(98 days)
THE NORTECH FLUID CENTURION UNIT IS INDICATED FOR USE WHERE POST-OPERATIVE IRRIGATOIN IS INDICATED.
The Fluid Centurion is designed to be used where post-operative irrigation is required.
The Fluid Centurion is comprised of a battery operated, stand alone unit that is substantially equivalent in design, materials, and intended use to the Smith & Nephew Dyonics Levelert™ Fluid Level Sensor.
The provided document is a 510(k) submission, a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. This type of document does not typically contain information about a dedicated study proving device performance against specific acceptance criteria in the way a clinical trial or algorithm validation study would.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device. This means the manufacturer is asserting their device is similar enough to an already approved device in terms of intended use, technology, and safety/effectiveness that it doesn't require a new, extensive clinical trial.
Therefore, the specific information requested in your prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in this document because it's not a study report. The document describes the device, its intended use, and argues for its substantial equivalence to an existing product, the Smith & Nephew Dyonics Levelert™ Fluid Level Sensor.
If this were a document describing an AI/ML device, the detailed information about acceptance criteria and studies would be crucial and would likely be found in a separate validation study report or in the detailed technical specifications accompanying the 510(k).
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Image /page/0/Picture/0 description: The image shows the word "NORTECH" in bold, sans-serif font. The word is underlined by a thick, black line. The background of the image is dark and textured, which contrasts with the white text.
Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '1', '7', '3', '0', '2', and '5'. The numbers are written in a simple, slightly irregular style, typical of handwriting.
NOV 20 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
Electronic monitor for gravity flow infusion systems. Common/Usual Name:
Fluid Centurion Proprietary Name:
CLASS II Classification:
Materials:
All materials used to manufacture the Northgate Technologies Inc. Fluid Centurion have been previously used to manufacture other medical devices.
Description:
The Fluid Centurion is designed to be used where post-operative irrigation is required.
Substantial Equivalence:
Northgate's Fluid Centurion is comprised of a battery operated, stand alone unit that is substantially equivalent in design, materials, and intended use to the Smith & Nephew Dyonics Levelert™ Fluid Level Sensor.
Intended Use:
The Nortech Fluid Centurion Unit shall be used as a means of alerting hospital personnel if a low fluid condition arises during post-operative irrigation.
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest the shape of a bird in flight. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 20 1997
Ms. Casey Kurek ·Requlatory Manager Northgate Technologies, Incorporated 600 Church Road 60123 Elgin, Illinois
K973025 Re : Fluid Centurion (4-100-00) Trade Name: Requlatory Class: II Product Code: FLN Dated: October 6, 1997 Received: October 9, 1997
Dear Ms. Kurek:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Ms. Kurek
through 542 of the Act for devices under the Electronic chrough 512 or the not 11 provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on eempliated as (advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to ene regaracion Chereica, "Missianalig by Sother general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
. Enclosure
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K973025 510(k) Number (if known):
Device Name: FLUID CENTURION
Indications For Use:
THE NORTECH FLUID CENTURION UNIT IS INDICATED FOR USE WHERE POST-OPERATIVE IRRIGATOIN IS INDICATED.
Larry Kirk
S. Kirk / R. Robinson, Manager
C. Kurek, Regulatory Manager
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrenge of CDRH, Office of Device Evaluation (ODE)
belle coper (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number 2 OR
Prescription Use (Per 21 CFR 801.109) Over-the-Counter Use
(Optional Format 1-2-96)
§ 880.2420 Electronic monitor for gravity flow infusion systems.
(a)
Identification. An electronic monitor for gravity flow infusion systems is a device used to monitor the amount of fluid being infused into a patient. The device consists of an electronic transducer and equipment for signal amplification, conditioning, and display.(b)
Classification. Class II (performance standards).