BPBIO750

K231174 · Inbody Co., Ltd. · DXN · Aug 2, 2023 · Cardiovascular

Device Facts

• Record ID: K231174
• Device Name: BPBIO750
• Applicant: Inbody Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 2, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The BPBIO750 is a digital monitor intended for use in measuring blood pressure and pulse rate in user population with left and right upper arm circumference ranging from 22 cm (8.7-inch to 16.5-inch). The systolic blood pressure and diastolic blood pressure are measured by non-invasive blood pressure ("NIBP") measuring method. The BPBIO750 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.

Device Story

BPBIO750 is a kiosk-type, automated, single upper-arm cuff oscillometric blood pressure monitor for public space use. Device features fixed tubular opening for arm insertion; integral cuff inflates to measure BP during inflation. User positions arm in elbow groove; device performs auto-zero calibration and functional self-check of motor/cuff position upon startup. Device measures systolic/diastolic BP, pulse rate, and calculates Mean Arterial Pressure, Pulse Pressure, and Pressure Rate Product. Results displayed on LED screen and printed automatically. Used in professional settings (not home) by adult patients. Healthcare providers use output for clinical assessment of hypertension status. Benefits include automated, standardized BP measurement in public/clinical environments.

Clinical Evidence

Clinical validation study per ISO 81060-2:2018. 102 subjects recruited, 85 analyzed (mean age 56.7 ± 15.4 years; 40 men; arm circumference 32.3 ± 5.3 cm). Criterion 1: mean difference ± SD was 2.2 ± 6.1 mmHg (systolic) / -2.2 ± 5.2 mmHg (diastolic). Criterion 2: SD of averaged BP differences was 5.00 mmHg (systolic) / 4.63 mmHg (diastolic). Device met all AAMI/ESH/ISO Universal Standard requirements.

Technological Characteristics

Oscillometric NIBP monitor; Nylon/Polyurethane cuff; LED display; MCU-based control; AC power supply. Dimensions: 299x547x485 mm. Connectivity: USB for storage/updates. Standards: IEC 60601-1, IEC 60601-1-2, IEC 62304, ANSI AAMI IEC 80601-2-30, ISO 81060-2, ISO 10993 series.

Indications for Use

Indicated for adult patients with upper arm circumference 22-42 cm for non-invasive measurement of systolic/diastolic blood pressure and pulse rate in professional, non-home settings.

Regulatory Classification

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.

Predicate Devices

• BPBIO320/BPBIO320n (K131064)

Submission Summary (Full Text)

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August 2, 2023

InBody Co, Ltd. % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct Naples, Florida 34114

Re: K231174

Trade/Device Name: BPBI0750 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: July 4, 2023 Received: July 5, 2023

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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Stephen C. Browning -S

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) K231174

Device Name BPBIO750

#### Indications for Use (Describe)

The BPBIO750 is a digital monitor intended for use in measuring blood pressure and pulse rate in user population with left and right upper arm circumference ranging from 22 cm (8.7-inch to 16.5-inch). The systolic blood pressure and diastolic blood pressure are measured by non-invasive blood pressure ("NIBP") measuring method. The BPBIO750 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.

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) | X |

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Image /page/3/Picture/2 description: The image shows the word "InBody" in a bold, sans-serif font. The color of the text is a dark reddish-brown. The letters are closely spaced, giving the word a solid and compact appearance. The background is plain white, which makes the text stand out.

InBody Co., Ltd. 15, Heugam-Gil , Ipjang-Myueon, Seoubuk-Gu, Cheonan-Si Chungnam, KR 31025 TEL. [phone] Date prepared: July 3, 2023 Contact: Kichul Cha, CEO250

- 1. Identification of the Device: Proprietary-Trade Name: BPBIO750. 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
- 2. Predicate Device (Substantial Equivalence): K131064 Trade/Device Name: BPBIO320/BPBIO320n Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Meter Regulatory Class: Class II Product Code: DXN
- 3. Indications for Use: The BPBIO750 is a digital monitor intended for use in measuring blood pressure and pulse rate in user population with upper arm circumference ranging from 22 cm (8.7-inch to 17-inch). The systolic blood pressure and diastolic blood pressure are measured by non-invasive blood pressure ("NIBP") measuring method. The BPBIO750 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.
- Device Description: The InBody BPBIO750 is a kiosk-type, automated, single upper-arm cuff 4. oscillometric BP monitor developed for self-measurement of BP in public spaces. It is designed for BP measurements on either the right or left upper arm and has a fixed tubular opening to insert the user's arm, with an integral single-arm cuff, which when inflated surrounds the upper arm. It is suitable for arm circumference range 22-42 cm. The device has an elbow groove to ensure correct positioning of the arm and measures BP during inflation. A wide LED screen presents systolic and diastolic BP, heart rate and time of measurement, and print-out of these data is provided automatically to the user. When the device is turned on, an auto zero calibration is performed, as well as a functional self-check of the air pressure change according to motor operation, the initial cuff position, and the motor load according to the cuff movement. Its weight is 7.1 kg, width 299 mm, depth 547 mm, height 485 mm, and has power supply through cable (AC 250 V, 10A). Calibration is recommended once every 12 months. Measurements are:
- . Pulse rate

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- Systolic and diastolic blood pressure
- Mean Arterial Pressure [mmHg] [1/3 X SBP + 2/3 X DBP] (Caution: This is an ESTIMATED number). ● Source: https://en.wikipedia.org/wiki/Mean arterial pressure
- . Pulse Pressure (P.P) is the difference between your systolic blood pressure and diastolic blood pressure. It changes with each stroke volume of the heart. In addition to changes in stroke volume, pulse pressure may increase depending on the degree of arteriosclerosis.
- Pressure Rate Product is the product of heart rate and systolic blood pressure
- 5. 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.

| Item | Predicate Device K131064<br>Trade/Device Name:<br>BPBIO320/BPBIO320n | Proposed Model BPBIO750 | Comparison<br>Result |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Indications for<br>Use | The InBody blood pressure<br>monitor is designed to measure<br>blood pressure (diastolic and<br>systolic) and pulse rate in adult<br>patients with arm circumference<br>range between 17cm - 42cm. | The BPBIO750 is a digital monitor<br>intended for use in measuring blood<br>pressure and pulse rate in user population<br>with upper arm circumference ranging<br>from 22 cm to 42 cm (8.7-inch to 17-inch).<br>The systolic blood pressure and diastolic<br>blood pressure are measured by non-<br>invasive blood pressure ("NIBP")<br>measuring method. The BPBIO750 may<br>provide useful clinical information about<br>the current health status of not only the<br>users who are diagnosed with<br>hypertension but also those who are not<br>diagnosed with hypertension. | Essentially the<br>SAME, arm<br>circumference<br>range updated<br>to validated<br>size range. |
| Environment | Professional, not home | Professional, not home | Same |
| Patient<br>Population | Adult | Adult | Same |
| Measurement<br>location | Upper Arm | Upper Arm | Same |
| Measurement<br>Principle | Oscillometric | Oscillometric | Same |
| Measured: | Blood Pressure and Pulse | Blood Pressure and Pulse PLUS<br>Mean Arterial Pressure*<br>Pulse Pressure (P.P)*<br>Pressure Rate Product* | Greater<br>functionality<br>(computations) |
| Measurement<br>Range | Blood Pressure: 40-300mmHg,<br>Pulse Rate: 30-240bpm | Blood Pressure: 0-300mmHg,<br>Pulse Rate: 30-240bpm | Functionally<br>equivalent |
| | | | K231174 |
| Item | Predicate Device K131064<br>Trade/Device Name:<br>BPBIO320/BPBIO320n | Proposed Model BPBIO750 | Comparison<br>Result |
| Accuracy | Pressure: $\pm$ 3mmHg,<br>Pulse Rate: $\pm$ 2% | Pressure: $\pm$ 2mmHg,<br>Pulse Rate: $\pm$ 1.5% | Not<br>significantly<br>different,<br>improved<br>accuracy |
| Blood pressure<br>cuff | Internal to the device | Internal to the device | Same |
| Cuff material | Nylon +Polyurethane | Nylon +Polyurethane | Same |
| Range of Arm<br>Circumference | 17-42cm | 22-42cm | Different |
| Components | LCD, Cuff, MCU, Pump | LCD, Cuff, MCU, Pump | Same |
| Power Source | AC Line | AC Line | Same |
| Energy saving | Not available | Automatically enters energy saving mode<br>after 2 minutes of idle time | Does not affect<br>functionality,<br>saves energy<br>when not<br>actively being<br>used |
| Dimensions | 489(W) x 409(L) x 284(H) mm | 299(W) x 547(L) x 485(H) mm | Different but<br>functionally<br>equivalent |
| External<br>communication | RS-232 | USB for external measurement storage<br>and program updates | Updated |
| Printer | Yes | Yes | SAME |
| Photo | Image: Blood pressure machine | Image: Blood pressure machine | Different but<br>functionally<br>equivalent<br>Slimmer. |

### Comparison table

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- 6. 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 BPBIO320/BPBIO320n 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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#### K231174 7. Non-clinical testing: The proposed new model was tested and found to conform to the following international standards:

| FDA<br>Recognition # | 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 and A2:2010/(R)2012 (Consolidated Text)<br>Medical electrical equipment - Part 1: General requirements for basic safety 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 safety and essential performance<br>- 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 and essential performance -<br>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 basic safety and essential<br>performance of automated type non-invasive sphygmomanometers |
| 3-166 | ISO 81060-2 Third edition 2018-11 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated<br>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 testing within a risk management process |
| 2-245 | ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
| 2-174 | ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization |
| 2-276 | ISO 10993-18 Second edition 2020-01 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device<br>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<br>supplied - Part 1: General requirements |

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.

- 8. Clinical Testing: Successful testing was performed. Objective The aim of this study was to evaluate the accuracy of the single upper-arm cuff oscillometric blood pressure (BP) monitor InBody BPBIO750 developed for selfmeasurement by adults in public spaces (kiosk) according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018).
Methods: Subjects were recruited to fulfil the age, gender, BP and cuff distribution criteria of the AAM/ESH/ISO Universal Standard in general population using the same arm sequential BP measurement method. A total of 102 subjects were recruited and 85 were analyzed [mean age 56.7 ± 15.4 (SD) years, 40 men, arm circumference 32.3 ± 5.3 cm, range 22-42 cm]. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 2.2 ± 6.1/-2.2 ± 5.2 mmHg (systolic/diastolic). For criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 5.00/4.63 mmHg (systolic/diastolic). Conclusion The InBody BPBIO750 device fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in general population and can be recommended for clinical use in adults. Blood Press Monit 26: 146–148.

- 9. Conclusion, Comparison to the predicate device. Proposed Model BPBIO750 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.