The Lipose Disposable Cannulas are coated stainless steel cannulas designed for connection to syringes (Luer Lock connector or hub adaptor). The cannulas are designed to be used with a syringe aspirator or syringe re-injector. There is also an infiltrator configuration available, to administer a solution to surgery sites pre-lipoplasty. The cannulas are made of hydrophilic coated stainless steel, and are available in various diameters, lengths and tip configurations. The Lipose Disposable Cannulas are single-use disposables, supplied sterile (gamma radiation), packaged in a PETG tray sealed with a labeled or pre-printed Tyvek lid.

AI/ML Overview

This document is a 510(k) summary for the Lipose Disposable Cannula, which is a medical device used for aesthetic body contouring. The document does not describe a study that proves the device meets specific acceptance criteria in the way described in the prompt (e.g., performance metrics like sensitivity, specificity, or improvement with AI assistance).

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to a predicate device. The primary "acceptance criterion" in this context is showing that the new device is as safe and effective as a legally marketed predicate device.

Here's an analysis based on the provided document:

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

The document does not provide a table of quantitative acceptance criteria and device performance metrics in the way typically seen for diagnostic or AI-driven devices (e.g., sensitivity, specificity, AUC).

Instead, the "acceptance criteria" are demonstrating substantial equivalence in terms of:

Indications for Use: The Lipose Disposable Cannula is "intended for use in aesthetic body contouring." This is identical to the predicate device's intended use.
Technological Characteristics: The document states: "The design, use, and materials of the Lipose Disposable Cannulas and their predicate device are equivalent, in that all these cannulas are designed to be used for aesthetic body contouring and are fabricated out of stainless steel. Lipose Cannulas are all provided with a hydrophilic coating with lubricious properties as well, as are the Tulip Disposable Cannulas. No new technology or change in indications for use have been introduced by Lipose Corp. in the manufacture of the Disposable Cannulas."

Therefore, the "reported device performance" is essentially that its characteristics (design, materials, intended use, lubricious coating) are equivalent to the predicate device, thereby inferring equivalent safety and effectiveness.

2. Sample size used for the test set and the data provenance

There is no "test set" in the traditional sense of a study evaluating performance against ground truth. The submission relies on comparative data and descriptions against a predicate device. Therefore, no information on sample size or data provenance is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study requiring expert consensus for ground truth establishment. The evaluation is based on comparing the device's characteristics and intended use to a legally marketed predicate device.

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

Not applicable. No test set requiring adjudication.

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

Not applicable. This device is a surgical instrument (cannula), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is not relevant.

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

Not applicable. This device is a physical surgical instrument, not an algorithm.

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

The "ground truth" in this context is the safety and effectiveness profile of the predicate device, the Tulip Disposable Cannula (K060089), which has already been cleared by the FDA. The submission argues that the Lipose Disposable Cannulas are substantially equivalent to this established device.

8. The sample size for the training set

Not applicable. No training set for an algorithm.

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

Not applicable. No training set.

Summary

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June 9, 2021

Lipose Corp. Christine Emanuel President 1205 De La Vina Street Santa Barbara, California 93101

Re: K093067

Trade/Device Name: Lipose Disposable Cannula Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB

Dear Christine Emanuel:

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 December 29, 2009. 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

DEC 2 9 2009

Lipose Corporation % TECSA Technical Services, Inc. Ms. Christine Emanuel Regulatory Consultant 1205 De La Vina Street Santa Barbara, California 93101

Re: K093067

Trade/Device Name: Lipose Disposable Cannulas Regulation Number: 21 CFR 878-5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: September 09, 2009 Received: September 30, 2009

Dear Ms. Emanuel:

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.

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

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

cerely yours,

Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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(K093067 V/

Indications for Use

510(k) Number (if known): K093067

Device Name: Lipose Disposable Cannulas

Indications For Use:

The Lipose Disposable Cannula is intended for use in aesthetic body contouring.

Over-The-Counter Use _ _ _ _ _ (Part 21 CFR 801 Prescription Use AND/OR x Subpart D) (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)

Dail Krone for MxM
(Division Sign-Off)

Division o Surgical. Orthopedic. and Restorative Device

510(k) Number K093067

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093067

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LIPOSE CORP. DISPOSABLE CANNULA 510(k) Submission

DEC 2 9 2009

Section 5: 510(k) Summary

ﺷﻬﺮ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍ

This 510(k) summary is being submitted in accordance with the requirements of SMDA and 21CFR § 807.92

Submitted by:	Lipose Corp.280 Railroad Ave., Suite 200Greenwich, CT. 06830 USAPhone: 203-625-9700Lee Miller, Presidentemail: lee@reguluscapital.comFax: 203-625-9706Contact Person for premarket notification:Christine Emanuel, Regulatory Consultant1205 De La Vina StreetSanta Barbara, CA 93101Phone: 805.963.4312Fax: 805.564.8642
	Email: cemanuel@west.net
Date Prepared:	September 28, 2009
Proprietary Name:	Lipose Disposable Cannulas
Common Name:	Liposuction Cannulas
Classification:	Class II, MUU, 21 CFR 878.5040
Predicate Device:	Tulip Biomed (formerly Cell Bio-Systems, Inc., USA).Tulip Disposable Cannula, 510(k) number K060089
	Device Description: The Lipose Disposable Cannulas arecoated stainless steel cannulas designed for connection tosyringes (Luer Lock connector or hub adaptor). Thecannulas are designed to be used with a syringe aspirator orsyringe re-injector. There is also an infiltratorconfiguration available, to administer a solution to surgerysites pre-lipoplasty. The cannulas are made of hydrophiliccoated stainless steel, and are available in variousdiameters, lengths and tip configurations.
	The Lipose Disposable Cannulas are single-usedisposables, supplied sterile (gamma radiation), packagedin a PETG tray sealed with a labeled or pre-printed TyvekCONFIDENTIAL000000

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LIPOSE CORP. DISPOSABLE CANNULA 510(k) Submission

lid.

Indication for Use:

The Lipose Disposable Cannula is intended for use in aesthetic : body contouring.

Technological Characteristics:

The design, use, and materials of the Lipose Disposable Cannulas and their predicate device are equivalent, in that all these cannulas are designed to be used for aesthetic body contouring and are fabricated out of stainless steel. Lipose Cannulas are all provided with a hydrophilic coating with lubricious properties as well, as are the Tulip Disposable Cannulas. No new technology or change in indications for use have been introduced by Lipose Corp. in the manufacture of the Disposable Cannulas. For these reasons, Lipose Corp. considers the use of the Lipose Disposable Cannulas to be substantially equivalent to their predicate device.

CONFIDENTIAL

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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.