(113 days)
The Hologic Visceral Fat Software used on Hologic Discovery bone densitometer total body scans estimates the visceral adipose tissue (visceral fat) content within the android region in an adult male or female population, excluding pregnant women. The content that is estimated is the Visceral Fat Area, Visceral Fat Mass, and Visceral Fat Volume. These values can be displayed in user-defined statistical formats and trends.
The estimated visceral fat content is useful to health care professionals in their management of diseases/conditions where the disease/condition itself, or its treatment can affect the relative amounts of visceral fat content in the android region. The Hologic Visceral Fat software does not diagnose disease, or recommend treatment regimens, or quantify treatment effectiveness. Only the health care professional can make these judgments. Some of the diseases, conditions for which visceral fat estimation is useful include hypertension, impaired fasting glucose, impaired glucose tolerance, diabetes mellitus, dyslipidemia, and metabolic syndrome.
The proposed Hologic® Visceral Fat Software provides an estimate of a patient's visceral fat in the abdominal region of a whole body scan. The results are included in the Adipose Indices section of the Hologic Discovery bone densitometer's body composition report.
The submitted text consists of a 510(k) Premarket Notification for the "Hologic Visceral Fat Software". Unfortunately, the provided document does not contain detailed performance testing data, acceptance criteria, or a study design to prove the device meets specific acceptance criteria.
The document states:
- "Testing was successfully conducted and demonstrates that the Hologic Visceral Fat Software meets all of its functional requirements and performance specifications." (Page 2, Section 5)
- It claims substantial equivalence to predicate devices (GE Lunar Visceral Fat Software Option K103730 and Hologic NHANES Whole Body DXA Reference Database K103265) in terms of intended use, features, functions, performance, safety, and effectiveness. (Page 2, Section 5 and Section 6)
The 510(k) submission process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo clinical performance studies with specific statistical acceptance criteria for novel claims. This particular submission relies on comparative claims to existing devices.
Therefore, I cannot provide the requested information from the given text. The provided text is a summary of the 510(k) itself and the FDA's clearance letter, not the detailed study reports for performance testing.
§ 892.1170 Bone densitometer.
(a)
Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.