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K Number
K042293
Device Name
BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER
Manufacturer
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
Date Cleared
2004-09-08

(15 days)

Product Code
JAK
Regulation Number
892.1750
Type
Traditional
Panel
RA
Reference & Predicate Devices
K033326,K012009
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Philips Brilliance CT in the Private Practice CV configuration is a Computed Tomography X-Ray System intended to produce images of the heart, cardiovascular (including Pals, aorta, iliac, and other distal vessels imaged by CT angiography and peripheral vascular systems (including the carotics and pulmonary veins) by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

Device Description

The "Brilliance CT, Private Practice CV configuration" is a Computed Tomography X-Ray System featuring a continuously rotating X-ray tube and detectors, gantry, and multi-slice capability of up to 16 slices simultaneously. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the heart, cardiovascular, and peripheral vascular systems taken at different angles and planes. This device also includes signal analysis and display equipment, patient and equipment supports, components and accessories.

AI/ML Overview

This 510(k) summary for the "Brilliance CT, Private Practice CV configuration" CT Scanner does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

The document is a premarket notification for a new CT scanner, establishing its substantial equivalence to previously cleared devices. It focuses on:

  • Device Name and Classification: Identifies the device and its regulatory classification.
  • Device Description: Provides a general overview of the CT scanner's capabilities.
  • Intended Use: Specifies the medical imaging applications for which the device is designed (cardiovascular and peripheral vascular systems).
  • Comparison to Predicate Devices: Explicitly states that the new device has "the same technological characteristics such as design, material, and energy source" as its predicates and is "of comparable type and substantially equivalent."
  • Safety and Effectiveness Considerations: Addresses safety through adherence to GMP practices, international standards (IEC 60601-1, IEC 60625), and radiation safety regulations (21 CFR, Subchapter J). Software safety is mentioned as conforming to accepted practices and demonstrating that "option specifications and functional requirements were met."
  • Substantial Equivalency Statement: Reaffirms the substantial equivalence to predicate devices (Brilliance CT 40 Slice configuration, K033326 and Mx8000 IDT, K012009).

Here's a breakdown of why the requested information is absent:

  1. Acceptance Criteria and Reported Device Performance: These are not provided. The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting specific performance metrics against pre-defined acceptance criteria. The claim that "option specifications and functional requirements were met" is a general statement and not a detailed table of acceptance criteria and results.

  2. Sample Size, Test Set Data Provenance: Not applicable/not provided. No specific test set for performance evaluation is described, as the submission relies on substantial equivalence.

  3. Number of Experts, Qualifications for Ground Truth: Not applicable/not provided. Ground truth establishment is not discussed as no new performance study is detailed for this 510(k).

  4. Adjudication Method: Not applicable/not provided.

  5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: No MRMC study is mentioned.

  6. Standalone Performance Study: No standalone performance study (algorithm only) is described, as the device is a CT scanner, not an AI algorithm.

  7. Type of Ground Truth Used: Not applicable/not provided.

  8. Training Set Sample Size: Not applicable/not provided.

  9. How Ground Truth for Training Set was Established: Not applicable/not provided.

In summary, this 510(k) notification is a declaration of substantial equivalence based on technological similarity and adherence to safety standards, not a detailed report of a performance study with specific acceptance criteria and results for the device itself. The regulatory pathway for this device (a 510(k)) often relies on demonstrating equivalence to existing, legally marketed devices, rather than requiring extensive new clinical performance trials unless there are significant technological differences or new intended uses.

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.