UltraScan 650

K161919 · Cyberlogic, Inc. · MUA · Apr 5, 2017 · Radiology

Device Facts

• Record ID: K161919
• Device Name: UltraScan 650
• Applicant: Cyberlogic, Inc.
• Product Code: MUA · Radiology
• Decision Date: Apr 5, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1180
• Device Class: Class 2

Intended Use

UltraScan 650 can be used to determine BMDus Index in adult men and women and to assess appendicular fracture risk in postmenopausal women. The BMDus Index is a clinical measure based on ultrasound variables of the forearm which is highly correlated with the value of BMD of the 1/3 radius as provided by DXA, with a standard error of the estimate of 0.041 grams/cm2. BMDus Index is expressed in grams/cm² and as a T- and z-score, derived from comparison to a normative x-ray absorptiometry reference database. BMDus Index has a precision comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes in postmenopausal women.

Device Story

UltraScan 650 is an ultrasound bone sonometer for non-invasive, quantitative assessment of bone at the 1/3 radius of the forearm. Device uses through-transmission ultrasound with multiple transducers; requires user-supplied laptop for operation. System measures ultrasound variables to estimate bone mineral density (BMD) at the 1/3 radius, outputting BMDus Index (g/cm²), T-scores, and Z-scores. Used in hospitals, clinics, and physician offices by healthcare professionals. Output provides clinicians with data comparable to DXA for monitoring bone changes and assessing fracture risk. Benefits include non-ionizing radiation assessment of bone density and fracture risk.

Clinical Evidence

Clinical evidence includes simulation data, in vitro data, and clinical studies evaluating BMD estimation, reproducibility, fracture risk, normative reference database, and dominant vs. non-dominant arm comparisons. Device demonstrated a 0.93 correlation to DXA (Hologic QDR 4500) for BMD estimation. Precision (coefficient of variation) is 2.1%.

Technological Characteristics

Ultrasound through-transmission system; multiple transducers; 1/3 radius measurement location. Patient-contact materials meet ISO 10993-1 for limited duration. Electrical safety per AAMI/ANSI/ES60601-1; EMC per IEC 60601-1-2. Includes forearm length measuring device, elbow rest pad, and positioning device. Connectivity via user-supplied laptop.

Indications for Use

Indicated for adult men and women to determine BMDus Index and for postmenopausal women to assess appendicular fracture risk.

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

• GE Healthcare Achilles ultrasonometer (K103633)

Reference Devices

• BeamMed Omnisense 7000S (K110646)
• Hologic QDR Model 4500 (K023398)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 5, 2017

CyberLogic, Inc. % Mr. Paul Dryden Consultant ProMedic, Inc. 24301 Woodsage Drive BONITA SPRINGS FL 34134

Re: K161919

Trade/Device Name: UltraScan 650 Regulation Number: 21 CFR 892.1180 Regulation Name: Bone Sonometer Regulatory Class: II Product Code: MUA Dated: March 29, 2017 Received: March 31, 2017

Dear Mr. Dryden:

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.

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'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

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## Indications for Use

510(k) Number (if known)

#### K161919

Device Name

#### UltraScan 650

Indications for Use (Describe)

UltraScan 650 can be used to determine BMDus Index in adult men and women and to assess appendicular fracture risk in postmenopausal women.

The BMD [] Index is a clinical measure based on ultrasound variables of the forearm which is highly correlated with the value of BMD of the 1/3 radius as provided by DXA, with a standard error of the estimate of 0.041 grams/cm2.

BMDus Index is expressed in grams/cm² and as a T- and z-score, derived from comparison to a normative x-ray absorptiometry reference database.

BMD 15 Index has a precision comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes in postmenopausal women.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
| XX Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |

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CyberLogic, Inc. 611 Broadway Suite 707 New York, NY 10012

Tel – 212-260-1351

| Official Contact: | Jonathan J. Kaufman, President and CEO |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Proprietary or Trade Name: | UltraScan ™ 650 |
| Common/Usual Name: | Bone sonometer |
| Classification Name /<br>Product Classification | Bone sonometer<br>MUA, 21CFR 892.1180, Class II |
| Predicate Device:<br>Reference Devices: | K103633 – GE Healthcare Achilles ultrasonometer<br>K110646 – BeamMed – Omnisense 7000S<br>K023398 – Hologic QDR Model 4500 |

#### Device Description:

The UltraScan 650 is an ultrasound device that is designed to non-invasively and quantitatively assess the amount of bone at the 1/3 location of the radius in the forearm of an individual.

The UltraScan 650, with a user-supplied laptop, is designed for the estimation of bone mineral density (BMD in g/cm²) of the radius at the 1/3 location. The UltraScan 650 outputs a BMD is Index an estimate of the BMD that would be measured by dual-energy X-ray absorptiometry (DXA) at the same anatomical location, that is, an estimate of BMDDXA, at the 1/3 radius. The UltraScan 650 also outputs the T-score in standard deviations (SD) and Z-score in SD as well. The precision of the measurement is 2.1%, when expressed as a coefficient of variation. The range of the output of the UltraScan 650, depends on the subjects that are measured. However, based on the normative (reference) data, we can calculate the range that will include 99.85% of all subjects.

#### Indications for Use:

UltraScan 650 can be used to determine BMDys Index in adult men and women and to assess appendicular fracture risk in postmenopausal women.

The BMDus Index is a clinical measure based on ultrasound variables of the forearm which is highly correlated with the value of BMD of the 1/3 radius as provided by DXA, with a standard error of the estimate of 0.041 grams/cm2.

BMD IIs Index is expressed in grams/cm² and as a T- and z-score, derived from comparison to a normative x-ray absorptiometry reference database.

BMDgs Index has a precision comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes in postmenopausal women.

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# 510(k) Summary

| Table 1 Substantial equivalence Comparison to Predicate | | |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Attribute | Predicate<br>GE – Achilles EXPII<br>K103633 | Subject Device<br>UltraScan 650 |
| Indications for Use | Ultrasonometer measures<br>ultrasound variables of the os<br>calcis to provide a clinical<br>measure called Stiffness Index.<br>The Stiffness Index indicates risk<br>of osteoporotic fracture in<br>postmenopausal women<br>comparable to bone mineral<br>density (BMD) as<br>measured by X-ray<br>absorptiometry at the spine or hip.<br><br>Stiffness index results expressed<br>as T--scores are used to assist the<br>physicians in the diagnosis of<br>osteoporosis in the same way as<br>are T-scores obtained by x-ray<br>absorpiometry. Either the stiffness<br>index T-score or x-ray<br>absorptiometry T-score can be<br>utilized by a physician, in<br>conjunction with other clinical<br>risk factors, to provide a<br>comprehensive skeletal<br>assessment.<br><br>The stiffness index has a<br>precision error in older women<br>comparable to that of x-ray<br>absorptiometry, which makes it<br>suitable for monitoring bone<br>changes. | UltraScan 650 can be used to<br>determine BMDUS Index in adult<br>men and women and to assess<br>appendicular fracture risk in<br>postmenopausal women.<br><br>The BMDUS Index is a clinical<br>measure based on ultrasound<br>variables of the forearm which is<br>highly correlated with the value<br>of BMD of the 1/3 radius as<br>provided by DXA, with a<br>standard error of the estimate of<br>0.041 grams/cm2.<br><br>BMDUS Index is expressed in<br>grams/cm2 and as a T- and z-<br>score, derived from comparison to<br>a normative x-ray absorptiometry<br>reference database.<br><br>BMDUS Index has a precision<br>comparable to that of x-ray<br>absorptiometry, which makes it<br>suitable for monitoring bone<br>changes in postmenopausal<br>women. |
| Environment of Use | Hospital, sub-acute care facilities,<br>doctor's offices and clinics | Hospital, sub-acute care facilities,<br>doctor's offices and clinics |
| Patient Population | Postmenopausal women | Assess appendicular fracture risk<br>in postmenopausal women and<br>for determination of BMDUS<br>Index in adult men and women |
| Fundamental technology | Ultrasound | Ultrasound |
| Measurement mode | Transmission | Through-transmission |
| Measurement location | Heel | 1/3 radius |
| Output results | T-score<br>Stiffness Index | T-score<br>Z-score<br>BMDUS Index |
| Attribute | Predicate<br>GE - Achilles EXPII<br>K103633 | Subject Device<br>UltraScan 650 |
| Measurement precision | Not stated | 2.1% |
| Measurement time | < 1 minute | 15 seconds |
| Correlation to BMDDXA | N/A | 0.93 |
| Use of normative reference x-ray<br>absorptiometry database | No | Yes<br>Hologic 1/3 radius adult white<br>females and males, K023398 /<br>K103265. |
| Accessories | N/A | Forearm length measuring device,<br>elbow rest pad, and forearm<br>positioning device. |
| Materials in patient contact | N/A | Surface contact, Intact Skin,<br>Limited duration of Use per ISO<br>10993-1 |
| Performance Testing<br>Safety, EMC | IEC 60601-1 - Safety<br>IEC 60601-1-2 - EMC | IEC 60601-1 - Safety<br>IEC 60601-1-2 - EMC<br>Maximum acoustic output<br>Pulse intensity integrals<br>Pulse total energy<br>Pulse duration<br>Pulse repetition rate<br>Pulse average intensity<br>Time average intensity<br>Acoustic signal center frequency<br>Beam total power |
| Clinical | | Comparative data to DXA<br>Simulation Data<br>In Vitro Data<br>Clinical Data - Estimation of<br>BMD<br>Clinical Data - Reproducibility<br>Clinical Data - Fracture Risk<br>Clinical Data - Reference Data<br>Base<br>Clinical Data - Dominant vs Non-<br>Dominant Arm |

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#### 510(k) Summary 29-Mar-17 Page 3 of 8

#### Discussion of Substantial Equivalence to Predicate

Table 1 above compares the key features of the UltraScan™ 650 with the identified predicate and it demonstrates that the proposed device can be found to be substantially equivalent. Table 2 compares the subject device to the reference devices, specifically for the anatomical location for taking measurements and the comparison of ultrasound to DXA for a BMDw Index value.

Indications for Use - The indications for use of measuring bone density. Discussion - Both device has similar indications for use but differ in the location that the measurement is taken, however there are reference devices which take bone density measurements at the 1/3 radius, K110646.

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Patient Population - The patient population is for assessing appendicular fracture risk in postmenopausal women and for determination of BMDus Index in adult men and women. Discussion - The subject device has included all individuals who may need BMD testing while the predicate is limited to postmenopausal women. We have included clinical data to support the broader population.

Environment of Use - The environment of use is hospitals, sub-acute care facilities, physician's offices, and clinics.

Discussion - There are no differences in the environment of use between the subject device and the predicate.

Technology - The technology is ultrasound via transmission utilizing multiple transducers. The subject device is placing the transducers at the 1/3 radius whereas the predicate places the transducers at the heel.

Discussion - While there is a difference in the location of the transducers between the subject device and the predicate, the reference device, K110646, BeamMed Omnisense 7000S is an ultrasound bone sonometer that is placed at the 1/3 radius. Therefore the difference between the subject device and predicate is addressed via the reference device which has similar indications for use and technology. The difference does not raise any new concerns related to substantial equivalence.

Performance - The correlation of the subject device to the gold standard DXA for measuring BMD is 0.93 vs. the reference, Hologic QDR 4500, K023398, 0.8. We did not compare performance to the predicate.

Discussion - We are making no claim of performance other than the subject device is substantially equivalent to the reference. Hologic ODR 4500. K023398. While the predicate discusses a Stiffness Index they have equated it to BMD. We believe given the higher correlation of the subject device we can present the data as BMDus Index as compared to BMDxx from a marketing perspective.

Materials – The materials which are in patient contact are for less than 1 minute and would be considered as incidental.

Discussion - The type and time of patient contact to the materials is very small and poses no safety risks.

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#### 510(k) Summary 29-Mar-17 Page 5 of 8

| Attribute | Reference<br>BeamMed Omnisense 7000S<br>K110646 | Reference<br>Hologic QDR 4500<br>K023398 | Subject Device<br>UltraScan 650 |
|----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | A non-invasive device that is<br>designed for the quantitative<br>measurement of the signal<br>velocity of ultrasound waves<br>("Speed of Sound" or "SOS" in<br>m/sec) propagating at multiple<br>skeletal sites (i.e., the distal <i>one-third of the radius</i> , the proximal<br>third phalanx and the fifth<br>metatarsal). SOS provides an<br>estimate of skeletal fragility.<br><br>The output is also expressed as a<br><i>T-score</i> and a <i>Z-score</i> , and can be<br>used in conjunction with other<br>clinical risk factors as an aid to<br>the physician in the diagnosis of<br>osteoporosis and other medical<br>conditions leading to reduced<br>bone strength and, ultimately, in<br>the determination of fracture risk.<br><br>Multiple skeletal site testing<br>provided clinicians with<br>alternatives if one site is not<br>accessible and with additional<br>skeletal information (i.e., from<br>bones with different combinations<br>of cortical and cancellous material<br>and from weight bearing and non-<br>weight bearing sites) that assists<br>in diagnosing osteoporosis and<br>risk fracture.<br><br>The SOS measured by MiniOmni<br>has a precision error low enough<br>in comparison with the expected<br>annual change in a patient's<br>measurement to make it suitable | QDR X-Ray Bone<br>Densitometers is indicated for<br>the <i>estimation of bone<br/>mineral density (BMD)</i> ,<br>comparison of measured<br>variables obtained from a<br>given QDR scan to a database<br>of reference values, the<br>estimation of fracture risk,<br>vertebral deformity<br>assessment, body composition<br>analysis, and discrimination of<br>bone from prosthetics using<br>the Hologic QDR X-Ray Bone<br>Densitometers | UltraScan 650 can be used<br>to determine BMDUS Index<br>in adult men and women<br>and to assess appendicular<br>fracture risk in<br>postmenopausal women.<br><br>The BMDUS Index is a<br>clinical measure based on<br>ultrasound variables of the<br>forearm which is highly<br>correlated with the value of<br>BMD of the 1/3 radius as<br>provided by DXA, with a<br>standard error of the<br>estimate of $0.041 grams/cm^2$ .<br><br>BMDUS Index is expressed<br>in $grams/cm^2$ and as a T-<br>and z-score, derived from<br>comparison to a normative<br>x-ray absorptiometry<br>reference database.<br><br>BMDUS Index has a<br>precision comparable to<br>that of x-ray<br>absorptiometry, which<br>makes it suitable for<br>monitoring bone changes in<br>postmenopausal women. |
| Environment<br>of Use | for monitoring bone changes<br>which occur in the early years<br>following menopause (i.e., age<br>range approx... 50-65 years).<br>Hospital, sub-acute care facilities,<br>doctor's offices and clinics | Hospital, sub-acute care<br>facilities, doctor's offices and<br>clinics | Hospital, sub-acute care<br>facilities, doctor's offices<br>and clinics |
| Attribute | Reference<br>BeamMed Omnisense 7000S<br>K110646 | Reference<br>Hologic QDR 4500<br>K023398 | Subject Device<br>UltraScan 650 |
| Patient<br>Population | Females 50-65 years old | Not specified | Assess appendicular fracture<br>risk in postmenopausal women<br>and for determination of<br>BMDUS Index in adult men and<br>women |
| Fundamental<br>technology | Ultrasound | X-ray | Ultrasound |
| Measurement<br>mode | Axial Transmission | X-ray | Through-transmission |
| Measurement<br>location | Distal radius | 1/3 radius | 1/3 radius |
| Output results | T-score<br>Z-score<br>SOS | T-score<br>Z-score<br>BMDDXA | T-score<br>Z-score<br>BMDUS Index |
| Measurement<br>precision | Not stated | Not stated | 2.1% |
| Measurement<br>time | < 1 minute | < 1 minute | 15 seconds |
| Correlation to<br>BMDDXA | N/A | 0.8 | 0.93 |
| Use of<br>normative<br>reference x-ray<br>absorptiometry<br>database | No | Yes | Yes…