(282 days)
K9L4561, Osteometer MediTech A/S model DTX-200 bone densitometer
Not Found
No
The description focuses on the hardware (X-ray system, detector, computer) and the physical process (DXA, water bath, calibration). There is no mention of AI, ML, or advanced image processing techniques that would typically indicate the use of such technologies. The performance studies describe statistical analysis of collected data, not the training or validation of an AI/ML model.
No.
The device is used to estimate bone mineral content and density, which is a diagnostic function, not a therapeutic one. It provides information about a patient's condition but does not treat or alleviate any disease or condition.
Yes
The device is described as estimating "bone mineral content (BMC in grams) and bone mineral density (BMD in grams/cm²)" which are measurements often used in the diagnosis of conditions like osteoporosis. The output of the device (BMC and BMD values) is intended to be used by a "health care professional to compare BMC and BMD with age matched peers and for comparison with young adult mean value," indicating its role in providing data for a diagnosis or assessment of a patient's bone health.
No
The device description explicitly states it is a dual energy system using an X-Ray generator, detector, computer, keyboard, monitor, printer, and scanner system. These are hardware components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The DTX-200 device uses X-ray transmission (DXA) to measure bone mineral content and density in vivo (within the living body) in the forearm. It does not analyze samples taken from the body.
Therefore, the device described is a medical device used for in vivo measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the DTX-200 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').
Estimate bone mineral content (BMC in grams) and bone mineral density (BMD in grams/cm squared) in the distal section of the forearm.
Product codes (comma separated list FDA assigned to the subject device)
90 KGI
Device Description
The DTX-200 candidate device is a dual 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 55 Kv, with a current of 0.3 mAmps. The detector uses a scintillating crystal and a solid state dual energy sandwich detector. A highly stable X-Ray output, together with a source collimation of 1 mm diameter, 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 0.1 micro Sievert per scan.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray transmission source; dual X-ray photon absorptiometry (DXA)
Anatomical Site
forearm
Indicated Patient Age Range
The results of two (2) 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.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of two (2) 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: Title: "Determination of Forearm Bone Density in a Normal US Population and Comparison of Two New Procedures to Measure Bone Mineral Density". Conducted from February 1996 through September 1996.
- United States Department of Agriculture Human Nutrition Research Center on Aging at Tufts University (Boston, MA); protocol # 3895 Title: "Mineral Density in a Normal American Population". Conducted from March 1996 through October 1996.
Data in valid quantity (of a statistically female, normal, American, caucasian population) participating in the two clinical studies were collected using a model DTX-200 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.
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 (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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K9L4561, Osteometer MediTech A/S model DTX-200 bone densitometer
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K9L4561
510(k) Summary [This 510(k) summary is furnished in accordance with 21 CFR 807.92]
AUG 22 1997 21 CFR 807.92(a): 21 CFR 807.92(a)(1): Submitter's name and address: 米 Osteometer MediTech A/S Glerupvej 2, DK-2160 Rodovre Denmark 011 45 44 92 42 00 Submitter's telephone number: * Contact person: * Ms. Anja Koue Official Correspondent Osteometer MediTech A/S Glerupvej 2, DK-2160 Rodovre Denmark
Date this 510(k) summary was prepared: November 5, 1996 水
21 CFR 807.92(a)(2):
DTX-200 Bone Trade/proprietary name of the device: * Densitometer
- Classification name: Bone densitometer
Legally marketed device (predicate device) to 21 CFR 807.92(a)(3); which equivalence is claimed:
Osteometer MediTech A/S model DTX-200 bone densitometer *
Description of the device that is the subject of 21 CFR 807.92(a)(4); this premarket notification:
The DTX-200 candidate device is a dual energy system, where the measured object, in this case the forearm, is submerged into a soft tissue equivalent water bath.
0.3 The X-Ray generator is driven at 55 Kv, with a current of
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510(k) Summary
[This 510(k) summary is furnished in accordance with 21 CFR 807.92]
The detector uses a scintillating crystal and a solid state mAmps. dual energy sandwich detector. A highly stable X-Ray output, together with a source collimation of 1 mm diameter, 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 0.1 micro Sievert per scan.
21 CFR 807.92(a)(5); Intended use:
The intended use of the DTX-200 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 the subject device in comparison to those of the predicate of devices follows:
大 X-ray transmission source:
Both the DTX-200 candidate and the DTX-200 predicate bone densitometer devices consist of a computer, keyboard, monitor, printer, and scanner system using an X-ray transmission source. The DTX-200 candidate device and the DTX-200 predicate device are and use dual X-ray photon absorptiometry (DXA) to identical estimate bone mineral content (BMC) and bone mineral density (BMD).
Soft-tissue equivalent material: *
Both the candidate and predicate DTX-200 devices are identical and use water as soft tissue equivalent material.
Calibration: *
Both the DTX-200 candidate device and the DTX-200 predicate device use a line-by-line calibration system, ensuring good precision.
Imaging technique, data acquisition, and quality control *
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510(k) Summary
[This 510(k) summary is furnished in accordance with 21 CFR 807.92]
phantom:
These characteristics are the same on the DTX-200 candidate device as the DTX-200 predicate device.
Source collimation: 大
The source collimation for both the DTX-200 candidate device and the DTX-200 predicate device is the 1 mm diameter.
Reference location: 头
The reference location for both the DTX-200 candidate device and the DTX-200 predicate device is the 8 mm Ulna-Radius gap.
Accuracy and precision error: 女
Accuracy and precision error of the DTX-200 candidate device is comparable to that of the DTX-200 predicate device.
21 CFR 807.92(b);
for those premarket submissions in 510(k) which ਬ summaries of substantial equivalence is also based on determination performance data shall also contain the following:
tests Brief discussion of the nonclinical 21 CFR 807.92(b)(1); 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 two (2) 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 These clinical studies were conducted at: years.
Helen Hayes Hospital (West Haverstraw, NY); protocol # 94-12: 1.
"Determination of Forearm Bone Density in a Normal * Title:
3
3
510(k) Summary [This 510(k) summary is furnished in accordance with 21 CFR 807.92]
US Population and Comparison of Two New Procedures to Measure Bone Mineral Density".
Conducted from February 1996 through September 1996. *
States Department of Agriculture Human Nutrition 2 . United Research Center on Aging at Tufts University (Boston, MA); protocol # 3895
Title: "Mineral Density in a Normal American Population". *
Conducted from March 1996 through October 1996. 米
female, population (normal, American, a reference Data in valid quantity of of a statistically women caucasians) participating in the two clinical studies were collected using a model DTX-200 bone densitometer to estimate bone mineral content bone mineral density in the non-dominant forearm and 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 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.
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END OF 510(k) SUMMARY ... .
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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the edge. Inside the circle is an image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 22 1997
Bert Hudson. .. .. . . . . . . . . . Regulatory Consultant Osteometer Meditech A/S C/O Shotwell & Carr, Inc. 3003 LBJ Freeway Suite 100 Dallas, TX 75234
K964562 DTX-200 Bone Densitometer 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.
Re:
If your device is classified (see above) into either class II (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 yitro 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 Smal! Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmanam.hunl".
Sincerely yours.
h.7. Kiau Yi
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
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Appendix G1
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-200 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 NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
(Per 21 CFR 801.(09)
OR
Over-The-Counter Use _
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
OM67.3
510(k) Number
OM67.3
226