(234 days)
Phaser Lipoplasty System (K092066)
No
The 510(k) summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the mechanical and energy-based aspects of the liposuction system.
Yes
The device is used for "liquefaction and aspiration of localized subcutaneous fatty deposits for the purpose of aesthetic body contouring," which is a therapeutic intervention.
No
The device is described as a liposuction system used for liquefaction and aspiration of fatty deposits for aesthetic body contouring. It does not perform any diagnostic functions.
No
The device description explicitly details hardware components such as a console, handpiece, cannula, pumping mechanism, heat exchanger, and tubing, indicating it is a physical medical device system, not software-only.
Based on the provided information, the HydraSolve™ Lipoplasty System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "liquefaction and aspiration of localized subcutaneous fatty deposits for the purpose of aesthetic body contouring." This is a surgical procedure performed directly on the patient's body, not a test performed on samples taken from the body.
- Device Description: The device description details a system for performing liposuction, involving a console, handpiece, cannula, and suction. This is consistent with a surgical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The HydraSolve™ system does not fit this description.
N/A
Intended Use / 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. The HydraSolve™ Lipoplasty System is Indicated for use in aesthetic body contouring.
Product codes
QPB, MUU
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 in addition to suction.
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) tumescent 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical test data was used to support the decision of safety and effectiveness. Clinical testing was not necessary. Non-clinical testing consisted of performance testing of the new cannulae design.
Key Metrics
Not Found
Predicate Device(s)
Phaser Lipoplasty System (K092066)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in a stacked format. The FDA logo is often used on products that have been approved by the FDA.
Andrew Technologies, LLC Herbert Crane Vice President RA & Qa 3 Haddon Avenue Haddonfield, New Jersey 08033
June 9, 2021
Re: K121218
Trade/Device Name: Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4mm Dia, 26 Cm Length, 3 Aperture Reusable Cannula, 4mm Dia, Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB
Dear Herbert Crane:
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 13, 2012. 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
1
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
Letter dated: December 13, 2012
Andrew Technologies, LLC % Mr. Herbert Crane Vice President, Regulatory Affairs and Quality Assurance 3 Haddon Avenue Haddonfield, New Jersey 08033
Re: K121218
Trade/Device Name: Hydrasolve Console Sterile Treatment Kit Reusable Cannula Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU Dated: November 12, 2012 Received: November 13, 2012
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 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.
2
Page 2 - Mr. Herbert Crane
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/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 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.
Mark N. Melkerson
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K121218
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. The HydraSolve™ Lipoplasty System is Indicated for use in aesthetic body contouring.
| Prescription Use | X |
|---|---|
| (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: K121218
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1.4. 510(k) Summary of Safety and Effectiveness
DEC 1 3 2012
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: 1 April 2012
Classification Name: Suction Lipoplasty System (21 CFR 878.5040)
Trade or Proprietary or Model Name:
HydraSolve™ Lipoplasty System
Legally Marketed Devices: Phaser Lipoplasty System (K092066)
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 in addition to suction.
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) tumescent 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.
The HydraSolve™ Lipoplasty System is indicated for use in aesthetic body contouring.
Summary of testing to demonstrate safety and effectiveness
Non-clinical test data was used to support the decision of safety and effectiveness. Clinical testing was not necessary. Non-clinical testing consisted of performance testing of the new cannulae design.
Conclusion
The information provided in this submission demonstrates that the device is substantially equivalent to the predicate devices.