ENDOSCOPIC ACCESS DEVICE

K960232 · Applied Medical Technologies · GCJ · Mar 21, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K960232
• Device Name: ENDOSCOPIC ACCESS DEVICE
• Applicant: Applied Medical Technologies
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Mar 21, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Endoscopic Access Device is an instrument access portal for use during endoscopic surgery.

Device Story

Instrument access portal for endoscopic surgery; internal flange inserted into incision site; expands to retain position; allows passage of surgical instruments; external flange reduces site contamination and trauma; defines access region; shaft angulated 20°-90° (30° standard); single-use; sterile; physician-operated in clinical/surgical setting; provides stable access path for endoscopic tools; facilitates surgical procedures.

Clinical Evidence

Bench testing only; evaluated minimum pull-out force versus device strength to ensure mechanical integrity and functional performance.

Technological Characteristics

Injection molded biocompatible Dow Corning silicone (Q7-4840); angulated shaft (20°-90°); internal/external flange design; single-use; sterile.

Indications for Use

Indicated for use as an instrument access portal during endoscopic surgery in patients requiring endoscopic access.

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

• AMT Esophageal Overtube

Reference Devices

• AMT Button (K943392)

Submission Summary (Full Text)

{0}

EXHIBIT X
K960232
510(k) SUMMARY
MAR 21 1996

Kathy Feltrin
Director of Regulatory Affairs

January 15, 1996

Trade Name: Endoscopic Access Device
Common Name: Endoscopic Access Device
Classification name: Not Known

The Endoscopic Access Device is an instrument access portal for use during endoscopic surgery. It is designed to be substantially equivalent to the presently marketed AMT Esophageal Overtube. The devices' internal flange is inserted into the incision site and allowed to expand freely. Once in place, the internal flange retains the device in place and allows for the access of a variety of surgical instruments.

The shaft is angulated at 30° but can range from 20° to 90°, depending on the specific application. The external flange reduces site contamination and trauma. It also easily defines the access into the region.

The Endoscopic Access Device is injection molded from the same biocompatible Dow Corning silicone (Q7-4840) as the AMT Button (K943392). The Endoscopic Access Device has been developed incorporating all of the safety and effectiveness features for this devices' application. Bench testing and has been performed on the minimum pull out force versus the the strength of the device to ensure mechanical integrity for functional performance (see Exhibit VIa).

The Endoscopic Access Device is sold sterile for single use.

28