(126 days)
Not Found
Not Found
No
The document describes a surgical instrument for cutting and coagulation, with no mention of AI or ML technology in its function or description.
Yes
The device is described as "cutting soft tissue and providing hemostasis during endoscopic surgery" and is indicated for "soft tissue incisions when bleeding control and minimal thermal injury are desired," which directly relates to the treatment of a medical condition.
No
Explanation: The device description clearly states its purpose is for "cutting soft tissue and providing hemostasis during endoscopic surgery" and for "soft tissue incisions." There is no mention of it being used to detect, diagnose, or monitor a medical condition, which are the primary functions of diagnostic devices.
No
The device description clearly lists multiple hardware components including a titanium blade, sheath, hand piece, blade adaptor, blade wrench, generator, foot switch, and cart.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cutting soft tissue and providing hemostasis during endoscopic surgery." This describes a surgical tool used directly on the patient's body for treatment and manipulation of tissue.
- Device Description: The description details a surgical instrument with a blade, sheath, handpiece, generator, etc., designed for physical interaction with tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic or other health-related information. This device is a surgical instrument used for direct intervention on the patient.
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
NOV - 4 1996
Appendix A
510(k) Summary of Safety and Effectiveness
| Statement | Information supporting claims of substantial equivalence, as defined under the
Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is
summarized below. For the convenience of the Reviewer, this summary is
formatted in accordance with the Agency's final rule "...510(k) Summaries and
510(k) Statements..." (21 CFR § 807) and can be used to provide a substantial
equivalence summary to anyone requesting it from the Agency. |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
| Intended use | 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. |
| Indications
statement | 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. |
| Technological
characteristics | The technological characteristics of the New Devices are the same as the
Predicate Device. The same ultrasonic characteristics remain as a method of
activation. |
| Performance
data | 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. |
| | Continued on next page |
1
510(k) Summary of Safety and Effectiveness, Continued
.. . . .
ﺮ ﻣﺤﻤﺪ ﺳﻴﺴﺎ
| 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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