SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE

K034059 · Sectra AB · LLZ · Mar 9, 2004 · Radiology

Device Facts

• Record ID: K034059
• Device Name: SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE
• Applicant: Sectra AB
• Product Code: LLZ · Radiology
• Decision Date: Mar 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Sectra Angiography and Cardiology Package provides quantitative and reproducible information regarding the calculated dimensions of arterial segments, and quantitative information regarding the calculated dimensions and calculated performance characteristics of the left vertical of the heart, imaged during angiographic x-ray procedures typically performed in cath labs. This information is suitable for use in the following applications: 1. Scientific and research studies, assessing the angiographic condition of patients and the result of device and drug therapeutics, 2. Review and analysis of patient angiographic imaging records, providing additional information to physicians and administrators. Typical users of the device are trained professionals, e.g. physicians, radiologists, cardiologists and scientists.

Device Story

Sectra Angiography and Cardiology Package is a software-based image processing system for cath lab environments. It takes angiographic x-ray images as input to perform quantitative analysis of arteriograms (QCA/QVA) and left ventricular angiographic images (LVA). The device calculates dimensions of arterial segments and performance characteristics of the left ventricle. Operated by physicians, radiologists, and cardiologists on a Sectra IDS5 Radiology Workstation, the system provides quantitative data to support diagnostic processes, research studies, and clinical review. Output is interpreted by the clinician to assess patient condition and therapeutic outcomes. The device does not contact the patient or control life-sustaining equipment; human intervention is required for all clinical decisions.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Software-based image processing system running on Windows 2000/XP PCs with Sectra IDS5 Radiology Workstation. Complies with ACR/NEMA DICOM 3.0 standards. Developed under ISO 9001:2000. Password-protected access control.

Indications for Use

Indicated for use by trained professionals (physicians, radiologists, cardiologists, scientists) to provide quantitative analysis of arterial segments and left ventricular performance characteristics from angiographic x-ray images. Used for scientific/research studies and clinical review of patient imaging records.

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

• QCA-View (Cardiovascular Measurement System - View) (K993761)
• QCA-CMS (Quantitative Analysis of Coronary Angiograms) (K993763)
• QLV-CMS (Quantitative Analysis of Left Ventricular Angiograms) (K993765)
• OVA-CMS (OVA-CMS Analytical software package) (K023970)

Submission Summary (Full Text)

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MAR - 9 2004

# 510(k) Summary of Safety & Effectiveness

(as required by 21 CFR 807.92c)

Date Prepared:

Dec 18, 2003

# Submitter's Information:

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

#### Trade Name, Common Name, Classification:

(03,4054

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

### Predicate Devices:

| Applicant: | Medical Imaging Systems (MEDIS) |
|----------------|---------------------------------------------------------------|
| 510(k) Number: | K993761 |
| Device: | QCA-View (Cardiovascular Measurement System - View) |
| Applicant: | Medical Imaging Systems |
| 510(k) Number: | K993763 |
| Device: | QCA-CMS (Quantitative Analysis of Coronary Angiograms) |
| Applicant: | Medical Imaging Systems (MEDIS) |
| 510(k) Number: | K993765 |
| Device: | QLV-CMS (Quantitative Analysis of Left Ventricular Angiograms |
| Applicant: | Medical Imaging Systems (MEDIS) |
| 510(k) Number: | K023970 |
| Device | OVA-CMS (OVA-CMS Analytical software package) |

#### Device Description:

Sectra Angiography and Cardiology Package is intended to support radiologists and cardiologists in the diagnostic process to quantify findings. The device has functionality for quantitative analysis of the arteriograms (QCA and QVA) and quantitative analysis of the left ventricular angiographic images (LVA). Measurements can be applied on angiographic images.

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### Indications for Use:

The Sectra Angiography and Cardiology Package provides quantitative and reproducible information regarding the calculated dimensions of arterial segments, and quantitative information regarding the calculated dimensions and calculated performance characteristics of the left vertical of the heart, imaged during angiographic x-ray procedures typically performed in cath labs.

This information is suitable for use in the following applications:

1. Scientific and research studies, assessing the angiographic condition of patients and the result of device and drug therapeutics,

2. Review and analysis of patient angiographic imaging records, providing additional information to physicians and administrators.

Typical users of the device are trained professionals, e.g. physicians, radiologists, cardiologists and scientists.

#### Technological Characteristics:

The Sectra Angiography and Cardiology Package will run on the Windows 2000, and Windows XP operating systems for PCs (as a minimum and depending upon system configuration) featuring a Sectra IDS5 Radiology Workstation.

#### 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 devices, the Sectra Angiography and Cardiology 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 a trained professional, e.g. radiologist, cardiologist, providing ample opportunity for competent human intervention. 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 devices.

Ri AL

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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 9 2004

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

Trade/Device Name: Sectra Angiography and Cardiology Package Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ

Dated: December 22, 2003 Received: December 31, 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.

Re: K034059

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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. brydon

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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:

510(k) Number: Ko3 4059

Device Name: Sectra Angiography and Cardiology Package

Indications For Use:

.

The Sectra Angiography and Cardiology Package provides quantitative and reproducible information regarding the calculated dimensions of arterial segments, and quantitative information regarding the calculated dimensions and calculated performance characteristics of the left vertical of the heart, imaged during angiographic x-ray procedures typically performed in cath labs.

This information is suitable for use in the following applications: 1. Scientific and research studies, assessing the angiographic condition of patients and the result of device and drug therapeutics, 2. Review and analysis of patient angiographic imaging records, providing additional information to physicians and administrators.

Typical users of the device are trained professionals, e.g. physicians, radiologists, cardiologists and scientists.

# (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 | K034059 |
|---------------|---------|
|---------------|---------|

Nancy Brogdon