(78 days)
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No
The description focuses on the mechanical automation of a cytology brush and does not mention any computational analysis, learning, or decision-making processes characteristic of AI/ML.
No
The device is used for the collection and retrieval of cells for cytological evaluation, which is a diagnostic purpose, not a therapeutic one.
No
Explanation: The device is described as an automated cytology brush for the collection and retrieval of cells for cytological evaluation. Its purpose is to collect samples, not to analyze them or provide a diagnosis. The evaluation of the collected cells is done separately.
No
The device description clearly outlines physical components such as a brush, shaft, sheath, console, hand switches, foot pedal, and battery. It is a hardware device with some automated features.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "collection and retrieval cells for cytological evaluation." This describes a tool used to obtain a sample, not a test performed on a sample to diagnose a condition.
- Device Description: The description details a physical brush and automated system for collecting cells. It doesn't describe reagents, assays, or any process for analyzing biological samples in vitro.
- Lack of IVD Characteristics: The text does not mention any of the typical components or processes associated with IVD devices, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, DNA, etc.)
- Using reagents or assays
- Providing diagnostic information based on the analysis of the sample.
The device is a tool for sample collection, which is a step that might precede an IVD test, but the device itself is not the diagnostic test.
N/A
Intended Use / Indications for Use
The MDT Cell Recovery System™ (CRS) is an automated cytology brush for use with a rigid or flexible cystoscope in the collection and retrieval cells for cytological evaluation.
Product codes
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Device Description
The MDT Cell Recovery System™ (CRS) is an automated cytology brush for use with a rigid or flexible cystoscope in the collection and retrieval cells for cytological evaluation. The brush, consisting of nylon bristles secured by twisted stainless steel wires fused and blunted at the tip, is attached to a nickeltitanium shaft and housed in a Teflon sheath. The brush and sheath are designed for single use with cystoscopes having a 6 French working channel. The brush diameter is 10 mm, the brush is 6.4 mm, and the sheath is 156 cm long. This cytology brush is similar in size, features and components to other commercially available cytology brushes and has the same intended use.
The CRS facilitates brushing of cells by automating the rotation of the cytology brush and aspiration of dislodged cells using a battery operated console coupled to the brush. The console is operated using either hand switches or a foot pedal for hands free operation. By pre-selecting the rotation speced between 0-300 rpm the operator can maneuver the brush to the desired location and initiate the brushing procedure as well as the sample retrieval into a syringe using the foot pedal.
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
Results from non-clinical studies including bench top testing, in-vivo studies and biocompatability testing with the CRS to as well as clinical studies with a similar prototype have also shown automated brushing to be safe and effective. These studies have demonstrated that the automated features do not pose new safety questions when compared to currently marketed manual cvlology brushes.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
MEDICAL DEVICE TECHNOLOGIES, INC.
CELL RECOVERY SYSTEM™ (CRS) 510(k)
MAR 2 0 1996
| Company: | Medical Device Technologies, Inc.
9191 Towne Centre Drive, Suite 430
San Diego, CA 92122
Tel: (619) 455-7127 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Company Representative: | Dick Sloan
Project Engineer |
| Date 510(k) Prepared: | December 28, 1995 |
| Device Name: | Cell Recovery System™ |
| Classification Name: | Endoscope and Accessories |
| Classification: | Class II |
The MDT Cell Recovery System™ (CRS) is an automated cytology brush for use with a rigid or flexible cystoscope in the collection and retrieval cells for cytological evaluation. The brush, consisting of nylon bristles secured by twisted stainless steel wires fused and blunted at the tip, is attached to a nickeltitanium shaft and housed in a Teflon sheath. The brush and sheath are designed for single use with cystoscopes having a 6 French working channel. The brush diameter is 10 mm, the brush is 6.4 mm, and the sheath is 156 cm long. This cytology brush is similar in size, features and components to other commercially available cytology brushes and has the same intended use.
The CRS facilitates brushing of cells by automating the rotation of the cytology brush and aspiration of dislodged cells using a battery operated console coupled to the brush. The console is operated using either hand switches or a foot pedal for hands free operation. By pre-selecting the rotation speced between 0-300 rpm the operator can maneuver the brush to the desired location and initiate the brushing procedure as well as the sample retrieval into a syringe using the foot pedal.
Results from non-clinical studies including bench top testing, in-vivo studies and biocompatability testing with the CRS to as well as clinical studies with a similar prototype have also shown automated brushing to be safe and effective. These studies have demonstrated that the automated features do not pose new safety questions when compared to currently marketed manual cvlology brushes.
The CRS is substantially equivalent to a variety of currently marketed cytology brushes by various manufacturers including Surgitek, Telemed, Microvasive, Wiltek, Hobbs, Mill-Rose, and Cook Urological.