The intelliFat Disposable Adipose Tissue Harvesting and Transfer or BOD Kit is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be transferred, the harvested fat is only to be used without any additional manipulation.

Device Description

The intelliFat Disposable Adipose Tissue Harvesting and intelliFat BOD Kits are sterile single-use, disposable suction lipoplasty systems that are intended for closed-loop processing of lipoaspirate tissue in various medical procedures involving harvesting autologous adipose tissue. These kits contain stand-alone components that are assembled by the physician user. Primary components include: cannulae, filters, resizer, luer adapters, and syringe caps. The intelliFat Kits accommodate minimal handling of adipose tissue. These devices may be used in combination with FDA-cleared device such as syringes.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called the "intelliFat Disposable Adipose Tissue Harvesting and Transfer Kit" (and "intelliFat BOD Kit"). This document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance in a clinical setting.

Specifically:

No table of acceptance criteria and reported device performance is provided. The document is a regulatory filing for substantial equivalence, not a performance report.
No sample size for a test set or data provenance is mentioned for proving clinical performance. The "nonclinical testing" section describes lab-based tests (biocompatibility, sterilization, packaging, nucleated cell viability), not clinical or performance outcome studies.
No information about experts used for ground truth, adjudication methods, or MRMC studies is present. These are typically relevant for AI/imaging device evaluations, which this device is not.
No standalone (algorithm-only) performance is discussed as this is a physical medical device, not an AI algorithm.
No type of ground truth is specified for clinical performance, as no clinical performance study demonstrating efficacy is detailed.
No training set sample size or ground truth establishment for a training set is mentioned. This information would be relevant for machine learning models, which this device is not.

The document explicitly states: "Clinical testing was not required to support a substantial equivalence determination for the intelliFat Kits." This means the FDA cleared the device based on its similarity in intended use and technological characteristics to existing devices, and not on new clinical performance data from the manufacturer.

Summary

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March 16, 2022

Millennium Medical Technologies Inc (DBA Cellmyx) % Jacqueline Hauge Regulatory Consultant Cellmvx 37743 175th Avenue Avon, Minnesota 56310

Re: K210528

Trade/Device Name: IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit IntelliFat Body On Demand (BOD) Kit Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU Dated: January 28, 2022 Received: January 31, 2022

Dear Jacqueline Hauge:

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/cfpmn/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.

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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 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.

for Deborah Fellhauer, RN, BSN 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) K210528

Device Name intelliFat™ Disposable Adipose Tissue Harvesting and Transfer Kit intelliFat™ BOD Kit

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Date Prepared:

Submitter

March 15, 2022

Name and Address: Cellmyx 6352 Corte Del Abeto Suite A Carlsbad, CA 92011 Primary Contact: Jacqueline A. Hauge Regulatory Consultant Minneapolis, MN Phone: 763-269-2069 Email: jacqueline.hauge@gmail.com Secondary Contact: Michelle Nguyen Quality Assurance and Regulatory Manager, Cellmyx 6352 Corte de Abeto, Suite A Carlsbad, CA 92011 Phone: (949) 215-8560 Email: michelle@cellmyx.com II. Device Information FDA Product Code: MUU FDA Regulation Number: 21 CFR 878.5040 FDA Classification Name: System, Suction, Lipoplasty Classification Panel: General and Plastic Surgery Common Name: Lipoplasty System

FDA Classification: Class II

intelliFat™ Disposable Adipose Tissue Harvesting and Transfer Kit Device Name:

intelliFat™ Body On-Demand (BOD) Kit

Predicate	510(k) Number	Trade Name	Submitter
Primary	K161636	Lipogems System	Lipogems International SpA
Reference	K162932	Ranfac Fat Aspiration Cannula	Ranfac Corp.
Reference	K113255	Puregraft 850/PURE System	Cytori Therapeutics, Inc.

lll. Predicate Information

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IV. Device Description

V. Indication for Use

The intelliFat Disposable Adipose Tissue Harvesting and Transfer or BOD Kit is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating, and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be transferred, the harvested fat is only to be used without any additional manipulation.

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Image /page/5/Picture/1 description: The image shows the logo for Cellmyx. The logo consists of a cluster of three yellow hexagons on the left, followed by the word "Cellmyx" in a simple, sans-serif font. The word is in black, and the "x" has a unique design where the two lines do not intersect in the middle.

VI. Comparison of Technological Characteristics

TechnologicalCharacteristics	Predicate Device	Reference Devices		Subject Device
	Lipogems System	Ranfac Fat Aspiration Cannula	Puregraft 850/PURESystem	IntelliFat™ Kits
Regulatory Information
510(k) Number	K161636	K162932	K113255	This submission
Device Name	Lipogems System	Ranfac Fat Aspiration Cannula	Puregraft 850/PURE System	intelliFat Disposable AdiposeTissue Harvesting andTransfer Kit,intelliFat BOD Kit
Manufacturer	Lipogems International SpA	Ranfac Corp.	Cytori Therapeutics, Inc.	Cellmyx
Common Name	Lipoplasty System	Ranfac Fat Aspiration Cannula	Puregraft 850/PURE System	Lipoplasty System
Regulation Number	21 CFR 878.5040	21 CFR 878.5040	21 CFR 878.5040	21 CFR 878.5040
Device Class	Class II	Class II	Class II	Class II
Product Code	MUU	MUU	MUU	MUU
Classification Panel	General and Plastic Surgery	General and Plastic Surgery	General and Plastic Surgery	General and Plastic Surgery
Intended Use
Indications for UseStatement	The Lipogems System is asterile medical deviceintended for the closed-loop processing oflipoaspirate tissue inmedical proceduresinvolving the harvesting,concentrating, andtransferring of autologousadipose tissue harvestedwith a legally marketedlipoplasty system. Thedevice is intended for use in	The Ranfac Fat AspirationCannula are intended for use inaesthetic body contouring. Ifharvested fat is to be re-implanted, the harvested fat isonly to be used without anyadditional manipulation.	The Puregraft 850/PURESystem is indicated for usein the harvesting, filteringand transferring ofautologous fat tissue forreinjecting back into thesame patient for aestheticbody contouring.	The intelliFat DisposableAdipose Tissue Harvestingand Transfer or BOD Kit is asterile medical deviceintended for the closed-loopprocessing of lipoaspiratetissue in medical proceduresinvolving the harvesting,concentrating, andtransferring of autologousadipose tissue harvested witha legally marketed lipoplastysystem. The device isintended for use in the
TechnologicalCharacteristics	Predicate DeviceLipogems System	Reference Devices		Subject DeviceIntelliFat™ Kits
	specialties when thetransfer of harvestedadipose tissue is desired:orthopedic surgery,arthroscopic surgery,neurosurgery,gastrointestinal andaffiliated organ surgery,urological surgery, generalsurgery, gynecologicalsurgery, thoracic surgery,laparoscopic surgery, andplastic and reconstructivesurgery when aestheticbody contouring is desired.Only legally marketedaccessory items, such assyringes, should be usedwith the system. Ifharvested fat is to betransferred, the harvestedfat is only to be usedwithout any additionalmanipulation.	Ranfac Fat Aspiration Cannula	Puregraft 850/PURESystem	following surgical specialtieswhen the transfer ofharvested adipose tissue isdesired: orthopedic surgery,arthroscopic surgery,neurosurgery,gastrointestinal and affiliatedorgan surgery, urologicalsurgery, general surgery,gynecological surgery,thoracic surgery, laparoscopicsurgery, and plastic andreconstructive surgery whenaesthetic body contouring isdesired. Only legallymarketed accessory items,such as syringes, should beused with the system. Ifharvested fat is to betransferred, the harvested fatis only to be used without anyadditional manipulation.
Technological Characteristics	-	-	-	-
System	Closed loop	-	Closed loop	Closed loop
Construction	Preassembled	-	-	Assembly by user
Use and Sterility	Single-use, sterile	Single-use, sterile	Single-use, sterile	Single-use, sterile
Sterilization Method	Ethylene Oxide	Ethylene Oxide	Gamma irradiation	Gamma Radiation
Biocompatibility	Biocompatible	Biocompatible	Biocompatible	Biocompatible
TechnologicalCharacteristics	Predicate DeviceLipogems System	Reference DevicesRanfac Fat Aspiration Cannula	Reference DevicesPuregraft 850/PURESystem	Subject DeviceIntelliFat™ Kits
Mechanical Operation	Manual shaking of stainless-steel spheres throughfiltered chamber	-	Manually operated systemthat receive adipose tissue,filter the adipose tissue,and temporarily hold theadipose tissue until it isremoved or placed into asyringe that delivers / re-injects the adipose tissueback into the same patientduring the same surgicalprocedure	Manual transfer back andforth through filtered syringe
Source of Energy	None required	None required	None required	None required
Tissue Washing Media	Physiological saline	-	-	Physiological saline
Harvesting Cannula Ga.Size	13Ga.	11Ga., 13Ga. & 14Ga.	-	12Ga.
Harvesting CannulaLength	19cm	10cm, 12cm, 15cm, 20cm &25cm	-	15cm
Filter / Mesh sizes	LGD 240 and LGD60: 2000micron mesh at inlet and1000 micron mesh at outlet- collected adipose tissuepasses though both meshes	-	The Puregraft 850 Bagcontains two (2) filters thatare continuous within thebag. The first filter is an 800micron filter mesh and thesecond filter is a 74 micronfilter mesh.	Filters: 100 micron and 300micronResizer: 500 micron

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Image /page/6/Picture/1 description: The image contains the word "Cellmyx" in a sans-serif font. To the left of the word is a cluster of three yellow hexagons. The hexagons are arranged in a way that they are partially overlapping.

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Image /page/7/Picture/1 description: The image shows the logo for Cellmyx. The logo consists of three hexagons of varying shades of yellow-orange on the left, followed by the company name "Cellmyx" in a simple, sans-serif font. The text is black and the overall design is clean and modern.

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VII. Summary of Non-Clinical Testing and Risk Analysis

The performance of the device is entirely controlled by the user and is not predetermined by the device itself. The instructions for use advise the user on the proper user of the device.

Nonclinical testing included:

Biocompatibility testing: .
- o Cytotoxicity
- o Sensitization
- o Intracutaneous Reactivity
- o Acute Systemic Toxicity
- Pyrogen o
. Sterilization validation
. Packaging validation
. Nucleated cell viability

VIII. Clinical Testing

Clinical testing was not required to support a substantial equivalence determination for the intelliFat Kits.

IX. Conclusion

Based on the comparison of intended use and technological characteristics, Cellmyx has demonstrated that the intelliFat Kits are substantially equivalent to the predicate device.

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.