.2920
Product Code:	FLL / FLK
Device Class:	Class II
Submission Type:	510(k)
Review Panel:	General Hospital
Indications for use:	The Disposable Thermometer Covers and Sheaths are intended for use as
	barriers between digital or mercury thermometers and users' rectum or oral
	cavities to avoid the possible contamination and infection during temperature
	measuring. These covers and sheaths are non-sterile and intended for single use
	only.
Device Description:	The Disposable Thermometer Covers and Sheaths, made of PE and EVA, are
	used for either oral or rectal measurements for digital or mercury thermometers.
	The products and packaging are non-sterile and are not made with natural rubber
	latex.
	The size may vary to accommodate differences in digital and mercury
	thermometers.
	The inner packing material is paper, while the outer packing material is carton.
	Each outer packing contains 100 pieces of covers and sheaths.

3. Substantial Equivalence:

Detailed comparison data is included in "Section 9 - Substantial Equivalence Discussion" of this 510(k)

{1}------------------------------------------------

KANG ZE INDUSTRIAL CO., LTD.

KANG ZE INDUSTNTAL CO., LTD.
No. 9 Venture Industry Park, Jane Sandbar, Wanjiang Area, Dongguan, Guangdong, China 523063 submission

Predicate 510(k) Numbers:	K983406	K061007
Marketing clearance date:	October 19th, 1998	June 14th, 2006
Product name:	SaniTherm Thermometer Sheaths, Oral and Rectal, Digital and Mercury	GOOD MEDY Disposable Thermometer Sheaths
Manufacturer:	Banta Healthcare Products	GOOD MEDY ENTERPRISES LTD
Differences:	The material and packing specification differ from the Predicate Devices of K983406 and K061007.
Similarities:	Same intended use, non-sterile, and similar testing standards.
Equivalence conclusion:	The new devices, Disposable Thermometer Covers and Sheaths, are substantially equivalent to the predicate devices: SaniTherm Thermometer Sheaths (K983406) and GOOD MEDY Disposable Thermometer Sheaths (K061007). The devices have same intended use, are non-sterile and latex-free, and passed biocompatibility tests by ISO 10993. Thus the new devices are substantially equivalent to the predicate devices.

4. Safety and Effectiveness of the device:

The Disposable Thermometer Covers and Sheaths were tested and found to meet the standards of

ISO 10993-5: 1999: Tests for cytotoxicity: In vitro methods,

ISO 10993-10: 2002: Tests for Irritation and Sensitization,

ASTM E1104-98(2003): Standard Specification for Clinical Thermometer Probe Covers and Sheaths, IEC 62321 Ed. 1: Electrotechnical products - Determination of levels of six regulated substances (lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, polybrominated diphenyl ethers), as well as EPA Method 3546 Microwave extraction.

The conclusion drawn from the bench testing and safety testing is that the device is as safe and effective as the predicate device. Furthermore, the device complies with the recognized standards and performs its intended tasks as well as or better than the legally marketed predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

DEC 1 6 2011

Kang ZE Industrial Company, Limited C/O Ms. Doris Dong Manager Shanghai CV Technology Company Limited RM 1706 Yuesha Building No 128 Songle Road Songjiang Area. Shanghai

Re: K112289

Trade/Device Name: Disposable Thermometer Covers and Sheaths Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electric Thermometer Regulatory Class: II Product Code: FLL、FLK Dated: November 18, 2011 Received: November 23, 2011

Dear Ms. Dong:

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.

{3}------------------------------------------------

Page 2- Ms. Dong

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 (OS) 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 /yom 1 1 5809.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,

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

{4}------------------------------------------------

Section 4 Indications for Use Statement

510(k) Number (if known); K 112289

Device Name:

Disposable Thermometer Covers and Sheaths

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Weihny Crn for Richard Chapman
Division Sign Off

Division Sign-Off Division of Surgical, Orthopedic, And Restorative Devices

510(k) Number 112289

Page I of l

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.