Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the device's function as a printer for medical images, accepting analog and digital inputs and producing hard copies. There is no mention of any analytical or interpretive functions that would typically involve AI/ML.

Therapeutic

No
The device is a printer used to produce hard copy prints of still images from medical imaging systems for patient records or referrals; it does not directly treat or diagnose a medical condition.

Diagnostic

No
The device explicitly states in the 'Device Description' section that "The images cannot be utilized for diagnostic purposes." Its primary function is to produce hard copy prints of still images for patient records or referrals, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device is explicitly described as a "compact, medical grade black and white digital printer" and a "compact, medical grade black and white printer," indicating it is a physical hardware device. The summary also mentions "hardware and software testing" and compliance with hardware-related standards (IEC 60601-1, AAMI/ANSI ES 60601-1, IEC 60601-1-2).

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The Sony UP-D898MD and UP-X898MD Graphic Printers are described as devices that produce hard copy prints of still images captured by medical imaging systems (like ultrasound, c-arm, etc.).
Intended Use: The intended use is to provide hard copies for patient records or referrals.
Lack of Biological Sample Analysis: There is no mention of the device analyzing biological samples or performing any tests on them.

The device is a medical imaging accessory that provides a physical output of images generated by other diagnostic equipment. It does not perform any diagnostic testing itself.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Like the proposed device, the predicate Sony Video Graphic Printer UP-850 are medical grade black and white printers, indicated for use with a wide range of electronic medical diagnostic equipment. The predicate printers were indicated for use with ultrasound and radiological imaging systems and surgical camera systems as well as any other systems that generate the specified video signal output.

Product codes (comma separated list FDA assigned to the subject device)

LMC

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Digital, Analog

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The safety and effectiveness of the proposed UP-D898MD and UP-X898MD Graphic Printers have been confirmed by hardware and software testing. The proposed printers comply with applicable requirements of the following standards:

IEC 60601-1:2005 + C1:2006 + C2:2007
AAMI/ANSI ES 60601-1: 2005 + C1:2009 + A2:2010
IEC 60601-1-2:2007

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K890826

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

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IUN 2 6 2014

K 141454
Page 1 of 6

510(K) SUMMARY FOR THE SONY ELECTRONICS, INC. Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Graphic Printers (per 21 CFR 807.92 and http://www.fda.gov/MedicalDeviceRegulationandGuidance/default.htm)

1. SUBMITTER/510(K) HOLDER

Sony Electronics Inc. Sony Medical Systems Division 1 Sony Drive Park Ridge, NJ 07656 Phone: 201-258-4182 Establishment Registration No: 2246606

Contact: Brian Zimmer Contact's Phone: 201-930-6746 Contact's Fax: 201-358-4977 Contact's Email: Brian.zimmer@am.sony.com

2. DEVICE NAME

UP-D898MD (Digital) / UP-X898MD (Hybrid) Graphic Proprietary Name: Printers Common/Usual Name: Medical Image Hardcopy Device Classification Name: Camera, Multi Format, Radiological Classification Panel: Radiology Device Class: Class II Classification Number: 21 CFR 892.2040 Product Code: LMC

3. PREDICATE DEVICE

The proposed Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Printers are substantially equivalent to the Sony Video Graphic Printer UP-850, cleared under K890826.

4. DEVICE DESCRIPTION

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

1

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.

5. INDICATIONS FOR USE / INTENDED USE

The Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Printers are compact, medical grade black and white printers. The UP-D898MD (Digital) only accepts digital signal inputs and the UP-X898MD (Hybrid) accepts both analog and digital signal inputs. Both printers 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.

Like the proposed device, the predicate Sony Video Graphic Printer UP-850 are medical grade black and white printers, indicated for use with a wide range of electronic medical diagnostic equipment. The predicate printers were indicated for use with ultrasound and radiological imaging systems and surgical camera systems as well as any other systems that generate the specified video signal output.

6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE

The proposed Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Printers represent a technological upgrade to the predicate Sony UP-850 Video Graphic Printer. Both the proposed and predicate devices are thermal printers that provide hard copy images captured by connected imaging systems. The proposed UP-D898MD and UP-X898MD Printers have increased resolution and provide a number of technological features that are an improvement from the predicate devices - including an LCD display panel with LED backlight for controlling settings easily, faster printing speed, and ability to accept digital video input.

7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

The safety and effectiveness of the proposed UP-D898MD and UP-X898MD Graphic Printers have been confirmed by hardware and software testing. The proposed printers comply with applicable requirements of the following standards:

2

· IEC 60601-1:2005 + C1:2006 + C2:2007
AAMI/ANSI ES 60601-1: 2005 + C1:2009 + A2:2010
IEC 60601-1-2:2007

8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

Not applicable.

9. SUMMARY OF OTHER INFORMATION

Not applicable.

10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS

The indications for use, principles of operation, and technological characteristics of the proposed Sony UP-X898MD (Digital) / UP-D898MD (Hybrid) Graphic Printers are substantially equivalent to the predicate Sony Video Graphic Printer UP-850 (subject of K890826). Differences between the proposed device and the Sony Video Graphic Printer UP-850 predicate device are limited to minor differences in technological characteristics. These differences do not impact the safety and effectiveness of the printers for the intended use.

The safety and performance of the Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Graphic Printer for its intended use is demonstrated by non-clinical testing. Based on the evidence provided, Sony Electronics believes that the proposed Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Graphic Printers are substantially equivalent to the predicate Sony Video Graphic Printer UP-850.

3

| | Sony Electronics Inc.
Sony UP-X898MD / UP-D898MD Graphic Printers | Sony Electronics Inc.
Sony Video Graphic Printer UP-850 |
|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Characteristics
Regulatory Status
Product Code
Indications for Use | Proposed | |
| | LMC | K890826
KQM |
| | 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 Video Printers UP Series is a general purpose device and is intended for use as an accessory for a wide range of electronic medical diagnostic equipment to provide hard copy images. This equipment includes ultrasound and radiological imaging systems and surgical camera systems as well as any other systems that generate the specified video signal output. |
| | Features | |
| Printing Method
High Resolution | Direct thermal printing
325 dpi | Direct thermal printing
325 dpi |
| Gradations | 256 levels | 128 levels |
| Picture Elements | 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 | NORM: 472 lines x 700 dots (EIA), 560 lines x 700 dots (CCIR)

WIDEI: 490 lines x 736 dots (EIA), 582 lines x 736 dots (CCIR)

WIDE2: 508 lines x 768 dots (EIA), 608 lines x 768 dots (CCIR) |
| Picture Area | UP-X898MD:
Digital: 320 x 100 mm (12 5/8 x 3 7/8 inch) (Max)
STD Video NTSC: 94 x 73 mm
Video PAL: 94 x 71 mm (WIDEI)
SIDE Video-NTSC: 124 x 96 mm, Video-PAL: 127 x 96 mm (WIDEI) | NORM: 70 x 91 mm (2 2/4 x 3 37/64 inch) (EIA and CCIR)

WIDE1: 73 x 96 mm (2 7/8 x 3 25/32) (EIA and CCIR)

de-by-Side Comparison of Sony UP-X898MD / UP-D898MD Graphic Printers with Sony Video Graphic Printer UP-8

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Sony Electronics Inc., Traditional 510(k)
Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Graphic Printer

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May 30, 2014 Sony Electronics Inc., Traditional 510(k)
Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) (Hybrid) Graphic Printer

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6

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Public Health Service

June 26, 2014

Sony Electronics, Inc. % Ms. Joanne Bronikowski Senior Regulatory Project Manager Aptiv Solutions, an ICON plc company 62 Forest Street, Suite 300 MARLBOROUGH MA 01752

Re: K141454

Trade/Device Name: Sony Digital Printer UP-D898MD/Sony Hybrid Printer UP-X898MD Regulation Number: 21 CFR 892.2040 Regulation Name: Medical image hardcopy device Regulatory Class: II Product Code: LMC Dated: May 30, 2014 Received: June 2, 2014

Dear Ms. Bronikowski:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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); medical device reporting (reporting of medical 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.

7

Page 2-Ms. Bronikowski

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

8

INDICATIONS FOR USE 4.

DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
Food and Drug Administration	Expiration Date: January 31, 2017
Indications for Use	See PRA Statement below.
510(k) Number (if known)

KH1454 Device Name

Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Grephic Printers

Indications for Use (Describe)

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-NYRMA (Hytrid) Granhic Printer can accept hath analog and digital signal inguts. Thath models are deaigned to be integrated into digital radiology imaging such as mobile c-arm. Ultrasound, cardiac cathelerization laboratory and other compatible medical imaging systems and produce hard copy prints of still images captured by the patient record or for referrais.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

[ ] Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

For FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

/

"DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden ume for this collection of information is estimated to average 79 hours per response. Including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information Send comments regarding this burden estimate or any other aspect of this information collection, Including suggestions for reducing this burden, to

Department of Health and Human Services Food and Drug Administration Other of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRASlatt@lda hhs gov

An agency may not conduct or sponsor, and a person is not required to respond to. a collection of information unless it displays a currently valid OMB number

FORM FDA 3881 (1/14)

Page 1 of 1

BILL OF SALE

May 30, 2014 Sony Electronics Inc., Traditional 510(k) Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Graphic Printers

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