. 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.

AI/ML Overview

The provided document describes a 510(k) submission for the "Vitruvian Ultimate Aspirator." This product is a suction lipoplasty system, which is a medical device and not an AI/ML software device. Therefore, the questions related to AI/ML specific aspects like training data, inference, expert adjudication, etc., are not applicable.

Here's the information derived from the document regarding the acceptance criteria and performance testing for this physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are based on compliance with recognized medical device standards and functional performance testing. The reported performance indicates compliance with these criteria.

Acceptance Criteria (Standard/Test)	Reported Device Performance
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	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
Vitruvian Ultimate Aspirator Vacuum Display Calibration	All test results are within acceptable criteria range
Functional Equivalence to Predicate Device (Byron PSI-TEC Aspirator, K981215) in terms of:
- Pump type (Two cylinder piston)	Same (Two cylinder piston)
- AC Power input (115-240V, 60-50Hz)	Similar (120V/230V, 50/60Hz)
- Maximum Vacuum (28 in of Hg)	Similar (27.5 in of Hg)
- Maximum flow rate (4.75 CFM)	Similar (6.4 CFM)
- Sound level (52 dB)	Similar (50 dB)
- Pressure control (Knob to control vacuum)	Same (Knob to control vacuum)
- Footswitch (Dual activated air powered)	Same (Dual activated air powered)
- Safety Features (Manual overflow valve in canister)	Same (Manual overflow valve in canister)
- Housing (Powder Coated Steel)	Same (Powder Coated Steel)
- IV Pole for Solutions	Same (Yes)
- Filter port	Same (Yes)
- Filter (0.3 Micron)	Same (0.3 Micron)
- Indication for Use	Same (Aesthetic body contouring)

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of data for AI/ML. Instead, performance testing was conducted on the physical device itself. The provenance of this testing is indicated as the "Manufacturing Facility."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/ML device requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical medical device, not an AI assistance tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the functional aspects, the "ground truth" or reference for performance is established by the specified industry standards (e.g., IEC 60601 series) and the functional specifications of the predicate device. For the vacuum display calibration, the "acceptable criteria range" serves as the ground truth.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML system requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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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

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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 features a stylized depiction of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.

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.

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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

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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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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

1. Name of Device: Vitruvian Ultimate Aspirator
  Proprietary Name: Vitruvian Ultimate Aspirator

Common Name: Aspirator Pump, Liposuction Aspirator, Power Suction Pump

1. Classification: Suction Lipoplasty System, Class II - 21 CFR §878.5040 (1998)
1. 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.
1. Indications for Use: Aesthetic body contouring.

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8. Comparison to Predicate

Item	Predicate Device	Subject Device	Similarity
Device name	PSI-TEC Aspirator	Vitruvian Ultimate Aspirator	N/A
DeviceManufacturer	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
SafetyFeatures(over flow valve)	Manual (canister)	Manual (canister)	Same
Housing	Powder Coated Steel	Powder Coated Steel	Same
IV Pole forSolutions:	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 18.32in (W)	18 in (H) x18 in (W) x38 in (H)(45cm x45cmx97cm)	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.

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9. Performance Testing

The device complies with the following standards:

Tested/Evaluated Standard	Results
IEC/EN 60601-1-2:2007/AC:2010Clause 4.1	Complies
IEC/EN 60601-1-2:2007/AC:2010Clause 5	Complies
IEC 60601-1:2005 (ThirdEdition) + CORR. 1:2006 +CORR. 2:2007 + A1:2012 (orIEC 60601-1: 2012 reprint)	All Requirements/Testseither Passed or wereN/A
IEC 60601-1-6:2010 (ThirdEdition)	All Requirements/Testseither Passed or wereN/A
IEC 62366: 2007 (FirstEdition)	All Principles Evaluatedeither Passed or wereN/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.

Regulation Number and Section

§ 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.