(297 days)
Not Found
No
The description focuses on the hardware and physical process of measurement, and there is no mention of AI, ML, or advanced image processing techniques typically associated with these technologies. The performance studies describe statistical analysis of collected data, not the training or validation of an AI/ML model.
No
The device is described as estimating bone mineral content and density, which is a diagnostic function to provide information, not a therapeutic intervention to treat or cure a disease.
Yes
The device estimates bone mineral content and density, which are diagnostic measurements used by healthcare professionals to assess bone health and diagnose conditions like osteoporosis.
No
The device description explicitly details hardware components such as an X-Ray generator, detector (scintillating crystal and photomultiplier tube), and source collimation, indicating it is a hardware device with integrated software, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices analyze samples taken from the human body (like blood, urine, tissue). They are used to provide information about a person's health status based on these samples.
- This device directly measures bone mineral content and density within the body using X-rays. It's a non-invasive imaging device, not a device that analyzes biological samples.
The description clearly indicates it's an X-ray based system for measuring bone density in the forearm, which is a form of medical imaging, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
"To estimate bone mineral content (BMC, grams) and bone mineral density (BMD, grams/cm²)."
Product codes
90 KGI
Device Description
The DTX-100 candidate device is a single energy system, where the measured object, in this case the forearm, is submerged into a soft tissue equivalent water bath.
The X-Ray generator is driven at 40 kV, with a current of 0.2 mAmps . The detector uses scintillating and a crystal photomultiplier tube. A highly stable X-Ray output, together with a source collimation of 1 mm, and excellent pixel resolution, yields images of very high quality.
The typical time to estimate bone mineral content and bone mineral density is approximately 3.0 to 4.5 minutes. The effective patient dose is estimated to be 0.01 micro Sievert per scan.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Forearm
Indicated Patient Age Range
The summary mentions a reference data base for normal American female caucasians ranging in age from 20 to 80 years, with clinical studies used to obtain data for this reference base.
Intended User / Care Setting
Health care professional
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
Four clinical tests were used to obtain data to establish a reference data base for a reference population of normal American female caucasians ranging in age from 20 to 80 years.
- Helen Hayes Hospital (West Haverstraw, NY); protocol # 94-12: "Determination of Forearm Bone Density in a Normal US Population and Comparison of Two New Procedures to Measure Bone Mineral Density". Conducted from May 1995 through May 1996.
- New England Medical Center Hospitals (Boston, MA); protocol # 540: "Is the Current Recommended Dietary Allowance of Vitamin D Sufficient for Minimizing Bone Loss?" Conducted from May 22, 1991 through August 17, 1993.
- New England Medical Center Hospitals (Boston, MA); protocol # 620: "Effect of Calcium and Vitamin D on Bone Loss from the Hip" Conducted from February 6, 1992 through February 8, 1996.
- New England Medical Center Hospitals (Boston, MA); protocol # 770: "Seasonal Changes in Bone Mass of Premenopausal Women" Conducted from January 31, 1993 through April 10, 1995.
Data (normal, American, female, caucasians) of a statistically valid quantity of women participating in the four clinical studies were collected using a model DTX-100 bone densitometer to estimate bone mineral content and bone mineral density in the non-dominant forearm of a representative sample of the reference population and included at least 50 persons in ten year peer age groups. The mean and standard deviations of the data was calculated using appropriate statistical methods and was used to establish the reference data base for the reference population.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Tests: There were no nonclinical tests submitted, referenced, or relied on in this submission.
Clinical Tests: The results of four clinical tests were used to establish a reference data base for a reference population of normal American female caucasians ranging in age from 20 to 80 years. The studies involved collecting data on bone mineral content and density in the non-dominant forearm using the DTX-100 bone densitometer. The sample sizes included at least 50 persons in ten year peer age groups.
Key Results: The standard deviation of estimated bone mineral content (BMC) and bone mineral density (BMD) of the reference population of participating female caucasians is statistically representative of the reference population and the American reference data base (derived from this data) is suitable for use by a health care professional to compare BMC and BMD with age matched peers and for comparison with young adult mean value. The accuracy and precision error of the DTX-100 candidate device is comparable to that of the DTX-100 predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K963787, Osteometer MediTech A/S model DTX-100 bone densitometer
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
K963787
superseded
510(k) Summary [This 510(k) summary is furnished in accordance with 21 CFR 807.92]
JUL 1 4 1997
21 CFR 807.92(a):
(
ు
(
21 CFR 807.92(a)(1):
Submitter's name and address: *
Osteometer Meditech A/S Glerupvej 2, DK-2160 Rodovre Denmark
011 45 44 92 42 00 ★ Submitter's telephone number:
Contact person: 水
Ms. Anja Koue Official Correspondent Osteometer Meditech A/S Glerupvej 2, DK-2160 Rodovre Denmark
September 15, 1996 ★ Date this 510(k) summary was prepared:
CFR 807.92(a)(2): 21
DTX-100 Bone * Trade/proprietary name of the device: Densitometer
オ Classification name: Bone densitometer
CFR 807.92(a)(3); Legally marketed device (predicate device) 21 to which equivalence is claimed:
- Osteometer MediTech A/S model DTX-100 bone densitometer
21 CFR 807.92(a)(4); Description of the device that is the subject of this premarket notification:
The DTX-100 candidate device is a single energy system, where the measured object, in this case the forearm, is submerged into a soft tissue equivalent water bath.
The X-Ray generator is driven at 40 kV, with a current of 0.2 mAmps . The detector uses scintillating and a crystal
1
510(k) Summary
[This 510(k) summary is furnished in accordance with 21 CFR 807.92]
photomultiplier tube. A highly stable X-Ray output, together with a source collimation of 1 mm, and excellent pixel resolution, yields images of very high quality.
The typical time to estimate bone mineral content and bone mineral density is approximately 3.0 to 4.5 minutes. The effective patient dose is estimated to be 0.01 micro Sievert per scan.
21 CFR 807.92(a)(5); Intended use:
The intended use of the DTX-100 candidate device is the same as the labeled intended use of the predicate device to which equivalence is claimed; i.e., "To estimate bone mineral content (BMC, grams) and bone mineral density (BMD, grams/cm").
21 CFR 807.92(a)(6); Technological characteristics:
The design, material, chemical composition, energy source and other technological characteristics of the subject device are considered be the same as the technological characteristics of the to predicate devices. A summary of the technological characteristics of the subject device in comparison to those of the predicate devices follows:
X-ray transmission source: 大
DTX-100 subject Both the and the DTX-100 predicate bone densitometer devices consist of a computer, keyboard, monitor, printer, and scanner system using an X-ray transmission source. The DTX-100 candidate device and the DTX-100 predicate device are identical and use single X-ray photon absorptiometry (SXA) to estimate bone mineral content (BMC) and bone mineral density (BMD).
大 Soft-tissue equivalent material:
Both the candidate and predicate DTX-100 devices are identical and use water as soft tissue equivalent material.
* Calibration:
Both the DTX-100 candidate device and the DTX-100 predicate device use a line-by-line calibration system, ensuring qood precision.
Imaging technique, data acquisition, and quality control ★ phantom:
f
1
2
510(k) Summary
[This 510(k) summary is furnished in accordance with 21 CFR 807.92]
These characteristics are the same on the DTX-100 candidate device as the DTX-100 predicate device.
Source collimation: ★
f
(
The source collimation for both the DTX-100 candidate device and the DTX-100 predicate device is the 1 mm diameter.
Reference location: ★
The reference location for both the DTX-100 candidate device and the DTX-100 predicate device is the 8 mm Ulna-Radius gap.
Accuracy and precision error: 大
Accuracy and precision error of the DTX-100 candidate device is comparable to that of the DTX-100 predicate device.
21 CFR 807.92(b);
summaries for those premarket submissions in which a 510(k) substantial equivalence is also based on determination of performance data shall also contain the following:
807.92(b)(1); CFR Brief discussion of the nonclinical tests 21 submitted, referenced, or relied on in this premarket notification submission:
There were no nonclinical tests submitted, referenced, or relied on in this submission.
21 CFR 807.92(b)(2); Brief discussion of the clinical tests submitted, referenced, or relied on in this premarket notification submission:
The results of four (4) clinical tests were used to obtain data to establish a reference data base for a reference population of normal American female caucasians ranging in age from 20 to 80 years. These clinical studies were conducted at:
1. Helen Hayes Hospital (West Haverstraw, NY); protocol # 94-12:
"Determination of Forearm Bone Density in a Normal 大 Title: US Population and Comparison of Two New Procedures to Measure Bone Mineral Density".
3
510(k) Summary
[This 510(k) summary is furnished in accordance with 21 CFR 807.92]
Conducted from May 1995 through May 1996. *
New England Medical Center Hospitals (Boston, MA); protocol # 2. 540 :
"Is the Current Recommended Dietary Allowance of Title: 水 Vitamin D Sufficient for Minimizing Bone Loss?"
Conducted from May 22, 1991 through August 17, 1993 米
New England Medical Center Hospitals (Boston, MA); protocol # 3. 620 :
"Effect of Calcium and Vitamin D on Bone Loss from * Title: the Hip"
Conducted from February 6, 1992 through February 8, 1996. 大
New England Medical Center Hospitals (Boston, MA); protocol # 4. 770 :
"Seasonal Changes in Bone Mass of Premenopausal Women" *
Conducted from January 31, 1993 through April 10, 1995. *
reference population (normal, in a American, female, Data a statistically valid quantity of women caucasians) of participating in the four clinical studies were collected using a model DTX-100 bone densitometer to estimate bone mineral content and bone mineral density in the non-dominant forearm of a representative sample of the reference population and included at least 50 persons in ten year peer age groups. The mean and standard deviations of the data was calculated using appropriate statistical methods and was used to establish the reference data base for the reference population.
The conclusions drawn from the nonclinical and 21 CFR 807.92(b)(3); clinical tests that demonstrate that the subject device is as safe, as effective, and performs as well as or better than the predicate device:
The standard deviation of estimated bone mineral content (BMC) and bone mineral density (BMD) of the reference population of participating female caucasians is statistically representative (as required by FDA's "Draft Guidance for Review of Bone Densitometer 510(k) Submissions"; i.e., at least 50 people in each ten year age
:
4
510(k) Summary [This 510(k) summary is furnished in accordance with 21 CFR 807.92]
group) of the reference population and the American reference data base (derived from this data) is suitable for use by a health care professional to compare BMC and BMD with age matched peers and for comparison with young adult mean value.
.... END OF 510(k) SUMMARY .....
OM53.6
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5
Image /page/5/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a snake winding around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Osteometer Meditech A/S c/o Mr. Bert Hudson Regulatory Consultant Shotwell & Carr. Inc. 3003 LBJ Freeway, Suite 100 Dallas, TX 75234-7755
UL 1 4 1997
Re: K963789 DXT-100 Bone Densitometer, Part # 9SCA0006 Dated: May 28, 1997 Received: May 29, 1997 Regulatory Class :- II ........................ 21 CFR 892.1170/Procode: 90 KGI
Dear Mr. Hudson:
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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) 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 531 through 542 of the Act for devices under 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 question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation of titled, "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/dsmamain.html".
Sincerely yours,
W.Liliau Yin
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
K 765'89
Appendix H1
FDA's New Form Describing "Indications for Use".
Page 1 of 1
510(k) Number (if known): Unknown; Not yet assigned by FDA .
Device Name: Model DTX-100 Bone Densitometer
Indications For Use for the device: Estimate bone mineral content (BMC in grams) and bone mineral density (BMD in grams/cm²) in the distal section of the forearm.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF HEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ) (Per 21 CFR 801.109)
OR
510(k) Number
Over-The-Counter Use
(Optional Format 1-2-96)
Raice Petty
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Dev
M53.3