iConnection 3D is a software application intended for integrated processing and distribution of 2D and 3D digitized data derived from CT and MRI (and others) scans for use by radiologists, clinicians, and other professionals to acquire, process, render, review, store, print, and distribute DICOM 3.0 compliant images utilizing standard PC hardware with MS 98, NT, or MS 2000 operating systems. CAUTION: Federal (US) law restricts the use of this device to licensed professionals.

Device Description

iConnection 3D is a picture archiving and communications system as described in 21 CFR 892.2050.

AI/ML Overview

This 510(k) premarket notification for iConnection 3D does not include information about acceptance criteria or a study proving the device meets them.

The device, "iConnection 3D," is a Picture Archiving and Communication System (PACS) software application. The summary explicitly states:

1. A table of acceptance criteria and the reported device performance:
Not provided. The document states "Performance Data: None required."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not provided. No test set is mentioned because performance data was not required.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC study was done or reported. This product is a PACS system, not an AI-assisted diagnostic tool in the sense of recent AI applications.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable/Not done. The device is a PACS system for processing and viewing images, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not provided.

8. The sample size for the training set:
Not provided.

9. How the ground truth for the training set was established:
Not provided.

Conclusion from the 510(k) Summary:
The claim of substantial equivalence for iConnection 3D is based solely on "comparisons of intended use(s) and specifications/functions of the cited predicate devices" (Voxar Limited PLUG 'N VIEW 3D and Applicable Medical Imaging B.V. devices). No performance data or clinical studies were presented to demonstrate the device's efficacy or meet specific acceptance criteria. This approach was acceptable by the FDA for this particular type of device (a PACS system) in 2001.

Summary

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Ko 12779

NOV 0 2 2001

SECTION 10

510(k) SUMMARY

This 510(k) summary of safety and effectiveness for iConnection 3D is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

HInnovation, Inc. Applicant:
Address: 10437 Innovation Drive Suite 236 Wauwatosa, WI 53226-4815

Y. Isabelle Sun, Ph.D. Contact Person: Vice President, Business Development

Telephone: 414-453-7881 253-550-0903 (fax)
Preparation Date: August 2001 (of the Summary)

Device Name: iConnection 3D

Common Name: Picture Archiving and Communication System
、
Class II Medical Device; (21 CFR 892.2050) Classification: Product Code: LLZ Panel: 90
Predicate devices: Voxar Limited (PLUG 'N VIEW 3D, Version 1.0; K992654) and Applicare Medical Imaging, B.V, as described in K982862 and K962699;

Device description: iConnection 3D is a picture archiving and communications system as described in 21 CFR 892.2050.

Indications: iConnection 3D is a software application intended for integrated processing and distribution of 2D and 3D digitized data derived from CT and MRI (and others) scans for use by radiologists, clinicians, and other professionals to acquire, process, render, review, store, print, and distribute DICOM 3.0 compliant images utilizing standard PC hardware with MS 98, NT, or MS 2000 operating systems.
"CAUTION: Federal (US) law restricts the use of this device to licensed professionals."

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The claim of substantial equivalence is based on Performance Data: None required. comparisons of intended use(s) and specifications/functions of the cited predicate devices.

i i

CONCLUSION: Based on the information in the notification HInnovation, Inc. believes that iConnection 3D is substantially equivalent to the claimed predicate devices.

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Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized birds in flight, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 2 2001

Hui Hu, Ph.D. President and CEO Hinnovation, Inc. 10437 Innovation Drive, Suite 236 WAUWATOSA WI 53226

Re: K012779 Trade/Device Name: iConnection 3D Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: II Product Code: 90 LLZ Dated: August 20, 2001 Received: August 20, 2001

Dear Dr. Hu:

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.

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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	(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/cdrh/dsma/dsmamain.html.

Sincerely yours,

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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KD12770,

NOV 0 2 2001

SECTION 7

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): __ Ko /_ 2779_______________________________________________________________________________________________________________________________________

Device Name: iConnection 3D

Indications for Use Statement:

iConnection 3D is a software application intended for integrated processing and IColinection of 2D and 3D digitized data derived from CT and MRI (and others) scans for use by radiologists, clinicians, and other professionals to acquire, process, render, for use by radiologists, chilicians, and outs. processliant images utilizing standard PC hardware with MS 98, NT, or MS 2000 operating systems.

CAUTION: Federal (US) law restricts the use of this device to licensed professionals.

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

Concurrence of CDRH, Office of Device Evaluation

Prescription Use	✓
(Per 21 CFR 801.109)

Over-The Counter Use	_
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signature

Name: Nancy C. Brogdon

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).