SECTRA ORTHOPEDIC PACKAGE

K031590 · Sectra-Imtec AB · LLZ · Oct 2, 2003 · Radiology

Device Facts

• Record ID: K031590
• Device Name: SECTRA ORTHOPEDIC PACKAGE
• Applicant: Sectra-Imtec AB
• Product Code: LLZ · Radiology
• Decision Date: Oct 2, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The device is intended for the manipulation and displaying of medical images. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. The device assists orthopedic surgeons when doing preoperative planning and post-operative follow-up.

Device Story

Sectra Orthopedic Package is a software tool for orthopedic surgeons; used for preoperative planning and postoperative follow-up. Inputs include medical images from various modalities via DICOM or similar standards. Device provides functionality for overlaying prosthesis templates on images, repositioning templates, and performing measurements. Output is displayed on a PC workstation for clinician review. Assists surgeons in implant selection, cut line placement, and surgical follow-up. Operates in clinical environments; requires trained professional users. Does not contact patient; does not control life-sustaining devices. Relies on human interpretation for clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only; device developed according to ISO 9001:2000 and complies with ACR/NEMA DICOM version 3.0 standards.

Technological Characteristics

Software-based image processing system; runs on Windows 2000 and Windows XP PC platforms. Supports DICOM 3.0 interface standards. Features include prosthesis template overlay, template repositioning, and image measurement tools. Password-protected access control.

Indications for Use

Indicated for orthopedic surgeons, physicians, and radiologists for preoperative planning and postoperative follow-up using medical images from various modalities.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• Sectra IDS5 Radiology Workstation (K002936)

Submission Summary (Full Text)

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Date: May 16, 2003

Sectra Document Number: 3-03.1020-1.0

page inf 2

Kp3159ø

# 510(k) Summary of Safety & Effectiveness

(as required by 21 CFR 807.92c)

Date Prepared:

May 16, 2003

# Submitter's Information:

Sectra Imtec AB Teknikringen 20 SE-583 30 Linköping Sweden Phone: [phone] Fax: [phone]

## Trade Name, Common Name, Classification:

| Trade name: | Sectra Orthopedic Package |
|----------------------|---------------------------------------------------|
| Common Names: | Picture Archiving and Communications System |
| Classification Name: | Image Processing System (LLZ) (21 CFR § 892.2050) |

## Predicate Device:

| Applicant: | Sectra Imtec AB |
|----------------|-----------------------------------|
| 510(k) Number: | K002936 |
| Device: | Sectra IDS5 Radiology Workstation |

#### Device Description:

Sectra Orthopedic Package is intended to assist orthopedic surgeons when doing preoperative planning and post-operative follow-up. The device has functionality for overlaying prosthesis templates on radiological images, tools for repositioning the templates, and tools for measurements in the images.

More specifically the Sectra Orthopedic Package shall: (1) assist the orthopedic surgeons in choosing which implants to use, (2) assist the orthopedic surgeons in choosing were to place cut lines etc., and (3) assist the orthopedic surgeons in following-up of surgical procedures.

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Date: May 16, 2003

K03/59d

#### Indications for Use:

The device is intended for the manipulation and displaying of medical images. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.

The device assists orthopedic surgeons when doing preoperative planning and postoperative follow-up.

Typical users of this system are trained professionals, for example orthopedic surgeons, physicians, and radiologists.

#### Technological Characteristics:

The Sectra Orthopedic Package will run on the Windows 2000, and Windows XP 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:

Similar to the predicate device, the Sectra Orthopedic Package does not contact the patient, nor does it control any life sustaining devices. Images and information being reviewed, processed, relayed, and or transmitted are interpreted by an orthopedic surgeons or trained medical personnel, providing ample opportunity for competent human intervention. The device and the predicate device share the same certification or conformance to performance standards and both function as Picture Archiving and Communications Systems. Device failures, which might result in partial or failed transmissions, images, or data, may be recovered from storage or re-transmission after correcting the problem(s). Passwords are required for operation and to protect against unauthorized use.

Based on the information supplied in this 510(k), we conclude that the subject device is safe, effective, and substantially equivalent to the predicate device.

Peter Andersson Regulatory Affairs Officer Sectra Imtec AB Teknikringen 20 SE-58330 Linköping Sweden

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines extending from its head, resembling feathers or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circular logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 2 2003

Sectra Imtec AB % Mr. Carl Alletto OTech, Inc. 1100 Lakeview Blvd. DENTON TX 76208

# Re: K031590

Trade/Device Name: Sectra Orthopedic Package Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system

Regulatory Class: II Product Code: 90 LLZ Dated: September 5, 2003 Received: September 9, 2003

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 Section 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 the 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" (21CFR Part 807.97) you may obtain. 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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Page 1 of -1

510(k) Number:

K\$\phi\$3159\$\phi\$

Device Name: Sectra Orthopedic Package

Indications For Use:

The device is intended for the manipulation and displaying of medical images. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.

The device assists orthopedic surgeons when doing preoperative planning and post-operative follow-up.

Typical users of this system are trained professionals, for example orthopedic surgeons, physicians, and radiologists.

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Number __

| Prescription Use | <div style="display:inline-block; vertical-align:top;">✓</div> | OR | Over-The-Counter Use |
|----------------------|----------------------------------------------------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | | |
| | <img alt="signature" src="signature.png"/> | | (Optional Format 1-2-96) |
| | (Division Sign-Off) | | |
| | Division of Reproductive, Abdominal, | | |
| | and Radiological Devices | | |
| 510(k) Number | K031590 | | |