(53 days)
The Vacuson 40 and Vacuson 60 are intended as extraction suction units for vacuum extraction, aspiration and removal of fluids, and infectious material from wounds or tissue either during surgery or at the patient 's bedside.
Every model has at least one suction jar with overflow safety device, bacterial filter and optional a castered troiley. The optional foot switch can be used to activate the suction opinonal a castered a most can be continuously regulated by a valve and monitored through the manometer.
Vacuson 40 and Vacuson 60 are different in the maximum suction flow rate.
The Vacuson 40 has a built-in piston pump with the name "P40". The maximum suction flow rate for the Vacuson 40 Device is specified with 40 litres/min.
The Vacuson 60 has a built-in piston pump with the name "P70". The maximum suction flow rate for the Vacuson 60 Device is specified with 60 litres/min.
Sterility:
Suction tube, Suction jars with jar lids: Sterility by user up to 134°C.
This K042943 submission for the NOUVAG AG Vacuson 40 and Vacuson 60 is a 510(k) premarket notification. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details on a comprehensive de novo validation study with specific acceptance criteria and detailed performance reporting.
Based on the provided information, here's a breakdown of what can and cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the typical sense for a 510(k) submission of this nature. 510(k)s for devices like powered suction pumps often rely on demonstrating adherence to recognized standards and direct comparison of functional specifications to a legally marketed predicate device.
The brief summary of nonclinical tests states: "The Vacuson 40 and Vacuson 60 have been designed and tested to applicable safety standards. The Vacuson 40 and Vacuson 60 do not raise any new issues of safety, effectiveness, or performance of the product." This indicates an implicit acceptance criterion of meeting applicable safety standards and performing similarly to the predicate without introducing new risks.
Key Performance Specifications (from Device Description):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maximum Suction Flow Rate: | |
| Vacuson 40 | 40 litres/min |
| Vacuson 60 | 60 litres/min |
| Sterility: | Sterility by user up to 134°C for suction tube, suction jars with jar lids. |
| Operational Mechanism: | Continuously regulatable suction by a valve, monitored through a manometer. |
| Safety Features: | At least one suction jar with overflow safety device, bacterial filter. |
2. Sample Size Used for the Test Set and Data Provenance
Not specified. This type of detail is not typically included in a 510(k) summary for a powered suction pump where testing is more focused on engineering specifications and adherence to standards rather than a clinical "test set" in the context of diagnostic accuracy. The testing would primarily involve laboratory measurements of flow rates, pressure, and safety features.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The "ground truth" for a device like a powered suction pump would be its engineering specifications and performance against industry standards, not expert clinical interpretation of data.
4. Adjudication Method for the Test Set
Not applicable. There's no indication of a test set requiring adjudication in the context of this device and submission type.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device is a powered suction pump, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is not an algorithm. Performance would be assessed in terms of its mechanical function (suction power, flow rate) in a standalone manner, separate from human operation, to meet its specifications.
7. The Type of Ground Truth Used
The ground truth used for this type of device would be its engineering specifications and performance against recognized industry standards. This includes:
- Measurement of maximum suction flow rate.
- Verification of overflow safety device functionality.
- Confirmation of bacterial filter efficacy (if applicable to the device, or specified for the filter itself).
- Temperature resistance for sterilization.
- Compliance with electrical safety and electromagnetic compatibility (EMC) standards.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned for this device.
In summary:
This 510(k) submission primarily relies on demonstrating substantial equivalence to a legally marketed predicate device (Medela AG Medela "Basic 30" and "Dominant 50" Suction Pumps K021368) by showing similar intended use, technological characteristics, and adherence to applicable safety standards. The information provided is typical for a summary of a traditional medical device's premarket notification, where the "study" is often a series of engineering tests and comparisons rather than a clinical trial with acceptance criteria defined by diagnostic accuracy metrics.
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NOUVAG AG Vacuson 40 and Vacuson 60
DEC 17 2004
510(k) Notification October 22, 2004
SECTION 5
510(k) SUMMARY
| Submitter: | NOUVAG AGSt. Gallerstrasse 23-25CH-9403 GoldachSwitzerland |
|---|---|
| Contact Person: | Benno FreiTechnical Director, New Product DevelopmentPhone +41 (0)71 846 66 00Fax +41 (0)71 845 35 36 |
| Date Summary Prepared: | October 22, 2004 |
| Device Name: | |
| Proprietary Name | Vacuson 40 and Vacuson 60 |
| Common Name | Powered suction pump |
| Classification Name | Pump, Portable, Aspiration (Manual or Powered)(per 21 CFR section 878.4780) |
Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:
Medela AG Medela "Basic 30" and "Dominant 50" Suction Pumps K021368, Cleared on 05/15/2002
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Device Description:
Every model has at least one suction jar with overflow safety device, bacterial filter and optional a castered troiley. The optional foot switch can be used to activate the suction opinonal a castered a most can be continuously regulated by a valve and monitored through the manometer.
Vacuson 40 and Vacuson 60 are different in the maximum suction flow rate.
The Vacuson 40 has a built-in piston pump with the name "P40". The maximum suction flow rate for the Vacuson 40 Device is specified with 40 litres/min.
The Vacuson 60 has a built-in piston pump with the name "P70". The maximum suction flow rate for the Vacuson 60 Device is specified with 60 litres/min.
Sterility:
Suction tube, Suction jars with jar lids: Sterility by user up to 134°C.
Intended use of the Devices:
The Vacuson 40 and Vacuson 60 are intended as extraction suction units for vacuum extraction, aspiration and removal of fluids, and infectious material from wounds or tissue either during surgery or at the patient 's bedside.
Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device:
The Vacuson 40 and Vacuson 60 are substantially equivalent to other legally marketed devices in the United States. The Vacuson 40 and Vacuson 60 function in a manner similar and are intended for the same use as the Devices designed by Medela AG.
Brief summary of nonclinical tests and results:
The Vacuson 40 and Vacuson 60 have been designed and tested to applicable safety standards. The Vacuson 40 and Vacuson 60 do not raise any new issues of safety, effectivness, or performance of the product.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling an eagle or bird in flight, positioned above a wavy line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 2004
Nouvag AG c/o Mr. Erich Forster INTRATest Systems GmbH St. Gallerstrasse 23-25 CH-9403 Goldach Switzerland
Re: K042943
Trade/Device Name: Vacuson 40 and Vacuson 60 Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: BTA Dated: October 22, 2004 Received: October 25, 2004
Dear Mr. Forster:
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.
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Page 2 - Mr. Erich Forster
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yours ough finding of substantial equivalence of your device to a legally promation in a classification for your device and thus, permits 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 in you deall office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general micromation and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
uriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K042943
Device Name: Vacuson 40 and Vacuson 60
Indications For Use:
The Vacuson 40 and Vacuson 60 are intended as extraction suction units for vacuum The vacuson 40 and Vacuson of fluids, and infectious material from wounds or Extraction, dopiration argery or at the patient's bedside.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
iriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of
510(k) Number_Ko42943_________________________________________________________________________________________________________________________________________________________
§ 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.