Temperature Probe

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. October 10, 2018 Orantech Inc. % Kevin Wang Chonconn Medical Device Consulting Co., Ltd. 22A, Haijing Square, No. 18, Taizi Road Nanshan District, Shenzhen, 518067 China Re: K173194 Trade/Device Name: Temperature Probe (Models: TS-Y400-AG30. TS-Y400-AS30. TS-PH-AG30 and TS-PH-AS30) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: September 13, 2018 Received: September 13, 2018 Dear Mr. Kevin 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/cfpmp/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 {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Geeta K. Pamidimukkala -S for Tina Kiang, Ph.D. Acting 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) K173194 ### Device Name Temperature Probe (Model: TS-Y400-AG30, TS-Y400-AS30, TS-PH-AG30 and TS-PH-AS30) Indications for Use (Describe) Orantech Temperature Probes are intended to be used for monitoring temperature probes are reusable and designed for use with monitors of Philips Model MP30 and Nihon Kohden Model BSM-6301A. These devices are indicated for used by qualified medical personnel only. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------| | <span> <span style="font-family: DejaVu Sans, sans-serif">✔</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> | 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."* {3}------------------------------------------------ # 510(K) Summary Prepared in accordance with the requirements of 21 CFR Part 807.92 ## Prepared Date: 2018/02/05 ### 1. Submission sponsor Name: Orantech Inc. Address: Zone#A,4F,1st Bld,7th Industrial Zone, Yulv Community, GongMing, Guangming New District, Shenzhen, P.R. China 518106 Contact person: Hsin Xiong Title: General manager E-mail: Yunxi.xiong@orantech.cn Tel: +86-755 23699939 ### 2. Submission correspondent Name: Chonconn Medical Device Consulting Co., Ltd. Address: 22A, Haijing Square, No. 18, Taizi Road, Nanshan District, Shenzhen, P.R. China 518067 Contact person: Kevin Wang E-mail: kevin(@chonconn.com Tel: +86-755 33941160 | Trade/Device Name | Temperature Probe | |-------------------|--------------------------------------------------------| | Model | TS-Y400-AG30, TS-Y400-AS30, TS-PH-AG30 and TS-PH-AS30 | | Common Name | Temperature Probe | | Regulatory Class | Class II | | Classification | 21CFR 880.2910 / Clinical electronic thermometer / FLL | | Submission type | Traditional 510(K) | #### 3. Subject Device Information ### 4. Predicate Device - 1. Unimed Medical Supplies Inc. Temperature Probe under K121427. ### 5. Device Description Reusable temperature probes are used during patient temperature measurement for multi-patient use. These probes consist of a phone plug connector on the monitor end and a thermistor on the patient end. Temperature probes measure temperature by a resistor that is sensitive to temperature changes. These probes are connected to the patient monitor either directly by using a phono plug or by an interconnect cable. These probes have a skin or core contact with a patient. These temperature probes are typically used with legacy Philips monitor model MP30 and Nihon Kohden monitor model BSM-6301A. {4}------------------------------------------------ Products are packed individually into a plastic bag in non-sterile condition. Package label describes product REF codes, manufacturing date, CE-mark, legal entity information and a caution "Rx Only ". ### Product Specification | Model | Application<br>site | length | Compatible<br>monitors | Measurement<br>range | Accuracy | |--------------|---------------------|--------|-----------------------------------|----------------------|-------------| | TS-PH-AG30 | Rectum | 3.0m | Philips<br>Model: MP30 | 25-45°C | $\pm$ 0.1°C | | TS-PH-AS30 | Skin | 3.0m | Philips<br>Model: MP30 | 25-45°C | $\pm$ 0.1°C | | TS-Y400-AG30 | Rectum | 3.0m | Nihon Kohden<br>Model: BSM-6301A | 25-45°C | $\pm$ 0.1°C | | TS-Y400-AS30 | Skin | 3.0m | Nihon Kohden<br>Model: BSM-6301 A | 25-45°C | $\pm$ 0.1°C | ### Indication for use 6. Orantech Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable and designed for use with monitors of Philips Model MP30 and Nihon Kohden Model BSM-6301A. These devices are indicated for used by qualified medical personnel only. ### Comparison to the Predicate Device 7. | Orantech Model | Predicate Model | Description | |----------------|-----------------|------------------------------------------------| | TS-PH-AG30 | THP-AG | Reusable Temperature Probe, adult rectum, 3.0M | | TS-PH-AS30 | THP-AS | Reusable Temperature Probe, adult skin, 3.0M | | TS-Y400-AG30 | T2252-AG | Reusable Temperature Probe, adult rectum, 3.0M | | TS-Y400-AS30 | T2252-AS | Reusable Temperature Probe, adult skin, 3.0M | | Features | Subject Device<br>Orantech Temperature<br>Probe | Predicate Device<br>Unimed Temperature<br>Probe<br>K121427 | Comparison | |------------------------|-------------------------------------------------|------------------------------------------------------------|---------------| | Classification<br>Name | Temperature Probe | Temperature Probe | Same | | Product Code | FLL | FLL | Same | | Regulation Number | 880.2910 | 880.2910 | Same | | | | | | | Panel | General Hospital | General Hospital | Same | | Class | II | II | Same | | Thermistor | NTC resistance | NTC resistance | Same | | | (2252 Ohms in 25°C) | (2252 Ohms in 25°C) | | | Accuracy range | 25-45°C | 25-45°C | Same | | Accuracy | +0.1℃C | +0.1℃C | Same | | Measure site | Skin & Rectum | Skin & Rectum | Same | | Patient population | Adult | Adult | Same | | Material contact to | Thermistor Sensor Tip: | Thermistor Sensor Tip: | Different (1) | | body | Epoxy & Stainless steel | Stainless steel | | | Length | 3m | 1.5m & 3m | Same | | Cable material | PVC & TPU | PVC & TPU | Same | | Plug material | PA66 | ABS | Different (2) | | Biocompatibility | Cytotoxicity | Cytotoxicity | Same | | | Sensitization | Sensitization | | | | Irritation | Irritation | | | Operational | Continual | Continual | Same | | Principles | | | | | Indication for Use | Orantech Temperature | Unimed Temperature Probes | Different (3) | | | Probes are intended to be | are intended to be used for | | | | used for monitoring | monitoring temperature. The | | | | temperature. The | temperature probes are | | | | temperature probes are | designed for use with | | | | reusable and designed for | monitors of Philips, | | | | use with monitors of | Marquette, Mindray, | | | | Philips Model MP30 and | Spacelabs, Siemens, | | | | Nihon Kohden Model | Artema/S&W and other | | | | BSM-6301A. These | monitors compatible with | | | | devices are indicated for | YSI 400 series temperature | | | | used by qualified medical | probes. | | | | personnel only. | These devices are indicated | | | | | for used by qualified | | | | | medical personnel only. | | {5}------------------------------------------------ Justifications for differences between Orantech Temperature Probe and the predicate device are shown as below: Different (1): It's different with the patient contacted material of predicate device. However, it's conformed with ISO 10993 series standard. According to analysis results, all the Patient Contacting Materials shows no cytotoxicity, irritation response was negligible and no sensitization. Thus, different material will not raise any safety or biocompatibility issues. Different (2): It's different with the plug material of predicate device. However, it's conformed with ISO 10993 series standard. According to analysis results, all the materials shows no cytotoxicity, irritation {6}------------------------------------------------ response was negligible and no sensitization. Thus, different material of plug will not raise any safety or biocompatibility issues. Different (3): The compatible monitors of proposed devices are different from the predicate device. The proposed devices are intended to use with Philips and Nihon Kohden monitors and the predicate devices are intended to use with Philips, Marquette, Mindray, Spacelabs, Siemens, Artema/S&W and other monitors. The core component of temperature probe is Negative Coefficient (NTC) which is identical to the NTC used in predicate device. The NTC determines the accuracy and range of temperature measurement. Therefore, the indication for use of proposed devices is essentially the same as predicate device. ### Performance Data 8. ## Biocompatibility testing The biocompatibility evaluation for the Orantech Temperature Probe was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests: - Cytotoxicity - Sensitization - Irritation The Orantech Temperature Probe is considered surface contacting for a duration of exceed 24 hours but not 30 days. ## Non-clinical data The Orantech Temperature Probe has been tested according to the following standards: | Test | Description | Result | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Safety | Ensures the temperature probes meet the requirements of IEC 60601-1 electrical safety | Pass | | Laboratory accuracy | Not greater than 0.3 °C for a continuous clinical thermometer that is not an adjusted mode clinical thermometer | Pass | | Time response | Heating transient time < 150s | Pass | | Use life testing | Ensures the temperature probes meet the requirements of the expected service life of the probe. | Pass | | Cleaning and Disinfection | Validate the cleaning and disinfection method is effective. The study was conducted based on following documents:<br>1) AAMI TIR 30: 2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices;<br>2) AAMI TIR 12: 2010 Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers; | Pass | {7}------------------------------------------------ # Oral ntech | 3) FDA Guidance, Reprocessing Medical Devices in Health Care<br>Settings: Validation Methods and Labelling document issued on:<br>March 17, 2015. | | |---------------------------------------------------------------------------------------------------------------------------------------------------|--| |---------------------------------------------------------------------------------------------------------------------------------------------------|--| # 9. Conclusion Performance testing and compliance with voluntary standards demonstrate that the proposed are substantially equivalent to the predicate device.