(116 days)
Not Found
No
The device is a simple physical barrier (sheath) for a thermometer probe and the description focuses on material properties and physical performance, with no mention of AI/ML.
No.
The device is a probe sheath intended to prevent contamination during temperature measurement, not to directly treat or cure any medical condition.
No
The device is a non-sterile sheath used as a barrier for a digital thermometer to prevent contamination and infection during temperature measurement. It does not perform any diagnostic function itself.
No
The device description clearly states it is a "shell-like device, made of PE/EVA" and describes physical components and materials, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to act as a physical barrier between a digital thermometer and the user's oral cavity to prevent contamination and infection during temperature measurement. This is a physical function, not a diagnostic one.
- Device Description: The device is described as a "shell-like device" made of PE/EVA used to cover the thermometer. This further reinforces its role as a physical barrier.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (like blood, urine, or tissue) or to provide information about a disease or condition. Its purpose is solely to maintain hygiene during a measurement taken by another device (the thermometer).
- Performance Studies: The performance studies focus on biological compatibility (cytotoxicity, irritation), physical properties (dimensions, integrality, strength), and the impact on the thermometer's accuracy (which is a function of the thermometer itself, not the sheath). These are not typical performance metrics for an IVD.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such test.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FLL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
Indications for Use
510(k) Number (if known) K152690
Device Name Disposable Thermometer Probe Sheath
Indications for Use (Describe)
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.
| 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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3
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
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.
4
K152690 -510K Summary
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.
| ITEM | Proposed Device-K112289 | Predicate Device-K152690 |
|---|---|---|
| Intended Use | 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. | 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. | ||
| 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 Materials | ||
| Composition | PE/EVA | PE/EVA |
| Size | One size | Varied size |
| Thickness | 23.5 um | NA |
| Outsider | ||
| Dimension | Length | |
| 115 mm | ||
| Width | ||
| 30 mm | Length | |
| 120 mm | ||
| Width | ||
| 33 mm | ||
| Available | ||
| Dimension | Length | |
| 90 mm | ||
| Width | ||
| 30 mm | Length | |
| 88 mm | ||
| Width | ||
| 29 mm | ||
| Density | 0.87-0.88g/cm3 | N/A |
| Strength | Meet the requirements of ASTM 1104 | |
| Air Pressure of 8.4 kPa (1.2 psi) for 5 | ||
| seconds | Meet the requirements of ASTM 1104 |
Subject and Predicate Device Comparison:
5
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.