The Basic and Dominant Flex Suction Pumps are indicated for vacuum extraction, aspiration during flexible endoscopy and aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system either during surgery or at the bedside.

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 I/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

The provided text describes a 510(k) summary for the Medela Basic and Dominant Flex Suction Pumps. It aims to demonstrate substantial equivalence to predicate devices rather than conducting a de novo study to establish new acceptance criteria and prove performance against them.

Therefore, the submission does not contain information typically found in a study designed to prove a device meets specific acceptance criteria using defined performance metrics, sample sizes, expert ground truth, or MRMC studies. Instead, it focuses on comparing the new device's technological characteristics and intended use to previously cleared predicate devices.

Here's a breakdown of why the requested information is largely absent or not directly applicable to this type of submission, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not presented in the context of a de novo study the device meets. The submission primarily compares the new device's specifications (flow, maximum vacuum) to predicate devices and asserts equivalence.

Characteristic	Acceptance Criteria (from study)	Reported Device Performance (from study)	Why not available/applicable
Vacuum Performance	(Not explicitly defined as acceptance criteria for a new study)	Basic: -675mmHg (-90kPa)Dominant Flex: -713mmHg (-95kPa)	These are specifications of the new device, compared to predicate device specifications for equivalence, not new acceptance criteria proven by a study. The "Discussion of Differences" states "Equivalent. Dominant Flex now offers a slightly higher vacuum."
Flow Rate	(Not explicitly defined as acceptance criteria for a new study)	Basic: 30 l/minDominant Flex: Selectable 40, 50, 60 l/min	These are specifications of the new device, compared to predicate device specifications for equivalence. The "Discussion of Differences" states "Equivalent."
Noise Level	(Not explicitly defined, but "Low vibrations and quiet" is a claimed feature)	"Bench Testing demonstrated that the specifications for vacuum, flow, noise and endurance were met."	Specific quantitative noise acceptance criteria and measured performance are not provided.
Endurance	(Not explicitly defined)	"Bench Testing demonstrated that the specifications for vacuum, flow, noise and endurance were met."	Specific quantitative endurance acceptance criteria and measured performance are not provided.
Electrical Safety	Compliance with IEC 60601-1	Compliance demonstrated	Non-quantitative (compliance with standard)
EMC	Compliance with IEC 60601-1-2	Compliance demonstrated	Non-quantitative (compliance with standard)
Electrically Powered Suction Pump Safety	Compliance with ISO 10079-1	Compliance demonstrated	Non-quantitative (compliance with standard)

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

Not applicable. The submission does not describe a clinical study with a "test set" in the sense of patient data or samples used to evaluate device performance against clinical endpoints. The "non-clinical tests" mentioned (Risk Analysis, Software Validation, Electrical Safety, etc.) are engineering and regulatory compliance activities, not clinical performance studies on a specific dataset.

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

Not applicable. No multi-reader, multi-case study with ground truth established by experts is described.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "The Basic and Dominant Flex Suction Pumps have not been the subject of clinical testing."

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

Not applicable. This device is a powered suction pump, a physical medical device, not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

Not applicable. There is no clinical study described that required a "ground truth" (e.g., pathology, outcomes data) to evaluate diagnostic or therapeutic accuracy. The closest concept is the "Bench Testing" which verified engineering specifications.

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/ML device, there is no "training set" in the context of machine learning.

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

Not applicable for the same reason as point 8.

In summary, the provided document is a 510(k) submission which focuses on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices through a comparison of technological characteristics, intended use, and adherence to relevant voluntary standards. It explicitly states that no clinical testing was performed on the new device, and thus, does not detail studies designed to establish and meet specific performance acceptance criteria in the manner requested.

Summary

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

510(k) Summary

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

DATE: October 10, 2013

SUBMITTER:

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

OCT 1 1 2013

PRIMARY CONTACT PERSON:

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

SECONDARY CONTACT PERSON:

Orlando Atunes Vice President Regulatory Affairs 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:

Extractor, vacuum, fetal- HDB, 21 CFR 884.4340

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

Medela AG Basic and Dominant Flex Suction Pumps

PREDICATE DEVICE(S):

K021368 Medela "Basic 30" and "Dominant 50" Suction Pumps, Models 037, 057

K011725 Olympus Suction Pump, Model KV-5

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 I/m.

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

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

Medela AG Basic and Dominant Flex Suction Pumps

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.

INTENDED USE:

DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

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

The Basic and Dominant Flex Suction Pumps use the same fundamental technology as the Basic 30 and Dominant 50 Suction Pumps for most features. Basic and Dominant Flex are similar to the predicate devices in their indications for use. The user interface is also similar to the predicate devices. The main differences are improvements in the housing for easier maintenance and cleaning and the selectable flow feature of Dominant Flex. The table below summarizes the key differences between the Basic and Dominant Flex Suction Pumps and the main predicate devices.

	Basic and Dominant Flex	Basic 30 and Dominant 50	Discussion of Differences
510(k)Number	---	K021368
Indicationsfor Use	The Basic and DominantFlex Suction Pumps areindicated for vacuumextraction, aspirationduring flexibleendoscopy andaspiration and removalof surgical fluids, tissue(including bone), gases,bodily fluids orinfectious materialsfrom wounds or from apatient's airway orrespiratory supportsystem either duringsurgery or at thebedside.	The Basic 30 anddominant 50 SuctionPumps are indicated forvacuum extraction,aspiration and removal ofsurgical fluids, tissue(including bone), gases,bodily fluids or infectiousmaterials from wounds orfrom a patient's airway orrespiratory supportsystem, either duringsurgery or at the patient'sbedside.	Equivalent. Dominant 50was cleared for generalsuction in K021368. TheOlympus KV-5 SuctionPump (K011725) iscleared for the indicationfor aspiration duringflexible endoscopy.

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

	Basic and Dominant Flex		Basic 30 and Dominant 50		Discussion of Differences
Housing andUser Interface	Capacitive Touch Sensorswhich allows housing withall flat surfaces:LED Indicators		On/Off Switch whichcreates gaps in thehousing.LED Indicators		Equivalent. Both deviceshave similar controls andindicators. There are nogaps/edges around the"buttons" of the Basic andDominant Flex leading toa full surface for a wipe-off disinfection.
Flowliters/min	30 l/min (Basic)Selectable 40 l/min, 50l/min, 60 l/min (DominantFlex)		30 l/min (Basic 30)50 l/min (Dominant 50)		Equivalent. Other pumps,including the Vacuson 40and Vacuson 60(K042943, ReferenceDevice) which was clearedas substantiallyequivalent to thepredicate Basic 30 andDominant 50 have flowsof 40 and 60 liters/min.
MaximumvacuummmHg/kPa	Basic-675mmHg-90 kPa	DominantFlex-713mmHg-95 kPa	Basic 30-638 mmHg-85 kPa	Dominant50-675 mmHg-90 kPa	Equivalent. DominantFlex now offers a slightlyhigher vacuum.
Flow control	Software is used tochange the revolutionsper minute (RPM) of themotor allowing thedifferent flow values.		Flow is not adjustable.The different flow rates ofthe Basic 30 andDominant 50 werecontrolled based on thesize of the cylinder		Equivalent. Bothtechnologies (changingmotor RPM or usingdifferent cylinder sizes)achieve the desired flowrates.The Laerdal Suction Unit(K993668) also haselectronics to control theflow rate. Their flow rateis coupled with thevacuum level (the higherthe vacuum, the higherthe flow).

・

Medela AG Basic and Dominant Flex Suction Pumps

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

Medela AG Basic and Dominant Flex Suction Pumps

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 following quality assurance measures were applied to the development of the system:

. Risk Analysis
Software Validation
Electrical safety and electromagnetic compatibility testing per IEC 60601-1 and IEC . 60601-1-2 standards, respectively
Safety testing per ISO 10079-1 standard for electrically powered suction pumps .
Bench Testing demonstrated that the specifications for vacuum, flow, noise and . endurance were met.

SUMMARY OF CLINICAL TESTS:

The Basic and Dominant Flex Suction Pumps have not been the subject of clinical testing. A clinical evaluation of published literature has been conducted for Basic and Dominant Flex Suction Pumps to support the use for the listed indications.

CONCLUSION:

Medela AG considers the Basic and Dominant Flex Suction Pumps to be as safe, as, as effective as, and substantially equivalent to the predicate devices.

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

Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The bird is positioned within a circular border. Encircling the bird are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

October 11, 2013

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

Medela AG % Ms. Adrienne Lenz, RAC Member W324 S3649 County Road E Dousman. Wisconsin 53118

Re: K130123 Trade/Device Name: Basic and Dominant Flex Suction Pumps Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: BTA, HDB Dated: September 9, 2013 Received: September 10. 2013

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

Page 2 - Ms. Adrienne Lenz, RAC

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,

Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

K130123 510{k) Number (if known):

Basic and Dominant Flex Suction Pumps Device Name:

Indications for Use:

Prescription Use_ X

AND/OR

Over-The-Counter Use_

(Part 21 CFR 801 Subpart D)

(Part 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)

Image /page/7/Picture/11 description: The image shows the name "Jiyoung Dang -S" in a bold, sans-serif font. The text is black against a white background, making it highly legible. The name appears to be a signature or a title, with the "-S" possibly indicating an initial or a designation.

Regulation Number and Section

§ 878.4780 Powered suction pump.

(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.