This oscillometric blood pressure monitor is intended to measure the systolic blood pressure, pulse rate and mean arterial pressure (MAP) in people aged 3 years or older. This device is intended to be operated by trained personnels only. Examples of trained operators include professional clinical and healthcare personnels.

This oscillometric blood pressure monitor is intended for measuring non-invasive blood pressure in people aged 3 years or older. It is clinically validated in patients with hypertension, hypotension, diabetes, pregnancy, pre-eclampsia, atherosclerosis, end-stage renal disease, obesity and the elderly. This device is intended to be operated by trained personnels only. Examples of trained operators include professional clinical and healthcare personnels.

Device Description

The proposed device, oscillometric blood pressure monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure, pulse rate and mean arterial pressure of the person aged 3 years or older at upper arm within its claimed range and accuracy via the oscillometric technique.

The proposed oscillometric blood pressure monitor is available in one model, RBP 100.

Three sizes of cuffs are provided with proposed device, which are S size, M size and L-XL size: 14~~22cm; M size: 22~~32cm; L-XL size: 32~52cm).

The proposed device is intended to be used in medical facilities.

AI/ML Overview

The provided text describes the regulatory clearance of an oscillometric blood pressure monitor (K190927) and references a clinical study conducted to demonstrate its accuracy.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a non-invasive blood pressure monitor. The key performance acceptance criterion for such devices is accuracy as defined by the ISO 81060-2:2013 standard. This standard dictates limits for the difference between the device's measurements and reference measurements (typically from a mercury sphygmomanometer).

Acceptance Criteria (per ISO 81060-2:2013)	Performance (Reported in Clinical Study)
Systematic Error (Mean difference): Mean difference between device and reference measurements must be within ± 5 mmHg.	Not explicitly stated as a single numerical value, but the document states "The test results can meet the requirements of acceptance criteria and ISO 81060." This implies the mean difference was within ± 5 mmHg.
Random Error (Standard Deviation): Standard deviation of the differences between device and reference measurements must be less than or equal to 8 mmHg.	Not explicitly stated as a single numerical value, but the document states "The test results can meet the requirements of acceptance criteria and ISO 81060." This implies the standard deviation was within 8 mmHg.

Note: While the document mentions "Blood Pressure Accuracy: ±3 mmHg" in the comparative table (Page 6), this is likely a more general specification for the device's internal accuracy, whereas the clinical validation against ISO 81060-2 is what demonstrates its performance in a clinical setting against a reference standard. The ISO standard has specific, more complex criteria involving mean difference and standard deviation of differences across subjects. The statement "The test results can meet the requirements of acceptance criteria and ISO 81060" confirms adherence to the ISO standard.

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

Test Set Sample Size:
- Adults: Three distinct groups were recruited: "Three 85 subjects (aged 54±19 years)", "33 subjects (aged 53±17 years)", and 41 children. It's unclear if the "Three 85 subjects" refers to 3 groups of 85, or if "85 subjects" is the total. However, the ISO 81060-2 standard typically requires a minimum of 85 subjects for a full validation. Given the multiple age ranges and types of subjects mentioned, it indicates efforts to cover the required demographic spread.
- Children: 41 children (7.7±2.8 years).
Data Provenance: The document does not explicitly state the country of origin for the clinical study data. It was a primary clinical study conducted for the predicate device (WatchBP, K101275) and re-used for the current device due to identical blood pressure models. The study was conducted retrospectively in relation to the current device's submission, but was likely a prospective study at the time it was originally performed for the predicate device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The context of the study is a comparison of an automated device against a reference method (likely a mercury sphygmomanometer as per ISO 81060-2). The "ground truth" for blood pressure measurements in such studies is established by trained oscillometric and auscultatory observers who follow strict protocols for manual blood pressure measurement to serve as the reference. The document does not specify the number or qualifications of these observers, but the adherence to ISO 81060-2 implies that appropriately trained personnel performed the reference measurements.

4. Adjudication Method for the Test Set

The study used the "same-arm sequential BP measurement method" which is a standard procedure in ISO 81060-2. This method involves taking alternating measurements from the test device and a reference device (e.g., a mercury sphygmomanometer) on the same arm. Adjudication in the typical sense (e.g., 2+1 or 3+1 reader consensus for imaging studies) is not applicable here as the ground truth is established by a direct physical measurement comparison. The ground truth itself is derived from the reference standard measurements.

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

No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI devices where human readers interpret images with and without AI assistance. This submission pertains to a blood pressure monitor, which is a standalone measurement device, and the clinical study focuses on its measurement accuracy compared to a reference standard, not its impact on human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) was Done

Yes, the clinical study performed for the predicate device (WatchBP) and referenced here is effectively a standalone performance study. The study evaluated the accuracy of the oscillometric blood pressure monitor in measuring blood pressure values compared to a reference standard, independent of human interpretation or intervention beyond operating the device. The device itself performs the measurement and outputs the values.

7. The Type of Ground Truth Used

The ground truth used was reference blood pressure measurements obtained from a standard method (implied to be auscultatory measurements using a mercury sphygmomanometer) as mandated by the ISO 81060-2:2013 standard. This is a form of empirical measurement ground truth.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is because the device described is a traditional oscillometric blood pressure monitor, not an AI/ML-driven device that typically requires a large training dataset. The "blood pressure model" refers to the underlying algorithm or method for oscillating blood pressure measurement, which would have been developed and refined through engineering, calibration, and clinical validation, not necessarily "trained" in the machine learning sense. The clinical study described is for validation/performance, not for training.

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

As there's no mention of a "training set" in the context of an AI/ML model, the concept of establishing ground truth for a training set is not applicable here. The "blood pressure model" was likely developed based on known physiological principles of oscillometry and extensively tested/calibrated using controlled experimental setups and initial clinical trials (which are distinct from the final validation study mentioned).

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 24, 2019

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

Re: K190927

Trade/Device Name: Oscillometric Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: February 21, 2019 Received: April 9, 2019

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. 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 located 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.

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

{1}------------------------------------------------

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,

Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K190927

Device Name Oscillometric Blood Pressure Monitor

Indications for Use (Describe)

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 Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"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."

{3}------------------------------------------------

Tab 7 510(k) Summary

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

The assigned 510(k) Number: K190927

1. Date of Preparation: 06/24/2019
1. Sponsor Identification

Rudolf Riester GmbH.

P.O. Box 35 Bruckstrasse 31, Baden-Württemberg, D-72417, Germany

Establishment Registration Number: 8010482

Contact Person: Vivi Ding Position: Regulatory & Register Engineer Tel: +49 7477 9270-43 Fax: +49 7477 9270-70 Email: vivi@riester-china.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Mr. Chengyu Wang (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

{4}------------------------------------------------

4. Identification of Proposed Device

Trade Name: Oscillometric Blood Pressure Monitor; Common Name: Blood Pressure Monitor; Models: RBP-100

Regulatory Information

Classification Name: Noninvasive blood pressure measurement system Classification: II Product Code: DXN; Regulation Number: 21 CFR 870.1130; Review Panel: Cardiovascular;

Indication for Use Statement:

This oscillometric blood pressure monitor is intended to measure the systolic and diastolic blood pressure, pulse rate and mean arterial pressure (MAP) in people aged 3 years or older. This device is intended to be operated by trained personnels only. Examples of trained operators include professional clinical and healthcare personnels.

Device Description:

The proposed oscillometric blood pressure monitor is available in one model, RBP 100.

Three sizes of cuffs are provided with proposed device, which are S size, M size and L-XL size: 14~~22cm; M size: 22~~32cm; L-XL size: 32~52cm).

The proposed device is intended to be used in medical facilities.

{5}------------------------------------------------

న్. Identification of Predicate Device
510(k) Number: K101275 Product Name: Upper Arm Automatic Digital Blood Pressure Monitor Manufacturer: Microlife Intellectual Property GmbH
1. Non-Clinical Test Conclusion
  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:

IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012, Medical electrical equipment - Patt 1: General requirements for basic safety, and essential performance.

IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility

IEC 80601-2-30:2009, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers

1. Clinical Test Conclusion
  The blood pressure model for proposed device is identical to the device WatchBP cleared in K101275. Therefore, a new clinical study was not conducted on the proposed device and a study performed on WatchBP per ISO 81060-2:2013 is provided to demonstrate the accuracy of the professional oscillometric blood pressure monitor in adults and children, the clinical study result is summarized in following.

Three 85 subjects (aged 54±19 years), 33 subjects (aged 53±17 years ) and 41 children (7.7±2.8 years) were respectively recruited to fulfil the age, sex, BP and cuff distribution criteria of the ISO standard using the same-arm sequential BP measurement method. Three cuffs were tested in this clinical study to cover all proposed cuff models (small for arm circumference 14-22 cm, medium for 22-32cm and large cuff for 32-52cm). The test results can meet the requirements of acceptance criteria and ISO 81060. Therefore, the clinical accuracy of proposed device used on adult and children can be demonstrated.

{6}------------------------------------------------

8. Substantially Equivalent

Table 1 Substantially Equivalent Comparison

ITEM	Proposed Device	Predicate Device, K101275
Product Code	DXN	DXN
Regulation No.	21 CFR 870.1130	21 CFR 870.1130
Class	II	II
Indication for Use	This oscillometric blood pressure monitor is intended for measuring non-invasive blood pressure in people aged 3 years or older. It is clinically validated in patients with hypertension, hypotension, diabetes, pregnancy, pre-eclampsia, atherosclerosis, end-stage renal disease, obesity and the elderly. This device is intended to be operated by trained personnels only. Examples of trained operators include professional clinical and healthcare personnels.	The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office AFIB (TWIN200 AFS) is a device intended to measure the systolic and diastolic blood pressure, pulse rate, pulse pressure (PP) and mean arterial pressure (MAP) of an adult individual by using a non-invasive oscillometric technique in one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper arm(s). The device detects the appearance of atrial fibrillation during measurement and gives a warning signal with the reading once the atrial fibrillation is detected.
MeasurementType	Upper arm	Upper arm
PatientPopulation	People aged 3 years or older	Adult
MeasurementItem	Systolic Pressure, Diastolic Pressure, Pulse Rate, MAP	Systolic Pressure, Diastolic Pressure, Pulse Rate, MAP
Principle	Oscillometric	Oscillometric
Armcircumference	S size: 14~~22cm;M size: 22~~32cm;L-XL size: 32~52cm	M size: 22~~32cm;L size: 32~~42cm
Blood PressureRange	60 - 255 mmHg - systolic blood pressure30 - 200 mmHg - diastolic blood pressure	30 ~ 280 mmHg
Blood PressureAccuracy	3 mmHg	3 mmHg
Pulse RateRange	40 ~ 200 bpm	40 ~ 200 bpm
Dimensions	170mm×135mm×41mm	200mm×125mm×90mm
Weight	510g (including batteries)	1100g (including batteries)
Patient ContactMaterial	Cuff – Nylon	Cuff – Nylon
Electrical Safety	Comply with IEC 60601-1	Comply with IEC 60601-1
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2
ParticularPerformance	Comply with IEC 80601-2-30:2009and ISO 81060-2:2013	Comply with IEC 80601-2-30:2009and ISO 81060-2:2013
Software LevelConcern	Moderate	Moderate

{7}------------------------------------------------

The differences between proposed device and predicate include target population, arm circumference and blood pressure range. Target population and arm circumference of proposed device has been validated by clinical trials. The range of proposed device is completely covered by that of predicate. These differences do not raise any question regarding its safety and effectiveness.

1. Substantially Equivalent (SE) Conclusion
  Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate devices.

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).