K Number

Device Name

BASIC AND DOMINANT FLEX SUCTION PUMPS

Manufacturer

MEDELA AG

Date Cleared

2013-10-11

(267 days)

Product Code

BTA HDB

Regulation Number

878.4780

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K021368, K011725

Reference Devices

K042943

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a mechanical suction pump with a microcontroller for basic control, but no mention of AI/ML capabilities or data processing for decision-making.

Therapeutic

Yes
The device is clearly indicated for medical purposes such as "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." These are therapeutic interventions aimed at treating or managing patient conditions.

Diagnostic

The device is a suction pump designed for the removal of fluids and materials, which is a therapeutic rather than a diagnostic function.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components like a piston and cylinder system, vacuum gauge, vacuum regulator knob, operating elements, Safety Set, and capacitive sensors, indicating it is a hardware device with integrated software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes the device as being used for vacuum extraction, aspiration of fluids and materials from the body (wounds, airways, etc.) during surgical procedures or at the bedside. This is a direct interaction with the patient's body for therapeutic or procedural purposes.
Device Description: The description details a suction pump designed to create vacuum and move fluids. This aligns with the intended use of physically removing substances from the body.
Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes. The provided information does not mention any analysis or testing of the collected fluids or materials in vitro. The device's function is solely the collection and removal of these substances.

The device is a medical device used for aspiration and suction, which are clinical procedures performed on the patient. It does not perform any diagnostic testing on samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

BTA, HDB

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

wounds or from a patient's airway or respiratory support system

Indicated Patient Age Range

Not Found

Intended User / Care Setting

hospital, ambulatory surgery center, clinic, and doctors' practice / nurses or doctors

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)

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.

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.

K021368 Medela "Basic 30" and "Dominant 50" Suction Pumps, Models 037, 057, K011725 Olympus Suction Pump, Model KV-5

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.

K042943

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

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.

Summary

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

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.

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
510(k)
Number	---	K021368
Indications
for Use	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.	The Basic 30 and
dominant 50 Suction
Pumps are indicated for
vacuum extraction,
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 patient's
bedside.	Equivalent. Dominant 50
was cleared for general
suction in K021368. The
Olympus KV-5 Suction
Pump (K011725) is
cleared for the indication
for aspiration during
flexible endoscopy.

	Basic and Dominant Flex
Housing and
User Interface	Capacitive Touch Sensors
which allows housing with
all flat surfaces:
LED Indicators		On/Off Switch which
creates gaps in the
housing.
LED Indicators		Equivalent. Both devices
have similar controls and
indicators. There are no
gaps/edges around the
"buttons" of the Basic and
Dominant Flex leading to
a full surface for a wipe-
off disinfection.
Flow
liters/min	30 l/min (Basic)
Selectable 40 l/min, 50
l/min, 60 l/min (Dominant
Flex)		30 l/min (Basic 30)
50 l/min (Dominant 50)		Equivalent. Other pumps,
including the Vacuson 40
and Vacuson 60
(K042943, Reference
Device) which was cleared
as substantially
equivalent to the
predicate Basic 30 and
Dominant 50 have flows
of 40 and 60 liters/min.
Maximum
vacuum
mmHg/kPa	Basic
-675mmHg
-90 kPa	Dominant
Flex
-713mmHg
-95 kPa	Basic 30
-638 mmHg
-85 kPa	Dominant
50
-675 mmHg
-90 kPa	Equivalent. Dominant
Flex now offers a slightly
higher vacuum.
Flow control	Software is used to
change the revolutions
per minute (RPM) of the
motor allowing the
different flow values.		Flow is not adjustable.
The different flow rates of
the Basic 30 and
Dominant 50 were
controlled based on the
size of the cylinder		Equivalent. Both
technologies (changing
motor RPM or using
different cylinder sizes)
achieve the desired flow
rates.
The Laerdal Suction Unit
(K993668) also has
electronics to control the
flow rate. Their flow rate
is coupled with the
vacuum level (the higher
the vacuum, the higher
the flow).

・

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.

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

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

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.