(98 days)
Not Found
Not Found
No
The summary describes a fluid level sensor for post-operative irrigation and makes no mention of AI or ML.
No
The device is used for post-operative irrigation, which is a supportive function and not directly therapeutic in itself. It appears to be a fluid management system rather than a device that treats a disease or condition.
No
Explanation: The device is described as an irrigation unit, used for post-operative irrigation, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "battery operated, stand alone unit," indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "post-operative irrigation." This is a procedure performed directly on a patient's body, not on a sample of bodily fluid or tissue in vitro (outside the body).
- Device Description: The description focuses on a "battery operated, stand alone unit" used for irrigation. This aligns with a medical device used for a therapeutic or procedural purpose, not for diagnostic testing of samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
The device is clearly intended for a procedural application (irrigation) rather than a diagnostic one.
N/A
Intended Use / Indications for Use
THE NORTECH FLUID CENTURION UNIT IS INDICATED FOR USE WHERE POST-OPERATIVE IRRIGATOIN IS INDICATED.
Product codes
FLN
Device Description
The Fluid Centurion is designed to be used where post-operative irrigation is required. Northgate's Fluid Centurion is comprised of a battery operated, stand alone unit.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital personnel
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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
2
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
3
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)