SECTRA OSTEOPOROSIS PACKAGE

K021527 · Sectra-Imtec AB · KGI · Jun 7, 2002 · Radiology

Device Facts

• Record ID: K021527
• Device Name: SECTRA OSTEOPOROSIS PACKAGE
• Applicant: Sectra-Imtec AB
• Product Code: KGI · Radiology
• Decision Date: Jun 7, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1170
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

Sectra Osteoporosis Package is a software-based bone densitometer; estimates forearm bone mineral density (BMD) from digital computed radiography (CR) images. Operates within Sectra IDS5 Radiology Workstation; utilizes DICOM standard images. Physician-operated; provides BMD estimates, T-scores, and Z-scores by comparing patient data against reference populations. Assists in diagnosing osteoporosis in at-risk subjects. Features clinical and research modes; integrates with third-party PACS networks. Benefits patients by facilitating fracture risk assessment and clinical decision-making regarding osteoporosis management.

Clinical Evidence

Both in vitro and in vivo performance testing conducted to verify that design differences (direct digital image analysis vs. digitized X-ray) do not impact safety or efficacy. No specific clinical trial metrics (e.g., sensitivity, specificity) provided in the summary.

Technological Characteristics

Software-based bone densitometer; runs on Windows NT 4.0/2000 PCs. Utilizes DXR (Digital X-ray Radiogrammetry) techniques for BMD analysis. Complies with ACR/NEMA DICOM 3.0 standards. ISO 9001:2000 certified development. Integrates with Sectra IDS5 Radiology Workstation.

Indications for Use

Indicated for patients identified at risk for osteoporosis to estimate forearm bone mineral density (BMD) and assess fracture risk per WHO criteria. Used to assist physician diagnosis in conjunction with clinical risk factors (e.g., age, fracture history, lifestyle factors) and to compute T-scores and Z-scores via comparison to young and age-matched normal reference populations.

Regulatory Classification

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.

Predicate Devices

• X-Posure System Version 2 RAD (K002500)

Submission Summary (Full Text)

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# 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: [phone] Fax: [phone]

#### 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.

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#### 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.

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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

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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.

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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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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<br>(Per 21 CFR 801.109) | ✓ |
|-----------------------------------------------------------------------------------------|--------------------------|
| OR | |
| Over -The-Counter Use | |
| | (Optional Format 1-2-96) |
| (Division Sign-Off)<br>Division of Reproductive, Abdominal,<br>and Radiological Devices | |
| 510(k) Number | K021527 |