(268 days)
The sterile temperature probe is used with Mindray BeneVision N17 patient monitor to monitor body or skin surface temperature. The device is for use by qualified healthcare personnel.
The probe is offered in the following three configurations:
- Body cavity temperature probe for monitoring of the core temperature in adult and pediatric patients by insertion into the esophageal; and for monitoring of the body temperature in adult and pediatric patients by insertion into the rectal or nasopharyngeal cavity.
- Skin contact temperature probe for monitoring of skin temperature to an adult and pediatric patient’s skin surface.
- Ear cavity temperature probe for monitoring of body temperature by insertion of the foam into pediatric or adult’s auditory canal.
For pediatric population, the subpopulations are children and adolescents.
The sterile temperature probe is a compatible sensor for use with Mindary BeneVision N17 patient monitor, as an accessory of the legally marketed patient monitor on the US market, the sterile temperature probe is indicated for continuous monitoring of body temperature in hospital settings. It mainly consists of plug, cable, and probe at patient side. When in use, the probe should be connected to the compatible device, and the temperature change of the patient's measured part is sensed through the built-in NTC thermistor at the probe end and the patient's body temperature is measured. The subject devices are used with Mindray BeneVision N17 patient monitor, which was cleared under K182075.
The temperature probes are packed individually into a paper plastic pouch in sterile condition and are single use only.
N/A
FDA 510(k) Clearance Letter - K251160
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.02
January 8, 2026
Shenzhen Med-link Electronics Tech Co., Ltd.
Summer Xia
Regulatory Affairs Specialist
Zone A of 1st and 2nd Floor, and 3rd Floor, Building A, No. 7, Tongsheng Industrial Park Road
Shanghenglang Community,
Shenzhen, 518109
China
Re: K251160
Trade/Device Name: Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)
Regulation Number: 21 CFR 880.2910
Regulation Name: Clinical Electronic Thermometer
Regulatory Class: Class II
Product Code: FLL
Dated: December 12, 2025
Received: December 12, 2025
Dear Summer Xia:
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.
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K251160 - Summer Xia Page 2
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" (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 QS 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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K251160 - Summer Xia Page 3
assistance/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,
Colleen J. Lawrimore -S
Colleen Lawrimore, Ph.D.
For David Wolloscheck, Ph.D.
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
Page 4
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K251160
Device Name: Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)
Indications for Use (Describe)
The sterile temperature probe is used with Mindray BeneVision N17 patient monitor to monitor body or skin surface temperature. The device is for use by qualified healthcare personnel.
The probe is offered in the following three configurations:
- Body cavity temperature probe for monitoring of the core temperature in adult and pediatric patients by insertion into the esophageal; and for monitoring of the body temperature in adult and pediatric patients by insertion into the rectal or nasopharyngeal cavity.
- Skin contact temperature probe for monitoring of skin temperature to an adult and pediatric patient's skin surface.
- Ear cavity temperature probe for monitoring of body temperature by insertion of the foam into pediatric or adult's auditory canal.
For pediatric population, the subpopulations are children and adolescents.
Type of Use (Select one or both, as applicable)
☒ 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
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"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."
Page 5
510(k) Summary - K251160
Shenzhen Med-link Electronics Tech Co.,LTD. Version: A.4
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
Type of submission: Traditional
The assigned 510(k) number: K251160
1. Submitter information
Manufacturer Name: Shenzhen Med-link Electronics Tech Co., Ltd.
Address: Zone A of 1st and 2nd Floor, and 3rd Floor, Building A, No. 7, Tongsheng Industrial Park Road, Shanghenglang Community, Dalang Street, Longhua District, 518109 Shenzhen, PEOPLE'S REPUBLIC OF CHINA
Tel: 86-755-61568825
Fax: 86-755-61120055
Establishment Registration Number: 3006636961
2. Correspondent information
Summer Xia (Regulatory Affairs Specialist)
Shenzhen Med-link Electronics Tech Co., Ltd.
Zone A of 1st and 2nd Floor, and 3rd Floor, Building A, No. 7, Tongsheng Industrial Park Road, Shanghenglang Community, Dalang Street, Longhua District, 518109 Shenzhen, PEOPLE'S REPUBLIC OF CHINA
E-mail: user22@med-linket.com
Tel: 86-755-61568825 ext:887
Fax: 86-755-61120055
3. Data of Preparation
8th, January, 2026
4. Identification of the subject device
Device Common Name: Temperature Probe
Trade/Device name: Sterile Temperature Probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)
Classification name: Clinical Electronic Thermometer
Regulation number: 21 CFR 880.2910
Device Class: Class II
Product Code: FLL
Review Panel: General Hospital
Page 6
5. Identification of the Predicate Device
| No. | Device Name | Common Name | Manufacture | Classification and Code | Classification regulation | 510(k) number |
|---|---|---|---|---|---|---|
| 1 | DeRoyal Temperature Monitoring Probe | Temperature Monitoring Probe | DeRoyal Industries, Inc. | Class II, FLL | 21 CFR 880.2910 | K200631 |
6. Indications for Use of the Subject Device
The sterile temperature probe is used with Mindray BeneVision N17 patient monitor to monitor body or skin surface temperature. The device is for use by qualified healthcare personnel.
The probe is offered in the following three configurations:
- Body cavity temperature probe for monitoring of the core temperature in adult and pediatric patients by insertion into the esophageal; and for monitoring of the body temperature in adult and pediatric patients by insertion into the rectal or nasopharyngeal cavity.
- Skin contact temperature probe for monitoring of skin temperature to an adult and pediatric patient's skin surface.
- Ear cavity temperature probe for monitoring of body temperature by insertion of the foam into pediatric or adult's auditory canal.
For pediatric population, the subpopulations are children and adolescents.
7. Device Description
The sterile temperature probe is a compatible sensor for use with Mindary BeneVision N17 patient monitor, as an accessory of the legally marketed patient monitor on the US market, the sterile temperature probe is indicated for continuous monitoring of body temperature in hospital settings. It mainly consists of plug, cable, and probe at patient side. When in use, the probe should be connected to the compatible device, and the temperature change of the patient's measured part is sensed through the built-in NTC thermistor at the probe end and the patient's body temperature is measured. The subject devices are used with Mindray BeneVision N17 patient monitor, which was cleared under K182075.
The temperature probes are packed individually into a paper plastic pouch in sterile condition and are single use only.
Page 7
8. Comparison table for subject device and predicate device
| Item | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Device name | Sterile temperature probe | Temperature Monitoring Probe | / |
| Trade name | / | DeRoyal Temperature Monitoring Probe | / |
| 510(K) number | K251160 | K200631 | / |
| 510(K) Owner | Shenzhen Med-link Electronics Tech Co., LTD. | DeRoyal Industries, Inc | / |
| Indications for Use | The sterile temperature probe is used with Mindray BeneVision N17 patient monitor to monitor body or skin surface temperature. The device is for use by qualified healthcare personnel. The probe is offered in the following three configurations: - Body cavity temperature probe for monitoring of the core temperature in adult and pediatric patients by insertion into the esophageal; and for monitoring of the body temperature in adult and pediatric patients by insertion into the rectal or nasopharyngeal cavity. - Skin contact temperature probe for monitoring of skin temperature to an adult and pediatric patient's skin surface - Ear cavity temperature probe for monitoring of body temperature by insertion of the foam into pediatric or adult's auditory canal. For pediatric population, the subpopulations are children and adolescents. | The DeRoyal Temperature Monitoring Probe is used for routine monitoring of the patient's core body or skin surface temperature. The probe is offered in the following three configurations: - General Purpose Temperature Probe for routine monitoring of the core 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 | Note 1 |
Page 8
| Item | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Patient population | Type / Device Model / Patient populationSkin surface: W0001ES, W0028ES - Adult, children and adolescentsEar cavity: W0101FS-A - Adult; W0101FS-P - Children and adolescentsBody cavity: W0099LS, W0099FS, W0099PS - Adult, children and adolescents | Type / Device Model / Patient populationAdult Skin Sensor: Not provided - AdultTympanic Probe: Not provided - Adult and pediatricGeneral Purpose: Not provided - Adult and pediatric | Note 2 |
| Intended User | Healthcare professional | Licensed healthcare practitioners | SE |
| Use Environment | Hospital settings | Hospital | SE |
| Prescription use or Over-The-Counter Use | Prescription use | Prescription use | SE |
| Measuring Site | Type / Device Model / Measuring SiteSkin surface: W0001ES, W0028ES - Skin surfaceEar cavity: W0101FS-A, W0101FS-P - Auditory canalBody cavity: W0099LS, W0099FS, W0099PS - Esophageal, rectal, nasopharyngeal cavities | Type / Device Model / Measuring SiteAdult Skin Sensor: Not provided - Skin surfaceTympanic Probe: Not provided - Auditory CanalGeneral Purpose: Not provided - Nasopharyngeal, esophageal, rectal cavities | SE |
| Mode of Operation | Direct Mode | Direct Mode | SE |
Page 9
| Item | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Patient population | Type / Device Model / Patient populationSkin surface: W0001ES, W0028ES - Adult, children and adolescentsEar cavity: W0101FS-A - Adult; W0101FS-P - Children and adolescentsBody cavity: W0099LS, W0099FS, W0099PS - Adult, children and adolescents | Type / Device Model / Patient populationAdult Skin Sensor: Not provided - AdultTympanic Probe: Not provided - Adult and pediatricGeneral Purpose: Not provided - Adult and pediatric | Note 2 |
| Intended User | Healthcare professional | Licensed healthcare practitioners | SE |
| Use Environment | Hospital settings | Hospital | SE |
| Prescription use or Over-The-Counter Use | Prescription use | Prescription use | SE |
| Measuring Site | Type / Device Model / Measuring SiteSkin surface: W0001ES, W0028ES - Skin surfaceEar cavity: W0101FS-A, W0101FS-P - Auditory canalBody cavity: W0099LS, W0099FS, W0099PS - Esophageal, rectal, nasopharyngeal cavities | Type / Device Model / Measuring SiteAdult Skin Sensor: Not provided - Skin surfaceTympanic Probe: Not provided - Auditory CanalGeneral Purpose: Not provided - Nasopharyngeal, esophageal, rectal cavities | SE |
| Mode of Operation | Direct Mode | Direct Mode | SE |
Page 10
| Item | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Nature of Body Contact | Body cavity: Mucosal MembraneSkin surface: Intact SkinEar cavity: Intact Skin | General Purpose: Mucosal MembraneAdult Skin Sensor: Intact SkinTympanic Probe: Intact Skin | SE |
| Duration of Contact | Body cavity: Limited ( < 24 hours)Skin surface: Limited ( < 24 hours)Ear cavity: Limited ( < 24 hours) | General Purpose: Limited ( < 24 hours)Adult Skin Sensor:Prolonged (≥24 hours)Tympanic Probe: Prolonged (≥24 hours) | Note 3 |
| Reference Body Site | Body cavity:Esophageal, rectal or nasopharyngeal cavitiesSkin surface: Skin SurfaceEar cavity: Auditory canal | General Purpose: Esophageal, rectal or nasopharyngeal cavitiesAdult Skin Sensor: Skin SurfaceTympanic Probe: Aural canal | SE |
| Principle of operation | Resistance of thermistor based on the metal conductor increases with temperature decrease, and the linear changes to the characteristics of the temperature measurement | Thermistor resistance based on the metal conductor increase with temperature decrease, and the linear changes to the characteristics of the temperature measurement | SE |
| Design/ Construction | ① Body cavity: Wire set with a connector at the proximal end and a thermistor on the patient end. The wire set is enclosed in a tube that may be inserted into the application site.② Skin surface: Wire set with a connector at the proximal end and a thermistor on the patient end. An adhesive probe cover applies the device to the patients'skin.③Ear cavity: Wire set with a connector at the proximal end and a thermistor on the patient end. A foam earplug is used to insert into the patient's auditory canal | ① General Purpose: Wire set with a thermistor chip at the distal end and a blue connector at the proximal end. The wire set is enclosed in a tube that may be inserted into the application site.② Adult Skin Sensor: 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'skin③Tympanic Probe: Wire set with a thermistor chip at the distal end and a blue connector at the proximal end. A foam ear plug is used to insert the device into the patient's aural canal | SE |
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| Item | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Material | ① Body cavity:PVC connector and PVC tube cableThermistor: Ceramic② Skin surface:Cover: double faced adhesive and foamWire:Tinned copper with PVC insulationThermistor: CeramicConnector: PVCStrain Relief: PVCCap: Epoxy③Ear cavity:Ear Plug: FoamWire: Tinned copper with PVC insulationThermistor: CeramicConnector: PVCStrain Relief: PVCCap: Epoxy | ① General Purpose:Tube: PVCWire: Copper with PVC insulationThermistor: CeramicConnector: PVC-molded brassStrain Relief: PVCCap: UV-cured adhesive② Adult Skin Sensor:Cover: Adhesive foamWire: Copper with PVC insulationThermistor: CeramicConnector: PVC-molded brassStrain Relief: PVCCap: UV-cured adhesive③Tympanic Probe:Ear Plug: Foam and/or cotton ballWire: Copper with PVC insulationThermistor: CeramicConnector: PVC-molded brassStrain Relief: PVCCap: UV-cured adhesive | Note 4 |
| Power supply | Via patient monitor | Via patient monitor | SE |
| Thermistor | 2.252 KΩ@25℃ | / | Note 5 |
Page 12
| Item | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Length | Body cavity: 600mm, 750mmSkin surface: 800mmEar cavity: 800mm | Length: Body cavity: <br>Skin contact: <br>Tympanic Probe: \ | Note 6 |
| Rated Output Range | 25℃~45℃ | 25°C to 45°C | SE |
| Accuracy | ±0.1℃ | ±0.2°C | Note 7 |
| Operating condition | 5℃ ~ 40℃, 0～95%RH, 86kPa ~ 106kPa | 25°C ~ 45°C | Note 8 |
| Storage Condition | -10°C to +40°C, -10°C to +40°C, 86kPa ~ 106kPa | -25°C to +55°C | Note 9 |
| Disposable or Reusable | Disposable | Disposable | SE |
| Sterile or Non-sterile | Sterile | General purpose temperature probe: SterileAdult skin temperature sensor: SterileTympanic configuration is non-sterile | Note 10 |
| Sterilization method | Sterilized with Ethylene Oxide | General Purpose: Sterilized with Ethylene OxideAdult Skin Sensor: Sterilized with Ethylene OxideTympanic Probe: No | Note 11 |
| Biocompatibility | Cytotoxicity complied with ISO 10993-5Sensitization complied with ISO 10993-10Irritation complied with ISO 10993-23 | Cytotoxicity complied with ISO 10993-5Sensitization complied with ISO 10993-10Irritation complied with ISO 10993-10 | SE |
| Basic Safety | IEC 60601-1 | IEC 60601-1 | SE |
| Performance | ISO 80601-2-56 | ISO 80601-2-56 | SE |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | SE |
| Clinical Testing | Not applicable | Not applicable | SE |
Page 13
Note 1: Predicate K200631 skin probe is only applicable to adult while the subject skin surface probe is applicable to adult, children and adolescents; the general purpose and tympanic probe of the predicate device are applicable to adult and pediatric patient, while the body cavity and ear cavity probes of the subject device are applicable to adult and children and adolescents. However, the subject device meets design requirements and complies with requirements of IEC 60601-1, IEC 60601-1-2 and ISO 80601-2-56 standard. This difference therefore does not raise new questions of safety or effectiveness.
The compatible monitor of the subject device is different from the predicate device, but the electrical safety, EMC and performance testing were performed on the subject devices, and the results of testing demonstrate the subject device complies with the requirements of IEC 60601-1, IEC 60601-1-2 and ISO 80601-2-56. Therefore, this difference does not raise new questions of safety or effectiveness.
Note 2: Predicate K200631 skin probe is only applicable to adult while the subject skin surface probe is applicable to adult, children and adolescents; the general purpose and tympanic probe of the predicate device are applicable to adult and pediatric patient, while the body cavity and ear cavity of the subject device are applicable to adult and children and adolescents. However, the subject device meets design requirements and complies with requirements of IEC 60601-1, IEC 60601-1-2 and ISO 80601-2-56 standard. This difference therefore does not raise new questions of safety or effectiveness.
Note 3: The duration of contact for skin surface and ear cavity of subject device is less than predicate device. The subject device complies with ISO 10993-5, ISO 10993-10, ISO 109963-23 and ISO 80601-2-56, so this difference does not raise new questions of safety or effectiveness.
Note 4: There are some differences in the materials used in the subject devices and the predicate devices. Biocompatibility testing was performed on the subject devices. Electrical Safety and EMC testing were performed on the subject devices. These test results demonstrate the subject devices comply with ISO 10993-5, ISO 10993-10 and ISO 10993-23 standard and this difference does not raise new questions of safety or effectiveness.
Note 5: The thermistor information of predicate device is not available. However, the validation test was conducted according to ISO 80601-2-56 standard and the difference does not raise new questions of safety or effectiveness.
Note 6: The length information of predicate device is not available. However, the validation test was conducted according to ISO 80601-2-56 standard and the difference does not raise new questions of safety or effectiveness.
Note 7: Although the measurement accuracy of the subject devices is different from the predicate device, but the subject devices comply with the requirements of ISO 80601-2-56 standard. Therefore, this difference does not raise new questions of safety or effectiveness.
Note 8 and 9: The operating and storage conditions of the subject device are different from the predicate device. Validation testing was conducted according to ISO 80601-2-56 standard
Page 14
and the difference does not raise new questions of safety or effectiveness.
Note 10 and 11: The ear cavity probe of the subject device is sterile whereas the tympanic probe of the predicate device is non-sterile. The sterilization method for subject device was validated according to the requirements of ISO 11135. Biocompatibility testing was performed on the subject device, and the results of the testing demonstrate the subject device complies with the requirements of ISO 10993-5, ISO 10993-10 and ISO 109963-23. Electrical safety and EMC testing were also performed on the subject devices and the results of the testing demonstrate the subject device complies with the requirement of IEC 60601-1, IEC 60601-1-2 and ISO 80601-2-56. This difference does not raise new questions of safety or effectiveness.
9. Non- Clinical Testing
The following testing was conducted to demonstrate substantial equivalence.
Biocompatibility evaluation
The biocompatibility evaluation for the subject devices were 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 biocompatibility testing included the following tests:
- ISO10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- Cytotoxicity
- ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- Sensitization
- ISO10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation
- Irritation
- Oral and rectal Irritation (Body cavity temperature probe only)
The sterile temperature probe is considered surface/mucosal contacting for a duration of not to exceed 24 hours.
Performance Testing
Non-clinical testing has been conducted to verify that the subject devices meet all design specifications which supports the conclusion that it is Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the subject device complies with the following standards:
- IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests - ISO 80601-2-56 Second edition 2017-03
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)]. - ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems
10. Clinical Testing
No clinical testing was needed to demonstrate substantial equivalence with the predicate device.
11. Conclusion
Based on above comparison and analysis, the Med-link Sterile Temperature Probes are substantially equivalent to the predicate device.
§ 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.