(266 days)
No
The summary describes a device that uses ultrasound to estimate BMD and calculate scores based on a reference database. There is no mention of AI or ML in the device description, intended use, or performance studies. The correlation to DXA and precision metrics are standard for this type of device and do not inherently indicate AI/ML.
No.
The device is used to determine BMDus Index and assess fracture risk, which are diagnostic purposes, not therapeutic.
Yes
Explanation: The device is used to determine the BMDus Index and assess appendicular fracture risk, both of which are used to identify or characterize a disease (osteoporosis or risk of fracture).
No
The device description explicitly states "The UltraScan 650 is an ultrasound device" and "The UltraScan 650, with a user-supplied laptop, is designed for the estimation of bone mineral density". This indicates the device includes hardware components (the ultrasound device itself) in addition to software.
Based on the provided information, the UltraScan 650 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- UltraScan 650 Function: The UltraScan 650 is an ultrasound device that directly measures bone properties (BMDus Index) in the forearm of a living individual. It does not analyze specimens taken from the body.
The device is a non-invasive diagnostic tool that uses ultrasound to assess bone health in vivo.
N/A
Intended Use / 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.
Product codes
MUA
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 BMDus 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
forearm (1/3 radius)
Indicated Patient Age Range
adult men and women, postmenopausal women
Intended User / Care Setting
Hospital, sub-acute care facilities, doctor's offices and clinics
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)
Non-Clinical Testing Summary included:
- AAMI/ANSI/ES60601-1:2005 for electrical safety
- IEC 60601-1-2:2007 for EMC
- Distance Validation
- Time Delay Correction
- Quality Control
- Acoustic output
Clinical Testing Summary included:
- 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
Key results include:
- The precision of the measurement is 2.1%, when expressed as a coefficient of variation.
- Correlation to BMDDXA: 0.93
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Measurement precision: 2.1%
Correlation to BMDDXA: 0.93
Predicate Device(s)
Reference Device(s)
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 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 | 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 |