(69 days)
No
The description mentions "various algorithms" for image analysis, but there is no mention of AI, ML, deep learning, or any related concepts. The analysis appears to be based on standard algorithmic processing of the dual-energy x-ray data.
No.
The accuDEXA is a diagnostic device that aids physicians in determining fracture risk by estimating bone density; it does not treat or cure medical conditions.
Yes
The device is described as estimating bone density and providing values that can be used as an aid to the physician in determining fracture risk, which indicates a diagnostic purpose.
No
The device description explicitly states it is a Dual Energy X-Ray Absorptiometer (DEXA) device, which is a hardware-based imaging system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves analyzing substances like blood, urine, tissue, etc., outside of the body.
- accuDEXA Function: The accuDEXA device uses X-rays to directly measure bone density within the patient's body (specifically, the finger). It does not analyze a specimen taken from the body.
Therefore, based on the provided information, the accuDEXA is a medical imaging device used for in-vivo measurement, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The accuDEXA is a dual-energy x-ray device indicated for use in estimating the bone density of the middle finger of the non-dominant hand (BMD). This BMD value is a relative indicator of bone density elsewhere in the body. accuDEXA BMD estimates can be used as an aid to the physician in determining fracture risk.
Product codes
KGI
Device Description
The accuDEXA device is a Dual Energy X-Ray Absorptiometer (DEXA) device. The device is intended to estimate bone mineral density in the middle finger of the non-dominant hand. By changing the high voltage on the X-ray tube, two energies are produced. Each of the two settings produces an image of the finger and each image is analyzed using various algorithms to produce a value of bone mineral density (BMD) and bone mineral content (BMC). These values are compared with a normative database, yielding a t-score and a z-score. The t-score is the number of standard deviations that the patient is above or below the mean of a reference sample of young healthy individuals. The z-score is the number of standard deviations that the patient is above or below the mean of a reference sample of individuals of the same age as the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Dual Energy X-Ray Absorptiometer (DEXA)
Anatomical Site
middle finger of the non-dominant hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K973104, Norland Model 178
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1170 Bone densitometer.
(a)
Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
981124
510(k) Summary
Schick accuDEXA Bone Densitometer Fracture Risk Claim
Common/Classification Name. Bone Densitometer 21 CFR 892.1170
Schick Technologies, Inc. 31-00 47th Avenue Long Island City, NY 11101 718-937-5765. 718-937-5962 (FAX) Contact: Enrico Renzi, Prepared: March 6, 1998
LEGALLY MARKETED PREDICATE DEVICES A.
The accuDEXA Bone Densitometer is substantially equivalent to the Norland pDEXA and Model 178 bone densitometer devices with respect to the fracture risk claim. The Norland pDEXA device was found to be substantially equivalent (K973104) with regard to claims of fracture risk to the Norland Model 178, which has been determined by CDRH to have been in commercial distribution prior to May 28, 1976 for use as an aid to the physician in determining fracture risk. The Norland pDEXA device was originally cleared under K931996
DEVICE DESCRIPTION B.
The accuDEXA device is a Dual Energy X-Ray Absorptiometer (DEXA) device. The device is intended to estimate bone mineral density in the middle finger of the non-dominant hand. By changing the high voltage on the X-ray tube, two energies are produced. Each of the two settings produces an image of the finger and each image is analyzed using various algorithms to produce a value of bone mineral density (BMD) and bone mineral content (BMC). These values are compared with a normative database, yielding a t-score and a z-score. The t-score is the number of standard deviations that the patient is above or below the mean of a reference sample of young healthy individuals. The z-score is the number of standard deviations that the patient is above or below the mean of a reference sample of individuals of the same age as the patient.
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C. INDICATIONS FOR USE
The accuDEXA is a dual-energy x-ray device indicated for use in estimating the bone density of the middle finger of the non-dominant hand (BMD). This BMD value is a relative indicator of bone density elsewhere in the body. accuDEXA BMD estimates can be used as an aid to the physician in determining fracture risk.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
The addition to the indications statement for the accuDEXA and the indications statement cleared by FDA for the predicate device are the same. The accuDEXA Bone Densitometer has the same technological characteristics as the predicate devices. The descriptive characteristics with respect to the fracture risk claim are precise enough to assure substantial equivalence. Therefore, the accuDEXA Bone Densitometer is substantially equivalent to the predicate devices with respect to the fracture claim.
TECHNOLOGICAL CHARACTERISTICS E.
See Device Description, above.
F. FRACTURE RISK DETERIMINATION
The recommendations of the World Health Organization and the National Osteoporosis Foundation were used in developing a modification to the patient report printout, an addition to the User Manual, and a Patient Information Brochure.
G. CONCLUSIONS
Schick Technologies has demonstrated through its comparison of characteristics with the predicate devices that the accuDEXA Bone Densitomctor is substantially equivalent to the predicate devices.
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Public Health Service
21 CFR 892.1170/Procode: 90 KGI
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
K981124 Re: accuDEXA Bone Densitometer Dated: March 25, 1998 Received: March 27, 1998 Regulatory class: II
Dear Mr. Athey:
IUN
Whit Athey
1 1998
c/o C.L. Mcintosh & Associates, Inc. 12300 Twinbrook Parkway, Suite 625
Schick Technologies, Inc.
Rockville, MD 20852
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 Festeral Food, Drug, and Commenc Act (Act.). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Feleral Regulations, Title 21, Parts 800 to 895. A substantially oquivaliation assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices). please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
William Hio, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Far, Nose and Thros and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): _
Device Name: _Schick accuDEXA Bone Densitometer
Indications For Use:
The accuDEXA is a dual-energy x-ray device indicated for use in estimating the bone density of the middle finger of the non-dominant hand (BMD). This BMD value is a relative indicator of bone density elsewhere in the body. accuDEXA BMD estimates can be used as an aid to the physician in determining fracture risk.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Bergman
Division Sign Off
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Ramrological Devices
510(k) Number K981124
OR
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
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