(83 days)
The Imation™ MODEL 9410 NETWORK INTERFACE Network Interface is intended for use as a communications gateway. It accepts input from imaging source modalities and transfers the image data to a compatible printing, viewing, archive or network system. The MODEL 9410 NETWORK INTERFACE accepts input in DICOM standard, digital or video formats and converts, if needed, to DICOM Standard or other digital formats. The system is intended for use with a variety of imaging modalities including CT, MR and CR for the transmission of image data to a variety of printing, viewing and storage devices.
The Imation™ MODEL 9410 NETWORK INTERFACE Network Interface is intended for use as a communications gateway. It accepts input from imaging source modalities and transfers the image data to a compatible printing, viewing, archive or network system. The MODEL 9410 NETWORK INTERFACE accepts input in DICOM standard, digital or video formats and converts, if needed, to DICOM Standard or other digital formats. The system is intended for use with a variety of imaging modalities including CT, MR and CR for the transmission of image data to a variety of printing, viewing and storage devices.
The provided 510(k) summary for the Imation™ MODEL 9410 NETWORK INTERFACE does not contain detailed information regarding specific acceptance criteria or a dedicated study explicitly designed to prove the device meets such criteria in terms of image quality or clinical performance.
Instead, the submission relies on the following points to establish safety and effectiveness, and thus 'acceptance':
1. Acceptance Criteria and Device Performance (Inferred):
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Compliance with voluntary safety standards. (Specifically mentioned: UL950, CSA C22.2 No. 950) | The device adheres to UL950 and CSA C22.2 No. 950. The device has no patient contact and does not control, monitor, or affect any devices directly connected to or affecting the patient. Released software undergoes testing, hazard analysis, and approval equivalent to the initial release. |
| Effectiveness (Image Quality Preservation): Maintain or improve image properties (spatial resolution, gray-scale resolution, density uniformity) compared to predicate devices. | "Images communicated by the subject device maintain the same or better image properties in the areas of spatial and gray-scale resolution and in density uniformity as the predicate. No lossy compression is used in this device." |
| Functional Equivalence: Performs as a communications gateway, accepting and transferring image data in specified formats. | The device "accepts input from imaging source modalities and transfers the image data to a compatible printing, viewing, archive or network system." It accepts "DICOM standard, digital or video formats and converts, if needed, to DICOM Standard or other digital formats." |
| Substantial Equivalence: Demonstrated similarity in technical characteristics and intended use to predicate devices (Cemax-Icon Scanlink V and Merge MVP). | The submission asserts that "The subject device and predicate devices use the same technical design base." and "The subject and predicate device(s) have all been designed to equivalent safety standards." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a distinct "test set" in the context of image quality performance or clinical evaluation. The statement "Images communicated by the subject device maintain the same or better image properties..." implies an internal assessment, but details about the number of images, their origin, or whether this was a retrospective or prospective collection are not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The submission does not describe a study involving expert readers to establish ground truth for image interpretation or diagnosis. The phrase "Images communicated by the subject device and its predicates are reviewed by medical personnel, offering ample opportunity for competent human intervention in case of a malfunction or other failure" suggests that medical personnel ultimately review images, but this is not a ground truth establishment process for a test set.
4. Adjudication Method for the Test Set:
Not applicable. No test set adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was conducted or reported. The submission focuses on device functionality and equivalence, not on the impact of the device on human reader performance.
6. Standalone (Algorithm Only) Performance:
The device is a network interface, a hardware/software system for data transfer and conversion. It does not perform diagnostic algorithms in the sense of an AI model that interprets images. Therefore, a standalone (algorithm only) performance study as typically understood for AI-powered diagnostic devices is not applicable. Its performance is based on its ability to accurately transmit and convert data without degradation.
7. Type of Ground Truth Used:
The concept of "ground truth" as typically used in the context of diagnostic AI algorithms (e.g., pathology, clinical outcomes) is not applicable here. The evaluation of this device is based on technical specifications and faithful transmission/conversion of image data, not on the accuracy of diagnostic findings. The implied 'ground truth' for its performance relates to the integrity of the transmitted image data compared to the original, which would be evaluated through technical measurements rather than clinical expert consensus.
8. Sample Size for the Training Set:
Not applicable. This device is a network interface and does not involve AI/machine learning models that require a "training set" in the typical sense for image interpretation. Its software converts data formats and manages communication, which is developed through standard software engineering practices rather than data-driven machine learning.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for an AI algorithm.
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510(k) Summary
Sept 2, 1997
NOV 25 1997
Imation Corp. 1 Imation Place Oakdale MN 55128 Contact: Stephen G. Slavens 3M Center, 235-2B-23 St. Paul MN 55144-1000
Phone: 612-704-3536 612-736-3116 FAX:
| Device: | |
|---|---|
| Trade name: | Imation™ MODEL 9410 NETWORK INTERFACE |
| Common name: | PACS Communication Device |
| Classification name: | Medical Image Digitizer (Proposed)21 CFR 892.2030 (Proposed) |
Cemax-Icon Scanlink V and Merge MVP Predicate devices:
Description And Intended Use of Device:
The Imation™ MODEL 9410 NETWORK INTERFACE Network Interface is intended for use as a communications gateway. It accepts input from imaging source modalities and transfers the image data to a compatible printing, viewing, archive or network system. The MODEL 9410 NETWORK INTERFACE accepts input in DICOM standard, digital or video formats and converts, if needed, to DICOM Standard or other digital formats. The system is intended for use with a variety of imaging modalities including CT, MR and CR for the transmission of image data to a variety of printing, viewing and storage devices.
Technological Characteristics:
The subject device and predicate devices use the same technical design base. The communications gateway devices receive image data from an imaging modality. User control is performed by a keypad or directly by the modality through the host control. Based on the control data from the modality, image information is transferred to the appropriate destination device.
Software is used to convert, as needed, image and control data from one digital format to another. In the case of analog video digitization, a commercially available video frame grabber / digitizer board is used.
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Performance Data:
Safety and effectiveness are key activities in the commercialization and are assured via meeting voluntary standards, including UL950, CSA C22.2 No. 950, and Imation™ MODEL 9410 NETWORK INTERFACE Requirements specification(Part B).
Released software, according to the established procedures, is given a production level code and subsequent code changes undergo testing, hazard analysis and approval equivalent to the initial release.
Conclusion:
The subject device, like the predicates, has no patient contact. The devices also do not control, monitor or otherwise effect any devices directly connected to or effecting the patient. Images communicated by the subject device and its predicates are reviewed by medical personnel, offering ample opportunity for competent human intervention in case of a malfunction or other failure.
Images communicated by the subject device maintain the same or better image properties in the areas of spatial and gray-scale resolution and in density uniformity as the predicate. No lossy compression is used in this device.
The subject and predicate device(s) have all been designed to equivalent safety standards.
Imation therefore concludes that the Imation™ MODEL 9410 NETWORK INTERFACE Network Interface is as safe and effective as the predicate device
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 5 1997
Imation Corporation c/o Stephen G. Slavens 3M Center, 235-2B-23 St. Paul, MN 55144-1000 Re: K973303
Imation ™ Model 9410 Network Interface Dated: September 2, 1997 Received: September 3, 1997 Regulatory class: Unclassified Procode: 90 LMD
Dear Mr. Slavens:
We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
h.J. Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
.
Enclosure
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ATTACHMENT 2
Statement of Indications for Use:
510(K) Number (if known): _ k 973 303
Device Name: Imation™ MODEL 9410 NETWORK INTERFACE Network Interface
Indications for Use:
The Imation™ MODEL 9410 NETWORK INTERFACE Network Interface is intended for use as a communications gateway. It accepts input from imaging source modalities and transfers the image data to a compatible printing, viewing, archive or network system. The MODEL 9410 NETWORK INTERFACE accepts input in DICOM standard, digital or video formats and converts, if needed, to DICOM Standard or other digital formats. The system is intended for use with a variety of imaging modalities including CT, MR and CR for the transmission of image data to a variety of printing, viewing and storage devices.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use
David C. Severson
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological De 510(k) Number
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.