Aesthetic body contouring. This Infiltration Pump is used to cause a flow of fluid from an IV bag into patient in a manner controlled manually by a health care professional.

Device Description

The B89055 Vitruvian Infiltration Pump is intended to be used for aesthetic body contouring. Normal use includes general tumescent infiltration. It has a self-adjusting power converter which works with either 100V or 240V currents, and includes a pneumatic foot-switch and selfadjusting tubing guide to prevent tubing slippage during operation. It has a fully adjustable flow rate between 0 mL/min and 475 mL/min.

The Vitruvian Infiltration Pump is a pre-assembled device consisting of:

Housing: ABS Plastic
Power Operation: 100-240VAC, 50-60Hz, 1.8-1.0A
Head: 3 roller peristaltic action
Control: Knob used to set mL/min
Display: LED
Foot Switch: Air Powered ON/OFF
Power Cord: Yes

The infiltration pump does not contact the patient.

AI/ML Overview

This document is an FDA 510(k) premarket notification for the Vitruvian Infiltration Pump, which is a medical device. The purpose of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This process typically relies on comparing indications for use, technological characteristics, and performance data to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Vitruvian Infiltration Pump are primarily demonstrated through compliance with electrical safety standards and performance testing related to its function, particularly flow rate calibration. The document states compliance with general design and safety standards, and specifically mentions performance testing for flow rate.

Acceptance Criteria / Standard	Reported Device Performance
IEC 60601-1:2005 (+ CORR. 1:2006 + CORR. 2:2007 + A1:2012 /IEC 60601-1: 2012 reprint) - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance	Complies
ANSI/AAMI ES60601-1:2005 + A1:2012 + A2:2010, ed. 3.1	Complies
CAN/CSA C22.2 No. 60601-1 Ed. 3 + A1(2014)	Complies
EN 60601-1:2006 + A1:2013 (2013) + A11 (2011), + A12 (2014)	Complies
IEC 60601-1-2:2007 (3rd Edition) - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests	Complies
Vitruvian Infiltration Pump Flow Rate Display Calibration	Pass

It's important to note that for a 510(k), the "acceptance criteria" are typically demonstrating substantial equivalence to a predicate, which often involves showing the new device performs as intended and meets relevant safety standards, rather than defining specific statistical endpoints for a comparative clinical study against a disease state.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify a separate "test set" in the context of clinical data for algorithmic performance or diagnostic accuracy. The performance testing mentioned is for the device's functional characteristics (e.g., electrical safety, flow rate calibration). The data provenance for this functional testing is stated as "Performed at Manufacturing Facility." No patient-specific data or country of origin for such data is provided, as it is not a study involving patient outcomes or diagnostic outputs.

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 a study assessing diagnostic accuracy or requiring expert-derived ground truth. The "ground truth" for the performance testing cited (electrical safety, flow rate calibration) would be the established engineering standards and specifications.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is not a study involving diagnostic accuracy and expert adjudication. The "adjudication" for the performance tests would be whether the device passed or failed the specified standard's requirements.

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. The Vitruvian Infiltration Pump is an infiltration pump for aesthetic body contouring; it is not an AI-powered diagnostic or interpretive device that would involve human readers.

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

Not applicable. The Vitruvian Infiltration Pump is a medical device, not a standalone algorithm.

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

For the performance testing mentioned (IEC standards, flow rate calibration), the ground truth is established by the technical specifications and requirements of those international and national standards. For example, a flow rate calibration would involve comparing the pump's output to accurately measured fluid volumes over time, with the "ground truth" being the true measured flow rate.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set of data.

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

Not applicable. This is not an AI/ML device that requires a training set of data.

Summary

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Black & Black Surgical, Inc. % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

June 9, 2021

Re: K170629

Trade/Device Name: Vitruvian Infiltration Pump 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 June 22, 2017. 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 22, 2017

Black & Black Surgical, Inc. % Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street. NW Buffalo, Minnesota 55313

Re: K170629

Trade/Device Name: Vitruvian Infiltration Pump Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: June 16, 2017 Received: June 20, 2017

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 vour 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 device

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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 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name Vitruvian Infiltration Pump

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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Black & Black Surgical 5238 Royal Woods Parkway Suite 170 Tucker, GA. 30084 nblack3@blackandblacksurgical.com 770-414-4880

510(k) Summary

This summary of 5 10(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

Submitter Information: 1.

Prepared: 02/10/2017

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

2. Name of Device: Vitruvian Infiltration Pump

Proprietary Name: Vitruvian Infiltration Pump

Common Name: Infiltration Pump

1. Classification: Suction Lipoplasty System, Class II - 21 CFR §878.5040 (1998)
1. Product Code: MUU

5. Substantial Equivalence:

The Vitruvian Infiltration Pump is believed to be substantially equivalent to the infiltration devices listed below in terms of use, design, operating principles, materials and performance.

HK Surgical: K031432 MOELLER MEDICAL GMBH & CO. KG: K072793

6. Device Description:

The Vitruvian Infiltration Pump is a pre-assembled device consisting of:

Housing: ABS Plastic
Power Operation: 100-240VAC, 50-60Hz, 1.8-1.0A
Head: 3 roller peristaltic action ●
. Control: Knob used to set mL/min
Display: LED
Foot Switch: Air Powered ON/OFF
. Power Cord: Yes

The infiltration pump does not contact the patient.

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Black & Black Surgical 5238 Royal Woods Parkway Suite 170 Tucker, GA. 30084 nblack3@blackandblacksurgical.com 770-414-4880

7. Indications for Use: Aesthetic Body Contouring

8. Comparison to Predicate

Item	Predicate Device 1	Predicate Device 2	Subject Device: #1	Similarity1/2
Device name	HK Klein Surgical KIP-IIInfiltrator	Liposat Basic	VitruvianInfiltrationPump	N/A
Device Manufacturer	HK Surgical	Moller MedicalGmbH	Black & Black Surgical,Inc.	N/A
510(k) Reference	K031432	K072793	Not yet assigned	N/A
FDA Product Code	FRN	MUU	MUU	Different/Same
FDA Classification	SuctionSystem	LipoplastySuctionSystem	SuctionLipoplastySystem	Same
FDA Regulation #	880.5725	878.5040	878.5040	Different/Same
Indication for Use /Intended Use	This Infiltration Pump is usedto cause a flow of fluid froman IV bag into patient in amanner controlled manuallyby a health care professional.The Klein Pump is notintended to be used as an IVinfusion pump.	Aesthetic Bodycontouring	Aesthetic bodycontouring.	Similar/ Same
Specific drug, biologicuse	N/A	N/A	N/A	Same
Administrative sets &reservoir	N/A	N/A	N/A	Same
Mechanical Operation
Item	Predicate Device	Predicate Device	Subject Device	Similarity
Pump type	Peristaltic	Peristaltic	Peristaltic	Same
AC Power input	115/230V, 60/50Hz	230 VAC, 50Hz	110-240V, 50/60Hz	Similar
Maximum flow rate	600 RPM /1000 mL/min	200 mL/min	475 mL/min	Different
Safety/Alarmfunctions	N/A	N/A	N/A	Same
Pressure control	Knob to control RPM	Pressure Button	Knob to control RPM	Same/Similar
Footswitch	Air Powered	Air Powered	Air powered	Same
Display	Gage	LED	LED	Different/similar
Pumping Mechanism	One Roller	Two Rollers	Three Rollers	Similar
Housing / Materials	Powder Coated Steel	High PerformancePlastic	ABS plastic	Different /Similar
Weight	10 lbs	2.5 kg	7.2 lbs	Similar
Dimensions	12" x 9" x 6"	6.7" x 7.8" x 5.5"	11" x 8" x 7"	Similar

Performance Testing

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Black & Black Surgical 5238 Royal Woods Parkway Suite 170 Tucker, GA. 30084 nblack3@blackandblacksurgical.com 770-414-4880

The device complies with the following standards:

Tested/EvaluatedStandard	Results
IEC 60601 1:2005 (Third Edition)+ CORR. 1:2006 + CORR. 2:2007+ A1:2012 (or IEC 60601-1: 2012reprint)	Complies
ANSI/AAMI ES60601-1:2005+A1:2012 + A2:2010, ed. 3.1	Complies
CAN/CSA C22.2 No. 60601-1 Ed.3 + A1(2014)	Complies
EN 60601-1:2006 + A1:2013(2013) + A11 (2011), + A12 (2014)	Complies
IEC 60601-1-2:2007 (3rd Edition)	Complies

Performance Testing Performed at Manufacturing Facility:

· Vitruvian Infiltration Pump Flow Rate Display Calibration Pass

10. Substantial Equivalence Conclusion:

Based on the information contained in this submission, it is concluded that the Vitruvian Infiltration Pump is substantially equivalent to the identified predicate devices, which are already in interstate commerce within the USA.

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.