The HydraSolve™ Lipoplasty System is intended to be used for liquefaction and aspiration of localized subcutaneous fatty deposits for the purpose of aesthetic body contouring. Adipose tissue harvested with the HydraSolve™ Lipoplasty System may be used for autologous transfer following the method provided in the manual.

Device Description

The Andrew Technologies HydraSolve "" Lipoplasty System is a liposuction system used to perform body contouring. It is designed to perform selective tissue extraction through a cannula that utilizes pressurized, heated, and pulsed saline solution to suction. Adipose tissue aspirated with the HydraSolve™ Lipoplasty System can be harvested for subsequent autologous transfer.

The device includes the HydraSolve™ Console which contains within its durable case: a user interface, controller, power supply, and Phaser™ energy transfer systems (both heat and pressure). The system also includes a tumescent infusion component which is compatible with commercial off-the-shelf (COTS) turnescent cannulae and tubing. The device also includes the Sterile Treatment Kit consisting of a pumping mechanism, heat exchanger and tubing and a reusable limited-use handpiece with integral cannula. The device interfaces with COTS waste canisters and suction tubing.

AI/ML Overview

Acceptance Criteria and Study for HydraSolve™ Lipoplasty System (K130152)

This document details the acceptance criteria and the study performed to demonstrate the safety and effectiveness of the HydraSolve™ Lipoplasty System for an expanded indication (autologous fat transfer).

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the submission (510(k) for an extended indication and substantial equivalence based on non-clinical data), specific quantitative acceptance criteria in terms of performance metrics (like sensitivity, specificity, etc.) are not explicitly stated in the provided text. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices and proving the safety and effectiveness for the new indication through non-clinical testing.

The "reported device performance" in this context refers to the outcomes of the non-clinical tests that supported the substantial equivalence and the expanded indication.

Acceptance Criterion (Implicit)	Reported Device Performance
Substantial Equivalence to Predicate Devices (K121218 & K121005)	The subject device (HydraSolve™ Lipoplasty System with AFT Indication) is substantially equivalent in major components, technological characteristics, user population, and intended use to the predicate HydraSolve™ Lipoplasty System (K121218). The new indication for autologous fat transfer (AFT) makes it substantially equivalent to the Harvest AdiPrep (K121005) in terms of tissue processing and implantation technique. The only difference is the expanded Indications for Use statement.
Safety and Effectiveness for Autologous Fat Transfer	Non-clinical testing demonstrated: - Adepted aspirate cell viability - Fat graft survivability - Fat graft quality

Acceptance Criterion (Implicit)

Reported Device Performance

Substantial Equivalence to Predicate Devices (K121218 & K121005)

The subject device (HydraSolve™ Lipoplasty System with AFT Indication) is substantially equivalent in major components, technological characteristics, user population, and intended use to the predicate HydraSolve™ Lipoplasty System (K121218). The new indication for autologous fat transfer (AFT) makes it substantially equivalent to the Harvest AdiPrep (K121005) in terms of tissue processing and implantation technique. The only difference is the expanded Indications for Use statement.

Safety and Effectiveness for Autologous Fat Transfer

Non-clinical testing demonstrated: - Adepted aspirate cell viability - Fat graft survivability - Fat graft quality

Note: The FDA's 510(k) clearance (K130152) confirms that based on the provided information, the device is substantially equivalent to the predicate devices and may be marketed. This implicitly means the acceptance criteria for market clearance under the 510(k) pathway were met.

Details of the Study

The provided text describes a non-clinical study to demonstrate safety and effectiveness, especially for the expanded indication of autologous fat transfer.

Type of Study: Non-clinical testing. The submission explicitly states: "Clinical testing was not necessary."
Purpose: To demonstrate the safety and effectiveness of the HydraSolve™ Lipoplasty System for its intended use, particularly with the addition of autologous fat transfer. This was done to establish substantial equivalence to predicate devices.

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

Sample Size for Test Set: Not specified. Non-clinical studies (e.g., in-vitro or animal studies) typically involve a different kind of "sample size" than human clinical trials. The document does not provide details on the number of samples (e.g., tissue samples, animals) used for the cell viability, survivability, and quality tests.
Data Provenance: Not specified (e.g., country of origin, whether retrospective or prospective). Given it's a non-clinical study, "country of origin" might refer to where the lab work was conducted, which is not mentioned. The data would be prospective in the sense that the tests were specifically conducted for this submission.

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

Not applicable. As this was a non-clinical study involving laboratory and bench testing (cell viability, fat graft survivability, and quality), there was no "ground truth" established by human experts in the way it would be for diagnostic imaging or clinical assessment. The "truth" would be based on scientific measurements and established protocols for evaluating these biological parameters.

4. Adjudication Method for the Test Set

Not applicable. There was no human expert adjudication of test results in the manner described (e.g., 2+1, 3+1). The outcomes of the non-clinical tests would typically be objectively measured and analyzed according to scientific standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not done. The submission explicitly states "Clinical testing was not necessary," and the study described is non-clinical. Therefore, there is no information on human reader improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Not applicable. This device is a medical device (a liposuction system), not an AI or algorithm-based diagnostic tool. Therefore, the concept of a "standalone algorithm-only performance" study does not apply. The device's performance is tied to its mechanical and biological effects, not an algorithm's classification or detection capabilities.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" in this context refers to established scientific measurements and biological parameters for evaluating aspirated adipocyte cell viability, fat graft survivability, and fat graft quality. This would involve specific laboratory assays, histological assessments, or other quantifiable biological markers considered standard in the field for assessing the health and integrity of adipose tissue for autologous transfer.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not an AI/machine learning algorithm that requires a "training set."

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

Not applicable, as there is no training set for this type of medical device.

Summary

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510(k) Summary A.4.

APR 1 8 2013

Submitted by:	Herbert CraneVice President Regulatory Affairs and Quality Assurance
Address:	Andrew Technologies3 Haddon AvenueHaddonfield, NJ 08033
Telephone:	(959) 502-1907
Facsimile:	(856) 433-8092
Date of Submission:	17 January 2013
Classification Name:Device Product Code	Suction Lipoplasty System (21 CFR 878.5040)MUU
Trade or Proprietaryor Model Name:	HydraSolve™ Lipoplasty System
Legally Marketed Devices:	HydraSolve™ Lipoplasty System (K121218)Harvest AdiPrep Adipose Transfer System (K121005)

Device Description:

Indications for Use:

Comparison to Predicate Device

A table comparing the technological characteristics of the subject device and predicate devices is included as a third page of this Summary of Safety and Effectiveness. With the exception of the Indications for Use statement, the subject device is identical to the predicate device cleared under K121218.

Andrew Technologies Traditional 510(k) Notification HydraSolve™ Lipoplasty System (AFT Indication) January 2013

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K130152 Page 2 of 3

Summary of testing to demonstrate safety and effectiveness

Nonclinical test data was used to support the decision of safety and effectiveness. Clinical testing was not necessary. Non-clinical testing consisted of testing aspirated adipocyte cell viability fat graft survivability, and fat graft quality.

Conclusion

The information provided in this submission demonstrates that the device is substantially equivalent to the predicate devices.

Andrew Technologies Traditional 510(K) Notification
HydraSolve™ Lipoplasty System (AFT Indication) January 2013

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Substantial Equivalence Comparison to Predicate Devices

ATTRIBUTE	SUBJECT DEVICE	PREDICATE	PREDICATE
	HydraSolveTM Lipoplasty System(AFT Indication)	Harvest AdiPrep(K121005)	HydraSolveTM Lipoplasty System(K121218)
User Population	Trained Medical Professionals	Trained Medical Professionals	Trained Medical Professionals
Major Components	- System Console- Wetting Infusion Unit- Aspiration Unit- Phaser Stream Heating and PumpingUnit	- Syringes with removable plunger- Centrifuge tubes with filter- Aspiration & fat injection cannula- Fat injection syringes- Skin puncture needles- Oil extraction syringe & needle	- System Console- Wetting Infusion Unit- Aspiration Unit- Phaser Stream Heating and PumpingUnit
TechnologicalCharacteristics	- Phaser Cannula- Aspirate Collection Unit- Pressurized, heated, and pulsed salineto liquefy fatty deposits while aspirationis engaged to remove liquefied material	N/A	- Phaser Cannula- Aspirate Collection Unit- Pressurized, heated, and pulsed saline toliquefy fatty deposits while aspiration isengaged to remove liquefied material
Intended Use	Aesthetic Body Contouring	Aesthetic Body Contouring	Aesthetic Body Contouring
Tissue Processing &ImplantationTechnique	Concentration of aspirated adiposetissue using a centrifuge followed byinjection using a syringe	Concentration of aspirated adipose tissueusing a centrifuge followed by injection usinga syringe	N/A
Indications for Use	The HydraSolveTM Lipoplasty System isintended to be used for liquefaction andaspiration of localized subcutaneousfatty deposits for the purpose ofaesthetic body contouring. Adiposetissue harvested with the HydraSolveTMLipoplasty System may be used forautologous transfer following themethod provided in the manual.	The AdiPrep Adipose Transfer System isused in medical procedures involving theharvesting and transferring of autologousadipose tissue. The AdiPrep system is usedfor concentrating adipose tissue harvestedwith a legally marketed lipoplasty system.The AdiPrep Adipose Transfer System isintended for use in the following surgicalspecialties when the concentration ofharvested adipose tissue is desired.Neurosurgery, Gastrointestinal Surgery,Urological Surgery, Plastic andReconstructive Surgery, General Surgery,Orthopedic Surgery, Gynecological Surgery,Thoracic Surgery, Laparoscopic Surgery,Arthroscopic Surgery	The HydraSolveTM Lipoplasty System isintended to be used for liquefaction andaspiration of localized subcutaneous fattydeposits for the purpose of aesthetic bodycontouring.The HydraSolveTM Lipoplasty System isindicated for use in aesthetic bodycontouring.

Andrew Technologies Traditional 510(k) Notification
HydraSolve™ Lipoplasty System (AFT Indication)
January 2013

K130152 page 3 of

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three horizontal lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Andrew Technologies % Mr. Herbert Crane Vice President, Regulatory Affairs and Quality Assurance 3 Haddon Avenue Haddonfield, New Jersey 08033

April 18, 2013

Re: K130152

Trade/Device Name: HydraSolve™ Lipoplasty System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: March 29, 2013 Received: April 01, 2013

Dear Mr. Crane:

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

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Page 2 - Mr. Herbert Crane

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 device-related 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.

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/MedicalDevices/Safetv/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 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, FOR

Peter D Rümm -S

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

Enclosure

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Indications for Use

510(k) Number (if known): K130152

Device Name: HydraSolve™ Lipoplasty System

Indications For Use:

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krause

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130152

Page 1 of 1

A.3.

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.