JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100

• K Number: K963334
• Device Name: JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100
• Manufacturer: JAMIESON FILM CO.
• Date Cleared: 1996-09-11 ( 16 days)
• Product Code: IXX
• Regulation Number: 892.1900
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Not Found

Device Description

The Model 2100 is a leader card black-and-white 35 mm cine film processor, most commonly used for developing cineangiogram films. The Model 2100 has four (4) tanks, the developer, fixer, wash, and dryer tanks. The Model 2100 is 58.5 inches long, 17 inches wide, and 43 inches high.

AI/ML Overview

This document is a 510(k) Summary for a film processor (Jamieson Model 2100 Cine Processor and Kodak Cineflure Processor Model 2100). It describes the device, its intended use (developing cine angiogram films), and states that it has been altered to meet electrical and safety requirements and customer preferences.

However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies pertaining to AI or algorithmic performance.

The document is a safety and efficacy summary for a physical medical device (film processor), not a software or AI-driven diagnostic device. Therefore, the questions posed in the prompt (which are typically relevant for AI/ML-based medical devices) are not applicable to the information provided in this 510(k) summary.

In summary:

1. A table of acceptance criteria and the reported device performance: Not found.
2. Sample sized used for the test set and the data provenance: Not found.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not found.
4. Adjudication method for the test set: Not found.
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, no AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, no algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary

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K 96334

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Summary of Safety and Efficacy

510(k) Summary for the Jamieson Model 2100 Cine Processor and the Kodak Cineflure Processor Model 2100

This summary of 510(k) safety and efficacy information is being submitted in compliance with the requirements of SMDA 1990 and 21 CFR 807.92.

Submitter's Name

Jamieson Film Company 10425 Olympic Drive Dallas, TX 75220-4427 Contact: George Leon, Product Line Manager Phone: [phone] Fax: [phone]

Device Name and Classification

Trade name: Jamieson Model 2100 Cine Processor Kodak Cineflure Processor Model 2100 Common Name: Black-and-white 35 mm cine film processor Classification: Class II, Automatic Radiographic Film Processor, 21 CFR 892.1900

Predicate Device

The Model 2100 is substantially equivalent to the Jamieson JT/Kodak Ektacath, accepted on September 24, 1991, K# K913241/A.

Description of the Model 2100

The Model 2100 is a leader card black-and-white 35 mm cine film processor, most commonly used for developing cineangiogram films. The Model 2100 has four (4) tanks, the developer, fixer, wash, and dryer tanks. The Model 2100 is 58.5 inches long, 17 inches wide, and 43 inches high.

The Model 2100 has been altered to meet the electrical and safety requirements of the CE Medical Device Directive. Some minor modifications have been made to the transport assembly as well in response to customer preferences. None of the changes made adversely affect the safety or efficacy of the processor or can be considered new indications of use.

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.