(17 days)
The APC Connector Hose and Probes are intended for use in argon plasma coagulation. The device is used to treat many conditions in endoscopy for various surgical procedures.
The APC Connector Hose is a flexible connecting cable. It has a pronged connecting end to the APC Probe and is 8.2ft. (2.5m) in length. The connector ends of the Hose are made of polyamide, poly ether ether ketone (PEEK), and plastic (Thermoflex). The cable portion of the Hose is silicone. The Hose is a conduit for both electrosurgical current and argon gas. The APC Connector Hose is provided non-sterile and is reusable.
The APC Probes are also tubular instruments and are flexible. They are provided in various lengths and diameter sizes to accommodate the various size/types of endoscopes for a variety of applications (i.e., the treatment of various target tissues inside a patient). The lengths of the APC Probes are 4.9ft. (1.5m) to 9.8ff. (3m). The diameters of the APC Probes are 4.5 French (1.5mm) to 9.6 French (3.2mm). For the Probe, the connector end is made of plastics (polypropylene and Thermoflex). The tube portion of the Probe is made of Teflon (PTFE) and has a stainless steel wafer shape electrode close to the tip for terminating electrical current. For the lateral opening (side fire) Probe there is a glued on ceramic tip. The APC Probes have either an axial (straight fire) or a lateral (side fire) opening allowing the energy to be delivered straight or at a 45 to 90 degree angle. The two types of openings for the APC Probes allow the physician a choice in the direction of delivering the argon plasma to the treatment site. The APC Probes are provided sterile by means of ethylene oxide and are disposable (Single Use).
The APC Connector Hose and Probes are accessories of the ERBE Argon Plasma Coagulator Model APC 300. The APC Connector Hose attaches to gas as well as electrical inputs of the Coagulator and then to an APC Probe. An endoscope is manipulated inside the patient to locate tissue that requires treatment. Upon finding the target tissue, the APC Probe is threaded into the working channel of the endoscope, until the tip of the APC Probe slightly protrudes from the end of the scope. Then opening of the APC Probe is positioned towards/in close proximity of the area to be treated. The APC/ICC system is activated via a footswitch. When high frequency voltage reaches the critical level 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 probe 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.
This 510(k) summary describes modifications to an existing device, the ERBE Argon Plasma Coagulator (APC) Connector Hose and Probes. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study with statistical endpoints. The document states that "All the changes have been verified or validated in design control," indicating bench testing and engineering verification were likely performed.
Therefore, the requested information about acceptance criteria, study details, sample sizes, expert ground truth, and comparative effectiveness studies is not explicitly available within the provided text. The document primarily focuses on describing the changes made to the device and asserting that these changes do not adversely affect safety or effectiveness.
However, I can extract the following relevant information:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in a table format in the document, nor are explicit quantitative acceptance criteria stated. The document instead makes qualitative claims:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Maintain Performance Specifications (APC Connector Hose) | "The modified Hose has the same performance specifications..." |
| Maintain Performance Specifications (APC Probes) | "The modified APC Probes have the same performance specifications..." |
| Secure Connection to APC Filter/Coagulator (APC Connector Hose) | "Change was made to make the connection to the APC Filter/Coagulator (Model APC-300) more secure/tighter." |
| Enhanced Integrity (APC Connector Hose) | "The modified Hose has a one piece v-connector where as the predicate's is a two-piece v-connector (Note: Change enhances integrity)." |
| Easier Manipulation (APC Connector Hose) | "The cable of the modified Hose is more flexible then the cable of the predicate, making manipulation easier." |
| More Secure Connection to APC Probe (APC Connector Hose) | "The modified connection to the APC Probe is more secure." |
| Hardier Attachment End & More Secure Connection (APC Probe) | "The attachment end is hardier and the connection to the APC Connector Hose is more secure with the two pins." |
| Improved Electrode Ignition & Cooling (APC Probe) | "The internal electrode... ignites better and cools quicker because of the larger surface area... (i.e., there is more consistency in activation)." |
| Reduced Agglutination (Straight Fire Probes) | "The ceramic tip has been found not to be necessary for the straight fire Probes which helps reduce agglutination at the tip." |
| No Adverse Affect on Safety or Effectiveness (APC Connector Hose) | "The dimensional or structural modification as well as the material change... does not adversely affect the safety or effectiveness of the accessory." |
| No Adverse Affect on Safety or Effectiveness (APC Probes) | "The structural modification... as well as the redesigned internal electrode does not adversely affect the safety or effectiveness of the accessories." |
| No Safety or Efficacy Impact (Longer Probe & Packaging) | "Also, the one Probe being longer and the packaging changes did not have a safety or efficacy impact." |
| No Safety or Efficacy Concerns (Contract Manufacturing) | "Also, the contract manufacturing... does not raise safety or efficacy concerns." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not specified in the document. The statement "All the changes have been verified or validated in design control" implies in-house testing, likely bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable/not specified. The "ground truth" here would relate to engineering specifications and performance, not medical diagnoses by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a medical device accessory submission, not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device accessory submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" would likely be based on engineering specifications, validated test methods for mechanical properties, electrical performance, material compatibility, and sterilization efficacy. Not explicitly detailed in the summary.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established:
Not applicable. This is not a machine learning or AI device.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.