(76 days)
No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML capabilities. The performance study relies on a predicate device and standard clinical testing methods, not AI/ML model validation.
No.
The device is a blood pressure monitor intended for measurement and diagnosis, not for treating any medical condition.
Yes
This device is an oscillometric blood pressure monitor intended to measure systolic blood pressure, pulse rate, and mean arterial pressure (MAP), and is clearly stated to be intended for measuring non-invasive blood pressure. These measurements are used to assess a patient's health status, which is a diagnostic purpose. The clinical validation for conditions like hypertension, hypotension, and pre-eclampsia further indicates its use in the diagnosis and management of these conditions.
No
The device description explicitly states it is a "battery driven automatic non-invasive blood pressure monitor" and mentions physical components like "Three sizes of cuffs are provided". This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- 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 Function: The description clearly states that this device is an "oscillometric blood pressure monitor" that measures "systolic blood pressure, pulse rate and mean arterial pressure (MAP)" and "non-invasive blood pressure" by applying a cuff to the "upper arm".
- Method of Measurement: The measurement is performed externally on the body using the oscillometric technique, not on a sample taken from the body.
Therefore, this device falls under the category of a non-invasive medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DXN
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: 1422cm; M size: 2232cm; L-XL size: 32~52cm).
The proposed device is intended to be used in medical facilities.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
3 years or older
Intended User / Care Setting
trained personnels only. Examples of trained operators include professional clinical and healthcare personnels.
in medical 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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Blood Pressure Accuracy: 3 mmHg
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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
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Indications for Use
510(k) Number (if known) K190927
Device Name Oscillometric Blood Pressure Monitor
Indications for Use (Describe)
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.
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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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
-
- Date of Preparation: 06/24/2019
-
- 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
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Chengyu Wang (Alternative Contact Person)
- Designated Submission Correspondent
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
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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 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: 1422cm; M size: 2232cm; 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 -
- 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:
- Non-Clinical Test Conclusion
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
-
- 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.
- Clinical Test Conclusion
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.
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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. |
| Measurement | ||
| Type | Upper arm | Upper arm |
| Patient | ||
| Population | People aged 3 years or older | Adult |
| Measurement | ||
| Item | Systolic Pressure, Diastolic Pressure, Pulse Rate, MAP | Systolic Pressure, Diastolic Pressure, Pulse Rate, MAP |
| Principle | Oscillometric | Oscillometric |
| Arm | ||
| circumference | S size: 14~22cm; | |
| M size: 22~32cm; | ||
| L-XL size: 32~52cm | M size: 22~32cm; | |
| L size: 32~42cm | ||
| Blood Pressure | ||
| Range | 60 - 255 mmHg - systolic blood pressure | |
| 30 - 200 mmHg - diastolic blood pressure | 30 ~ 280 mmHg | |
| Blood Pressure | ||
| Accuracy | 3 mmHg | 3 mmHg |
| Pulse Rate | ||
| Range | 40 ~ 200 bpm | 40 ~ 200 bpm |
| Dimensions | 170mm×135mm×41mm | 200mm×125mm×90mm |
| Weight | 510g (including batteries) | 1100g (including batteries) |
| Patient Contact | ||
| Material | 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 |
| Particular | ||
| Performance | Comply with IEC 80601-2-30:2009 | |
| and ISO 81060-2:2013 | Comply with IEC 80601-2-30:2009 | |
| and ISO 81060-2:2013 | ||
| Software Level | ||
| Concern | Moderate | Moderate |
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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.
-
- 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.
- Substantially Equivalent (SE) Conclusion