BASIC AND DOMINANT FLEX SUCTION PUMPS
Device Facts
| Record ID | K130123 |
|---|---|
| Device Name | BASIC AND DOMINANT FLEX SUCTION PUMPS |
| Applicant | Medela AG |
| Product Code | BTA · General, Plastic Surgery |
| Decision Date | Oct 11, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4780 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
AC-powered high vacuum/flow suction pumps for hospital, ambulatory surgery, clinic, or bedside use. System utilizes piston/cylinder mechanism for fluid aspiration. Operated by physicians, nurses, or technicians via front-panel capacitive touch sensors (CleanTouch) and vacuum regulator knobs. Microcontroller manages motor speed and user interface; LED indicators display status. Safety Set (jar, lid, float) prevents pump overflow. Dominant Flex model offers selectable airflow (40, 50, 60 l/m); Basic model provides fixed 30 l/m. Output is vacuum pressure displayed on gauge. Device facilitates rapid fluid removal, aiding surgical procedures and airway management. Mobile configurations available via trolley.
Clinical Evidence
No clinical testing performed. Evidence consists of bench testing (vacuum, flow, noise, endurance) and a clinical evaluation of published literature to support the intended indications.
Technological Characteristics
AC-powered piston/cylinder suction pump. Materials: unspecified. Features: capacitive touch sensors, LED indicators, vacuum gauge, regulator knob. Flow: 30 l/m (Basic); 40/50/60 l/m (Dominant Flex). Vacuum: -675 mmHg (Basic); -713 mmHg (Dominant Flex). Connectivity: standalone. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), ISO 10079-1 (suction pumps). Software: microcontroller-based motor speed control.
Indications for Use
Indicated for patients requiring vacuum extraction, aspiration during flexible endoscopy, or removal of surgical fluids, tissue (including bone), gases, bodily fluids, or infectious materials from wounds, airways, or respiratory support systems in surgical or bedside settings.
Regulatory Classification
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.
Predicate Devices
Reference Devices
Submission Summary (Full Text)
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# 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
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## 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:
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.
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#### 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:
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.
## 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)<br>Number | --- | K021368 | |
| Indications<br>for Use | The Basic and Dominant<br>Flex Suction Pumps are<br>indicated for vacuum<br>extraction, aspiration<br>during flexible<br>endoscopy and<br>aspiration and removal<br>of surgical fluids, tissue<br>(including bone), gases,<br>bodily fluids or<br>infectious materials<br>from wounds or from a<br>patient's airway or<br>respiratory support<br>system either during<br>surgery or at the<br>bedside. | The Basic 30 and<br>dominant 50 Suction<br>Pumps are indicated for<br>vacuum extraction,<br>aspiration and removal of<br>surgical fluids, tissue<br>(including bone), gases,<br>bodily fluids or infectious<br>materials from wounds or<br>from a patient's airway or<br>respiratory support<br>system, either during<br>surgery or at the patient's<br>bedside. | Equivalent. Dominant 50<br>was cleared for general<br>suction in K021368. The<br>Olympus KV-5 Suction<br>Pump (K011725) is<br>cleared for the indication<br>for aspiration during<br>flexible endoscopy. |
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| | Basic and Dominant Flex | | Basic 30 and Dominant 50 | | Discussion of Differences |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Housing and<br>User Interface | Capacitive Touch Sensors<br>which allows housing with<br>all flat surfaces:<br>LED Indicators | | On/Off Switch which<br>creates gaps in the<br>housing.<br>LED Indicators | | Equivalent. Both devices<br>have similar controls and<br>indicators. There are no<br>gaps/edges around the<br>"buttons" of the Basic and<br>Dominant Flex leading to<br>a full surface for a wipe-<br>off disinfection. |
| Flow<br>liters/min | 30 l/min (Basic)<br>Selectable 40 l/min, 50<br>l/min, 60 l/min (Dominant<br>Flex) | | 30 l/min (Basic 30)<br>50 l/min (Dominant 50) | | Equivalent. Other pumps,<br>including the Vacuson 40<br>and Vacuson 60<br>(K042943, Reference<br>Device) which was cleared<br>as substantially<br>equivalent to the<br>predicate Basic 30 and<br>Dominant 50 have flows<br>of 40 and 60 liters/min. |
| Maximum<br>vacuum<br>mmHg/kPa | Basic<br>-675mmHg<br>-90 kPa | Dominant<br>Flex<br>-713mmHg<br>-95 kPa | Basic 30<br>-638 mmHg<br>-85 kPa | Dominant<br>50<br>-675 mmHg<br>-90 kPa | Equivalent. Dominant<br>Flex now offers a slightly<br>higher vacuum. |
| Flow control | Software is used to<br>change the revolutions<br>per minute (RPM) of the<br>motor allowing the<br>different flow values. | | Flow is not adjustable.<br>The different flow rates of<br>the Basic 30 and<br>Dominant 50 were<br>controlled based on the<br>size of the cylinder | | Equivalent. Both<br>technologies (changing<br>motor RPM or using<br>different cylinder sizes)<br>achieve the desired flow<br>rates.<br>The Laerdal Suction Unit<br>(K993668) also has<br>electronics to control the<br>flow rate. Their flow rate<br>is coupled with the<br>vacuum level (the higher<br>the vacuum, the higher<br>the flow). |
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## Medela AG Basic and Dominant Flex Suction Pumps
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## 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.
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## 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
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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
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K130123 510{k) Number (if known):
Basic and Dominant Flex Suction Pumps Device Name:
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.
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)
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