InBody

• K Number: K200560
• Device Name: InBody
• Manufacturer: InBody Co. Ltd.
• Date Cleared: 2021-01-06 ( 308 days)
• Product Code: DXN DXQ
• Regulation Number: 870.1130

Intended Use

The subject device is a manual blood pressure (BP) monitor, and requires the user to listen for Korotkoff sounds to determine systolic and diastolic pressure. Further, patients whose Korotkoff sounds are not clear or absent, such as children younger than 3 years of age, will not be suitable for the subject device. Pulse rate is also measured.

Device Description

This device can be used to measure blood pressure and pulse rate non-persistently using the Korotkoff sound method of measuring blood pressure in vitro. The user can measure the blood pressure using this device and cuff, stethoscope. Basically, it has the same function as a conventional mercury sphygmomanometer. However, instead of using harmful mercury to the human body, it displays the pressure on the LCD screen, so that the blood pressure can be measured harmlessly to the human body. In addition, using the 'Mark' function can conveniently display the systolic and diastolic pressures. And using its backlight, the user can measure blood pressure in the dark place. If air pressure exceeds 320mmHg, it will automatically exhaust quickly. If an emergency occurs during the measurement, pressing On/Off button will turn off the equipment and allow rapid exhaust. The device is for use by medical professional. The testing person supplies their own stethoscope, which is required for making the measurements.

Predicate Devices

K061456

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description explicitly states the device is a manual blood pressure monitor requiring the user to listen for Korotkoff sounds, and the technology described is a digital display of pressure, not AI/ML for interpretation or analysis.

Therapeutic

Yes
The device is a manual blood pressure monitor, which is inherently a therapeutic device used for diagnosis and monitoring of a medical condition (blood pressure).

Diagnostic

Yes

Explanation: The device is a manual blood pressure (BP) monitor that measures blood pressure and pulse rate, which are physiological parameters used in the diagnosis of various health conditions. The "Intended Use / Indications for Use" section explicitly states it determines systolic and diastolic pressure. Therefore, it provides information that can be used for diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical device with an LCD screen, automatic exhaust, and an On/Off button, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, 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: This device measures blood pressure and pulse rate non-invasively by listening for Korotkoff sounds. It does not analyze any biological samples taken from the body.
• Method of Measurement: The method described (Korotkoff sound method) is a physical measurement technique, not a diagnostic test performed on a sample.
• Intended Use: The intended use is to measure blood pressure and pulse rate, which are physiological parameters, not to diagnose a disease or condition based on a biological sample.

The description explicitly states it measures blood pressure "in vitro" in the device description, but this seems to be a misstatement or a misunderstanding of the term "in vitro" in the context of IVDs. The rest of the description clearly indicates a non-invasive, physical measurement.

Therefore, this device falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The subject device is a manual blood pressure (BP) monitor, and requires the user to listen for Korotkoff sounds to determine systolic and diastolic pressure. Further, patients whose Korotkoff sounds are not clear or absent, such as children younger than 3 years of age, will not be suitable for the subject device. Pulse rate is also measured.

Product codes (comma separated list FDA assigned to the subject device)

DXN, DXQ

Device Description

This device can be used to measure blood pressure and pulse rate non-persistently using the Korotkoff sound method of measuring blood pressure in vitro. The user can measure the blood pressure using this device and cuff, stethoscope. Basically, it has the same function as a conventional mercury sphygmomanometer. However, instead of using harmful mercury to the human body, it displays the pressure on the LCD screen, so that the blood pressure can be measured harmlessly to the human body. In addition, using the 'Mark' function can conveniently display the systolic and diastolic pressures. And using its backlight, the user can measure blood pressure in the dark place. If air pressure exceeds 320mmHg, it will automatically exhaust quickly. If an emergency occurs during the measurement, pressing On/Off button will turn off the equipment and allow rapid exhaust. The device is for use by medical professional. The testing person supplies their own stethoscope, which is required for making the measurements. The measurement method is as follows.

1. BPBIO220/BPBIO210: Place the device on a sturdy table or the cart. For BPBIO220T/BPBIO210T: Assemble the stand and the device.
2. Sit properly in chair and place patient's arm at heart height.
3. Wind the cuff around the patient's arm.
4. Pressurize manually.
5. Depressurize manually and listen to the Korotkoff sound.
6. Determine the systolic blood pressure and the diastolic blood pressure by Korotkoff sound.
7. When the measurement is complete, the heart rate appears on the heart rate display is an incidental result of the Korotkoff sound identification and is not intended to be diagnostic or act as a heart rate monitor or alarm.

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

patients whose Korotkoff sounds are not clear or absent, such as children younger than 3 years of age, will not be suitable for the subject device.
Adult

Intended User / Care Setting

medical professional

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)

Non-clinical testing:
Study Type: Bench testing to compare the proposed device results to the regular manual method of measuring blood pressure.
Sample Size: 102 subjects
Key Results: "InBody has compared the accuracy between mercury manometer using the stethoscope and the non-invasive sphygmomanometer, BPBIO210/220/210T/220T. We found and concluded that they are substantially equal to each other. The accuracy of the BPBIO210/220T which acquired from the clinical investigation implemented by InBody is respectively the systolic (Mean = 0mmHg, Std. Dev = 1.206mmHg), and the diastolic (Mean = 0mmHg, Std. Dev = 1.424mmHg). This testing was done in accordance with EN 1060-4. Non-invasive sphygmomanometers. Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers. This is an international version of SP-10 which is referenced in the FDA Guidance."

Clinical Testing: Not required for this type of device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Accuracy: Pressure: ±3 mmHg, Pulse: ±3%

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.

K061456

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

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).

Summary

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Image /page/0/Picture/0 description: The image contains 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.

January 6, 2021

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

Re: K200560

Trade/Device Name: InBody Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, DXQ Dated: December 5, 2020 Received: December 9, 2020

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.

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

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

Sincerely,

for LT 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) K200560

Device Name BPBIO210/220/210T/220T

Indications for Use (Describe)

The subject device is a manual blood pressure (BP) monitor, and requires the user to listen for Korotkoff sounds to determine systolic and diastolic pressure. Further, patients whose Korotkoff sounds are not clear or absent, such as children younger than 3 years of age, will not be suitable for the subject device. Pulse rate is also measured.

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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K200560 510(k) Summary K200560

Image /page/3/Picture/1 description: The image shows the logo for InBody. The logo is in a bold, sans-serif font and is a dark reddish-brown color. The letters are close together, giving the logo a compact appearance. The background is plain white.

InBody Co., Ltd. InBody Bldg., 625, Eonju-ro, Gangnam-gu Seoul KOREA 06106 TEL. [phone] Date prepared: January 5, 2021 Contact: Kichul Cha, CEO

• 1. Identification of the Devices: Proprietary-Trade Names: InBody Blood Pressure Monitor, BPBIO210/220/210T/220T. Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN, DXQ
• 2. Equivalent legally marketed device: K061456, A&D Engineering, Inc. Proprietary-Trade Names: A&D Medical UTM-101 Digital Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN
• 3. Indications for Use: The subject device is a manual blood pressure (BP) monitor, and requires the user to listen for Korotkoff sounds to determine systolic and diastolic pressure. Further, patients whose Korotkoff sounds are not clear or absent, such as children younger than 3 years of age, will not be suitable for the subject device. Pulse rate is also measured.
• 4. Product Description: This device can be used to measure blood pressure and pulse rate non-persistently using the Korotkoff sound method of measuring blood pressure in vitro. The user can measure the blood pressure using this device and cuff, stethoscope. Basically, it has the same function as a conventional mercury sphygmomanometer. However, instead of using harmful mercury to the human body, it displays the pressure on the LCD screen, so that the blood pressure can be measured harmlessly to the human body. In addition, using the 'Mark' function can conveniently display the systolic and diastolic pressures. And using its backlight, the user can measure blood pressure in the dark place. If air pressure exceeds 320mmHg, it will automatically exhaust quickly. If an emergency occurs during the measurement, pressing On/Off button will turn off the equipment and allow rapid exhaust. The device is for use by medical professional. The testing person supplies their own stethoscope, which is required for making the measurements. The measurement method is as follows.

1. BPBIO220/BPBIO210: Place the device on a sturdy table or the cart. For BPBIO220T/BPBIO210T: Assemble the stand and the device.

• 2. Sit properly in chair and place patient's arm at heart height.
• 3. Wind the cuff around the patient's arm.
• 4. Pressurize manually.
• 5. Depressurize manually and listen to the Korotkoff sound.

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K200560

• 6. Determine the systolic blood pressure and the diastolic blood pressure by Korotkoff sound.

7. When the measurement is complete, the heart rate appears on the heart rate display is an incidental result of the Korotkoff sound identification and is not intended to be diagnostic or act as a heart rate monitor or alarm.

• 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.

| ltem | K061456, A&D Engineering, Inc.
UM-101 SPHYGMOMANOMETER | InBody Blood Pressure Monitor,
BPBIO210/220/210T/220T. | Comparison
Result |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Intended Use | Measure blood pressure (systolic and
diastolic) and pulse rate. | The subject device is a manual blood
pressure (BP) monitor, and requires the
user to listen for Korotkoff sounds to
determine systolic and diastolic pressure.
Further, patients whose Korotkoff sounds
are not clear or absent, such as children
younger than 3 years of age, will not be
suitable for the subject device. Pulse rate
is also measured. | Same |
| Patient
Population | Adult | Adult | Same |
| Measurement
location | Upper Arm | Upper Arm | Same |
| Measurement
Principle | Korotkoff sounds. | Korotkoff sounds. | Same |
| Measured: | Blood Pressure Pulse Rate | Blood Pressure and Pulse Rate | Same |
| Blood Pressure
Cuff | External | External | Same |
| Inflation
system | Manual | Manual | Same |
| Components | Gauge, Cuff, Pump | Gauge, Cuff, Pump | Same |
| Power Source | 2 x 1.5V alkaline batteries (LR6 or AA) | 4 x alkaline batteries (AA) | Similar,
battery
operation |
| Dimensions | 12,7" Gauge, Rectangular | 12.6" Gauge, Rectangular | Nearly
identical. |
| Overpressure
safety | An automatic quick exhaust valve is installed
in the device to prevent over
pressurization of 320mmHg or higher,
therefore protecting the patient. | If air pressure exceeds 320mmHg, it will
automatically exhaust quickly. If an emergency
occurs during the measurement, pressing
On/Off button will turn off the equipment and
allow rapid exhaust | Same |
| Measurement
range | Blood Pressure 0-300 mmHg,
Pulse: 30-240 bpm | Blood Pressure 0-300 mmHg,
Pulse: 30-240 bpm | Same |
| Measurement
storage | Up to 5 measurements may be stored via a
marking on the vertical LCD scale | Up to 5 measurements may be stored via a
marking on the vertical LCD scale | Same. |
| Accuracy | Pressure: ±3mmHg
Pulse: ±5 % | Pressure: ±3 mmHg,
Pulse: ±3% | Essentially
the same |
| Item | K061456, A&D Engineering, Inc.
UM-101 SPHYGMOMANOMETER | InBody Blood Pressure Monitor,
BPBIO210/220/210T/220T. | Comparison
Result |
| Range of cuff
sizes | Large cuff 33 cm to 45 cm
Medium cuff 23 cm to 33 cm
Small cuff 16 cm to 23 cm | Large cuff 32 cm to 42 cm
Medium cuff 22 cm to 32 cm
Small cuff 17 cm to 22 cm. | Similar range
of sizes |
| Photos | Image: A&D Engineering UM-101 SPHYGMOMANOMETER | Image: InBody Blood Pressure Monitor BPBIO210/220/210T/220T | Very similar
in
appearance. |

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• 6. Summary of technological characteristics of the device compared to the predicate device. These blood pressure meters are intended to be used in measuring human systolic blood pressure using Korotkoff sounds. In addition to being able to manually measure (and store up to 5 measurements) this electronic version of the classical blood pressure meter can display pulse rate. The following FDA guidance was consulted in the design and testing of the device: Non-Invasive Blood Pressure (NIBP) Monitor Guidance MARCH 1997, Final.
• 7. Non-clinical testing: The proposed new models were tested and found to conform to the following international standards:

IEC 60601-1 :2005/AMD1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance FDA recognition 19-4

IEC 60601-1-2 [2014] Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic Compatibility Requirements and tests FDA recognition 19-8

In additional to standards testing, we did bench testing to compare the proposed device results to the regular manual method of measuring blood pressure. InBody has implemented the bench testing procedure to determine the overall system accuracy of non-invasive sphygmomanometers with the intent to verity the overall accuracy of BPBIO210/220/210T/220T. 102 subjects were tested. The comparison results are as follows: InBody has compared the accuracy between mercury manometer using the stethoscope and the non-invasive sphygmomanometer, BPBIO210/220/210T/220T. We found and concluded that they are substantially equal to each other. The accuracy of the BPBIO210/220T which acquired from the clinical investigation implemented by InBody is respectively the systolic (Mean = 0mmHg, Std. Dev = 1.206mmHg), and the diastolic (Mean = 0mmHg, Std. Dev = 1.424mmHg). This testing was done in accordance with EN 1060-4. Non-invasive sphygmomanometers. Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers. This is an international version of SP-10 which is referenced in the FDA Guidance.

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K200560

• 8. Clinical Testing: Not required for this type of device. Blood pressure measurement is manually done by the testing person.
• 9. Conclusion, Comparison to the predicate device. Proposed Models: BPBIO210/2207. are substantially equivalent to the predicate whose 510(k) number is K061456. The devices are identical in the intended use, and similar in the design principles, the performance and the applicable standards. Only their appearance and the user interfaces are different.