(112 days)
This blood pressure monitor is designed to measure (diastolic and systolic) and pulse rate in adult patients with arm circumference range between 22 cm - 42 cm.
The BPBIO480KV is a digital monitor intended for use in measuring blood pressure and pulse rate in user population with upper arm circumference ranging from 22cm (8.6-inch to 16.5-inch). The systolic blood pressure and diastolic blood pressure are measured by non-invasive blood pressure ("NIBP") measuring method and also by utilizing the Auto auscultation method and Oscillometric method. The BPBIO480KV may provide useful clinical information about the current health status of not only the users who are diagnosed with hypertension but also those who are not diagnosed with hypertension. Warnings and cautions described in the user's manual should be observed at all times. Automated Auscultation is a method that combines the accuracy of auscultation, and the convenience of the Oscillometric method. To measure the blood pressure, wrap the cuff around the upper arm and inflate it to a pressure above the systolic pressure. Then slowly release the air to detect the Korotkoff sound signal and the pressure sensor signal, which you can listen with the stethoscope attached to the cuff, to measure the systolic and diastolic blood pressure. The Automated Auscultation applied to BPBIO480KV combines the accuracy of the auscultation method with the convenience of easy measurement. The signals are electronically processed to compensate for the possible errors in the auscultation method caused by movement, external noise, etc., enabling a more accurate blood pressure measurement. Included components are the main unit, a large and a medium size cuff, a users manual, an AC adapter, a power cord, and an internal rechargeable lithium rechargeable battery. Measurement methods: Auscultation and Oscillometric.
Here's an analysis of the provided text regarding the acceptance criteria and study for the BPBIO480KV device:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy (Blood Pressure) | Pressure: ± 3mmHg |
| Accuracy (Pulse Rate) | Pulse: Within ± 3% |
Note: The text explicitly states these accuracy metrics as both "Accuracy" in the comparison table and also references conformity to ISO 81060-2:2018, which sets similar accuracy requirements. The "Validation Results" section states: "The system passed the deviation limits initially set by the protocol," which implies these criteria were met.
Study Details
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Sample Size for Test Set and Data Provenance:
- Sample Size: 85 total subjects (also stated as "among 93 participants" for both cuff sizes). This discrepancy might refer to 85 subjects contributing to the core data and 93 participants being enrolled to test both cuff sizes. Given the context of ISO 81060-2, a typical minimum sample size for validation is around 85 for a general population.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, the mention of "European Society of Hypertension recommendations" and "ISO 14155:2020 principles for Good Clinical Practice" suggests a prospective clinical investigation.
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Number of Experts and Qualifications for Ground Truth:
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. However, ISO 81060-2:2018 implicitly requires trained observers (auscultators) for reference measurements. The text mentions "medical staffs hear directly" when describing the auscultation method, implying human expert involvement in establishing ground truth.
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Adjudication Method for Test Set:
- Adjudication Method: Not explicitly stated. The description mentions "A 'V' tube was used to connect both the automated meter and the standard mercury sphygmomanometer to the cuff." This standard methodology for blood pressure validation typically involves simultaneous measurements by the device under test and human observers using a reference method (mercury sphygmomanometer and stethoscope), with statistical analysis of the differences. It doesn't explicitly describe an adjudication process for discrepancies between human observers, but ISO 81060-2:2018 often details such procedures (e.g., blinded observers, averaging, or a third arbitrator).
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study was not reported. The study focused on the standalone accuracy of the device against a reference standard, not its impact on human reader performance.
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Standalone Performance (Algorithm Only without Human-in-the-Loop):
- Yes, a standalone performance study was conducted. The "Clinical Testing" section describes measuring the BPBIO480KV's performance against a reference standard (mercury sphygmomanometer) using a "V" tube setup, which is a direct validation of the device's accuracy.
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Type of Ground Truth Used:
- Expert Consensus / Reference Standard Measurement: The ground truth was established by simultaneous measurements using a "standard mercury sphygmomanometer" and presumably auscultation by human observers, which is considered the gold standard for non-invasive blood pressure measurement in such validation studies.
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Sample Size for Training Set:
- Not explicitly stated. The document focuses on the validation study (clinical testing), not the development or training process of the device's algorithms.
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How Ground Truth for Training Set Was Established:
- Not explicitly stated. As with the training set size, the document does not elaborate on the development phase or how any internal algorithms were trained. The focus is solely on the validation demonstrating the device's accuracy against recognized standards.
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October 7, 2022
InBody Co, Ltd. % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct Naples, Florida 34114
Re: K221764
Trade/Device Name: BPBIO480KV Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 25, 2022 Received: August 29, 2022
Dear Daniel Kamm:
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 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K22####
Device Name BPBIO480KV
Indications for Use (Describe)
This blood pressure monitor is designed to measure (diastolic and systolic) and pulse rate in adult patients with arm circumference range between 22 cm - 42 cm.
| 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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Image /page/3/Picture/1 description: The image shows the words "510(k) Summary K221764" at the top. Below that is the word "InBody" in a large, stylized font. The word is in a dark red color. The text appears to be a title or heading for a document or presentation.
InBody Co., Ltd. 15, Heugam-Gil , Ipjang-Myueon, Seoubuk-Gu, Cheonan-Si Chungnam, KR 31025 TEL. +82 02-501-3939 Date prepared: August 24, 2022 Contact: Kichul Cha, CEO
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- Identification of the Devices: Proprietary-Trade Name: BPBIO480KV. Common/Usual Name: Blood pressure monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Meter Regulatory Class: Class II Product Code: DXN
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- Equivalent legally marketed device: K200442 Proprietary-Trade Names: BP170; BP170B; BP160; BP160B; BPBIO250 Common/Usual Name: Blood pressure monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Meter Regulatory Class: Class II Product Code: DXN
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- Indications for Use: This blood pressure monitor is designed to measure blood pressure (diastolic and systolic) and pulse rate in adult patients with arm circumference range between 22 cm – 42 cm.
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- Device Description: The BPBIO480KV is a digital monitor intended for use in measuring blood pressure and pulse rate in user population with upper arm circumference ranging from 22cm (8.6-inch to 16.5-inch). The systolic blood pressure and diastolic blood pressure are measured by non-invasive blood pressure ("NIBP") measuring method and also by utilizing the Auto auscultation method and Oscillometric method. The BPBIO480KV may provide useful clinical information about the current health status of not only the users who are diagnosed with hypertension but also those who are not diagnosed with hypertension. Warnings and cautions described in the user's manual should be observed at all times. Automated Auscultation is a method that combines the accuracy of auscultation, and the convenience of the Oscillometric method. To measure the blood pressure, wrap the cuff around the upper arm and inflate it to a pressure above the systolic pressure. Then slowly release the air to detect the Korotkoff sound signal and the pressure sensor signal, which you can listen with the stethoscope attached to the cuff, to measure the systolic and diastolic blood pressure. The Automated Auscultation applied to BPBIO480KV combines the accuracy of the auscultation method with the convenience of easy measurement. The signals are electronically processed to compensate for the possible errors in the auscultation method caused by movement, external noise, etc., enabling a more accurate blood pressure measurement. Included components are the main unit, a large and a medium size cuff, a users manual, an AC adapter, a power cord, and an internal rechargeable lithium rechargeable battery. Measurement methods: Auscultation and Oscillometric. What is the Oscillometric method? The Oscillometric method is similar to the auscultation method,
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K221764
where the cuff is inflated to reach above the systolic pressure and then deflated. The blood pressure is measured using the pressure change in the blood flow while the cuff is being deflated. Systolic, diastolic, and mean pressure are estimated based on Oscillometric waveforms generated by the pressure changes. Compared to auscultation, it is convenient because it is easy to use and is less affected by external noise or movement, so it is widely used in automatic blood pressure monitors. However, conventional automatic blood pressure monitors, which use their own estimation algorithms, have problems with different measurements and poor accuracy. To perform a measurement, BPBIO480KV inflates the cuff above the systolic pressure and then deflates it to obtain the cuff pressure value and Korotkoff sound. As the pressure falls to the patient's systolic blood pressure, the first Korotkoff sound is heard. When the pressure drops below the diastolic pressure, it disappears after the last Korotkoff sound is heard. BPBIO480KV determines whether a Korotkoff sound is heard using the volume, distribution, Oscillometric signal, and filter of the sound acquired during the measurement, and determines the blood pressure value.
What is Auscultation? Auscultation is a method of measuring blood pressure directly using stethoscope, pressure gauge, and a cuff. It is the most traditional and a recognized standard. Wrap the upper arm with a cuff, inflate the cuff to pressurize the artery that passes under the skin to completely occlude the blood flow. Then release the air to reduce pressure, and use a stethoscope to listen to the sound from the pressed arteries when blood flows back into the pressed area. The sound generated at this moment is called the Korotkoff sound, and it is known to be caused by turbulence caused by the blood flow. As the pressure in the cuff falls to or below the patient's systolic blood pressure, some blood will be able to pass through the upper arm and the first Korotkoff sound is heard. Korotkoff sound continues to be heard as long as the pressure in the cuff is between the systolic and diastolic pressures, and it disappears altogether when the pressure in the cuff drops below the diastolic pressure. When the pressure in the cuff drops below the diastolic pressure, the cuff no longer interferes with blood flow, so there is no more audible sound as the blood flows without the turbulence.
This equipment tracks and analyzes the blood flow oscillations under the pressure using the cuff from the highest to the lowest pressure when the minute pressure speed is determined by the heartbeat. This equipment adopts Oscillometric method and automated auscultation method using a cuff for blood pressure measurement. In case of Oscillometric method, the device determines the systolic, diastolic and average pressure on the basis of the blood flow oscillations measured through the cuff. The point where the maximum amplitude of the blood flow oscillation appeared is the average pressure, the points where the 70% and 60% amplitudes appeared are the systolic and the diastolic pressure respectively. On the other hand, in case of Auto auscultation method, it is a method that combines the accuracy of auscultation, which is regarded as the gold standard for blood pressure measurement. To measure the blood pressure, wrap the cuff around the upper arm and inflate it to a pressure above the systolic pressure. Then slowly release the air to detect the Korotkoff sound signal and the pressure sensor signal, which you can catch with the stethoscope attached to the cuff, to measure the systolic and diastolic blood pressure. The Automated Auscultation applied to BPBIO480KV combines the accuracy of the auscultation method that the medical staffs hear directly with the convenience of easy measurement. The signals are electronically processed to compensate for the possible errors in the auscultation method caused by movement, external noise, etc., enabling a more accurate blood pressure measurement.
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- Safety and Effectiveness, comparison to predicate device. The testing results and specification comparisons indicate that the new models are as safe and effective as the predicate device. A comparison table is presented below.
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Comparison table
| Item | Predicate Device K200442Proprietary-Trade Names: BP170;BP170B; BP160; BP160B; BPBIO250 | Proposed Model BPBIO480KV | ComparisonResult |
|---|---|---|---|
| Intended Use | The InBody blood pressure monitor isdesigned to measure blood pressure(diastolic and systolic) and pulse ratein adult patients with armcircumference range between 17cm -42cm. | This blood pressure monitor isdesigned to measure blood pressure(diastolic and systolic) and pulse ratein adult patients with armcircumference range between 22 cm- 42 cm. | SAME (slightlydifferent rangeof armcircumference.) |
| PatientPopulation | Adult | Adult | Same |
| Measurementlocation | Upper Arm | Upper Arm | Same |
| MeasurementPrinciple | Oscillometric | Auto auscultation method andOscillometric method | Similar |
| Measured: | Blood Pressure and Pulse | SAME | Same |
| Blood PressureCuff | External to the device | External to the device | same |
| Components | LCD, Cuff, MCU, Pump | LCD, Cuff, MCU, Pump | Same |
| Memory | Internal only, 99 readings | Internal or transfer to external USBstick.USB facilitates program update aswell. | Similar |
| Power Source | BP170; 4-AA Size Alkaline(or AC Line)BPBIO250; Rechargeable Lithiumwith AC Line adapter | Rechargeable Lithium with AC Lineadapter | Similar,rechargeableinstead of AA. |
| Dimensions | BPBIO250: 122(W) x 150(L) x 195(H):mm | 200(W) x 180(H) x 210(L) mm | Similar |
| Measurementrange | Blood pressure: 40-300mmHg,Pulse rate: 30-240bpm | Blood Pressure 0-300mmHg, Pulse:30-240bpm | Ranges arecomparable. |
| Accuracy | BPBIO250: Pressure: Within $\pm$ 3mmHg,Pulse: Within $\pm$ 3% | Pressure: $\pm$ 3mmHg, Pulse: Within $\pm$ 3% | SAME |
| Range of armcircumference | 17cm - 42cm. | 22cm-42cm | Similar |
| Memory | 99 measurements | 1000 measurements | More internalstorage |
| Externalcommunication | NONE | USB for external measurementstorage and program updates | More useful inthe clinicalenvironment |
| K221764 | |||
| Item | Predicate Device K200442Proprietary-Trade Names: BP170;BP170B; BP160; BP160B; BPBIO250 | Proposed Model BPBIO480KV | ComparisonResult |
| Photos | BPBIO250Image: BPBIO250 | BPBIO480KVImage: BPBIO480KV | Similarappearance |
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- Summary of technological characteristics of the device compared to the predicate device. This blood pressure/pulse rate meter is intended to be used in measuring human systolic, diastolic and pulse rate by oscillometric (or manual) method. Performance characteristics are in accordance with standards listed below. The substantial equivalence between these new meters and the predicate BPBIO250 can be evaluated from several aspects as listed in above table. The following FDA guidance was consulted in the design and testing of the device: Non-Invasive Blood Pressure (NIBP) Monitor Guidance MARCH 1997, Final.
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- Non-clinical testing: The proposed new model was tested and found to conform to the following international standards:
| FDARecognition # | Standard Number and Title. |
|---|---|
| 19-4 | IEC 60601-1:2005/A1:2012 ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 andA2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basicsafety and essential performance (IEC 60601-1:2005, MOD) |
| 19-8 | IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safetyand essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| 5-89 | 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety andessential performance - Collateral standard: Usability |
| 13-79 | IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes |
| 3-123 | ANSI AAMI IEC 80601-2-30:2018 Medical electrical equipment - Part 2-30: Particular requirements for basicsafety and essential performance of automated type non-invasive sphygmomanometers |
| 3-166 | ISO 81060-2 Third edition 2018-11 Non-invasive sphygmomanometers - Part 2: Clinical investigation ofintermittent automated measurement type [Including: Amendment 1 (2020)] |
| 2-282 | ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice |
| 2-258 | ANSI AAMI ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testingwithin a risk management process |
| 2-245 | ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitrocytotoxicity |
| 2-174 | ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation andskin sensitization |
| 2-276 | ISO 10993-18 Second edition 2020-01 Biological evaluation of medical devices - Part 18: Chemicalcharacterization of medical device materials within a risk management process. |
| 5-117 | ISO 15223-1 Third Edition 2016-11-01 Medical devices - Symbols to be used with medical device labels, labelling,and information to be supplied - Part 1: General requirements |
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Because the unit has a USB port (for external storage of measurements and program updates) cybersecurity is a concern. We added cybersecurity precautions to the labeling and to our internal software generation and distribution procedures, after consulting the FDA guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff. Our company is certified to ISO27001 Information technology - Security techniques - Information security management systems -Requirements.
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- Clinical Testing: Successful testing was performed according to (i) the ISO Standard 81060-2:2018 for clinical investigation of intermittent automated measurement type [1], (ii) the European Society of Hypertension recommendations for its clinical application, and (iii) the ISO 14155:2020 principles for Good Clinical Practice (Clinical investigation of medical devices for human subjects. There were 85 total subjects. Both cuff sizes were employed among 93 participants, both male and female, over the age of 12. A "V" tube was used to connect both the automated meter and the standard mercury sphygmomanometer to the cuff. Validation Results: The system passed the deviation limits initially set by the protocol.
Conclusion, Comparison to the predicate device. Proposed Model BPBIO480KV is substantially equivalent to the predicate. The devices are identical in the intended use, and very similar in the design principles, the performance and the applicable standards. Only their appearance and the user interfaces are different.
- Clinical Testing: Successful testing was performed according to (i) the ISO Standard 81060-2:2018 for clinical investigation of intermittent automated measurement type [1], (ii) the European Society of Hypertension recommendations for its clinical application, and (iii) the ISO 14155:2020 principles for Good Clinical Practice (Clinical investigation of medical devices for human subjects. There were 85 total subjects. Both cuff sizes were employed among 93 participants, both male and female, over the age of 12. A "V" tube was used to connect both the automated meter and the standard mercury sphygmomanometer to the cuff. Validation Results: The system passed the deviation limits initially set by the protocol.
§ 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).