(69 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes quantitative analysis based on measurements applied to images, which is a traditional image processing technique.
No
The device provides quantitative information for diagnostic purposes and research studies but does not directly treat or alleviate a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" states that the device provides "quantitative and reproducible information" for "assessing the angiographic condition of patients," and the "Device Description" section states it is "intended to support radiologists and cardiologists in the diagnostic process to quantify findings."
Yes
The device description explicitly states it is a "Package" with "functionality for quantitative analysis" and "Measurements can be applied on angiographic images." This strongly suggests a software-based tool for image analysis, without mentioning any dedicated hardware component. The predicate devices are also described as "Measurement System" or "Analytical software package," further supporting the software-only nature.
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 Function: The Sectra Angiography and Cardiology Package analyzes images (angiographic x-ray procedures) of the human body (arterial segments and the left ventricle of the heart). It does not analyze biological samples.
- Intended Use: The intended use describes providing quantitative information from images for scientific/research studies and review/analysis of imaging records. This is consistent with medical image analysis software, not IVDs.
- Device Description: The description focuses on analyzing angiographic images to quantify findings, which aligns with image processing for diagnostic support.
- Input Modality: The input is angiographic x-ray procedures, which are imaging procedures, not biological samples.
Therefore, while this device is used in a diagnostic context and provides information to aid in diagnosis, it does so by analyzing medical images, not biological samples. This places it outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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:
- Scientific and research studies, assessing the angiographic condition of patients and the result of device and drug therapeutics,
- Review and analysis of patient angiographic imaging records, providing additional information to physicians and administrators.
Product codes
90 LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
angiographic x-ray procedures
Anatomical Site
arterial segments, left vertical of the heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals, e.g. physicians, radiologists, cardiologists and scientists.
cath labs.
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
The subject device is developed according to ISO 9001:2000 and complies with ACR/NEMA Digital Imaging Communications in Medicine version 3.0.
Key Metrics
Not Found
Predicate Device(s)
K993761, K993763, K993765, K023970
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
0
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: +1 46 13 23 52 00 Fax: +1 46 13 21 21 85
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.
1
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:
-
Scientific and research studies, assessing the angiographic condition of patients and the result of device and drug therapeutics,
-
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
2
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.
3
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 | (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" (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 (800) 638-2041 or (301) 443-6597 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
4
:
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