(163 days)
No reference devices were used in this submission.
No
The summary describes a standard predictive thermometer and does not mention any AI or ML components. The performance studies focus on standard electrical safety, biocompatibility, and performance testing against established standards, not on AI/ML model validation.
No
Explanation: This device is a thermometer used for measuring body temperature, which is a diagnostic tool, not a therapeutic intervention.
No
The device measures body temperature, which is a vital sign indicating a patient's current state, but it does not diagnose a disease or condition. It is a measurement tool.
No
The device description explicitly states it is a "clinical instrument" and mentions physical components like "probes" and a "power supply," indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is used for measuring body temperature. This is a physiological measurement taken directly from the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states it's a "clinical instrument for measuring patient temperatures by oral, axillary or rectal means." This involves direct contact with the patient.
The device is a clinical thermometer, which is a medical device used for measuring body temperature, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FLL
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.
Mentions image processing
No
Mentions AI, DNN, or ML
No
Input Imaging Modality
Not Found
Anatomical Site
mouth (oral), anus (rectal), armpit (axillary)
Indicated Patient Age Range
adults, children and infants
Intended User / Care Setting
hospitals, clinics, medical practices or similar facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests determined that the ri-former® Predictive Thermometer performance is substantially equivalent to the predicate device.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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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1
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ 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:
4
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 | ||
| measurement of temperature by | |||
| Oral, Axillary, or Rectal means. | |||
| It is intended for use on people of | |||
| all ages. | The device is used for measuring | ||
| body temperature in the mouth | |||
| (oral) in the anus (rectal) and in | |||
| armpit | |||
| (axillary). It | |||
| the | |||
| ાંડ | |||
| intended for adults, children and | |||
| 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 | |
| designed as a base unit for the | |||
| power supply. | Different, the proposed product | ||
| was | |||
| demonstrated | |||
| electromagnetic compatibility | |||
| and electrical safety by the | |||
| testing. The difference does not | |||
| raise the issues of product's | |||
| 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 | |
| validated to be electrical safety, | |||
| refer to the test report of IEC | |||
| 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 | |
| device. The proposed device is | |||
| designed to be mounted on the | |||
| wall, so the mounting plates are | |||
| required. | |||
| Specification | Predicate Device | Proposed Device | Discussion of Differences |
| Materials | Enclose cover: Flame retardant | ||
| polycarbonate-polyester blend | Enclose cover: Acrylonitrile | ||
| butadiene styrene copolymers | |||
| (ABS D-1000) | The material of the enclose cover | ||
| is different. The ABS material is | |||
| widely used in medical devices | |||
| Probe Handle: Flame retardant | |||
| polycarbonate-polyester blend | Probe Handle: Flame retardant | ||
| polycarbonate-polyester blend | Identical | ||
| Probe Shaft: Flame retardant | |||
| polyester | Probe Shaft: Flame retardant | ||
| polyester | Identical | ||
| Probe Cable: Polyurethane jacket | |||
| with TPE over mold | Probe Cable: Polyurethane jacket | ||
| with TPE over mold | Identical | ||
| Tip: Aluminum | Tip: Aluminum | Identical | |
| Probe cover: High density | |||
| polyethylene ( HDPE) | Probe cover: High density | ||
| polyethylene ( HDPE) | Identical | ||
| The device is constructed with non- | |||
| latex materials | The device is constructed with | ||
| non-latex materials | Identical | ||
| Sensor | Thermistor | Identical | |
| Anatomic site | Oral, axillary, rectal | Identical | |
| Environment of | |||
| Use | Hospital, clinics, medical practices or similar facilities. No use in MR | ||
| environment. | Identical | ||
| Temperature range | 30 °C to 43 °C (86 °F to 109 °F) | Identical | |
| Specification | Predicate Device | Proposed Device | Discussion of Differences |
| Ambient | |||
| temperature | |||
| 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): ± | ||
| 0.1 °C (±0.2 °F) | |||
| Standard Prediction Mode (All Sites)**: ±0.1 °C (±0.2°F) | |||
| Quick Prediction Mode (Oral Only)**: ±0.3 °C (±0.5°F) | |||
| Patient Accuracy: In standard predict mode, thermometer accuracy | |||
| meets EN 12470-3 | |||
| A Standard Prediction Mode reading and a Direct Mode reading will | |||
| differ by less than ±0.2°C (±0.4 °F) on 98% of tested patients | Identical | ||
| Precision and | |||
| repeatability | A Standard Prediction Mode reading and a Direct Mode reading will | ||
| 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 | ||
| temps) | |||
| Oral (Standard Mode): 6-10 seconds | |||
| Axillary Mode: 8-12 seconds | |||
| Rectal Mode: 10-14 seconds | |||
| Direct Mode (All Sites): 60-120 seconds | Identical | ||
| Probe | The probe used in proposed device is the identical one of the predicate | ||
| device. | Identical | ||
| Specification | Predicate Device | Proposed Device | Discussion of Differences |
| Patient contact | |||
| materials | Probe cover: High density polyethylene ( HDPE) | ||
| The probe cover used in proposed device is the identical one of the | |||
| predicate device. | Probe cover: High density polyethylene ( HDPE) | ||
| The probe cover used in proposed device is the identical one of the | |||
| predicate device. | Identical | ||
| User function | Direct Mode | Direct Mode | Identical |
| Quick Mode | Quick Mode | Identical | |
| Cold Mode | Cold Mode | Identical |
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Image /page/6/Picture/1 description: The image contains the logo for Riester. The logo consists of a circular symbol on the left and the word "Riester" in blue, block letters on the right. The circular symbol appears to be a stylized representation of an eye or a lens.
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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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Image /page/11/Picture/0 description: The image shows the logo for Riester. The logo consists of a circular symbol on the left and the word "Riester" in blue on the right. The circular symbol has a gray sphere in the center, surrounded by two blue arcs.
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.