AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE

K963999 · United States Surgical, A Division of Tyco Healthc · OCW · Nov 27, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K963999
• Device Name: AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: OCW · Gastroenterology, Urology
• Decision Date: Nov 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AUTO SUTURE* Modified Endoscopic Fascia Stapler** device is intended for use in affixing prosthetic material or approximating tissue. This device may be used both endoscopically and in open procedures.

Device Story

Disposable, sterile endoscopic stapling device; used for affixing prosthetic material or approximating tissue; operated by surgeons in endoscopic or open procedures; provides fastener security; mechanical operation.

Clinical Evidence

Bench testing only; in-vivo and in-vitro testing performed to evaluate fastener security; results demonstrate adequate fastener strength.

Technological Characteristics

Disposable endoscopic stapler; materials compliant with ISO 10993-1; mechanical actuation; sterile.

Indications for Use

Indicated for affixing prosthetic material or approximating tissue in endoscopic and open surgical procedures.

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

• Origin® Tacker™ System (K944415)

Submission Summary (Full Text)

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United States Surgical Corporation
510(k) Premarket Notification
AUTO SUTURE* Modified Endoscopic Fascia Stapler**
K963999

# SUMMARY 510(K) SUMMARY OF INFORMATION SUPPORTING SAFETY AND EFFECTIVENESS

SUBMITTER: United States Surgical Corporation
150 Glover Avenue
Norwalk, CT 06856
[phone]
NOV 27 1996

CONTACT PERSON: Christopher Taylor
DATE PREPARED: October 4, 1996
CLASSIFICATION NAME: Implantable Staple
COMMON NAME: Surgical Staple
PROPRIETARY NAME: Trademark name not yet determined.
PREDICATE DEVICE: Origin® Tacker™ System (K944415)
DEVICE DESCRIPTION: The AUTO SUTURE* Modified Endoscopic Fascia Stapler** device is an endoscopic stapling device. The device is disposable and is supplied sterile.
INTENDED USE: The AUTO SUTURE* Modified Endoscopic Fascia Stapler** device is intended for use in affixing prosthetic material or approximating tissue. This device may be used both endoscopically and in open procedures.
MATERIALS: All component materials of the AUTO SUTURE* Modified Endoscopic Fascia Stapler** device are comprised of materials which are in accordance with ISO Standard #10993-1.
PERFORMANCE: The AUTO SUTURE* Modified Endoscopic Fascia Stapler** device was tested both in-vivo and in-vitro to evaluate fastener security. The results of this testing demonstrate that the subject device provides adequate fastener strength.

* Trademark of United States Surgical Corporation
** Trademark name not yet determined