ENDO-TECH LTD., TIPS

K961695 · Ratio Design Lab · HFG · Jul 1, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K961695
• Device Name: ENDO-TECH LTD., TIPS
• Applicant: Ratio Design Lab
• Product Code: HFG · Obstetrics/Gynecology
• Decision Date: Jul 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4160
• Device Class: Class 2
• Attributes: Therapeutic

Indications for 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.

Device Story

Laparoscopic Unipolar Tips function as electrosurgical accessories for the Endo-Aid (K930756) aspiration-irrigation device. Tips (Spatula, L Hook, J Hook, Needle) thread into the control handle to deliver electrosurgical energy, perform hydro-dissection, aspiration, irrigation, lavage, blunt dissection, and smoke evacuation. Used by surgeons in hospital operating rooms. Features include adjustable, ratcheting insulation sheath to cover/expose tips, removable components for cleaning, and nonconductive case. Device is reusable and autoclavable. Benefits include improved surgical access and fluid management during minimally invasive abdominal procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Stainless steel tips, nonconductive case material (USP Class VI). Design: Threaded connections (3/8-16AWC), ratcheting adjustable insulation sheath. Reusable, autoclavable. Hospital solvent resistant. Operating temperature range 40-110°F.

Indications for Use

Indicated for use by surgeons during laparoscopic and electrosurgical abdominal procedures in a hospital operating room environment. Patient population includes adult males and females.

Regulatory Classification

Identification

A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.

Predicate Devices

• Electrosurgical Attachments (American Hydro-Surgical)

Reference Devices

• Endo-Aid (K930756)

Submission Summary (Full Text)

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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

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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)

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# 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.

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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.