The Automatic Radiographic Film Processor is intended to be used to process films exposed for medical purposes. The automatic and continuous process contains developing, fixing, washing and drying of films. This may be used in all general radiographic, diagnostic imaging procedures.

Device Description

Due to the precise roller transport system, both sheet and roller films can be processed. The Automatic film registration is activated immediately when a film is fed in. The transport system starts running. The film material is developed , fixed, rinsed and dried. With the easy to operate micro-processor, the processing conditions can be adjusted to suit the various film and chemical types. The developing solutions are temperature-regulated, circulated and automatically replenished. The feed with of the LifeRay PRO 1000 is 35cm, the smallest film format of the processor is 10x10cm.

AI/ML Overview

This 510(k) submission (K023801) is for a medical device called the "LIFERAY PRO 1000 Automatic Radiographic Film Processor." It is important to note that this document does not contain information about a study proving the device meets acceptance criteria.

The purpose of this 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove specific performance metrics through a clinical study with acceptance criteria.

Here's why;

Device Type: This is an automatic radiographic film processor. Its function is to develop, fix, wash, and dry X-ray films. It is a piece of equipment that processes analog data (film), not a device that generates or analyzes diagnostic information itself (like an AI model for image interpretation).
510(k) Process: The 510(k) pathway for medical devices focuses on demonstrating that a new device is substantially equivalent to a legally marketed predicate device. This often involves comparing technological characteristics, intended use, and safety/effectiveness profiles, rather than conducting new clinical trials with acceptance criteria for device performance.
Content of the Document: The document explicitly states: "The comparison of similarities and differences shows that the new device LifeRay PRO 1000 Automatic Radiographic Film Processor... Have the same intended use. Have the same target user group. Have the same technological characteristics. There are no new questions about safety and effectiveness. The new device is a safe and effective as the predicate device." This statement is the core of its argument for substantial equivalence.

Therefore, most of the specific information requested in your prompt (e.g., acceptance criteria, test set sample size, expert ground truth, MRMC study, standalone performance, training set) would not be relevant or present in this type of 510(k) submission for this particular device. These types of studies are typically associated with devices that perform diagnostic interpretations, especially those incorporating AI or novel diagnostic algorithms.

Based on the provided document, here's what can be extracted related to your request, with the understanding that direct "acceptance criteria" and "study results" as you've framed them are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Not explicitly stated as such, but inferred from Substantial Equivalence Claim)	Reported Device Performance (Inferred from Substantial Equivalence Claim)
Intended Use: Process films exposed for medical purposes; automatic and continuous development, fixing, washing, drying.	Meets: Same intended use as predicate device.
Technological Characteristics: Mechanically transports film, immersion in chemical baths (developer, fixer), water rinse, drying, ejection. Temperature-regulated/circulated/replenished solutions, anti-crystallization, stand-by mode. Integrated software control.	Meets: Same technological characteristics as predicate device.
Safety and Effectiveness: No new questions regarding safety and effectiveness compared to predicate.	Meets: As safe and effective as predicate device.

2. Sample size used for the test set and the data provenance:

Not applicable. This submission focuses on substantial equivalence based on technological comparison, not a performance study using a test set of data.

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

Not applicable. No test set or ground truth establishment by experts is described in this submission.

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

Not applicable. No test set described.

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:

No. An MRMC study was not done. This device is a film processor, not an AI-assisted diagnostic tool for human readers.

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

No. This device is a film processor, not a standalone diagnostic algorithm. Its performance is related to consistent and correct film processing.

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

Not applicable. Ground truth, in the context of diagnostic performance, is not relevant for this device's type of submission.

8. The sample size for the training set:

Not applicable. This device does not use a training set in the context of machine learning.

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

Not applicable. Same as above.

In summary: This 510(k) is a declaration of substantial equivalence for an automatic film processor. The "study" here is essentially the internal analysis by the manufacturer demonstrating that their new device is technologically equivalent to an already approved predicate device, and thus, does not raise new questions of safety or effectiveness. The detailed performance metrics, test sets, and ground truth methodologies typically associated with diagnostic AI or similar advanced diagnostic devices are not part of this submission.

Summary

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KO23801

510(k) Safety and Effectiveness Summary.

The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR 807.92(a)

Submitter Information

FEB 1 2 2003

FERRANIA USA INC., Official Corrispondent Ferrania Imaging Technologies 2700-EAST FRONTAGE ROAD WEATHERFORD, OK 73096 Phone: (580) 774-3623 Fax: (580) 774-3658 Contact Person: Mr Doug Hale

S.a.i.e.p. S.r.l., Manufacturer Via Stalingrado 4/32 17014 Cairo Montenotte - GENOVA - ITALY Phone: 0039 019 506108 Fax: 0039 019 5091323 Contact Person: Mario Daniel

Date: 2002-10-29

Trade Name:

LIFERAY PRO 1000

Common Name: Automatic Radiographic Film Processor

Classification Name: Automatic Radiographic Film Processor

Regulation Number: 892.1900

Product Code: IXW

Predicate Device

Additional Substantial Equivalence Information is provided in the following Substantial Equivalence Comparison Table

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· Device Description:

Due to the precise roller transport system, both sheet and roller films can be processed. The Automatic film registration is activated immediately when a film is fed in. The transport system starts running. The film material is developed , fixed, rinsed and dried. With the easy to operate micro-processor, the processing conditions can be adjusted to suit the various film and chemical types. The developing solutions are temperatureregulated, circulated and automatically replenished. The feed with of the LifeRay PRO 1000 is 35cm, the smallest film format of the processor is 10x10cm.

• Intended Use:

The Automatic X-Ray Film Processor is intended to be used to process films exposed for medical purposes. The automatic and continuous process contains developing, fixing, washing and dryng of films.

Summary of Substantial Equivalence Comparison: .

The comparison of similarities and differences shows that the new device LifeRay PRO 1000 Automatic Radiographic Film Processor, which is intended to market and the predicate device:

1. Have the same intended use.
1. Have the same target user group.
1. Have the same technological characteristics.

There are no new questions about safety and effectiveness. The new device is a safe and effective as the predicate device.

The Automatic Radiographic Film Processor is substantially equivalent to the Protec Optimax Automatic X-Ray Film Processor.

· Technological Characteristics:

The photographic processing (developing) technique employed by the Automatic Radiographic Film Processor is the same as the predicate device. The film medium is mechanically transported for immersion in two chemical baths (developer and fixer), is rinsed in water, dried, and then ejected for viewing. The processors use mechanical rollers and guides for transportation, the solutions are temperature-regulated, circulated and automatically replenished, and same additional functions (anti-crystallization cycle, stand-by mode). Both are controlled by an integrated software.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in all capital letters.

FEB 1 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

S.A.I.E.P. S.r.1. % Mr. Mario Daniel Ferrania USA, Inc. Ferrania Imaging Technologies 2700 East Frontage Road WEATHERFORD OK 73096-6104 Re: K023801 Trade/Device Name: Film Processor, Life Ray Pro 1000 Regulation Number: 21 CFR 892.1900 Regulation Name: Automatic radiographic film processor Regulatory Class: II Product Code: 90 IXW Dated: October 29, 2002 Received: November 14, 2002

Dear Mr. Daniel:

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 (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); 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 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.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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Indication for use.

Applicant:

510(k) Number (if known):

Device Name: Automatic Radiographic Film Processor LifeRay PRO 1000.

Indication For Use: The Automatic Radiographic Film Processor is intended to be used to process films exposed for medical purposes. The automatic and continuous process contains developing, fixing, washing and drying of films. This may be used in all general radiographic, diagnostic imaging procedures. Typical users of this system are trained medical professionals, including but not limited to physicians, nurses, and lab technicians.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).

Concurrence of CDRH, Office of Device Evaluation (ODE).

1 Prescription Use (Per 21 CFR 801.109)

Daniel A. Legum

(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number

Regulation Number and Section

§ 892.1900 Automatic radiographic film processor.

(a)
Identification. An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.(b)
Classification. Class II (special controls). 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.