Who is the manufacturer of Sterile Disposable Temperature Probe?

Shenzhen Envisen Industry Co., Ltd. filed the 510(k) submission for Sterile Disposable Temperature Probe (K212945).

What is the FDA product code for Sterile Disposable Temperature Probe?

FLL. It is classified under 21 CFR 880.2910 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Sterile Disposable Temperature Probe?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Sterile Disposable Temperature Probe?

DeRoyal Temperature Monitoring Probe (K200631).

Who can help prepare an FDA 510(k) submission like Sterile Disposable Temperature Probe?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Sterile Disposable Temperature Probe

K212945 · Shenzhen Envisen Industry Co., Ltd. · FLL · Mar 1, 2022 · General Hospital

Device Facts

Record ID	K212945
Device Name	Sterile Disposable Temperature Probe
Applicant	Shenzhen Envisen Industry Co., Ltd.
Product Code	FLL · General Hospital
Decision Date	Mar 1, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.2910
Device Class	Class 2
Attributes	Pediatric

Intended Use

The Sterile Disposable Temperature Probe is to be used with Mindray uMEC10 to monitor core temperature or skin temperature. The device is for use by licensed healthcare practitioners only. The probe is offered in the following two configurations: - Body cavity Temperature Probe TGMS-1691 for monitoring of the core temperature in adult and pediatric patients by insertion into the esophageal or rectal cavities. - Skin contact Temperature Probe TSMS-1191 for monitoring of skin temperature by application of the probe's adhesive cover to an adult and pediatric patient's skin surface.

Device Story

Sterile disposable temperature probes (TGMS-1691, TSMS-1191) monitor patient temperature when connected to Mindray uMEC10 patient monitors. Input: temperature-dependent resistance changes via thermistor at patient end. Principle: thermistor resistance changes linearly with temperature; signal transmitted via interconnect cable to monitor. Output: temperature data displayed on monitor. Used in clinical settings by healthcare practitioners. Benefits: provides continuous core or skin temperature monitoring for adult and pediatric patients.

Clinical Evidence

Bench testing only. Compliance verified with IEC 60601-1, IEC 60601-1-2, and ISO 80601-2-56. Biocompatibility testing (cytotoxicity, sensitization, irritation) performed per ISO 10993-1. Stability and performance testing for 24-hour continuous use conducted.

Technological Characteristics

Thermistor-based temperature sensing. Materials: PVC, PVDF, copper, ceramic, PET, aluminum foil, stainless steel. Connectivity: wired connection to patient monitor via phone plug. Sterilization: Ethylene Oxide. Standards: ISO 10993-5, ISO 10993-10, ISO 80601-2-56, IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for adult and pediatric patients requiring core temperature monitoring (via esophageal or rectal cavities) or skin temperature monitoring (via adhesive skin application). For use by licensed healthcare practitioners only.

Regulatory Classification

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.

Special Controls

(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.

Predicate Devices

DeRoyal Temperature Monitoring Probe (K200631)

Related Devices

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K121427 — UNIMED TEMPERATURE PROBE · Unimed Medical Supplies, Inc. · May 29, 2012
K193338 — Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes · Shenzhen Med-Link Electronics Tech Co., Ltd. · Aug 25, 2020
K223807 — Reusable Temperature Probe, Disposable Temperature Probe · Shenzhen Sino-K Medical Technology Co.,Ltd · Aug 25, 2023
K203636 — PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, PTSL-AS, PTMR-AS; Rectum Types: PT2252-AG, PTHP-AG, PTMQ-AG, PTSW-AG, PTSM-15AG, PTSL-AG, PTMR-AG · Jkh USA, LLC · Aug 31, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 1, 2022 Shenzhen Envisen Industry Co., Ltd % Kevin Wang Consultant Shenzhen Chonconn Medical Consulting Co., Ltd. Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 China Re: K212945 Trade/Device Name: Sterile Disposable Temperature Probe/Model: TGMS-1691 and TSMS-1191 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 26, 2022 Received: January 28, 2022 Dear 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/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 {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/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 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 medical devices and radiation-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, Gang Peng for Payal Patel 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K212945 Device Name Sterile Disposable temperature probe/Model: TGMS-1691 and TSMS-1191 Indications for Use (Describe) The Sterile Disposable Temperature Probe is to be used with Mindray uMEC10 to monitor core temperature or skin temperature. The device is for use by licensed healthcare practitioners only. The probe is offered in the following two configurations: - Body cavity Temperature Probe TGMS-1691 for monitoring of the core temperature in adult and pediatric patients by insertion into the esophageal or rectal cavities. - Skin contact Temperature Probe TSMS-1191 for monitoring of skin temperature by application of the probe's adhesive cover to an adult and pediatric patient's skin surface. | | Prescription Use (Part 21 CFR 801 Subpart D) 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." FORM FDA 3881 (6/20) Type of Use (Select one or both, as applicable) {3}------------------------------------------------ # 510(K) Summary for K212945 Prepared in accordance with the requirements of 21 CFR Part 807.92 ### Prepared Date: 2022/2/25 #### Submission sponsor 1. Name: Shenzhen Envisen Industry Co., Ltd. Address: Block 1, Room 201, 301, 401, 40 Jianlong Street, Baoan Community, Yuanshan Town, Longgang District, Shenzhen, P.R. China Contact person: Ailsa Huang Title: Management Representative E-mail: ailsa.huang@envisen.com Tel: +86 0755 88827227 #### 2. Submission correspondent Name: Shenzhen Chonconn Medical Device Consulting Co., Ltd. Address: Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P.R. China Contact person: Kevin Wang E-mail: kevin@chonconn.com Tel: +86-755 33941160 | Trade/Device Name | Sterile Disposable Temperature Probe | |-------------------|--------------------------------------| | Model | TGMS-1691 and TSMS-1191 | | Common Name | Temperature Probe | | Regulatory Class | Class II | | Regulation Number | 21CFR 880.2910 | | Regulation Name | Clinical Electronic Thermometer | | Product Code | FLL | #### Subject Device Information 3. #### Predicate Device 4. - 1. DeRoyal Industries, Inc., DeRoyal Temperature Monitoring Probe under K200631. #### Device Description ട്. Sterile Disposable Temperature Probes are used during patient temperature measurement. These probes consist of a phone plug connector on the adapter cable 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 by using an interconnect cable which is also included in the submission as an accessory. These probes {4}------------------------------------------------ have a skin or core contact with a patient. These temperature probes are typically used with Mindray uMEC10, which was cleared under K171901. Products are packed individually into a paper pouch in sterile condition. #### 6. Indications for use The Sterile Disposable Temperature Probe is to be used with Mindray uMEC10 to monitor core temperature or skin temperature. The device is for use by licensed healthcare practitioners only. The probe is offered in the following two configurations: - Body cavity Temperature Probe TGMS-1691 for monitoring of the core temperature in adult and pediatric patients by insertion into the esophageal or rectal cavities. - Skin contact Temperature Probe TSMS-1191 for monitoring of skin temperature by application of the probe's adhesive cover to an adult and pediatric patient's skin surface. | Features | Configuration | Subject Device Sterile Disposable Temperature Probe K212945 | Predicate Device DeRoyal Temperature Monitoring Probe K200631 | Comparison | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------| | Classification Name | Body cavity Skin contact | Temperature Probe | Temperature Probe | Same | | Product Code | Body cavity Skin contact | FLL | FLL | Same | | Regulation Number | Body cavity Skin contact | 880.2910 | 880.2910 | Same | | Panel | Body cavity Skin contact | General Hospital | General Hospital | Same | | Class | Body cavity Skin contact | II | II | Same | | Indications for Use | Body cavity Skin contact | The Sterile Disposable Temperature Probe is to be used with Mindray uMEC10 to | The DeRoyal Temperature Monitoring Probe is used for routine monitoring of the patient's core body or skin surface | Different 1 | | | monitor core temperature. temperature or skin temperature. The device is for use by licensed healthcare practitioners only. The probe is offered in the following two configurations: - Body cavity Temperature Probe TGMS-1691 for monitoring of the core temperature in adult and pediatric patients by insertion into the esophageal or rectal cavities. - Skin contact Temperature Probe TSMS-1191 for monitoring of skin temperature by application of the probe's adhesive cover to an adult and pediatric patient's skin surface. | The probe is offered in the following three configurations: - General Purpose Temperature Probe for routine monitoring of the core body temperature in adult and pediatric patients by insertion into the nasopharyngeal, esophageal, or rectal cavities. - Adult Skin Temperature Sensor for routine monitoring of skin temperature by application of the probe's adhesive cover to an adult patient's skin surface. - Tympanic Temperature Probe for routine monitoring of the core body temperature in adult and pediatric patients by insertion of the ear piece into the aural canal. The device is single use and for use by licensed | | | | | | | healthcare practitioners only. The probes are designed to interface with DeRoyal- branded cables for connection with YSI 400 or 700 series compatible monitors, including the following patient monitors and equivalent models: Mindray Passport, Philips IntelliVue, Siemens/Draeger Infinity, and GE Datex-Ohmeda brands. | | | Application Population | Body cavity Skin contact | adult and pediatric | adult and pediatric adult | Same Different 2 | | Prescription Only | Body cavity Skin contact | Yes | Yes | Same | | Mode of operation | Body cavity Skin contact | Direct mode | Direct mode | Same | | Measure site | Body cavity Skin contact | Rectum, Esophagus Skin Surface | Rectum, Esophagus, Nasopharynx Skin Surface | Different 3 Same | | Sensor | Body cavity Skin contact | Thermistor which is sensitive to temperature change. | Thermistor which is sensitive to temperature change. | Same | | Reference Body Site | Body cavity Skin contact | Core Body Skin Surface | Core Body Skin Surface | Same | | Principle of operation | Body cavity Skin contact | Thermistor resistance based | Thermistor resistance based | Same | | | | on the metal conductor increase with temperature decrease, and the linear changes to the characteristics of the temperature measurement. | on the metal conductor increase with temperature decrease, and the linear changes to the characteristics of the temperature measurement. | | | Rated Range | Body cavity Skin contact | 0-50°C (32°F- 122°F) | 25-45°C | Different 4 | | Accuracy | Body cavity Skin contact | $\pm$ 0.1°C/0.2°F in the range 25°C/77°F to 45°C/113°F $\pm$ 0.2°C/0.4°F in the range 0°C/32°F to 24.9°C/76.8°F and 45.1°C/113.2°F to 50°C/122°F | $\pm$ 0.2°C | | | Operating Conditions | Body cavity Skin contact | 5°C to 40°C(41°F to 104°F) 20% to 85%RH, | 25°C to 45°C \ | Different 5 | | storage conditions | Body cavity Skin contact | -20 to 55°C (- -4°F to 131°F), 10% to 93%RH, | -25°C to +55°C \ | Different 6 | | diameter | Body cavity | 3mm | 3mm,4mm | Same | | Length | Body cavity Skin contact | 0.75m 0.95m | \ | Different 7 | | Design | Body cavity | Wire set with a phone plug connector on the adapter cable end and a thermistor on | Wire set with a thermistor chip at the distal end and a blue connector at the proximal end. The wire set is | Same | | | | | | | | | | the patient end. The wire set is enclosed in a tube that may be inserted into the application site. | enclosed in a tube that may be inserted into the application site. | | | | Skin contact | Wire set with a phone plug connector on the adapter cable end and a thermistor on the patient end. An adhesive probe cover applies the device to the patients' skin. | Wire set with a thermistor chip at the distal end and a blue connector at the proximal end. An adhesive probe cover applies the device to the patients' skin. | Same | | Materials | Body cavity | PVC Connector and Tube Cable (PVDF Material) | Tube: PVC Wire: Copper with PVC insulation Thermistor: Ceramic Connector: PVC molded brass Strain Relief: PVC Cap: UV-cured adhesive | Different 8 | | | Skin contact | Cover: Release liner:(PET) and Foam(aluminum foil/PET) with 3M glue Wire: Copper with PVDF insulation Thermistor: Ceramic Connector: PVC molded brass Strain Relief: | Cover: Adhesive foam Wire: Copper with PVC insulation Thermistor: Ceramic Connector: PVC molded brass Strain Relief: PVC Cap: UV-cured adhesive | | | | | PVC Cap: stainless steel and epoxy glue | | | | Biocompatibility | Body cavity | Cytotoxicity complied with ISO 10993-5 | Cytotoxicity complied with ISO 10993-5 Sensitization complied with ISO 10993-10 Irritation complied with ISO 10993- 10 | Same | | | Skin contact | Sensitization complied with ISO 10993-10 Irritation complied with ISO 10993-10 | | Same | | Sterilization | Body cavity | Sterilized with Ethylene Oxide | Sterilized with Ethylene Oxide | Same | | | Skin contact | Sterilized with Ethylene Oxide | Sterilized with Ethylene Oxide | Same | | Disposable | Body cavity Skin contact | Yes | Yes | Same | #### Comparison to the Predicate Device 7. {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ Different The subject device has the same Intended use as the predicate device. However, there is some differences in the indications for use. Predicate K200631 General purpose probe has one more application site nasopharyngeal compared with the subject body cavity probe. The esophageal and rectal cavities measurement sites of the subject body cavity temperature probe and predicate device general purpose temperature probe are the same. The measurement site of the subject body cavity temperature probe is a subset of the predicate device. The difference does not raise any new safety and effective questions. Predicate K200631 skin probe is only appliable to adult while the subject skin probe is applicable to adult and pediatric. However, the skin contact probe design meets design requirements and is complied with ISO 80601-2-56 standard. The difference does not raise any new safety and effective questions. The compatible monitors of proposed devices are different from the predicate device. The validate testing was conducted in accordance with the ISO 80601-2-56 standard. The difference does not raise any new safety and effective questions. Different 2 Predicate K200631 skin probe is only appliable to adult while the subject skin probe is applicable to adult and pediatric. However, the skin contact probe design meets design {10}------------------------------------------------ requirements and is complied with ISO 80601-2-56 standard. The difference does not raise any new safety and effective questions. ## Different 3 K200631 General purpose probe has one more application site nasopharyngeal compared with the subject body cavity probe. The application site of the subject device is the subset of the predicate device and complies with ISO 80601-2-56 standard, the difference does not raise any new safety and effective questions. ## Different 4 Although the measurement range and accuracy of the subject devices are different form the predicate device, the design meets the design requirement. The subject devices are complied with ISO 80601-2-56 standard. Therefore, the difference does not raise any new safety and effective questions. Different 5 The operating conditions of the subject devices are different from the predicate device. According to ISO 80601-2-56, a clinical thermometer shall operate in normal use over the ranges of an ambient temperature operating range from 15℃ to 40℃. The ambient temperature of the subject device covers this range, it has also been tested according to ISO 80601-2-56, which has proved that the subject device functions well under specified ambient temperature environment. ## Different 6 The storage temperature is the same while the humidity range information of the predicate is not available. However, the validation test was conducted according to ISO 80601-2-56 standard, which has proved that the subject device functions well under specified humidity environment. Different 7 The information of the predicate is not available. However, the validation test was conducted according to ISO 80601-2-56 standard and the difference does not raise any new safety and effective questions. # Different 8 There are some differences in the materials used in the subject devices and the predicate devices. A biocompatibility testing was performed on the subject products. Electrical Safety and EMC testing also were performed on the subject devices. The results of the testing demonstrate the subject devices comply with ISO 10993-5 and ISO 10993-10 standard and the difference does not raise any new safety and effective questions. #### Performance Data 8. The following performance data were provided in support of the substantial equivalence determination. # Biocompatibility testing {11}------------------------------------------------ The biocompatibility evaluation for the proposed Temperature Probes was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests: - Cytotoxicity - Sensitization - Irritation - Rectal Irritation (Body cavity Temperature Probe only) - Oral mucosa Irritation (Body cavity Temperature Probe only) The Sterile Disposable temperature probe is considered surface/mucosal contacting for a duration of not exceed 24 hours. ## Non-clinical data Non-clinical testing has been conducted to verify that the Sterile Disposable Temperature Probe meets all design specifications which support the conclusion that it's Substantially Equivalent (SE) to the predicate devices. The testing results demonstrate that the targeted device complies with the following standards: - IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance - IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests - ISO 80601-2-56:2017+A1:2018 Medical electrical equipment – Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement. - Stability and performance test of the skin temperature probe for 24hrs continues use. #### 9. Conclusion Based on the performance testing, comparison and analysis, the proposed subject devices are substantially equivalent to the predicate device.