K Number
K091674
Device Name
ARTHROCARE COBLATOR IQ SYSTEM
Manufacturer
Date Cleared
2010-01-15

(220 days)

Product Code
Regulation Number
878.4400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ArthroCare Coblator IQ System is indicated for the following procedures: - For resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in spinal and neurological procedures; and - 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 - Traditional Uvulopalatoplasty (RAUP) - Tumors - Tissue in the Uvula/Soft Palate for the Treatment of Snoring
Device Description
The ArthroCare Coblator IQ System is a bipolar, high frequency, electrosurgical generator called the Controller that is intended to be used with a family of disposable, bipolar, single use Wands.
More Information

Not Found

No
The summary describes a standard electrosurgical generator and disposable wands, with no mention of AI or ML capabilities in the device description, intended use, or performance studies.

Yes
The device is used for medical procedures like resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in various surgical contexts, which are therapeutic interventions.

No
The device is described as an electrosurgical generator used for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels, which are interventional procedures, not diagnostic ones.

No

The device description explicitly states it is a "bipolar, high frequency, electrosurgical generator called the Controller that is intended to be used with a family of disposable, bipolar, single use Wands," indicating it is a hardware device with associated disposable components.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes surgical procedures performed on the patient's body (resection, ablation, coagulation of soft tissue, hemostasis of blood vessels) in various anatomical locations. IVDs are used to examine specimens from the body (like blood, urine, tissue samples) to provide information about a person's health.
  • Device Description: The device is an electrosurgical generator and disposable wands used for surgical intervention. This is consistent with a surgical device, not a diagnostic device that analyzes samples.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.

Therefore, the ArthroCare Coblator IQ System is a surgical device, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The ArthroCare Coblator IQ System is indicated for the following procedures:

  • For resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels . in spinal and neurological procedures; and
  • 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 י
    • Nasopharyngeal/Laryngeal indications including Tracheal Procedures, . Laryngeal Polypectomy, and Laryngeal Lesion Debulking
    • Neck Mass .
    • Papilloma Keloids י
    • Submucosal Palatal Shrinkage 내
    • Submucosal Tissue Shrinkage .
    • Tonsillectomy ﻻ
    • Traditional Uvulopalatoplasty (RAUP) י
    • Tumors #
    • Tissue in the Uvula/Soft Palate for the Treatment of Snoring g

Product codes (comma separated list FDA assigned to the subject device)

79GEI

Device Description

The ArthroCare Coblator IQ System is a bipolar, high frequency, electrosurgical generator called the Controller that is intended to be used with a family of disposable, bipolar, single use Wands.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Spinal, Neurological, Otorhinolaryngology (ENT) surgery (Adenoid, Cysts, Head, Neck, Oral, Sinus, Mastoid, Myringotomy, Nasal Airway, Nasopharyngeal/Laryngeal, Neck, Papilloma Keloids, Palatal, Uvula/Soft Palate, Tonsil)

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 testing has been completed to demonstrate the substantial equivalence of the ArthroCare Coblator IQ System to the predicate devices. The performance testing and device comparison demonstrated that the subject device is substantially equivalent to the predicate device, and is safe and effective for its intended use.

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.

K030108, K053297, K080482

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

K091674

JAN 1 5 2010

510(k) Summary

ArthroCare® Corporation ArthroCare® Coblator IQ™ System

General Information

| Submitter Name/Address: | ArthroCare Corporation
680 Vaqueros Avenue
Sunnyvale, CA 94085-3523 |
|------------------------------------|---------------------------------------------------------------------------|
| Establishment Registration Number: | 2951580 |
| Contact Person: | Valerie Defiesta-Ng
Director, Regulatory Affairs |
| Date Prepared: | December 18, 2009 |

Device Description

Trade Name:ArthroCare® Coblator IQ™ System
Generic/Common Name:Electrosurgical Device and Accessories
Classification Name:Electrosurgical Cutting and Coagulation
Device and Accessories (Class II, 21 CFR
878.4400, Product Code 79G - - EI)

Predicate Devices

F

ArthroCare Coblator ENT Surgery System K030108 (February 3, 2003) ArthroCare 8000S Coblator Surgery System K053297 (December 6, 2005) ArthroCare Irrigation Pump K080482 (March 20, 2008)

Product Description

The ArthroCare Coblator IQ System is a bipolar, high frequency, electrosurgical generator called the Controller that is intended to be used with a family of disposable, bipolar, single use Wands.

1

Intended Uses

The ArthroCare Coblator IQ System is indicated for the following procedures:

  • For resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels . in spinal and neurological procedures; and
  • 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 י
    • Nasopharyngeal/Laryngeal indications including Tracheal Procedures, . Laryngeal Polypectomy, and Laryngeal Lesion Debulking
    • Neck Mass .
    • Papilloma Keloids י
    • Submucosal Palatal Shrinkage 내
    • Submucosal Tissue Shrinkage .
    • Tonsillectomy ﻻ
    • Traditional Uvulopalatoplasty (RAUP) י
    • Tumors #
    • Tissue in the Uvula/Soft Palate for the Treatment of Snoring g

Substantial Equivalence

In establishing substantial equivalence to the predicate device. ArthroCare compared the indications for use, dimensional specifications, and performance specifications of the subject device and the predicate device. Additionally, performance testing has been completed to demonstrate the substantial equivalence of the ArthroCare Coblator IQ System to the predicate devices. The performance testing and device comparison demonstrated that the subject device is substantially equivalent to the predicate device, and is safe and effective for its intended use.

Summary of Safety and Effectiveness

The ArthroCare Coblator IO System, as described in this premarket notification 510(k), is substantially equivalent to the predicate device. The differences in performance specifications and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the proposed device.

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of a human figure with outstretched arms, overlaid with an eagle-like symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Arthrocare Corporation % Ms. Valerie Defiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085

JAN 1 5 2010

Re: K091674

Trade/Device Name: ArthroCare® Coblator IOTM System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 18, 2009 Received: December 22, 2009

Dear Ms. Defiesta-ng:

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.

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 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.

3

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115800.htm fast the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its tolloffree no (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson
Director

Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

ArthroCare® Coblator IQ™ System Device Name

510(k) Number: K

Indications for Use:

The ArthroCare Coblator IQ System is indicated for the following procedures:

  • For resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in spinal and neurological procedures; and
  • 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 파
    • Mastoidectomy .
    • Myringotomy with Effective Hemorthage 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
    • Traditional Uvulopalatoplasty (RAUP)

X

  • Tumors
  • Tissue in the Uvula/Soft Palate for the Treatment of Snoring

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-the-Counter Use

FOR M.MELKERSON

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091674

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