ACCENT

K013574 · Confirma, Inc. · LLZ · Jan 15, 2002 · Radiology

Device Facts

• Record ID: K013574
• Device Name: ACCENT
• Applicant: Confirma, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jan 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

ACCENT™ is a computerized tissue segmentation device intended for use in conjunction with magnetic resonance (MRI) imaging data to identify similar tissue types. When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. ACCENT can also be used to provide accurate and reproducible measurements of the longest diameter and volume of identified tissue. Patient management decisions should not be made based solely on the results of ACCENT analysis.

Device Story

ACCENT is a computerized tissue segmentation system; inputs are pixel signal intensities from multiple MRI sequences. System uses multivariate pattern recognition to analyze signal intensities; identifies and classifies similar tissue types. Operates on off-the-shelf PC with dedicated display station. Physician uses output to assist in screening and diagnosis; provides diameter and volume measurements of identified tissue. Intended to support clinical decision-making; not for sole reliance in patient management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based tissue segmentation system; runs on off-the-shelf PC hardware. Utilizes multivariate pattern recognition for image analysis. Categorized as Minor Level of Concern. Complies with IEC 601-1-4 for hazard analysis.

Indications for Use

Indicated for use in conjunction with MRI imaging data to identify similar tissue types for screening and diagnosis; provides measurements of diameter and volume of identified tissue. Intended for use by skilled physicians.

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

• Vital Images Vitrea
• Acculmage Image Display Software
• Siemens BOLD MRI
• Voxar Plug n' View 3D

Submission Summary (Full Text)

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K013574

## Administrative Information

# 'JAN 1 5 2002

## a. Summary of Safety and Effectiveness

## 1. Company Identification

Confirma, Inc. 821 Kirkland Avenue Kirkland, WA 98033-6318 Phone: [phone] FAX: [phone] www.confirma.com

#### 2. Official Correspondent

Cheryl L. Shea VP - RA/QA/CA Phone: [phone] [e-mail]

#### 3. Date of Submission: October 26, 2001

## 4. Device Trade Name: ACCENT™

#### 5. Device Description

The ACCENT device relies on the assumption that pixels having similar MR signal intensities represent similar tissues. The ACCENT software simultaneously analyzes the pixel signal intensities from multiple MR sequences and applies multivariate pattern recognition methods to perform tissue segmentation and classification.

The ACCENT system consists of proprietary software developed by Confirma installed on an off-the-shelf personal computer and a monitor configured as an ACCENT display station.

#### 6. Intended Use

ACCENT™ is a computerized tissue segmentation device intended for use in conjunction with magnetic resonance (MRI) imaging data to identify similar tissue types. When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. ACCENT can also be used to provide accurate and reproducible measurements of the longest diameter and volume of identified tissue. Patient management decisions should not be made based solely on the results of ACCENT analysis.

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#### 7. Software

The ACCENT device developed and manufactured by Confirma, Inc. has been designed, developed, tested and validated according to has been aesigned, acvelopment identify functions within the while procuurersponsible for developing and approving product organizations, coding and testing, verification and validation testing, and technical support.

## 8. Hazard Analysis

Hazard analysis on this product has been performed throughout the Hazard unalysis ent process in accordance with internal procedures and IEC 601-1-4. This process emphasizes:

- Identification of potential hazards, their causes, and their effects; 해
- Development of methodologies to control the occurrence of . hazards and to mitigate their effects; and,
- Determination of any effect on patient safety and system ● effectiveness.

It is our conclusion that there is no hardware or software component integral to this device, operating in a properly configured integral to this dove failure or latent design defect would be expected to result in death or serious injury to a patient. The "Level of Concern" is categorized as "Minor."

#### 9. Substantial Equivalence

The intended use, design, function and performance characteristics for ACCENT are substantially equivalent to the following predicate devices:

- Vital Images Vitrea ■
- Acculmage Image Display Software .
- Siemens BOLD MRI I
- Voxar Plug n' View 3D 체

It is the opinion of Confirma, Inc. that ACCENT raises no new issues of safety and effectiveness as compared to the predicate devices.

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping birds in flight, representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 5 2002

Ms. Cheryl Shea Vice President, RA/QA/CA Confirma 821 Kirkland Avenue KIRKLAND WA 98033

Re: K013574 Trade/Device Name: Accent MRI Image Processing Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications system Regulatory Class: II Product Code: 90 LLZ Dated: October 26, 2001 Received: October 29, 2001

Dear Ms. Shea:

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 (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.

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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. Brogdo Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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b. Indication for Use Form

510(k) Number (if known): _K (ك / 35 74

Device Name: ACCENT™

Indication for Use:

ACCENT™ is a computerized tissue segmentation device intended for use in conjunction with magnetic resonance (MRI) imaging data to identify similar tissue types. When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. ACCENT can also be used to provide accurate and reproducible measurements of the longest diameter and volume of identified tissue. Patient management decisions should not be made based solely on the results of ACCENT analysis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Hodgson

(Division Sign-ON)
Division of Reproductive, Abdominal
and Radiological Devices
510(k) Number
K01

Prescription Use