PHILIPS HARMONY RELEASE 1

K022788 · Philips Medical Systems North America Co. · LLZ · Oct 25, 2002 · Radiology

Device Facts

• Record ID: K022788
• Device Name: PHILIPS HARMONY RELEASE 1
• Applicant: Philips Medical Systems North America Co.
• Product Code: LLZ · Radiology
• Decision Date: Oct 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Philips "Harmony" software package is an integrated multimodality image and information system designed to perform import, export, storage, archiving, review, analysis, reporting and database management of digital medical images.

Device Story

Harmony is a modular software suite for cardiology image management; runs on Intel-based hardware with Windows OS. Inputs include digital cardiovascular images via DICOM 3.0, DSR-TIFF, or media. Performs import, export, storage, archiving, review, analysis, reporting, and database management. Used by clinicians in cardiology departments to access and exchange exams. Output includes displayed images, reports, and exported files (BMP, JPG, AVI). Facilitates clinical decision-making by providing centralized access to multimodality cardiovascular data; supports multiple windows, digital zoom, and contrast/brightness adjustments. Benefits include improved workflow efficiency and data accessibility for cardiology exams.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on technological comparison, hazard analysis, and performance specifications consistent with predicate devices.

Technological Characteristics

Modular software suite; runs on Intel-based commercial hardware; Windows NT/2000/XP OS. Connectivity via DICOM 3.0 (Store SCP, Verification, Storage Commit), Philips HSDII, and Philips SONOS. Supports multimodality image display (up to 60 fps), annotation, and digital zoom. Software is classified as minor level of concern.

Indications for Use

Indicated for the import, export, storage, archiving, review, analysis, reporting, and database management of multimodality digital medical images in a cardiology clinical setting.

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

• Inturis Suite (K994210)
• EnConcert (K954668)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the Philips logo, which consists of the word "PHILIPS" in bold, sans-serif font above a shield-like emblem. The emblem features a stylized representation of radio waves or sound waves, with a pattern of stars or crosses above and below the waves. The logo is presented in black and white, with the text and emblem outlined in black against a white background.

# PHILIPS

## Philips Medical Systems

## 510(k) Summary

K022788

Philips "Harmony" Release 1

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

| I | General Information | |
|---|----------------------|------------------------------------------------------------------------------------------|
| | Company Name: | Philips Medical Systems North America Company |
| | Address: | 22100 Bothell Everett Highway 98021-8431<br>Bothell Washington<br>USA |
| | Contact Person | Lynn T. Harmer |
| | Telephone Number: | 425-478-7312 |
| | Prepared (date): | August 20, 2002 |
| | Device Name: | Philips Harmony Release 1 |
| | Classification Name: | System, Image Processing |
| | Regulation number | 892.2050 |
| | Classification: | Class: II |
| | ProCode: | LLZ |
| | Common/Usual Name: | Workstation |
| | Predicate Devices: | Philips Inturis Suite<br>Philips EnConcert (Formerly HP Echo Image Management<br>System) |

{1}------------------------------------------------

#### Information Supporting Substantial Equivalence Determination II

#### System Description:

Philips "Harmony" software is a suite of DICOM products containing scalable levels of modular software programs, designed to perform the necessary functions required for the import/export/storage/archiving/review/analysis/reporting and database management of digital cardiovascular images within the cardiology domain.

It allows multiple users quick access to, and exchange of specific and/or multiple cardiology exams.

Because of the open architecture, the "Harmony" software will run on Intel based commercial hardware under Microsoft Windows based operating systems. Together with the modular design it allows the user to tailor the image import, archive and communications solution to his particular budgetary and performance needs and the number of modalities and reporting and/or viewing sites he decides to connect. PHILIPS will guarantee stability and (different levels of) performance when used with specific hardware configurations and network infrastructure.

The following packages are marketed:

- Standalone Workstation .
- Integrated Workstation network solution ●
- Base, Advanced and Premium network solutions .

These software packages will be delivered on a set of CD-ROMs, which contain the installation application, the application software, the service software and an electronic copy of the instructions for use.

#### Intended Use:

Philips "Harmony" software package is an integrated multimodality image and information system designed to perform import, export, storage, archiving, review, analysis, reporting and database management of digital medical images.

#### Substantial equivalence:

Predicate devices

The Philips "Harmony" software release 1 is substantially equivalent to

- Inturis Suite (K994210) a. Philips Medical Systems, Best , The Netherlands
- EnConcert (K954668) b. Philips Medical Systems, Andover MA, USA (formerly HP Echo Image Management System Hewlett Packard Co, Andover MA, USA)

{2}------------------------------------------------

#### Comparison matrix / technological characteristics

| Characteristics | PHILIPS<br>Inturis Suite R2.2 | PHILIPS<br>EnConcert B.0 | PHILIPS<br>"Harmony" R1 |
|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Operating System | Windows NT<br>Windows 2000 | Windows NT | Windows NT/2000/XP |
| Memory Requirement | 256 MB (minimum)<br>512 MB (recommended) | 128 MB (minimum)<br>256 MB (recommended) | 512 MB (minimum)<br>1 GB (recommended) |
| Image Source | DICOM 3.0 SCU<br>DICOM 3.0 CD-ROM | DICOM 3.0 SCU<br>DSR-TIFF I/F<br>DICOM 3.0 Media | DICOM 3.0 SCU<br>DSR-TIFF I/F<br>DICOM 3.0 Media |
| Connectivity | Philips HSDII<br>DICOM Store SCP<br>DICOM Verification<br>DICOM Storage Commit<br>Card. Info System I/F | Philips SONOS<br>DICOM Store SCP | Philips HSDII<br>Philips SONOS<br>DICOM Store SCP<br>DICOM Verification<br>DICOM Storage Commit<br>Card. Info System I/F |
| Display Rate | Up to 30 fps | Up to 30 fps | Up to 60 fps |
| Multiple Windows | Yes | Yes | Yes |
| Image Display Controls<br>Digital Zoom<br>Window (contrast)<br>Level (brightness) | Yes<br>Yes<br>Yes | Yes<br>Yes<br>Yes | Yes<br>Yes<br>Yes |
| Annotation | Yes | Yes | Yes |
| Image Export | BMP, JPG, AVI<br>DICOM Store SCU<br>DICOM Q/R SCP<br>DICOM Q/R SCU | BMP, AVI<br>DICOM Store SCU | BMP, JPG, AVI<br>DICOM Store SCU<br>DICOM Q/R SCP<br>DICOM Q/R SCU |
| Network Access | Yes | Yes | Yes |
| Regulatory Status | K994210 | K954668 | Proposed |

### Safety information:

No new hazards are introduced by the development of "Harmony" software. Hazards known during the lifecycle of the predicate devices Inturis Suite and EnConcert are again considered. The results of the hazard analysis, combined with the appropriate preventive measures taken indicate that the device is of minor level of concern.

{3}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the circle. Inside the circle is a stylized image of an eagle. The eagle is facing to the right and has three lines representing its wings.

OCT 25 2002

Food and Drug Administrati 9200 Corporate Boulevard Rockville MD 20850

Mr. Lynn T. Harmer Manager, Regulatory Submissions Philips Medical Systems 22100 Bothell Everett Highway BOTHELL WA 98021-8431

#### Re: K022788

Trade/Device Name: Harmony Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system -

Regulatory Class: II Product Code: 90 LLZ Dated: August 21, 2002 Received: August 22, 2002

Dear Mr. Harmer:

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 (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.

{4}------------------------------------------------

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/cdrls/dsmamain.html.

Sincerely yours,

Nancy C. Grigdon

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

Enclosure

{5}------------------------------------------------

510(K) Number (if known): ___

Device Name:

"Harmony"

Indications for Use::

"Harmony", is a suite of products comprised out of scalable levels of modular software programs, designed to perform the necessary functions required for the import, export, storage, archiving, review, analysis, reporting and database management of multimodality digital medical images.

"Harmony" software will run on Intel based commercial hardware under Microsoft Windows based operating systems.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Olinil A. Sefrom

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)