(169 days)
,The UsteoGram is a pre-Amendments device
Not Found
No
The description focuses on software changes for user help and record keeping, and the performance study compares human operators, not algorithmic performance. There is no mention of AI or ML terms or concepts.
No
The device is used for estimating bone mineral density to aid in determining fracture risk and monitoring changes in bone mass, which are diagnostic purposes for assessing a condition, not for treating or curing it.
Yes
The device is described as aiding physicians in determining fracture risk and monitoring bone mass changes, which are diagnostic purposes.
No
The device description explicitly states it involves the processing of x-rays and scanning, which implies the use of hardware (scanner) in addition to the software for analysis. The modification described is a change in software for user help and record keeping, but the core functionality still relies on hardware for image acquisition and scanning.
Based on the provided information, the OsteoGram 2000 is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- OsteoGram 2000 analyzes images: The OsteoGram 2000 analyzes X-ray images of the hand. It processes and analyzes these images to estimate bone mineral density. It does not directly analyze any biological samples.
- The intended use is image-based: The intended use clearly states it's for "estimating bone mineral density (BMD)" based on "exposures and processing of ordinary x-rays of the hand."
Therefore, the OsteoGram 2000 falls under the category of a medical device that uses imaging and software analysis, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The OsteoGram 2000 is indicated for use in estimating bone mineral density (BMD). The estimate of BMD and t-score may be used as an aid to the physician in determining fracture risk, and for monitoring changes in bone mass over time.
Product codes
90 KGI
Device Description
The use of the currently marketed device involves exposures and processing of ordinary x-rays of the hand and scanning and analysis of those x-rays at a central processing lab. The present 510(k) is for a modification to the device, one that would allow the analysis of the x-rays at the same hospital or clinic where the x-rays were taken using off-the-shelf scanner and computer equipment. The proposed device is basically a change in software to provide user help and enhanced records keeping capability.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-rays
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital or clinic
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
CompuMed carried out performance testing that compared the results of CompuMed carried out performance transmission and assays by both naïve the scanning and analysis of several patient and accuracy of the operators and central lab operators. The precision and accuracy of the operators and central lab operators were almost identical.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
CompuMed carried out performance testing that compared the results of CompuMed carried out performance transmission and assays by both naïve the scanning and analysis of several patient and accuracy of the operators and central lab operators. The precision and accuracy of the operators and central lab operators were almost identical. The validation studies have demonstrated that the modified OsteoCram The validation studies nave demonstrator than currently marketed OsteoGram device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
The modified OsteoGram® 2000 device is substantially equivalent to the currently marketed OsteoGram device. The UsteoGram is a pre-Amendments device.
Reference Device(s)
Not Found
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
510(k) Summary
OsteoGram® 2000
Common/Classification Name: Bone Densitometer, 21 CFR 892.1170
CompuMed, Inc. 1230 Rosecrans Avenue Manhattan Beach, CA 90266
Contact: David Edelstein, Prepared: December 1, 1998
LEGALLY MARKETED PREDICATE DEVICES A.
The modified OsteoGram® 2000 device is substantially equivalent to the currently marketed OsteoGram device. The UsteoGram is a pre-Amendments device.
DEVICE DESCRIPTION B.
The use of the currently marketed device involves exposures and processing of ordinary x-rays of the hand and scanning and analysis of those x-rays at a central processing lab. The present 510(k) is for a modification to the device, one that would allow the analysis of the x-rays at the same hospital or clinic where the x-rays were taken using off-the-shelf scanner and computer equipment. The proposed device is basically a change in software to provide user help and enhanced records keeping capability.
C. INDICATIONS FOR USE
The OsteoGram 2000 is indicated for use in estimating me ostimoral density (BMD). The estimate of BMD and t-score may be used as an aid to the physician in escore may be association and for monitoring changes in bone mass over time.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
The OsteoGram 2000 has the same indications for use as the currently marketed device. The OsteoGram 2000 has the same technological characteristics as the predicate device. However, the
1
characteristics may not be sufficiently procise to assure equivalence.
The sufficiently because and welidation, and, nerformance characteristics may not be sumolonely providation and performance
Therefore, CompuMed has carried out valistrate, that the modified , Compulvied nas carred out vanstrate that the modified testing. testing. The results of this testing domently marketed device.
OsteoGram 2000 performs as well as the currently marketed device.
TECHNOLOGICAL CHARACTERISTICS E.
The technological characteristics of the modified device are very similar The technological charactenstics of the modified only difference is that to those of the currently marketed device. The oil / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / the analysis software has been mounted is a lows the OsteoGram ximproved patient revorus managers managers they are made.
TESTING F.
CompuMed carried out performance testing that compared the results of Compulvied carned out performance transmission and assays by both naïve
the scanning and analysis of several patient and annuracy of the the scanning and analysis of several pation and accuracy of the
operators and central lab operators. The precision and accuracy of the operators and central lab operators were almost identical.
CONCLUSIONS G.
The validation studies have demonstrated that the modified OsteoCram The validation studies nave demonstrator than currently marketed OsteoGram device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 1999
Compumed, Inc. C/O T. Whit Athey, Ph.D. Senior Consultant C.L. McIntosh Associates, Inc. Medical & Regulatory Affairs Services 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852
RE:
K984285 OsteoGram 2000 Bone Densitometer Dated: March 17, 1999 Received: March 17, 1999 Regulatory Class: II 21 CFR 892.1170/Procode: 90 KGI
Dear Dr. Athey:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have We nower reviewed your ooking with a windications for uses stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce pror to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been redassified in accordance with the provisions of the Medical Dood, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls r cocial Programs Controls provisions of the Act include requirements for annual registration, listing of provices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Special Controls) or class III (Premarket Approval), it may if your device to such additional control ajor regulations affecting your device can be found in the Code of be Subjict to odor additional Sontrolly equivalent determination assumes compliance with r Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for the Outlett Ooo manandelaning Praxion CEFR Part 820) and that, through periodic QS inspections, the Food and Mcalour Devilled (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in Drog Nammatication. In addition, FDA may publish further announcements concerning your device in the Federal register. In addition, PDF may pour premarket notification submission does not affect any obligation you might have under sections 531 through 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 oquivalone of your dovice 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 il you desire specific devices), please control conficience at (301) 554-4613. Additionally for quostions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-9639. Allso, the promotion and dreitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other please not regulation entilibed with 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/dsma/dsmamain.html".
Sincerety yours.
APT Daniel G. Schultz, M.D Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, 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: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The OsteoGram 2000 is indicated for use in estimating bone mineral density (BMD). The estimate The OsteoGram 2000 is indicated for use in estimating bone innized collably (2007).
of BMD and t-score may be used as an and to the physician in determining fracture risk, an of BMD and t seers may -------------------------------------------------------------------------------------------------------------------------------------------------------
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
David A. Segura
(Division Sign-Off) Division of Reproductiv Abdominal, EN and Radiological D 510(k) Number