ULTRACISION 5MM HARD SHEATH LAPAROSONIC BLADE by ETHICON ENDO-SURGERY, INC.

The intended use for the New Device is the same as that of the Predicate Device in that it is for cutting soft tissue and providing hemostasis during endoscopic surgery.

The UltraCision 5mm Hard Sheath LaparoSonic® Blade is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels.

Device Description

The UltraCision 5mm Hard Sheath LaparoSonic® Blade instruments are 3 styles of sterile, single patient use instruments consisting of a titanium blade with a non-removable sheath. The three styles consist of a Sharp Hook, Dissecting Hook and a Ball Coagulator. The working lengths are approximately 32 cm. The system consists of a blade affixed with a sheath, a hand piece, blade adaptor, blade wrench, generator, foot switch and cart.

AI/ML Overview

The provided text describes a medical device, the UltraCision 5mm Hard Sheath LaparoSonic® Blade instruments, and claims substantial equivalence to a predicate device. However, the document does not contain the information requested in points 1 through 9 regarding acceptance criteria and a study proving the device meets those criteria.

Here's a breakdown of what is and isn't present:

Information Present in the Document:

Device Description: The UltraCision 5mm Hard Sheath LaparoSonic® Blade instruments are sterile, single-patient use instruments (Sharp Hook, Dissecting Hook, Ball Coagulator) with a titanium blade and non-removable sheath. They are approximately 32 cm long and are part of a system including a hand piece, blade adaptor, blade wrench, generator, foot switch, and cart.
Intended Use: Cutting soft tissue and providing hemostasis during endoscopic surgery.
Indications Statement: Soft tissue incisions when bleeding control and minimal thermal injury are desired. Can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels.
Technological Characteristics: Same as the Predicate Device, using ultrasonic characteristics for activation.
Performance Data (Limited): "Pre-clinical laboratory evaluations were performed to ensure that the device can be used as designed. The studies demonstrated acceptable performance in cutting, blunt tissue dissection and coagulation."

Missing Information (Points 1-9):

A table of acceptance criteria and the reported device performance: The document states "acceptable performance in cutting, blunt tissue dissection and coagulation" but does not define what "acceptable" means or provide specific metrics or a table.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method for the test set: Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned, and highly unlikely for this type of device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a surgical instrument, not an AI algorithm.
The type of ground truth used: Not applicable in the context of typical AI algorithm evaluation. For a surgical device, "ground truth" would be related to clinical outcomes or direct observations of its physical performance against a standard, but these details are not provided.
The sample size for the training set: Not applicable as this is a surgical instrument.
How the ground truth for the training set was established: Not applicable as this is a surgical instrument.

Conclusion based on the provided text:

The document states that "Pre-clinical laboratory evaluations were performed to ensure that the device can be used as designed. The studies demonstrated acceptable performance in cutting, blunt tissue dissection and coagulation." However, it does not provide any specific quantitative or qualitative acceptance criteria beyond "acceptable performance," nor does it detail the study methodology, sample sizes, or how performance was measured against those criteria. Therefore, the requested information (points 1-9) cannot be extracted from this summary.

Summary

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K962584

Appendix A

510(k) Summary of Safety and Effectiveness

Statement	Information supporting claims of substantial equivalence, as defined under theFederal Food, Drug and Cosmetic Act, respecting safety and effectiveness issummarized below. For the convenience of the Reviewer, this summary isformatted in accordance with the Agency's final rule "...510(k) Summaries and510(k) Statements..." (21 CFR § 807) and can be used to provide a substantialequivalence summary to anyone requesting it from the Agency.
Devicedescription	The UltraCision 5mm Hard Sheath LaparoSonic® Blade instruments are 3styles of sterile, single patient use instruments consisting of a titanium bladewith a non-removable sheath. The three styles consist of a Sharp Hook,Dissecting Hook and a Ball Coagulator. The working lengths areapproximately 32 cm. The system consists of a blade affixed with a sheath, ahand piece, blade adaptor, blade wrench, generator, foot switch and cart.
Intended use	The intended use for the New Device is the same as that of the PredicateDevice in that it is for cutting soft tissue and providing hemostasis duringendoscopic surgery.
Indicationsstatement	The UltraCision 5mm Hard Sheath LaparoSonic® Blade is indicated for softtissue incisions when bleeding control and minimal thermal injury are desired.The instruments can be used as an adjunct to or substitute for electrosurgery,lasers, and steel scalpels.
Technologicalcharacteristics	The technological characteristics of the New Devices are the same as thePredicate Device. The same ultrasonic characteristics remain as a method ofactivation.
Performancedata	Pre-clinical laboratory evaluations were performed to ensure that the devicecan be used as designed. The studies demonstrated acceptable performance incutting, blunt tissue dissection and coagulation.
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510(k) Summary of Safety and Effectiveness, Continued

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Conclusion	Based on the 510(k) summaries and 510(k) statements (21 CFR §807) and the information provided herein, we conclude that the New Devices are substantially equivalent to the Predicate Device under the Federal Food, Drug and Cosmetic Act.
Contact	Lonnie Pace Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242
Date	June 27, 1996

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Regulation Number and Section

N/A