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.

Device Description

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.

AI/ML Overview

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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 25, 2017

Lifecell Corporation Ms. Anuja Yardi Regulatory Affairs Specialist One Millennium Way Branchburg, New Jersey 08876

Re: K163647

Trade/Device Name: Revolve Envi 600 Advanced Adipose System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU Dated: July 25, 2017 Received: July 26, 2017

Dear Ms. Yardi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163647

Device Name REVOLVE™ ENVI 600 Advanced Adipose System

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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7. 510(K) SUMMARY

7.1 SUBMITTER

Name and Address of Submitter:

LifeCell Corporation One Millennium Way Branchburg, NJ 08876

Contacts:

Anuja Yardi Senior Regulatory Affairs Analyst Phone: (908) 947-1018 Fax: (908) 325-0020

Jessica Campagna Associate Director, Regulatory Affairs Phone: (908) 809-7852 Fax: (908) 325-0020

Prepared by and Date: Anuja Yardi December 22, 2016

7.2 SUBJECT DEVICE

Name of Device: Revolve™ Envi 600 Advanced Adipose System Common or Usual Name: Suction Lipoplasty System Classification Name: System, Suction, Lipoplasty (21 C.F.R. §878.5040) Device Class: Class II Product Code: MUU

7.3 PREDICATE DEVICE

Predicate Device: Revolve ™ System (cleared as "GID 700" via K120902) The predicate device has not been subject to a design-related recall.

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7.4 DEVICE DESCRIPTION

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.

List of Materials for Revolve ENVI 600 System Components
Name of Component	Raw Material
Handle Assembly	Acrylonitrile butadiene styrene (ABS)
Manifold Assembly*	ABS, Thermoplastic Elastomers
Filter*	Polytetrafluroethylene
Canister*	Polycarbonate
Mesh Basket Lower Cap*	ABS
Mesh Basket Shaft*
Mesh Basket Comb*
Mesh Basket Mesh Basket*	Polycarbonate

Device Materials

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List of Materials for Revolve ENVI 600 System Components
Name of Component	Raw Material
	Mesh*	Monofilament Nylon 6A
Base	Base	ABS
	Extraction Port*
	Extraction Port Insert*
Accessories	Luer Extraction Tip*	ABS
	Toomey/CatheterExtraction Tip*
	Toomey/Catheter to LuerAdapter*
	Temperature Strip	LCR Hallcrest P/N 4573 ADP
	Lactated Ringer's tubingset*	Polyvinyl chloride
	Suction tubing set*

*Tissue Contacting Component

Device Specifications

Canister Volume	1500 ml
Processing Volume	600 ml
Ports	Vacuum, Lactated Ringer's (LR),
	vent, patient, extraction
Filter	200um mesh filter
Source of Energy	User Supplied Vacuum

7.5 INDICATIONS FOR USE

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 apparatus 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, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery..

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7.6 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject Revolve Envi 600 System and the predicate device, Revolve System are both lipoplasty suction systems used in the aspiration, harvesting, filtering and transferring of autologous adipose tissue. Both devices have the same intended use, principle of operation and consist of a canister, mesh filter, extraction port and accessories used to collect, filter and transfer the adipose tissue during lipoplasty procedures. When the tissue is collected into the canister, it is filtered through a mesh filter to capture the tissue. The vacuum source is user or institution supplied. Various ports on the canister on both devices are provided to access the vacuum source (vacuum port), collect the adipose tissue (patient port) , receive the Lactated Ringer's solution during washing (Lactated Ringer's port) and transfer the filtered tissue (extraction port).

7.7 PERFORMANCE

The subject device, Revolve Envi 600 System has undergone appropriate performance, biocompatibility and shelf life testing to ensure safety and effectiveness of the device. The sterilization of the device is assured using a sterilization method validated in accordance with ISO 11137-2:2013 "Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose" to provide a Sterility Assurance Level (SAL) of 105.

Biocompatibility:

In accordance with ISO 10993-1, the subject device. Revolve Envi 600 System is classified as: Externally Communicating Device, Tissue, Limited Contact (≤24 hours). The subject device was tested in accordance with the tests recommended in the FDA's General Program Memorandum #G95-1 - "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and International Standard ISO 10993-1:2009 -"Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." Revolve Envi 600 System has passed cytotoxicity, sensitization, irritation, acute systemic toxicity and material mediated pyrogenicity testing demonstrating that the device is biocompatible.

Bench Testing:

Bench testing was performed to support substantial equivalence to the predicate device. The table below provides a list of performance tests conducted on both the subject and predicate devices to demonstrate substantial equivalence.

Bench Testing / Evaluation	Applicable Standard
Adipose tissue viability (via LactateDehydrogenase assessment)	N/A
Simulated use testing which included the	N/A

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Bench Testing / Evaluation	Applicable Standard
evaluation of the following devicecharacteristics:
- Device stability
- Leakage during extraction andprocessing
- Time from completion of harvest tohaving processed adipose materialready for injection
- Ability to remain functional whensubjected to vacuum (29.9 inHg)
- Tubing Connection Tensile Strength

Substantial equivalence data demonstrate that Revolve Envi 600 System is comparable to the predicate Revolve System in product performance characteristics relevant to the intended use of the device.

Clinical Testing:

No clinical testing was included in this submission.

7.8 CONCLUSION

In summary, Revolve Envi 600 System, subject of this 510(k), is substantially equivalent in its intended use, principle of operation and performance to its legally marketed predicate device, Revolve System (K120902).

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.