(51 days)
The Planmed Sophie Nuance Classic is a mammography x-ray system, which is intended to be used to produce radiographs of the human breast. The device can be equipped with accessories to fulfil different diagnostic needs. Spot mammography is only used in combination with stereotactic needle biopsy guidance.
The Planmed Sophie Nuance Classic is a conventional mammography x-ray system utilizing films and cassettes. This product is a modification of the previous devices Planmed Sophie and Planmed Sophie Classic, where the changes made are concentrated on the lower shelf construction (with easier assembly and better serviceability), a new Flex AEC system, more modern overall design and enhanced user friendliness. The modification also serves as a base to an easy upgradeability to full field digital imaging use in the future.
This document is a 510(k) summary for a mammographic x-ray system, the Planmed Sophie Nuance Classic. It establishes substantial equivalence to previously marketed predicate devices rather than providing information about specific acceptance criteria and a study proving a device meets them.
Therefore, the requested information elements related to acceptance criteria, device performance, study details (sample sizes, data provenance, expert qualifications, adjudication, MRMC, standalone performance), and ground truth establishment are not available in the provided text.
The document primarily focuses on:
- Device Identification: Trade name, common name, classification, regulation number.
- Manufacturer Information: Name, address, contact persons.
- Intended Use: To produce radiographs of the human breast, with accessories for different diagnostic needs.
- Product Description: A conventional mammography x-ray system utilizing films and cassettes, described as a modification of previous Sophie models with improvements in shelf construction, AEC system, design, and user-friendliness, and future upgradeability to digital.
- Substantial Equivalence: A list of predicate devices (Planmed Sophie models) to which the new device is considered substantially equivalent in design, composition, and function, concluding it is "as safe and effective as the predicate devices."
- FDA Correspondence: Official letter from the FDA confirming the substantial equivalence determination and outlining regulatory requirements.
§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.