(47 days)
Not Found
No
The document describes a web-based system for viewing, storing, and routing medical images with standard image processing tools. There is no mention of AI, ML, or related concepts.
No
The device is described as software for viewing and interpreting medical images, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "software intended for viewing and diagnostic interpretation of images."
Yes
The device is described as a "fully web-based system" and "software intended for viewing and diagnostic interpretation of images". While it requires "suitable commercial standard hardware" and operates within specific software environments (Microsoft Internet Explorer, Windows 2003, Microsoft SQL 2000), the core medical device functionality is explicitly defined as the software itself for image handling and interpretation. The description focuses on the software's capabilities and configurations (Encompass.Net, R1.Net, R2.Net, R3.Net) rather than any proprietary or specific medical device hardware.
Based on the provided information, the Encompass.Net™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Encompass.Net™ function: The description clearly states that Encompass.Net™ is software intended for "viewing and diagnostic interpretation of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems." It deals with medical images, not biological samples.
- Intended Use: The intended use is for interpreting medical images, which is a different category of medical device than an IVD.
Therefore, Encompass.Net™ falls under the category of medical imaging software or a PACS (Picture Archiving and Communication System), not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Encompass.Net™ device is software intended for viewing and diagnostic interpretation of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Encompass.Net™ receives imaging studies over a network from Empiric Systems servers or directly from CD with images utilizing both lossless (reversible) and lossy (irreversible) compression. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Encompass.Net™ is a fully web-based system that operates in a Microsoft Internet Explorer (Version 6.0 and above) environment. Encompass.Net™ is run in a Windows 2003 environment, using Microsoft's Internet Information Server functions. The core database is Microsoft SQL 2000. Encompass. Net is intended to acquire medical images for storage, archiving, and routing to medical professionals. In addition, Encompass.Net allows medical professionals to retrieve medical images on demand using Internet communication protocols according to various user options and lossy and/or lossless compression techniques for subsequent review. A host of image process tools are available for the medical professional. In addition to Encompass. Net, the fully integrated RIS/PACS device, there are also multiple stand-alone PACS models (subsets of Encompass Net) that will be marketed. Those configurations are: R1.Net, R2.Net, and R3.Net.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, CR, DR, US and other DICOM compliant medical imaging systems
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical 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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K os 3455
Image /page/0/Picture/1 description: The image shows the logo for "Empiric Systems". The word "Empiric" is in a bold, sans-serif font, with a curved line extending from the left side of the "E". The word "Systems" is in a smaller, italicized font below "Empiric".
JAN 2 5 2006
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:
November 30, 2005
Submitter's Information: 21 CFR 807.92(a)(1) Mark Janas Chief Technology Officer Empiric Systems, LLC 1800 Perimeter Park Dr., Suite 120 Morrisville, NC 27560 866-367-4742 (phone)
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Trade Name: | Encompass.Net™ |
|---|---|
| Common Name: | Picture Archiving Communications System |
| Device Classification: | 892.2050 System, Image Processing |
| Product Code: | LLZ |
Predicate Device: 21 CFR 807. 92(a)(3)
| 510(k) Number | K022970 | |
|---|---|---|
| Regulation Number | 892.2050 | |
| Device Name | Amicas Light Beam Workstation | |
| Applicant | Arnicas Inc. | |
| Classification Product CodeLLZ | ||
| Device Classification Name | SYSTEM, IMAGE PROCESSING, | |
| RADIOLOGICAL |
Device Description: 21 CFR 807 92(a)(4)
Encompass.Net™ is a fully web-based system that operates in a Microsoft Internet Explorer (Version 6.0 and above) environment. Encompass.Net™ is run in a Windows 2003 environment, using Microsoft's Internet Information Server functions. The core database is Microsoft SQL 2000.
Encompass. Net is intended to acquire medical images for storage, archiving, and routing to medical professionals. In addition, Encompass.Net allows medical professionals to retrieve medical images on demand using Internet communication protocols according to various user options and lossy and/or lossless compression techniques for subsequent review. A host of image process tools are available for the medical professional.
In addition to Encompass. Net, the fully integrated RIS/PACS device, there are also multiple stand-alone PACS models (subsets of Encompass Net) that will be marketed. Those configurations are: R1.Net, R2.Net, and R3.Net.
1
Image /page/1/Picture/0 description: The image shows the logo for Empiric Systems. The word "Empiric" is in bold, and the word "Systems" is below it in a smaller font. There is a trademark symbol to the right of the word "Empiric". There is a black graphic to the left of the word "Empiric".
510(k) Summary of Safety and Effectiveness
Indications for Use: 21 CFR 807 92(a)(5)
Encompass.Net™ device is software intended for viewing and diagnostic interpretation of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Encompass.Net™ receives imaging studies over a network from Empiric Systems servers or directly from CD with images utilizing both lossless (reversible) and lossy (irreversible) compression. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.
Technological Characteristics: 21 CFR 807 92(a)(6)
Encompass.Net™ device is a software product that handles digital medical images.
The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.
Conclusion: 21 CFR 807 92(b)(1)
The 510 (k) Pre-Market Notification for Encompass.Net™ device contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
Encompass.Net™ 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".
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Empiric Systems, LLC % Mr. Carl Alletto Consultant OTech. Inc. 1600 Manchester Way CORINTH TX 76210
Re: K053455 Trade/Device Name: Encompass.Net™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 18, 2005 Received: December 9, 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, 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.
JAN 2 5 2006
3
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.
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
(Indications for Use Form)
510(k) Number: K 05 3455
Device Name:
Encompass.Net™
Indications for Use:
Encompass.Net™ device is software intended for viewing and diagnostic interpretation of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Encompass.Net™ receives imaging studies over a network from Empiric Systems servers or directly from CD with images utilizing both lossless (reversible) and lossy (irreversible) compression.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | AND/OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number: K053455