INTELEPACS

K070080 · Intelerad Medical Systems, Inc. · LLZ · Jan 24, 2007 · Radiology

Device Facts

• Record ID: K070080
• Device Name: INTELEPACS
• Applicant: Intelerad Medical Systems, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jan 24, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

IntelePACS™ is a device that receives digital images and data from various sources (such as, CT scanners, MR scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). lmages and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and/or across computer networks at distributed locations. Postprocessing of the images can be performed using Multi Planar Reconstruction (MPP), Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mannographic images may only be interpreted using an FDA approved monitor that protateliar manimographio may only be medification specifications reviewed and accepted by FDA. Typical users of this system are trained professionals, physicians, nurses, and technicians.

Device Story

IntelePACS is a Picture Archiving and Communications System (PACS) software suite; receives digital medical images/data from various modalities (CT, MR, US, R/F, CR/DR) via DICOM gateways; enables communication, processing, enhancement, manipulation, storage, and display of images across distributed networks. Used by physicians, nurses, and technicians in clinical environments. Provides tools for image post-processing, including Multi Planar Reconstruction (MPR). Healthcare providers view images on workstations to assist in clinical decision-making and diagnosis. Benefits include efficient image management, distribution, and access to diagnostic data.

Clinical Evidence

Bench testing only. No clinical data provided. Hazard analysis performed; device classified as minor level of concern.

Technological Characteristics

Software-based PACS; operates on standard computer hardware. Supports DICOM image acquisition, storage, and network distribution. Features include image enhancement, manipulation, and Multi Planar Reconstruction (MPR). Connectivity via network; DICOM gateway used for non-DICOM sources. Software hazard level: minor.

Indications for Use

Indicated for trained professionals, physicians, nurses, and technicians to receive, communicate, process, manipulate, enhance, store, and display digital medical images from various imaging sources (CT, MR, US, R/F, CR/DR). Not for primary interpretation of lossy compressed mammographic images or digitized film screen images.

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

• IntelePACS (K032533)
• PACSPLUS (K023460)
• Synapse 3D MIP/MPR Image Visualization Software OBLIQUUS (K061672)

Submission Summary (Full Text)

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#### 510(k) Summary of Safety and Effectiveness K070080

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared: August 14, 2006

### Submitter's Information: 21 CFR 807.92(a)(1)

Intelerad Medical Systems Inc. Anibal Jodorcovsky Executive Vice President, Quality Systems 460 Ste-Catherine West, Suite 210 Montreal, QC Canada H3B 1A7 Tel: [phone] Fax: [phone]

#### Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)

| Trade Name: | IntelePACS™ |
|------------------------|-----------------------------------------|
| Common Name: | Picture Archiving Communications System |
| Device Classification: | 892.2050 |
| Name: | System, Image Processing, Radiological |

#### Predicate Devices: 21 CFR 807. 92(a)(3)

| Device Classification Name | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL |
|-----------------------------------|----------------------------------------|
| Regulation Number | 892.2050 |
| 510(k) Number | K032533 |
| Device Name | IntelePACS |
| Applicant | Intelerad Medical Systems Incorporated |
| Product Code | LLZ |
| Date Received | 08/15/2003 |
| Decision Date | 10/16/2003 |
| Decision | SUBSTANTIALLY EQUIVALENT (SE) |
| Classification Advisory Committee | Radiology |
| Review Advisory Committee | Radiology |

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| Device Classification Name | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL |
|--------------------------------------|----------------------------------------|
| Regulation Number | 892.2050 |
| 510(k) Number | K023460 |
| Device Name | PACSPLUS |
| Applicant | MEDICAL STANDARD CO., LTD. |
| Product Code | LLZ |
| Date Received | 10/15/2002 |
| Decision Date | 01/09/2003 |
| Decision | SUBSTANTIALLY EQUIVALENT (SE) |
| Classification Advisory<br>Committee | Radiology |
| Review Advisory Committee | Radiology |

| Device Classification Name | System, Image, Processing, Radiological |
|--------------------------------------|-------------------------------------------------------------|
| Regulation Number | 892.2050 |
| 510(k) Number | K061672 |
| Device Name | Synapse 3D MIP/MPR Image Visualization Software<br>OBLIQUUS |
| Applicant | FUJIFILM Medical Systems USA, Inc. |
| Product Code | LLZ |
| Date Received | 06/14/2006 |
| Decision Date | 06/29/2006 |
| Decision | SUBSTANTIALLY EQUIVALENT (SE) |
| Classification Advisory<br>Committee | Radiology |
| Review Advisory Committee | Radiology |

## Device Description: 21 CFR 807 92(a)(4)

IntelePACS™ is comprised of software modules that provide image capture, storage, distribution, enhancement, manipulation, and networking of medical images at distributed locations. In cases where DICOM images are not directly available to IntelePACS™, the system can acquire medical imem mugos using a DICOM image gateway, which generates DICOM-type files. For example, and a Broom images from original film and convert

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them to meet DICOM standards and stored. Stored files are transmitted using a network and can be viewed or manipulated from imaging workstation.

### Indications for Use: 21 CFR 807 92(a)(5) Technological Characteristics: 21 CFR 807 92(a)(6)

The device is medical device image software that is used with computer hardware in a picture archiving and communications system user environment. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human interprets images and information being displayed and printed.

#### Conclusion: 21 CFR 807 92(b)(1)

The 510(k) Pre-Market Notification for IntelePACS™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate devices.

IntelePACS™ system will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the "Level of Concern" for potential hazards has been classified as "minor".

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# Third Party Review Quality Assessment

#### Section 1 – Submission Information

| 510(k) No.: | K070080 |
|------------------------------------|---------------------------|
| Third Party Organization: | Intertek Testing Services |
| Third Party's Primary Reviewer(s): | Jay Y. Kogoma |
| ODE/OIVD Division: | DRARD |
| Branch/Team: | RDB |

Section 2 - 510(k) Decision

| Third party recommendation: | SE x ___ NSE ___ Other (specify): ___ |
|-----------------------------|---------------------------------------|
| ODE/OIVD final decision: | SE x ___ NSE ___ Other (specify): ___ |

### Section 3 - Assessment of Third Party Review

| Review Element | Rating (check one) | | |
|---------------------------------------------------------------------------------------------------------------------------------------------|--------------------|----------------|----------------|
| | Adequate | Minor Issue(s) | Major Issue(s) |
| a. Determination of device eligibility for third party review | X | | |
| b. Extent of pre-submission consultation with ODE/OIVD division | | | |
| c. Organization and format of review documentation | X | | |
| d. Determination of 510(k) administrative completeness (screening review) | X | | |
| e. Summary of device characteristics, intended use, and performance (including accessories, if applicable) and reason for 510(k) submission | X | | |
| f. Comparison to legally marketed devices—identification and analysis of key similarities and differences | X | | |
| g. Rationale for conclusions and recommendation | X | | |
| h. Use of guidance documents and standards | X | | |
| i. Resolution of 510(k) deficiencies and FDA requests for additional information | X | | |
| j. Scope of reviewer expertise and use of consulting reviewers | | | |
| k. Other (specify): | | | |

Comments (explanation of ratings/issues): ___________________________________________________________________________________________________________________________________

### Section 4 – ODE/OIVD Assessor Information

_Sunder Rajan_ Date: 1/22/07 Tel. No.: [phone] Assessed by:

Routing: Division--Clip completed assessment (this page only) to inside front cover of 510(k).

DMC-Forward this page only to Eric Rechen, POS/ODE, Rm. 120J, Corp. Blvd. (HFZ-402).

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Intelerad Medical Systems, Inc. % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 TWINSBURG OH 44067

JAN 2 4 2007

Re: K070080

K070080
Trade/Device Name: IntelePACS™ from Intelerad Medical Systems, Inc. Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 8, 2007 Received: January 9, 2007

Dear Mr. Lehtonen:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nate reviewed you beceremined 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 provision in the provision 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 androis, mainton are as no 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/4/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the logo. The letters "FDA" are in the center of the logo in a bold, stylized font. The word "Centennial" is below the letters "FDA". 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 (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.

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 [phone] or [phone]

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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## Indications for Use

510(k) Number (if known): _ KO 70080

Device Name:

IntelePACS™ from Intelerad Medical Systems Inc.

Indications for Use:

IntelePACS™ is a device that receives digital images and data from various sources (such as, CT scanners, MR scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). lmages and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and/or across computer networks at distributed locations. Postprocessing of the images can be performed using Multi Planar Reconstruction (MPP),

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mannographic images may only be interpreted using an FDA approved monitor that protateliar manimographio may only be medification specifications reviewed and accepted by FDA.

Typical users of this system are trained professionals, physicians, nurses, and technicians.

Prescription Use _ V __ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Segner

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _

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