(451 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement and irregular heartbeat detection, with no mention of AI or ML algorithms. The performance metrics are standard for blood pressure monitors and do not indicate AI/ML involvement.
No
The device is designed to measure blood pressure and pulse rate, and to detect irregular heartbeats. It does not perform any therapeutic action. Its function is diagnostic/monitoring rather than treatment.
Yes
Explanation: The device is designed to measure systolic and diastolic pressure and pulse rate, and can detect irregular heartbeats, which are all diagnostic capabilities. The output measurements are used to provide information about the patient's physiological state.
No
The device description clearly outlines hardware components such as an inflatable cuff, internal pump, internal exhaust valve, quick exhaust mechanism, and an LCD display. While it has Bluetooth connectivity for data transmission, it is fundamentally a hardware device with integrated software for measurement and display.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Device Function: The UM-212BLE blood pressure monitor measures blood pressure and pulse rate directly from the patient's upper arm. This is a non-invasive measurement taken on the body, not a test performed on a specimen taken from the body.
- Intended Use: The intended use clearly states it's designed to measure blood pressure and pulse rate of children and adults. It does not mention analyzing any biological samples.
- Device Description: The description details the mechanical process of inflating a cuff and using the oscillometric method to determine blood pressure. This process does not involve the analysis of biological specimens.
Therefore, based on the provided information, the UM-212BLE blood pressure monitor is a medical device, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
UM-212BLE blood pressure monitor is designed to measure systolic, diastolic pressure, and pulse rate of children and adults who are three (3) years and older in clinics and hospitals. The arm size is from 12 cm (4.7 inches) to 50 cm (19.7 inches). It can detect irregular heartbeats and display a symbol on its display and transmit the measurement by Bluetooth to other devices, such as PC, mobile phones, and gateways.
Product codes (comma separated list FDA assigned to the subject device)
DXN, DXQ
Device Description
UM-212BLE Blood Pressure Monitors have the same design as the predicate devices with an inflatable cuff which is wrapped around the patient's upper arm. The blood pressure measurement starts with the inflation process by an internal pump. The systolic and diastolic blood pressures are determined by oscillometric method during the deflation process. The deflation rate is controlled by an internal exhaust valve. There is a quick exhaust mechanism so that the cuff pressure can be completely released immediately. There is a maximum pressure safety setting at 299 mmHg. UM-212BLE Blood Pressure Monitor will not inflate the cuff higher than 299 mmHg. The device will display an irregular heartbeat indicator if an irregular heartbeat was detected during the measurement process. At the end of the measurement, the systolic and diastolic pressure reading with pulse rate are shown on the LCD. The values can also be transmitted by Bluetooth communication. The cuff is automatically deflated to 0 mmHg at the same time that the measurement is being displayed. If the monitor receives no further action from the user for 1 minute, it will automatically turn off.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's upper arm
Indicated Patient Age Range
children and adults who are three (3) years and older
Intended User / Care Setting
clinics and hospitals.
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)
Test Summary based on FDA recognized standards:
- Safety & Performance IEC 60601-1:2005
- Safety & EMC Tests: IEC 60601-1-2: 2014
- Reliability Tests: ASMI/ANSI/IEC 80601-2-30:2009 & A1:2013
- Risk Assessment: ISO 14971:2012
- Software Assessment: IEC 62304 Software Life Cycle Process
- Clinical BP Measurement: ISO 81060-2:2013
Key Results:
Criterion 1 for adults: Mean error of measurement: SYS = +3.05 mmHg, DIA = +2.87 mmHg. Standard deviation: SYS = 3.59 mmHg, DIA = 3.48 mmHg. All Pass.
Criterion 2 for adults: Std deviation: SYS = 3.50 mmHg, DIA = 3.11 mmHg. All Pass.
Criterion 1 for children: Mean error of measurement: SYS = +3.74 mmHg, DIA = +2.88 mmHg. Standard deviation: SYS = 1.15 mmHg, DIA = 1.55 mmHg. All Pass.
Criterion 2 for children: Std deviation: SYS = 1.04 mmHg, DIA = 1.37 mmHg. All Pass.
UM-212BLE passed all blood pressure measurement accuracy requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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
§ 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).
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 6, 2022
A&D Company, Ltd Chanda Melville Quality Manager 1756 Automation Parkway San Jose, California 95131
Re: K212168
Trade/Device Name: A&D Medical UM-212BLE Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 22, 2022 Received: September 6, 2022
Dear Chanda Melville:
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.
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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 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 medical devices and radiation-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.
LCDR 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) K212168
Device Name
A&D Medical UM-212BLE Blood Pressure Monitor
Indications for Use (Describe)
UM-212BLE blood pressure monitor is designed to measure systolic, diastolic pressure, and pulse rate of children and adults who are three (3) years and older in clinics and hospitals. The arm size is from 12 cm (4.7 inches) to 50 cm (19.7 inches). It can detect irregular heartbeats and display a symbol on its display and transmit the measurement by Bluetooth to other devices, such as PC, mobile phones, and gateways.
| Type of Use (Select one or both, as applicable) | ☐ Remediation Use (Part 21 CFR 201 Subpart D) ☑ On-The-Spot Use (21 CFR 201 Subpart C) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------ |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summarv
This 510(k) summary provides information to demonstrate substantial equivalence and is submitted in accordance with the requirement of 21 CFR 807.92.
Date Prepared 1.
October 4, 2022
2. Submitter's Information
A&D Engineering, Inc. Ms. Chanda Melville 4622 Runway Boulevard, Ann Arbor, MI 48108 Tel: 678-230-8565 Email: cmelville@andonline.com
3. Device Information
| Proprietary Name: | A&D Medical UM-212BLE Blood Pressure Monitor |
|---|---|
| Regulation Number: | 21 CFR 870.1130, 21 CFR 870.1120 |
| Regulation Name: | Noninvasive Blood Pressure Measurement System |
| Regulatory Class: | Class II |
| Product Code: | DXN, DXQ |
4. Information for the 510(k) Cleared Devices (Predicate Devices)
- A&D Medical UM-211 Digital Blood Pressure Monitor 510(k) number K173191 ●
- A&D Medical UA-767PBT Digital Blood Pressure Monitors with 510(k) number ● K043217
5. Indications for Use
UM-212BLE blood pressure monitor is designed to measure systolic pressure, and pulse rate of children and adults who are three (3) years and older in clinics and hospitals. The arm size is from 12 cm (4.7 inches) to 50 cm (19.7 inches). It can detect irregular heartbeats and display a symbol on its display and transmit the measurement by Bluetooth to other devices, such as PC, mobile phones, and gateways.
6. Intended Use
A&D Medical UM-212BLE Blood Pressure Monitor is designed for use in clinics and hospitals. It measures systolic, diastolic, and pulse rate. UM-212BLE uses the oscillometric and auscultatory methods to determine blood pressure.
7. Device Description - Technological and Operational Characteristics Comparison
UM-212BLE Blood Pressure Monitors have the same design as the predicate devices with an inflatable cuff which is wrapped around the patient's upper arm. The blood pressure measurement starts with the inflation process by an internal pump. The systolic and diastolic blood pressures are determined by oscillometric method during the deflation process. The deflation rate is controlled by an internal exhaust valve. There is a quick exhaust mechanism so that the cuff pressure can be completely released immediately. There is a maximum pressure safety setting at 299 mmHg. UM-212BLE Blood Pressure Monitor will not inflate the cuff higher than 299 mmHg. The device will display an irregular heartbeat indicator if an irregular heartbeat was detected during the measurement process. At the end of the measurement, the systolic and diastolic pressure reading with pulse rate are shown on the LCD. The values can also be
4
transmitted by Bluetooth communication. The cuff is automatically deflated to 0 mmHg at the same time that the measurement is being displayed. If the monitor receives no further action from the user for 1 minute, it will automatically turn off.
UM-212BLE shares the same design and technologies with the two comparison models. Refer to the product comparison table below for the differences among these three models.
| PRODUCT SPECIFICATION COMPARISON TABLE | |||
|---|---|---|---|
| Predicate Device | Modified Device | ||
| UA-767PBT | UM-211 | UM-212BLE | |
| Measurement method | Oscillometric | Oscillometric and Auscultatory | Oscillometric and Auscultatory |
| Blood Pressure | |||
| Measurement | Automatic (One-time) | Automatic (One-time) Auscultation | Automatic |
| Multiple measurement (Average) | |||
| Auscultation | |||
| AOBP (multiple | |||
| measurement mode) | N/A | N/A | 2 times, 3 times |
| First Measurement | |||
| Wait Time | N/A | N/A | 0 sec, 3 min, 5 min, 10 min |
| Measurement | |||
| Interval | N/A | N/A | 30 sec, 1 min, 2 min |
| BP Measurement | |||
| Range | Systolic: 60 – 279 mmHg | ||
| Diastolic: 40 – 200 mmHg | |||
| Pulse: 40 – 200 beats per minute | Systolic: 60 – 279mmHg | ||
| Diastolic: 40 – 200 mmHg | |||
| Pulse: 40-200 beats per minute | Systolic: 60 – 279 mmHg | ||
| Diastolic: 40 – 200 mmHg | |||
| Pulse: 40-200 beats per minute | |||
| Pressure | |||
| Measurement Range | 0 – 299 mmHg | 0 – 299 mmHg | 0 – 299 mmHg |
| Measurement | |||
| Accuracy | BP: ± 3 mmHg | ||
| Pulse: ±5% | BP: ± 3mmHg | ||
| Pulse: ± 5% | BP: ±3 mmHg | ||
| Pulse: ±5% | |||
| Deflation Method | Mechanical exhaust valve | Constant speed electrical controlled exhaust valve | Constant speed electrical controlled exhaust valve |
| Pressure Sensor | Capacitance type | Semiconductor type | Semiconductor type |
| Bluetooth | |||
| Communication | Bluetooth ver2.1 | N/A | Bluetooth low energy ver 4.1 |
| Cuff Size | Small Size: 16-24 cm | ||
| Medium Size: 24- | |||
| 36cm | |||
| Large Size: 36-45 cm | Small Size: 16-24 cm | ||
| Adult Size: 22-32cm | |||
| Large Size: 31-45 cm | |||
| Extra Large Size: 41-50 cm | Extra Small Size: 12 – 17cm | ||
| Small Size: 16-24 cm | |||
| Adult Size: 22-32cm | |||
| Large Size: 31-45 cm | |||
| Extra Large Size: 41-50 cm | |||
| Memory Size | 200 | 99 | 99 |
8. Modifications made from the predicate devices (UM-211 & UA-767PBT):
- · Modify the internal layout of the circuit and components, and ISO/IEC 80369-5 compliant cuff hose connector.
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- · Include AOBP mode setting (multiple measurement mode)
- · Update Bluetooth technology to Bluetooth low energy ver4.1
- Add extra small cuff size
9. Discussion of standards used in the design verification and design validation
A&D Medical conducted design verification and design validation activities based on comparisons of the UM-211 and UA-767PBT predicate devices. Based on the changes, we conducted the appropriated test methodology and pass/fail criteria. After the tests were conducted, the test records were added to the UM series design history file (DHF).
A&D Medical follows FDA recognized consensus standards and guidance documents in our medical device development and manufacturing processes. The following standards were used for the design verification and evaluation of UM-212BLE blood pressure monitor. These standards include the general quality system requirements, the special requirements for CDRH (870.1130), and software and app life cycle processes requirements.
- . AAMI/ANSI/ISO 14971:2007/(R) 2010 (Corrected 4 October 2007) Medical Devices - Applications Of Risk Management To Medical Devices (FDA Recognized Number 5-40)
- AAMI/ANSI/IEC 60601-1:2005 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (FDA Recognized Number 19-4)
- . AAMI/ANSI/IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements And Tests (FDA Recognized Number 19-8)
- AAMI/ANSI/IEC 80601-2-30:2009 & A1:2013 Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Noninvasive Sphygmomanometers (FDA Recognized Number 3-152)
- AAMI/ANSI/IEC 62304:2006 Medical Device Software - Software Life Cycle Processes (FDA Recognized Number 13-79)
- AAMI/ANSI/ISO 81060-2:2013 ● Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (FDA Recognized Number 3-130)
10. Substantial Equivalence Conclusion:
Test Summary based on FDA recognized standards:
- Safety & Performance IEC 60601-1:2005
- Safety & EMC Tests: ● IEC 60601-1-2: 2014
- Reliability Tests: ASMI/ANSI/IEC 80601-2-30:2009 & A1:2013
- Risk Assessment: ISO 14971:2012
- Software Assessment: IEC 62304 Software Life Cycle Process ●
- Clinical BP Measurement: ISO 81060-2:2013
005 510(k) Summary rev2
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| Standard Requirements | Test Result | Result | |
|---|---|---|---|
| Criterion 1: | |||
| Max Mean error of | |||
| measurement & | |||
| Standard deviation | Mean : ± 5.0 mmHg | Mean value: SYS = +3.05 mmHg | |
| DIA = +2.87 mmHg | Pass | ||
| S. D. : 8.0 mmHg or | |||
| less | Std deviation: SYS = 3.59 mmHg | ||
| DIA = 3.48 mmHg | Pass | ||
| Criterion 2: | |||
| Max Mean error of | |||
| measurement & | |||
| Standard deviation | |||
| meet ISO 81060- | |||
| 2:2013 Table 1 | SYS=6.20 mmHg, | ||
| DIA=6.30 mmHg | Std deviation: SYS = 3.50 mmHg | ||
| DIA = 3.11 mmHg | Pass | ||
| Standard Requirements | Test Result (Test on Child) | Result | |
| Criterion 1: | |||
| Max Mean error of | Mean : ± 5.0 mmHg | Mean value: SYS = +3.74 mmHg | |
| DIA = +2.88 mmHg | Pass | ||
| measurement & | |||
| Standard deviation | S. D. : 8.0 mmHg or | ||
| less | Std deviation: SYS = 1.15 mmHg | ||
| DIA = 1.55 mmHg | Pass | ||
| Criterion 2: | |||
| Max Permissible | |||
| Standard Deviation | |||
| per ISO 81060- | |||
| 2:2013 Table 1 | SYS=5.77 mmHg, | ||
| DIA=6.30 mmHg | Std deviation: SYS = 1.04 mmHg | ||
| DIA = 1.37 mmHg | Pass |
The summary of the test results of ISO 81061-2 is listed below. UM-212BLE passed all blood pressure measurement accuracy requirements.
UM-212BLE met all applicable requirements of the FDA recognized consensus standards and guidance documents. None of the test demonstrated that the UM-212BLE bring new issues of safety and effectiveness.
As a conclusion, UM-212BLE blood pressure monitor as described in its labeling and comparison analysis has not changed as a result of the modifications. The fundamental scientific technology of the modified device has not changed, either. There is no significant difference that affects the safety or effectiveness of the modified device as compared to the predicate devices.