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The PlasmaJet™ System is a neutral plasma coagulator that is designed for coagulation in open surgery and laparoscopic surgery.

The PlasmaJet™ system consists of a range of single-use open or laparoscopic handpieces that are assured for obagains. A console is used to power the handpiece and a footswitch and a service module (providing a used to power the handplose for an argon tank) completes the system.

In the PlasmaJet™ system, as in a bipolar electrosurgery system, both anode and cathode used to generate the argon partic no ground plate is used. "Decated bour the patient and no more of alternate the liandpiece there is no carrent no niece, a specially designed series of electrodes and allows a relatively low voltage (of about 30V) to generate a more energetic and allows a relatively 101. PlasmaJet™ plasma uses a much lower flow of argon gas than is used in the argon I lasmarco - plasma ases a mis electrically neutral and comprises a mixture of excited Deall Coagulator, the plasma is crocere....) argon atoms, argon ions, and electrons that emerge from the tip of the handpiece in an intense pale blue jet or beam.

When the plasma jet reaches the bleeding tissue, it gives up its kinctic energy as heat which the plasma fer reasies in the bleeding surface by a series of processes. First, the allu causes coaganacon of the broom of argon plasma removes liquid blood from the tissue surface or vessel. Secondly, the energy dissipated from the plasma to the tissue ussuc surface of recom of corm a series of layers of eschar that seal the tissue surface and prevent further bleeding.

The provided text is a 510(k) summary for the PlasmaJet™ system, which is a neutral plasma coagulator. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies (MRMC or standalone).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

The document focuses on:

• Identifying the submitter and contact person.
• Naming the device and its classification.
• Listing predicate devices to establish substantial equivalence.
• Providing a general description of how the PlasmaJet™ system works and its components.
• Stating the intended use: "coagulation in open surgery and laparoscopic surgery."
• Referencing "Animal and clinical studies have been performed to establish that the neutral plasma coagulator have been more effective coagulation than the predicate devices," but provides absolutely no details about these studies or their results.
• The remainder of the document is the FDA's clearance letter.

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The ERBE APC Applicators' intended use is for the delivery of argon gas plasma energy for coagulation of tissue.

The APC Applicators are used with the ERBOTOM ICC Series Electrosurgery Units and ERBE's APC 300 (K963189) Argon Plasma Coagulator.

The APC Applicators are provided in various shaft lengths, shaft diameters, and bend angles to accommodate the variations in anatomical configuration of the target population and surgeon preference. The shaft lengths vary from 110 mm to 500 mm. The shaft diameters vary from 1.5 mm to 2.3 mm.

The APC Applicators work by using argon gas with a monopolar power source. The electrode in the argon channel of the applicator is connected to an electrosurgical generator. When high frequency voltage is high enough, and the proximity to tissue is close enough, electrically conductive argon plasma forms in the gas stream. This allows the current to flow between the applicator and the tissue. Current density upon arrival at the tissue surface causes coagulation. The application of the energy to the tissue is uniform and contact free. A silicon sleeve is available for APC Applicators with lateral openings at the distal end that are used in small lumen.

The APC Applicators' tips are either straight, curved, angled, or needle. The APC Applicators are made of PTFE shafts, ceramic tips, and Zytel and steel connector assemblies.

Both the flexible and rigid APC Applicators are provided non-sterile and are reusable using steam sterilization, whereas the other devices are provided sterile and are disposable. ERBE USA has conducted a sterilization validation per EN45001 to define and support the resterilization.

This 510(k) summary describes a device, ERBE APC Applicators, which is a reusable accessory for electrosurgery systems. The submission asserts substantial equivalence to predicate devices. However, the provided document does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert involvement, ground truth, or adjudication methods.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as this information is absent from the provided text.

The document primarily focuses on:

• Device Identification: Trade name, proprietary name, common name, classification, and product code.
• Predicate Devices: Listing of substantially equivalent legally marketed devices.
• Device Description: Explanation of how the APC Applicators work, their physical characteristics (shaft lengths, diameters, tips), materials, and reusability/sterilization.
• Intended Use: For the delivery of argon gas plasma energy for coagulation of tissue, specifically with ERBOTOM ICC Series Electrosurgery Units and ERBE's APC 300.
• Regulatory Correspondence: An FDA letter confirming the substantial equivalence determination and allowing the device to be marketed.

To answer your questions, details of performance testing or clinical studies would need to be present in the submission. For a device like this (an accessory to an electrosurgical unit), the focus of a 510(k) submission is typically on substantial equivalence to existing devices based on technological characteristics and intended use, rather than extensive clinical performance studies. Performance data, if any, would likely relate to safety aspects (e.g., electrical safety, biocompatibility, sterilization validation) and functional performance to demonstrate it performs as intended and is equivalent to predicates, usually through bench testing or limited animal/cadaver studies, not necessarily large-scale clinical trials with acceptance criteria for diagnostic accuracy or treatment efficacy as might be seen for AI/diagnostic devices.

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The ERBE APC Raspatory Handle and Tip's intended use is for the APC cutting and coagulation. The ERBE APC Raspatory Handle and Tip is used with the ERBOTOM ICC Series Electrosurgery Systems and Argon Plasma Coagulation devices (K963189). The Beacon Laboratories Argon Beam Laparoscopic Electrode also uses argon beam for coagulation, whereas the Valleylab Curved Spatula Tip Electrode uses general electrosurgical current for cutting and coagulation. All three devices target electrosurgical patients.
Argon Plasma Cutting and Coagulation

The ERBE APC Raspatory Handle and Tip and the two substantially equivalent devices meet the AAMI/ANSI HF-18 standard. The ERBE APC Raspatory Handle and Tip is made of a zytel shaft and a ceramic tip. Beacon Laboratories' Argon Beam Laparoscopic Electrode also uses a similar plastic shaft and a ceramic tip. The ERBE APC Raspatory Handle and Tip has a curved spatula-like configuration, which is substantially equivalent to Valleylab's Curved Spatula Tip Electrode. The Valleylab Curved Spatula Tip Electrode uses a similar plastic for the shaft, but uses a steel tip. ERBE has extensive experience in using ceramic tips for APC Applicators; ERBE APC Probes (K963189). The ERBE APC Raspatory Handle and Tip assembly's overall length is 8.5 inches. ERBE APC Raspatory Handle and Tip are two separate components that can be changed/replaced as required. The ERBE APC Raspatory Tip possesses three openings on the concave side of the palatine arch. The argon flows out of the middle opening of the raspatory tip while the side openings suction secretions and possible smoke plume.

ERBE APC Raspatory Handle and Tip is provided non-sterile and are reusable using steam sterilization, whereas the other devices are provided sterile (via Ethylene Oxide and Gamma Radiation) and are disposable. ERBE USA has conducted a sterilization validation per EN45001 to define and support the resterilization. ERBE's APC Raspatory Handle and Tip and Beacon's electrode use argon gas, whereas the Valleylab uses conventional electrosurgical current.

The provided text is a 510(k) summary for the ERBE APC Raspatory Handle and Tip. This document focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than presenting a study that demonstrates the device meets specific performance acceptance criteria.

Therefore, the provided document does not contain the information required to answer the prompt regarding acceptance criteria and a study proving the device meets those criteria.

The 510(k) summary describes the device, its intended use, and identifies predicate devices. It mentions that the device and the predicate devices "meet the AAMI/ANSI HF-18 standard," and that "ERBE USA has conducted a sterilization validation per EN45001," but it does not provide details about the specific acceptance criteria within these standards, nor does it present a study report with performance metrics to prove the device met those criteria.

To answer the prompt, a different type of document, such as a detailed design validation report or a clinical study report, would be necessary.

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