(149 days)
Not Found
No
The summary describes a standard flexible fiber optic endoscope with no mention of AI, ML, image processing, or any data-driven analytical capabilities. The performance studies focus on physical characteristics.
No
Explanation: The device is intended for visualization of tissue, not for treating or providing therapy.
No.
The device's intended use is solely for "visualization of tissue," without any mention of analyzing, interpreting, or diagnosing conditions based on the visualized data. It functions as an imaging tool, not a diagnostic one.
No
The device description clearly describes a physical, flexible, deflectable endoscope made of materials and constructed using methods substantially equivalent to previous endoscope products. It also mentions physical testing of the product. This indicates a hardware device, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "visualization of tissue in general surgical applications." This describes a device used in vivo (within the body) for direct observation, not for testing samples in vitro (outside the body).
- Device Description: The description clearly states it's a "flexible deflectable endoscope intended to allow physicians to visualize tissue in body cavities and through natural body orifices." This further reinforces its use for internal visualization.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or performing tests on them outside the body.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. The FlexScope's function is direct visualization within the body.
N/A
Intended Use / Indications for Use
FlexScope is intended to be used for visualization of tissue in The general surgical applications.
Product codes
Not Found
Device Description
The FlexScope™ is a flexible deflectable endoscope intended to allow physicians to visualize tissue in body cavities and through natural body orifices. The device is designed to be advanced to the site of interest through a cannula or trocar or may be used in an open procedure. The device will is available in various diameters. The method of construction and materials used for these flexible fiber optic endoscopes are substantially equivalent to previous endoscope products.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
body cavities and through natural body orifices
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Physical testing of the product included: dimensional inspection. bond strength testing, optical clarity, and performance under simulated conditions. All testing of the product yielded acceptable results.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
General Information
FD 18 800
Classification Class II
FlexScope™ Fiber Optic Endoscope Trade Name
Submitter
MatRix Medical, Inc. 14055 Grand Avenue Suite D Burnsville, MN 55337 (612) 892-0822
Contact
Amjad Ahmad President
Predicate Devices
Endoscopes from:
| Microvasive, Inc. | K850393 |
|---|---|
| A | 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 |
- . Codman & Shurtleff K871978
Device_Description
The FlexScope™ is a flexible deflectable endoscope intended to allow physicians to visualize tissue in body cavities and through natural body orifices. The device is designed to be advanced to the site of interest through a cannula or trocar or may be used in an open procedure. The device will is available in various diameters.
The method of construction and materials used for these flexible fiber optic endoscopes are substantially equivalent to previous endoscope products.
Intended Use
FlexScope is intended to be used for visualization of tissue in The general surgical applications.
MatRix Medical Inc.
1
Testing
All materials are biocompatible and are suitable for this application.
Physical testing of the product included: dimensional inspection. bond strength testing, optical clarity, and performance under simulated conditions. All testing of the product yielded acceptable results.
Summary of Substantial Equivalence
The FlexScope family of endoscopes are constructed of the same or substantially equivalent materials as the predicate products. The sizes and configurations available are also equivalent.
The clinical indications for use are identical to the predicate devices.
Therefore, due to the similarity of materials to other endoscopes, the test results and the identical indications for use to other endoscopes, MatRix Medical believes these products do not raise any new safety or effectiveness issues.