Who is the manufacturer of HYDRASOLVE LIPOPLASTY SYSTEM?

Andrew Technologies, LLC filed the 510(k) submission for HYDRASOLVE LIPOPLASTY SYSTEM (K130152).

What is the FDA product code for HYDRASOLVE LIPOPLASTY SYSTEM?

MUU. It is classified under 21 CFR 878.5040 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for HYDRASOLVE LIPOPLASTY SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for HYDRASOLVE LIPOPLASTY SYSTEM?

HydraSolve™ Lipoplasty System (K121218); Harvest AdiPrep Adipose Transfer System (K121005).

Who can help prepare an FDA 510(k) submission like HYDRASOLVE LIPOPLASTY SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

HYDRASOLVE LIPOPLASTY SYSTEM

K130152 · Andrew Technologies, LLC · MUU · Apr 18, 2013 · General, Plastic Surgery

Device Facts

Record ID	K130152
Device Name	HYDRASOLVE LIPOPLASTY SYSTEM
Applicant	Andrew Technologies, LLC
Product Code	MUU · General, Plastic Surgery
Decision Date	Apr 18, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.5040
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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 Story

HydraSolve™ Lipoplasty System performs body contouring and adipose tissue harvesting. System inputs include pressurized, heated, and pulsed saline solution delivered via a specialized cannula. The Phaser™ energy transfer system liquefies subcutaneous fatty deposits while simultaneous aspiration removes the material. Operated by trained medical professionals in a clinical setting. Output is aspirated adipose tissue, which can be processed via centrifuge for autologous transfer. Device includes a console (controller, power supply, Phaser™ unit), tumescent infusion component, and a sterile treatment kit (pumping mechanism, heat exchanger, handpiece with integral cannula). Benefits include selective tissue extraction and preparation of fat for grafting. Healthcare providers use the system to facilitate fat transfer procedures.

Clinical Evidence

No clinical data. Non-clinical bench testing only. Testing evaluated aspirated adipocyte cell viability, fat graft survivability, and fat graft quality to support the safety and effectiveness of the device for autologous fat transfer.

Technological Characteristics

System utilizes Phaser™ energy transfer technology (heat and pressure) to deliver pulsed, heated saline through a cannula for tissue liquefaction. Components include a console, wetting infusion unit, aspiration unit, and sterile treatment kit with handpiece. Compatible with COTS cannulae and waste canisters. Class II device (21 CFR 878.5040).

Indications for Use

Indicated for aesthetic body contouring via liquefaction and aspiration of localized subcutaneous fatty deposits in patients requiring adipose tissue harvesting for autologous transfer.

Regulatory Classification

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 of 1/3 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.

Special Controls

*Classification.* Class II (special controls). Consensus standards and labeling restrictions.

Predicate Devices

HydraSolve™ Lipoplasty System (K121218)
Harvest AdiPrep Adipose Transfer System (K121005)

Related Devices

K121218 — HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA, · Andrew Technologies, LLC · Dec 13, 2012
K092066 — PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DIS-01), PHASER WASTE COLLECTION KIT (WAS-01), PHASER CANNULAE · Andrew Technologies, LLC · Apr 12, 2010
K004005 — MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED) · Mentor Corp. · Oct 12, 2001
K053451 — LIPOSAT (INFILTRATION PUMP), MODEL 00 002 274; VACUSAT (SUCTION UNIT), MODEL 00 002 252 (220 V), 00 002 318 (110 V); · Moeller Medical GmbH & Co. KG · Aug 25, 2006
K082025 — BODY-JET · Human Med AG · Aug 13, 2008

Submission Summary (Full Text)

{0}------------------------------------------------ #### 510(k) Summary A.4. # APR 1 8 2013 | Submitted by: | Herbert Crane Vice President Regulatory Affairs and Quality Assurance | |---------------------------------------------|----------------------------------------------------------------------------------------------| | Address: | Andrew Technologies 3 Haddon Avenue Haddonfield, 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 Proprietary or Model Name: | HydraSolve™ Lipoplasty System | | Legally Marketed Devices: | HydraSolve™ Lipoplasty System (K121218) Harvest AdiPrep Adipose Transfer System (K121005) | ### 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. #### Indications for Use: 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. ### 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ 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 Pumping Unit | - 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 Pumping Unit | | Technological Characteristics | - Phaser Cannula - Aspirate Collection Unit - Pressurized, heated, and pulsed saline to liquefy fatty deposits while aspiration is engaged to remove liquefied material | N/A | - Phaser Cannula - Aspirate Collection Unit - Pressurized, heated, and pulsed saline to liquefy fatty deposits while aspiration is engaged to remove liquefied material | | Intended Use | Aesthetic Body Contouring | Aesthetic Body Contouring | Aesthetic Body Contouring | | Tissue Processing & Implantation Technique | Concentration of aspirated adipose tissue using a centrifuge followed by injection using a syringe | Concentration of aspirated adipose tissue using a centrifuge followed by injection using a syringe | N/A | | Indications for Use | The HydraSolveTM 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 HydraSolveTM Lipoplasty System may be used for autologous transfer following the method provided in the manual. | The AdiPrep Adipose Transfer System is used in medical procedures involving the harvesting and transferring of autologous adipose tissue. The AdiPrep system is used for concentrating adipose tissue harvested with a legally marketed lipoplasty system. The AdiPrep Adipose Transfer System is intended for use in the following surgical specialties when the concentration of harvested adipose tissue is desired. Neurosurgery, Gastrointestinal Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery, Arthroscopic Surgery | The HydraSolveTM Lipoplasty System is intended to be used for liquefaction and aspiration of localized subcutaneous fatty deposits for the purpose of aesthetic body contouring. The HydraSolveTM Lipoplasty System is indicated for use in aesthetic body contouring. | Andrew Technologies Traditional 510(k) Notification HydraSolve™ Lipoplasty System (AFT Indication) January 2013 K130152 page 3 of 3 . . {3}------------------------------------------------ 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 {4}------------------------------------------------ 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 {5}------------------------------------------------ # Indications for Use 510(k) Number (if known): K130152 Device Name: HydraSolve™ Lipoplasty System Indications For Use: 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. × 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.