(150 days)
Subject Device(s) Indications of Use ENT Wands ENT Plasma Wands
Indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral, and sinus surgery, mastoidectomy, myringotomy with effective hemorrhage control, nasal airway obstruction of hypertrophic nasal turbinates, nasopharyngeal/ laryngeal indications including tracheal procedures, laryngeal polypectomy, and laryngeal lesion debulking, neck mass, papilloma keloids, submucosal palatal shrinkage, submucosal tissue shrinkage, tonsillectomy (including palatine tonsils), traditional uvulopalatoplasty (RAUP), tumors, and tissue in the uvula/soft palate for the treatment of snoring.
Turbinator Wands
Indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) sinus surgery involving nasal airway obstruction of hypertrophic nasal turbinates and submucosal tissue shrinkage. The Wand is designed to be used exclusively with the COBLATOR II (CII) controller and Irrigation pump or the WEREWOLF COBLATION System (in conjunction with the ENT Adapter and Irrigation Tube Set). Other controllers/pumps must not be used.
WEREWOLF ENT Adapter
The WEREWOLF ENT Adapter, in conjunction with the Smith & Nephew COBLATOR II Compatible ENT Wands, the Smith & Nephew WEREWOLF COBLATION System and the WEREWOLF Irrigation Tube Set (as needed) are indicated for the ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in ENT/otorhinolaryngology procedures.
WEREWOLF Irrigation Tube Set
The WEREWOLF Irrigation Tube Set, in conjunction with the Smith & Nephew COBLATOR II Compatible ENT Wands, the Smith & Nephew WEREWOLF COBLATION System and the WEREWOLF ENT Adapter are indicated for the ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in ENT/otorhinolaryngology procedures.
The ENT Plasma Wands (K070374 and K142999) and Turbinator Wand (K122652) are currently cleared to be used with the ArthroCare ENT Coblator Surgery System (COBLATOR II) (K030108). This 510(k) is to obtain clearance for the use of ENT Wands, in conjunction with two accessories, with the recently cleared WEREWOLF COBLATION System (K192027 - Dec 20, 2019). The accessories are the WEREWOLF ENT Adapter and the WEREWOLF Irrigation Tube Set The extended compatibility does not result in any changes to the overall design or to the indications of use for the ENT Wands nor the WEREWOLF COBLATION System.
ENT Plasma Wands are bipolar, single use, high frequency electrosurgical devices designed for use in ablation, resection and coagulation of soft tissue, and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery.
Turbinator Wand is a bipolar, single use, high frequency electrosurgical device designed for use for specific turbinate indications in otorhinolaryngology (ENT) procedures.
The WEREWOLF ENT Adapter is a reusable, electrically-activated adapter with an 8pin connector at the distal end an 18-pin connector at the proximal end. The reusable WEREWOLF ENT Adapter is designed to be used with the COBLATOR II Compatible ENT Wands (8-pin connector) and WEREWOLF COBLATION System (18-pin connector), along with the WEREWOLF Irrigation Tube Set, as needed.
The WEREWOLF Irrigation Tube Set is a single use, disposable, sterile device. The Irrigation Tube Set is designed to be used with COBLATOR II compatible ENT Wands and WEREWOLF COBLATION System, along with the reusable WEREWOLF ENT Adapter. The spike of the Irrigation Tube Set is connected to an irrigation source for select ENT Wands; that is, the ENT wands that use a conductive media, such as normal saline intraoperatively.
The provided text does not contain detailed acceptance criteria and a study proving the device meets these criteria in the format requested. The document describes a 510(k) submission for ENT Plasma Wands, Turbinator Wands, and accessories for use with the WEREWOLF COBLATION System. This submission aims to demonstrate substantial equivalence to predicate devices, not necessarily to meet specific, quantitatively defined acceptance criteria through a dedicated study.
However, based on the non-clinical performance testing section, we can infer some aspects of what would typically be considered "acceptance criteria" through design verification.
Here's an attempt to extract and describe the information, inferring where necessary based on the context of a 510(k) submission for substantial equivalence:
Inferred Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Design Verification) | Reported Device Performance (Summary from Non-Clinical Testing) |
|---|---|
| Electrical Safety & Performance | Met established design criteria. |
| * Input Power Range (100-240 VAC, 50-60 Hz) | Same as predicate devices. |
| * Fuse Rating (16 Amps) | Differs from predicate (8 Amps) but met design criteria. |
| * Output Nominal Voltage Max (340 Vrms) | Differs slightly from predicate (320 +/- 10% Vrms) but met design criteria. |
| * Rated Wand Voltage (320 +/- 10% Vrms) | Same as predicate devices. |
| * Ablation/Coagulation Set Points/Output Voltage | Default set points are same; ablation range adjusted (0-300Vrms) from predicate (100-300Vrms) but met design criteria. |
| * COBLATION System Waveform (Square) | Same as predicate devices. |
| * Output Frequency (100kHz) | Same as predicate devices. |
| Mechanical/Functional Performance | Met established design criteria. |
| * Suction System Compatibility | Same as predicate devices (connects to hospital suction). |
| * Saline Delivery System | Demonstrated effective saline delivery (integrated peristaltic pump vs. external flow control unit in predicate), met design criteria. |
| * Activation Method (Foot Control) | Same as predicate devices. |
| * User Interface Functionality (GUI) | Functional and simplified system performance (new feature). |
| * Software Control and Performance | Main 4.1 and GUI 3.0 effectively controlled intended use. |
| * Weight (10 kg) | Differs from predicate (8.2 kg) but met design criteria. |
| Biocompatibility | Met requirements for clinical use. |
| * ENT Wands | Materials unchanged, therefore no new testing required. |
| * ENT Adapter & WEREWOLF Controller | Non-patient contacting, no biocompatibility testing required. |
| * Irrigation Tube Set | Met ISO 10993-1:2018 for cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, materials mediated pyrogenicity, and hemocompatibility (leveraged from K192027). |
| Sterilization Assurance | Validated sterilization methods achieving SAL of 10^-6. |
| * ENT Wands | Radiation sterilization, SAL 10^-6 (unchanged). |
| * Irrigation Tube Set | EtO gas sterilization, SAL 10^-6. |
| Thermal Effects (Ablation/Coagulation Modes) | Ex-vivo bench testing demonstrated performance substantially equivalent to predicate devices. |
| Verified that subject devices performed substantially equivalent to predicate devices for ablation and coagulation mode thermal effects. |
1. Sample sized used for the test set and the data provenance:
- Test Sample Size: Not explicitly stated as a numerical sample size. The testing involved "ex-vivo bench testing" on "bovine myocardial tissue" for thermal effects. Other tests (electrical, mechanical/functional) likely involved multiple units or measurements but specific numbers are not provided.
- Data Provenance: The ex-vivo bench testing used bovine myocardial tissue. This implies laboratory-controlled experiments rather than human patient data. The country of origin is not specified but implicitly within the ArthroCare Corporation's testing facilities (likely in the US, given the FDA submission). This was a retrospective evaluation in the sense that it was conducted for the 510(k) submission, confirming design aspects before market release for this specific compatibility.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The testing described is primarily engineering and bench testing, demonstrating technical equivalence and safety rather than diagnostic accuracy requiring expert interpretation.
3. Adjudication method for the test set:
- Not applicable. The testing described does not involve expert adjudication as it's not a diagnostic study requiring human interpretation of output.
4. 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 device is an electrosurgical cutting and coagulation device, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a surgical instrument. Performance is inherently tied to its physical and energetic effects, not an algorithm's output in isolation from human use. While the device does have "Software controlled" and a "Graphical User Interface," the "standalone" performance notion as used in AI/diagnostic studies does not apply here.
6. The type of ground truth used:
- For electrical and mechanical performance: Engineering specifications and standards.
- For biocompatibility: ISO 10993-1:2018 standards; leverage from previously cleared device (K192027).
- For sterilization: Validated sterilization cycles achieving specific Sterility Assurance Levels (SAL).
- For thermal effects: Direct measurement of ablation and coagulation thermal effects on ex-vivo bovine tissue, likely compared against established performance metrics or the predicate devices.
7. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
8. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this 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.