(56 days)
Reformat Gateway™ is a software application for the display and 3D visualization of medical data derived from digital modalities (CT and MRI scanners). It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print, and distribute DICOM compliant image studies using standard PC hardware.
Reformat Gateway is a software that receives original data from several devices or PACS system, which reconstructs and sends it to other system automatically. Reformat Gateway reconstructs the thin section slice data into thick section slice data automatically for a fast and routine diagnosis. Also, it generates a MPR reconstructed image automatically according to data specification and distributes original data or reconstructed data to distributed different systems.
The provided text describes the "Reformat Gateway™" software, a Picture Archiving Communications System. However, it does not include detailed acceptance criteria or a specific study proving the device meets performance claims. Instead, it focuses on the substantial equivalence to a predicate device for 510(k) clearance.
Therefore, I cannot populate the table and answer the study-related questions as this information is not present in the provided text.
Here's an explanation of why the information is missing based on the document:
- Focus on Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This often means showing that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
- "Validation testing" mentioned, but no details: The text states, "Validation testing was provided that confirms that Reformat Gateway™ performs all input functions, output functions, and all required actions according to the functional requirements specified in the Software Requirements Specification (SRS)." This indicates that some testing was done, but the document does not elaborate on the specific acceptance criteria, the study design, results, or statistical analysis. This level of detail is typically found in a separate validation report, not the 510(k) summary itself.
- "Hazard analysis" mentioned: The submission contains results of a "hazard analysis," classifying potential hazards as "minor," but again, no specifics on how this analysis was conducted or what criteria were used.
Conclusion:
Based on the provided snippets, there is no detailed information about specific acceptance criteria or a study that proves the device meets those criteria in terms of clinical performance, accuracy, or efficacy. The document focuses on regulatory clearance through substantial equivalence.
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Image /page/0/Picture/1 description: The image shows the word "INFINITT" in a bold, sans-serif font, set against a black rectangular background. Below the word, there is a handwritten number "K052284" in black ink. The number appears to be a reference or identification code.
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared:
August 10, 2005
Submitter's Information: 21 CFR 807.92(a)(1)
Ms. Bo Hyoung Kim, Director INFINITT CO.,LTD Taesuk Bldg. 9F, 275-5 Yangjae-Dong Seocho-Gu, Seoul, South Korea 137-943 Fax: 82-2-2194-1688 Email: lemon@infinitt.com
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Trade Name: | Reformat Gateway™ |
|---|---|
| Common Name: | Picture Archiving Communications System |
| Device Classification: | 892.2050 |
| Product Code: | LLZ |
| Classification Name: | System. Image Processing |
Predicate Device: 21 CFR 807. 92(a)(3)
Reformat Gateway™ software device is substantially equivalent to the
| Manufacturer: | Voxar LimitedBonnington Bond, 2 Anderson PlaceEdinburgh, UK EH6 5 NP |
|---|---|
| Device Name: | plug 'n view 3d, version 1.0 |
| 510(k) Number: | K 992654 |
| Decision Date: | 11/05/1999 |
| Decision: | Substantially Equivalent |
| Panel Code reviewed by: | Radiology |
| Panel Code classified by: | Radiology |
| Product Code: | LLZ |
| Device Classification Name: | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL |
| Regulation Number: | Class II - 892.2050 |
Device Description: 21 CFR 807 92(a)(4)
Reformat Gateway is a software that receives original data from several devices or PACS system, which reconstructs and sends it to other system automatically. Reformat Gateway reconstructs the thin section slice data into thick section slice data automatically for a fast and routine diagnosis. Also, it generates a MPR
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Koszty
Image /page/1/Picture/1 description: The image shows the word "INFINITT" in white letters against a black background. The font is a bold sans-serif style, and the letters are evenly spaced. The text is centered in the image, and the overall impression is clean and modern.
reconstructed image automatically according to data specification and distributes original data or reconstructed data to distributed different systems.
Indications for Use: 21 CFR 807 92(a)(5)
Reformat Gateway™ is a software application for the display and 3D visualization of medical data derived from digital modalities (CT and MRI scanners) It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print, and distribute DICOM compliant image studies using standard PC hardware.
Technological Characteristics: 21 CFR 807 92(a)(6)
The proposed and predicate devices are both software programs that can be used for manipulation of DICOM-compliant images. The proposed and predicate software can be operated from a personal computer. Differences between the oroposed and predicate devices are limited to the availability of certain image viewing and editing features
The Reformat Gateway™ software conforms to DICOM (Digital Imaging and Communications in Medicine) Version 3
Validation testing was provided that confirms that Reformat Gateway™ performs all input functions, output functions, and all required actions according to the functional requirements specified in the Software Requirements Specification (SRS).
Conclusion: 21 CFR 807 92(b)(1)
The 510 (k) Pre-Market Notification for the Reformat Gateway™ software contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
The Reformat Gateway™ device has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "minor".
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three curved lines representing its wings or feathers. The image is in black and white.
OCT 1 7 2005
Food and Drug Administrati 9200 Corporate Boulevard Rockville MD 20850
Infinitt Co., Ltd % Mr. Carl Alletto Consultant OTech, Inc. 1600 Manchester Way CORINTH TX 76210
Re: K052284 Trade/Device Name: Reformat Gateway Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 1, 2005 Received: August 24, 2005
Dear Mr. Alletto:
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, therefor require, 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 provides of the Al 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 aos not mour mark 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 Section 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:
| 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/cdrh/industry/support/index.html.
Sincercly 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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(Indications for Use Form)
510(k) Number:
Device Name:
Reformat Gateway™
Indications for Use:
Reformat Gateway™ is a software application for the display and 3D visualization of medical data derived from digital modalities (CT and MRI scanners). It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print, and distribute DICOM compliant image studies using standard PC hardware. Typical users of this system are trained professionals, i.e. physicians, radiologists, nurses, medical technicians, and assistants.
Prescription Use (Part 21 CFR 801 Subpart D)
ANDIOR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Posted November 13, 2003)
David A. Slayton
(Division Sign-Off) Division of Reproductive, Al and Radiological Devices 510(k) Number
Page 1 of -1
§ 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).