(22 days)
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No
The description focuses on the mechanical automation of a cytology brush and aspiration, with no mention of AI or ML for analysis, image processing, or decision-making.
No
The device is described as an automated cytology brush 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 used for the "collection and retrieval of cells for cytological evaluation," which is a sample collection function, not a diagnostic one. The evaluation is performed separately.
No
The device description clearly details physical components such as a brush, shaft, sheath, battery-operated console, and foot pedal, indicating it is a hardware device with some automated functionality.
Based on the provided information, the MDT Cell Recovery System™ (CRS) is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to collect and retrieve cells for cytological evaluation. It is a tool for obtaining a sample, not for performing a diagnostic test on that sample.
- Device Description: The description focuses on the mechanical aspects of the device – the brush, sheath, console, and how it operates to collect cells. It does not describe any components or processes that would analyze the collected cells or provide a diagnostic result.
- Lack of Diagnostic Function: The device's function is limited to the physical act of collecting cells. The subsequent "cytological evaluation" is a separate process performed on the collected sample, likely in a laboratory setting using other methods (which might involve IVDs).
In essence, the MDT Cell Recovery System™ is a sample collection device, which is distinct from an IVD that performs a diagnostic test on a sample.
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 of 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 of 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 nickel-titanium 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 length 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, including the previous CRS version, 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 a foot pedal for hands free operation. The operator can maneuver the brush to the desired location and initiate the brushing procedure as well as the sample retrieval into a 60 cc syringe.
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)
Results from bench-top testing showed the modified CRS is substantially equivalent to the previous version of the CRS device cleared for marketing on March 20, 1996. These studies have demonstrated that the modified CRS features do not pose new safety questions when compared to the currently marketed CRS device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
8 1997 JAN
SUMMARY OF SAFETY AND EFFECTIVENESS MEDICAL DEVICE TECHNOLOGIES, INC. CELL RECOVERY SYSTEM™ (CRS) 510(k)
Company:
Medical Device Technologies, Inc. 9171 Towne Centre Drive, Suite 355 San Diego, CA 92122 Tel: (619) 455-7127 Fax: (916) 455-7295
| Company Representative: | Dick Sloan |
|---|---|
| VP New Business Development |
Date 510(k) Prepared: December 16, 1996 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 of 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 nickel-titanium 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 length 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, including the previous CRS version, 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 a foot pedal for hands free operation. The operator can maneuver the brush to the desired location and initiate the brushing procedure as well as the sample retrieval into a 60 cc syringe.
Results from bench-top testing showed the modified CRS is substantially equivalent to the previous version of the CRS device cleared for marketing on March 20, 1996. These studies have demonstrated that the modified CRS features do not pose new safety questions when compared to the currently marketed CRS device.