(105 days)
The Tulip Disposable Cannula is intended for use in aesthetic body contouring.
The Tulip Disposable Cannulas are coated stainless steel cannulas designed for connection to syringes (Luer Lock® tip type or hub adaptor). The cannulas are designed to be used with a syringe aspirator or syringe re-injector. There is also an infiltrator configuration available, to administer a solution to surgery sites prelipoplasty. The cannulas are made of hydrophilic coated stainless steel, and are available in various diameters, lengths and tip configurations. The Tulip Disposable Cannulas are single-use disposables, supplied sterile (e beam).
This document is a 510(k) summary for the "Tulip Disposable Cannulas" by Cell Bio-Systems, Inc. It details the device's substantial equivalence to predicate devices, rather than a study demonstrating its performance against specific acceptance criteria for a new technology or algorithm. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not applicable.
However, I can extract the relevant information concerning the device's description and the rationale for its substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a substantial equivalence determination for a medical device (cannulas) and not an AI/algorithm-based device, there are no specific performance metrics like sensitivity, specificity, or F1 score with numerical acceptance criteria and reported performance in the context of an AI study. The "performance" is implicitly tied to safety and effectiveness, which are deemed substantially equivalent to predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance (Rationale for SE) |
|---|---|
| Similar Design and Materials | The Tulip Disposable Cannulas are coated stainless steel cannulas. Predicate devices (Byron Medical, Richter LTDA) also consist of cannulas fabricated out of stainless steel. |
| Similar Intended Use | The Tulip Disposable Cannula is intended for use in aesthetic body contouring. Predicate devices are also designed for lipoplasty/liposuction and aspiration/infiltration for aesthetic body contouring. |
| No New Technology or Change in Indications for Use | Cell Bio-Systems states that "No new technology or change in indications for use have been introduced by Cell Bio-Systems in the manufacture of the Disposable Cannulas." |
| Sterility | The Tulip Disposable Cannulas are supplied sterile (e-beam). |
| Coating (addressed for equivalence) | Tulip Cannulas are provided with a hydrophilic coating. Predicate devices offer similar coatings (e.g., Byron cannulas offer PTFE or hydrophilic Slik-Tip coating; Richter cannulas offer PTFE coating). This difference is presented as not impacting substantial equivalence. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. This is not a study testing an algorithm's performance on a dataset. It's a regulatory submission for substantial equivalence of a physical medical device.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the context of an algorithm's performance, is not relevant to this type of device submission.
4. Adjudication method for the test set:
- Not applicable.
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. MRMC studies are used for evaluating diagnostic systems with human interpretation, typically AI models. This is a physical surgical tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm.
7. The type of ground truth used:
- Not applicable.
8. The sample size for the training set:
- Not applicable. This device did not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of the document's relevance to the prompt:
This document is a 510(k) Premarket Notification for a medical device (Tulip Disposable Cannulas). The core of a 510(k) submission is to demonstrate that the new device is substantially equivalent to legally marketed predicate devices. This means that the new device has the same intended use as a predicate device, and the same technological characteristics as the predicate device; or has different technological characteristics from a predicate device but information is submitted that demonstrates that the device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness.
The document does not describe a study involving acceptance criteria for an AI or algorithmic device, nor does it provide performance metrics from such a study. Instead, it establishes "substantial equivalence" based on:
- Identical intended use (aesthetic body contouring).
- Similar technological characteristics (stainless steel cannulas, various diameters, lengths, and tip configurations).
- Similar materials (stainless steel, with a note on coatings being comparable if not identical).
- No new technology or changes in indications for use.
The "study" here is essentially the comparison and justification provided in the 510(k) summary, arguing that the Tulip Disposable Cannulas meet the requirements for safety and effectiveness because they are fundamentally similar to approved predicate devices.
§ 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.