(34 days)
Not Found
No
The device description explicitly states that the software does not control the unit and does not accept any input, indicating a lack of AI/ML functionality. The control is purely mechanical via a pressure control valve and footswitch.
Yes.
The device is used for aesthetic body contouring, which is a therapeutic purpose.
No
The intended use of the Vitruvian Aspirator is "Aesthetic body contouring," which is a treatment or modification of the body, not a process of identifying or diagnosing a condition or disease.
No
The device description clearly outlines multiple hardware components including a housing, vacuum pump, vacuum meter display, power operations, control, footswitch, IV pole, and filter. The software component is explicitly stated as not controlling the unit or accepting input.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Aesthetic body contouring." This is a procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device is a vacuum aspirator designed to remove material from the body. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any other components typically associated with in vitro diagnostics.
IVDs are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Aesthetic body contouring.
Product codes (comma separated list FDA assigned to the subject device)
QPB, MUU
Device Description
The Vitruvian Aspirator is a pre-assembled device consisting of:
- . Housing: Powder Coated Steel
- . Vacuum Pump: Dual ½ hp dual voltage rocking piston motor with Maximum Suction flow rate of 125PSI, 6.4 cfm, 27.5in HG(711 mm of Hg)
- . Vacuum Meter Display: The device displays the vacuum levels digitally. The software does not control the unit in any way and does not accept any input.
- . Power Operations: 120/230 volt 50/60hz
- . Control: Pressure control valve located on the face of the device with rotary control knob with both LED numerical and Color Graphic LED display
- . Footswitch: Dual activated air powered
- IV Pole .
- . Filter: Bacterial filter having a pore size of 0.3 microns or less.
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)
Performance Testing Performed at Manufacturing Facility:
- Vitruvian Ultimate Aspirator Vacuum Display Calibration All test results are within acceptable criteria range
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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Black & Black Surgical, Inc. % Mark Job Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
June 9, 2021
Re: K161722
Trade/Device Name: Vitruvian Ultimate Aspirator Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB
Dear Mark Job:
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 26, 2016. 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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 26, 2016
Black & Black Surgical, Inc. Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K161722
Trade/Device Name: Vitruvian Ultimate Aspirator Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU Dated: July 18, 2016 Received: July 19, 2016
Dear Mr. Job:
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 devicerelated 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.
2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K161722
Device Name
Black & Black Vitruvian Ultimate Aspirator
Indications for Use (Describe) Aesthetic body contouring.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
This summary of 510(k) safety and effectiveness is being submitterd in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
Submitter Information: 1.
Prepared: June 15, 2016
Est. Reg. #: 3006142527
Norman M. Black. CEO. normanblack@blackandblacksurgical.com Black & Black Surgical. Inc. 5238 Royal Woods Parkway Suite 170 Tucker, GA 30084 770-414-4880 T / 770-414-4879 F
Contact Person: Cynthia Rees, Regulatory Engineer, crees@blackandblacksurgical.com
-
- Name of Device: Vitruvian Ultimate Aspirator
Proprietary Name: Vitruvian Ultimate Aspirator
- Name of Device: Vitruvian Ultimate Aspirator
Common Name: Aspirator Pump, Liposuction Aspirator, Power Suction Pump
-
- Classification: Suction Lipoplasty System, Class II - 21 CFR §878.5040 (1998)
-
- Product Code: MUU
5. Substantial Equivalence:
The Vitruvian Ultimate Aspirator is substantially equivalent to the aspiration device listed below in terms of use, design, operating principles, materials and performance.
Byron Medical: K981215
6. Device Description:
The Vitruvian Aspirator is a pre-assembled device consisting of:
- . Housing: Powder Coated Steel
- . Vacuum Pump: Dual ½ hp dual voltage rocking piston motor with Maximum Suction flow rate of 125PSI, 6.4 cfm, 27.5in HG(711 mm of Hg)
- . Vacuum Meter Display: The device displays the vacuum levels digitally. The software does not control the unit in any way and does not accept any input.
- . Power Operations: 120/230 volt 50/60hz
- . Control: Pressure control valve located on the face of the device with rotary control knob with both LED numerical and Color Graphic LED display
- . Footswitch: Dual activated air powered
- IV Pole .
- . Filter: Bacterial filter having a pore size of 0.3 microns or less.
-
- Indications for Use: Aesthetic body contouring.
5
8. Comparison to Predicate
| Item | Predicate Device | Subject Device | Similarity | |
|---|---|---|---|---|
| Device name | PSI-TEC Aspirator | Vitruvian Ultimate Aspirator | N/A | |
| Device | ||||
| Manufacturer | Byron Medical. Inc. | Black & Black Surgical, Inc. | N/A | |
| 510(k) Reference | K981215 | K161722 | N/A | |
| FDA Product Code | MUU | MUU | Same | |
| FDA Classification | Suction Lipoplasty System | Suction Lipoplasty System | Same | |
| FDA Regulation # | 878.5040 | 878.5040 | Same | |
| Indication for Use / | ||||
| Intended Use | Aesthetic body contouring | Aesthetic body contouring | Same | |
| Mechanical Operation | ||||
| Item | Predicate Device | Subject Device | Similarity | |
| Pump type | Two cylinder piston | Two cylinder piston | Same | |
| AC Power input | 115-240V, 60-50Hz | 120V/230V, 50/60Hz | Similar | |
| Maximum Vacuum | 28 in of Hg | 27.5 in of Hg | Similar | |
| Maximum flow rate | 4.75 CFM | 6.4 CFM | Similar | |
| Sound level | 52 dB | 50 dB | Similar | |
| Pressure control | Knob to control vacuum | Knob to control vacuum | Same | |
| Footswitch | Dual activated air powered | Dual activated air powered | Same | |
| Display | Vacuum gage | Vacuum gage w/LED color graphic read out | Different | |
| Safety | ||||
| Features | ||||
| (over flow valve) | Manual (canister) | Manual (canister) | Same | |
| Housing | Powder Coated Steel | Powder Coated Steel | Same | |
| IV Pole for | ||||
| Solutions: | Yes | Yes | Same | |
| Filter port: | Yes | Yes | Same | |
| Filter | 0.3 Micron | 0.3 Micron | Same | |
| Dimensions | 20.18 in (H) x 22.96 in (D) x 18.32 | |||
| in (W) | 18 in (H) x18 in (W) x38 in (H)(45cm x45cm | |||
| x97cm) | Similar | |||
| Weight | 80 lbs. /36.288 Kilograms | 100 lbs | Similar |
The Black & Black suction aspirator is substantially equivalent in function and intended use to the Byron PSI-TEC (K981215). Both the Byron PSI-TEC and the Black Vitruvian Aspirator have Dual vacuum motors, a Vacuum gage read-out, metal housing, 4 casters, an IV pole, fitting for suction tubing, and a 0.3 micron filter. Both devices are used for aesthetic body contouring.
The steps of operation of the Vitruvian Aspirator can be found in the IFU.
6
9. Performance Testing
The device complies with the following standards:
| Tested/Evaluated Standard | Results |
|---|---|
| IEC/EN 60601-1- | |
| 2:2007/AC:2010 | |
| Clause 4.1 | Complies |
| IEC/EN 60601-1- | |
| 2:2007/AC:2010 | |
| Clause 5 | Complies |
| IEC 60601-1:2005 (Third | |
| Edition) + CORR. 1:2006 + | |
| CORR. 2:2007 + A1:2012 (or | |
| IEC 60601-1: 2012 reprint) | All Requirements/Tests |
| either Passed or were | |
| N/A | |
| IEC 60601-1-6:2010 (Third | |
| Edition) | All Requirements/Tests |
| either Passed or were | |
| N/A | |
| IEC 62366: 2007 (First | |
| Edition) | All Principles Evaluated |
| either Passed or were | |
| N/A |
Performance Testing Performed at Manufacturing Facility:
- Vitruvian Ultimate Aspirator Vacuum Display Calibration All test results are within acceptable criteria range
10. Substantial Equivalence Conclusion:
Based on the information contained in this submission, it is concluded that the Vitruvian Ultimate Aspirator is substantially equivalent in function and intended use to the identified predicate device, the Byron PSI-TEC Aspirator, K981215.