(247 days)
Not Found
No
The device is a simple disposable probe cover for an ear thermometer and does not involve any computational or analytical functions.
No
The device is a probe cover for a thermometer, acting solely as a sanitary barrier. It does not perform any therapeutic function or interact with the body in a way that would treat or alleviate a medical condition.
No
The device is a probe cover for an infrared thermometer, designed as a sanitary barrier, not for diagnosing medical conditions.
No
The device description clearly states it is a disposable plastic cover, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, or disease.
- This device is a probe cover for an ear thermometer. Its function is to provide a sanitary barrier between the thermometer and the ear canal. It does not analyze any bodily fluids or tissues.
- The intended use and device description clearly state its purpose as a sanitary barrier.
- The performance studies focus on the physical properties of the cover and its biocompatibility, not on diagnostic accuracy or analysis of biological samples.
Therefore, this device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The Disposable Ear Thermometer Probe Cover is a disposable plastic cover made of a biocompatible 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 also compatible with Braun Thermoscan® IRT1020/IRT2020/IRT2520/IRT3020/ IRT3520/IRT4020/IRT4520/IRT6020/IRT6520 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear canal, auditory canal
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 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
- ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
Clinical testing was not required for this submission.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
July 28, 2021
Huaian Zhongxin Packing Material Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM. 608, No. 738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K203431
Trade/Device Name: Disposable Ear Thermometer Probe Cover Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: July 1, 2021 Received: July 9, 2021
Dear Boyle 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. 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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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,
CAPT Alan M. Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, 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) K203431
Device Name Disposable Ear Thermometer Probe Cover
Indications for Use (Describe)
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.
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 (K203431)
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: Huaian Zhongxin Packing Material Co.,Ltd. Address: No.128-5,West Meigao Road,Qingpu Industrial Park, Huaian, Jiangsu Province,223022 China Tel: +86 -15751384913 Fax: +86- 517-83852820 Contact: Fenq Zuo Date of Preparation: July.24,2021
Designated Submission Correspondent
Mr. Boyle Wanq Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Disposable Ear Thermometer Probe Cover Common name: Thermometer Probe Covers and Sheaths Classification name: Clinical electronic thermometer Model(s): 4#.6#
3.0 Classification
Production code: FLL Requlation number: 21CFR 880.2910 Classification: Class II Panel: General Hospital
4.0 Predicate Device Information
Manufacturer: Kaz, USA Inc. Device: Braun Thermoscan® Pro 4000 Series/IRT 4000 Series
4
Thermometers 510(k) number: K101747
5.0 Device Description
The Disposable Ear Thermometer Probe Cover is a disposable plastic cover made of a biocompatible 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 also compatible with Braun Thermoscan® IRT1020/IRT2020/IRT2520/IRT3020/ IRT3520/IRT4020/IRT4520/IRT6020/IRT6520 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
K203431 | Predicate Device
K101747 | Remark |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Type of
Thermometer | Disposable Ear Thermometer
Probe Cover | Probe Cover | -- |
| Product Code | FLL | FLL | Same |
| Regulation No. | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Class | II | II | Same |
| Indications for
use | 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. | The Braun
Thermoscan®IRT 4000
series and Braun
Thermoscan® PRO 4000
series Clinical Infrared Ear
Thermometers is indicated | Same* |
7.0 Comparison to the Predicate Device
5
| | | for the intermittent
measurement and
monitoring of human body
temperature by consumers
of all ages in a home
use/professional use
environment.
The probe cover is used as
a sanitary barrier between
the infra red thermometer
and the ear canal. | |
|------------------------------------------|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Prescription/ove
r-the-counter
use | Over-the-counter use | Over-the-counter use | Same |
| Design Features | Conforms to ASTM Standard
E1104 | Conforms to ASTM
Standard E1104 | Same |
| Design
Configurations | One size | One size | Same |
| Performance
Specifications | Conforms to ASTM Standard
E1104 | Conforms to ASTM
Standard E1104 | Same |
| Prescription vs.
OTC | OTC | OTC | Same |
| Sterile vs.
Non-Sterile | Non-sterile | Non-sterile | Same |
| Patient contact
materials | Polypropylene | Polypropylene | Same |
| Biocompatibility | ISO 10993-5
ISO 10993-10 | ISO 10993-5
ISO 10993-10 | Same |
*The predicate's thermometer probe covers are accessories to the thermometer itself, and were included in its 510(k) clearance under K101747.Only the probe covers are included in this current 510(k),as there is no thermometer or any accessory marked with the current subject device. The subject device's indications are only applicable 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.
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:
6
● 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
● ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests
for irritation and skin sensitization
9.0 Summary of Clinical Testing
Clinical testing was not required for this submission.
10.0 Conclusion
Performance testing contained in this submission demonstrates the minor differences in technological characteristics between the subject device and the predicate do not raise different questions of safety and effectiveness. Based on the performance testing and compliance with acceptable voluntary standards, the subject device is substantially equivalent to its predicate device in K101747.