VITRUVIAN INFILTRATION PUMP

K170629 · Black & Black Surgical, Inc. · QPB · Jun 22, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K170629
• Device Name: VITRUVIAN INFILTRATION PUMP
• Applicant: Black & Black Surgical, Inc.
• Product Code: QPB · General, Plastic Surgery
• Decision Date: Jun 22, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5040
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

Aesthetic body contouring

Device Story

Vitruvian Infiltration Pump is a peristaltic pump used for aesthetic body contouring; specifically, general tumescent infiltration. Device operates by drawing fluid from an IV bag and delivering it at a controlled flow rate. Input is manual setting via a control knob (0-475 mL/min); output is fluid delivery through tubing. Device features a 3-roller peristaltic head, LED display, and pneumatic foot-switch for ON/OFF control. It is intended for use by healthcare professionals in a clinical setting. The pump does not contact the patient directly. The device benefits patients by providing controlled fluid infiltration during body contouring procedures.

Clinical Evidence

Bench testing only. Performance testing included flow rate display calibration and verification of compliance with IEC 60601-1 and IEC 60601-1-2 standards.

Technological Characteristics

Peristaltic pump with 3-roller head; ABS plastic housing; 100-240VAC, 50-60Hz power input; flow rate 0-475 mL/min; LED display; pneumatic foot-switch. Complies with IEC 60601-1 (3rd Ed), ANSI/AAMI ES60601-1, CAN/CSA C22.2 No. 60601-1, and IEC 60601-1-2.

Indications for Use

Indicated for aesthetic body contouring in patients undergoing tumescent infiltration procedures.

Regulatory Classification

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 of 1/3 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.

Special Controls

*Classification.* Class II (special controls). Consensus standards and labeling restrictions.

Predicate Devices

• HK Klein Surgical KIP-II Infiltrator (K031432)
• Liposat Basic (K072793)

Submission Summary (Full Text)

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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, [e-mail].

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 [phone] or [phone] 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 [phone] or [phone] 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) | |
|------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| <span style="font-size: 100%;"> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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Black & Black Surgical 5238 Royal Woods Parkway Suite 170 Tucker, GA. 30084 [e-mail] 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, [e-mail] 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, [e-mail]

#### 2. Name of Device: Vitruvian Infiltration Pump

Proprietary Name: Vitruvian Infiltration Pump

Common Name: Infiltration Pump

- 3. Classification: Suction Lipoplasty System, Class II - 21 CFR §878.5040 (1998)
- 4. 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 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.

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Black & Black Surgical 5238 Royal Woods Parkway Suite 170 Tucker, GA. 30084 [e-mail] 770-414-4880

#### 7. Indications for Use: Aesthetic Body Contouring

#### 8. Comparison to Predicate

| Item | Predicate Device 1 | Predicate Device 2 | Subject Device: #1 | Similarity<br>1/2 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|-----------------------------------|------------------------|
| Device name | HK Klein Surgical KIP-II<br>Infiltrator | Liposat Basic | Vitruvian<br>Infiltration<br>Pump | N/A |
| Device Manufacturer | HK Surgical | Moller Medical<br>GmbH | Black & Black Surgical,<br>Inc. | N/A |
| 510(k) Reference | K031432 | K072793 | Not yet assigned | N/A |
| FDA Product Code | FRN | MUU | MUU | Different/Same |
| FDA Classification | Suction<br>System | Lipoplasty<br>Suction<br>System | Suction<br>Lipoplasty<br>System | Same |
| FDA Regulation # | 880.5725 | 878.5040 | 878.5040 | Different/Same |
| Indication for Use /<br>Intended Use | This Infiltration Pump is used<br>to cause a flow of fluid from<br>an IV bag into patient in a<br>manner controlled manually<br>by a health care professional.<br>The Klein Pump is not<br>intended to be used as an IV<br>infusion pump. | Aesthetic Body<br>contouring | Aesthetic body<br>contouring. | Similar/ Same |
| Specific drug, biologic<br>use | N/A | N/A | N/A | Same |
| Administrative sets &<br>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/Alarm<br>functions | 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 Performance<br>Plastic | ABS plastic | Different /<br>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 |

9. Performance Testing

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Black & Black Surgical 5238 Royal Woods Parkway Suite 170 Tucker, GA. 30084 [e-mail] 770-414-4880

The device complies with the following standards:

| Tested/Evaluated<br>Standard | Results |
|------------------------------------------------------------------------------------------------------------------|----------|
| IEC 60601 1:2005 (Third Edition)<br>+ CORR. 1:2006 + CORR. 2:2007<br>+ A1:2012 (or IEC 60601-1: 2012<br>reprint) | Complies |
| ANSI/AAMI ES60601-1:2005<br>+A1:2012 + A2:2010, ed. 3.1 | Complies |
| CAN/CSA C22.2 No. 60601-1 Ed.<br>3 + A1(2014) | Complies |
| EN 60601-1:2006 + A1:2013<br>(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.