CELL RECOVERY SYSTEM

K960004 · Medical Device Technologies, Inc. · FDX · Mar 20, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K960004
• Device Name: CELL RECOVERY SYSTEM
• Applicant: Medical Device Technologies, Inc.
• Product Code: FDX · Gastroenterology, Urology
• Decision Date: Mar 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended 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.

Device Story

Automated cytology brush system for cell collection during cystoscopy; consists of nylon bristles on stainless steel wire, nickel-titanium shaft, and Teflon sheath. Battery-operated console controls brush rotation (0–300 rpm) and aspiration of dislodged cells into a syringe. Operated by clinician via hand switches or foot pedal. Facilitates standardized brushing procedure; improves sample retrieval efficiency compared to manual methods. Used in clinical settings; compatible with 6 French cystoscope working channels.

Clinical Evidence

Evidence includes bench-top testing, in-vivo studies in pig bladders, biocompatibility testing, and clinical studies using a similar prototype. Results demonstrate that automated brushing is safe and effective and does not introduce new safety risks compared to manual cytology brushes.

Technological Characteristics

Materials: nylon bristles, stainless steel wire, nickel-titanium shaft, Teflon sheath. Dimensions: 10 mm brush diameter, 6.4 mm brush length, 156 cm sheath length. Compatibility: 6 French cystoscope working channel. Energy source: battery-operated console. Operation: automated rotation (0–300 rpm) and aspiration. Single-use device.

Indications for Use

Indicated for the collection and retrieval of cells for cytological evaluation in patients undergoing cystoscopy using a rigid or flexible cystoscope with a 6 French working channel.

Regulatory Classification

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.

Special Controls

*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.

Reference Devices

• Surgitek cytology brushes
• Telemed cytology brushes
• Microvasive cytology brushes
• Wilson-Cook cytology brushes
• Wiltek cytology brushes
• Hobbs cytology brushes
• Mill-Rose cytology brushes
• Cook Urological cytology brushes

Submission Summary (Full Text)

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K960004

# SUMMARY OF SAFETY AND EFFECTIVENESS MEDICAL DEVICE TECHNOLOGIES, INC.

## CELL RECOVERY SYSTEM™ (CRS) 510(k)

MAR 20 1996

| Company: | Medical Device Technologies, Inc.
9191 Towne Centre Drive, Suite 430
San Diego, CA 92122
Tel: [phone] |
| --- | --- |
| 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 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 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 speed 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 in pig bladders and biocompatibility 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 cytology brushes.

The CRS is substantially equivalent to a variety of currently marketed cytology brushes by various manufacturers including Surgitek, Telemed, Microvasive, Wilson-Cook, Wiltek, Hobbs, Mill-Rose, and Cook Urological.