(90 days)
Not Found
No
The device description focuses on the physical characteristics and intended use of a disposable cannula, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
No.
The intended use is for aesthetic body contouring, which is typically considered a cosmetic procedure rather than a therapeutic one aimed at treating a disease or medical condition.
No
Explanation: The device is described as being used for "aesthetic body contouring" and to "administer a solution to surgery sites pre-lipoplasty". These actions are therapeutic or procedural, not diagnostic. There is no mention of the device being used to identify or analyze a condition.
No
The device description clearly states it is a physical, disposable cannula made of stainless steel, designed for surgical procedures. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "aesthetic body contouring." 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 surgical instrument (cannula) used for aspiration or injection within the body. It does not describe a device used to analyze biological samples (like blood, urine, tissue, etc.) to diagnose, monitor, or screen for diseases or conditions.
- Lack of IVD Characteristics: The description does not mention any components or functions typically associated with IVDs, such as reagents, assays, analyzers, or the measurement of biomarkers.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for medical purposes. The Lipose Disposable Cannula is a surgical tool used directly on the body for a cosmetic procedure.
N/A
Intended Use / Indications for Use
The Lipose Disposable Cannula is intended for use in aesthetic body contouring.
Product codes (comma separated list FDA assigned to the subject device)
QPB, MUU
Device Description
The Lipose Disposable Cannulas are coated stainless steel cannulas designed for connection to syringes (Luer Lock connector or hub adaptor). The cannulas are designed to be used with a syringe aspirator or syringe re-injector. There is also an infiltrator configuration available, to administer a solution to surgery sites pre-lipoplasty. The cannulas are made of hydrophilic coated stainless steel, and are available in various diameters, lengths and tip configurations. The Lipose Disposable Cannulas are single-use disposables, supplied sterile (gamma radiation), packaged in a PETG tray sealed with a labeled or pre-printed Tyvek lid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 9, 2021
Lipose Corp. Christine Emanuel President 1205 De La Vina Street Santa Barbara, California 93101
Re: K093067
Trade/Device Name: Lipose Disposable Cannula Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB
Dear Christine Emanuel:
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 29, 2009. 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
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
DEC 2 9 2009
Lipose Corporation % TECSA Technical Services, Inc. Ms. Christine Emanuel Regulatory Consultant 1205 De La Vina Street Santa Barbara, California 93101
Re: K093067
Trade/Device Name: Lipose Disposable Cannulas Regulation Number: 21 CFR 878-5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: September 09, 2009 Received: September 30, 2009
Dear Ms. Emanuel:
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.
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
Image /page/1/Picture/12 description: The image shows a scattering of small, dark, irregularly shaped spots against a white background. The spots are distributed unevenly across the frame, with some clustering in certain areas and others appearing more isolated. The overall impression is that of a random distribution of small particles or imperfections on a surface.
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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 (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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours.
cerely yours,
F
Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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(K093067 V/
Indications for Use
510(k) Number (if known): K093067
Device Name: Lipose Disposable Cannulas
Indications For Use:
The Lipose Disposable Cannula is intended for use in aesthetic body contouring.
Over-The-Counter Use _ _ _ _ _ (Part 21 CFR 801 Prescription Use AND/OR x Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dail Krone for MxM
(Division Sign-Off)
Division o Surgical. Orthopedic. and Restorative Device
510(k) Number K093067
Page 1 of
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093067
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LIPOSE CORP. DISPOSABLE CANNULA 510(k) Submission
DEC 2 9 2009
Section 5: 510(k) Summary
ﺷﻬﺮ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍ
This 510(k) summary is being submitted in accordance with the requirements of SMDA and 21CFR § 807.92
| Submitted by: | Lipose Corp.
280 Railroad Ave., Suite 200
Greenwich, CT. 06830 USA
Phone: 203-625-9700
Lee Miller, President
email: lee@reguluscapital.com
Fax: 203-625-9706
Contact Person for premarket notification:
Christine Emanuel, Regulatory Consultant
1205 De La Vina Street
Santa Barbara, CA 93101
Phone: 805.963.4312
Fax: 805.564.8642 |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Email: cemanuel@west.net |
| Date Prepared: | September 28, 2009 |
| Proprietary Name: | Lipose Disposable Cannulas |
| Common Name: | Liposuction Cannulas |
| Classification: | Class II, MUU, 21 CFR 878.5040 |
| Predicate Device: | Tulip Biomed (formerly Cell Bio-Systems, Inc., USA).
Tulip Disposable Cannula, 510(k) number K060089 |
| | Device Description: The Lipose Disposable Cannulas are
coated stainless steel cannulas designed for connection to
syringes (Luer Lock connector or hub adaptor). The
cannulas are designed to be used with a syringe aspirator or
syringe re-injector. There is also an infiltrator
configuration available, to administer a solution to surgery
sites pre-lipoplasty. The cannulas are made of hydrophilic
coated stainless steel, and are available in various
diameters, lengths and tip configurations. |
| | The Lipose Disposable Cannulas are single-use
disposables, supplied sterile (gamma radiation), packaged
in a PETG tray sealed with a labeled or pre-printed Tyvek
CONFIDENTIAL
000000 |
5
LIPOSE CORP. DISPOSABLE CANNULA 510(k) Submission
lid.
Indication for Use:
The Lipose Disposable Cannula is intended for use in aesthetic : body contouring.
Technological Characteristics:
The design, use, and materials of the Lipose Disposable Cannulas and their predicate device are equivalent, in that all these cannulas are designed to be used for aesthetic body contouring and are fabricated out of stainless steel. Lipose Cannulas are all provided with a hydrophilic coating with lubricious properties as well, as are the Tulip Disposable Cannulas. No new technology or change in indications for use have been introduced by Lipose Corp. in the manufacture of the Disposable Cannulas. For these reasons, Lipose Corp. considers the use of the Lipose Disposable Cannulas to be substantially equivalent to their predicate device.
CONFIDENTIAL
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