(90 days)
Not Found
No
The summary describes a standard powered suction pump/aspirator and does not mention any AI or ML capabilities.
Yes
The device is used for "esthetic body contouring," involving the removal of fat/adipose and soft tissue through liposuction, which is a therapeutic intervention.
No
Explanation: The device description states its purpose is for the removal of fat/adipose, soft tissue, and general surgical waste, indicating a therapeutic or procedural function rather than a diagnostic one.
No
The device description clearly states it is a "Powered Suction Pump(s)/Aspirator(s)" which are hardware components used for generating negative pressure and removing tissue. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "esthetic body contouring" and the removal of fat/adipose, soft tissue, and general surgical waste. This is a surgical procedure performed on a living patient, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a powered suction pump/aspirator. This is a surgical tool used for physical removal of tissue and waste, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly designed for surgical procedures and waste management during those procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The PSI-TEC Liposuction Aspirator(s) indications for use is for esthetic body contouring.
Aesthetic Body Contouring.
Product codes (comma separated list FDA assigned to the subject device)
OPB, MUU
Device Description
Powered Suction Pump(s)/Aspirator(s) which use an electrically (AC) driven vacuum pump generating a negative pressure for the removal of fat/adipose, soft tissue, and general surgical waste. The Psi-Tec Aspirator 2 also has the capability to capture the waste air "exhaust" (that creates the negative pressure) in an enclosed container. This now, contained and pressurized air, can then be utilized for driving other devices requiring the use of pressurized air.
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 (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.
0
June 8, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Byron Medical Steve Bollinger V.P. Research And Development 3280 E. Hemisphere Loop Suite 100 Tucson, Arizona 85706
Re: K981215
Trade/Device Name: Psi-Tec Liposuction Aspirator Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: OPB
Dear Steve Bollinger:
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 July 1, 1998. 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/2 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 a stylized symbol resembling a caduceus, with three curved lines representing snakes or streams.
JUL - 1 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Steve Bollinger ·Vice President. Research and Development Byron Medical 3280 East Hemisphere Loop Suite 100 Tucson, Arizona 85708
Re: K981215 Trade Name: PSI-Tec Liposuction Aspirator Regulatory Class: II Product Code: MUU Dated: April 1, 1998 Received: April 2, 1998
Dear Mr. Bollinger:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that. through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page2 - Mr. Steve Bollinger
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K981215 510(k) Number (if known): __
Device Name: The PSI-TEC Liposuction Aspirator(s)
Indications for Use:
..............................................................................................................................................................................
he PSI-TEC Liposuction Aspirator(s) indications for use is for esthetic body contouring.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEÈDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
pcaillef
(Division Sign-Off) Division of General Restorative Devices 510(k) Numbe 981215
Prescription Use
X
(Per 21 CFR 801.109
Over-The Counter Use _
(Optional Format 1-2-96)
4
JUL - 1 1998
Byron Medical Confidential - TRADE SECRET
510(k) SUMMARY
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92
1981215
The assigned 510(k) number is:
Submitted by:
Steve Bollinger V.P. Research and Development Byron Medical, Inc. 3280 East Hemisphere Loop Tucson, AZ 85706
Telephone #: (520) 573-0857 Facsimile #: (520) 746-1757
Date Prepared:
01 April, 1998
Establishment Registration Number: Byron Medical is located at 3280 East Hemisphere Loop, Tucson, AZ 85706. We are registered with the Food and Drug Administration as Establishment Number 2025576.
Classification Name:
Suction Lipoplasty System Class II 21 CFR § 878.5040 (1998)
Aspirator, Apparatus, Suction, Operating Class II Room, Wall Vacuum Powered 21 CFR § 880.6740 (1997)
Aspirator, Apparatus, Suction, Ward Use. Class II Portable, AC -Powered 21 CFR § 878.4780 (1997)
Powered Suction Pump
Psi-Tec Liposuction Aspirator
Common/Usual Name:
Proprietary Name:
5
Byron Medical Confidential - TRADE SECRET
510(k) SUMMARY (cont.)
Indication for Use:
Device Description:
Aesthetic Body Contouring.
Powered Suction Pump(s)/Aspirator(s) which use an electrically (AC) driven vacuum pump generating a negative pressure for the removal of fat/adipose, soft tissue, and general surgical waste. The Psi-Tec Aspirator 2 also has the capability to capture the waste air "exhaust" (that creates the negative pressure) in an enclosed container. This now, contained and pressurized air, can then be utilized for driving other devices requiring the use of pressurized air.
Substantial Equivalence Claim:
The PSI-TEC Liposuction Aspirator(s) are IDENTICAL to the following legally-marketed devices ("Predicate Devices") in terms of safety, effectiveness, with a change of intended use:
Product: Psi-Tec Aspirator(s) Manufacturer: Byron Medical 3280 East Hemisphere Loop Tucson, AZ 85706 510(k) Number: K880392 Substantial Equivalence Date: 05 March 1998
-end of summarv-