(150 days)
No
The document describes electrosurgical devices and accessories for ENT procedures, focusing on ablation, resection, and coagulation. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is used for ablation, resection, coagulation, and hemostasis of soft tissue and blood vessels, which are medical interventions directly aimed at treating conditions and restoring health within the otorhinolaryngology (ENT) surgical field.
No.
The device is described as an electrosurgical device for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels, which are interventional procedures, not diagnostic ones.
No
The device description clearly outlines hardware components including wands, adapters, and irrigation tube sets, which are physical medical devices used in surgical procedures.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The provided text clearly describes the devices as electrosurgical devices used for ablation, resection, coagulation, and hemostasis of soft tissue and blood vessels during surgical procedures in the ENT area. They are used directly on the patient's tissue, not on specimens taken from the body.
- Lack of Mention of Specimen Analysis: There is no mention of analyzing any biological specimens or providing diagnostic information based on such analysis.
Therefore, these devices are surgical instruments used for therapeutic purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Accessories
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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, blood vessels, adenoid, cysts, head, neck, oral, sinus, mastoid, myringotomy, nasal turbinates, nasopharyngeal, larynx, trachea, neck mass, papilloma keloids, palate, tonsil, uvula
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)
Non-clinical performance testing:
Non-clinical performance testing of the ENT Wands with the accessories used in conjunction with the WEREWOLF COBLATION System verified that the subject devices met the established design criteria and supported substantial equivalence with the predicate devices, ENT Wands in conjunction with COBLATOR II System. It included design verification testing, consisting of electrical and mechanical/functional testing, which verified that the design meets the performance specifications. Pre-clinical ex-vivo bench testing was conducted to assess ablation and coagulation mode thermal effects, as well as suction, on bovine myocardial tissue, which verified that the subject devices performed substantially equivalent to the predicate devices.
Neither "Performance Testing - Animal" nor "Performance Testing - Clinical" was conducted to support this 510(k).
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.
K070374, K142999, K122652, K030108
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.
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.
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December 18, 2020
ArthroCare Corporation Jean Asquith Senior Regulatory Affairs Specialist 7000 West William Cannon Drive, Building One Austin, Texas 78749
Re: K202006
Trade/Device Name: ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewoff ENT Adapter. Werewolf Coblation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: July 20, 2020 Received: November 19, 2020
Dear Jean Asquith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202006
Device Name
ENT Plasma Wands and Turbinator Wands
Indications for Use (Describe)
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.
-Continued-
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K202006
Accessories
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.
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Image /page/4/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a stylized red graphic on the left and the name "ArthroCare" in gray text on the right. The graphic is made up of several curved lines that are arranged in a circular pattern. The word "ArthroCare" is written in a sans-serif font, and there is a registered trademark symbol next to the word "Care".
510(k) Summary ArthroCare® Corporation
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
1. GENERAL INFORMATION
ArthroCare® Corporation 7000 W. William Cannon Drive Building One Austin, TX 78735
| Company Contact: | Jean Asquith |
|---|---|
| Tel: (512) 680-5802 | |
| Fax: (512) 895-1489 | |
| Email: | jean.asquith@smith-nephew.com |
Date Prepared: December 18, 2020
2. DEVICE IDENTIFICATION
| Device Trade Name: | ENT Plasma Wands, Turbinator Wand, Werewolf
Irrigation Tube Set, Werewolf ENT Adapter, Werewolf
Coblation System |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Common Name: | Electrosurgical Devices and Accessories |
| Regulation Number: | 21 CFR 878.4400 |
| Regulation Description: | Electrosurgical Cutting and Coagulation Devices and
Accessories |
| Product Code: | GEI |
| Device Class: | Class II |
| Classification Panel: | General & Plastic Surgery |
| Predicate Device: | ENT Plasma Wands (K070374 – February 7, 2007 and
K142999 – Nov 19, 2014) and Turbinator Wand
(K122652- July 02, 2013) used with the ENT Coblator
Surgery System (K030108 – Feb 03, 2003) |
3. DEVICE DESCRIPTION
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
7000 W. William Cannon Drive | Building One | Austin, Texas 78735 | phone 512.391.3901 | www.arthrocare.com
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Image /page/5/Picture/1 description: The image contains the logo for ArthroCare. The logo consists of a stylized, abstract symbol on the left and the word "ArthroCare" on the right. The symbol is made up of several curved, parallel lines that create a sense of motion or flow. The word "ArthroCare" is written in a dark gray, sans-serif font, with the "®" symbol in superscript next to the word.
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.
| 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 by reduction 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. |
4. INDICATIONS FOR USE
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Image /page/6/Picture/1 description: The image contains the logo for ArthroCare. The logo features a stylized graphic on the left, consisting of several curved red lines arranged in a semi-circular shape. To the right of the graphic is the company name, "ArthroCare," written in a bold, sans-serif font. The wordmark is in a dark gray color, and a registered trademark symbol is visible next to the name.
| Subject Device(s) | Indications of Use |
|---|---|
| ENT Wands | |
| 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 by reduction | |
| 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. | |
| Accessories | |
| 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 |
5. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS
The overall technological characteristics of the proposed devices are the same as the predicate devices with exceptions listed in Table 1.
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Image /page/7/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a red, circular design on the left and the word "ArthroCare" in gray on the right. The circular design is made up of several curved lines that come together to form a sphere-like shape. The word "ArthroCare" is written in a sans-serif font, and the "R" is a registered trademark symbol.
| Table 1: Summary of Comparison of the Technological Features of Subject and Predicate | |
|---|---|
| Devices |
| Parameter | PREDICATE DEVICE(S): | SUBJECT DEVICE(S): |
|---|---|---|
| Wands: ENT Wands | ||
| (K070374, K142999 and | ||
| K122652) |
COBLATION System:
COBLATOR II
COBLATION System
(K030108) | Wands: ENT Wands
(K070374, K142999 and
K122652)+
Accessories
(ENT Adapter + Irrigation
Tube Set)
+
COBLATION System:
WEREWOLF
COBLATION System
(K192027) |
| Intended Use
and Indications
of Use | Indicated for ablation,
resection, and coagulation of
soft tissue and hemostasis of
blood vessels in
otorhinolaryngology (ENT)
procedures | Same |
| Input power | 100-240 VAC | Same |
| Frequency | 50-60 Hz | Same |
| Fuse Rating | 8 Amps | 16 Amps |
| Output
Nominal
Voltage
Maximum | $320\pm10%$ Vrms | 340 Vrms |
| COBLATION
System input
power | 100-120V ~ 8A
220-240V ~ 4A | Same |
| Rated Wand
Voltage | $320\pm10%$ Vrms | Same |
| Default
Ablation
Set Point /
Output Voltage | Set Point 7
(265 Vrms) | Same |
| Default
Coagulation
Set Point /
Output Voltage | Set Point 3
(75 Vrms) | Same |
| Ablation Set
Point Range /
Output Voltage | Set Points 1 - 9
(100-300 Vrms) | Set Points 0 - 9
(0-300 Vrms) |
| Parameter | PREDICATE DEVICE(S):
Wands: ENT Wands
(K070374, K142999 and K122652)
+
COBLATION System:
COBLATOR II
COBLATION System
(K030108) | SUBJECT DEVICE(S):
Wands: ENT Wands
(K070374, K142999 and K122652)+
Accessories
(ENT Adapter + Irrigation Tube Set)
+
COBLATION System:
WEREWOLF
COBLATION System
(K192027) |
| Coagulation
Set Point
Range / Output
Voltage | Set Points 1 - 5
(65-87 Vrms) | Same |
| Coagulation
Setting | Adjustable (5 Set Points) | Same |
| COBLATION
System wave
form | Square | Same |
| Output
Frequency | 100kHz | Same |
| Suction | Connects to hospital suction system | Same |
| Saline Delivery | External Flow Control Unit
used with the COBLATION System supplies saline to the wand. | Integrated peristaltic pump (FLOW IQ pump – K192027) on the COBLATION System controls saline delivery to the wand. |
| Activation | Foot Control | Same |
| Software
controlled | No | Yes |
| Software
Version | N/A | Main 4.1 and GUI 3.0 |
| Graphical User
Interface | No | Yes |
| Weight | 8.2kg | 10 kg |
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Image /page/8/Picture/1 description: The image shows the ArthroCare logo. The logo consists of a red circular design on the left and the word "ArthroCare" in gray on the right. The circular design is made up of several curved lines that resemble a stylized wave or swirl.
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Image /page/9/Picture/1 description: The image shows the ArthroCare logo. The logo consists of a stylized wave-like graphic in red on the left, followed by the word "ArthroCare" in a gray, sans-serif font. A small registered trademark symbol is present to the upper right of the word "ArthroCare". The logo appears to be part of a larger document or presentation, as there is text visible below it.
COMPARISON TO PREDICATE DEVICES
The ENT Wands with the accessories (subject) when used in conjunction with the WEREWOLF COBLATION System are substantially equivalent to the ENT Wands when used with ENT Coblator Surgery System (predicate devices).
The intended use, indications of use, fundamental technology and principle of operation of the subject devices are same as the predicate devices with exceptions including: 1. Compatibility of the subject device wands with the WEREWOLF COBLATION System; 2. Touch-controlled Graphical User Interface (GUI); 3. Integration of software to the WEREWOLF COBLATION System for controlling the wands; and 4. Integrated fluid control module for saline delivery.
7. STERILIZATION
The sterilization nor the shelf life has changed for the ENT wands since the 510(k) clearances. All legacy ENT Wands are still sterilized using radiation with a minimum sterilization assurance level (SAL) of 10-6.
The ENT Adapter and WEREWOLF Controller are supplied non-sterile and reusable. Cleaning measures are provided in the IFU and manual, respectively.
The Irrigation Tube Set is sterilized utilizing 100% Ethylene Oxide (EtO) gas via an existing validated EtO Cycle. The sterilization method ensures a minimum sterility assurance level of 10-6.
8. BIOCOMAPTIBILITY
There is no change in the materials used to manufacture the ENT Wands. Therefore, biocompatibility testing of the ENT Wands was not required for this 510(k) submission.
The ENT Adapter and the WEREWOLF Controller are non-patient contacting; therefore, biocompatibility testing was not required for this 510(k) submission.
The Irrigation Tube Set has indirect patient contact and is classified as an external communicating medical device with tissue/bone/dentin with indirect blood contact with limited duration (