(112 days)
Not Found
No
The device description focuses on mechanical components and a piston-cylinder system, with no mention of AI or ML. The submission is for a labeling change and additional indications, with no design modifications.
Yes.
The device is intended for aesthetic body contouring, which is a therapeutic purpose.
No
The device is described as a suction pump for aesthetic body contouring (liposuction), which is a treatment procedure, not a diagnostic one.
No
The device description clearly outlines a physical suction pump with mechanical components (motor, pistons, cylinders, etc.) and electrical components (AC power, switches, cords). It is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "aesthetic body contouring," which is a surgical procedure performed on the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a suction pump used to remove fluids (likely fat and other tissues) during liposuction procedures. This is a therapeutic/surgical function, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) to diagnose a condition or disease.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device operates in vivo (within the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
The Medela® Dominant 50 Lipo is intended to be used for aesthetic body contouring.
Product codes (comma separated list FDA assigned to the subject device)
QPB, MUU
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body
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)
Not Found
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.
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 Lipo
Secretion & Surgical Aspirator |
|----------------------|-------------------------------------------------------------------------------|
| Common Name: | Powered Suction Pump Dominant 50 Lipo |
| Classification Name: | SUCTION LIPOPLASTY SYSTEM
Classified 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 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.
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.