(245 days)
REVOLVE™ ENVI 600 System is used for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator as a source of suction. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.
REVOLVE™ ENVI 600 System is intended for use in the following surgical specialties when the aspiration of soft tissue is desired: plastic and reconstructive surgery, gastrontestinal and affiliated organ surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery.
Revolve Envi 600 System consists of a sterile, single use canister and accessories intended to be used for harvesting, filtering and transferring of autologous adipose tissue. Such products have been classified by FDA as Class II devices under 21 CFR §878.5040, Suction Lipoplasty System, and assigned product code MUU. The subject device is intended to be used with a legally marketed vacuum or aspirator apparatus as a source of suction. The adipose tissue is collected from the patient using liposuction tubing and cannula that are supplied by the user or the institution. This tissue is harvested inside the canister which contains a 600ml inner basket with 200um mesh filter. A manual stirring assembly allows the user to mix the tissue and fluids during the washing step. The processed adipose tissue is removed from the device via an extraction port located on the bottom of the device using a syringe.
For user convenience, the device is supplied with the following accessories designed for use with the Revolve Envi 600 System:
- . Luer extraction tip
- . Toomey and catheter syringe extraction tip
- . Toomey/Catheter tip syringe to Luer syringe adapter
- . Temperature strip
- . Lactated Ringer's tubing set
- . Suction tubing set.
The device is offered in a single size, is packaged in a thermoformed tray and lid with Tyvek® lidding, and is sterilized via gamma irradiation. The device is a single use device to be used in a healthcare facility.
Here's an analysis of the provided text regarding acceptance criteria and the study conducted for the Revolve Envi 600 Advanced Adipose System:
This document is a 510(k) summary for a medical device (Revolve Envi 600 Advanced Adipose System). As such, it reports on studies performed to demonstrate substantial equivalence to a predicate device, rather than a clinical trial demonstrating efficacy of a novel device. Therefore, many of the typical elements of an AI-specific study focusing on metrics like sensitivity, specificity, and reader performance are not applicable or not reported in this type of submission. The 'acceptance criteria' in this context refer to engineering and performance benchmarks for the device itself, rather than diagnostic performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Testing / Evaluation) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet standards for Externally Communicating Device, Tissue, Limited Contact (≤24 hours) per ISO 10993-1. | Passed cytotoxicity, sensitization, irritation, acute systemic toxicity, and material mediated pyrogenicity testing. |
| Sterilization: Achieve a Sterility Assurance Level (SAL) of 10⁻⁵. | Sterilization assured using a validated method (gamma irradiation) in accordance with ISO 11137-2:2013 to provide a SAL of 10⁻⁵. |
| Adipose tissue viability (via Lactate Dehydrogenase assessment) | Performed to support substantial equivalence. (No specific numerical viability metric provided, but implied to be comparable to predicate). |
| Simulated use testing for device characteristics: | Performed to support substantial equivalence. (Implied that the device functioned as intended and met design requirements.) |
| - Device stability | |
| - Leakage during extraction and processing | |
| - Time from completion of harvest to having processed adipose material ready for injection | |
| - Ability to remain functional when subjected to vacuum (29.9 inHg) | |
| - Tubing Connection Tensile Strength |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not explicitly stated in numerical terms for the bench testing. The document mentions "performance tests conducted on both the subject and predicate devices," implying a comparison. For biocompatibility, it refers to testing samples of the device materials.
- Data Provenance: Not applicable in the context of clinical data for a diagnostic device. The data are from laboratory bench testing of the physical medical device and its components, in-house or by contracted labs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This device is a mechanical system for processing adipose tissue, not an AI or diagnostic device requiring expert interpretation for "ground truth" establishment in a diagnostic context. The "ground truth" here is the physical performance of the device and biological response to its materials.
4. Adjudication Method for the Test Set
- Not Applicable. As there are no human interpretations or diagnostic outcomes to adjudicate, this concept does not apply to the provided study summary.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- No, an MRMC study was not done. This is a review of a device for processing adipose tissue, not an AI-assisted diagnostic tool. Therefore, such a study is not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This device does not involve an algorithm or AI. It is a physical medical device.
7. The Type of Ground Truth Used
- For Biocompatibility: Laboratory testing results based on standard biological assays (cytotoxicity, sensitization, irritation, acute systemic toxicity, material mediated pyrogenicity). The "ground truth" is the biological standard for acceptable responses.
- For Sterilization: Laboratory validation demonstrating that the gamma irradiation process achieves the specified SAL. The "ground truth" is the established SAL of 10⁻⁵.
- For Bench Testing (Adipose tissue viability, simulated use testing): Laboratory measurements and observations of the device's physical performance, material integrity, and biological viability markers according to established test protocols. The "ground truth" is the direct measurement and observation of device function against predetermined design specifications or in comparison to the predicate device.
8. The Sample Size for the Training Set
- Not Applicable. This device does not involve an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. No training set is involved for this type of device.
Summary of the Study:
The provided document describes a 510(k) premarket notification for the Revolve Envi 600 Advanced Adipose System. The "study" refers to a series of bench tests and biocompatibility assessments designed to demonstrate the device's safety and effectiveness and its substantial equivalence to a legally marketed predicate device (Revolve™ System, K120902).
The core of the "study" is:
- Biocompatibility Testing: According to ISO 10993-1 and FDA guidance, classifying the device as an "Externally Communicating Device, Tissue, Limited Contact (≤24 hours)". It passed tests for cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogenicity.
- Sterilization Validation: Demonstrated a Sterility Assurance Level (SAL) of 10⁻⁵ through gamma irradiation, validated per ISO 11137-2:2013.
- Bench Testing: Included evaluation of adipose tissue viability (via Lactate Dehydrogenase assessment) and simulated use testing covering device stability, leakage, processing time, functionality under vacuum, and tubing connection tensile strength. These tests were performed on both the subject and predicate devices to show comparability.
Crucially, no clinical testing was included in this submission, and this is explicitly stated. The acceptance criteria are engineering and biological safety standards for a mechanical medical device, rather than diagnostic performance metrics (like sensitivity/specificity) typical for AI or imaging devices. Environmental or operational conditions are tested, but not in a 'diagnostic accuracy' sense.
§ 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.