Who is the manufacturer of CELL RECOVERY SYSTEM?

Medical Device Technologies, Inc. filed the 510(k) submission for CELL RECOVERY SYSTEM (K965037).

What is the FDA product code for CELL RECOVERY SYSTEM?

FDX. It is classified under 21 CFR 876.1500 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for CELL RECOVERY SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CELL RECOVERY SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CELL RECOVERY SYSTEM

K965037 · Medical Device Technologies, Inc. · FDX · Jan 8, 1997 · Gastroenterology, Urology

Device Facts

Record ID	K965037
Device Name	CELL RECOVERY SYSTEM
Applicant	Medical Device Technologies, Inc.
Product Code	FDX · Gastroenterology, Urology
Decision Date	Jan 8, 1997
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 of cells for cytological evaluation.

Device Story

Automated cytology brush system for cell collection; used with rigid/flexible cystoscopes (6 French working channel). Components: nylon bristles, stainless steel wires, nickel-titanium shaft, Teflon sheath. Battery-operated console with foot pedal control; automates brush rotation and aspiration of dislodged cells into 60 cc syringe. Used in clinical settings by physicians; enables hands-free operation during procedure. Facilitates cytological evaluation by improving sample retrieval efficiency.

Clinical Evidence

Bench testing only. No clinical data presented.

Technological Characteristics

Materials: nylon bristles, stainless steel wires, nickel-titanium shaft, Teflon sheath. Dimensions: 10 mm brush diameter, 6.4 mm brush length, 156 cm sheath length. Energy source: battery-operated console. Operation: automated rotation and aspiration via foot pedal. Single-use device.

Indications for Use

Indicated for use with rigid or flexible cystoscopes for the collection and retrieval of cells for cytological evaluation in patients requiring bladder or urinary tract assessment.

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.

Predicate Devices

CRS (cleared March 20, 1996)

Related Devices

K960004 — CELL RECOVERY SYSTEM · Medical Device Technologies, Inc. · Mar 20, 1996
K172663 — Cytology Brush · Micro-Tech (Nanjing) Co., Ltd. · Mar 5, 2018
K182231 — Brush Biopsy Set ; Deflectable Brush Biopsy Set · Cook Incorporated · May 1, 2019
K971849 — CYTOLOGY BRUSH · Team Technologies, Inc. · Jul 24, 1997
K043369 — CERVEX-BRUSH COMBI · Rovers Medical Devices B.V. · Feb 2, 2005

Submission Summary (Full Text)

{0} K965037 JAN 8 1997 # 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.