(86 days)
The AXIS Radiology Monochrome Medical Displays are intended to be used to display and view digital images for review and analysis by trained medical practitioners. The AXIS 5MP display is currently not cleared in the U.S. for use with Full Field Digital Mammography (FFDM). The AXIS 1MP, 2MP and 3MP displays are not intended for use with FFDM.
The AXIS Monochrome Display is a diagnostic display. The AXIS Monochrome Display is a high resolution, Liquid Crystal Display (LCD) with electronic capabilities used for the review and analysis of high-resolution medical images.
This 510(k) pertains to monochrome medical display monitors and therefore doesn't involve a study with acceptance criteria in the typical sense of algorithm performance. The FDA clearance is based on substantial equivalence to predicate devices. This means the new device (AXIS I, II, III, and V Monochrome Displays) has the same intended use and technological characteristics as already legally marketed devices, and they do not raise new questions of safety or effectiveness.
Therefore, many of the typical questions for AI/algorithm-based devices (like sample sizes, ground truth establishment, MRMC studies) are not applicable here.
Here's a breakdown of what can be extracted and how it relates to acceptance criteria in this context:
1. Table of Acceptance Criteria and Reported Device Performance:
For a display device, "acceptance criteria" primarily revolve around demonstrating performance similar to predicate devices and meeting relevant display standards. The document doesn't provide specific numerical performance metrics for the AXIS displays, but rather establishes equivalence to predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance (Reference to Predicate) |
|---|---|
| Intended Use Equivalence: The display must be suitable for displaying and viewing digital medical images for review and analysis by trained medical practitioners. | Met: Explicitly stated as intended use. Proven by substantial equivalence to predicate devices with the same intended use. |
| Technological Equivalence: The display must have similar technological characteristics (e.g., resolution, display type) to legally marketed devices. | Met: The AXIS displays are described as "high resolution, Liquid Crystal Display (LCD) with electronic capabilities." Substantial equivalence is claimed for various resolutions (1MP, 2MP, 3MP, 5MP) to corresponding predicate devices. |
| Safety and Effectiveness Equivalence: The device must not raise new questions of safety or effectiveness compared to predicate devices. | Met: The FDA's substantial equivalence determination implies that no new safety or effectiveness concerns were identified compared to the predicate devices. |
| Limitations of Use: Adherence to existing limitations for similar devices (e.g., FFDM use). | Met: Clearly states that the AXIS 5MP is not cleared for FFDM in the U.S., and the 1MP, 2MP, and 3MP displays are not intended for use with FFDM, mirroring predicates or current regulations. |
2. Sample Sizes and Data Provenance:
- Test Set Sample Size: Not applicable. There was no specific "test set" of medical images or patient data used to evaluate the device's diagnostic performance in a clinical study. The evaluation is based on technical specifications and comparison to predicate devices.
- Data Provenance: Not applicable.
3. Number of Experts and Qualifications for Ground Truth:
- Not applicable. Ground truth, in the sense of expert consensus on medical findings, is not relevant for the substantial equivalence of a display monitor. The evaluation focuses on the technical specifications and intended use of the display itself, not its impact on diagnostic accuracy, which is presumed to be equivalent to the predicate devices.
4. Adjudication Method:
- Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study was not done. These studies are typically conducted for AI algorithms or new diagnostic methodologies to assess their impact on human reader performance. For a display device, the focus is on its technical specifications and equivalence, not its direct impact on reader performance beyond providing a clear image comparable to existing displays.
6. Standalone Performance Study:
- No. A standalone algorithm performance study was not done because this is a hardware device (a display monitor), not an algorithm or AI system. Its "performance" is inherently tied to its technical specifications and its ability to display images, which is assumed to be equivalent to the predicate devices.
7. Type of Ground Truth Used:
- Not applicable. The "ground truth" for this submission is the technical specifications and regulatory status of the predicate devices. The new device's compliance with similar specifications and its intended use form the basis for its clearance.
8. Sample Size for the Training Set:
- Not applicable. The AXIS Monochrome Display is a hardware device; it does not involve machine learning or an algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
In summary: This 510(k) is a typical substantial equivalence submission for a medical display device. The "acceptance criteria" are implicitly met by demonstrating that the new device shares the same intended use and similar technological characteristics to already cleared predicate devices, without raising new concerns about safety or effectiveness. Clinical performance studies are not required for this type of submission.
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K04-2353
NOV 2 4 2004 510(k) Summary National Display Systems, Inc A. Manufacturer: 16245 Vineyard Boulevard Morgan Hill, CA 95037 USA B. Submitted By: Ron Hansen Product Manager National Display System, Inc. C. Date of Preparation: August 18, 2004 D. Contact Information: Tel: 408.776.0085 Ext. 128 Fax: 408.776.9878 E. Classification Name: System, image processing F. Common Name: Monitor, display, and others G. Proprietary Name: AXIS I Monochrome Display (1MP) AXIS II Monochrome Display (2MP) AXIS III Monochrome Display (3MP) and AXIS V Monochrome Display (5MP) 21 CFR 892.2050/Procode 90LLZ H. Classification Number: Substantial Equivalence: I.
| AXIS I (1MP) | = Nova 1MP (NDS) K040310 and Coronis 1MP (Barco) K023340 |
|---|---|
| AXIS II (2MP) | = Nova 2MP (NDS) K040310; Coronis 2MP (Barco) K023322 andDome C2 (Planar Systems) K032202 |
| AXIS III (3MP) | = Nova 3MP (NDS) K040310; Coronis 3MP (Barco) K013922 andDome C3 (Planar Systems) K032638 |
| AXIS V (5MP) | = Nova 5MP (NDS) K040310; Coronis 5MP (Barco) K023341 andDome C5i (Planar Systems) K032202 |
| J. Device Description: | The AXIS Monochrome Display is a diagnostic display. |
| K. Intended Use: | The AXIS Monochrome Medical Displays are intended tobe used to display and view digital images for review andanalysis by trained medical practitioners. The AXIS V(5MP) display is currently not cleared in the U.S. for usewith Full Field Digital Mammography (FFDM). The AXIS |
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I (1MP), AXIS II (2MP) and AXIS III (3MP) displays are not intended for use with FFDM.
- L. Technological Characteristics: The AXIS Monochrome Display is a high resolution, Liquid Crystal Display (LCD) with electronic capabilities used for the review and analysis of high-resolution medical images.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized emblem resembling a bird or abstract human figure, with three curved lines forming its body. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the emblem. The text and emblem are both in black, set against a white background.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 2004
Mr. Ron Hansen Product Manager National Display Systems, Inc. 16245 Vineyard Blvd. MORGAN HILL CA 95037
Re: K042353 Trade/Device Name: AXIS I (1MP), II (2MP), III (3MP), and V (5MP) Monochrome Displays Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications systems
Regulatory Class: II Product Code: 90 LLZ Dated: October 20, 2004 Received: October 25, 2004
Dear Mr. Hansen:
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 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 premated 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/cdrb/dsmaldsmamain.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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Indications for Use
510(k) Number (if known): N/A
Device Name: AXIS FAMILY OF MEDICAL RADIOLOGY MONOCHROME DISPLAYS
Indications for Use:
The AXIS Radiology Monochrome Medical Displays are intended to be used to display and view digital images for review and analysis by trained medical practitioners. The AXIS 5MP display is currently not cleared in the U.S. for use with Full Field Digital Mammography (FFDM). The AXIS 1MP, 2MP and 3MP displays are not intended for use with FFDM.
Prescription Use × (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)
Nancy Hogdon
(Division Sign-Off)
Abdomi Division of Reproductive and Radiological Devices 510(k) Number _
Page 1 of 1 __________________________________________________________________________________________________________________________________________________________________
§ 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).