(80 days)
This device is intended for high resolution hard copy imaging of digital image source material (DICOM). The hardcopy output includes however is not limited to, digital radiography, nuclear medicine, ultrasound, CT, MRI, CR and Radiation Therapy planning; Images are suitable for medical image diagnosis use and referral. The system is intended for use by medical radiologists, imaging modality specialists, and communications to referring physicians. Not for mammography use.
CYPHER implements the necessary DICOM services to receive DICOM print jobs and provides an interface for printing the received data on a Windows™ printer. The device is designed for use with the CANON imagePRESS™ C1 Digital Print System. It consists of an Intel® 945GSE Mini-ITX Board in a shielded enclosure. The user interface is implemented on either an attached monitor or via the remote desktop function inherent in Windows XP. Power is supplied via an external UL listed 12 volt power supply.
The provided text describes a medical image hardcopy device, the "Cypher DICOM Print Solution," and its FDA 510(k) summary. However, it does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and the comprehensive study proving its performance.
The document is a regulatory submission for substantial equivalence to a predicate device, focusing on its DICOM compatibility and ability to produce high-quality hardcopy printouts. It mentions "Performance Testing/Data" that demonstrated the device is "safe and effective, performs comparably to and is substantially equivalent to the predicate device," and that "Tests include: Software Validation and evaluation of hardcopy output." Beyond this general statement, specific acceptance criteria, detailed study design, sample sizes, expert qualifications, or ground truth methods are not provided.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|
| Safe and effective | Device is safe and effective (claimed) |
| Performs comparably to predicate device | Performs comparably to predicate device (claimed) |
| Substantially equivalent to predicate device | Is substantially equivalent to predicate device (claimed) |
| DICOM compatible | Implements necessary DICOM services to receive DICOM print jobs |
| Produces high-quality hardcopy printouts in black & white and color | Produces high-quality hardcopy printouts in black & white and color |
| Software Validation | Software Validation was performed |
| Evaluation of hardcopy output | Evaluation of hardcopy output was performed |
| Electrical safety | Assured via use of a UL listed 12 volt power supply |
Note: The document only states that the device meets these general criteria but does not provide specific quantitative metrics or results that would typically constitute detailed acceptance criteria (e.g., specific resolution targets, color accuracy thresholds, DICOM conformance test results with pass/fail ratios).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document states "Tests were performed on the device," but gives no details about the size or nature of the test set, nor the provenance of any data used for evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not provided. While the device is intended for "medical image diagnosis use and referral" by "medical radiologists, imaging modality specialists," the document does not mention the involvement of experts in establishing ground truth for any performance testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided. The document does not describe any adjudication method, suggesting that such a method was either not relevant to the type of testing performed (e.g., functional and imaging quality evaluation for a printer) or not considered necessary for this 510(k) submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC study was not done, nor would it be relevant for this device. This device is a "Medical Image Hardcopy Device (Printer)," not an AI-powered diagnostic tool. Its function is to print DICOM images, not to assist in image interpretation or diagnosis directly via AI. Therefore, an MRMC study measuring human reader improvement with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in the sense that the "device" (printer) was tested independently. The performance testing mentioned ("Software Validation and evaluation of hardcopy output") would inherently be a standalone evaluation of the printer's output quality and DICOM conformance. However, this is not an "algorithm only" in the context of an AI device, but rather a functional evaluation of a hardware/software system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated in terms of diagnostic ground truth. For a printer, the "ground truth" would likely involve objective measures of print quality, color accuracy, resolution, adherence to DICOM standards for rendering, and potentially comparison to the digital image data itself. It's not about clinical diagnosis ground truth (like pathology or patient outcomes).
8. The sample size for the training set
- Not applicable / Not provided. This is a medical image printer, not an AI model requiring a training set in the conventional sense. The "training" would be more akin to software development and testing, not machine learning model training.
9. How the ground truth for the training set was established
- Not applicable / Not provided. See point 8.
{0}------------------------------------------------
510(k) SUMMARY
Image /page/0/Picture/2 description: The image shows the logo for Virtual Imaging, a Canon USA company. The logo features a stylized "V" shape on the left, followed by the words "VIRTUAL IMAGING" in bold, block letters. Below the company name, the text "A CANON USA Company" is written in a smaller font size.
Image /page/0/Picture/3 description: The image shows the word "Canon" in a bold, sans-serif font. The letters are black, and the background is white. The word is slightly distorted, with some of the letters appearing to be slightly blurred.
ANON USA Company
720 S. Powerline Road, Suite E Deerfield Beach, FL 33442 954-428-6191 (Office)
OCT 1 6 2009
954-428-6195 (Fax) Page 1 of 2, 510(k) Summary: Cypher DICOM Print Solution
| Date Prepared | July 20, 2009 |
|---|---|
| Summary prepared by: | Chris Duca, Chief Operating Officer |
| Device Name | Medical Image Hardcopy Device (Printer) |
| Trade Name | Cypher DICOM Print Solution |
| Common Name | Printer |
| Classification | Class: IIProduct Code: LMCRegulation: 21 CFR 892.2040; |
| Identification ofPredicate Devices andSummary of SubstantialEquivalence | Horizon® Series MEDICAL IMAGE HARDCOPY MULTIMEDIAPRINTERS, K060440 and K042232, manufactured by Codonics, |
| Device Description | CYPHER implements the necessary DICOM services to receiveDICOM print jobs and provides an interface for printing thereceived data on a Windows™ printer. The device is designed foruse with the CANON imagePRESS™ C1 Digital Print System. Itconsists of an Intel® 945GSE Mini-ITX Board in a shieldedenclosure. The user interface is implemented on either anattached monitor or via the remote desktop function inherent inWindows XP. Power is supplied via an external UL listed 12 voltpower supply. |
{1}------------------------------------------------
| Intended Use andIndications | This device is intended for high resolution hard copy imaging ofdigital image source material (DICOM). The hardcopy outputincludes however is not limited to, digital radiography, nuclearmedicine, ultrasound, CT, MRI, CR and Radiation Therapy planning;Images are suitable for medical image diagnosis use and referral.The system is intended for use by medical radiologists, imagingmodality specialists, and communications to referring physicians.Not for mammography use. |
|---|---|
| TechnologicalCharacteristics andSubstantial Equivalence | Comparison with the predicate shows the technologicalcharacteristics of the Cypher DICOM Print Solution are equal to orbetter than the predicate device. Both units are DICOMcompatible (optional on the predicate) and produce high qualityhardcopy printouts in black & white and color. |
| PerformanceTesting/Data | Tests were performed on the device which demonstrated that thedevice is safe and effective, performs comparably to and issubstantially equivalent to the predicate device.Tests include: Software Validation and evaluation of hardcopyoutput. Electrical safety is assured via use of a UL listed powersupply. |
Page 2 of 2, 510(k) Summary: Cypher DICOM Print Solution
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
:
14:00 PM IST ST 11:00 PM
:
:
.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Virtual Imaging, Inc. % Mr. Daniel Kamm Principal Consultant Kamm & Associates 333 Milford Road DEERFIELD IL 60015
OCT 1 6 2009
Re: K092280
Trade/Device Name: Cypher DICOM Print Solution Regulation Number: 21 CFR 892,2040 Regulation Name: Medical image hardcopy device Regulatory Class: II Product Code: LMC Dated: July 21, 2009 Received: July 28, 2009
Dear Mr. Kamm:
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 (PMA), it may be subject to 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 mav 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); medical device reporting (reporting of medical
{3}------------------------------------------------
Page 2 -
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janina M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
INDICATIONS FOR USE
510(k) Number (if known): K09-2290 Device Name: Cypher DICOM Print Solution
This device is intended for high resolution hard copy imaging of digital image source material (DICOM). The hardcopy output includes however is not limited to, digital radiography, nuclear medicine, ultrasound, CT, MRI, CR and Radiation Therapy planning; Images are suitable for medical image diagnosis use and referral. The system is intended for use by medical radiologists, imaging modality specialists, and communications to referring physicians. Not for mammography use.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
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)
Norm B. Khan
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Deviceş
510(k) Number. K092280
Page 1 of 1
:
§ 892.2040 Medical image hardcopy device.
(a)
Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.(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). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.