(24 days)
The Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Graphic Printers are compact, medical grade black and white digital printers. The Sony UP-D898MD (Digital) Graphic Printer accepts only digital signal inputs. The Sony UP-X898MD (Hybrid) Graphic Printer can accept both analog and digital signal inputs. Both models are designed to be integrated into digital radiology imaging systems such as mobile c-arm, ultrasound, cardiac catheterization laboratory and other compatible medical imaging systems and produce hard copy prints of still images captured by these systems for the patient record or for referrals.
The Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Printers are compact, medical grade black and white printers. The UP-D898MD only accepts digital signal inputs and the UP-X898MD accepts both analog and digital signal inputs. The printers are designed to be integrated into radiology imaging systems such as mobile c-arm, ultrasound, cardiac catheterization laboratory and other compatible medical imaging systems and produce 325 dpi high resolution hard copy prints of still images captured by these systems for the patient record purposes or referrals. The images cannot be utilized for diagnostic purposes. Additionally, the UP-X898MD (Hybrid) Printer can store images on a connected USB flash drive.
The provided text is a 510(k) summary for the Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Graphic Printers. This document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a study to prove the device meets specific acceptance criteria for diagnostic performance.
Therefore, many of the requested sections about a study demonstrating clinical performance do not apply to this type of regulatory submission for this device. The device is a "Medical Image Hardcopy Device" which explicitly states "The images cannot be utilized for diagnostic purposes." Its purpose is to produce hard copy prints for patient records or referrals.
Here's an breakdown based on the provided text, highlighting what is available and what is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not specify "acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, AUC) for the proposed device, as it is a printer and not a diagnostic tool. Instead, it compares the technological characteristics to a predicate device to establish substantial equivalence.
Here's a table summarizing the comparison of technological characteristics, which serves as the basis for demonstrating equivalence and "performance" in this context:
| Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Regulatory Status | K890826 | Proposed |
| Product Code | KQM | LMC |
| Indications for Use | Medical grade black and white printers for a wide range of electronic medical diagnostic equipment (ultrasound, radiological imaging, surgical camera systems) to provide hard copy images. | Compact, medical grade black and white digital printers for integration into digital radiology imaging systems (mobile c-arm, ultrasound, cardiac catheterization laboratory) to produce hard copy prints of still images for patient records or referrals (images cannot be utilized for diagnostic purposes). |
| Printing Method | Direct thermal printing | Direct thermal printing |
| High Resolution | 325 dpi | 325 dpi |
| Gradations | 128 levels | 256 levels |
| Picture Elements | NORM: 472x700 (EIA), 560x700 (CCIR); WIDE1: 490x736 (EIA), 582x736 (CCIR); WIDE2: 508x768 (EIA), 608x768 (CCIR) | UP-X898MD: Digital: 4096 x 1280 dots; Video NTSC: 720 x 504 dots; Video PAL: 720 x 604 dots. UP-D898MD: Digital: 4096 x 1280 dots. |
| Picture Area | NORM: 70x91mm; WIDE1: 73x96mm; WIDE2: 75x100mm | UP-X898MD: Digital: 320x100mm (Max); STD Video NTSC: 94x73mm; Video PAL: 94x71mm (WIDE1); SIDE Video-NTSC: 124x96mm, Video-PAL: 127x96mm (WIDE1). UP-D898MD: 320x100mm. |
| Paper Size | 110mm (4 3/8 inch) | UP-D898MD: 320x100mm (12 5/8 x 4 inch); 110mm (4 3/8 inch). |
| Picture Memory | Not specified / Implicitly less advanced | UP-X898MD: Digital: 4096 x 1280 x 8 bits; Video: 10 frame memories (850 k x 8 bits per frame). UP-D898MD: Not specifically listed, but digital input implies substantial memory. |
| Interface | VIDEO INPUT (BNC type), MONITOR OUT (BNC type), DIP Switches, REMOTE Commander. | UP-D898MD: Digital: 4,096 x 1,280 x 8 (bit). UP-X898MD: USB connector (Type A), USB connector (Type B), VIDEO INPUT (BNC type), VIDEO OUT (BNC type), REMOTE Commander. |
| Power Requirements | AC 100 V to 240 V, 50/60Hz | UP-D898MD: USB connector; AC 100 V to 240 V, 50/60Hz. |
| Weight | 8lb 10oz (3.9 kg) | 5lb 8oz (2.5 kg) |
| Digital Video Input | No | Yes (UP-D898MD and UP-X898MD) |
| Analog Video Input | Yes | Yes (UP-X898MD only) |
| Multi-picture Mode | No | Yes |
| Printing Speed | 9 seconds per image (at aspect ratio 3:4) | UP-X898MD: Approx. 1.9 seconds/image (standard setting); Normal speed mode: Approx. 3.3 seconds/image. UP-D898MD: Approx. 1.9 seconds/image (960 x 1,280 dots); Normal speed mode: Approx. 3.3 seconds/image. |
| Storage Media | No | USB Flash drive (UP-X898MD only) |
| Dimensions | 6 1/16 (W) x 6 ½ (H) x 12 43/64 (D) inches | 6 1/16 (W) x 3 ½ (H) x 9 ½ (D) inches |
| LCD Display Panel | No | Yes |
| LED Backlight | No | Yes |
| Function Keys | Front Panel | Front Panel |
| Settings Auto Lock | No | Yes |
| Contrast Knob | Yes | Yes |
| Brightness Knob | Yes | Yes |
| Volume Knob | No | Yes |
| Menu Lever (Joystick) | No | Yes |
| Paper Cutter | Yes | Yes |
| Print Media | Type I: UPP-110S, UPP-110; Type II: UPP-110HD | Type I: UPP-110S High Quality Printing Paper; Type II: UPP-110HD High Density Printing Paper; Type V: UPP-110HG High Glossy Printing Paper. |
| Foot Switch | Optional (FS-20) | Optional (FS-24) |
| Remote Control | Optional (RM-81) | Optional (RM-91) |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This submission is for a medical image printer, not a diagnostic device that requires a test set of clinical data for performance evaluation in the typical sense (e.g., assessing an AI algorithm's accuracy). The "testing" referred to is hardware and software testing for safety and compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. See point 2.
4. Adjudication method for the test set:
- Not Applicable. See point 2.
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:
- Not Applicable. This device is a printer and is specifically stated as not for diagnostic purposes. It does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a hardware printer, not an algorithm.
7. The type of ground truth used:
- Not Applicable. No clinical ground truth (like pathology or outcome data) is established or used for this device's performance evaluation because it is a printer and not a diagnostic device. The "ground truth" for its performance is its adherence to technical specifications and safety standards.
8. The sample size for the training set:
- Not Applicable. This device is a printer, not a machine learning algorithm. It does not have a "training set" in the context of AI or diagnostic performance.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
Summary of the Study Proving Device Meets Acceptance Criteria:
The "study" proving the device meets its "acceptance criteria" (which in this context are primarily safety, effectiveness for its intended use, and substantial equivalence to a predicate device) is based on non-clinical performance testing:
- Hardware and software testing: The submission explicitly states, "The safety and effectiveness of the proposed UP-D898MD and UP-X898MD Graphic Printers have been confirmed by hardware and software testing."
- Compliance with applicable standards: The printers comply with:
- IEC 60601-1:2005 + C1:2006 + C2:2007
- AAMI/ANSI ES 60601-1: 2005 + C1:2009 + A2:2010
- IEC 60601-1-2:2007
- Comparison to Predicate Device: The side-by-side comparison (table above) demonstrates that while there are technological upgrades (e.g., increased resolution, faster printing, digital input), these "differences do not impact the safety and effectiveness of the printers for the intended use" compared to the predicate device (Sony Video Graphic Printer UP-850). The intended use itself explicitly states the images are not for diagnostic purposes.
Therefore, for this specific device, the "acceptance criteria" are related to its functional performance as a hardcopy printer, safety, and electromagnetic compatibility, all validated through non-clinical testing and comparison to an established predicate. No clinical studies (as typically understood for diagnostic devices evaluating disease detection) were performed or required, as explicitly stated under "SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE: Not applicable."
§ 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.