(54 days)
OrthoPACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualified healthcare professional. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. OrthoPACS also uses such images, in conjunction with templates for prosthetic devices, for the purposes of choosing the nature and characteristics of the prosthetic device to be used when planning a potential surgical procedure.
eTrauma's OrthoPACS is a Digital Info-Imaging System for orthopaedic specific applications in office, private practice, surgery and clinics. The system allows orthopaedic surgcons to navigate quickly through a typical office day by using an efficient and fast system for viewing clinical images and retrieval of information regarding patient historicals whether tocal or residing on other digital information systems such as electronic medical record and/or practice management software. The four general classes of users for OrthoPACS include x-ray technicians, office managers, physicians and nurses. OrthoPACS consists of the following components: Acquisition and Transmission Modules, Viewing Station Module, Storage Module, RemoteImage Accessibility.
The provided 510(k) summary for the OrthoPACS device (K033825) does not contain performance data or a study that establishes acceptance criteria for the device's specific functions as a medical image management system or for its use with prosthetic templates.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Not available. The document states:
"#### 7. PERFORMANCE DATA: The subject device is developed according to ISO 9001:1994 and complies with ISO 13485:1996."
This statement indicates compliance with general quality management system standards (ISO 9001 and ISO 13485). It does not provide specific quantitative performance metrics, acceptance criteria, or a study demonstrating clinical or technical performance of the device's image manipulation, display, or prosthetic templating functions.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not mentioned. Since no specific performance study is detailed, there is no mention of a test set, its sample size, or data provenance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable/Not mentioned. No performance study is detailed, therefore no ground truth establishment is described.
4. Adjudication Method for the Test Set
Not applicable/Not mentioned. No performance study is detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not mention an MRMC study or any comparative effectiveness study with human readers, either with or without AI assistance. The device's description is that of an image management system, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
No. The document does not describe any standalone performance study of an algorithm.
7. Type of Ground Truth Used
Not applicable/Not mentioned. No performance study is detailed.
8. Sample Size for the Training Set
Not applicable/Not mentioned. As this is an image management system and not an AI/ML device relying on a training set, this information is not relevant or provided.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not mentioned. (See point 8)
Summary of Device and Regulatory Context for K033825:
The K033825 submission for OrthoPACS is for an image archiving and communication system (PACS) with specific orthopaedic applications, including the use of templates for prosthetic devices. The key aspects of the submission are:
- Intended Use: Manipulation and display of medical images by a qualified healthcare professional, showing images from different modalities, interfacing with storage/printing devices, and using templates for prosthetic device planning.
- Predicate Devices: Sectra Orthopedic Package (K031590) and Cedara I-SoftView (K022881).
- Regulatory Determination: The FDA determined that OrthoPACS was substantially equivalent to its predicate devices based on the information provided, which likely focused on the functional equivalence of its image display, manipulation, and storage features, as well as its existing quality certifications (ISO 9001, ISO 13485). For this type of device (a PACS system), specific clinical performance studies demonstrating diagnostic accuracy are typically not required unless new functionalities or AI algorithms are introduced that make diagnostic claims. The "performance data" referred to in section 7 is limited to compliance with quality management systems, which is common for PACS predicate device submissions.
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OrthoPACS Device
eTrauma.com Corporation 510(k) Premarket Notification
FEB - 2 2004
510(K) SUMMARY OrthoPACS December 10, 2003
1. SUBMITTER:
eTrauma.com Corporation 1425 East Newport Center Drive Deerfield Beach, FL 33442 Telephone: 877-387-2862 Contact: Dan Hodgeman, President Date Prepared: December 10, 2003
2. DEVICE:
| Trade name: | OrthoPACS |
|---|---|
| Classification Name: | Picture Archiving and Communications System |
| Classification Number: | 892.2050 |
| Product Code | LLZ |
| Common Name: | Medical Image Management System |
| Classification: | Class II |
| Classification Panel: | Radiology |
3. PREDICATE DEVICE:
The predicate devices used to determine substantial equivalence for the eTrauma OrthoPACS System were the Sectra Orthopedic Package (K031590) and the Cedara I-SoftView (K022881).
4. DEVICE DESCRIPTION:
eTrauma's OrthoPACS is a Digital Info-Imaging System for orthopaedic specific applications in office, private practice, surgery and clinics. The system allows orthopaedic surgcons to navigate quickly through a typical office day by using an efficient and fast system for viewing clinical images and retrieval of information regarding patient historicals whether tocal or residing on other digital information systems such as electronic medical record and/or practice management software. The four general classes of users for OrthoPACS include x-ray technicians, office managers, physicians and nurses.
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OrthoPACS Device
K033825
Page 2 of 2
OrthoPACS consists of the following components:
- Acquisition and Transmission Modules ●
- Viewing Station Module .
- Storage Module .
- RemoteImage Accessibility .
5. INDICATIONS FOR USE:
OrthoPACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualified healthcare professional. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. OrthoPACS also uses such images, in conjunction with templates for prosthetic devices, for the purposes of choosing the nature and characteristics of the prosthetic device to be used when planning a potential surgical procedure.
6. COMPARISON OF CHARACTERISTICS:
All of the systems have the same intended use and are stand alone software packages that allow digital image processing and measurement capability. All systems transmit to remote viewing stations over a medical imaging network. None of the systems contact or require interaction with, the patient. All are used by health care professionals who interpret images and information being displayed or printed.
7. PERFORMANCE DATA:
The subject device is developed according to ISO 9001:1994 and complies with ISO 13485:1996.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 2 2004
eTrauma.com Corporation % Ms. Debbie Iampictro President QRC Consulting 7 Tiffany Trail HOPKINTON MA 01748 Re: K033825 Trade/Device Name: OrthoPACS
Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ Dated: December 10, 2003 Received: December 10, 2003
Dear Ms. Iampietro:
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 nanufacturing 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 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 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 the 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" (21CFR Part 807.97) you may obtain. 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/cdrfv/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brydon
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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eTrauma.com Corporation 510(k) Premarket Notification OrthoPACS Device
Page 1 of 1
KO33825 510(k) Number (if known):
Device Name: OrthoPACS
Indications for Use:
OrthoPACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualified healthcare professional. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. OrthoPACS also uses such images, in conjunction with templates for prosthetic devices, for the purposes of choosing the nature and characteristics of the prosthetic device to be used when planning a potential surgical procedure.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted July 1, 1998)
Qurich. derme
(Division Sign-Off) Division of Reproductive, Abdominal, Lad Radiological Devices 510(k) Number .
(Optional Format 3-10-98)
Prescription Use
(Per 21 CFR 801.109)
§ 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).