ri-former Predictive Thermometer
Device Facts
| Record ID | K171182 |
|---|---|
| Device Name | ri-former Predictive Thermometer |
| Applicant | Rudolf Riester GmbH |
| Product Code | FLL · General Hospital |
| Decision Date | Oct 4, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.2910 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The device is used for measuring body temperature in the mouth (oral) in the anus (rectal) and in the armpit (axillary). It is intended for adults, children and infants.
Device Story
The ri-former Predictive Thermometer is a clinical instrument for measuring patient temperature via oral, axillary, or rectal probes. It integrates with the ri-former diagnostic station for power. The device uses a thermistor sensor to detect temperature; internal algorithms calculate readings in either 'Direct' or 'Predictive' modes to provide fast, accurate results. It is intended for use in hospitals, clinics, and medical practices by healthcare professionals. Disposable probe covers are used to prevent cross-contamination. The device displays temperature data on an LCD, allowing clinicians to monitor patient status and inform clinical decision-making. Benefits include rapid temperature assessment across diverse patient populations.
Clinical Evidence
No clinical testing data. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993-5, ISO 10993-10), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance testing against ISO 80601-2-56 and ASTM E1112-00 standards.
Technological Characteristics
Thermistor-based clinical electronic thermometer. Components: probe, probe cover (HDPE), LCD, button, circuit board, wall mounting plates. Materials: ABS enclosure, flame-retardant polycarbonate-polyester probe handle/shaft, aluminum tip. Power: AC via ri-former diagnostic station. Connectivity: Standalone/integrated with station. Software: Moderate level of concern. Sterilization: Non-sterile (disposable covers used).
Indications for Use
Indicated for measuring body temperature in oral, rectal, and axillary sites for adults, children, and infants.
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
- FILAC FAS TEMP ELECTRONIC THERMOMETER (K003313)
Submission Summary (Full Text)
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 4, 2017
Rudolf Riester GmbH % Mike Gu Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 7th Floor, Jingui Business Building No.982 Congyun Rd. Baiyun District Guangzhou, 510420 CHINA
Re: K171182
Trade/Device Name: ri-former Predictive Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: August 25, 2017 Received: August 28, 2017
Dear Mike Gu:
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. 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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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Tina
Kiang-S
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
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# Indications for Use
510(k) Number (if known) K171182
Device Name ri-former® Predictive Thermometer
## Indications for Use (Describe)
The device is used for measuring body temperature in the anus (rectal) and in the armpit (axillary). It is intended for adults, children and infants.
Type of Use (Select one or both, as applicable)
| <span style="font-size:100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------------------------------------------------------------------------------|
| <span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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# 510(k) Summary
# K171182
In accordance with 21 CFR 807.92 the following summary of information is provided:
### SUBMITTER l.
Rudolf Riester GmbH P.O. Box 35, Bruckstraße 31, DE - 72417Jungingen, Germany Phone: +74 77-92 70-0
Fax: +74 77-92 70-70
| Primary Contact Person: | Mike Gu |
|---------------------------|--------------------------------------------|
| | Regulatory Affairs Manager |
| | OSMUNDA Medical Device Consulting Co., Ltd |
| | Tel: (+86) 20-6232 1333 |
| | Fax: (+86) 20-8633 0253 |
| Secondary Contact Person: | Artur Pfister |
| | Quality Manager & Regulatory Affairs |
| | Rudolf Riester GmbH |
| | Tel: +74 77-92 70-0 |
| | Fax: +74 77-92 70-70 |
| Date Prepared: | Apr 21, 2017 |
II. DEVICE
| Name of Device: | ri-former® Predictive Thermometer |
|-----------------------|---------------------------------------------------|
| Common/Usual Name: | Clinical electronic thermometer |
| Classification Names: | Clinical electronic thermometer (21 CFR 880.2910) |
FLL Product Code:
ll
Regulation Class:
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### lll. PREDICATE DEVICE
# FILAC FAS TEMP ELECTRONIC THERMOMETER, K003313
This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
### IV. DEVICE DESCRIPTION
The ri-former® Predictive Thermometer is a fast, highly accurate, and easy to use clinical instrument for measuring patient temperatures by oral, axillary or rectal means. The thermometer is driven by the power supply of our ri-former® diagnostic station.
There are rectal (red) and oral, axillary (blue) probes available.
To prevent from cross contamination the thermometer needs to be used with disposable probe covers. The thermometer can be used for the temperature measurement of all patients and is designed for the use in hospitals, clinics, medical practices or similar facilities.
### V. INDICATION FOR USE
The device is used for measuring body temperature in the mouth (oral) in the anus (rectal) and in the armpit (axillary). It is intended for adults, children and infants.
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Image /page/5/Picture/1 description: The image shows the Riester logo. The logo consists of a circular symbol on the left and the word "Riester" on the right. The circular symbol is made up of two concentric circles with a gray sphere in the center. The word "Riester" is written in a bold, blue font.
## VI. SUBSTANTIAL EQUIVELENCE
| Specification | Predicate Device | Proposed Device | Discussion of Differences |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | FILAC FAS TEMP ELECTRONIC | ri-former PREDICTIVE | |
| | THERMOMETER | THERMOMETER | |
| K number | K003313 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| Classification | Class II | Class II | Identical |
| Product code | FLL | FLL | Identical |
| Intended use | The device is used as a predictive<br>measurement of temperature by<br>Oral, Axillary, or Rectal means.<br>It is intended for use on people of<br>all ages. | The device is used for measuring<br>body temperature in the mouth<br>(oral) in the anus (rectal) and in<br>armpit<br>(axillary). It<br>the<br>ાંડ<br>intended for adults, children and<br>infants. | Identical |
| Mechanism of | The electronic thermometer is detected by thermistor and calculated | | Identical |
| action | to provide fast and accurate temperature measurements. | | |
| Specification | Predicate Device | Proposed Device | Discussion of Differences |
| Power source | Battery | ri-former diagnostic station is<br>designed as a base unit for the<br>power supply. | Different, the proposed product<br>was<br>demonstrated<br>electromagnetic compatibility<br>and electrical safety by the<br>testing. The difference does not<br>raise the issues of product's<br>safety and effectiveness. |
| Components | Probe | Probe | Identical |
| | Plastic enclose | Plastic enclose | Identical |
| | LCD | LCD | Identical |
| | Button | Button | Identical |
| | battery | AC power | Different, the proposed device is<br>validated to be electrical safety,<br>refer to the test report of IEC<br>60601-1 and IEC 60601-1-2. |
| | Probe cover | Probe cover | Identical |
| | Probe cable | Probe cable | Identical |
| | Circuit Board | Circuit Board | Identical |
| | No mounting | Wall mounting plates | Similar. The predicate is a handle<br>device. The proposed device is<br>designed to be mounted on the<br>wall, so the mounting plates are<br>required. |
| Specification | Predicate Device | Proposed Device | Discussion of Differences |
| Materials | Enclose cover: Flame retardant<br>polycarbonate-polyester blend | Enclose cover: Acrylonitrile<br>butadiene styrene copolymers<br>(ABS D-1000) | The material of the enclose cover<br>is different. The ABS material is<br>widely used in medical devices |
| | Probe Handle: Flame retardant<br>polycarbonate-polyester blend | Probe Handle: Flame retardant<br>polycarbonate-polyester blend | Identical |
| | Probe Shaft: Flame retardant<br>polyester | Probe Shaft: Flame retardant<br>polyester | Identical |
| | Probe Cable: Polyurethane jacket<br>with TPE over mold | Probe Cable: Polyurethane jacket<br>with TPE over mold | Identical |
| | Tip: Aluminum | Tip: Aluminum | Identical |
| | Probe cover: High density<br>polyethylene ( HDPE) | Probe cover: High density<br>polyethylene ( HDPE) | Identical |
| | The device is constructed with non-<br>latex materials | The device is constructed with<br>non-latex materials | Identical |
| Sensor | Thermistor | | Identical |
| Anatomic site | Oral, axillary, rectal | | Identical |
| Environment of<br>Use | Hospital, clinics, medical practices or similar facilities. No use in MR<br>environment. | | Identical |
| Temperature range | 30 °C to 43 °C (86 °F to 109 °F) | | Identical |
| Specification | Predicate Device | Proposed Device | Discussion of Differences |
| Ambient<br>temperature<br>environment | 10 °C to 40 °C (50 °F to 104 °F) | | Identical |
| Accuracy | Water Bath Accuracy (35.5 °C to 42.0 °C): Direct Mode (All Sites): ±<br>0.1 °C (±0.2 °F)<br>Standard Prediction Mode (All Sites)**: ±0.1 °C (±0.2°F)<br>Quick Prediction Mode (Oral Only)**: ±0.3 °C (±0.5°F)<br>Patient Accuracy: In standard predict mode, thermometer accuracy<br>meets EN 12470-3<br>A Standard Prediction Mode reading and a Direct Mode reading will<br>differ by less than ±0.2°C (±0.4 °F) on 98% of tested patients | | Identical |
| Precision and<br>repeatability | A Standard Prediction Mode reading and a Direct Mode reading will<br>differ by less than ± 0.2 °C (± 0.4 °F) on 98% of tested patients | | Identical |
| Response time | Oral (Quick Mode): 3-5 seconds (non-fever temps), 8-10 seconds (fever<br>temps)<br>Oral (Standard Mode): 6-10 seconds<br>Axillary Mode: 8-12 seconds<br>Rectal Mode: 10-14 seconds<br>Direct Mode (All Sites): 60-120 seconds | | Identical |
| Probe | The probe used in proposed device is the identical one of the predicate<br>device. | | Identical |
| Specification | Predicate Device | Proposed Device | Discussion of Differences |
| Patient contact<br>materials | Probe cover: High density polyethylene ( HDPE)<br>The probe cover used in proposed device is the identical one of the<br>predicate device. | Probe cover: High density polyethylene ( HDPE)<br>The probe cover used in proposed device is the identical one of the<br>predicate device. | Identical |
| User function | Direct Mode | Direct Mode | Identical |
| | Quick Mode | Quick Mode | Identical |
| | Cold Mode | Cold Mode | Identical |
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# () Riester
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# () Riester
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# () Riester
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Image /page/10/Picture/1 description: The image shows the logo for the company Riester. The logo consists of a blue circle with a smaller black circle inside, and the word "Riester" in blue, block letters. The logo is simple and modern, and the blue color gives it a professional look.
#### VII. NON-CLINICAL PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence:
## Biocompatibility:
The human contacting components, the probe and probe cover,
were tested in accordance with:
-ISO 10993-5:2009 biological evaluation of medical devices – Part
5: Tests for in vitro cytotoxicity
-ISO 10993-10:2013 biological evaluation of medical devices – Part
10: Tests for irritation and skin sensitization
# Electrical Safety and EMC:
The device was tested accordance with:
- IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
- IEC 60601-1-2:2007(Third edition), Medical Electrical Equipment -- Part 1-2: General Requirements for Basic Safety and Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements and Tests
## Performance Testing:
- ISO 80601-2-56 First Edition 2009-10-01 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
-ASTM E1112-00 (Reapproved 2011) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
# Software Verification and Validation:
Per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", Riester has provided appropriate software documentation based on moderate Level of Concern. A system level software verification and validation protocol was developed to
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test each requirement. Results of each test are recorded and compared to the pass/fail criteria. All software verification and validation activities show that the software meets product requirements documentation.
#### VIII. CLINICAL TESTING DATA
No clinical testing data is included in this submission.
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### CONCLUSION IX.
ri-former® Predictive Thermometer and its application comply with the thermometer performance standards. Non-clinical tests determined that the ri-former® Predictive Thermometer performance is substantially equivalent to the predicate device.
