"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.

Device 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.

AI/ML Overview

The provided text is a 510(k) summary for the Philips "Harmony" Release 1 software. It details the device's general information, system description, intended use, and comparison to predicate devices for substantial equivalence. However, it does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria.

The document primarily focuses on:

General Information: Company name, address, contact, device name, classification, and predicate devices.
System Description: Philips Harmony software is a suite of DICOM products for managing digital cardiovascular images (import/export/storage/archiving/review/analysis/reporting and database management).
Intended Use: Integrated multimodality image and information system for managing digital medical images.
Substantial Equivalence: Comparison with Philips Inturis Suite and Philips EnConcert based on technological characteristics (Operating System, Memory Requirement, Image Source, Connectivity, Display Rate, Multiple Windows, Image Display Controls, Annotation, Image Export, Network Access).
Safety Information: States that no new hazards are introduced and the device is of minor level of concern.
FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence to predicate devices.
Indications for Use: Reiterates the device's functions.

Since the document does not present specific acceptance criteria or an associated study, I cannot fill in the requested table and details. The 510(k) process for devices like this typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical performance studies with acceptance criteria in the same way a de novo or PMA submission might. The "performance" described is largely about features and functionalities aligning with existing cleared devices.

Summary

{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 98021-8431Bothell WashingtonUSA
	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 SuitePhilips EnConcert (Formerly HP Echo Image ManagementSystem)

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

Information Supporting Substantial Equivalence Determination II

System Description:

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

The following packages are marketed:

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

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	PHILIPSInturis Suite R2.2	PHILIPSEnConcert B.0	PHILIPS"Harmony" R1
Operating System	Windows NTWindows 2000	Windows NT	Windows NT/2000/XP
Memory Requirement	256 MB (minimum)512 MB (recommended)	128 MB (minimum)256 MB (recommended)	512 MB (minimum)1 GB (recommended)
Image Source	DICOM 3.0 SCUDICOM 3.0 CD-ROM	DICOM 3.0 SCUDSR-TIFF I/FDICOM 3.0 Media	DICOM 3.0 SCUDSR-TIFF I/FDICOM 3.0 Media
Connectivity	Philips HSDIIDICOM Store SCPDICOM VerificationDICOM Storage CommitCard. Info System I/F	Philips SONOSDICOM Store SCP	Philips HSDIIPhilips SONOSDICOM Store SCPDICOM VerificationDICOM Storage CommitCard. 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 ControlsDigital ZoomWindow (contrast)Level (brightness)	YesYesYes	YesYesYes	YesYesYes
Annotation	Yes	Yes	Yes
Image Export	BMP, JPG, AVIDICOM Store SCUDICOM Q/R SCPDICOM Q/R SCU	BMP, AVIDICOM Store SCU	BMP, JPG, AVIDICOM Store SCUDICOM Q/R SCPDICOM 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	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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" 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)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).