CARDIONOW CARDIOLOGY WIDE AREA ARCHIVE AND RETRIEVAL SYSTEM

K020449 · Cardionow, Inc. · LLZ · May 10, 2002 · Radiology

Device Facts

• Record ID: K020449
• Device Name: CARDIONOW CARDIOLOGY WIDE AREA ARCHIVE AND RETRIEVAL SYSTEM
• Applicant: Cardionow, Inc.
• Product Code: LLZ · Radiology
• Decision Date: May 10, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The CardioNow Cardiology Wide Area Archive and Retrieval System is intended to collect, archive, and display diagnostic information and images. The intent is to provide long-term archival as well as retrieval of this information to/from Hospital Site Servers and to provide compressed versions of these images to Internet Web Clients.

Device Story

System collects, archives, and displays diagnostic information and images from DICOM-compliant imaging systems; maintains exams for local review at hospital site servers. Transforms data for transfer to Internet Data Center; applies lossy MPEG-4 compression via Apple QuickTime platform for distribution to Internet Web Clients. Used in hospital/clinical environments; operated by healthcare professionals. Provides remote access to cardiology images for review via web-based interface; facilitates clinical decision-making by enabling retrieval of diagnostic data.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

PACS system; DICOM-compliant; utilizes Apple QuickTime platform for MPEG-4 lossy image compression; networked architecture consisting of Hospital Site System, Internet Data Center, and Web/ClinSend Clients.

Indications for Use

Indicated for the collection, archival, and display of diagnostic information and images in a clinical setting. No specific patient population, age, or gender restrictions are defined.

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

• Siemens ACOM.Web (MagicWeb Cardiac system) (K973131)

Submission Summary (Full Text)

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MAY 1 0 2002

**CardioNow**

K020449
Page 1 of 2
www.cardionow.com

535 Encinitas Boulevard Suite 118 Encinitas, CA 92024

Tel [phone] Fax [phone]

## 9.0 510(k) Summary

## Submitter

CardioNow, Inc. 535 Encinitas Boulevard Suite 118 Encinitas, CA 92024

## Contact

Johnny Garza Tel: [phone] x500 Fax: [phone]

## Device Name

Classification: Class II

Common/usual name: Cardiology archive and review system commonly known as PACS (Picture Archiving and Communications Systems Proprietary Name: CardioNow Cardiology Wide Area Archive and Retrieval System

## Intended Use

The CardioNow Cardiology Wide Area Archive and Retrieval System is intended to collect, archive, and display diagnostic information and images. The intent is to provide long-term archival as well as retrieval of this information to/from Hospital Site Servers and to provide compressed versions of these images to Internet Web Clients.

## Device Description

The CardioNow Cardiology Wide Area Archive and Retrieval System consists of: a Hospital Site System, the Internet Data Center, Web Client, and the ClinSend Client. Each Hospital Site System collects, archives, and displays diagnostic information and images. The Hospital Site System maintains the imaging exams and related data for local review. It also formats the data for transfer to the Internet Data Center.

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Image /page/1/Picture/1 description: The image shows the logo for CardioNow. The logo consists of a flower-like symbol on the left, followed by the text "CardioNow" in a bold, sans-serif font. A horizontal line is present below the text.

K020449
Page 2 of 2

## Comparisons to Predicate Device

The substantially equivalent device is the Siemens ACOM.Web, also marketed as the MagicWeb Cardiac system, FDA 510k number K973131.

In reviewing the comparison between CardioNow's Wide Area Archive and Review System and the predicate device, very little difference can be found. Both systems take DICOM image data from DICOM compliant imaging systems. Both systems archive this data in the DICOM format and provide a retrieval function for review. And both systems use a lossy compression technique to provide access to these images over the Internet to users with the appropriate login and password.

The only difference is that the compression technique employed by Siemens is a lossy algorithm following the JPEG standard and the one employed by CardioNow is a lossy algorithm provided by the Apple QuickTime platform, which follows the MPEG-4 standard.

## Conclusion

For the acquisition of images from DICOM compliant imaging systems and the conversion of these images using lossy compression for distribution over the Internet, the CardioNow system and the Siemens system use similar techniques and have the same functions. Thus, for DICOM compliant image distribution over the Internet, the CardioNow device is substantially equivalent to the predicate device, the Siemens ACOM.Web.

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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 & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Johnny M. Garza Director, Software Quality Assurance CardioNow, Inc. 535 Encinitas Blvd., Suite 118 ENCINITAS CA 92024

# MAY 1 0 2002

Re: K020449 Trade/Device Name: CardioNow Cardiology Wide Area Archive and Retrieval System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: 90 LLZ Dated: February 4, 2002 Received: February 11, 2002

Dear Mr. Garza:

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 vours.

Nancy C. Brogdon

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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Page _1_of _1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K003089 KO20449

Device Name: _CardioNow Cardiology Wide Area Archive and Retrieval System Indications for Use:

The CardioNow Cardiology Wide Area Archive and Retrieval System is intended to collect, archive, and display diagnostic information and images. The intent is to provide long-term archival as well as retrieval of this information to/from Hospital Site Servers and to provide compressed versions of these images to Internet Web Clients.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

(Posted July 1, 1998)

Prescription Use (Per 21 CFR 801.109)

Nancy Broadon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K0204

COMPANY CONFIDENTIA

February 4, 2002