(61 days)
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.
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. 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).
This 510(k) submission (K961695) is for a medical device that does not involve AI/ML. There is no information in the provided text regarding acceptance criteria, device performance, sample sizes, expert involvement, or any studies related to AI/ML performance.
Therefore, I cannot provide a response with the requested information based on the provided text. The document describes a comparison to a predicate device based on physical and functional characteristics, not performance metrics usually associated with AI/ML systems.
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510K Summa
11 - 1 1996
1. IDENTIFICATION OF SUBMITTER
Submission of 510(K) approval is made by: Endo-Tech Ltd., Inc.
Establishment Registration Number 1.1
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 1100 F
Storage temperature range -40 to 1500 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 hydrodissection of tissue, aspiration and irrigation of fluids, lavage, blunt dissection, smoke evacuation, and the delivery of electrosurgical energy.
8. CONCLUSION
This concludes the section.
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§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
(a)
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.(b)
Classification. Class II (performance standards).