The Red Head and Jordy Connection System is indicated for use as a liposuction adipose (fatty) collection system used in the aesthetic body contouring and collection of autologous adipose tissue. The Red Head and Jordy Connection System is intended to be used in the following surgical procedures:

Aspiration of adipose (fatty) tissue
Harvesting adipose (fatty) tissue
Filtering adipose (fatty) tissue
Extraction of autologous adipose (fatty) tissue

Device Description

Device Functions:

1. Single Use closed loop system collection device (same)
1. Canister contains ports on lids for interface between: Jordy Connection System to Canister and aspirator pump.
1. Connection system to connect tubing to interfaces
1. Funnel to enable fat to separate from fluids
1. Channel for fluid evacuation.
Toomey Syringe to extract fat from device. 6.

Device Design:

1. Owner holds patent to predicate device and has improved performance and safety through this design.
1. Non-Sterile, Single Use
1. Canister able to withstand 30 in/Hg (18 in/Hg maximum vacuum used for collection of adipose (fatty tissue) for harvesting.
1. Tissue enters canister through collection port on canister lid.
1. Funnel perforation large enough for only adipose (fatty) tissue to be collected
1. Waste material is removed from canister by closing valve on center of lid.
1. Remaining adipose (fatty) tissue can be withdrawn through tissue port on bottom of center of canister for autologous adipose (fatty) tissue extraction.

Physical Properties and Materials Used:

1. Canister, Funnel and Outer Lid made from Polycarbonate
1. Evacuation spout and pinch clamps made from Polypropylene
1. Tubing made from silicone

Intended use of Device:
For use in aspirating subcutaneous fatty tissue including autologous fat collection.

AI/ML Overview

The provided document describes a medical device, "The Red Head and Jordy Connection System," and its substantial equivalence to a predicate device, "Lipisystems Aquavage." This is a 510(k) premarket notification to the FDA, which focuses on demonstrating substantial equivalence rather than independent clinical efficacy studies typically associated with new drug applications or novel high-risk devices. Therefore, the information required for directly answering all parts of your request about acceptance criteria and a study proving the device meets the acceptance criteria in the context of an AI/algorithm-driven device is largely not present in this document.

Here's an analysis based on the provided text, focusing on what is available and explaining the gaps:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of AI performance metrics (e.g., sensitivity, specificity, AUC). Instead, it lists performance tests conducted to demonstrate the device operates as designed and functions as intended, often in comparison to a predicate device.

Acceptance Criteria (Inferred/Stated)	Reported Device Performance
Functional Performance:
Assembly Verification	Operates as designed
Leak Testing	Operates as designed
Canister Implosion Test	Operates as designed
Tubing Collapse Test	Operates as designed
Pull Off Force Testing	Operates as designed
Biocompatibility:
Cytotoxicity (ISO 10993)	Passed
Intracutaneous Reactivity (ISO 10993)	Passed
Sensitization (ISO 10993)	Passed
Acute Systemic Toxicity (ISO 10993)	Passed
Tissue Viability:
No adverse effect on adipose tissue	Found no adverse effect
Vacuum Withstand:
Withstand 30 in/Hg vacuum	Canister able to withstand 30 in/Hg (for 18 in/Hg max use)

Notes on "Acceptance Criteria" for this device:

This is a physical medical device for collection of adipose tissue, not an AI or diagnostic algorithm. Therefore, the "acceptance criteria" are related to mechanical integrity, material safety, and functional equivalence to a predicate device, rather than diagnostic accuracy.
The document states, "Performance testing has demonstrated that the subject device operates as designed and functions as intended." This general statement serves as the "reported performance" for the functional tests.

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

The document does not specify sample sizes for any of the performance tests (e.g., number of units tested for leak, implosion, etc.), nor does it mention data provenance in terms of country of origin or retrospective/prospective nature. This level of detail is typically not required nor provided in a 510(k) summary for this type of device.

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 and therefore not provided. The "ground truth" for a physical device like this is not established by human experts in the way it is for diagnostic algorithms. Instead, it's determined by engineering specifications and material science for the mechanical/biocompatibility tests, and potentially by laboratory analysis for tissue viability.

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

This is not applicable and therefore not provided. Adjudication methods are relevant for subjective assessments or disagreements in diagnostic tasks (e.g., by experts for an AI model), not for objective physical device testing.

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 is not applicable and therefore not provided. An MRMC study is relevant for evaluating the performance of diagnostic algorithms, often with human readers. The Red Head and Jordy Connection System is a physical device for tissue collection and is not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable and therefore not provided. This device is not an algorithm.

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

As explained in point 3, the concept of "ground truth" in the context of an AI algorithm based on expert consensus, pathology, or outcomes data is not directly applicable to this physical device.

The closest equivalent to "ground truth" for the performance tests would be:

Engineering specifications/standards: For functional tests like implosion, leak, pull-off force.
Standardized laboratory tests: For biocompatibility (ISO 10993) which involves specific in-vitro or in-vivo assays with established pass/fail criteria.
Laboratory analysis of tissue samples: For tissue viability. The document states "Tissue viability testing found no adverse effect on adipose tissue with use of the subject device," implying laboratory assessment of the collected tissue.

8. The sample size for the training set

This is not applicable and therefore not provided. The device is a physical product, not an algorithm that requires a "training set."

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

This is not applicable and therefore not provided.

In Summary:

The provided document is a 510(k) summary for a physical medical device. It focuses on demonstrating substantial equivalence to a predicate device through functional, mechanical, and biocompatibility testing. The questions regarding AI/algorithm performance metrics, expert adjudication, MRMC studies, and training/test sets for algorithms are not applicable to the information presented in this regulatory submission for "The Red Head and Jordy Connection System."

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine.

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

February 24, 2017

Miami Fat Supply % Ms. Ayanna Brown Bgf Consulting 325 South Mcgee Ave. Apopka. Florida 32703

Re: K161372

Trade/Device Name: The Red Head Collection Device. The Jordy Connection System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU Dated: May 9, 2016 Received: May 17, 2016

Dear Ms. Brown:

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 yours,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K161372

Device Name

Red Head Collection Device and Jordy Connection System

Indications for Use (Describe)

Aspiration of adipose (fatty) tissue
Harvesting adipose (fatty) tissue
Filtering adipose (fatty) tissue
Extraction of autologous adipose (fatty) tissue

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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510(k) Summary

Device Name:	The Red Head and Jordy Connection System
510(k) Submission:	K161372
Date of Submission:	January 25, 2017
510(k) Owner & Manufacturer:	Donnell Mark JordanMiami Fat Supply Inc.1510 Max Hooks Rd. #FGroveland, FL 34736Telephone: 352-557-6979Fax: 352-388-9447miamifatsupply@gmail.com
510(k) Submitter and Contact:	Ayanna BrownBGF Consulting LLC325 South McGee AvenueApopka, FL 32703Phone: 407-574-7195Fax: 407-814-0127ayanna@bgfconsulting.com
FDA Classification Name:	21 CFR Part 878- General and Plastic SurgerySubpart E - Surgical DevicesSec. 878.5040 Suction Lipoplasty SystemClass II DeviceProduct Code MUU
Classification Panel:Common Name:Predicate Device:	21 CFR Part 880- General Hospital and Personal UseSubpart G - General Hospital and Personal UseSec. 880.6960 Irrigation SyringeClass I (Sterile) DeviceProduct Code KYZGeneral and Plastic SurgeryLipoplasty SystemK092284 Lipisystems AquaVage(Product Code MUU)21CFR 880.6960 Irrigation Syringe Classification(Product Code KYZ)

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Indications for Use:

Aspiration of adipose (fatty) tissue
Harvesting adipose (fatty) tissue
Filtering adipose (fatty) tissue
Extraction of autologous adipose (fatty) tissue

Device Description:

Device Functions:

1. Single Use closed loop system collection device (same)
1. Canister contains ports on lids for interface between: Jordy Connection System to Canister and aspirator pump.
1. Connection system to connect tubing to interfaces
1. Funnel to enable fat to separate from fluids
1. Channel for fluid evacuation.
Toomey Syringe to extract fat from device. 6.

Device Design:

1. Owner holds patent to predicate device and has improved performance and safety through this design.
1. Non-Sterile, Single Use
1. Canister able to withstand 30 in/Hg (18 in/Hg maximum vacuum used for collection of adipose (fatty tissue) for harvesting.
1. Tissue enters canister through collection port on canister lid.
1. Funnel perforation large enough for only adipose (fatty) tissue to be collected
1. Waste material is removed from canister by closing valve on center of lid.
1. Remaining adipose (fatty) tissue can be withdrawn through tissue port on bottom of center of canister for autologous adipose (fatty) tissue extraction.

Physical Properties and Materials Used:

1. Canister, Funnel and Outer Lid made from Polycarbonate
1. Evacuation spout and pinch clamps made from Polypropylene
1. Tubing made from silicone

Intended use of Device:

For use in aspirating subcutaneous fatty tissue including autologous fat collection.

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Predicate and Reference device comparison table

Device Name	The Red HeadMiami Fat Supply	Medical Device ResourceCorp.Lipisystems AquavagePredicate Device
DeviceDescription	The Red Head is a single use, closed looptissue collection device comprised of amedical grade canister, vacuum port,collection port, tissue port and capintended to be used with standardliposuction aspiration to collect fattytissue for aesthetic body contouring. Asthe tissue is harvested from the patient itenters the canister through the collectionport on the canister lid. The physicianremoves waste materials from the canisterby closing the valve on the center of the lid.The fatty tissue remains that can bewithdrawn through the tissue port on thebottom center of the canister forautologous fat re-injection.	The Lipisystems Aquavage consists of aplastic canister, silicone tubing, with avacuum port, collection port and bottomtissue port and lid, intended to be usedwith a standard liposuction pump tocollect fatty tissue for aesthetic bodycontouring. As the tissue is harvestedfrom the patient it enters the canister viathe port in the canister lid. The physicianremoves unwanted waste materials fromthe collection system via the vacuum portby closing the valve on the lid. Thisprocess leaves fatty tissue that can betransferred to syringes via the tissue portfor autologous fat reinjection.
Picture ofProduct	Image: The Red Head product	Image: Lipisystems Aquavage product
Intended Use:	The Red Head is used in the aspiration,harvesting, filtering and extraction ofautologous adipose tissue for aestheticbody contouring	The Aquavage is used in the aspiration,harvesting, filtering and extraction ofautologous adipose tissue for aestheticbody contouring
TechnologyComparison	The Red Head employs the sametechnological characteristics as thepredicate device.	The Lipisystems Aquavage employs thesame technological characteristics as thepredicate device.
SuctionSource	Aspiration Device	Aspiration Device
Volume	Up to 2500 mL	2000 cc or 1200 cc
Range
Shipped Sterile	No, sterilized by user prior to use	Yes
Sterility Assurance Level	$10^{-6}$	$10^{-6}$
Disposable or Reusable	Single Use, Disposable	Single Use Disposable
Resterilization Method	Not Applicable	Not Applicable

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Substantial Equivalence Discussion:

The Subject and Predicate device are identical in terms of function and performance. Performance testing has demonstrated that the subject device operates as designed and functions as intended. Performance tests include Assembly Verification, Leak Testing, Canister Implosion, Tubing Collapse and Pull Off Force Testing. Biocompatibility was evaluated in accordance with ISO 10993 - Biological Evaluation of Medical Devices. Tests for cytotoxicity, intracutaneous reactivity, sensitization, and acute systemic toxicity were completed and passed. The subject device of this submission is indicated for collection and transfer of autologous adipose tissue. Tissue viability testing found no adverse effect on adipose tissue with use of the subject device. The minimally manipulated nature of such tissue in the subject device and the predicate device form the basis of substantial equivalence.

Conclusion for the Substantial Equivalence of the Device:

Based on the performance and comparison data contained within this submission, Miami Fat Supply deems that the Red Head and Jordy Connection System is substantially equivalent to the identified 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.