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

Device Description

The Disposable Thermometer Probe Sheaths are used for oral measurements for digital thermometers. The products and packaging are non-sterile, not made with natural rubber latex, and intended for single patient use only.

The proposed device is a shell-like device, made of PE/EVA, use to cover the oral thermometer as barrier for avoiding possible contamination and infection during measurement of temperature. The device is covered by the paper (Medical Kraft Paper) at the top and bottom which to avoid unnecessary touch with the device before usage and will be removed from the device before use. The outer most packing material is carton box. Each outer packing contains 100 pieces of the device.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the {0} device, based on the provided text:

Device Name: Disposable Thermometer Probe Sheath

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Performance Requirement	Reported Device Performance
Material/Design
Basic Design	3 layer design (Bottom Side Paper + PE/EVA film + Top Side Paper); Removing paper before use;	3 layer design (Bottom Side Paper + PE/EVA film + Top Side Paper); Removing paper before use;
Device Materials Composition	PE/EVA	PE/EVA
Thickness	23.5 um	23.5 um
Density	0.87-0.88g/cm3	0.87-0.88g/cm3
Color	None	None
Sterile	No	No
Functional Performance
Strength (ASTM 1104)	Air Pressure of 8.4 kPa (1.2 psi) for 5 seconds	Meets the requirements of ASTM 1104
Accuracy (ASTM E1104/E1112)	±0.3℃, Less than 38 ℃; ±0.2℃,35.8℃ to less than 37 ℃; ±0.1℃, 37.0 ℃ to 39.0 ℃; ±0.2℃, greater than 39.0 ℃ to 41.0 ℃;	Meets the requirements of ASTM E1104/E1112 (specific values not explicitly re-stated but implied as met)
Biocompatibility
Cytotoxicity (ISO 10993-5)	Meets standard requirements	Complies with ISO 10993-5
Irritation/Sensitization (ISO 10993-10)	Meets standard requirements	Complies with ISO 10993-10

(Note: The "Available Dimension" and "Outsider Dimension" are listed as comparative information but not explicitly stated as acceptance criteria with numerical targets in the text beyond simply reporting the device's values.)

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

The document does not explicitly state the sample size used for the test set for its performance evaluations (e.g., strength, accuracy, biocompatibility). It mentions "non clinical tests were conducted," but not the number of units tested.

The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It implies internal testing by the manufacturer.

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

This information is not applicable. The device is a physical barrier (thermometer probe sheath), and its performance is evaluated against engineering standards and material properties, not through expert interpretation or clinical judgment requiring ground truth establishment by experts.

4. Adjudication Method for the Test Set

This information is not applicable. As explained above, the testing involves objective measurements against predefined standards rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data. The Disposable Thermometer Probe Sheath is a physical barrier accessory, and its effectiveness is determined by its physical properties and ability to maintain thermometer accuracy, not by human interpretation.

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

Yes, a standalone performance evaluation was done. The non-clinical tests described (strength, accuracy, biocompatibility) are evaluations of the device's inherent properties and performance without human interaction beyond operating test equipment. The device itself does not involve algorithms or AI. The standard tests (ASTM E1104, ASTM E1112, ISO 10993) assess the device's standalone physical and functional characteristics.

7. The Type of Ground Truth Used

The "ground truth" for evaluating the performance of the Disposable Thermometer Probe Sheath is established by internationally recognized engineering and biocompatibility standards. Specifically:

ASTM E1104-98: Standard Specification for Clinical Thermometer Probe Covers and Sheaths
ASTM E1112-00: Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization

These standards define the acceptable limits and methodologies for testing these types of devices.

8. The Sample Size for the Training Set

This information is not applicable. The device is a manufactured medical accessory, not an AI/ML model that requires a training set.

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

This information is not applicable, as there is no training set for this type of device.

Summary

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

January 15, 2016

Pinghu Sama Medical Packing Co., Ltd. c/o Mr. Ray Wang Beijing Believe Tech. Service Co., Ltd. 1-202, Build 3, Beijing New World No.5 Chaogyang Rd., Chaogyang District Beijing, 100024 CHINA

Re: K152690

Trade/Device Name: Disposable Thermometer Probe Sheath Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: December 15, 2015 Received: December 18, 2015

Dear Mr. 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. 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. Ray Wang

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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

lina Kiana -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152690

Device Name Disposable Thermometer Probe Sheath

Indications for Use (Describe)

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 - K152690

Date of Preparation: 9/17/2015

Sponsor Identification PINGHU SAMAMEDICAL PACKING CO., LTD. (Establishment Reg: 3010521050) 1 Qunfeng Road, South of Lindai, PingHu, Zhejiang, 314202, China

Contact Person: Ma JianZhong Position: General Manager Tel: +86-573-85923333 Fax:+86-573-85924444 Email: mjz1966@163.com

Submission Correspondent: Mr. Ray Wang

Beijing Believe Tech. Service Co., Ltd 1-202, Build 3, Beijing New World No.5 Chaogyang Rd., Chaogyang District Beijing, 100024 CN Tel: +86-21-50313932, Fax: +86-21-68093116 Email: Ray.Wang@believe-med.com

Identification of Proposed Device

Trade name: Disposable Thermometer Probe Sheath Common Name: Thermometer Probe Covers and Sheaths Model: Oral

Regulatory Information

Classification Name: Clinical Electronic Thermometer Classification: 2 Product Code: FLL Regulation Number: 880.2910 Review Panel: General Hospital

Proposed Predicate Device

K112289 Disposable Thermometer Covers and Sheaths KANG ZE INDUSTRIAL Co., Ltd.

Intended Use Statement

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K152690 -510K Summary

Device Description

ITEM	Proposed Device-K112289	Predicate Device-K152690
Intended Use	The Disposable Thermometer Probe Sheathsare intended for use as barriers between digitalthermometers and users' oral cavities to avoidthe possible contamination and infectionduring temperature measuring. The sheaths arenon-sterile and intended for single use only.	The Disposable Thermometer Covers andSheaths are intended for use as barriersbetween digital or mercury thermometers andusers' rectum or oral cavities to avoid thepossible contamination and infection duringtemperature measuring. These covers andsheaths are non-sterile and intended for singleuse only.
OTC use	Yes	Yes
Basic Design	3 layer design (Bottom Side Paper +PE/EVA film + Top Side Paper);Removing paper before use;	3 layer design (Bottom Side Paper +PE/EVA film + Top Side Paper);Removing paper before use;
Device MaterialsComposition	PE/EVA	PE/EVA
Size	One size	Varied size
Thickness	23.5 um	NA
OutsiderDimension	Length115 mmWidth30 mm	Length120 mmWidth33 mm
AvailableDimension	Length90 mmWidth30 mm	Length88 mmWidth29 mm
Density	0.87-0.88g/cm3	N/A
Strength	Meet the requirements of ASTM 1104Air Pressure of 8.4 kPa (1.2 psi) for 5seconds	Meet the requirements of ASTM 1104

Subject and Predicate Device Comparison:

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K152690 -510K Summary

Accuracy	Meet the requirements of ASTM E1104/E1112	Meet the requirements of ASTM E1104/E1112
	±0.3℃, Less than 38 ℃;
	±0.2℃,35.8℃ to less than 37 ℃;
	±0.1℃, 37.0 ℃ to 39.0 ℃;
	±0.2℃, greater than 39.0 ℃ to 41.0 ℃;
Color	None	None

Sterile	No	No

Discussion

The basic intended use is the same for both the predicate and subject device in that the device functions as an outer barrier to the thermometer. The predicate device is indicated for both oral and rectal thermometer whereas the subject device is only indicated for oral thermometers. Although small differences exist with predicate device in terms of dimension specification. whether the dimension differences affects temperature measuring accuracy of covered thermometers was evaluated. Performance testing for temperature accuracy was investigated per ASTM E1104/ASTM E1112, the test results showed compliance with the temperature accuracy requirements, thus the subject device has demonstrated it is substantially equivalent with the predicate device.

Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications to perform similarly and in a substantially equivalent manner to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro ■ Cytotoxicity
ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.

-ASTM E1104-98: Standard Specification for Clinical Thermometer Probe Covers and Sheaths

-ASTM E1112-00: Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature

-Bench Testing for the performance of Dimensions, Integrality

Conclusion: The Disposable Thermometer Probe Sheaths have demonstrated the product is similar in intended use and materials of construction as that of the predicate device. Performance testing showed it performs in a manner that is substantially equivalent to the legally marketed predicate device.

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.