(33 days)
No
The document describes a standard electrosurgical device and its intended uses, focusing on changes related to cable design, sterilization, and a use-limiting feature. There is no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
The device is indicated for ablation of soft tissue and hemostasis of blood vessels in various ENT surgical procedures, which are therapeutic interventions.
No
The device is described as an electrosurgical device indicated for ablation of soft tissue and hemostasis of blood vessels, which are therapeutic actions, not diagnostic ones.
No
The device description clearly outlines physical components such as electrodes, suction lines, saline lines, a plastic handle, and a cable connector, which are hardware. While there is mention of an "Electronic Use-Limiting (EUL) feature" which implies software or firmware, the device itself is a physical electrosurgical wand.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "ablation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery." This describes a surgical procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details a "bipolar, high frequency electrosurgical device" that delivers radiofrequency energy to tissue. This is consistent with a surgical tool, not a diagnostic test.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions in vitro (outside the body)
The device is a surgical instrument used directly on the patient's tissue during ENT procedures.
N/A
Intended Use / Indications for Use
The ArthroCare ENT Plasma Wands are indicated for ablation 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 Polypectomy, and Laryngeal Lesion Debulking
- Neck Mass
- · Papilloma Keloids
- · Submucosal Palatal Shrinkage
- Submucosal Tissue Shrinkage
- · Tonsillectomy (including palatine tonsils)
- · Traditional Uvulopalatoplasty (RAUP)
- Tumors
- · Tissue in the Uvula/Soft Palate for the Treatment Of Snoring
Product codes
GEI
Device Description
The ArthroCare ENT Plasma Wands are bipolar, high frequency electrosurgical devices designed for use in otorhinolaryngology (ENT) surgery. The Wands consists of a single or multiple active electrode(s) located on the distal end of the shaft, a suction line, a saline line, and an injection molded, medical grade plastic handle with integrated cable at the proximal end of the wand. A cable connector is attached to the end of the cable, which connects the wand directly to the ArthroCare Coblator II Controller (CII Controller). The EVac 70 Xtra and PROcise XP Wands with Integrated Cable (EVac 70 Xtra and PROcise XP Wands) are a part of the ENT Plasma Wand family previously cleared under 510(k) K070374 for a change in indications; the integrated cable design was first cleared under 510(k) K033257.
Consistent with the predicate cleared under 510(k) K070374, the ENT Plasma Wands are only compatible with the CII Controller. The controller is designed to deliver radiofrequency energy to the active electrode(s) at the distal end of the wand. Each Wand is designed for soft tissue procedures where tissue resection, ablation, coagulation, and hemostasis are desired. The Wands are provided sterile, and are intended for single use.
This 510(k) seeks clearance for the following changes:
- 트 Addition of an Electronic Use-Limiting (EUL) feature to the integrated cable which will limit the re-use of these single-use disposable Wands.
- 트 A change in the design of the cable connector which mates with the Controller.
- 트 Implementation of Ethylene Oxide (EO) sterilization in lieu of e-Beam sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear, Nose, Throat (Otorhinolaryngology)
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)
Performance bench testing, including functional testing, ablation life, coagulation, software testing, biocompatibility, and electrical safety testing were performed on the proposed EVac 70 Xtra and PROcise XP Wands with Integrated Cable, which demonstrated the new cable assembly met the required specifications.
Ablation and coagulation testing were performed in animal tissue to compare the tissue effects using the modified Wands as compared to the predicate devices to support substantial equivalence. No clinical data is required to support the proposed change.
Summary: All testing demonstrates that the EVac 70 Xtra and PROcise XP Wands with Integrated Cable perform as intended and have acceptable mechanical properties when used in accordance with its labeling.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 19, 2014
ArthroCare Corporation Ms. Ashley Johnston Regulatory Affairs Specialist 7000 West William Cannon Drive Austin, Texas 78735
Re: K142999
Trade/Device Name: ArthroCare ENT Plasma Wands Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: October 15, 2014 Received: October 17, 2014
Dear Ms. Johnston:
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. 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.
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 (reporting of medical
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
for
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K142999
Device Name ArthroCare ENT Plasma Wands
Indications for Use (Describe)
The ArthroCare ENT Plasma Wands are indicated for ablation 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 Polypectomy, and Laryngeal Lesion Debulking
- Neck Mass
- · Papilloma Keloids
- · Submucosal Palatal Shrinkage
- Submucosal Tissue Shrinkage
- · Tonsillectomy (including palatine tonsils)
- · Traditional Uvulopalatoplasty (RAUP)
- Tumors
- · Tissue in the Uvula/Soft Palate for the Treatment Of Snoring
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
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Image /page/4/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized, abstract symbol on the left and the word "ArthroCare" in a bold, sans-serif font on the right. The symbol is made up of several curved lines, creating a sense of movement and flow.
510(k) Summary
ArthroCare Corporation
EVac 70 Xtra and PROcise XP Wands with Integrated Cable
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.
General Information
| Submitter Name: | ArthroCare Corporation |
|---|---|
| Address | 7000 West William Cannon Drive |
| Austin, TX 78735 | |
| Contact Person: | Ashley Johnston |
| Regulatory Affairs Specialist | |
| Phone: 512-385-5762 | |
| Fax: 512-895-1489 | |
| Date Prepared: | October 15, 2014 |
| Device Name | |
| Proprietary Name: | EVac 70 Xtra Wand with Integrated Cable |
| PROcise XP Wand with Integrated Cable | |
| Common Name: | Electrosurgical devices and accessories |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Device Class: | Class II |
| Product Code: | GEI |
| CFR Section: | 21 CFR 878.4400 |
Predicate Device
ENT Plasma Wands EVac 70 Xtra Wand with Integrated Cable PROcise XP Wand with Integrated Cable
K070374 (April 25, 2007) K070374 (April 25, 2007)
Description
The ArthroCare ENT Plasma Wands are bipolar, high frequency electrosurgical devices designed for use in otorhinolaryngology (ENT) surgery. The Wands consists of a single or multiple active electrode(s) located on the distal end of the shaft, a suction line, a saline line, and an injection molded, medical grade plastic handle with integrated cable at the proximal end of the wand. A cable connector is attached to the end of the cable, which connects the wand directly to the ArthroCare
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Image /page/5/Picture/0 description: The image shows 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 in a reddish-brown color, arranged in a circular or spherical shape. The word "ArthroCare" is written in a dark gray, sans-serif font, with the "A" slightly larger than the other letters. There is a registered trademark symbol to the upper right of the word "ArthroCare".
Coblator II Controller (CII Controller). The EVac 70 Xtra and PROcise XP Wands with Integrated Cable (EVac 70 Xtra and PROcise XP Wands) are a part of the ENT Plasma Wand family previously cleared under 510(k) K070374 for a change in indications; the integrated cable design was first cleared under 510(k) K033257.
Consistent with the predicate cleared under 510(k) K070374, the ENT Plasma Wands are only compatible with the CII Controller. The controller is designed to deliver radiofrequency energy to the active electrode(s) at the distal end of the wand. Each Wand is designed for soft tissue procedures where tissue resection, ablation, coagulation, and hemostasis are desired. The Wands are provided sterile, and are intended for single use.
This 510(k) seeks clearance for the following changes:
- 트 Addition of an Electronic Use-Limiting (EUL) feature to the integrated cable which will limit the re-use of these single-use disposable Wands.
- 트 A change in the design of the cable connector which mates with the Controller.
- 트 Implementation of Ethylene Oxide (EO) sterilization in lieu of e-Beam sterilization.
Intended Use/Indications For Use
The ArthroCare ENT Plasma Wands are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolarvngology (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, tissue in the uvula/soft palate for the treatment of snoring.
Summary of Technological Characteristics
No changes or modifications have been made to the distal Wand elements (i.e. electrodes, materials, shaft, and insulation), indications for use, technology, or principle of operation previously cleared in 510(k) K070374. The following table represents a summary of the technological characteristics of the modified ENT Plasma Wands.
| PREDICATE DEVICE: | PROPOSED DEVICE: | |
|---|---|---|
| ENT Plasma Wands (K070374) | Modified ENT Plasma Wands | |
| ■ EVac 70 Xtra Wand with IC | ||
| ■ PROcise XP Wand with IC | ||
| Intended Use | The ArthroCare ENT Plasma Wands are intended for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery. | Same |
| Patient Usage | Single Use | Same |
| Sterilization | Radiation | EO |
| Electrical | ||
| Safety/EMC | IEC 60601-2-2 compliant | Same |
| Use-limit Feature | No | Yes |
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Image /page/6/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized red symbol on the left and the word "ArthroCare" in black on the right. The symbol is made up of several curved lines that form a circular shape. The word "ArthroCare" is written in a sans-serif font, and there is a trademark symbol after the word.
| Cable connector
| design | Press-fit | Snap-fit |
|---|---|---|
| --------------------------- | ----------- | ---------- |
Performance Data
Performance bench testing, including functional testing, ablation life, coagulation, software testing, biocompatibility, and electrical safety testing were performed on the proposed EVac 70 Xtra and PROcise XP Wands with Integrated Cable, which demonstrated the new cable assembly met the required specifications.
Ablation and coagulation testing were performed in animal tissue to compare the tissue effects using the modified Wands as compared to the predicate devices to support substantial equivalence. No clinical data is required to support the proposed change.
Summary
All testing demonstrates that the EVac 70 Xtra and PROcise XP Wands with Integrated Cable perform as intended and have acceptable mechanical properties when used in accordance with its labeling.
As the intended use, operating principle, materials and technological characteristics are unchanged from the predicate devices, the EVac 70 Xtra and PROcise XP Wands with Integrated Cable are substantially equivalent. The modifications to the design and sterilization method do not affect the safety or efficacy of the devices.