(59 days)
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Not Found
No
The device description details a system based on a peristaltic pump and conventional fluid management principles, with no mention of AI or ML components or functionalities.
No
The device is used for supplying fluid for general endoscopic procedures, which is a supportive rather than a direct therapeutic function. It manages fluid for the procedure, but doesn't actively treat a condition or provide therapy itself.
No
The device is used for supplying fluid for general endoscopic procedures and managing fluid flow, not for diagnosing medical conditions.
No
The device description explicitly lists hardware components such as a peristaltic pump, motor, controller, power supply, tubing, and a sensor. This indicates it is a hardware-based medical device with integrated software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "SUPPLYING FLUID FOR GENERAL ENDOSCOPIC PROCEDURES." This describes a device used during a medical procedure on a patient, not a device used to examine specimens outside the body to diagnose or monitor a condition.
- Device Description: The description details a system for managing fluid flow during endoscopy. This aligns with a device used for procedural support, not for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVDs are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
THE NORTECH HYDROTOWER FLUID MANAGEMENT SYSTEMS SHALL BE USED FOR SUPPLYING FLUID FOR GENERAL ENDOSCOPIC PROCEDURES.
Product codes (comma separated list FDA assigned to the subject device)
OCX
Device Description
The Hydrotower ® Fluid Management System incorporates a peristaltic pump, motor, controller, power supply, and associated tubing and a sensor. The product allows continuous flow to an Endoscopic instrument by the constant refilling of a fluid "reservoir" bag. The control of flow rates and source pressures remains in the physician's control by the conventional method of raising or lowering the "reservoir" bag.
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
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Indicated Patient Age Range
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Intended User / Care Setting
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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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three wing segments, suggesting movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle, with the words following the curve of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Northgate Technologies, Inc. Mr. Casey Kurek Regulatory Manager 600 Church Road Elgin. IL 60123
JUL 2 7-2015
K993778 Trade/Device Name: Hydrotower® Fluid Management System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCX Dated (Date on orig SE Itr): December 6, 1999 Received (Date on orig SE ltr): December 9, 1999
Dear Mr. Kurek,
Re:
This letter corrects our substantially equivalent letter of January 6, 2000.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be
1
Page 2 -
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive. Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
长993778 510(k) Number (if known):
Hydrotower® Eluid Management System Device Name:
Indications For Use:
THE NORTECH HYDROTOWER FLUID MANAGEMENT SYSTEMS SHALL BE USED FOR SUPPLYING FLUID FOR GENERAL ENDOSCOPIC PROCEDURES.
Casey Kurek
C. Kurek, Regulatory Manager
C. Kurek, Regulatory Manager
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
V Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use
J.A.
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 13778 510(k) Number.
3
Image /page/3/Picture/0 description: The image shows the logo for NORTECH. The logo is in a bold, sans-serif font, with the letters "NORTECH" stacked on top of each other. The logo is black and white, and the background is a dark color. The logo is simple and modern, and it is likely used to represent a company or organization.
JAN - 6 2000
K993778
Page 1
SUMMARY OF SAFETY AND EFFECTIVENESS
Endoscopic Accessory Common/Usual Name:
Hydrotower ® Fluid Management System Proprietary Name:
Class II Classification:
Materials:
All materials used to manufacture the Northgate Technologies Inc. Hydrotower ® Fluid Management System and tubing sets are non-toxic and have been previously used to manufacture other medical devices.
Description:
The Hydrotower ® Fluid Management System incorporates a peristaltic pump, motor, controller, power supply, and associated tubing and a sensor. The product allows continuous flow to an Endoscopic instrument by the constant refilling of a fluid "reservoir" bag. The control of flow rates and source pressures remains in the physician's control by the conventional method of raising or lowering the "reservoir" bag.
Substantial Equivalence:
Northgate's Hydrotower ® Fluid Management System and tubing sets are substantially equivalent in design materials, and intended use to numerous currently marketed devices. Other manufactures of similar devices are Biomedical Dynamics, Olympus, Solos. Zimmer, Sun Medical, and Storz.
Intended Use:
The Nortech Hydrotower ® Fluid Management System shall be used for supplying fluid for general endoscopic procedures.
Northgate Technologies Incorporated 600 Church Road, Elgin, IL 60123 1-800-348-0424 IL: 847-608-9405