(51 days)
No
The description focuses on the mechanical and electrical components of a suction pump and does not mention any AI or ML capabilities.
Yes
The device is clearly indicated for the aspiration and removal of fluids, tissue, gases, and infectious materials from various parts of the body during surgery or at the patient's bedside, directly addressing patient treatment and medical conditions.
No
This device is a suction pump designed for the aspiration and removal of fluids and tissues, not for diagnosing medical conditions.
No
The device description clearly details physical components like a motor, pistons, cylinders, vacuum gauge, and tubing, indicating it is a hardware device with potential software control, not a software-only device.
Based on the provided text, the Medela Vario 8/18/ci Suction Pumps are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids (including vomit) or infectious materials from a patient's airway or respiratory support system". This is a direct interaction with the patient's body for therapeutic or procedural purposes.
- Device Description: The description details a suction pump mechanism designed to create vacuum for aspiration. This aligns with a device used for physical removal of substances from the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Medela Vario does not perform any analysis or testing of the collected materials; it simply removes them.
Therefore, the Medela Vario 8/18/ci Suction Pumps are considered a medical device used for aspiration and suctioning, not an IVD.
N/A
Intended Use / Indications for Use
The Medela® Vario 8/18/ci Suction Pumps are indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids (including vomit) or infectious materials from a patient's airway or respiratory support system, either during surgery or at the patient's bedside.
Generally the Medela® Vario 8/18/ci is intended to be used for a variety of suctioning procedures including nasopharyngeal, tracheal, surgical, gastrointestinal and thoracic drainage (in combination with a water seal or dry seal chest drain) in either "constant" or "intermittent" mode. Especially for thoracic drainage the Medela® Vario 8 is indicated in situations such as pneumothorax, after surgery (post operative), thorax injury, pleura effusion, pleuryempyem or other related conditions.
Product codes
BTA
Device Description
This notification for the Medela® Vario 8/18/ci Suction Pumps is for labeling change and to include additional indications. There have been no significant modifications or design changes to the currently cleared and marketed Medela® Vario, 510(k) No. K983552.
The Medela® Vario 8/18/ci Suction Pumps is a further innovative development of Medela's well-proven piston/cylinder system. With its QuatroFlex™ technology, the drive power is transferred to the four piston/cylinder modules by means of high-grade, flexible thin-films hinges. The required suction value is rapidly built-up. High suction performance and low weight are positive features of the Vario pump.
The Medela® Vario 8/18/ci is an AC or an AC/DC-powered portable aspirator and incorporates in its medium sized housing an AC respectively DC-motor with a flat belt power transmission to the pistons and cylinders, an ON/OFF-switch, a vacuum gauge in kPa and mmHG, a self-bleeding membrane vacuum regulator, an overflow protection device (hydrophobic filter) and connection tubing, an electric cord and an instruction manual.
The Medela® Vario 18 "high vacuum" suction pump has a suction capacity of 18 liters per minute and a maximum vacuum up to -75 kPa (-563 mmHd). The pump is marked "low flow - high vacuum".
The Medela® Vario 18 "medium vacuum" suction pump has a suction capacity of 18 liters per minute and a maximum vacuum up to -50 kPa (-375 mmHq). The pump is marked "low flow - medium vacuum".
The Medela® Vario 8 "low vacuum" suction pump has a suction capacity of 8 liters per minute and a maximum vacuum up to -9 kPa (-68 mmHg). The pump is marked "low flow - low vacuum".
A variety of reusable and disposable accessories are available. A variety of disposables for thoracic drainage are also available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway or respiratory support system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 878.4780 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.
0
Medela AG, Laettichstrasse 4b, CH-6341 Baar, Switzerland Applicant: Werner Frei, Tel +41 (41) 769 51 51 ext. 228; Fax +41 (41) 769 51 00 Contact Person: werner frei@medela.ch Traditional 510(k) Submission for Medela® Vario Suction Pump
JUN 2 1 2006
KO61205
Section E - 510(k) Summary
This 510(k) summary for the Medela® Vario 8/18/ci Powered Suction Pumps meets the requirements of 21 CFR 807.92.
Sponsor's Name, Address and Contact Person 1
Sponsor: Medela AG Medical Equipment Laettichstrasse 4b 6341 Baar Switzerland +41 41 769 5151 ext. 228 Ph: +41 41 769 5100 Fax:
Contact Person Werner Frei Manager Regulatory Affairs
Date Summary Prepared: April 18, 2006
2 Name of Device
| Trade Name: | Medela® Vario 8/18/ci
Secretion & Surgical Aspirator |
|----------------------|--------------------------------------------------------------------------------------------|
| Common Name: | Powered Suction Pump |
| Classification Name: | PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
Classified Class II, per 21 CFR 878.4780 |
| Product Code: | BTA |
3 Name of the predicate Device(s)
- Medela® Basic, Median, Dominant, Vario Suction Pumps, by Medela Inc. ● K983552
- Medela® Dominant 35 c/i, by Medela AG . K043544
1
Medela AG. Laettichstrasse 4b. CH-6341 Baar. Switzerland Apolicant: Contact Person: Werner Frei, Tel +41 (41) 769 51 51 ext. 228; Fax +41 (41) 769 51 00 werner.frei@medela.ch Traditional 510(k) Submission for Medela® Vario Suction Pump
Device Description 4
This notification for the Medela® Vario 8/18/ci Suction Pumps is for labeling change and to include additional indications. There have been no significant modifications or design changes to the currently cleared and marketed Medela® Vario, 510(k) No. K983552.
The Medela® Vario 8/18/ci Suction Pumps is a further innovative development of Medela's well-proven piston/cylinder system. With its QuatroFlex™ technology, the drive power is transferred to the four piston/cylinder modules by means of high-grade, flexible thin-films hinges. The required suction value is rapidly built-up. High suction performance and low weight are positive features of the Vario pump.
The Medela® Vario 8/18/ci is an AC or an AC/DC-powered portable aspirator and incorporates in its medium sized housing an AC respectively DC-motor with a flat belt power transmission to the pistons and cylinders, an ON/OFF-switch, a vacuum gauge in kPa and mmHG, a self-bleeding membrane vacuum regulator, an overflow protection device (hydrophobic filter) and connection tubing, an electric cord and an instruction manual.
The Medela® Vario 18 "high vacuum" suction pump has a suction capacity of 18 liters per minute and a maximum vacuum up to -75 kPa (-563 mmHd). The pump is marked "low flow - high vacuum".
The Medela® Vario 18 "medium vacuum" suction pump has a suction capacity of 18 liters per minute and a maximum vacuum up to -50 kPa (-375 mmHq). The pump is marked "low flow - medium vacuum".
The Medela® Vario 8 "low vacuum" suction pump has a suction capacity of 8 liters per minute and a maximum vacuum up to -9 kPa (-68 mmHg). The pump is marked "low flow - low vacuum".
A variety of reusable and disposable accessories are available. A variety of disposables for thoracic drainage are also available.
5 Indications for use
The Medela® Vario 8/18/ci Suction Pumps are indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids (including vomit) or infectious materials from a patient's airway or respiratory support system, either during surgery or at the patient's bedside.
Generally the Medela® Vario 8/18/ci is intended to be used for a variety of suctioning procedures including nasopharyngeal, tracheal, surgical, gastrointestinal and thoracic drainage (in combination with a water seal or dry seal chest drain) in either "constant" or "intermittent" mode. Especially for thoracic drainage the Medela® Vario 8 is indicated in situations such as pneumothorax, after surgery (post operative), thorax injury, pleura effusion, pleuryempyem or other related conditions.
2
Medela AG, Laettichstrasse 4b, CH-6341 Baar, Switzerland Applicant: Contact Person: Werner Frei, Tel +41 (41) 769 51 51 ext. 228; Fax +41 (41) 769 51 00 werner.frei@medela.ch Traditional 510(k) Submission for Medela® Vario Suction Pump
Summary of Technological Characteristics 6
The Medela® Vario 8/18/ci suction pumps are identical in construction and performance to the legally marketed device as submitted under FDA File Number K983552 there are no technical differences which would raise new aspects regarding safety and effectiveness.
The only modifications relate to a change from lead acid to NiMH batteries and more differentiated trade names - Medela® Vario 8 or Medela® Vario 18 instead of Medela® Vario only (the number reflects the different flow rates - 8 I/min or 18 I/min).
7 Conclusion
According to the FDA Guidance "Deciding When to Submit a 510(k) for a Change to an Existing Device", the modification mentioned above does not significantly affect the safety or effectiveness of the device (e.g. a significant change or modification in design, material, chemical composition, energy source or manufacturing process). All conclusions are made by the decision making process according this guidance document.
Based upon the information presented above and in this 510(k) submission, it is concluded that the proposed Medela® Vario 8/18/ci powered suction pump is reliable, safe and effective for the intended use.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with outstretched wings.
JUN 2 1 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medela AG c/o Werner Frei, Manager Regulatory Affairs Laettichstrasse 4b 6341 Baar Switzerland CH-6341
Re: K061205
Trade/Device Name: Medela Vario Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: BTA Dated: April 18, 2006 Received: May 8, 2006
Dear Werner Frei:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Hulut Lemern
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
KOG1205 510(k) Number (if known):
Device Name:
Medela Vario
Indications For Use:
The Medela Vario 8/18/ci Suction Pumps are indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids (including vomit) or infectious materials from a patient's airway or respiratory support system, either during surgery or at the patients bedside.
Generally the Medela Vario 8/18/ci is intended to be used for a variety of suctioning procedures including nasopharyngeal, tracheal, surgical, gastrointestinal and thoracic drainage (in combination with a water seal or dry seal chest drain) in either "constant" or "intermittent" mode. Especially for thoracic drainage the Medela Vario 8 is indicated in situations such as pneumothorax, after surgery (post operative), thorax injury, pleura effusion, pleuryempyem or other related conditions.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Huker
Division Sign Off
Division of General, Restorative, and Neurological Devices
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510(k) Number K061205