MODIFIED HAND INSTRUMENT DEVICES

K960748 · United States Surgical, A Division of Tyco Healthc · GCJ · Apr 5, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K960748
• Device Name: MODIFIED HAND INSTRUMENT DEVICES
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Apr 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The AUTO SUTURE* Biopsy Instrument** device is designed and indicated for the same procedures as the predicate device.

Device Story

Reusable biopsy instrument for laparoscopic surgery; used by surgeons to obtain tissue samples; identical in design and function to predicate IMAGYN biopsy instrument; manual operation; facilitates tissue collection during endoscopic procedures.

Clinical Evidence

No clinical data; substantial equivalence based on design and functional identity to predicate.

Technological Characteristics

Reusable endoscopic hand instrument; manual actuation; materials and manufacturing processes consistent with existing USSC endoscopic instrument line.

Indications for Use

Indicated for use in laparoscopic surgical procedures for obtaining biopsy samples.

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

• IMAGYN Medical Inc biopsy instrument (K944129)

Submission Summary (Full Text)

{0}

United States Surgical Corporation
510(k) Premarket Notification
AUTO SUTURE* Biopsy Instrument** device
APR - 5 1995
K960748

# SUMMARY OF INFORMATION SUPPORTING SAFETY AND EFFECTIVENESS:

The AUTO SUTURE* Biopsy Instrument** device is identical in safety and effectiveness to its currently marketed predicate - IMAGYN Medical Inc’s biopsy instrument as described in *Laparoscopic Instruments* - 510(k) #K944129. United States Surgical Corporation has been manufacturing endoscopic hand instruments as accessories in surgical procedures for a number of years. It is now the intention of USSC to manufacture for the marketplace a reusable biopsy instruments identical to that described in IMAGYN’s 510(k). The information included in this notification demonstrates that the device is substantially equivalent to its predicate in respect to design, function, performance, labeling and sterilization.

- Both the subject and predicate devices are designed and indicated for the same procedures.
- Both the subject device and other currently marketed United States Surgical Corporation devices are manufactured in the same facilities, using similar processes and controls.
- Both the subject device and other currently marketed United States Surgical Corporation devices are packaged in the same facilities using similar processes and controls.
- Both the subject and predicate devices perform the exact same function in the same way.