(86 days)
Not Found
No
The description focuses on mechanical and fluid-based mechanisms (pressurized, heated, pulsed saline) for tissue liquefaction and aspiration. There is no mention of AI, ML, image processing, or data-driven decision-making within the device's operation.
No
The device is described as a liposuction system intended for aesthetic body contouring through the liquefaction and aspiration of localized subcutaneous fatty deposits. While it performs a medical procedure, its primary purpose is cosmetic, not to treat or cure a disease or medical condition.
No
The device description indicates that the HydraSolve™ Lipoplasty System is used for liquefaction and aspiration of fatty deposits for aesthetic body contouring and for harvesting adipose tissue for autologous transfer. It is a tool for performing a procedure, not for diagnosing a condition or disease.
No
The device description clearly outlines multiple hardware components including a console, handpiece, cannula, pumping mechanism, and heat exchanger, indicating it is not a software-only device.
Based on the provided information, the HydraSolve™ Lipoplasty System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for liquefaction and aspiration of subcutaneous fatty deposits for aesthetic body contouring and potential autologous transfer. This is a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The description details a liposuction system with components for delivering heated saline, suctioning tissue, and potentially harvesting tissue. These are all related to a surgical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze a sample (like blood, urine, or tissue) outside of the body to provide diagnostic information. The harvested adipose tissue is for autologous transfer, meaning it's put back into the same patient, not used for diagnostic testing.
In summary, the HydraSolve™ Lipoplasty System is a surgical device used for body contouring and fat harvesting, not a device used for in vitro diagnostic testing.
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. Adipose tissue harvested with the HydraSolve™ Lipoplasty System may be used for autologous transfer following the method provided in the manual.
Product codes (comma separated list FDA assigned to the subject device)
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Localized subcutaneous fatty deposits
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained Medical Professionals
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
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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.