ENDOSCOPIC CLIP APPLIER

K962493 · Aesculap, Inc. · OCW · Sep 11, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K962493
• Device Name: ENDOSCOPIC CLIP APPLIER
• Applicant: Aesculap, Inc.
• Product Code: OCW · Gastroenterology, Urology
• Decision Date: Sep 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The devices presented in this submission are intended for use in endoscopic surgery for ligating and marking vessels and tubular structures.

Device Story

Reusable stainless steel endoscopic clip appliers (10mm diameter, 260-370mm length); used with disposable clip magazine holding 8 titanium clips. Instrument features handle with separate control levers for clip supply and closure. Design allows multiple clip applications without device withdrawal/reinsertion. Disassemblable for cleaning, disinfection, and sterilization. Operated by surgeons in endoscopic surgical settings. Output is mechanical ligation/marking of vessels/tubular structures; facilitates hemostasis or tissue marking.

Clinical Evidence

No clinical data provided. Bench testing only; manufacturing follows ISO and German DIN standards; manufacturer holds ISO 9001 certification.

Technological Characteristics

Reusable stainless steel construction; 10mm diameter; 260-370mm length. Mechanical actuation via handle control levers. Disposable titanium clip magazine. Disassemblable for cleaning/sterilization. Manufactured per ISO and German DIN standards.

Indications for Use

Indicated for use in endoscopic surgery for ligating and marking vessels and tubular structures in patients requiring such 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

• Aesculap Endoscopic Clip Appliers (predecessor 510(k)s)
• Baxter Endoscopic Clip Appliers
• Ethicon Endoscopic Clip Appliers
• Horizon Surgical Endoscopic Clip Appliers
• U.S. Surgical Endoscopic Clip Appliers

Submission Summary (Full Text)

{0}

K962493

SEP 11 1996

AESCULAP.

Page 1 of 2

# 510(k) Summary of Safety and Effectiveness

(in Accordance with SMDA of 1990)

Aesculap Endoscopic Clip Appliers

June 25, 1996

**Submitted by:** Aesculap®, Inc.
1000 Gateway Blvd.
So. San Francisco, CA 94080
Contact: Mary Ellen Holden
Phone: [phone] x348
FAX: [phone]

## Product Name

Trade Name: Endoscopic Clip Appliers
Common Name: Endoscopic Instruments
Classification Name: Endoscope and Accessories

## Predicate Device

Aesculap's Endoscopic Clip Appliers with disposable clip magazine represents a modification to existing devices. The modified devices are compared to their predecessors, which were previously cleared in Aesculap's 510(k)'s. The modified Endoscopic Clip Appliers with disposable clip magazine are also compared to endoscopic clip appliers and implantable clips by Baxter, Ethicon, Horizon Surgical, and U.S. Surgical.

## Device Description

Aesculap's Endoscopic Clip Appliers (PL506R, PL508R) are reusable stainless steel instruments 10mm in diameter and ranging in length from 260mm to 370mm. They are designed for use with a disposable clip magazine which attaches to the shaft of the clip applier. The clip magazine cartridge holds 8 titanium clips which can be applied one at a time. The instrument handle has a control lever for supplying the clips and a separate control lever for closing the clips. The design enables the surgeon to apply several clips without the need for withdrawing and reinserting the clip applier each time.

Like Aesculap's Modular Endoscopic Instruments, these clip appliers can be disassembled for cleaning, disinfection and sterilization. The handle can be removed, allowing the shaft of the instrument to be disassembled into three separate pieces.

1000 GATEWAY BOULEVARD • SOUTH SAN FRANCISCO, CA 94080-7030 • USA • 415-876-7000 • FAX: [phone]
04

{1}

Page 2 of 2

# 510(k) Summary of Safety and Effectiveness
*(in Accordance with SMDA of 1990)*

## Aesculap Endoscopic Clip Appliers

### Intended Use

The devices presented in this submission are intended for use in endoscopic surgery for ligating and marking vessels and tubular structures.

### Summary of Technological Characteristic

Aesculap's Endoscopic Clip Appliers represent no change in technological characteristics, only modifications to instrument design.

### Performance Data

No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, the Endoscopic Clip Appliers and disposable clip magazine will be manufactured in accordance with ISO and German Din Standards. Furthermore, Aesculap AG has received ISO 9001 certification.

### Substantial Equivalence

Aesculap believes that the Endoscopic Clip Appliers presented in this submission are substantially equivalent in design, function, and intended use to the presented devices from Baxter, Ethicon, Horizon Surgical, and U.S. Surgical.

05