(220 days)
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
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.
The provided text is a 510(k) summary for the ArthroCare Coblator IQ™ System, an electrosurgical device. It outlines the device's description, intended uses, and claims of substantial equivalence to predicate devices, but it does not contain the detailed information necessary to answer all sections of your request.
Specifically, the document states: "performance testing has been completed to demonstrate the substantial equivalence of the ArthroCare Coblator IQ System to the predicate devices." However, it does not provide any specific acceptance criteria or the results of this performance testing in a quantifiable manner. It also does not define what "performance" specifically refers to in this context (e.g., coagulation efficacy, tissue ablation rate, etc.), nor does it provide the results of such tests or the methodology used to demonstrate the device meets any specific criteria.
Therefore, for many of your points, the answer will be that the information is not provided in the submitted text.
Here's a breakdown of what can and cannot be answered based on the provided text:
Acceptance Criteria and Device Performance
-
A table of acceptance criteria and the reported device performance:
Acceptance Criteria Reported Device Performance Not specified Not specified (The document states "performance testing has been completed to demonstrate the substantial equivalence," but does not list specific criteria or results.) (The document claims "the subject device is substantially equivalent to the predicate device, and is safe and effective for its intended use" based on this testing, but provides no quantitative results.)
Study Details
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample size: Not specified.
- Data provenance: Not specified. (No information regarding the country of origin of data, or if it was retrospective or prospective.)
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not applicable and not provided. The device is an electrosurgical tool, and the "performance testing" mentioned likely refers to bench testing or animal studies, not interpretative studies requiring expert ground truth in the way medical imaging AI devices do.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable and not provided. See point 3.
-
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:
- A MRMC study was not done. This type of study is relevant for diagnostic imaging AI, not for an electrosurgical device. The document does not describe AI assistance for human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm. The device is a physical electrosurgical system.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The concept of "ground truth" as used for AI/diagnostic devices doesn't directly apply here. The "performance testing" would likely involve objective measurements in a lab or animal model.
Training Set Details (Not applicable for this type of device)
-
The sample size for the training set:
- Not applicable. This is not an AI or machine learning device; therefore, there is no "training set."
-
How the ground truth for the training set was established:
- Not applicable. See point 8.
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JAN 1 5 2010
510(k) Summary
ArthroCare® Corporation ArthroCare® Coblator IQ™ System
General Information
| Submitter Name/Address: | ArthroCare Corporation680 Vaqueros AvenueSunnyvale, CA 94085-3523 |
|---|---|
| Establishment Registration Number: | 2951580 |
| Contact Person: | Valerie Defiesta-NgDirector, 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 CoagulationDevice and Accessories (Class II, 21 CFR878.4400, 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.
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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.
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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.
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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
12
§ 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.