SMITH & NEPHEW MIS INSTRUMENTS

K970949 · Smith & Nephew Endoscopy, Inc. · GCJ · Apr 23, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970949
• Device Name: SMITH & NEPHEW MIS INSTRUMENTS
• Applicant: Smith & Nephew Endoscopy, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Apr 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smith & Nephew MIS Instruments are intended to be used in the surgical management of soft tissue. The instruments are intended to be used to grasp, dissect, and cut soft tissue.

Device Story

Hand-held, reusable, non-sterile surgical instruments; includes graspers, dissectors, and scissors. Used in endoscopic, laparoscopic, and thoracoscopic procedures. Operated by surgeons to grasp, dissect, and cut soft tissue. Design features dual/single action jaw with 360-degree rotation; 3-component assembly. Provides mechanical manipulation of tissue during surgery.

Clinical Evidence

Bench testing only; no clinical data provided. Equivalence established through comparison of design, materials, and intended use.

Technological Characteristics

Materials: Stainless steel and Kynar insulation. Design: Hand-held, 3-component assembly, dual/single action jaw with 360-degree rotation. Reusable, non-sterile.

Indications for Use

Indicated for use in endoscopic procedures, including thoracoscopic surgery and laparoscopic procedures for the management of soft tissue.

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

• Karl Storz Take-Apart Endoscopic Instruments
• Richard Wolf Laparoscopic Instruments
• Smith & Nephew and Acufex MIS Instruments

Submission Summary (Full Text)

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APR 23 1997

# Section 8-510k Summary of Safety and Effectiveness
**K 970949**

| 8.1 Statement | This summary of 510k safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92 |
| --- | --- |
| 8.2 Submitter | Smith and Nephew Endoscopy, Inc.
Endoscopy Division
130 Forbes Boulevard
Mansfield, Ma. 02048 |
| 8.3 Company Contact | Amy Walters
Clinical/ Regulatory Manager
[phone] |
| 8.4 Device Name | Proprietary Name: Smith & Nephew MIS Instruments

Common Name: Minimally Invasive Surgical Instruments: graspers, dissectors, scissors.
Classification Name: Endoscopic accessories(78 GCJ)
Laparoscopic accessories (85 HET)
Electrosurgical accessories (79 BWA, 78 KNS) |
| 8.5 Predicate Legally Marketed Devices | - Karl Storz Take-Apart Endoscopic Instruments
- Richard Wolf Laparoscopic Instruments
- Smith & Nephew and Acufex MIS Instruments |
| 8.6 Device Description | The Smith & Nephew MIS Instruments are a line of hand-held, non-sterile, reusable instruments. |
| 8.7 Intended Use | The Smith & Nephew MIS Instruments are intended to be used in the surgical management of soft tissue. The instruments are intended to be used to grasp, dissect, and cut soft tissue. |

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| 8.8 Device Indications | The Smith & Nephew MIS Instruments are indicated for use in endoscopic procedures, including thoracoscopic surgery and laparoscopic procedures. |
| --- | --- |
| 8.9 Substantial Equivalence | The Smith & Nephew MIS Instruments are substantially equivalent to the Karl Storz Take-Apart Endoscopic Instruments and the Richard Wolf Laparoscopic Instruments.

The table below summarizes the similarities of the three product lines. The similarities in design, materials, intended use, and indications for use between the Smith & Nephew MIS Instruments and the predicate devices support the claim of substantial equivalence. |

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| | Smith & Nephew MIS Instruments | Karl Storz Take-Apart Endoscopic Instruments | Richard Wolf Laparoscopic Instruments | Smith Nephew & Acufez Endoscopic Instruments |
| --- | --- | --- | --- | --- |
| **Product Labeling** | non-sterile/reusable | non-sterile/reusable | non-sterile/reusable | non-sterile reusable |
| **Materials** | Stainless steel/Kynar insulation | Stainless steel/ insulation | Stainless steel/ plastic/insulation | Stainless Steel/Kynar insulation |
| **Indications** | Endoscopic Surgical Procedures | Endoscopic Surgical Procedures | Endoscopic Surgical Procedures | Endoscopic Surgical Procedures |
| **Intended Use** | Management of Soft Tissue | Management of Soft Tissue | Management of Soft Tissue | Management of Soft Tissue |
| **Tip Styles** | graspers, dissectors, scissors | graspers, dissectors, scissors | graspers, dissectors, scissors | graspers, scissors, dissectors |
| **Number of separate components** | 3 | 3 | 3 | 1 |
| **Design** | Dual / single action jaw design with 360 degree rotation | Dual / single action jaw design with 360 degree rotation | Dual / single action jaw design with 360 degree rotation | Dual / single action jaw design |

Applicant Amy L. Watkins
Date 3/7/77