(278 days)
Not Found
No
The device description and performance studies focus on mechanical and thermal mechanisms for fat liquefaction and removal, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is used for aesthetic body contouring through the removal of fatty deposits, which is typically considered a cosmetic procedure rather than a therapeutic one aimed at treating a disease or condition.
No
The device is described as a surgical liposuction device intended for aesthetic body contouring by liquefying and aspirating fatty deposits. It is a therapeutic device, not a diagnostic one, as it performs a treatment rather than identifying a condition or disease.
No
The device description clearly states it is a surgical liposuction device that utilizes pressurized, heated and pulsed saline streams in conjunction with a specialized cannula, indicating it is a hardware-based system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 body.
- Device Description: The device is described as a "surgical liposuction device" that uses "pressurized, heated and pulsed saline streams" and a "specialized cannula" to remove adipose tissue from the body. This is an invasive surgical tool.
- Anatomical Site: The target is "localized subcutaneous fatty deposits," which are within the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
The Phaser Lipoplasty System is a surgical device used for a cosmetic procedure performed directly on the patient's body, not for testing samples taken from the body.
N/A
Intended Use / Indications for Use
The Phaser Lipoplasty System is intended to be used for liquefaction and aspiration of localized subcutaneous fatty deposits for the purpose of aesthetic body contouring.
The Phaser Lipoplasty System is indicated for use in aesthetic body contouring.
Product codes (comma separated list FDA assigned to the subject device)
QPB, MUU
Device Description
The Phaser Lipoplasty System is a surgical liposuction device that utilizes pressurized, heated and pulsed saline streams ("the Phaser stream") in conjunction with a specialized cannula to transition adipose tissue from a solid state to a liquid or gel state so as to facilitate its removal from the body. The physician can employ standard surgical liposuction techniques when using the device, the low pressure and temperature allow adipose tissue removal without burning or otherwise damaging non-target tissues within the surgical field.
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
Physician / 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The company conducted in-vivo testing in a porcine model to assess the safety and performance of the device and the heat generated at the entrance/puncture site, comparing these results to concurrent testing performed with suction assisted lipoplasty (SAL). Temperature readings were taken from worst case locations on the skin surface and on the highest temperature region of the cannula. In addition, tissue was examined histologically to assess potential thermal damage. The data gathered in this study confirms that there is no thermal damage association with the use of the Phaser, with the impact on the Phaser test animals' skin directly comparable to the effects seen with SAL. Specifically, average skin temperatures with the Phaser ranged from 31.4 to 35.8℃ as compared to 26.2 to 31.1℃ for SAL. Average Phaser cannula temperatures ranged from 36.7 to 40.2℃, with corresponding SAL cannula temperatures of 28.5 to 33.8℃. Importantly, no histological evidence of thermal damage was seen with either the Phaser or SAL.
A simulated use study to address the use environment and the device user interface was also performed. The study evaluated human factor considerations, including the device's use environment, user capabilities, and the product's user interface. These evaluations demonstrated that the device performed and functioned as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Average skin temperatures with the Phaser ranged from 31.4 to 35.8℃ as compared to 26.2 to 31.1℃ for SAL. Average Phaser cannula temperatures ranged from 36.7 to 40.2℃, with corresponding SAL cannula temperatures of 28.5 to 33.8℃.
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.
K980292, K041058, K052183, K981215, K040149, K981172, K032802
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
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
Andrew Technologies, LLC Jonathan Kahan 555 13th St., NW Washington, District of Columbia 20004
June 8, 2021
Re: K092066
Trade/Device Name: Phaser Lipoplasty System (dur-01), Phaser Disposable Kit (dis-01), Phaser Waste Collection Kit (was-01), Phaser Cannulae Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB
Dear Jonathan Kahan:
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 April 12, 2010. 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
Image /page/1/Picture/1 description: The image is a circular logo for the U.S. Department of Health and Human Services. The logo features the department's symbol, which is a stylized caduceus with three lines representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Andrew Technologies, LLC % Hogan & Hartson LLP Mr. Luis Davila 555 13th Street, Northwest Washington, District of Columbia 20004
APR 1 2 2010
Re: K092066
Trade Name: Phaser™ Lipoplasty System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: II Product Code: MUU Dated: April 9, 2010 Received: April 9, 2010
Dear Mr. Davila:
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. Iisting 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
2
Page 2 - Mr. Luis Davila
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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
erely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
092066 y/
Indications for Use Statement
510(k) Number (if known): K092066
Device Name: Phaser TM Lipoplasty System
Indications for Use:
The Phaser Lipoplasty System is intended to be used for liquefaction and aspiration of localized subcutaneous fatty deposits for the purpose of aesthetic body contouring.
The Phaser 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 801 Subpart C)
. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krone for MXM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092066
\\DC - 030929/000002 - 3023709 v2
4
510(k) SUMMARY
Andrew Technologies' Phaser Lipoplasty System (K092066)
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Contact Person: Luis Davila Phone: 770-715-9258 Facsimile: 770-886-6585
APR 1 2 2010
Date Prepared: April 12, 2010
Name of Device and Name/Address of Sponsor:
Phaser™ Lipoplasty System
Andrew Technologies. LLC 3 South Haddon Avenue, Suite 3 Haddonfield, NJ 008033
Common or Usual Name: Suction Lipoplasty System
Classification Name: Suction Lipoplasty System, Class II, 21 C.F.R. § 878.5040 (MUU)
Predicate Devices
-
- Alcon Laboratories, Cataract Liquefracture Device (K980292)
-
- Misonix Inc., Lysonix 2000/3000 Ultrasonic Surgical Aspiration Systems (K041058)
-
- Soring GmbH Medizintechnik, Sonoca-Lipo (K052183)
-
- Byron Medical, PSI-Tec Liposuction Aspirator (K981215)
-
- Byron Medical , PSI-Tec Syringe Infusion Pump (K040149)
-
- Byron Medical, Liposuction Aspiration and Tumescent Infiltration Cannulae/Needles (K981172)
-
- HK Surgical Inc., HK Liposuction Aspirator III (K032802)
Intended Use / Indications for Use
The Phaser Lipoplasty System is intended to be used for liquefaction and aspiration of localized subcutaneous fatty deposits for the purpose of aesthetic body contouring.
The Phaser Lipoplasty System is indicated for use in aesthetic body contouring.
Technological Characteristics
The Phaser Lipoplasty System is a surgical liposuction device that utilizes pressurized, heated and pulsed saline streams ("the Phaser stream") in conjunction with a specialized
5
cannula to transition adipose tissue from a solid state to a liquid or gel state so as to facilitate its removal from the body. The physician can employ standard surgical liposuction techniques when using the device, the low pressure and temperature allow adipose tissue removal without burning or otherwise damaging non-target tissues within the surgical field.
Performance Data
The company conducted in-vivo testing in a porcine model to assess the safety and performance of the device and the heat generated at the entrance/puncture site, comparing these results to concurrent testing performed with suction assisted lipoplasty (SAL). Temperature readings were taken from worst case locations on the skin surface and on the highest temperature region of the cannula. In addition, tissue was examined histologically to assess potential thermal damage. The data gathered in this study confirms that there is no thermal damage association with the use of the Phaser, with the impact on the Phaser test animals' skin directly comparable to the effects seen with SAL. Specifically, average skin temperatures with the Phaser ranged from 31.4 to 35.8℃ as compared to 26.2 to 31.1℃ for SAL. Average Phaser cannula temperatures ranged from 36.7 to 40.2℃, with corresponding SAL cannula temperatures of 28.5 to 33.8℃. Importantly, no histological evidence of thermal damage was seen with either the Phaser or SAL.
A simulated use study to address the use environment and the device user interface was also performed. The study evaluated human factor considerations, including the device's use environment, user capabilities, and the product's user interface. These evaluations demonstrated that the device performed and functioned as intended.
Substantial Equivalence
The Phaser Lipoplasty System has the same intended uses and similar indications, technological characteristics, and principles of operation as the following predicate devices: the Misonix Inc. Lysonix 2000/3000 Ultrasonic System (K041058); the Soring GmbH, Sonoca Lipo (K052183) ("Sonoca-Lipo"); the Alcon Cataract Liquefracture Device (K980292); the PSI-Tec Peristaltic Infiltration Pump, Byron Medical Inc. (K040149); the Byron Medical Inc. PS1-Tec Liposuction Aspirator (K981215); the Byron Medical Inc. Byron Liposuction Aspiration and Tumescent Infiltration Cannulae/Needles (K981172); and the HK Surgical Inc., HK Liposuction Aspirator III (K032802). The minor technological differences between the Phaser Lipoplasty System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Phaser Lipoplasty System has comparable performance and safety as compared to the Lysonix 2000/3000, Sonoca-Lipo and the AquaLase. Thus, the Phaser Lipoplasty System is substantially equivalent to its predicate devices.