The MEDIPORT is a medical grade device to be used as a platform for PACS software or DICOM viewer software. It is intended for use in all Hospital environments (OR, ER etc.) as well as Physicians' Offices and Clinical Laboratories.

In light of the fact that MEDIPORT is a high performance computer it may also be used to access patient records or perform other functions that may be required.

This device in not qualified or intended for use for mammographic purposes.

Device Description

The MEDIPORT is a high performance medical grade computer with DICOM calibrated monitors that may be used as a platform for PACS software. It is designed for use in all Hospital environments (OR, ER etc.) as well as Physicians' Offices and Clinical Laboratories. It may also be used to access patient records or perform other functions that may be required.

AI/ML Overview

The Kobo200 document is a 510(k) summary for a medical device called MEDIPORT, a medical-grade computer system intended as a platform for PACS software. The application was filed in 2006. This document does not contain any information about a study that assesses the device's performance against acceptance criteria.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices by comparing technical specifications and safety certifications. The MEDIPORT is presented as a hardware system acting as a host for PACS software, implying its performance is largely tied to the software it runs and its adherence to relevant standards rather than a specific clinical performance metric.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them, as this information is not present in the provided text. The document is primarily a regulatory filing to establish equivalence for marketing purposes.

Here's a breakdown of why the requested information cannot be extracted:

Acceptance Criteria and Reported Device Performance: This document states the device's technical specifications (CPU, RAM, Hard drive, etc.) and its adherence to standards like DICOM and UL60601-1. It does not specify acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity for image interpretation) nor the results of a study demonstrating such performance.
Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, ground truth for training set: All these points relate to a clinical or performance study, which is entirely absent from this 510(k) summary. The document focuses on hardware specifications and regulatory compliance, not on the performance of a clinical algorithm or diagnostic aid.

Summary

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

Kobo200

FEB 1 0 2006 510(K) Summary

This 510(K) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR 807.87(h)

Company Identification:	Maxant Technologies, Inc.7540 Caldwell AvenueNiles, Illinois 60714Phone 847 588 2280Fax 847 588 1920
Registration Number:	1419703
Principal contact:	Donald P. DeValeVice President -- Engineering847 588 2280 extension 231
Trade name andcommon name of device:	MEDIPORT a medical grade computer system, with aWindows XP Pro operating system, to be used as aplatform for PACS software systems digital imaging.
Device Classification:	The device is classified a Class II device, 90- LLZ underTitle 21 of the Code of Federal Regulations (CFR)892.2050, Picture archiving and communications systems.
Device Description:	The MEDIPORT is a high performance medical gradecomputer with DICOM calibrated monitors that may beused as a platform for PACS software. It is designed for usein all Hospital environments (OR, ER etc.) as well asPhysicians' Offices and Clinical Laboratories. It may alsobe used to access patient records or perform other functionsthat may be required.
Intended Use:	To provide an alternate technical solution for the display ofmedical images by providing a stable medical devicequalified platform to host a PACS environment and bymounting in the same configuration as medicalilluminators, thereby maintaining the same work flow andimage availability provided by an illuminator.

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

Substantially equivalent predicate devices

Since the MEDIPORT is an assemblage of components and we are only providing a hardware system to act as a host for PACS software, we will list a relatively large number of equivalents in order to be sure of covering all.

a. Konica Minolta Medical Graphic, Inc. product REGIUS RS-1000. K051521 Paragraph 11 shows its hardware as Computer "Off the shelf"

	MEDIPORT	REGIUS RS-1000
CPU	Celeron D (Pentium 4family)	Pentium 4
Bus	PCI, PCI Express	PCI
Ram	Up to 4 GB	1024MB
Hard drive	40GB	40GB
Floppy drive	None	3.5"
CD	CD/DVD Rom	CD-ROM
	Keyboard	Keyboard
	Mouse	Mouse
Operating system	Embedded WindowsXP-Pro	Windows XP
Ethernet	10/100/1000T	LAN
Image Display	1.3MP 19" Color	1MP 16" Color

Maxant is of the opinion that the MEDIPORT does not introduce any new potential safety risks and as a qualified medical device under UL60601-1 is superior in this regard and is substantially equivalent to and performs as well as this predicate device. This device in not qualified for use for mammographic purposes.

b. Siemens AG, Medical Solutions - K052461

Device Description

"The system is a "hardware independent" solution to be distributed either as software on or combined with common IT hardware which must comply to predefined minimum hardware requirements"

Technological Characteristics "or as a complete radiology solution consisting of common IT hardware and pre-installed software." "The workplaces are based on Windows XP. . . "

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

Phillips Orthopaedic Applications - K042867 C.

System Description

"The Phillips Orthopaedic Application software runs "off the shelf" standard PC components using a Microsoft Operating System."

Intended Use:

"The software packages are designed to run on standard PC hardware ("off the shelf" standard computer components) . . "

d. Totoku K050485, K050619

20.8" Gray scale or color 3MP monitor with DICOM calibration.

Maxant is of the opinion that the MEDIPORT does not introduce any new potential safety risks and is substantially equivalent to and performs as well as this predicate device.

Since our customers can select the monitor that is used in our system based on their preference, Totoku monitors may be used or any monitor that meets UL60601-1 and has 510(K) clearance. Please note that these monitors are purchased as "open frame" and mounted in the MEDIPORT enclosure using power supplies that meet medical standards. This device in not qualified for use for mammographic purposes.

e. BarcoView K052276

20.1" Gray scale 2MP monitor with DICOM calibration.

Maxant is of the opinion that the MEDIPORT does not introduce any new potential safety risks and is substantially equivalent to and performs as well as this predicate device.

Since our customers can select the monitor that is used in our system based on their preference, BarcoView monitors may be used or any monitor that meets UL60601-1 and has 510(K)

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

clearance. Please note that these monitors are purchased as "open frame" and mounted in the MEDIPORT enclosure using power supplies that meet medical standards. This device in not qualified for use for mammographic purposes.

Applicable mandatory and voluntary standards

DICOM (Digital Imaging and Communications in Medicine) Developed by the American College of Radiology and the National Electrical Manufacturers Association.

UL60601-1 as a class 1 medical device

UL60601-1-2 emissions (FCC class B) and immunity standards

I certify that the MEDIPORT conforms to the above-mentioned specifications and standards. The UL reports are available for review. The monitors that are included in this system are factory calibrated each with it's own DICOM Gamma Correction Curve. This built in Look Up Table (LUT) assures accurate reproduction of the image from the monitor regardless of the luminance set point. The monitor will display 256 distinct shades of gray from a pallet of 1024 shades stored on the internal graphics driver card.

While UL544 and UL187 are CDRH recognized standards, it should be noted that UL60601-1 (or EN60601-1) has replaced UL187 and incorporates what is also in UL544.

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

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling three human profiles facing right, stacked on top of each other, with a stylized wave or ribbon below them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAXANT Technologies, Inc. % Mr. Glenn Luchen Staff Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Rd. MELVILLE NY 11747

Re: K060210 Trade/Device Name: MEDIPORT Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 24, 2006 Received: January 27, 2006

Dear Mr. Luchen:

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 (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.

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 clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

FEB 1 0 2006

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

This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotter watification. 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.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrlv/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

{6}------------------------------------------------

Indications for Use

510(k) Number (if known):	K066210
Device Name:	MEDIPORT

Indications for Use:

In light of the fact that MEDIPORT is a high performance computer it may also be used to access patient records or perform other functions that may be required.

This device in not qualified or intended for use for mammographic purposes.

Prescription Use (Part 21 CFR 801 Subpart D) AND / OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. Syverson

(Division Sign-Off) Donann of Reproductive, Abdomina and administrational Devices on and Number ________________________________________________________________________________________________________________________________________________________________

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).