Basic: The intended use of the Basic suction pump is the creation of a constant vacuum for use in hospitals and clinics. This vacuum can be used for general suction, to aspirate and remove: surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials and during specific procedures which may include, vacuum extraction, aspiration during flexible endoscopy, use with cardiac tissue stabilizers during off-pump coronary artery bypass and epicardial ablation probes.

Dominant Flex: The intended use of the Dominant Flex suction pump is the creation of a constant vacuum for use in hospitals and clinics. This vacuum can be used for general suction, to aspirate and remove: surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials and during specific procedures which may include, vacuum extraction, aesthetic body contouring, aspiration during flexible endoscopy, use with cardiac tissue stabilizers during off-pump coronary artery bypass, and epicardial ablation probes.

Device Description

The Medela" Basic and Dominant Flex are high vacuum and high flow, AC-powered suction pumps that can be used when large quantities of fluid must be suctioned quickly in the hospital, ambulatory surgery center, clinic, and doctors' practice. Their construction includes a piston and cylinder system which provides strong suction performance and quiet, dependable operation and a microcontroller which is used to control motor speed and the user interface. Additional advantages of the Medela" Basic and Dominant Flex are user friendliness and simple cleaning.

Medela® Basic and Dominant Flex cover the 4 main functions of

. Powerful and high suction capacity
. Rapid vacuum build-up
Low vibrations and quiet
. Design; smooth surface and easy to use and clean

The Medela" Basic provides a fixed airflow of 30 l/m and the Medela" Dominant Flex offers the innovative function of selectable airflow of 40, 50 or 60 l/m.

All operating elements for nurses or doctors are located on the front side of both pumps. These include the vacuum gauge, vacuum regulator knob, operating elements and Safety Set. The Safety Set consists of a 0.25l jar, lid and float and prevents an overflow into the pump. The Medela" Basic and Dominant Flex suction pumps can be operated via capacitive sensors (called "CleanTouch") to turn the pumps on/off. Additionally the Dominant Flex has capacitive sensors for adjusting the flow between 40, 50 and 60 l/m. Both pumps have a knob for the vacuum regulator. The vacuum inside the tubing is displayed on the vacuum gauge. The Medela" Basic and Dominant Flex use three indicator lights to provide information to the user on the status of the pump. All operating elements for the biomedical technicians are located on the back side. This is where the appliance inlet for plugging in the power cord is located.

Both pumps are available either as rack or portable version can be combined with the trolley to create a mobile version.

A variety of reusable and disposable accessories are available for use with the Medela" Basic and Dominant Flex suction pumps or are intended to be marketed with these pumps.

AI/ML Overview

This document is an FDA 510(k) summary for the Medela Basic and Dominant Flex suction pumps. It states that no clinical testing was performed for this submission, as it relates primarily to re-phrased and slightly expanded indications for use. Therefore, the information typically found in acceptance criteria tables and study results for clinical performance is not present.

However, based on the provided document, here's what can be inferred and stated regarding the device and its compliance, specifically focusing on the non-clinical aspects and the lack of a clinical study for this 510(k):

Acceptance Criteria (Non-Clinical) and Reported Device Performance

Since this 510(k) is an administrative change to re-phrase and expand existing indications for use, and explicitly states "The Basic and Dominant Flex Suction Pumps have not been the subject of clinical testing," there isn't a table of clinical acceptance criteria and performance data as one would expect from a new device submission or a performance study.

Instead, the acceptance criteria for this specific submission relate to non-clinical performance and compliance with relevant standards. The document highlights:

Acceptance Criteria (Non-Clinical)	Reported Device Performance
Compliance with voluntary standards for electrical safety	Demonstrated compliance with standards.
Compliance with voluntary standards for electromagnetic compatibility	Demonstrated compliance with standards.
Compliance with voluntary standards for safety of electrically powered suction pumps	Demonstrated compliance with standards.
No impact on compliance to standards due to changes to product labeling/indications for use	Changes to labeling did not impact compliance.
Maintenance of performance as intended despite re-phrased indications	Verification and Validation testing demonstrated no adverse effects and device performs as intended.
Equivalence to predicate devices for new indications	Stated as "substantially equivalent" based on nonclinical testing and unchanged intended use.
Compliance with IEC 60601-1-2 (4th edition)	Demonstrated compliance with the newer 4th edition.

Study Details (Focusing on the 510(k) submission, not a clinical study):

For this particular 510(k) submission (K170329), a traditional clinical study with patient data was not conducted. The basis for substantial equivalence relies on:

Predicate Device Equivalence: The Medela Basic and Dominant Flex were previously cleared under K150134. This submission re-phrases indications and adds "general suction" which is stated as being identical to the predicate device, Penumbra Aspiration Pump (K051758).
Non-Clinical Testing: Verification and Validation testing were performed to ensure that the labeling changes did not adversely affect the device's performance or compliance with safety standards.

Therefore, many of the typical questions for a clinical study are not applicable here.

Sample sizes used for the test set and the data provenance: Not applicable, as no new clinical test set was used for this 510(k) submission. Non-clinical testing (e.g., electrical safety, EMC) would involve testing units of the device, not patient data. The document implies prior testing for the original clearance (K150134) is still valid.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth typically refers to clinical diagnosis or outcomes. For non-clinical testing, expert judgement might be involved in reviewing test protocols and results, but it's not "ground truth" in the clinical sense.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 suction pump, not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this specific submission, the "ground truth" for the device's performance is adherence to established engineering and safety standards, and functional verification that the re-phrased indications do not alter the physical operation or safety of the pump. The [K150134](https://510k.innolitics.com/search/K150134) submission, which initially cleared these devices, would have relied on previously established predicate device performance and non-clinical testing.
The sample size for the training set: Not applicable. This refers to machine learning algorithms, which is not what this device is.
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 logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.

Modela AG % Adrienne Lenz Member Pathway Regulatory Consulting, LLC W324S3649 County Road E Dousman. Wisconsin 53118

June 9, 2021

Re: K170329

Trade/Device Name: Basic, Dominant Flex Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB

Dear Adrienne Lenz:

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 March 24, 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

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 24, 2017

Medela Ag % Ms. Adrienne Lenz Pathway Regulatory Consulting, LLC W324S3649 County Road E Dousman, Wisconsin 53118

Re: K170329

Trade/Device Name: Basic, Dominant Flex Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: BTA, MUU, HDB Dated: January 30, 2017 Received: February 2, 2017

Dear Ms. Lenz:

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 device

{2}------------------------------------------------

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

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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

Indications for Use

510(k) Number (if known) K170329

Device Name Dominant Flex

Indications for Use (Describe)

The intended use of the Dominant Flex suction of a constant vacuum for use in hospitals and clinics.

This vacuum can be used for general suction, to aspirate and remove: surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials and during specific procedures which may include, vacuum extraction, aesthetic body contouring, aspiration during flexible endoscopy, use with cardiac tissue stabilizers during off-pump coronary artery bypass, and epicardial ablation probes.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

Indications for Use

510(k) Number (if known) K170329

Device Name Basic

Indications for Use (Describe)

The intended use of the Basic suction pump is the creation of a constant vacuum for use in hospitals and clinics.

This vacuum can be used for general suction, to aspirate and remove: surgical fluids, tissue (in-cluding bone), gases, bodily fluids or infectious materials and during specific procedures which may include, vacuum extraction, aspiration during flexible endoscopy, use with cardiac tissue stabilizers during off-pump coronary artery bypass and epicardial ablation probes.

Type of Use ( Select one or both, as applicable )
☑ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

510(k) Summary

K170329

In accordance with 21 CFR 807.92 the following summary of information is provided:

DATE: March 22, 2017

SUBMITTER:

Medela AG Lättichstrasse 4b 6341 Baar / Switzerland Phone +41 (0)41 561 66 71 Fax + 41 (0)41 769 51 00

PRIMARY CONTACT PERSON:

Adrienne Lenz, RAC Member Pathway Regulatory Consulting, LLC T 262-290-0023

SECONDARY CONTACT PERSON:

Markus Bütler Director Post Market Surveillance Medela AG

DEVICE:

TRADE NAME: Basic, Dominant Flex

COMMON/USUAL NAME: Powered Suction Pump

CLASSIFICATION NAMES: 21 CFR 878.4780 Powered Suction Pump

PRODUCT CODE: BTA

SECONDARY CLASSIFICATIONS:

System, suction, lipoplasty - MUU, 21 CFR 878.50406 Extractor, vacuum, fetal- HDB, 21 CFR 884.4340

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

PREDICATE DEVICE(S):

K150134 Basic and Dominant Flex Suction Pumps

K051758 Penumbra Aspiration Pump

DEVICE DESCRIPTION:

Medela® Basic and Dominant Flex cover the 4 main functions of

. Powerful and high suction capacity
. Rapid vacuum build-up
Low vibrations and quiet
. Design; smooth surface and easy to use and clean

The Medela" Basic provides a fixed airflow of 30 l/m and the Medela" Dominant Flex offers the innovative function of selectable airflow of 40, 50 or 60 l/m.

Both pumps are available either as rack or portable version can be combined with the trolley to create a mobile version.

A variety of reusable and disposable accessories are available for use with the Medela" Basic and Dominant Flex suction pumps or are intended to be marketed with these pumps.

{7}------------------------------------------------

INTENDED USE:

The intended use for Medela's Basic and Dominant Flex Suction Pumps is to provide a vacuum source for use in hospitals and clinics.

INDICATIONS FOR USE:

Basic

The intended use of the Basic suction pump is the creation of a constant vacuum for use in hospitals and clinics.

This vacuum can be used for general suction, to aspirate and remove: surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials and during specific procedures which may include, vacuum extraction, aspiration during flexible endoscopy, use with cardiac tissue stabilizers during off-pump coronary artery bypass and epicardial ablation probes.

Dominant Flex

The intended use of the Dominant Flex suction pump is the creation of a constant vacuum for use in hospitals and clinics.

DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

This 510(k) submission revises the labeling of the Basic and Dominant Flex to modify the indications for use. The indications for use have been re-phrased. The indication for aspiration and removal of infectious materials from wounds or from a patient's airway or respiratory support system either during surgery or at the bedside has been modified to remove the locations from which infectious materials are aspirated or removed.

A new indication for general suction has been added for the Basic and Dominant Flex Suction Pumps to cover other general uses. This additional indication does not affect the intended use of the pump to provide suction and is identical to the predicate device, Penumbra Aspiration Pump (K051758).

Several previously cleared indications are now identified as specific procedures: vacuum extraction, aesthetic body contouring, aspiration during flexible endoscopy, use with cardiac tissue stabilizers during off-pump coronary artery bypass and epicardial ablation probes.

{8}------------------------------------------------

There are no differences in the contraindications between the proposed and predicate devices. Additionally, the pumps have identical specifications and use identical technology to the Basic and Dominant Flex were cleared in K150134.

SUMMARY OF NON-CLINICAL TESTS:

The Basic and Dominant Flex Suction pumps comply with voluntary standards for electrical safety, electromagnetic compatibility, and safety of electrically powered suction pumps. The changes to the product labeling for new indications for use did not impact compliance to standards as compared to the pumps cleared in K150134. Although not driven by a change to the pump, compliance with the newer 4th edition of IEC 60601-1-2 was demonstrated. Previously submitted testing in K130123 and K150134 are still valid for the general suction and other specific procedures listed in the Basic and Dominant Flex Indications for Use.

SUMMARY OF CLINICAL TESTS:

The Basic and Dominant Flex Suction Pumps have not been the subject of clinical testing.

CONCLUSION:

The new indications for use do not change the intended use of the pump, to provide a vacuum source for use in hospitals and clinics, and do not raise new issues of safety and effectiveness as compared to the predicate devices. Verification and Validation testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended.

From the results of nonclinical testing described, Medela AG concludes that the Basic and Dominant Flex are substantially equivalent to the legally marketed predicate device.

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.