(361 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard ultrasound measurement and calculation of a Density Index. There is no mention of AI/ML in the device description, performance studies, or intended use.
No
The device is used as an aid in diagnosing medical conditions and determining fracture risk, but it does not directly treat or provide therapy.
Yes
The "Intended Use / Indications for Use" states that Bindex can be used "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." This explicitly indicates its role in diagnosis.
No
The device description explicitly states that the system consists of a "handheld ultrasound transducer and software" and is connected to a computer via USB, indicating the presence of hardware components beyond just software.
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: The Bindex Bl-2 system uses ultrasound to measure apparent cortical bone thickness directly on the patient's body at the proximal tibia. It does not analyze samples taken from the body.
- Intended Use: The intended use is to aid in the diagnosis of conditions leading to reduced bone strength and in the determination of fracture risk, which is a clinical assessment based on a physical measurement.
Therefore, the Bindex Bl-2 is a medical device that performs a non-invasive measurement on the patient, not an in vitro diagnostic test.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MUA
Device Description
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)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Proximal tibia, hip
Indicated Patient Age Range
The use of Bindex® DI thresholds are validated for Caucasian and Hispanic women at the age between 50 to 90 years.
Intended User / Care Setting
Bindex® device should be operated by a physician, or under supervision of physician by a nurse, pharmacist or other health professional who has gone through training. Bindex should not be used by patients.
Use in home healthcare environment.
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
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).
The study enrolled 293 postmenopausal women (153 Caucasian, 140 Hispanic) with and without osteoporosis.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Trial:
- Sample Size: 293 postmenopausal women (153 Caucasian, 140 Hispanic)
- Key Results: The sensitivity and specificity for DI thresholds to distinguish women with total hip or femoral neck T-score -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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Caucasian: sensitivity 80%, specificity 86%
Hispanics: sensitivity 80%, specificity 91%
Statistically at least 80% sensitivity and specificity for hip osteoporosis will be reached with 95% confidence.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1180 Bone sonometer.
(a)
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.(b)
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ 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: +358 45 896 2650 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).
5
III. DEVICE CHANGE COMPARISON
Changes to legally marketed device are described in Table 1.
| # | Item | Bindex BI-2 (Legally marketed,
K161971) | Bindex BI-2 (Modified, subject
device) |
|---|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Indications for 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 of
osteoporosis and other medical
conditions leading to reduced bone
strength and in the determination of
fracture risk. | 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 of
osteoporosis and other medical
conditions leading to reduced bone
strength and in the determination of
fracture risk. |
| 2 | Intended use | Bindex measures apparent cortical
bone thickness at the upper shaft of
tibia (See Figure 1) and reports
diagnostic parameter, Density Index
(DI), an estimate of hip Bone Mineral
Density measured with gold
standard Axial DXA. Thresholds for
osteoporosis for DI have been
determined in comparison to DXA.
The DI reported by Bindex is used as
an aid in osteoporosis diagnostics by
applying pre determined thresholds.
DI can help the clinician in
estimation of fracture risk.
After the measurement, Bindex®
software gives an estimation of the
presence of osteoporosis marked in
the color bar: Green (Low Probability
of Osteoporosis), Yellow (Additional
Investigations Needed) or Red area
(High Probability of Osteoporosis). A
total of 90% of osteoporotic patients
diagnosed by hip BMD are in the
yellow or red area (90% sensitivity)
and 90% of non osteoporotic | Bindex measures apparent cortical
bone thickness at the upper shaft of
tibia (See Figure 1) and reports
diagnostic parameter, Density Index
(DI), an estimate of hip Bone
Mineral Density measured with gold
standard Axial DXA. Thresholds for
osteoporosis for DI have been
determined in comparison to DXA.
The DI reported by Bindex is used as
an aid in osteoporosis diagnostics by
applying pre determined thresholds.
DI can help the clinician in
estimation of fracture risk.
After the measurement, Bindex®
software gives an estimation of the
presence of osteoporosis marked in
the color bar: Green (Low
Probability of Osteoporosis), Yellow
(Additional Investigations Needed)
or Red area (High Probability of
Osteoporosis). A total of 90% of
osteoporotic patients diagnosed by
hip BMD are in the yellow or red
area (90% sensitivity) and 90% of non osteoporotic |
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| | | patients are in the green or yellow
area (90% specificity). Statistically at
least 80% sensitivity and specificity
for hip osteoporosis will be reached
with 95% confidence. Patient
classification is based on thresholds
(separating red/yellow/green areas)
published in a study by Karjalainen
et al. "New method for point of care
osteoporosis screening and
diagnostics" in Osteoporosis
International 2016.
Currently the use of Bindex® DI
thresholds are validated for
Caucasian women at the age
between 50 to 90 years. Bindex®
measurement takes about one
minute. Bindex® device should be
operated by a physician, or under
supervision of physician by a nurse,
pharmacist or trained person with a
suitable background education and
skills. | non osteoporotic patients are in the
green or yellow area (90%
specificity). Statistically at least 80%
sensitivity and specificity for hip
osteoporosis will be reached with
95% confidence. Patient
classification is based on thresholds
(separating red/yellow/green areas)
published in a study by Karjalainen
et al. "New method for point of care
osteoporosis screening and
diagnostics" in Osteoporosis
International 2016.
Currently the use of Bindex® DI
thresholds are validated for
Caucasian and Hispanic women at
the age between 50 to 90 years.
Bindex® measurement takes about
one minute. Bindex® device should
be operated by a physician, or under
supervision of physician by a nurse,
pharmacist or other health
professional who has gone through
training. Bindex should not be used
by patients. |
|----|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 3 | Measurement
mode | Cortical Thickness (Ct.Th.). | Same |
| 4 | Probe compatibility | One transducer, centre frequency =
3.0 MHz (nominal) | Same |
| 5 | Electrical safety | IEC 60601-2-37:2001 including
Amendments 1 and 2; and IEC
60601-1:2005 | Same |
| 6 | Electromagnetic
compatibility | Complies with IEC 60601-1-2:2007 | Updated to IEC 60601-1-2 Edition
4.0, 2014 |
| 7 | Power supply | PC USB port powered. | Same |
| 8 | Operating
Environment | Temperature: +10°C to +40°C
Humidity: 5% to 85% RH, non-
condensing
Atmospheric Pressure: 600 to 1060
Pc | Temperature: +15°C to +40°C
Humidity: 5% to 90% RH, non-
condensing
Atmospheric Pressure: Same |
| 9 | Storage
Environment | Temperature: +10°C to +40°C
Humidity: 5% to 85% RH, non-
condensing | Temperature: +15°C to +40°C
Humidity: 5% to 90% RH, non-
condensing
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.
8
- . 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
Methods | Acceptance Criteria | Summary
Results |
|------------------------------------------|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Use in home
healthcare
environment | Electromagnetic
interference | IEC 60601-1-2 Edition
4.0
Conducted
disturbances induced
by RF fields, Test
method IEC 61000-4-6
Radiated radio
frequency (RF)
electromagnetic fields
(EM) , Test method IEC
61000-4-3 | Essential
performance and
Basic Safety
maintained. | Test samples
passed the tests
with intact Essential
Performance and
Basic Safety |
| | Environmental
hazards | Tests in accordance to
IEC 60601-1:2005
+Am1:2012; Clause
5.7, 8.8.3 and 8.7
IEC 60601-1-11:2015;
Clause 4.2.2, 4.2.3.1,
8.3.1 and 10.1.2 | Essential
performance and
Basic Safety
maintained. | Test samples
passed the tests
with intact Essential
Performance and
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.
9
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 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.