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

Device Description

REVOLVE ENVI™ 600 Advanced Adipose System (REVOLVE ENVI 600 System) consists of a sterile, single-use canister and components 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 should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. The adipose tissue is harvested from the patient using liposuction tubing and cannula that are supplied by the user or the institution. The harvested tissue is collected inside the device which contains an inner basket with 200 um mesh filter that can process up to 600 mL of collected tissue. A manual stirring assembly allows the user to mix the tissue and Lactated Ringer's 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.

The REVOLVE ENVI 600 System is comprised of the following components, intended to be used only as a system:

Canister (including mesh filter)
Syringe Adapter
Temperature Strip
Lactated Ringer's Tubing Set
Vacuum Tubing Set

The device is offered in a single size, is packaged in a thermoformed tray and 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 the REVOLVE ENVI 600 Advanced Adipose System, structured according to your request. However, it's important to note that this document is a 510(k) summary for a medical device and not a detailed study report for an AI/ML powered device. Therefore, many of your requested criteria, particularly those related to AI algorithm performance (like sample sizes for test/training sets, ground truth establishment methods, expert qualifications, MRMC studies, and standalone performance metrics), are unlikely to be found. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the typical sense of quantitative targets for each test in a table format. Instead, it states that the tests were performed "to support substantial equivalence" and that "data demonstrate that the device is biocompatible" and "is comparable to the predicate REVOLVE System in product performance characteristics relevant to the intended use of the device."

Below is a table summarizing the types of performance tests conducted. The specific quantitative results or acceptance thresholds for each test are not provided in this summary.

Test/Assessment	Reported Device Performance
Gross and microscopic assessments of adipose samples	Performed to support substantial equivalence.
Adipose tissue viability (via Lactate Dehydrogenase assessment)	Performed to support substantial equivalence.
System fluid leak	Performed to support substantial equivalence.
System vacuum leak	Performed to support substantial equivalence.
Tubing connection tensile strength	Performed to support substantial equivalence.
Hose collapse	Conforms to ISO 10079-1:2015(E) Medical Suction Equipment Part 1, Section 6.3.1 and Annex A.4
Implosion test	Conforms to ISO 10079-1:2015(E) Medical Suction Equipment Part 1, Section 6.1.3 and Annex A.3
Biocompatibility	Data demonstrates the device is biocompatible (classified as Externally Communicating Device, Tissue, Limited Contact (≤ 24 hours) as per ISO 10993-1:2018).
Sterilization	Validated in accordance with ISO 11137-2:2013 to provide a SAL of 10^-6.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. The document describes bench testing, which typically uses laboratory samples or device units, not patient data in the context of AI.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided. The performance evaluation described is for a physical medical device (lipoplasty system) through bench testing and biocompatibility assessments, not an AI/ML algorithm that requires expert-established ground truth from images or clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided. Adjudication methods are typically used in clinical studies or for establishing ground truth for AI algorithms, which is not the focus of the performance tests described here.

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

This information is not applicable. An MRMC study is relevant for AI-assisted diagnostic or interpretive devices. This 510(k) is for a physical surgical system for adipose tissue processing and does not involve AI assistance 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 device is a physical system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable/provided. The ground truth for this device would be established through engineering specifications, material properties, and standardized test methods (e.g., ISO standards for hose collapse, implosion, and sterilization).

8. The sample size for the training set

This information is not applicable/provided as the device is not an AI/ML algorithm.

9. How the ground truth for the training set was established

This information is not applicable/provided as the device is not an AI/ML algorithm.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 28, 2020

LifeCell Corporation Bozhana Hegarty Manager, Regulatory Affairs One Millennium Way Branchburg, New Jersey 08876

Re: K193539

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: April 29, 2020 Received: April 30, 2020

Dear Bozhana Hegarty:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K193539

Device Name REVOLVE ENVI™ 600 Advanced Adipose System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K193539 p. 1 of 4

510(K) SUMMARY 1

1.1 SUBMITTER

Name and Address of Submitter:

LifeCell Corporation One Millennium Way Branchburg, NJ 08876 USA

Contact:

Bozhana Hegarty Manager, Regulatory Affairs Phone: (908) 332-7484 Fax: (908) 325-0020 bozhana.hegarty@allergan.com

Prepared by and Date:

Bozhana Hegarty April 29, 2020

1.2 SUBJECT DEVICE

Trade name: REVOLVE ENVI™ 600 Advanced Adipose System Common Name: Suction Lipoplasty System Classification Name: System, Suction, Lipoplasty (21 C.F.R. §878.5040) Device Class: Class II Product Code: MUU

1.3 PREDICATE DEVICE

Predicate Device: REVOLVE™ Advanced Adipose System (cleared as "GID 700" via K120902)

Reference Device:

REVOLVE ENVI™ 600 Advanced Adipose System (cleared via K163647)

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1.4 DEVICE DESCRIPTION

REVOLVE ENVI™ 600 Advanced Adipose System (REVOLVE ENVI 600 System) consists of a sterile, single-use canister and components 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 should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. The adipose tissue is harvested from the patient using liposuction tubing and cannula that are supplied by the user or the institution. The harvested tissue is collected inside the device which contains an inner basket with 200 um mesh filter that can process up to 600 mL of collected tissue. A manual stirring assembly allows the user to mix the tissue and Lactated Ringer's 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.

The REVOLVE ENVI 600 System is comprised of the following components, intended to be used only as a system:

Canister (including mesh filter) o
Syringe Adapter .
0 Temperature Strip
Lactated Ringer's Tubing Set ●
Vacuum Tubing Set ●

1.5 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 reimplanted, 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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1.6 TECHNOLOGICAL CHARACTERISTICS

The subject device, REVOLVE ENVI 600 System, and the predicate device, REVOLVE System, are both lipoplasty suction systems used in the aspiration, 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 components used to collect, filter and transfer the adipose tissue during lipoplasty procedures. A mesh filter is used to capture the collected tissue in both devices. The vacuum source is user or institution supplied. Various ports on the canister of both devices are provided to access the vacuum source (vacuum port), collect the adipose tissue (liposuction port), and receive the Lactated Ringer's solution during washing (Lactated Ringer's port). The subject device has a dedicated port to transfer the filtered tissue (extraction port), whereas the predicate device utilizes the liposuction port for extraction. Additionally, the subject device has a larger processing volume, new materials of construction and is sterilized via gamma irradiation, compared to electron beam irradiation for the predicate device.

The subject device. REVOLVE ENVI 600 System, is a modified version of the reference device. cleared with the same trade name under K163647. The differences between the subject and reference devices include design modifications of existing parts, addition of new components. and addition of a new supplier.

1.7 PERFORMANCE

REVOLVE ENVI 600 System has undergone appropriate performance and biocompatibility testing to ensure safety and effectiveness of the device. Stability testing was completed to support the proposed shelf life. 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 10-6.

Biocompatibility:

In accordance with ISO 10993-1:2018 = "Biological evaluation of medical devices = Part 1: Evaluation and testing within a risk management process," REVOLVE ENVI 600 System is classified as Externally Communicating Device, Tissue, Limited Contact (≤ 24 hours). The subject device has undergone appropriate biocompatibility assessments and testing, and data demonstrates that the device is biocompatible.

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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 the subject device to demonstrate substantial equivalence.

Bench Testing/Assessment	Applicable Standard
Gross and microscopic assessments ofadipose samples	N/A
Adipose tissue viability (via LactateDehydrogenase assessment)	N/A
System fluid leak	N/A
System vacuum leak	N/A
Tubing connection tensile strength	N/A
Hose collapse	ISO 10079-1:2015(E) Medical SuctionEquipment Part 1, Section 6.3.1 andAnnex A.4
Implosion test	ISO 10079-1:2015(E) Medical SuctionEquipment Part 1, Section 6.1.3 andAnnex A.3

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.

1.8 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.