The LifeJet™ Printer 400 is an ink jet printer designed to provide referral high quality color and/or gray scale hard copies of medical images generated by medical equipment. The LifeJet™ Printer 400 has been developed to be used together with LifeJet™ Medical Paper and LifeJet™ Medical Ink Jet Cartridges to achieve the best quality medical images.

Device Description

The LifeJet™ Printer 400 is an inkjet printer designed to produce high quality color and gray-scale referral medical images. Together with specifically designed medical paper and inks (LifeJet™ Medical Paper and LifeJet™ Medical Ink Jet Cartridges) the LifeJet™ Printer 400 forms the LifeJet™ 400 System, which is an innovative, convenient and work-flow improving medical printing platform, based on the state of the art inkjet technology, capable of delivering superior and reliable printed images for any medical documentation requirement.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Ferrania LifeJet™ Printer 400. This document focuses on demonstrating substantial equivalence to a predicate device (Kodak Digital Science 1200 Distributed Medical Imager) rather than establishing novel safety and effectiveness through the demonstration of specific acceptance criteria from a clinical study.

Therefore, many of the requested categories for a study proving device acceptance criteria are not applicable in this context. The available information relates to performance testing for comparison, not an efficacy or diagnostic accuracy study against predefined clinical acceptance criteria.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This product is an inkjet printer. The "acceptance criteria" here are largely implicit in demonstrating substantial equivalence to a predicate device, focusing on technical specifications and basic performance (printing time, optical density, image artifacts). There are no specified clinical acceptance criteria in terms of diagnostic accuracy or clinical outcomes.

Feature/Specification	Acceptance Criteria (Implicit for Equivalence)	Reported Device Performance (LifeJet™ Printer 400)
Printing Technology	Ink-jet	Ink-jet
Operating System	Windows NT 4.0 (for predicate, but broader stated for LifeJet)	Windows NT 4.0
Printing Resolution	1200x1200 dpi	1200x1200 dpi
Tones	Color and gray scale	Color and gray scale
Number of Colors	256 x CMYK	256 x CMYK
Standards	UL, CSA, FCC, CE Mark, IEC 60601-1, Energy Star (Similar to predicate)	UL, CSA, FCC, CE Mark, IEC 60601-1, Energy Star
Interfaces	Parallel: IEEE 1284	Parallel: IEEE 1284
Cartridges	Specific DMI Ink cartridges (Predicate)	Black LifeJet™ Medical Ink Jet Cartridge, Color LifeJet™ Medical Ink Jet Cartridges
Printing Media	Coated paper (and film for predicate)	Coated paper
Sheet sizes	A4, A5, A6, US letter, 4"x6", etc. (Similar or greater range to predicate)	A4, A5, A6, US letter, 4"x6", personalized
Supply Tray Capacity	45 sheets (Predicate)	50 sheets
RAM	Not available (Predicate)	2 MB
Time to print one 203x203 mm SMPTE image	Substantially equivalent to predicate device	Testing confirmed substantial equivalence
Printed maximum optical density	Substantially equivalent to predicate device	Testing confirmed substantial equivalence
Image mottling and bleeding @ 100% density	Substantially equivalent to predicate device	Testing confirmed substantial equivalence
Overall Performance	Safe, effective, and performs as well as or better than the predicate device (based on comparison of features and performance test results).	The LifeJet™ Printer 400 is considered safe, effective, and performs as well as or better than the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test set: Not applicable for a clinical test set. The performance testing was based on printing a "203x203 mm image of a SMPTE pattern (512x512 pixel)". This implies a very limited "sample size" of images (likely a single standard test pattern) for objective measurements.
Data provenance: Not specified, but given the company's location (Ferrania S.p.A., Italy), it is likely the testing was conducted in Italy. It's a lab-based performance test, not a clinical data set.
Retrospective/Prospective: Not applicable, as this was a controlled laboratory performance test, not a study involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The "ground truth" for the performance tests (printing time, optical density, mottling, bleeding) would be derived from objective measurements using calibrated instruments, not expert human assessment of diagnostic images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The performance testing involved objective measurements of technical printing characteristics, not subjective interpretation requiring adjudication among experts.

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 medical inkjet printer, not an AI-powered diagnostic tool. There was no MRMC study, nor any assessment of human reader improvement with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a printer, not an algorithm. Its "performance" is inherent to its printing capabilities, not an algorithmic output that could be evaluated in a standalone manner.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" was based on objective physical measurements for quantitative metrics like printing time, optical density, and visual assessment of physical defects (mottling, bleeding) against a known standard (the SMPTE pattern).

8. The sample size for the training set

Not applicable. This device is an inkjet printer. It does not use a "training set" in the context of machine learning. The design and engineering process might involve iterative testing, but not a dataset used for algorithmic training.

9. How the ground truth for the training set was established

Not applicable (as there is no training set for this type of device).

Summary

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JUN - 8 2001 Section 10 - 510(k) Summary of Safey and Effectiveness as required by 21 CFR 807.92(c) Submitted by Ferrania S.p.A. 10.1 Viale della Libertà 57 17014 Ferrania Savona (Italy) Ing. Mannella Paolo 10.2 Contact person Regulatory Manager +39 0195224055 (phone) +39 0195224546 (fax). E-mail: pmannella@ferraniait.com March 30, 2001 10.3 Date Summary Prepared: Common Name: Medical Ink-jet printer 10.4 Device name: Trade name: LifeJet™ Printer 400 Classification Name: Medical image hardcopy device (per 21 CFR 892.2040) KODAK DIGITAL SCIENCE 1200 Distributed 10.5 Predicate device: Medical Imager (510(k) number: K983905) Eastman Kodak Company Health Imaging Division 343 State Street Rochester, NY 14650

10.6 Description of device

10.7 Statement of intended use

The LifeJet™ Printer 400 is an ink jet printer designed to provide referral high quality color and/or gray scale hard copies of medical images generated by medical equipment.

10.8 Comparison with predicate device

The purpose and functionality of the Ferrania LifeJet™ 400 Printer are substantially equivalent to the KODAK DIGITAL SCIENCE 1200 Distributed

KOII617

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510(k) PREMARKET NOTIFICATION FOR FERRANIA S.p.A. LifeJet™ Printer 400

Section 10 - 510(k) Summary of Safey and Effectiveness as required by 21 CFR 807.92(c)

The basis for the equivalence is that both of them are computer peripheral printing devices which print monochrome or color images on paper, using inkjet technology.

The only difference is that the LifeJet™ Printer 400 driver allows the user to format the print layout by printing one to eight images per page, in strips of two, either in portrait or landscape mode, as soon as they are available and while the diagnostic examination goes on.

The technological equivalence of the two printers and the equivalence in terms of their features is summarized in the table below.

Feature/Specification	LifeJet™ Printer 400	Kodak Digital Science 1200Distributed Medical Imager
Printing Technology	Ink-jet	Ink-jet
Operating System	Windows NT 4.0	Windows 95/98, NT 4.0
Printing Resolution	1200x1200 dpi	1200x1200 dpi
Tones	Color and gray scale	Color and gray scale
Number of Colors	256 x CMYK	256 x CMYK
Standards	UL, CSA, FCC, CE Mark, IEC 60601-1, Energy Star	UL, CSA, FCC, EN50082, CISPR 22,VCCI, CE Mark, C-Tick, Energy Star
Interfaces	Parallel: IEEE 1284	Parallel: IEEE 1284
Cartridges	Black LifeJet™ Medical Ink JetCartridge,Color LifeJet™ Medical Ink JetCartridges	DMI Ink cartridge 1DMI Ink Cartridge 2, orDMI Black Cartridge
Printing Media	Coated paper	Coated paperCoated film (blue)
Sheet sizes	A4, A5, A6, US letter, 4"x6",personalized	A4, A5, A6, B5, Executive, Legal, USletter, 4"x6", 8"x10"
Supply TrayCapacity	50 sheets	45 sheets
RAM	2 MB	Not available

Table of comparison of features of Predicate Device

10.9 Performance testing

The tests carried out to measure the printing time and image quality for the LifeJet™ Printer 400 in comparison with the predicate device confirmed their substantial equivalence also in terms of performances.

Objective test procedures were established to measure:

the time to print one 203x203 mm image of a SMPTE pattern (512x512 pixel), .
. the printed maximum optical density,

30-03-2001

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510(k) PREMARKET NOTIFICATION FOR FERRANIA S.p.A. LifeJet™ Printer 400

Section 10 - 510(k) Summary of Safey and Effectiveness as required by 21 CFR 807.92(c)

the image mottling and bleeding @ 100% density. ●

Conclusion 10.6

Based on the analysis of the comparisons made between the LifeJet™ Printer 400 Dason on the untaryse or are on the results of performance test results, Ferrania and the producted that the LifeJet™ Printer 400 is safe, effective and performs as well as or better than the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three flowing lines above it, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 8 2001

Ferrania S.P.A. % Ms. Chantel Carson Underwriters Laboratories Inc. 333 Pfingsten Road NORTHBROOK IL 60062

Re: K011617 LifeJet™ Printer 400 Dated: May 15, 2001 Received: May 25, 2001 Regulatory Class: II 21 CFR 892.2040/Procode: 90 LMC

Dear Ms. Carson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 the Electronic Product 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. 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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Nancy Crogdon

Nancy C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure (s)

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Statement of Indications for Use

510(k) Number (if known)

Device Name: LifeJet™ Printer 400

Indications for Use:

The LifeJet™ Printer 400 is an ink jet printer designed to provide referral high quality color and/or gray scale hard copies of medical images generated by medical equipment.

The LifeJet™ Printer 400 has been developed to be used together with LifeJet™ Medical Paper and LifeJet™ Medical Ink Jet Cartridges to achieve the best quality medical images.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use √

Over the Counter Use

David A. Stegman

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.