Probe Covers (YF-001, YF-002)

{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" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION". March 1, 2024 Shenzhen Yi Fang Blister Packaging Co., Ltd. Xu Junwen Manager 4/F, Bldg BC, Weixinda Industrial Park, Longteng Community Xixiang, Bao'an District Shenzhen, 518126 China Re: K240023 Trade/Device Name: Probe Covers (YF-001, YF-002) Regulation Number: 21 CFR 880.2910 Regulation Name: 880.2910 Regulatory Class: Class II Product Code: FLL Dated: January 3, 2024 Received: January 3, 2024 Dear Xu Junwen: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. David Walloschek David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, {2}------------------------------------------------ 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 {3}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K240023 Device Name Probe Covers (YF-001, YF-002) Indications for Use (Describe) The probe cover is used as a sanitary barrier between the infra red 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # K240023 - 510(k) Summary 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: | Shenzhen Yi Fang Blister Packaging Co., Ltd. | |----------|----------------------------------------------------------------------------------------------------------------| | Address: | 4/F, Bldg BC, Weixinda Industrial Park, Longteng Community<br>Xixiang, Bao'an District, Shenzhen, 518126 China | | Tel: | +86 - 13631618130 | | Fax: | +86- 755-23406821 | | Contact: | Junwen Xu | #### Designated Submission Correspondent | Contact: | Mr. Boyle Wang | |----------|------------------------------------------------------------------------| | Name: | Shanghai Truthful Information Technology Co., Ltd. | | Address: | Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai,<br>200120 China | | Tel: | +86-21-50313932 | | Email: | Info@truthful.com.cn | Date of Preparation: March 1, 2024 ### 2.0 Device Information | Trade name: | Probe Covers (YF-001, YF-002) | |------------------|--------------------------------------| | Common name: | Thermometer Probe Covers and Sheaths | | Regulation name: | Clinical electronic thermometer | | Model(s): | YF-001, YF-002 | ### 3.0 Classification | Product code: | FLL | |--------------------|------------------| | Regulation number: | 21CFR 880.2910 | | Classification: | Class II | | Panel: | General Hospital | ## 4.0 Predicate Device Information Manufacturer: Kaz, USA Inc. {5}------------------------------------------------ - Braun Thermoscan®V IRT 4000 Series/Pro 4000 Series Infra-Red Device: Ear Thermometers with Probe Cover 510(k) number: K101747 #### 5.0 Device Description The Probe Cover is a disposable plastic cover made of a biocompatible clarified 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 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 | Predicate Device<br>K101747 | Remark | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Device Name | Probe Covers | Probe Cover | -- | | Product Code | FLL | FLL | Same | | Regulation No. | 21 CFR 880.2910 | 21 CFR 880.2910 | Same | | Class | II | II | Same | | Indications for<br>use | The probe cover is used as a<br>sanitary barrier between the<br>infra red thermometer and the<br>ear canal. The probe cover is<br>provided non-sterile and for<br>single use only. | The<br>Thermoscan®IRT 4000<br>series and Braun<br>Thermoscan® PRO 4000<br>series Clinical Infrared Ear<br>Thermometers is indicated<br>for the intermittent<br>measurement and | Same* | #### 7.0 Comparison to the Predicate Device {6}------------------------------------------------ | | | monitoring of human body<br>temperature by consumers<br>of all ages in a home<br>use/professional use<br>environment.<br>The probe cover is used as<br>a sanitary barrier between<br>the infra red thermometer<br>and the ear canal. | | |--------------------------------------|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Compatible<br>thermometer<br>models | Braun Thermoscan®<br>PRO3000 series/PRO4000<br>series/PRO6000 series ear<br>thermometer | Braun Thermoscan® Pro<br>4000 Series/IRT 4000<br>Serie Thermometers | Same | | Prescription/over-the-counter<br>use | Over-the-counter use | Over-the-counter use | Same | | Design Features | Conforms to ASTM Standard<br>E1104 | Conforms to ASTM<br>Standard E1104 | Same | | Design<br>Configurations | One size | One size | Same | | Performance<br>Specifications | Conforms to ASTM Standard<br>E1104 | Conforms to ASTM<br>Standard E1104 | Same | | Prescription vs.<br>OTC | OTC | OTC | Same | | Sterile vs.<br>Non-Sterile | Non-sterile | Non-sterile | Same | | Patient contact<br>materials | Polypropylene | Polypropylene | Same | | Biocompatibility | ISO 10993-5<br>ISO 10993-10 | ISO 10993-5<br>ISO 10993-10 | Same | | Shelf Life | 5 years | Not publicly available | Different | *The predicate's thermometer probe covers are accessories to the thermometer itself, and were included in its 510(k) clearance under K101747. Only probe covers are included in this current 510(k). The subject device's indications are compared 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. The shelf life of the predicate device is not publicly available. An accelerated aging test was conducted per ASTM F1980. And the stability validation of the probe cover after accelerated aging condition meet the ASTM E1104 {7}------------------------------------------------ requirement for physical properties, the desired shelf life can be guaranteed. So the subject device is as safe and as effective as the predicate. #### 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: - · 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 - · ISO10993-10:2021 Biological evaluation of medical devices Part 10: Tests for skin sensitization - · ISO10993-23:2021 Biological evaluation of medical devices Part 23: Tests for irritation # 9.0 _Summary of Clinical Testing Clinical testing were not conducted for this submission. #### Conclusion 10.0 Performance testing contained in this submission demonstrates the minor differences in technological characteristics between the subject device and the predicate do not raise new or different questions of safety and effectiveness. Based on the performance testing and compliance with voluntary standards, the subject device is substantially equivalent to its predicate device K101747 with respect to the indications for use, treatment method, and technological characteristics.