FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Lipokit with disposable 50cc AFT Syringe is composed of one centrifuge unit with a motor for suction and positive pressure; a 50cc AFT (autologous fat transfer) syringe with weight-mesh piston, a cannula and other ancillary parts. The vacuum and positive pressures are controlled using a foot pedal control switch.

The Lipokit is a sterile, single-use, manual device consisting of a cannula, and a tissue collection container (the 50cc AFT Syringe) that relies on the centrifying unit for its energy supply. The cannula is attached directly to the 50cc AFT Syringe which simplifies and reduces the steps needed in the collection, filtering and transfer of the autologous fat. In so doing, the harvested fat is less traumatized and risk of contamination is lowered because the fat never leaves the harvesting syringe until re-injection. The cannula is a hollow tube with an opening near the tip to communicate the centrifuge unit to the tissues and subsequently aspirate, harvest and filter subcutaneous fatty tissues from the patient into the collection container (the 50cc AFT Syringe).

The stainless steel cannula that contacts the patient is provided in various sizes ranging from 2.5 - 4.0 mm in diameter. The tip region of the cannula may have a single or multiple openings that range in size from 170mm to 260mm in length distributed uniformly or randomly throughout the end of the cannula.

The 50cc AFT Syringe is a polymeric 50cc volume luer-lock style, single-use syringe consisting of a polypropylene barrel with printed graduations and a weight-mesh piston composed of polycarbonate.

AI/ML Overview

The provided document is a 510(k) summary for the Medi-Khan USA, Inc. Lipokit with disposable 50cc AFT Syringe. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

Crucially, this document does not contain a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would for a novel device. Instead, it relies on demonstrating "substantial equivalence" to existing, legally marketed devices.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the traditional sense, nor can I provide information on sample sizes, ground truth establishment, expert adjudication, or MRMC studies, as these types of studies were not conducted or reported in this submission for the purpose of establishing efficacy or performance against defined criteria.

The submission focuses on comparing the Lipokit's design and indications for use to three predicate devices:

Shippert Medical Tissu-Trans (K050797)
Cytori AFT System (K072587)
MaceneRoncel Lipoplasty System (K042261) (though later listed as Macropore Puricel Lipoplasty System (K042261))

The primary "acceptance criteria" here are implied to be that the device functions similarly to the predicate devices and meets general safety standards.

Here's a breakdown of what can be extracted from the document regarding the device's characteristics and the basis for its clearance, framed in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, this document does not present acceptance criteria and performance data from a dedicated study for the Lipokit. Instead, its "performance" is demonstrated through substantial equivalence to predicate devices. The implied "acceptance criteria" revolve around the device's ability to perform the same functions as the predicates without raising new questions of safety or effectiveness.

Aspect of Equivalence / "Acceptance Criteria" (Implied from 510(k) Process)	Reported Device Performance / Basis for Equivalence
Intended Use (ability to perform specific surgical procedures)	The Lipokit has the same indications for use as the predicate devices: tumescent injection, aspiration, harvesting, filtering, and transferring autologous fat tissue in plastic, reconstructive, general, dermatological, obstetrician & gynecological, and cosmetic surgery.
Technology/Design Principles (how the device achieves its intended use)	The Lipokit shares design principles with predicates: single-use, polymer-constructed, manually operated systems using manual or external vacuum sources to withdraw, hold, and/or inject fluids/tissues. Specifically, it's substantially equivalent to Tissu-Trans™ (K050797) in using a polypropylene piston syringe to collect and re-inject autologous fat.
Material Composition (safety of patient-contacting materials)	Components with direct patient contact are fabricated from surgical stainless steel, a commonly accepted material in medical devices. The 50cc AFT Syringe is polymeric (polypropylene barrel, polycarbonate piston).
Sterility (prevention of contamination)	The 50cc AFT Syringe is sterilized by ethylene oxide (EtO) gas, a common and accepted sterilization method for medical devices.
Mechanical Integrity/Functionality (device robustness under use)	"Mechanical testing of Lipokit demonstrates that the device is substantially equivalent to the predicate devices." (No specific test results or criteria are provided, but this statement implies internal verification of functional design.)
Reduced Traumatization/Contamination Risk (process efficiency/safety)	The design (cannula attached directly to the 50cc AFT Syringe) "simplifies and reduces the steps needed in the collection, filtering and transfer of the autologous fat." This is stated to result in "less traumatized" fat and lower contamination risk because "the fat never leaves the harvesting syringe until re-injection," similar to Tissu-Trans™.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. This submission relies on a comparison to predicate devices, not on a test set from a performance study of the Lipokit itself to establish efficacy. The "mechanical testing" mentioned is general and details (like sample size) are not provided.
Data Provenance: Not applicable in the context of a clinical test set. The data presented is descriptive of the device and comparative analysis against legally marketed devices regulated by the FDA (presumably in the USA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. There was no "test set" and thus no ground truth established by experts in the context of a performance study for the Lipokit's efficacy. The FDA's review process, however, involves internal experts assessing the submission for substantial equivalence.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication was conducted or described.

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. This device is a mechanical system for fat transfer, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a mechanical system, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the context of a clinical performance study. The "ground truth" for the submission is the regulatory precedent set by the predicate devices and the demonstration that the Lipokit is sufficiently similar in function, safety, and intended use.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical system and does not involve AI or algorithms that require a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This device is a mechanical system and does not involve AI or algorithms that require a training set.

In summary, the provided document is a regulatory submission for 510(k) clearance based on substantial equivalence, not a detailed report of a clinical efficacy study with performance metrics against predefined acceptance criteria. The "study" for this device was a comparative analysis against predicate devices, focusing on design, materials, intended use, and general safety considerations (like sterility and mechanical integrity).

Summary

Regulation Number and Section

§ 878.5040 Suction lipoplasty system.

(a)
Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.