(11 days)
Indications for use: Aesthetic body contouring
Intended use: Harvesting, filtering and transferring of autologous fat tissue
The LipoCollector II complete set consists of an autoclavable polymeric tissue collection container with a stainless steel lid and pre-fillering basket, and a disposable set including mesh filters. O-rings and inner tubing. The LipoCollector II complete set also includes a stainless steel extraction cannula (single-use) for withdrawal of the collection container. From the extraction cannula, the fat can be directly transferred to a Luer-Locksyringe (not part of the LipoCollector !! complete set) for autologous fat transfer. The intended use of the LipoCollector II complete set is to filter and collect the aspirated fat tissue for subsequent transfer of the autologous fat into subcutaneous fat tissues during the same procedure.
The provided text describes the LipoCollector II complete set, a device for harvesting, filtering, and transferring autologous fat tissue. The submission focuses on demonstrating substantial equivalence to predicate devices and adherence to recognized standards rather than presenting a study to prove performance against specific acceptance criteria for a novel algorithm or diagnostic output.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not specify quantitative acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity for a diagnostic device, or a specific metric for fat viability/purity). Instead, it relies on demonstrating compliance with recognized standards and substantial equivalence to predicate devices. The "acceptance criteria" discussed are related to design specifications, product function, safety, instructions for use, packaging, and risk management, which are general quality system requirements rather than specific performance metrics.
| Acceptance Criteria (Type) | Reported Device Performance/Compliance |
|---|---|
| Product Function, Safety, Instructions for Use, Packaging | "Acceptance criteria for verification and validation testing of the device are based upon the approved product design specifications, including any additional design requirements imposed by Risk Management Process. Acceptance criteria for the LipoCollector II complete set include factors addressing product function, product safety, instructions for use, and packaging. All requirements of ISO 14971:2007 were met." (General statement of compliance) |
| Biocompatibility | - Cytotoxicity test (EN ISO 10993-5): No cytotoxic effects found. |
- Irritation and delayed-type hypersensitivity (EN ISO 10993-10): No negative effects observed in an epicutaneous test with 10 volunteers.
- Endotoxin detection (EN ISO 10993-11): No endotoxins detected (LAL-Test).
-> Device considered biocompatible for intended use. |
| Sterilization (ETO) | - Validated by physical and microbiological methods (ISO 11135-1:2007). - Sterilization safety level of 10^-6 guaranteed.
- ETO residuals comply with ISO 10993-7. |
| Sterile Packaging | - Validated in accordance with ISO 11607-1, 11607-2, DIN 58953, EN 868-5. - Packaging is impervious to microorganisms. |
| Reprocessing (Reusable Parts) | - Reprocessing of reusable parts successfully validated according to AAMI/ANSI ST81:2004. |
| Quality Management System | - Implemented in accordance with DIN EN ISO 13485 and Council Directive 93/42/EEC. |
| Design and Manufacturing Controls | - In accordance with DIN EN ISO 13485 (Section 7.3) and 21 CFR 820.30. - Complies with DIN EN ISO 10079-1:2009, CSA Z 168.11-94, ISO 2768-1:1989, ISO 2768-2:1989, ISO 7153-1:1991/Amd.1:1999, and ISO 9626:1991/Amd.1:2001. |
| Labeling | - Complies with ISO 15223-1, FDA 21 CFR 801.1, and Canadian MDR labeling guidance. |
| Risk Management | - All requirements of ISO 14971:2007 were met. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For the biocompatibility test (Irritation and delayed-type hypersensitivity - Epicutane test), 10 volunteers were used.
- For other tests (cytotoxicity, endotoxin, sterilization, packaging, reprocessing), the "sample size" refers to tested components/devices, but specific numbers are not provided beyond the general statement that tests were conducted according to standards. The document doesn't define a "test set" in the context of device performance in humans or on clinical data, as it's not an AI/diagnostic device.
- Data Provenance: Not explicitly stated for all tests. For the epicutaneous test, it's a prospective human study. For other tests, they are laboratory-based, not clinical data provenance. The company is based in Germany.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the device is not an AI/diagnostic system requiring expert readers for ground truth establishment on a performance evaluation test set. The "ground truth" for compliance testing is defined by the standards themselves (e.g., cytotoxicity present/absent, sterility achieved/not achieved).
4. Adjudication Method for the Test Set
This information is not applicable as there is no diagnostic output or interpretation by experts requiring adjudication for a test set.
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
No, an MRMC comparative effectiveness study was not done. This device is a surgical tool for fat processing, not an AI diagnostic assistant tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The LipoCollector II is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" used for this device's validation is primarily defined by:
- Standard Compliance: Adherence to defined parameters and methodologies outlined in recognized international and national standards (e.g., ISO, EN, AAMI/ANSI, CFR).
- Laboratory Test Results: Factual outcomes from specific biocompatibility (cytotoxicity, endotoxin, irritation), sterilization, and packaging tests.
- Design Specifications: The device's ability to meet its pre-defined design and functional requirements.
8. The Sample Size for the Training Set
This information is not applicable as the device is a physical medical device, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
§ 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.