(63 days)
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No
The description details a conventional peristaltic pump system with manual control by the physician. There is no mention of AI, ML, or any automated decision-making or learning capabilities.
No
The CFS-1 Pump System is described as supplying fluid for general endoscopic procedures and does not directly treat or alleviate a medical condition.
No
Explanation: The device is a pump system used for supplying fluid during endoscopic procedures, not for identifying or diagnosing a disease or condition. Its function is to facilitate the procedure by managing fluid flow.
No
The device description explicitly lists hardware components such as a peristaltic pump, motor, controller, power supply, sensors, and tubing.
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 test samples outside of the body to diagnose a condition.
- Device Description: The description details a pump system for fluid delivery during endoscopy. This aligns with a medical device used for patient care, 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.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is to facilitate a medical procedure by providing fluid, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The Nortech CFS-1 Pump system shall be used for supplying fluid for general endoscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The CFS-1 Pump System incorporates a peristaltic pump, motor, controller, power supply, and associated sensors and tubing. The product allows continuous flow to an Endoscopic instrument by the constant re-filling of a fluid source container. The control of flow rates and source pressures remains in the physician's control by the conventional method of raising or lowering the fluid source container.
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
physician
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
SUMMARY OF SAFETY AND EFFECTIVENESS
Common/Usual Name: Endoscopic Accessory
Proprietary Name: CFS-1 Pump System
CLASS I Classification:
Materials:
All materials used to manufacture the Northgate Technologies Inc. CFS-1 Pump System and tubing sets are non-toxic and have been previously used to manufacture other medical devices.
Description:
The CFS-1 Pump System incorporates a peristaltic pump, motor, controller, power supply, and associated sensors and tubing. The product allows continuous flow to an Endoscopic instrument by the constant re-filling of a fluid source container. The control of flow rates and source pressures remains in the physician's control by the conventional method of raising or lowering the fluid source container.
Substantial Equivalence:
Northgate's CFS-1 Pump/tubing sets are substantially equivalent in design, materials, and intended use to numerous currently marketed devices. Other manufacturers of similar devices are Biomedical Dynamics, Olympus, Solos, Zimmer, Sun Medical, and Storz.
Intended Use:
The Nortech CFS-1 Pump system shall be used for supplying fluid for general endoscopic procedures.