The Medela® Dominant 50 Lipo Suction Pump is identical to original and approved Medela Dominant 50 Secretion Aspirators (K021368), which is all based on the wellproven Medela piston-cylinder system.

The Medela® Dominant 50 Lipo suction pump is an AC powered aspirator and incorporates in its housing an AC-motor with a flat belt power transmission to the pistons and cylinders, an ON/OFF-switch, a vacuum gauge in kPa and mmHG, a membrane vacuum requlator, a safety device of polysulfone with an overflow protection device and connection tubing, an electric cord and an instruction manual.

The standard mobile version includes a mobile stand with fitting rails 10 x 25 mm, 4 antistatic castors, two with locking device and an integrated ON/OFF foot switch. The Medela® Dominant 50 Lipo also comes in rack versions i.e. without handle and cable holder for storage/operation in racks with reduced space.

This notification for the Medela® Dominant 50 Lipo Suction Pump is for labeling change and to include additional indications. There have been no modifications or design changes to the currently cleared and marketed Medela® Dominant 50, 510(k) No. K021368.

The Medela® Dominant 50 Lipo Suction Pump is a further innovative development of Medela's well-proven piston/cylinder system. The drive power is transferred to the piston/cylinder modules. The required suction value is rapidly built-up. High suction performance and low weight are positive features of the Vario pump.

The Medela® Dominant 50 Lipo suction pump has a suction capacity of 50 liters per minute and a maximum vacuum up to -90 kPa (-675 mmHg). The pump is marked "high vacuum - high flow".

A variety of reusable and disposable accessories are available. A variety of cannuals for various liposuction procedures and aesthetic body contouring are also available.

AI/ML Overview

The Medela® Dominant 50 Lipo Suction Pump's acceptance criteria and the study proving its compliance are laid out below:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
No "new aspects regarding safety and effectiveness" due to modifications. (Implied acceptance criteria based on decision-making process for device changes.)	The device is "identical in construction and performance to the legally marketed device as submitted under FDA File Number K021368." The "only modification relates to a more differentiated trade name - Medela® Dominant 50 Lipo instead of Medela® Dominant 50 only (Lipo reflects the intended use)."
Substantial Equivalence to Predicate Device	Concluded to be "substantially equivalent, reliable, safe and effective for the intended use" to the Medela® Dominant 50 Secretion Aspirators (K021368) and other listed predicate devices (HK Liposuction Aspirator, Vacusat®).
Adherence to FDA Guidance "Deciding When to Submit a 510(k) for a Change to an Existing Device"	The modification (trade name and additional indications) "does not affect the safety or effectiveness of the device (e.g. a significant change or modification in design, material, chemical composition, energy source or manufacturing process)."
Specific Performance Metrics (for a powered suction pump)	Suction capacity of 50 liters per minute. Maximum vacuum up to -90 kPa (-675 mmHg). Marked "high vacuum - high flow." (These are performance characteristics of the identical predicate device, not new test results for this 510(k) submission).

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

The provided document describes a 510(k) summary for a substantial equivalence determination, not a clinical study with a distinct test set of patient data.

Sample Size: Not applicable. This submission relies on the existing clearance of an identical device and asserts that no new performance testing data from a "test set" is required because there are no technical changes affecting safety or effectiveness.
Data Provenance: Not applicable in the context of a new test set. The submission refers to the predicate device's existing clearance (K021368), which implies that any performance data from that previous clearance would be considered "retrospective" in relation to this administrative update. The document itself does not detail the provenance of the data that supported the original K021368 clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As described above, there was no new "test set" of data requiring expert evaluation for ground truth establishment. The substantial equivalence determination is based on the technical characteristics of the device and comparison to legally marketed predicates.

4. Adjudication Method for the Test Set

Not applicable. No new test set requiring adjudication was used.

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 device is a powered suction pump for lipoplasty and does not involve AI or human readers for diagnostic interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a mechanical medical device (suction pump), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness of the existing predicate device, the Medela® Dominant 50 Secretion Aspirator (K021368), and its adherence to relevant performance specifications (e.g., suction capacity, maximum vacuum). The claim is that the proposed device is identical in all relevant aspects to this predicate.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is in blue and consists of the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". To the left of the FDA logo is the Department of Health & Human Services logo.

June 8, 2021

Medela Ag Werner Frei Mgr., RA Laettichstrasse 4b Baar, Zug, CH-6341 Switzerland

Re: K063336

Trade/Device Name: Medela Dominant 50 Lipo, Model 600-5706 Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB

Dear Werner Frei:

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 February 26, 2007. 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}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three bars forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medela AG % Mr. Bruno Gretler Regulatory Affairs Laettichstrasse 4b 6341 Baar Switzerland

FEB 2 6 6 min

K063336 Re: Trade/Device Name: Medela® Dominant 50 Lipo, Model 600-5706 Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplarty system Regulatory Class: Class II Product Code: MUU Dated: January 30, 2007 Received: January 31, 2007

Dear Mr. Gretler:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 lisung (21 CFR Part 807); labeling (21 CFR Part 801); 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}------------------------------------------------

Page 2 - Mr. Bruno Gretler

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Neil R. Mc Gahan

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

KO63376 W

Indications for Use

510(k) Number (if known):

Device Name:

Medela® Dominant 50 Lipo

Indications For Use: The Medela® Dominant 50 Lipo is intended to be used for aesthetic body contouring.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nifkrol

Page 1 of 1

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K063330

{4}------------------------------------------------

CD63336 Medela AG, Laettichstrasse 4b, CH-6341 Baar, Switzerland Applicant: Contact Person: Werner Frei, Tel +41 (41) 769 51 51 ext. 228; Fax +41 (41) 769 51 00 werner frei@medela.ch Traditional 510(k) Submission for Medela® Dominant 50 Lipo

Section E - 510(k) Summary

This 510(k) summary for the Medela® Dominant 50 Lipo Powered Suction Pump meets the requirements of 21 CFR 807.92.

Sponsor's Name, Address and Contact Person 1

Sponsor: Medela AG Medical Equipment Laettichstrasse 4b 6341 Baar Switzerland +41 41 769 5151 ext. 228 Ph: +41 41 769 5100 Fax:

Contact Person Werner Frei Manager Regulatory Affairs

Date Summary Prepared: November 2, 2006

Name of Device 2

Trade Name:	Medela® Dominant 50 LipoSecretion & Surgical Aspirator
Common Name:	Powered Suction Pump Dominant 50 Lipo
Classification Name:	SUCTION LIPOPLASTY SYSTEMClassified Class II, per 21 CFR Section 878.5040
Product Code:	MUU

Name of the predicate Device(s) 3

Medela® Basic, Median, Dominant, Vario Suction Pumps, by Medela Inc. . K021368
. HK Liposuction Aspirator, Model AP-111 & AP230-III, by HK Surgical Inc. K032802
Vacusat® (Aspiration/Suction Pump), Model # 00 002 252 and Model # 00 002 318, . by Moeller Medical GmbH & Co. AG K053451

$\varphi_3$

FEB 2 6 2007

{5}------------------------------------------------

166336 711 Medela AG, Laettichstrasse 4b, CH-6341 Baar, Switzerland Applicant: Contact Person: Werner Frei, Tel +41 (41) 769 51 51 ext. 228; Fax +41 (41) 769 51 00 werner frei@medela.ch Traditional 510(k) Submission for Medela® Dominant 50 Lipo

Device Description ব

The Medela® Dominant 50 Lipo Suction Pump is identical to original and approved Medela Dominant 50 Secretion Aspirators (K021368), which is all based on the wellproven Medela piston-cylinder system.

The Medela® Dominant 50 Lipo suction pump has a suction capacity of 50 liters per minute and a maximum vacuum up to -90 kPa (-675 mmHg). The pump is marked "high vacuum - high flow".

A variety of reusable and disposable accessories are available. A variety of cannuals for various liposuction procedures and aesthetic body contouring are also available.

Indications for use 5

The Medela® Dominant 50 Lipo Suction Pump is intended to be used for aesthetic body contouring.

{6}------------------------------------------------

6063336 Applicant: Medela AG, Laettichstrasse 4b, CH-6341 Baar, Switzerland Contact Person: Werner Frei, Tel +41 (41) 769 51 51 ext. 228; Fax +41 (41) 769 51 00 werner.frei@medela.ch Traditional 510(k) Submission for Medela® Dominant 50 Lipo

Summary of Technological Characteristics 6

The Medela® Dominant 50 Lipo Suction Pump is identical in construction and performance to the legally marketed device as submitted under FDA File Number K021368 there are no technical differences which would raise new aspects regarding safety and effectiveness.

The only modification relates to a more differentiated trade name - Medela® Dominant 50 Lipo instead of Medela® Dominant 50 only (Lipo reflects the intended use).

Conclusion 7

According to the FDA Guidance "Deciding When to Submit a 510(k) for a Change to an Existing Device", the modification mentioned above does not affect the safety or effectiveness of the device (e.g. a significant change or modification in design, material, chemical composition, energy source or manufacturing process). All conclusions are made by the decision making process according above mentioned guidance document.

Based upon the information presented above and in this 510(k) submission, it is concluded that the proposed Medela® Dominant 50 Lipo suction pump is substantially equivalent, reliable, safe and effective for the intended use.

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.