ENDO-TECH LTD., TIPS

{0} K961695 S10K Summary JUL - 1 1996 # 1. IDENTIFICATION OF SUBMITTER Submission of 510(K) approval is made by: Endo-Tech Ltd., Inc. 1.1 Establishment Registration Number 1056537 1.2 Mailing Address 4040 Nine McFarland Drive Suite 800 Alpharetta, Georgia 30201 # 2. DEVICE NAME Endo-Tech, Ltd., Inc. Laparoscopic Unipolar Tips # 3. IDENTIFICATION OF PREDICATE We believe that these devices are substantially equivalent to Electrosurgical Attachments sold by American Hydro-Surgical. 3.1 Classification Name Laparoscope, Gynecologic( and accessories) or Coagulator, Laparoscopic, Unipolar( and accessories) 3.2 Common/Usual Name Laparoscopic Unipolar Tips 3.3 Classification Laparoscopic Unipolar Tips would most likely have been reviewed by the FDA Obstetrics and Gynecological Device Classification Panel. We believe that this device classification code is OBHET, a class II device under regulation number 884.1720 or, code OBHFG, a class II device under regulation number 884.4160. # 4. DEVICE DESCRIPTION 4.1 Function {1} The Laparoscopic Unipolar Tips will be threaded into the Endo-Tech, Ltd., Inc. Endo-Aid (K#930756) and will be used during Laparoscopic procedures. These tips will be used by a range of surgeons for various abdominal procedures in a hospital operating room environment. ## 4.2 Physical and Performance Characteristics ### Human Function User Range: - Adult, Male and Female - Left and Right Handed - 5 to 95%ile Surgeons - Removable sheath made for easier cleaning - Adjustable insulation sheath covers and exposes tips - Ratcheting sheath stays in fixed position until adjusted - Removable tip threads off for easier cleaning - Labeled tubing to reduce confusion - Labeling includes instructions and identification - Case and label colors approved by Endo-Tech, Ltd. - Attractive aesthetics - Reusable, Autoclaved. ### Technical Function - Drop proof from 45 inch height onto tile floors - Operating temperature range 40 to 110°F - Storage temperature range -40 to 150°F - Hospital solvent resistant: water, alcohols, blood, saline solutions - USP Class VI - stainless steel tips - Threaded connections accept Endo-Tech Ltd., Aspiration-Irrigation Device, K#930756 - Case material is nonconductive - reduction of component parts - High reliability design and documentation methods for FDA approval ### Production Function - Production quantities of 5,000 units first year - Total production run of 25,000 units - Simplified tooling design - Tooling and parts designed for manufacture by approved vendors - Qualification testing for tips and connections - Production engineered for low cost assembly - Package designed for efficient storage and handling - Packaging labeled for inventory controls ## 4.3 COMPONENTS The Laparoscopic Unipolar Tips consist of the following components: - Threaded adapter (Male) - Thread on probe and stainless tip (Female:Spatula, L Hook, J Hook, and Needle) - Insulation Sheath for Electrosurgical Tips (Ratcheting) {2} # 5. INTENDED USE The Laparoscopic Unipolar Tips will serve as accessories to the Endo-Tech, Ltd, Inc., Endo-Aid, which is an Aspiration-Irrigation Device. These tips will thread into the laparoscopic irrigation and aspiration control handle. The tips will be used during laparoscopic procedures and electrosurgical procedures. # 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS Most features of the laparoscopic unipolar tips are functionally identical to the predicate products; exceptions include dimensions/weigh, colors, and sheath design summarized here. ## 6.1 DIMENSIONS/WEIGHT | Characteristics | Endo-Tech | American Hydro-Surgical | | --- | --- | --- | | Tip Overall | 15.7" x .63" x .63" | 13.5" x .68" x .68" | | Tip Internal Diameter | .154" | .154" | | Tip Internal Diameter (Electrosurgical) | .1" | .1" | | Tubing Length | 13" | 11" | | Tubing Length (Electrosurgical) | 15" | 12.5" | | Thread | 3/8-16AWC | 3/8-16AWC | | Weight Overall | .8oz | .8oz | ## 6.2 COLORS | Characteristics | Endo-Tech | American Hydro-Surgical | | --- | --- | --- | | Threaded Adapter | white | white/black/clear | | Threaded Probe | white | white | | Threaded Probe (Electrosurgical) | black | black | | Insulated Sheath | black | black | ## 6.3 SHEATH DESIGN The insulation sheaths of both companies are designed to be adjustable to the desired length of the surgeon. The difference lies in the ability of the Endo-Ltd, laparoscopic unipolar tips to adjust and stay in a fixed position until moved by the surgeon. American Hydro-Surgical devices do not have the ratcheting mechanism. {3} 7. CONCLUSION DRAWN FROM DATA SUPPORTING EQUIVALENCE DETERMINATION The Endo-Tech Ltd., Inc. laparoscopic unipolar tips are designed to be equivalent to the electrosurgical attachments that are manufactured by American Hydro-Surgical. These tips are to be used in conjunction with the Endo-Aid(K#930756) during laparoscopic procedures. These tips, along with the Endo-Aid, enables hydro-dissection of tissue, aspiration and irrigation of fluids, lavage, blunt dissection, smoke evacuation, and the delivery of electrosurgical energy. 8. CONCLUSION This concludes the section.