EXAM-PACS

K042647 · Coactiv, LLC · LLZ · Oct 7, 2004 · Radiology

Device Facts

• Record ID: K042647
• Device Name: EXAM-PACS
• Applicant: Coactiv, LLC
• Product Code: LLZ · Radiology
• Decision Date: Oct 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended 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.

Device Story

Exam-PACS is a Picture Archiving and Communications System (PACS) for medical imaging. It receives digital images/data from modalities like CT, MR, ultrasound, R/F, and radiographic devices. It utilizes a DICOM image gateway to acquire images, including digitizing film-based images to DICOM standards. Software modules enable image capture, storage, distribution, enhancement, manipulation, and networking across distributed clinical locations. Operated by physicians, nurses, and technicians in clinical environments, the system displays images on workstations for diagnostic review. It does not contact patients or control life-sustaining equipment. Healthcare providers use the enhanced/manipulated images to support clinical decision-making. The system facilitates efficient image management and access, potentially improving diagnostic workflows and patient care delivery.

Clinical Evidence

Bench testing only. No clinical data provided. The submission relies on hazard analysis and demonstration of substantial equivalence to the predicate device.

Technological Characteristics

PACS software for use with standard computer hardware. Functions include image capture, storage, distribution, enhancement, and manipulation. Supports DICOM standards for image acquisition and transmission. Connectivity via network for distributed access. Does not contact patients. Software hazard level of concern: minor.

Indications for Use

Indicated for trained professionals, physicians, nurses, and technicians to receive, process, manipulate, enhance, store, and display digital medical images (including mammograms) and data from various imaging sources across distributed networks. Mammographic images require FDA-approved 5 Mpixel resolution monitors for primary interpretation; lossy compressed mammographic and digitized film images are contraindicated for primary interpretation.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• INTELEPACS™ (K032533)

Submission Summary (Full Text)

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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.

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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".

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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.

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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

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## 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