(15 days)
Aegis is a software application that is intended for use in analyzing magnetic resonance imaging (MRI) medical images as well as other multi-modality images. Its primary goal is to identify where and how deep a biopsy or localization needle should be inserted into an imaged breast in order to strike a targeted lesion or region of interest, as chosen by a trained medical professional. Aeris receives images and data from various sources (including but not linited to CT, MR, US, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Aegis can be used to communicate, process, and display medical images. Users have access to various image processing and measurement tools to assist them in viewing images. These user-defined post-processing functions include image subtractions, multiplanar reformats, maximum intensity projections, and segmenting of regions based on enhancement characteristics.
The digitized mammographic images and/or ultrasound images displayed by Aegis on the laptop display (or on any display not approved by the FDA for such purposes) must not be used for primary diagnostic interpretation.
Typical users of Aegis are trained medical professionals, including but not limited, to radiologists, technologists and clinicians. When interpreted by a skilled user, this device provides information that may be useful in screening and diagnosis. Patient management decisions shoulding be made solely on the results of Aegis analysis.
Aegis is one of the components of a PACS (Picture Archiving and Communications System), Aegis is visualization software designed for breast imaging and intervention procedures. Aegis receives DICOM 3.0 images over a medical imaging network where its primary goal is to identify where and how deep a biopsy needle should be inserted into an imaged breast in order to strike a targeted lesion or region of interest, as chosen by a trained medical professional.
This 510(k) submission (K070244) for Aegis does not contain specific acceptance criteria or details of a study proving the device meets acceptance criteria in the provided document. The submission focuses on device description, indications for use, and comparison to a predicate device to demonstrate substantial equivalence, which is typical for 510(k) submissions.
Therefore, I cannot populate the table or provide details for the requested points based solely on the provided text.
The document states: "The potential hazards have been studied and controlled as part of the product development validation houring risk analysis, test and design considerations, and planned verification and validation testing processes. Aegis provides images and functionality comparable to the breadicate device." This indicates that some validation and verification testing was performed, but the specifics of these tests, acceptance criteria, and results are not included in this summary.
Information not available in the provided document:
- A specific table of acceptance criteria and reported device performance.
- Sample sizes used for any test sets.
- Data provenance (country of origin, retrospective/prospective).
- Number and qualifications of experts for ground truth.
- Adjudication method for test sets.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results of a standalone (algorithm only) performance study.
- Type of ground truth used (pathology, expert consensus, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
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9 2007 FEB
510(k) Summary of Safety and Effectiveness
This summary of safety and effectiveness is provided as part of the Premarket Notification for Aegis, in accordance with SMDA 1990.
| Date Prepared: | January 19th/2007 |
|---|---|
| ---------------- | ------------------- |
Identification of Submitter:
Submitted By:
Sentinelle Medical Inc. 3080 Yonge St., Suite 6020 Toronto, Ontario, Canada M4N 3N1
Contact Name: Contact Email: Contact Telephone: Contact Fax:
Stephen Leung stephen.leung@sentinellemedical.com (416) 482-3831 (416) 482-3807
Identification of Product:
Device Trade Name: Device Common Name: Regulation Number: Device Classification: Classification Name:
Aegis Picture Archiving Communications System (PACS) CFR 892.2050 Class II Image Processing System
Marketed Device:
Predicate Device: Predicate Device Manufacturer: Predicate Device 510(k) Number: Date Received: Decision Date: Decision: Panel Code Device Reviewed by: Panel Code Device Classified by: Product Code: Regulation Number: Device Classification:
CADStream™ Version 4.0 Confirma, Inc. K043216 11/19/2004 11/22/2004 Substantially Equivalent Radiology Radiology LLZ 892.2050 Class II
Device Description
Aegis is one of the components of a PACS (Picture Archiving and Communications System), Aegis is visualization software designed for breast imaging and intervention procedures. Aegis receives DICOM 3.0 images over a medical imaging network where its primary goal is to identify where and how deep a biopsy needle should be inserted into an imaged breast in order to strike a targeted lesion or region of interest, as chosen by a trained medical professional.
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Indications for Use
Aegis is a software application that is intended for use in analyzing magnetic resonance imaging (MRI) medical images as well as other multi-modality images. Its primary goal is to identify where and how deep a biopsy or localization needle should be inserted into an imaged breast in order to strike a targeted lesion or region of interest, as chosen by a trained medical professional. Aeris receives images and data from various sources (including but not linited to CT, MR, US, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Aegis can be used to communicate, process, and display medical images. Users have access to various image processing and measurement tools to assist them in viewing images. These user-defined post-processing functions include image subtractions, multiplanar reformats, maximum intensity projections, and segmenting of regions based on enhancement characteristics.
The digitized mammographic images and/or ultrasound images displayed by Aegis on the laptop display (or on any display not approved by the FDA for such purposes) must not be used for primary diagnostic interpretation.
Typical users of Aegis are trained medical professionals, including but not limited, to radiologists, technologists and clinicians. When interpreted by a skilled user, this device provides information that may be useful in screening and diagnosis. Patient management decisions shoulding be made solely on the results of Aegis analysis.
Technological Characteristics
Aegis is a stand-alone software package that is pre-installed onto laptops before being sold to customers. It can also be installed on any computer as long as it meets the ning wom requirements stated in the User Manual.
The system allows digital image processing and measurement capability and can transmit images from remote devices to itself over a medical imaging network.
Aegis does not contact the patient, nor does it control any life-sustaining devices. A physician providing ample opportunity for competent human intervention interprets images and information being displayed.
Comparison with Predicate Devices
Aegis is substantially equivalent to the following image processing system used by radiologists:
| Confirma CADStream Version 4.0 | |
|---|---|
| Manufacturer: | Confirma Inc. |
| 510(k) Number: | K043216 |
This workstation allows easy selection, review, processing, and media interchange of multimodality images from a variety of diagnostic imaging systems.
Conclusion
Aegis provides additional features to further integrate radiological and interventional workflow. The potential hazards have been studied and controlled as part of the product development validation houring risk analysis, test and design considerations, and planned verification and validation testing processes. Aegis provides images and functionslity comparable to the breadicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
9 2007
Sentinelle Medical, Inc. c/o Mr. Daniel W. Lehtonen Intertek Testing Services 2307 East Aurora Road Unit B7 TWINSBURG OH 44087
Re: K070244
Trade/Device Name: Aegis Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 23, 2007 Received: January 25, 2007
Dear Mr. Lehtonen:
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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the logo. The letters "PDA" are in the center of the logo. The word "Centennial" is below the letters. Three stars are below the word "Centennial".
Protecting and Promoting Public Health
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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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
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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Indication(s) For Use
Ko70244 510(k) Number:
Device Name: Aegis
Indications for Use:
Aegis is a software application intended for use in analyzing magnetic resonance imaging (MRI) medical images as well as other modality images.
Aegis includes software to support the use of interventional breast coils and MR fiducial localization devices to perform MR-guided breast interventional procedures (BRIGHT"). Its primary goal is to identify where and how deep a biopsy or localization needle should be inserted into an imaged breast in order to strike a targeted lesion or region of interest, as chosen by a trained medical professional.
Aegis receives images and data from various sources (including CT, MR, US, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways and imaging sources). Aegis can be used to commonicate, process, and display medical images. Users have access to various image processing and measurement tools to assist them in wiewing images. These user-defined post-processing functions include image subtractions, multiplanar reformats, maximum intensity projections, and segmenting of regions based on enhancement characteristics.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mamnographic images may only be interpreted using a FDA approved monitor that offers at least 5 MPixel resolution and meets other technical specifications reviewed and accepted by the FDA.
Typical users of Aegis are trained medical professionals, including radiologists, technologists and clinicians. When interpreted by a skilled user, this device provides information that may be useful in screening and diagnosis. Patient management decisions should not be made solely of the results of Aegis analysis.
Prescription Use (Part 21 CFR 801 Subpart D):
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Seymour
(Division Sign-Off)
Division of Reproductive, Abdominal
and Radiological Devices
510(k) Number K070244
Page 1 of
§ 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).