(50 days)
Not Found
No
The description mentions a microcontroller for motor speed and user interface control, but there is no mention of AI or ML algorithms for data analysis, decision-making, or learning. The functionality described is standard for a controlled medical device.
Yes
The device is used to aspirate and remove surgical fluids, tissue, gases, bodily fluids, or infectious materials during specific medical procedures, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is a suction pump designed to remove fluids, tissue, or gases. Its purpose is to perform actions like aspiration and removal, rather than to diagnose medical conditions or provide diagnostic information.
No
The device description clearly outlines physical hardware components such as a piston and cylinder system, a microcontroller, a vacuum gauge, vacuum regulator knob, operating elements, Safety Set (jar, lid, float), capacitive sensors, indicator lights, and an appliance inlet. It is described as an AC-powered suction pump.
Based on the provided text, the Medela Basic and Dominant Flex Suction Pumps are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Intended Use: The intended use clearly states that the pumps provide a vacuum source for use in hospitals and clinics to aspirate and remove various substances from the body (surgical fluids, tissue, gases, bodily fluids, infectious materials). This is a direct interaction with the patient's body or materials removed from the body, not testing in vitro (outside the body).
- Device Description: The description focuses on the mechanical function of creating a vacuum for suction and the physical characteristics of the pump. There is no mention of analyzing samples, reagents, or any processes typically associated with in vitro diagnostics.
- Lack of IVD-related terms: The text does not contain any terms commonly associated with IVD devices, such as "assay," "reagent," "sample analysis," "diagnostic test," "laboratory," etc.
- Performance Studies: The summary of performance studies focuses on electrical safety, electromagnetic compatibility, and safety of electrically powered suction pumps. There are no studies related to the accuracy or performance of a diagnostic test.
In summary, the Medela Basic and Dominant Flex Suction Pumps are medical devices used for surgical and medical suction procedures, which are performed in vivo (within the body) or on materials directly removed from the body. They do not perform diagnostic testing in vitro.
N/A
Intended Use / Indications for Use
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
QPB, BTA, MUU, HDB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals and clinics
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)
The Basic and Dominant Flex Suction Pumps have not been the subject of clinical testing.
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 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.
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."
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
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PREDICATE DEVICE(S):
K150134 Basic and Dominant Flex Suction Pumps
K051758 Penumbra Aspiration Pump
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.
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.
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.
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.