(74 days)
Not Found
No
The summary describes a standard PACS system for image processing and distribution, with no mention of AI, ML, or related concepts.
No
The device is described as a software application for processing and distributing medical imaging data and a picture archiving and communications system, which are diagnostic or informational tools, not therapeutic devices.
Yes
The "Intended Use / Indications for Use" states it processes and distributes 2D and 3D data from CT and MRI scans for use by radiologists, clinicians, and other professionals, indicating its role in the diagnostic workflow. It also handles rendering, review, and distribution of DICOM images, which are key aspects of diagnostic imaging.
Yes
The device is explicitly described as a "software application" and its function is the processing and distribution of medical imaging data on standard PC hardware. There is no mention of proprietary hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the software is for processing and distributing medical images (CT, MRI, etc.) for use by medical professionals. This is related to medical imaging and picture archiving and communication systems (PACS), not in vitro testing of biological samples.
- Device Description: The device is described as a picture archiving and communications system (PACS) as defined in 21 CFR 892.2050. This regulation specifically covers medical image management systems, not IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of disease or for the assessment of health. This software does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
LLZ
Device Description
iConnection 3D is a picture archiving and communications system as described in 21 CFR 892.2050.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT and MRI (and others) scans
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists, clinicians, and other professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
None required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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."
1
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.
2
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.
3
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
4
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) |
OR
| Over-The Counter Use | _ |
|---|---|
| ---------------------- | --- |
Name: Nancy C. Brogdon