Bindex BI-2

K211350 · Bone Index Finland , Ltd. · MUA · Apr 29, 2022 · Radiology

Device Facts

• Record ID: K211350
• Device Name: Bindex BI-2
• Applicant: Bone Index Finland , Ltd.
• Product Code: MUA · Radiology
• Decision Date: Apr 29, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1180
• Device Class: Class 2

Intended Use

Bindex measures apparent cortical bone thickness at the proximal tibia and can be used in conjunction with other clinical risk factors or patient characteristics as an aid to the physician in the diagnosis and other medical conditions leading to reduced bone strength and in the determination of fracture risk.

Device Story

Bindex BI-2 is a handheld ultrasound bone sonometer; measures apparent cortical bone thickness at proximal tibia; provides Density Index (DI) parameter estimating hip bone mineral density (BMD). System consists of ultrasound transducer connected to computer via USB; controlled by software. Operator applies gel to skin; manually places transducer perpendicularly on proximal tibia; performs five measurements. Software processes ultrasound signals; calculates DI; displays osteoporosis probability via color-coded bar (Green/Yellow/Red). Used by physicians, nurses, pharmacists, or trained health professionals; not for patient self-use. Output aids clinicians in osteoporosis screening/diagnostics and fracture risk assessment. Benefits include point-of-care assessment of bone strength without ionizing radiation.

Clinical Evidence

Clinical trial (n=293 postmenopausal women: 153 Caucasian, 140 Hispanic) evaluated DI threshold performance. Results showed sensitivity of 80% and specificity of 91% for Hispanic women, and 80%/86% for Caucasians, consistent with previous studies (Schousboe et al., 2016). Bench testing included biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2 Ed 4.0), and environmental testing (IEC 60601-1-11) to support home healthcare use.

Technological Characteristics

Handheld ultrasound transducer; 3.0 MHz nominal center frequency. Powered via PC USB port. Materials: biocompatible for <24h skin contact. Connectivity: USB-tethered to PC. Software-based analysis. Sterilization: manual disinfection via isopropyl alcohol. Standards: IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2 Ed 4.0, IEC 60601-1-11.

Indications for Use

Indicated for use as an aid in the diagnosis of osteoporosis and other medical conditions leading to reduced bone strength and in the determination of fracture risk in postmenopausal Caucasian and Hispanic women aged 50 to 90 years.

Regulatory Classification

Identification

A bone sonometer is a device that transmits ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk. The primary components of the device are a voltage generator, a transmitting transducer, a receiving transducer, and hardware and software for reception and processing of the received ultrasonic signal.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers.” See § 892.1(e) for the availability of this guidance document.

Predicate Devices

• Bindex BI-2 model (K161971)

Submission Summary (Full Text)

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Bone Index Finland Ltd. Janne Karjalainen CTO Savilahdentie 14 Kuopio 70700 FINLAND

Re: K211350

Trade/Device Name: Bindex BI-2 Regulation Number: 21 CFR 892.1180 Regulation Name: Bone Sonometer Regulatory Class: Class II Product Code: MUA Dated: April 13, 2022 Received: April 21, 2022

April 29, 2022

Dear Janne Karjalainen:

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 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

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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.

Jessica Lamb, Ph.D. Assistant Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K211350

Device Name Bindex BI-2

Indications for Use (Describe)

Bindex measures apparent cortical bone thickness at the proximal tibia and can be used in conjunction with other clinical risk factors or patient characteristics as an aid to the physician in the diagnosis and other medical conditions leading to reduced bone strength and in the determination of fracture risk.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-family: Symbol;">☑</span> </span> </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-family: Symbol;">☐</span> </span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## K211350

# 510(k) Summary

## SUBMITTER

Bone Index Finland Ltd. Savilahdentie 14 Kuopio, Finland 70700 Establishment registration number: 3013328880 Phone: [phone] Contact Person: Janne Karjalainen Date Prepared: April 24th, 2022

Name of Device: Bindex, Model Bl-2 Common or Usual Name: Bone sonometer Classification Name: Bone sonometer (21 CFR 892.1180) Regulatory Class: II Product Code: MUA

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#### DEVICE DESCRIPTION l.

The Bindex Bl-2 system consists of handheld ultrasound transducer and software. Bindex Bl-2 is connected to the USB port of a computer and controlled with computer software. Bindex Bl-2 is used for measurement of cortical bone thickness and it provides Density Index (DI), a parameter which estimates bone mineral density at the hip as measured with DXA. For measurements, gel is applied on skin and ultrasound transducer is manually placed on the measurement location. Standardized measurement location is at proximal tibia (1/3 length of tibia). Transducer is manually oriented perpendicularly to the surface of the cortical bone to achieve accepted measurement. Measurement is repeated five times at each measurement location. Finally, transducer is disinfected by wiping gel off with isopropyl alcohol moistened cloth.

The associated accessories include:

- . Measurement stick
- Ultrasound gel (optional)

#### ll. PREDICATE DEVICES

Predicate devices:

- (1) Bindex Bl-2 model (K161971).

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# III. DEVICE CHANGE COMPARISON

Changes to legally marketed device are described in Table 1.

| # | Item | Bindex BI-2 (Legally marketed,<br>K161971) | Bindex BI-2 (Modified, subject<br>device) |
|---|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Indications for use | Bindex measures apparent cortical<br>bone thickness at the proximal tibia<br>and can be used in conjunction with<br>other clinical risk factors or patient<br>characteristics as an aid to the<br>physician in the diagnosis of<br>osteoporosis and other medical<br>conditions leading to reduced bone<br>strength and in the determination of<br>fracture risk. | Bindex measures apparent cortical<br>bone thickness at the proximal tibia<br>and can be used in conjunction with<br>other clinical risk factors or patient<br>characteristics as an aid to the<br>physician in the diagnosis of<br>osteoporosis and other medical<br>conditions leading to reduced bone<br>strength and in the determination of<br>fracture risk. |
| 2 | Intended use | Bindex measures apparent cortical<br>bone thickness at the upper shaft of<br>tibia (See Figure 1) and reports<br>diagnostic parameter, Density Index<br>(DI), an estimate of hip Bone Mineral<br>Density measured with gold<br>standard Axial DXA. Thresholds for<br>osteoporosis for DI have been<br>determined in comparison to DXA.<br>The DI reported by Bindex is used as<br>an aid in osteoporosis diagnostics by<br>applying pre determined thresholds.<br>DI can help the clinician in<br>estimation of fracture risk.<br>After the measurement, Bindex®<br>software gives an estimation of the<br>presence of osteoporosis marked in<br>the color bar: Green (Low Probability<br>of Osteoporosis), Yellow (Additional<br>Investigations Needed) or Red area<br>(High Probability of Osteoporosis). A<br>total of 90% of osteoporotic patients<br>diagnosed by hip BMD are in the<br>yellow or red area (90% sensitivity)<br>and 90% of non osteoporotic | Bindex measures apparent cortical<br>bone thickness at the upper shaft of<br>tibia (See Figure 1) and reports<br>diagnostic parameter, Density Index<br>(DI), an estimate of hip Bone<br>Mineral Density measured with gold<br>standard Axial DXA. Thresholds for<br>osteoporosis for DI have been<br>determined in comparison to DXA.<br>The DI reported by Bindex is used as<br>an aid in osteoporosis diagnostics by<br>applying pre determined thresholds.<br>DI can help the clinician in<br>estimation of fracture risk.<br>After the measurement, Bindex®<br>software gives an estimation of the<br>presence of osteoporosis marked in<br>the color bar: Green (Low<br>Probability of Osteoporosis), Yellow<br>(Additional Investigations Needed)<br>or Red area (High Probability of<br>Osteoporosis). A total of 90% of<br>osteoporotic patients diagnosed by<br>hip BMD are in the yellow or red<br>area (90% sensitivity) and 90% of non osteoporotic |

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| | | patients are in the green or yellow<br>area (90% specificity). Statistically at<br>least 80% sensitivity and specificity<br>for hip osteoporosis will be reached<br>with 95% confidence. Patient<br>classification is based on thresholds<br>(separating red/yellow/green areas)<br>published in a study by Karjalainen<br>et al. "New method for point of care<br>osteoporosis screening and<br>diagnostics" in Osteoporosis<br>International 2016.<br>Currently the use of Bindex® DI<br>thresholds are validated for<br>Caucasian women at the age<br>between 50 to 90 years. Bindex®<br>measurement takes about one<br>minute. Bindex® device should be<br>operated by a physician, or under<br>supervision of physician by a nurse,<br>pharmacist or trained person with a<br>suitable background education and<br>skills. | non osteoporotic patients are in the<br>green or yellow area (90%<br>specificity). Statistically at least 80%<br>sensitivity and specificity for hip<br>osteoporosis will be reached with<br>95% confidence. Patient<br>classification is based on thresholds<br>(separating red/yellow/green areas)<br>published in a study by Karjalainen<br>et al. "New method for point of care<br>osteoporosis screening and<br>diagnostics" in Osteoporosis<br>International 2016.<br>Currently the use of Bindex® DI<br>thresholds are validated for<br>Caucasian and Hispanic women at<br>the age between 50 to 90 years.<br>Bindex® measurement takes about<br>one minute. Bindex® device should<br>be operated by a physician, or under<br>supervision of physician by a nurse,<br>pharmacist or other health<br>professional who has gone through<br>training. Bindex should not be used<br>by patients. |
|----|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 3 | Measurement<br>mode | Cortical Thickness (Ct.Th.). | Same |
| 4 | Probe compatibility | One transducer, centre frequency =<br>3.0 MHz (nominal) | Same |
| 5 | Electrical safety | IEC 60601-2-37:2001 including<br>Amendments 1 and 2; and IEC<br>60601-1:2005 | Same |
| 6 | Electromagnetic<br>compatibility | Complies with IEC 60601-1-2:2007 | Updated to IEC 60601-1-2 Edition<br>4.0, 2014 |
| 7 | Power supply | PC USB port powered. | Same |
| 8 | Operating<br>Environment | Temperature: +10°C to +40°C<br>Humidity: 5% to 85% RH, non-<br>condensing<br>Atmospheric Pressure: 600 to 1060<br>Pc | Temperature: +15°C to +40°C<br>Humidity: 5% to 90% RH, non-<br>condensing<br>Atmospheric Pressure: Same |
| 9 | Storage<br>Environment | Temperature: +10°C to +40°C<br>Humidity: 5% to 85% RH, non-<br>condensing | Temperature: +15°C to +40°C<br>Humidity: 5% to 90% RH, non-<br>condensing<br>Atmospheric Pressure: Same |
| 10 | Calibration | Calibration before each use. | Same |

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### IV. PERFORMANCE DATA SUMMARY

This section describes the performance data generated to show safe and effective use of Bindex Bl-2 device. The data for the use in home healthcare environment is summarized in table 2. and described below in more detail.

## Biocompatibility testing

The biocompatibility evaluation for the Bindex Bl-2 device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing along the ISO 10993-1 would recommend the following tests:

- Cytotoxicity
- Sensitization
- Irritation

The Bindex Bl-2 is in skin contact for duration of less than 24 hours. Since the use of Bindex involves very short skin contact (typically less than 10 minutes) on a healthy skin and therefore poses a very low risk. Safety of the manufacturing and used materials has been further discussed in Biocompatibility report.

### Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the measurement system, consisting of the Bindex Bl-2 and a laptop computer (on battery use or connected to power supply). The system complies with the IEC 60601-1, and IEC 60601-2-37 standards for safety and the IEC 60601-1-2 standard for EMC.

### Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".

The software for this device was considered as a "moderate" level of concern.

### Mechanical and acoustic testing

The acoustic output and mechanical properties have been tested along the principles presented in harmonized standards IEC 62359 and IEC 60601-1:

- . Acoustic Testing has been conducted on the predicate device and test documentation shows equivalence of the devices on behalf of acoustic output.

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- . Drop test (hand piece dropped from 1m on hard surface).
- . Ball pressure test (pressed with steel ball 5mm in diameter with force of 20N one hour at a temperature of 75+2°C)
- Moulding stress relief (device placed in circulating air oven at 70 °C for 7 hours and let cool down)

| Device Change | Risks | Verification/Validation<br>Methods | Acceptance Criteria | Summary<br>Results |
|------------------------------------------|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Use in home<br>healthcare<br>environment | Electromagnetic<br>interference | IEC 60601-1-2 Edition<br>4.0<br><br>Conducted<br>disturbances induced<br>by RF fields, Test<br>method IEC 61000-4-6<br><br>Radiated radio<br>frequency (RF)<br>electromagnetic fields<br>(EM) , Test method IEC<br>61000-4-3 | Essential<br>performance and<br>Basic Safety<br>maintained. | Test samples<br>passed the tests<br>with intact Essential<br>Performance and<br>Basic Safety |
| | Environmental<br>hazards | Tests in accordance to<br>IEC 60601-1:2005<br>+Am1:2012; Clause<br>5.7, 8.8.3 and 8.7<br><br>IEC 60601-1-11:2015;<br>Clause 4.2.2, 4.2.3.1,<br>8.3.1 and 10.1.2 | Essential<br>performance and<br>Basic Safety<br>maintained. | Test samples<br>passed the tests<br>with intact Essential<br>Performance and<br>Basic Safety |

Table 2. Performance data summary, home healthcare environment.

EMC testing according to IEC 60601-1-2 Edition 4.0, 2014:

- -Changes in required test for Conducted disturbances induced by RF fields, Test method IEC 61000-4-6
- -Changes in required tests for Radiated radio frequency (RF) electromagnetic fields, Test method IEC 61000-4-3

Home healthcare environment standard IEC 60601-1-11:2015 and main safety standard IEC 60601-1:2005 related tests have been conducted.

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Expanding the population in the Intended Use statement to include Hispanic individuals:

- A clinical trial has been conducted in Albuquerque, New Mexico, USA to investigate whether the Density Index thresholds used with Bindex Bl-2 device need adjustments when applied in Hispanic population. The method and protocol for this study are same as used in previous clinical studies supporting the use of legally marketed device Bindex BI-2 (K161971), and well-established (several publications, suggested by International society for clinical densitometry). Key findings are summarized below, as written in publication by E. Lewiecki (J Clin Densitom 2020):
" The study enrolled 293 postmenopausal women (153 Caucasian, 140 Hispanic) with and without osteoporosis. The sensitivity and specificity for DI thresholds to distinguish women with total hip or femoral neck T-score <-2.5 or > -2.5 was similar in Caucasians (sensitivity 80%, specificity 86%) and Hispanics (sensitivity 80%, specificity 91%). The findings of this study confirm the utility of previously established DI thresholds to identify women who are likely to have osteoporosis and suggest that the same thresholds can be used for postmenopausal Caucasian and Hispanic women."

- -The results are similar than those found in previous study by Schousboe et al. published in Osteoporos Int 2016, (Sensitivity 80% and specificity 82%). These results were included in previous submission for the legally marketed device (K161971).
The labelling of the Bindex Bl-2 have been changed to reflect above described additions in use environment and addition of Hispanic ethnicity to intended population.

### V. CONCLUSIONS

The Bindex Bl-2 product has been reviewed for risks arising from the change of device use environment from PROFESSIONAL HEALTHCARE to HOME USE, in which the safe use is verified by tests. The changes in Bindex BI-2 described in this submission do not raise additional questions relating to safety and efficacy of the device. Thus, the device remains substantially equivalent to the previously cleared Bindex BI-2 device.