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 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.

AI/ML Overview

This FDA 510(k) premarket notification for the "ri-former Predictive Thermometer" indicates that no clinical studies were performed. The device's substantial equivalence to a predicate device ("FILAC FAS TEMP ELECTRONIC THERMOMETER", K003313) was established through non-clinical performance data.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies cannot be extracted from the provided document.

However, based on the non-clinical testing performed, we can infer some performance criteria that the device met:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria (Implied by Standards)	Reported Device Performance
Biocompatibility	- ISO 10993-5:2009 (Tests for in vitro cytotoxicity) compliant - ISO 10993-10:2013 (Tests for irritation and skin sensitization) compliant	Human contacting components (probe, probe cover) were tested in accordance with ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and skin sensitization). (Implies compliance as it was submitted in support of substantial equivalence).
Electrical Safety	- IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012 compliant (General Requirements for Basic Safety and Essential Performance)	Device was tested in accordance with IEC 60601-1. (Implies compliance as it was submitted in support of substantial equivalence and cited as evidence for different power source and materials).
Electromagnetic Compatibility (EMC)	- IEC 60601-1-2:2007 (Third edition) compliant (Collateral Standard: Electromagnetic Disturbances -- Requirements and Tests)	Device was tested in accordance with IEC 60601-1-2. (Implies compliance as it was submitted in support of substantial equivalence and cited as evidence for different power source).
Thermometer Performance (Overall)	- ISO 80601-2-56 First Edition 2009-10-01 compliant (Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement) - ASTM E1112-00 (Reapproved 2011) compliant (Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature) - Consistent with Predicate Device	Tests determined that the ri-former® Predictive Thermometer performance is substantially equivalent to the predicate device. The device was tested in accordance with ISO 80601-2-56 and ASTM E1112-00. (Implies compliance with these standards and substantial equivalence).
Software Verification & Validation	- FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" compliant (Moderate Level of Concern) - All software requirements met Pass/Fail criteria.	System level software verification and validation protocol developed. Results of each test recorded and compared to pass/fail criteria. All software verification and validation activities show that the software meets product requirements documentation. (Implies all requirements were met).
Power Source (Differences from Predicate)	The difference in power source (ri-former diagnostic station vs. battery) does not raise issues of product's safety and effectiveness. Electromagnetic compatibility and electrical safety demonstrated by testing.	Demonstrated electromagnetic compatibility and electrical safety by testing (IEC 60601-1 and IEC 60601-1-2). Validated to be electrical safety.
Enclose Cover Material (Differences from Predicate)	The ABS material is widely used in medical devices and does not raise issues of product's safety and effectiveness.	(Implied: ABS D-1000 is acceptable and does not raise new safety or effectiveness concerns, in line with its wide use in medical devices).

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No clinical test set was used. The substantial equivalence was based on non-clinical performance data and comparison to a predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. No clinical test set was used, and thus no ground truth established by experts for a test set.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states "No clinical testing data is included in this submission."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable in the context of an AI/ML algorithm. This device is a predictive thermometer, which is a hardware device with embedded software, not typically evaluated as a standalone AI algorithm in the same way imaging or diagnostic AI is. The software was verified and validated to meet product requirements.

7. The Type of Ground Truth Used

Not applicable in the context of clinical "ground truth" derived from patient data. For the non-clinical performance tests, such as those against ISO and ASTM standards, the "ground truth" would be established by the reference conditions and measurement techniques defined within those standards (e.g., calibrated water baths for temperature accuracy, standard test procedures for electrical safety).

8. The Sample Size for the Training Set

Not applicable. The document does not describe an AI/ML model that would require a "training set" in the conventional sense. The device is a "predictive thermometer," suggesting a model or algorithm for temperature prediction, but information on how this internal prediction algorithm was developed or trained is not provided in this 510(k) summary. The software verification and validation focused on meeting product requirements rather than describing a training process for an AI model.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as a training set for an AI/ML model is not described.

Summary

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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.

Image /page/0/Picture/10 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which consists of a stylized caduceus with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the seal.

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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)

☑ 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:

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

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 predictivemeasurement of temperature byOral, Axillary, or Rectal means.It is intended for use on people ofall ages.	The device is used for measuringbody temperature in the mouth(oral) in the anus (rectal) and inarmpit(axillary). Ittheાંડintended for adults, children andinfants.	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 isdesigned as a base unit for thepower supply.	Different, the proposed productwasdemonstratedelectromagnetic compatibilityand electrical safety by thetesting. The difference does notraise the issues of product'ssafety and effectiveness.
Components	Probe	Probe	Identical
	Plastic enclose	Plastic enclose	Identical
	LCD	LCD	Identical
	Button	Button	Identical
	battery	AC power	Different, the proposed device isvalidated to be electrical safety,refer to the test report of IEC60601-1 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 handledevice. The proposed device isdesigned to be mounted on thewall, so the mounting plates arerequired.
Specification	Predicate Device	Proposed Device	Discussion of Differences
Materials	Enclose cover: Flame retardantpolycarbonate-polyester blend	Enclose cover: Acrylonitrilebutadiene styrene copolymers(ABS D-1000)	The material of the enclose coveris different. The ABS material iswidely used in medical devices
	Probe Handle: Flame retardantpolycarbonate-polyester blend	Probe Handle: Flame retardantpolycarbonate-polyester blend	Identical
	Probe Shaft: Flame retardantpolyester	Probe Shaft: Flame retardantpolyester	Identical
	Probe Cable: Polyurethane jacketwith TPE over mold	Probe Cable: Polyurethane jacketwith TPE over mold	Identical
	Tip: Aluminum	Tip: Aluminum	Identical
	Probe cover: High densitypolyethylene ( HDPE)	Probe cover: High densitypolyethylene ( HDPE)	Identical
	The device is constructed with non-latex materials	The device is constructed withnon-latex materials	Identical
Sensor	Thermistor		Identical
Anatomic site	Oral, axillary, rectal		Identical
Environment ofUse	Hospital, clinics, medical practices or similar facilities. No use in MRenvironment.		Identical
Temperature range	30 °C to 43 °C (86 °F to 109 °F)		Identical
Specification	Predicate Device	Proposed Device	Discussion of Differences
Ambienttemperatureenvironment	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 accuracymeets EN 12470-3A Standard Prediction Mode reading and a Direct Mode reading willdiffer by less than ±0.2°C (±0.4 °F) on 98% of tested patients		Identical
Precision andrepeatability	A Standard Prediction Mode reading and a Direct Mode reading willdiffer 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 (fevertemps)Oral (Standard Mode): 6-10 secondsAxillary Mode: 8-12 secondsRectal Mode: 10-14 secondsDirect Mode (All Sites): 60-120 seconds		Identical
Probe	The probe used in proposed device is the identical one of the predicatedevice.		Identical
Specification	Predicate Device	Proposed Device	Discussion of Differences
Patient contactmaterials	Probe cover: High density polyethylene ( HDPE)The probe cover used in proposed device is the identical one of thepredicate device.	Probe cover: High density polyethylene ( HDPE)The probe cover used in proposed device is the identical one of thepredicate 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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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.

Regulation Number and Section

§ 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.