(17 days)
Not Found
No
The device description focuses on the physical components and mechanism of action (argon plasma coagulation) and does not mention any computational or algorithmic processing, let alone AI/ML.
Yes
The device is described as being used for "argon plasma coagulation" to "treat many conditions in endoscopy for various surgical procedures," and it facilitates the delivery of energy "to cause coagulation," all of which indicate a therapeutic purpose.
No
The device description clearly states its purpose is for "argon plasma coagulation" to "treat many conditions in endoscopy for various surgical procedures," and to cause "coagulation" of tissue. This indicates a therapeutic, rather than a diagnostic, function.
No
The device description clearly details physical components made of various materials (polyamide, PEEK, silicone, Teflon, stainless steel, etc.) and describes their function in delivering electrosurgical current and argon gas. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The APC Connector Hose and Probes are used directly on tissue inside the patient during endoscopic procedures. They deliver argon plasma coagulation for treatment, not for analyzing a sample taken from the body.
- Intended Use: The intended use clearly states "for use in argon plasma coagulation" and "to treat many conditions in endoscopy." This is a therapeutic/surgical application, not a diagnostic one.
The device is an accessory to an electrosurgical unit used for therapeutic purposes within the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
79GEI
Device Description
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 (Note: The other end of the hose connects to an ERBE Argon Plasma Coagulator Model APC 300.). 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 (Note: The cleaning and sterilization processes have been validated and are provided in the Notes for use to the customer.).
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 (Note: The Coagulator is used with an ERBOTOM ICC Series Electrosurgical Generator Unit.). The APC Connector Hose attaches to gas as well as electrical inputs of the Coagulator and then to an APC Probe (Note: The Coagulator has an instrument recognition system which identifies the Probe for argon gas flow purposes.). 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 ((Note: The APC Probes have depth marker rings close to the tip for positioning purposes.). 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0