(298 days)
Not Found
No
The device description focuses on mechanical components (vacuum pump, tumescent pump) and basic electronic controls (LCD touch screen, foot controls). There is no mention of AI, ML, or any features that would suggest intelligent data processing or decision-making.
Yes
The device is indicated for use in various surgical specialties for the fragmentation, emulsification, and aspiration of soft tissue, including subcutaneous fatty tissues for aesthetic body contouring, which are all therapeutic interventions.
No.
The device is described as a system for fragmentation, emulsification, and aspiration of soft tissue, used in various surgical specialties. Its function is to perform surgical procedures, not to diagnose conditions or diseases.
No
The device description clearly outlines a physical system including a wheeled cart, vacuum source, tumescent pump, control module with LCD touch screen, foot controls, and accessories. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the MicroAire LipoTower System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a system for the fragmentation, emulsification, and aspiration of soft tissue and subcutaneous fatty tissues within the body during surgical procedures. This is an in vivo application, not an in vitro (outside the body) diagnostic test.
- Device Description: The description details a surgical system with a vacuum source and tumescent pump, designed to physically manipulate tissue during surgery. This aligns with a surgical device, not a diagnostic device that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) to provide diagnostic information about a patient's health status. The system's function is purely procedural.
Therefore, the MicroAire LipoTower System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MicroAire LipoTower System is indicated for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired:
- Neurosurgery
- Gastrointestinal and Affiliated Organ Surgery
- Urological Surgery
- Plastic and Reconstructive Surgery
- General Surgery
- Orthopedic Surgery
- Gynecological Surgery l
- Thoracic Surgery
- Laparoscopic Surgery
The MicroAire LipoTower System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.
Product codes (comma separated list FDA assigned to the subject device)
QPB, MUU
Device Description
The MicroAire LipoTower System is a modular wheeled cart that contains an adjustable vacuum source and a tumescent pump (110/120 VAC, 60 Hz). The vacuum source is a rotary vane type pump that delivers 0-29 inHG vacuum and drives the suction of tissue. The tumescent pump is a peristaltic type that delivers 50-600 ml/min of fluid as required. The system includes a control module with an LCD touch screen for control and status of the system and foot controls for controlling the vacuum pump and tumescent pump. Accessories include a bag holding pole, canister rack and shelves with are included. The system requires a biofilter (non-sterile) on the vacuum inlet and collection canisters (non-sterile - 1200ml and 2000ml) which are available separately.
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
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 logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Microaire Surgical Instruments, LLC Darren Reeves Consultant 7305 Hancock Village Dr Suite 109 Chesterfield, Virginia 23832
June 9, 2021
Re: K113128
Trade/Device Name: Microaire Surgical Instruments Llc Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB
Dear Darren Reeves:
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 August 17, 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
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 1 7 2012
MicroAire Surgical Instruments, LLC % DP Distribution & Consulting, LLC Mr. Darren Reeves Consultant 15637 Fox Cove Circle Moseley, Virginia 23120
Re: K113128
Trade/Device Name: MicroAire LipoTower System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: July 5, 2012 Received: July 9, 2012
Dear Mr. Reeves:
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
2
Page 2 - Mr. Darren Reeves
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/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
Mark A. Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
11/3/28 510(K) Number known:
Device Name: MicroAire LipoTower System
Indications for Use:
The MicroAire LipoTower System is indicated for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired:
- -Neurosurgery
- Gastrointestinal and Affiliated Organ Surgery -
- ー Urological Surgery
- Plastic and Reconstructive Surgery -
- -General Surgery
- Orthopedic Surgery -
- Gynecological Surgery l
- Thoracic Surgery -
- Laparoscopic Surgery
The MicroAire LipoTower System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.
Prescription use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krave for MM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113128
4
11 3 2 8
Section 5: 510(k) Summary
-
- Preparation Date: October 12, 2011
-
- Submitted by:
MicroAire Surgical Instruments LLC 1641 Edlich Drive Charlottesville, Virginia 22911 Owner/Operator #: 9004658
Contact Person/Prepared by:
Darren Reeves Phone: (804) 307-7706 Fax: Email: dreeves@dpdconline.com
- Device Identification:
Trade Name: MicroAire LipoTower System Common Name: Lipoplasty Suction System Classification: Lipoplasty Suction System (21 CFR 878.5040, Product Code MUU)
-
- Predicate Device: Sound Surgical Technologies LLC - SoundVaser System (K022051)
-
- Device Description: The MicroAire LipoTower System is a modular wheeled cart that contains an adjustable vacuum source and a tumescent pump (110/120 VAC, 60 Hz). The vacuum source is a rotary vane type pump that delivers 0-29 inHG vacuum and drives the suction of tissue. The tumescent pump is a peristaltic type that delivers 50-600 ml/min of fluid as required. The system includes a control module with an LCD touch screen for control and status of the system and foot controls for controlling the vacuum pump and tumescent pump. Accessories include a bag holding pole, canister rack and shelves with are included. The system requires a biofilter (non-sterile) on the vacuum inlet and collection canisters (non-sterile - 1200ml and 2000ml) which are available separately.
6) Indications for Use:
The MicroAire LipoTower System is indicated for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired:
- l Neurosurgery
- -Gastrointestinal and Affiliated Organ Surgery
- Urological Surgery l
- Plastic and Reconstructive Surgery -
- General Surgery |
- Orthopedic Surgery 1
- -Gynecological Surgery
- Thoracic Surgery -
- Laparoscopic Surgery -
The MicroAire LipoTower System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.
AUG 1 7 2012
5
7) Comparison to Predicate:
',
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
- .
| General Technical | Predicate - Sound Surgical Technologies, LLC | Proposed device | |
|---|---|---|---|
| Characteristics | (K022051) | ||
| Indications for use | The MicroAire LipoTower System is indicated for use in | ||
| the following surgical specialties when the | |||
| fragmentation, emulsification, and aspiration of soft | |||
| tissue is desired: |
- Neurosurgery
- Gastrointestinal and Affiliated Organ Surgery
- Urological Surgery
- Plastic and Reconstructive Surgery
- General Surgery
- Orthopedic Surgery
- Gynecological Surgery
- Thoracic Surgery
- Laparoscopic Surgery
The System is indicated for use when the
fragmentation, emulsification, and aspiration of soft
tissue is desired or subcutaneous fatty tissues for
aesthetic body contouring is desired | Same | |
| | Size (cm) (H x W x D) | 89 x 46 x 43 | 106 x 56 x 69 |
| | Input Power | 115 & 230 VAC. 50-60 Hz | 115VAC, 50-60 Hz |
| | Handpiece | | N/A |
| | Diameter (cm) | 2.5 | N/A |
| | Length (cm) | 17.5 | N/A |
| | Transducer | PZT crystal | N/A |
| | Vibration Frequency | 36-55 kHz | N/A |
| | Probes | | N/A |
| | Material | Titanium alloy | N/A |
| | Diameter (mm) | 2.9-3.7 | N/A |
| | Length (cm) | 7.7-27.0 | N/A |
| | Irrigation | | |
| | Type | Adjustable Flow | Same |
| | Pump Type | Peristaltic | Same |
| | Flow Rate | | 50-600ml/min |
| Suction | | | |
| Vacuum | 24 in Hg | Adjustable up to 29 in Hg | |
| Pump Type | | Rotary Vane | |
| Sterilization | Steam | N/A | |
| Sterilization Validation | | N/A | |
| Residuals | | N/A | |
| Accessories | | N/A | |
| AC Power cord | 3 prong, Hosp Grade | Same | |
| Handpiece cable | 3 m, silicone | N/A | |
| Footswitch control | Yes | Yes | |
| Collection Canister | 1250ml | 1200ml, 2000ml | |
| Biofilter | N/A | Yes | |
| Prescription | Yes | Yes | |
| IEC Classification | Class I, Type BF | Class I, Type B | |
| | Predicate Used | MicroAire | |
| IEC EN 60601-1- Medical Electrical Equipment, Part 1: General Requirements for Safety - 2nd Edition | | | |
| Radiated emissions | | | |
| CISPR 11
for IEC 60601-1-2 clause 36.201.1 | Compliant | Compliant | |
| Conducted emissions | | | |
| CISPR 11
for IEC 60601-1-2 clause 36.201.1 | Compliant | Compliant | |
| Harmonics | | | |
| IEC 61000-3-2 for IEC 60601-1-2 clause 36.201.3.1 | N/A | Not applicable (to devices whose
voltage