(9 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard PACS functionalities like image capture, storage, distribution, enhancement, manipulation, and networking. There is no mention of AI/ML-specific features or performance metrics.
No
The device is described as receiving, processing, storing, and displaying medical images, which are functions of an image management system rather than directly treating or diagnosing a medical condition. It specifically states that lossy compressed mammographic images must not be reviewed for primary image interpretations, further indicating it's not intended for direct diagnostic interpretation, a key aspect of a therapeutic device.
No
The device is described as a system for receiving, communicating, processing, manipulating, enhancing, storing, and displaying digital images and data. Its primary function is image management and viewing, not the formulation of a medical diagnosis. It explicitly states that lossy compressed mammographic images should "not be reviewed for primary image interpretations," implying that the interpretation (diagnosis) is done by a trained professional using the displayed images, not by the device itself.
Yes
The device description explicitly states that Exam-PACS™ is "comprised of various software modules" and describes its functions solely in terms of software operations (receiving, communicating, processing, manipulating, enhancing, storing, and displaying digital images and data). While it interacts with hardware (scanners, monitors, networks), the device itself, as described, is the software system.
Based on the provided information, this 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.
- Exam-PACS™ Function: Exam-PACS™ is described as a system that receives, processes, stores, and displays medical images from various imaging modalities (CT, MR, ultrasound, etc.). It deals with images of the body, not samples taken from the body.
The device's function is clearly focused on the management and display of medical images for diagnostic interpretation by trained professionals, which falls under the category of medical imaging software or PACS (Picture Archiving and Communication System).
No
Explanation:
The provided clearance letter does not mention a Predetermined Change Control Plan (PCCP) or anything indicating that the device is authorized under such a plan. PCCPs are relatively new regulatory pathways, and their authorization would be explicitly stated in the clearance.
Intended Use / Indications for Use
Exam-PACS™ is a device that receives digital images (including mammograms) and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F units, computer & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and or across computer networks at distributed locations.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. 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.
Typical users of this system are trained professionals, physicians, nurses, and technicians.
Product codes
LLZ
Device Description
Exam-PACS™ is comprised of various software modules that can be configured to provide image capture, storage, distribution, enhancement, manipulation, and networking of medical images at distributed locations. In cases where DICOM images are not directly available to IntelePACS™, the system can acquire medical images using a DICOM image gateway, which generates DICOM-type files. For example, film digitizers obtain images from original film and convert them to meet DICOM standards and stored. Stored files are transmitted using a network and can be viewed or manipulated from imaging workstation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital images (including mammograms) and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F units, computer & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources).
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals, physicians, nurses, and technicians.
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)
Not Found
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
K04 2647
Image /page/0/Picture/1 description: The image shows the logo for CoActiv Medical Business Solutions. The logo is in black and white, with the words "CoActiv" in large, bold letters. Below the company name, in smaller letters, are the words "MEDICAL BUSINESS SOLUTIONS."
Image /page/0/Picture/2 description: The image contains the text "CoActiv" on the top line and "EXAM-PACS" on the second line. The text is in a bold, sans-serif font. The letters are black, and the background is white. The letters are slightly distorted, as if they were printed on a slightly uneven surface.
OCT 7 - 2004
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 28, 2004
Submitter's Information: 21 CFR 807.92(a)(1)
Mr. Edward Heere, President & CEO CoActiv, LLC CoActiv Medical Business Solutions 900 Ethan Allen Highway, Ridgefield, CT 06877
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Trade Name: | Exam-PACS™ |
|---|---|
| Common Name: | Picture Archiving Communications System |
| Device Classification: | 892.2050 |
| Name: | System, Image Processing |
Predicate Device: 21 CFR 807. 92(a)(3)
| Device Classification Name | System, Image Processing, Radiology |
|---|---|
| Regulation Number | 892.2050 |
| 510(k) Number | K032533 |
| Device Name | INTELEPACS™ |
| Applicant | Intelerad Medical Systems Inc. |
| Product Code | LLZ |
| Decision Date | 10/16/2003 |
| Decision | SUBSTANTIALLY EQUIVALENT (SE) |
| Classification Advisory Committee | Radiology |
| Review Advisory Committee | Radiology |
Device Description: 21 CFR 807 92(a)(4)
Exam-PACS™ is comprised of various software modules that can be configured to provide image capture, storage, distribution, enhancement, manipulation, and networking of medical images at distributed locations. In cases where DICOM images are not directly available to IntelePACS™, the system can acquire medical images using a DICOM image gateway, which generates DICOM-type files. For example, film digitizers obtain images from original film and convert them to meet DICOM standards and stored. Stored files are transmitted using a network and can be viewed or manipulated from imaging workstation.
1
Image /page/1/Picture/0 description: The image shows the logo for "CoActiv MEDICAL BUSINESS SOLUTIONS". The word "CoActiv" is in a large, bold font, with the letters slightly overlapping. Below "CoActiv" is the phrase "MEDICAL BUSINESS SOLUTIONS" in a smaller, sans-serif font. The logo is black and white.
Image /page/1/Picture/1 description: The image contains the words "CoActiv" on the top line and "EXAM-PACS" on the second line. The text is in bold and black. The letters are capitalized. There is a superscript to the right of the word PACS.
Indications for Use: 21 CFR 807 92(a)(5)
Exam-PACS™ is a device that receives digital images (including mammograms) and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F units, computer & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be imaging gatoways of or essed, manipulated, enhanced, stored, and displayed within the system and or across computer networks at distributed locations. oyetem and ressed mammographic images and digitized film screen images must not EUssy oomprooood manimographic interpretations. 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. Typical users of this system are trained professionals, physicians, nurses, and technicians.
Technological Characteristics: 21 CFR 807 92(a)(6)
Exam-PACS™ is medical device image software that is used with computer hardware in a picture archiving and communications system user environment. 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 Exam-PACS™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
Exam-PACS™ 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 a black and white logo for the Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the bird figure. The text is in all capital letters and is relatively small compared to the bird figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 7 - 2004
CoActive, LLC % Mr. N. E. Devine, Jr. Responsible Third Party Official Entela, Inc. · ·3033 Madison Ave., SE
GRAND RAPIDS MI 49548
Re: K042647
Trade/Device Name: EXAM-PACSTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: September 28, 2004 Received: September 28, 2004
`Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave revewed your becaller by to (2) persivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the cherosate) to regally manther Fr the Medical Device Amendments, or to devices that have been May 20, 1770, the charactirent 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 do not require approval or a provisions of the Act. The general controls provisions of the Act de nee, subjoct to the general 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 n your de rise to such additional controls. Existing major regulations affecting your Apploraly, it 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 I rease of actermination 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 r cartir starer and regulaing, 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) (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 Section 510(k) This ictici will anow you to to ogin mainers of your device of your device to a legally premarked 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 If you desire specifice 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 Also, please note the regaral information on your responsibilities under the Act from the 607.77). Tod may ocumers, International and Consumer Assistance at its toll-free number (800) DVISION or Officil Manakataractaras its Internet address http://www.fda.gov/cdrl/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
Page 1 of -1
510(k) Number:
Device Name: EXAM-PACS TM
Indications for Use:
Exam-PACS™ is a device that receives digital images (including mammograms) and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F units, computer & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and or across computer networks at distributed locations.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. 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.
Typical users of this system are trained professionals, physicians, nurses, and technicians.
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Brogdon
of Renrodu nd Radiological Devi 510(k) Number