Who is the manufacturer of UltraScan 650?

Cyberlogic, Inc. filed the 510(k) submission for UltraScan 650 (K161919).

What is the FDA product code for UltraScan 650?

MUA. It is classified under 21 CFR 892.1180 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for UltraScan 650?

510(k) clearance (submission type: Traditional).

What are the predicate devices for UltraScan 650?

GE Healthcare Achilles ultrasonometer (K103633).

Who can help prepare an FDA 510(k) submission like UltraScan 650?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

Indications for 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)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is 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. The profiles are stacked on top of each other, with the top profile being the most prominent. 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. {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. 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 {2}------------------------------------------------ ## 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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW * The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. " FORM FDA 3881 (8/14 {3}------------------------------------------------ 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 / Product Classification | Bone sonometer MUA, 21CFR 892.1180, Class II | | Predicate Device: Reference Devices: | K103633 – GE Healthcare Achilles ultrasonometer K110646 – BeamMed – Omnisense 7000S 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. {4}------------------------------------------------ # 510(k) Summary | Table 1 Substantial equivalence Comparison to Predicate | | | |-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Attribute | Predicate GE – Achilles EXPII K103633 | Subject Device UltraScan 650 | | Indications for Use | Ultrasonometer measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index. The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray absorptiometry at the spine or hip. Stiffness index results expressed as T--scores are used to assist the physicians in the diagnosis of osteoporosis in the same way as are T-scores obtained by x-ray absorpiometry. Either the stiffness index T-score or x-ray absorptiometry T-score can be utilized by a physician, in conjunction with other clinical risk factors, to provide a comprehensive skeletal assessment. The stiffness index has a precision error in older women comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes. | 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. | | Environment of Use | Hospital, sub-acute care facilities, doctor's offices and clinics | Hospital, sub-acute care facilities, doctor's offices and clinics | | Patient Population | Postmenopausal women | Assess appendicular fracture risk in postmenopausal women and for determination of BMDUS 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 Stiffness Index | T-score Z-score BMDUS Index | | Attribute | Predicate GE - Achilles EXPII K103633 | Subject Device 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 absorptiometry database | No | Yes Hologic 1/3 radius adult white females and males, K023398 / K103265. | | Accessories | N/A | Forearm length measuring device, elbow rest pad, and forearm positioning device. | | Materials in patient contact | N/A | Surface contact, Intact Skin, Limited duration of Use per ISO 10993-1 | | Performance Testing Safety, EMC | IEC 60601-1 - Safety IEC 60601-1-2 - EMC | IEC 60601-1 - Safety IEC 60601-1-2 - EMC Maximum acoustic output Pulse intensity integrals Pulse total energy Pulse duration Pulse repetition rate Pulse average intensity Time average intensity Acoustic signal center frequency Beam total power | | Clinical | | Comparative data to DXA Simulation Data In Vitro Data Clinical Data - Estimation of BMD Clinical Data - Reproducibility Clinical Data - Fracture Risk Clinical Data - Reference Data Base Clinical Data - Dominant vs Non- Dominant Arm | {5}------------------------------------------------ #### 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. {6}------------------------------------------------ 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. {7}------------------------------------------------ #### 510(k) Summary 29-Mar-17 Page 5 of 8 | Attribute | Reference BeamMed Omnisense 7000S K110646 | Reference Hologic QDR 4500 K023398 | Subject Device UltraScan 650 | |----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | A non-invasive device that is designed for the quantitative measurement of the signal velocity of ultrasound waves ("Speed of Sound" or "SOS" in m/sec) propagating at multiple skeletal sites (i.e., the distal one-third of the radius , the proximal third phalanx and the fifth metatarsal). SOS provides an estimate of skeletal fragility. The output is also expressed as a T-score and a Z-score , and can be used in conjunction with other clinical risk factors as an aid to the physician in the diagnosis of osteoporosis and other medical conditions leading to reduced bone strength and, ultimately, in the determination of fracture risk. Multiple skeletal site testing provided clinicians with alternatives if one site is not accessible and with additional skeletal information (i.e., from bones with different combinations of cortical and cancellous material and from weight bearing and non- weight bearing sites) that assists in diagnosing osteoporosis and risk fracture. The SOS measured by MiniOmni has a precision error low enough in comparison with the expected annual change in a patient's measurement to make it suitable | QDR X-Ray Bone Densitometers is indicated for the estimation of bone mineral density (BMD) , comparison of measured variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics using the Hologic QDR X-Ray Bone Densitometers | 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 $0.041 grams/cm^2$ . BMDUS Index is expressed in $grams/cm^2$ 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. | | Environment of Use | for monitoring bone changes which occur in the early years following menopause (i.e., age range approx... 50-65 years). Hospital, sub-acute care facilities, doctor's offices and clinics | Hospital, sub-acute care facilities, doctor's offices and clinics | Hospital, sub-acute care facilities, doctor's offices and clinics | | Attribute | Reference BeamMed Omnisense 7000S K110646 | Reference Hologic QDR 4500 K023398 | Subject Device UltraScan 650 | | Patient Population | Females 50-65 years old | Not specified | Assess appendicular fracture risk in postmenopausal women and for determination of BMDUS Index in adult men and women | | Fundamental technology | Ultrasound | X-ray | Ultrasound | | Measurement mode | Axial Transmission | X-ray | Through-transmission | | Measurement location | Distal radius | 1/3 radius | 1/3 radius | | Output results | T-score Z-score SOS | T-score Z-score BMDDXA | T-score Z-score BMDUS Index | | Measurement precision | Not stated | Not stated | 2.1% | | Measurement time | < 1 minute | < 1 minute | 15 seconds | | Correlation to BMDDXA | N/A | 0.8 | 0.93 | | Use of normative reference x-ray absorptiometry database | No | Yes | Yes…

UltraScan 650

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Indications for Use

Device Story

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Indications for Use

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Device Story

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Predicate Devices

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Submission Summary (Full Text)

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