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The aspiration and infusion cannulae and needles are indicated for aesthetic body contouring and general tissue aspiration.

Black and Black Surgical Cannulae and Needles are used to remove fluid, soft tissue, and exudates and infusion, utilizing a hollow stainless steel tube and multiple tips, handle and attachment connectors that are in reusable and disposable configuration. They are used during general, plastic, and reconstructive procedures.

This FDA 510(k) letter is for an administrative change to a previously cleared device, "Liposuction Aspiration and Tumescent Infiltration Cannulae and Needles," and primarily focuses on regulatory classification updates rather than a new device submission with performance studies.

Therefore, the document does not contain information regarding:

• Acceptance criteria and a study proving device performance
• Sample sizes used for test sets or data provenance
• Number of experts or their qualifications for ground truth establishment
• Adjudication method for the test set
• Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size
• Standalone (algorithm only) performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

The document explicitly states: "Please note that the 510(k) submission was not re-reviewed." The initial 510(k) clearance (K113795) was based on substantial equivalence to a predicate device (Byron Medical, Inc., Suction Cannulae and Needles, K981172). Substantial equivalence typically involves demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through technological comparison and established safety profiles, rather than extensive new clinical performance studies or AI algorithm validation as would be described by the questions.

Device Information Provided in the Document:

• Device Name: Liposuction Aspiration and Tumescent Infiltration Cannulae and Needles
• Regulation Number: 21 CFR 878.5040
• Regulation Name: Suction lipoplasty system
• Regulatory Class: Class II
• Product Codes: QPB (updated), MUU, GEA (original)
• Indications for Use: The aspiration and infusion cannulae and needles are indicated for aesthetic body contouring and general tissue aspiration.
• Predicate Device: Byron Medical, Inc., Suction Cannulae and Needles (510(k) Number: K981172, Substantially Equivalence Date: June 30, 1998)
• Device Description: "Black and Black Surgical Cannulae and Needles are used to remove soft tissue, and exudates and infusion, utilizing a hollow stainless steel tube and multiple tips, handle and attachment connectors that are in reusable and disposable configuration. They are used during general, plastic, and reconstructive procedures." Manufactured of stainless steel tubes with Aluminum Handles. Patient contacting material is stainless steel.

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