The MacroPore Puricel Lipoplasty System is intended for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired:

Neurosurgery
-Gastrointestinal and Affiliated Organ Surgery
-Urological Surgery
-Plastic and Reconstructive Surgery
-General Surgery
-Orthopedic Surgery
-Gynecological Surgery
-Thoracic Surgery
-Laparoscopic Surgery

The MacroPore Puricel Lipoplasty System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.

Device Description

The MacroPore Puricel Lipoplasty System is a single use, pre-assembled, manual lipoaspirate system that relies on house vacuum for its energy supply. The MacroPore Puricel Lipoplasty System consists of a cannula, connection tubing, and a waste collection container. The cannula handle is attached to the collection canister via connection tubing. The cannula is a hollow tube with a single opening near the tip to communicate house-vacuum to the tissues and subsequently fragment. emulsify, and aspirate subcutaneous fatty tissues from the patient into the waste collection canister for purposes of aesthetic body contouring. The collection canister contains various capped / sealed ports and a filter to trap large tissue masses

The Puricel Lipoplasty cannula is provided in various sizes ranging from 15cm - 36cm in length and 3.0 ~ 4.6mm in diameter with a single opening near the tip of the cannula. The tip region of the cannula may have a single or multiple openings that range in size from 4mm to length distributed uniformly or randomly throughout the end of the cannula. The handle of the device is 20mm in diameter and may be provided in diameters ranging from 20mm in diameter. The connecting tubing is provided with an inner diameter of 9.6mm (3/8"), an outer diameter of 14.3mm (9/16"), and a wall thickness of 2.2mm. The tubing that connects the cannula handle to the waste canister is provided in a length of 4 feet and may be provided in lengths ranging from 1 - 8 feet. The bottom of the waste collection container is also provided with the same 3/8" inner diameter connection tubing of various lengths. The proximal end of the exiting connection tubing may be provided with a barbed tubing connector to assist in the attachment of like-sized tubing for purposes of connecting the MacroPore Puricel Lipoplasty System to house vacuum and / or assorted waste traps. Connection tubing leading to and from the waste collection container is provided with a stepped clamp to allow the operator to seal the connection tubing on both sides of the waste container and prevent spillage of the collected fluids / tissues.

AI/ML Overview

This response is based on the provided text, which details an FDA 510(k) clearance letter for the "Macropore Puricel Lipoplasty System." This type of document focuses on establishing substantial equivalence to a predicate device, rather than presenting a detailed study with specific performance metrics and acceptance criteria for the new device as would be found in a clinical trial report or a performance study.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria cannot be fully extracted in the manner typically associated with an AI/device performance study. The document primarily describes the device and its substantial equivalence to previously cleared lipoplasty systems.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific numerical acceptance criteria and precise performance metrics are not explicitly stated. The FDA 510(k) clearance process, as reflected here, primarily assesses "substantial equivalence" to a predicate device rather than setting new, quantitative performance benchmarks for the new device in terms of clinical outcomes or specific efficacy and safety percentages.

However, the document implies that the device "meets" its intended purpose by demonstrating substantial equivalence to predicate devices already on the market. The "performance" described is in terms of design characteristics and intended use being similar to existing cleared devices.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (as described in the document)
Safety: Device components are safe for patient contact.	Components with patient contact are fabricated from surgical stainless steel – a material commonly recognized as safe for medical devices.
Efficacy/Intended Use Equivalence: Device performs fragmentation, emulsification, and aspiration of soft tissue as intended for lipoplasty.	"The MacroPore Puricel Lipoplasty System is intended for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired" and "shares indications and design principles with the following predicate devices..." It is indicated for "fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring."
Design Equivalence: Device design is comparable to predicate devices.	"The design and materials of MacroPore Puricel Lipoplasty System and the predicate devices... are substantially equivalent as they are all hollow tubular cannulas attached to a handle." "The MacroPore Puricel Lipoplasty System and the Sound Surgical predicate device are substantially equivalent in design as they both consists of a cannula, connection tubing, and a waste collection container."
Material Equivalence: Materials are comparable to predicate devices.	"The design and materials of MacroPore Puricel Lipoplasty System and the predicate devices... are substantially equivalent." (Specific materials of predicate are not detailed, but the new device uses surgical stainless steel for patient contact).
Mechanical Performance: Device functions mechanically as expected.	"Mechanical testing of the MacroPore Puricel Lipoplasty System demonstrates that the device is substantially equivalent to the predicate." (Specific mechanical parameters or thresholds are not provided).

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes in vitro testing ("Mechanical testing of the MacroPore Puricel Lipoplasty System") rather than a clinical study involving a "test set" of patient data. Therefore, information regarding sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not applicable in the context of this 510(k) summary. The testing appears to be primarily laboratory-based mechanical testing to demonstrate functional equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

As there is no mention of a "test set" of patient data or a clinical study with human interpretation, this information is not applicable. The "ground truth" for this regulatory submission is established by demonstrating equivalence to existing, legally marketed devices.

4. Adjudication Method for the Test Set

Again, this information is not applicable as the document does not describe a clinical study requiring adjudication of a test set.

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. The device described is a physical medical device (lipoplasty system) and not an AI-powered diagnostic or assistive technology 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 surgical tool, not an algorithm.

7. The Type of Ground Truth Used

For this 510(k) submission, the "ground truth" for demonstrating the safety and effectiveness of the MacroPore Puricel Lipoplasty System is its substantial equivalence to predicate devices that have already been cleared by the FDA and are legally marketed. The predicate devices identified are:

Byron Medical Lipoplasty / Liposuction and Tumescent Infusion Cannulae and Needles (cleared under K981172)
Sound Surgical Soundvaser System (cleared under K022051)

The grounds for equivalence are based on shared indications for use, similar design principles (hollow tubular cannulas, connection tubing, waste collection container), and comparable materials.

8. The Sample Size for the Training Set

This information is not applicable. The document describes a physical medical device, not a machine learning or AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as the concept of a "training set" for an algorithm is not relevant to this device's submission.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

Macropore Biosurgery, Inc. Kenneth Kleinhenz Director, RA 6740 Top Gun St. San Diego, California 92121

June 8, 2021

Re: K042261

Trade/Device Name: Macropore Puricel Lipoplasty System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB

Dear Kenneth Kleinhenz:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 20, 2004. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Cindy Chowdhury, OHT4: Office of Surgical and Infection Control Devices, 240-402-6647, Cindy.Chowdhury@fda.hhs.gov.

Sincerely,

Cindy Chowdhury -S

Cindy Chowdhury, Ph.D., M.B.A. 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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 0 2004

Mr. Kenneth K. Kleinhenz Director of Regulatory Affairs MacroPore Biosurgery, Inc. 6740 Top Gun Street San Diego, California 92121

Re: K042261

Trade/Device Name: MacroPore Puricel Lipoplasty System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: II Product Code: MUU Dated: August 20, 2004 Received: August 24, 2004

Dear Mr. Kleinhenz:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regard) the enactment date of the Medical Device American De commerce proc to thay 20, 2017 ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . devices that have been resuire approval of a premarket approval application (PMA). and Cosmetic Act (Tec) market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, manov and act include requirements for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elassified (600 a00 rols. Existing major regulations affecting your device can may be subject to back academant, 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dr Haval statutes and regulations administered by other Federal agencies. You must or any I caeral bakates and and ing, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of it 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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Page 2 - Mr. Kenneth K. Kleinhenz

This letter will allow you to begin marketing your device as described in your Section 510(k) rms letet notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you atten office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KOY226/

Indications for Use

Device Name: MacroPore Puricel Lipoplasty System

Indications for Use:

The MacroPore Puricel Lipoplasty System is intended for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired:

Neurosurgery
-Gastrointestinal and Affiliated Organ Surgery

-Urological Surgery

-Plastic and Reconstructive Surgery

-General Surgery

-Orthopedic Surgery

-Gynecological Surgery
-Thoracic Surgery

-Laparoscopic Surgery

The MacroPore Puricel Lipoplasty System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number K042261

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Page 1 of 3

SEP 2 0 2004

ADMINISTRATIVE INFORMATION

Manufacturer Name:

Official Contact:

MacroPore Biosurgery, Inc. 6740 Top Gun Street San Diego, CA 92121

Kenneth K. Kleinhenz Director of Regulatory Affairs Telephone (858) 458-0900 Fax (858) 458-0994

DEVICE NAME

Classification Name: · Trade/Proprietary Name:

Suction Lipoplasty System MacroPore Puricel Lipoplasty System

ESTABLISHMENT REGISTRATION NUMBER 2031733

DEVICE CLASSIFICATION AND PRODUCT CODE

As shown in 21 CFR 878.5040 Suction Lipoplasty Systems are defined as devices consisting of collection bottles, cannulas, and connecting tubing for use in aesthetic body contouring procedures. Suction Lipoplasty Systems are classified as Class II. They have been assigned Product Corde MUU.

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INTENDED USE

The MacroPore Puricel Lipoplasty System is intended for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired:

Neurosurgery -Gastrointestinal and Affiliated Organ Surgery -Urological Surgery -Plastic and Reconstructive Surgery -General Surgery -Orthopedic Surgery -Gynecological Surgery -Thoracic Surgery -Laparoscopic Surgery

The MacroPore Puricel Lipoplasty System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.

DEVICE DESCRIPTION

Design Characteristics

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Material Composition

The components of the MacroPore Puricel Lipoplasty System that have patient contact are fabricated from surgical stainless steel.

In Vitro Testing

Mechanical testing of the MacroPore Puricel Lipoplasty System demonstrates that the device is substantially equivalent to the predicate.

EQUIVALENCE TO MARKETED PRODUCT

MacroPore Puricel Lipoplasty System shares indications and design principles with the following predicate devices which have been determined by FDA to be substantially equivalent to preamendment devices: Byron Medical Lipoplasty / Liposuction and Tumescent Infusion Cannulae and Needles and Sound Surgical Soundvaser System, Class II medical devices that were cleared for marketing in the United States under K981172 and K022051 respectively.

Indications For Use

The MacroPore Puricel Lipoplasty System and the predicate devices share substantially equivalent indications for use as they are all indicated for aspiration of soft tissues in aesthetic body contouring procedures. The MacroPore Puricel Lipoplasty System shares identical indications for use language with the predicate devices.

Design and Materials

The design and materials of MacroPore Puricel Lipoplasty System and the predicate devices (Byron Medical Lipoplasty / Liposuction Aspiration and Tumescent Infusion Cannulae and Needles and Sound Surgical Soundvaser System) are substantially equivalent as they are all hollow tubular cannulas attached to a handle. The cannula tip of the subject device and the predicate devices contains one or several openings to allow communication between the applied vacuum and the patients tissues. The MacroPore Puricel Lipoplasty System and the Sound Surgical predicate device are substantially equivalent in design as they both consists of a cannula, connection tubing, and a waste collection container. The waste collection containers on the MacroPore Puricel Lipoplasty System and Sound Surgical predicate device are provided in substantially equivalent volume capacities.

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.