(28 days)
No
The document does not mention AI, ML, or related terms, and the description focuses on standard image processing and calculation methods for BMD.
No.
The device is used for estimating bone mineral density and assessing fracture risk, which are diagnostic purposes, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended to "(1) assist the physician in diagnosing subjects who already have been identified to be at risk for suffering from osteoporosis." This direct mention of 'diagnosing' indicates its function as a diagnostic device.
No
The device description explicitly states it uses digital image data according to the DICOM standard and operates via a Sectra IDS5 Radiology Workstation, implying reliance on existing hardware infrastructure for image acquisition and display. While the "Sectra Osteoporosis Package" itself might be software, its functionality is dependent on and integrated with hardware components (radiology workstation, CR imaging system).
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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device's function: This device estimates bone mineral density (BMD) using computed radiography (CR) images of the forearm. This is an in vivo measurement, meaning it's performed on a living subject, not on a sample taken from the body.
- Input: The input is image data (DICOM), not a biological sample.
- Output: The output is an estimate of BMD and associated scores (T-scores and Z-scores), not the detection of a substance or marker in a biological sample.
Therefore, the device falls under the category of a medical imaging device used for diagnostic purposes, but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Sectra Osteoporosis Package is intended for use to estimate bone mineral density ("BMD") in the forearm and to assess increased risk of osteoporotic fracture according to World Health Organization ("WHO") criteria. The device is indicated specifically for use to: (1) assist the physician in diagnosing subjects who already have been identified to be at risk for suffering from osteoporosis, together with other known risk factors (e.g., prior history of fractures, advanced age, low body weight, lack of physical exercise, lack of exposure to sunlight, insufficient dietary intake of vitamin D and/or calcium, and smoking); and (2) compare the BMD estimate with a reference population comprised of young normals and age-matched normals to compute T-scores and Z-scores, respectively.
Product codes
90 KGI
Device Description
The Sectra Osteoporosis Package is intended for use to estimate bone mineral densitv (BMD) in the forearm and to assess increased risk of osteoporotic fracture according to World Health Organization (WHO) criteria.
Sectra Osteoporosis Package features:
- indirect "DICOM capability" via the Sectra IDS5 Radiology workstation, i.e. it uses digital image data according to the DICOM standard.
- . single screen user interface reached via a right click on an image in a Sectra IDS5 Radiology Workstation.
- operates in two modes: Clinical mode and Research mode.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computed radiography ("CR") images
Anatomical Site
forearm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
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
JUN - 7 2002
K021527
Sectra Document Number: 3-02.832-1.0
510(k) Summary of Safety & Effectiveness
(as required by 21 CFR 807.92c)
Date Prepared:
May 8 2002
Submitter's Information:
Sectra Imtec AB Teknikringen 2 SE-583 30 Linköping Sweden Phone: +1 46 13 23 52 00 Fax: +1 46 13 21 21 85
Trade Name, Common Name, Classification:
Trade name: Sectra Osteoporosis Package Bone Densitometer Common Names: Classification Name: Bone Densitometer (90 KGI) (21 C.F.R. § 892.1170)
Predicate Device:
| Applicant: | Pronosco A/S |
|---|---|
| 510(k) Number: | K002500 |
| Device: | X-Posure System Version 2 RAD |
Device Description:
The Sectra Osteoporosis Package is intended for use to estimate bone mineral densitv (BMD) in the forearm and to assess increased risk of osteoporotic fracture according to World Health Organization (WHO) criteria.
Sectra Osteoporosis Package features:
- indirect "DICOM capability" via the Sectra IDS5 Radiology workstation, i.e. it uses digital image data according to the DICOM standard.
- . single screen user interface reached via a right click on an image in a Sectra IDS5 Radiology Workstation.
- operates in two modes: Clinical mode and Research mode.
1
Indications for Use:
The device is intended for use to estimate bone mineral density ("BMD") in the forearm and to assess increased risk of osteoporotic fracture according to World Health Organization ("WHO") criteria. The device is indicated specifically for use to: (1) assist the physician in diagnosing subjects who already have been identified to be at risk for suffering from osteoporosis, together with other known risk factors (e.g., prior history of fractures, advanced age, low body weight, lack of physical exercise, lack of exposure to sunlight, insufficient dietary intake of vitamin D and/or calcium, and smoking); and (2) compare the BMD estimate with a reference population comprised of young normals and age-matched normals to compute T-scores and Z-scores, respectively.
Technological Characteristics:
The Sectra Osteoporosis Package will run on the Windows NT 4.0 and Windows 2000 operating systems for PCs (as a minimum and depending upon system configuration).
Performance Data:
The subject device is developed according to ISO 9001:2000 and complies with ACR/NEMA Digital Imaging Communications in Medicine version 3.0.
Conclusion:
The Sectra Osteoporosis Package is substantially equivalent to the previously cleared X-Posure System Version 2 RAD (K002500). The intended use and indications for use are identical. The principal difference in technological features from the predicate devices is the image source. That is, the Sectra Osteoporosis Package analyzes computed radiography ("CR") images obtained directly in digital format. This is in contrast to the predicate devise, which is limited to analyzing either conventional X-ray images alone that must first be separately digitized by using a scanner. This difference in technical characteristics between the subject device and the predicate device does not raise any new questions of safety or effectiveness, because the question of whether the images are of sufficient quality to permit BMD analysis is common to both devices. Also, both devices use essentially the same DXR techniques to analyze the given images. Both in vitro and in vivo performance testing has been conducted to verify that this design difference does not impact either safety or efficacy.
Additionally, the Sectra Osteoporosis Package can receive digital DICOM images that have been stored in a third party's network or PACS system, while the predicate device did not have this option. However, the additional ability to retrieve digital images stored on these other information systems has been validated by the company and in no way affects how the software analyzes BMD or the quality of this analysis.
2
The other difference is that the Sectra Osteoporosis Package is integrated with a Sectra IDS5 Radiology Workstation giving the operator direct access to the BMD analysis. However, essentially the Sectra Osteoporosis Package is the same as the predicate device, its stand-alone counterpart, and presents no new safety or effectiveness concerns (as discussed above). Furthermore, as validated by the company, the packaging of these systems together in no way impacts the device's safety and effectiveness. Therefore, the Sectra Osteoporosis Package and the predicate device are substantially equivalent.
Peter Ander
Peter Andersson Regulatory Affairs Officer Sectra Imtec AB Teknikringen 2 SE-58330 Linköping Sweden
3
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN = 7, 2002 - 1
Sectra Imtec AB % Mr. Carl Alletto OTech, Inc. 1100 Lakeview Blvd. DENTON TX 76208 Re: K021527
Trade/Device Name: Sectra Osteoporosis Package Bone Densitometer Regulation Number: 21 CFR 892.1170 Regulation Name: Bone Densitometer Regulatory Class: II Product Code: 90 KGI Dated: May 8, 2002 Received: May 10, 2002
Dear Mr. Alletto:
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.
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); 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.
4
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer 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.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
KO21527
Page 1 of -1
510(k) Number:
Device Name: Sectra Osteoporosis Package
Indications for Use:
The device is intended for use to estimate bone mineral density ("BMD") in the forearm and to assess increased risk of osteoporotic fracture according to World Health Organization ("WHO") criteria.
The device is indicated specifically for use to:
- (1) assist the physician in diagnosing subjects who already have been identified to be at risk for suffering from osteoporosis, together with other known risk factors (e.g., prior history of fractures, advanced age, low body weight, lack of physical exercise, lack of exposure to sunlight, insufficient dietary intake of vitamin D and/or calcium, and smoking); and
- (2) compare the BMD estimate with a reference population comprised of young normals and age-matched normals to compute T-scores and Z-scores, respectively.
(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 | |
| (Optional Format 1-2-96) | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, | |
| and Radiological Devices | |
| 510(k) Number | K021527 |