(175 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on ultrasound measurement and software processing without mentioning AI/ML techniques.
No
The device is used as an aid in diagnosis and in the determination of fracture risk, not for treatment.
Yes
The Intended Use section 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 a diagnostic purpose.
No
The device description explicitly states that the system consists of a "handheld ultrasound transducer and software" and that the transducer is connected to a computer. This indicates the presence of a hardware component (the ultrasound transducer) in addition to the 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 BI-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 describes the device as an aid to the physician in diagnosis and fracture risk determination based on the bone measurement, not on the analysis of a biological sample.
Therefore, the Bindex BI-2 system falls under the category of a medical device that performs measurements in vivo (within the living body), not in vitro (in glass or outside the living body).
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
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 bensity 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 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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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)
The following performance data were provided in support of the substantial equivalence determination.
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.
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 with isolation transformer). 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." 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 in this submission shows equivalence of the devices on behalf of acoustic output. 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).
Clinical Studies: The same clinical and pre-clinical data supports the safe and effective use of Bindex Bl-100, to which substantial equivalence is shown. The safety and effectiveness of Bindex Bl-2 device has been discussed in clinical evaluation document Section 16.
Conclusions: The related safety standards are the same for the predicate and subject device. The same clinical evidence applies to both devices. In the present submission, the performance testing comparing the two models shows that the subject device is substantially equivalent to the predicate device and does not raise additional questions on safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 9, 2017
Bone Index Finland, Ltd. % Janne Karjalainen Chief Technology Officer (CTO) Microkatu 1 Kuopio 70211 FINLAND
Re: K161971 Trade/Device Name: Bindex BI-2 Regulation Number: 21 CFR 892.1180 Regulation Name: Bone sonometer Regulatory Class: II Product Code: MUA Dated: July 12, 2016 Received: December 15, 2016
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D.'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161971
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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510(k) Summary
SUBMITTER l.
Bone Index Finland, Ltd. Microkatu 1 Kuopio, Finland 70211 Phone: +358 45 896 2650 Contact Person: Janne Karjalainen Date Prepared: 2 Dec, 2016
II. DEVICE
Name of Device: Bindex BI-2 Common or Usual Name: Bone sonometer Classification Name: Bone sonometer (21 CFR 892.1180) Regulatory Class: II Product Code: MUA
III. PREDICATE DEVICE
Bindex BI-100 bone sonometer, K152020.
This predicate has not been subject to a design-related recall.
4
IV. 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 bensity 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 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)
V. 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.
Indications for use discussion
The Indications for Use statement for the Bindex Bl-2 is identical to the predicate device; thus raises no additional questions on safety and effectiveness.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VI. DEVICE
The predicate and subject devices are based similar ultrasound technology and are based on the same measurement principle. The main differences between the devices are structural in terms mechanics and electronics. Importantly, the transducer (responsible for conversion of electrical energy to kinetic mechanical energy), is the same for both devices.
The predicate and subject devices are compared in table 1.
Table 1. Device comparison table.
| # | Item | Bindex BI-100 (Predicate) | Bindex BI-2 (subject) |
|---|---|---|---|
| 1 | Indications for use | Bindex measures apparent cortical bone thickness at the proximal tibia | Same |
5
| | | 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 | Measurement mode | Apparent Cortical Thickness
(Ct.Th.). | Same |
| 3 | Probe compatibility | One transducer, centre frequency =
3.0 MHz (nominal) | Same |
| 4 | Electrical safety | IEC 60601-2-37:2001 including
Amendments 1 and 2; and IEC
60601-1:2005 | Same |
| 5 | Electromagnetic
compatibility | Complies with IEC 60601-1-2:2007 | Same |
| 6 | Power supply | PC USB port powered. | Same |
| 7 | Operating
Environment | Temperature: +10°C to +40°C
Humidity: 5% to 85% RH, non-
condensing
Atmospheric Pressure: 600 to 1060
Pc | Same |
| 8 | Storage Environment | Temperature: +10°C to +40°C
Humidity: 5% to 85% RH, non-
condensing | Same |
| 9 | Calibration | Calibration before each use. | Same |
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
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
6
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 (Section 13).
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 with isolation transformer). 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."
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 in this submission shows equivalence of the devices on behalf of acoustic output.
- 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)
Clinical Studies
The same clinical and pre-clinical data supports the safe and effective use of Bindex Bl-100, to which substantial equivalence is shown.
The safety and effectiveness of Bindex Bl-2 device has been discussed in clinical evaluation document Section 16.
CONCLUSIONS VIII.
7
The related safety standards are the same for the predicate and subject device. The same clinical evidence applies to both devices. In the present submission, the performance testing comparing the two models shows that the subject device is substantially equivalent to the predicate device and does not raise additional questions on safety or effectiveness.
Date: 12/02/2016
mm / dd / year
signature
Janne Karjalainen, CTO, Bone Index Finland Ltd.