(60 days)
Not Found
Circon/ACMI USA Elite™, Olympus A2757 Resectosope
No
The description focuses on mechanical and electrical components for tissue resection under direct visual control by the surgeon. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis.
Yes
The device is intended for urological transurethral resection to cut and coagulate tissue in the urethra, prostate, and bladder, which directly treats a medical condition.
No
The device is described as a "resectoscope" intended for "resection of tissue" and designed to "cut and coagulate prostate tissue." This indicates a surgical, therapeutic function, not a diagnostic one.
No
The device description clearly outlines a physical resectoscope with mechanical components (telescope, operative video camera system, loop assembly, handle/spring housing, finger rings, channels for irrigant) and compatibility with electro-surgery units, indicating it is a hardware 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 "urological transurethral resection by trained professional urologists in hospital environments" for "resection of tissue in the urethra, prostate and bladder." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description details a surgical instrument (resectoscope) used for cutting and coagulating tissue using electrocautery under visual control. This is a therapeutic and surgical device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) outside of the body to provide diagnostic information about a patient's health status. IVDs are specifically designed for this purpose.
In summary, the FemRx TURPSR™ System is a surgical device used for tissue removal and coagulation within the body, which is distinct from the function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The FemRx TURPSR™ System is intended for urological transurethral resection by trained professional urologists in hospital environments. This device is intended for resection of tissue in the urethra, prostate and bladder.
Product codes
Not Found
Device Description
The FemRx 100°SR™ System is a refined urologic resectoscope. A standard telescope is inserted into the device and coupled to an operative video camera system prior to use. The device is compatible with a variety of standard electro-surgery units (ESUs).
The system is designed to cut and coagulate prostate tissue by sliding the loop assembly in an axial manner relative to the handle/spring housing. Cutting and coagulation are accomplished by energizing the electrode with electrocautery current from an approved ESU. All cutting/coagulating occurs under visual control by a surgeon observing a video monitor displaying the view through the telescope. Cutting/coagulating is only performed while the device is moving towards the operator. Typically, the surgeon squeezes the finger rings to move cutting end distally; electrocautery is then applied and cutting/coagulating is accomplished by the active end as the spring returns the device to the most proximal resting location. The surgeon uses hand pressure to control the rate of sliding of the active end within the sheath. Separate channels are provided for irrigant inflow and outflow, permitting continuous fluid circulation for good visibility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra, prostate and bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professional urologists in hospital environments
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
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
the FemRx TURESTAR™ System
Reference Device(s)
Circon/ACMI USA Elite™, Olympus A2757 Resectosope
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
K964892
FEB - 4 1997
510(K) SUMMARY
The FemRx TURPSR™ System is intended for urological transurethral resection by trained professional urologists in hospital environments. This device is intended for resection of tissue in the urethra, prostate and bladder.
The FemRx 100°SR™ System is a refined urologic resectoscope. A standard telescope is inserted into the device and coupled to an operative video camera system prior to use. The device is compatible with a variety of standard electro-surgery units (ESUs).
The system is designed to cut and coagulate prostate tissue by sliding the loop assembly in an axial manner relative to the handle/spring housing. Cutting and coagulation are accomplished by energizing the electrode with electrocautery current from an approved ESU. All cutting/coagulating occurs under visual control by a surgeon observing a video monitor displaying the view through the telescope. Cutting/coagulating is only performed while the device is moving towards the operator. Typically, the surgeon squeezes the finger rings to move cutting end distally; electrocautery is then applied and cutting/coagulating is accomplished by the active end as the spring returns the device to the most proximal resting location. The surgeon uses hand pressure to control the rate of sliding of the active end within the sheath. Separate channels are provided for irrigant inflow and outflow, permitting continuous fluid circulation for good visibility.
The system as described in the preceeding 3 paragraphs is identical (substantially equivalent) in all design and component aspects, except one, to the FemRx TURESTAR™ System which is also used in urological applications. The TURPSTAR™ system has an additional component, a morcellator, which uses an arthroscopic shaver to reduce the size of the resected tissue prior to the tissue being carried out the fluid path. Neither of the other referenced predicate devices (the Circon/ACMI USA Elite™ and the Olympus A2757 Resectosope) nor the TURPSRTM have a morcellator.