The RVS-100 vital signs monitor is intended to be used for monitoring, reviewing, storing and sending alarms regarding multiple physiological patient parameters, including Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Noninvasive Blood Pressure (NIBP), and Temperature (Temp).

The RVS-100 vital signs monitor is intended to be used in controlled, hospital environments. It is not intended for helicopter transport, hospital ambulance or home use.

Device Description

The Riester RVS-100 vital signs monitor can perform automatic blood pressure, pulse oximetry and body temperature measurements for clinical professionals. The RVS-100 is a portable device, consist of main unit and accessories, including NIBP cuff, Temperature sensor, and SpO2 sensor.

RVS-100 vital signs monitor has a DC power connector, RVS-100 can connect with extension device RVS-200 and supply power for RVS-200 through the DC power connector.

AI/ML Overview

The provided text is a 510(k) summary for the RVS-100 Vital Signs Monitor. This document focuses on demonstrating substantial equivalence to a predicate device and includes information about non-clinical testing against recognized standards. It does not detail a clinical study with specific acceptance criteria, reported device performance metrics like sensitivity/specificity, or parameters related to AI/algorithm performance.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance

Cannot be directly created. The document lists non-clinical standards the device complies with (e.g., IEC 60601-1, IEC 80601-2-30). These standards have their own acceptance criteria, but they are general safety and performance standards for vital signs monitors, not specific performance metrics (like sensitivity, specificity, or agreement with a gold standard) for a diagnostic algorithm. The document states "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." However, specific quantitative performance data against acceptance criteria are not provided in this summary.

2. Sample size used for the test set and the data provenance

Not applicable / Not provided. No clinical test set data is described. The non-clinical tests would involve testing against equipment and simulated conditions, not a "sample size" of patients or data in the typical sense of a diagnostic study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable / Not provided. No clinical test set or ground truth establishment by experts is described.

4. Adjudication method for the test set

Not applicable / Not provided. No clinical test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This device is a vital signs monitor, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

N/A. The device itself performs measurements; it's not an "algorithm only" device in the context of diagnostic AI. Its performance is evaluated against physical measurement standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable (for a clinical context). For non-clinical tests, the "ground truth" would be established by reference measurement devices or calibrated standards as per the specific IEC/ISO standards mentioned (e.g., a calibrated pressure meter for NIBP, a reference oximeter for SpO2). The document explicitly states: "Non-clinical testing is included in this submission, because all modules have been previously cleared by FDA." This implies reliance on established methods for vital signs measurement.

8. The sample size for the training set

Not applicable / Not provided. This is not an AI/machine learning device that requires a training set in the typical sense.

9. How the ground truth for the training set was established

Not applicable / Not provided. As above, no training set for an AI/ML model is described.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.

October 17, 2017

Rudolf Riester GmbH % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China

Re: K170538

Trade/Device Name: RVS-100 Vital Signs Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Code: MWI Dated: September 5, 2017 Received: September 12, 2017

Dear Diana Hong:

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.

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 of medical device-related 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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

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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/MedicalDevicesforYou/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,

M.A. Wilhelm

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K170538

Device Name RVS-100 Vital Signs Monitor

Indications for Use (Describe)

The RVS-100 vital signs monitor is intended to be used in controlled, hospital environments. It is not intended for helicopter transport, hospital ambulance or home use.

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

This 510(k) Summary of 510(k) information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K170538_

1. Date of Submission:8/25/2017
1. Sponsor Identification

Rudolf Riester GmbH P.O.B. 35, Bruckstraße 31 DE-72417, Jungingen, Germany

Establishment Registration Number: 8010482

Contact Person: Christof Kleiner Position: Technical Director Tel: +49-7477-9270-43 Fax: +49-7477-9270-70 Email: kleiner@riester.de

1. Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Betty Xiao (Alternative Contact Person) Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

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1. Proposed Device Identification
  Proposed Device Name:RVS-100 Vital Signs Monitor Proposed Device Common Name: Vital Signs Monitor

Regulatory Information: Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): Classification: II; Product Code: MWI; Regulation Number: 21 CFR 870.2300; Review Panel: Cardiovascular;

Intended Use Statement:

The RVS-100 vital signs monitor is intended to be used for monitoring, displaying, storing and sending alarms regarding multiple physiological patient parameters, including Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), and Temperature (Temp).

The RVS-100 vital signs monitor is intended to be used in controlled, hospital environments. It is not intended for helicopter transport, hospital ambulance or home use.

5. Predicate Device Identification

510(k) Number: K153135 Product Name: Vital Signs Monitor V6 Manufacturer: Guangdong Biolight Meditech Co., Ltd

1. Device Description
  The Riester RVS-100 vital signs monitor can perform automatic blood pressure, pulse oximetry and body temperature measurements for clinical professionals. The RVS-100 is a portable device, consist of main unit and accessories, including NIBP cuff, Temperature sensor, and SpO2 sensor.

RVS-100 vital signs monitor has a DC power connector, RVS-100 can connect with extension device RVS-200 and supply power for RVS-200 through the DC power connector.

Note: RVS-200 Wall Diagnostic Station mainly consists of reservoir for ear specula and probe cover. It is classified as a Class I 510(k) Exempt medical device, and not included in this 510(k) submission

1. Non-Clinical Test Conclusion

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Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

A IEC 60601-1: 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
A IEC 60601-1-8: 2012 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
A IEC 80601-2-30:2013 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
A IEC 80601-2-61:2011 Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
ISO 80601-2-56: 2009 Medical electrical equipment - Part 2-56: Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement.
Clinical Test Conclusion 8.

Non-clinical testing is included in this submission, because all modules have been previously cleared by FDA.

Substantially Equivalent (SE) Conclusion 9.
The following table compares the DEVICE to the predicate device with respect to intended use, energy source and fluency, etc.

ITEM	Proposed Device	Predicate Device	Remark
	RVS-100 Vital Signs Monitor	Vital Signs Monitor V6
Product Code	MWI	MWI	Same
Regulation No.	870.2300	870.2300	Same
Class	II	II	Same
Intended use	The RVS-100 vital signs monitor is intended to be used for monitoring,	The Vital Signs Monitor V6 is intended to be used for monitoring, displaying,	Similar

Table 3-1 Comparison of Technology Characteristics

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	displaying, reviewing, storing andsending alarms regarding multiple	reviewing, storing and alarming ofmultiple physiological parameters of
	physiological patient parameters,	patients, including Pulse Oxygen
	including Pulse Oxygen Saturation(SpO2), Pulse Rate (PR), Non-invasive	Saturation (SpO2), Pulse Rate (PR),Non-invasive Blood Pressure (NIBP),
	Blood Pressure (NIBP), and Temperature(Temp).	Carbon dioxide (CO2) and Temperature(Temp). The Vital Signs Monitor V6 is
	The RVS-100 vital signs monitor isintended to be used in controlled,hospital environments. It is notintended for helicopter transport,hospital ambulance or home use.	intended to be use in outpatientdepartments and emergency treatmentrooms of hospitals, community clinics,private clinics and other medicalinstitutions. It is not intended forhelicopter transport, hospital ambulanceor home use.
IntendedPopulation	The monitors are intended for adult,pediatric and neonatal.	The monitors are intended for adult,pediatric and neonatal.	Same
IntendedEnvironment	The RVS-100 vital signs monitor isintended to be used in outpatientdepartments, emergency treatmentrooms, and low-acuity areas of hospitals,community clinics, private clinics andother medical institutions. It is notintended for helicopter transport, hospitalambulance or home use.	The vital signs monitor is used to be usedin hospital environments includingout-patient outpatient departments, wardsand NICU. It is not intended for helicoptertransport, hospital ambulance or homeuse.	Same
Power Supply	The monitors can be supplied by ACpower.	The monitors can be supplied by ACpower.	Similar
Number of Patientbe monitored eachtime	Single patient each time	Single patient each time	Same
	No	No	Same

The proposed device, RVS-100 Vital Signs Monitor, is determined to be Substantially Equivalent (SE) to the predicate device.

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).