(168 days)
The Dispenser DP 20 is intended for the general surgical fluid irrigation and infiltration under the direct control of a physician. The infiltration pump is not intended for intravascular infusion of fluids.
The principle of operation and technology incorporated in the Dispenser DP 20 are equivalent to peristaltic irrigation systems, which use peristalsis-type action to move fluid through a tube by alternating mechanical squeezing of fluid-filled tubing with a roller. As with all peristaltic pumps, the Dispenser DP 20 contacts only the tubing and never directly contacts the fluid, thus fluid sterility cannot be compromised by the pumping action. Sterility: Tubing set; disposable with plug-in cannula, sterile, length 4 m
The provided text is a 510(k) summary for the NOUVAG Dispenser DP 20, an infiltration pump. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with acceptance criteria in the way you've outlined.
Therefore, the information requested in your prompt regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from this document.
The 510(k) summary does contain the following relevant points:
- Device Description and Intended Use: The Dispenser DP 20 is an infiltration pump intended for general surgical fluid irrigation and infiltration under physician control, using a peristaltic action. It is not for intravascular infusion.
- Predicate Devices: The document identifies two predicate devices:
- Substantial Equivalence Claim: The manufacturer claims substantial equivalence based on the principle of operation and technology (peristaltic action for fluid delivery) being similar to other irrigation devices previously cleared by the FDA.
- Nonclinical Testing: A brief summary states: "The Dispenser DP 20 has been designed and tested to applicable safety standards. The Dispenser DP 20 does not raise any new issues of safety, effectiveness, or performance of the product." This indicates some form of testing was done to safety standards, but no specific criteria or results are provided.
In summary, this 510(k) document is a regulatory submission focused on comparing technological characteristics and intended use to existing devices, not on providing a detailed performance study with quantifiable acceptance criteria and results as typically found for novel AI/diagnostic devices.
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510(k) Summary
NDV 2 6 2007
| Submitter: | NOUVAG AGSt. Gallerstrasse 23-25CH-9403 GoldachSwitzerland |
|---|---|
| Contact Person: | Benno FreiTechnical Director, New Product DevelopmentPhone 0041 71 846 66 00Fax 0041 71 845 35 36 |
| Date Summary Prepared: | May 31, 2007 |
| Device Name: | |
| Proprietary Name | Dispenser DP 20 |
| Common Name | Infiltration Pump |
| Classification Name | Infusion Pump(per 21 CFR section 880.5725) |
Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:
| Product: | PSI-TEC Peristaltic Infiltration Pump |
|---|---|
| Manufacturer | Byron Medical, Incorporated |
| 510(k) Number | K040149 |
| Product: | Wells Johnson Infusion System, Model 20-6000-00 |
| Manufacturer | Wells Johnson |
| 510(k) Number | K991437 |
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Device Description:
The principle of operation and technology incorporated in the Dispenser DP 20 are equivalent to peristaltic irrigation systems, which use peristalsis-type action to move fluid through a tube by alternating mechanical squeezing of fluid-filled tubing with a roller.
As with all peristaltic pumps, the Dispenser DP 20 contacts only the tubing and never directly contacts the fluid, thus fluid sterility cannot be compromised by the pumping action.
Sterility: Tubing set; disposable with plug-in cannula, sterile, length 4 m
Intended use of the Devices:
The Dispenser DP 20 is intended for the general surgical fluid irrigation and infiltration under the direct control of a physician. The infiltration pump is not intended for intravascular infusion of fluids.
Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device:
The principle of operation and technology incorporated in the NOUVAG Dispenser DP 20 are similar to other irrigation devices with the function to deliver fluid with a roller, which the FDA has founded to be substantially equivalent to pre-amendment devices as outlined above.
Brief summary of nonclinical tests and results:
The Dispenser DP 20 has been designed and tested to applicable safety standards. The Dispenser DP 20 does not raise any new issues of safety, effectiveness, or nerformance of the product
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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. In the center of the seal is an abstract image of three human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 6 2007
NOUVAG AG. C/O Mr. Erich Forster Regulatory Consultant INTRATest Systems GmbH Reusswehrstrasse 1 CH-5412 Gebenstorf SWITZERLAND
Re: K071588
Trade/Device Name: Dispenser DP 20 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: November 15, 2007 Received: November 19, 2007
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.
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Page 2 - Mr. Forster
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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" (21CFR 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,
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K071588
Device Name: Dispenser DP 20
Indications for Use:
The Dispenser DP 20 is intended for the general surgical fluid irrigation and infiltration under the direct control of a physician. The infiltration pump is not intended for intravascular infusion of fluids.
x_____________________________________________________________________________________________________________________________________________________________________________ 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anting Dr-m
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K 471588 and the comments of the country of the country of
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).