(156 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies. The device is described as a radiofrequency-based electrosurgical system.
Yes
The device is used for ablation, resection, and coagulation of soft tissue, as well as hemostasis, in various ENT surgical procedures to treat medical conditions, indicating a therapeutic purpose.
No
The device is described as an electrosurgical system intended for ablation, resection, and coagulation of soft tissue, and hemostasis of blood vessels during surgical procedures; it does not mention diagnosing conditions.
No
The device description explicitly states that the system is comprised of hardware components: ArthroCare Coblator IQ ENT Plasma Wands (physical devices) and the ArthroCare Coblator IQ Controller (a physical generator with a pump).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The ArthroCare Coblator IQ ENT System is an electrosurgical device used during surgical procedures to ablate, resect, and coagulate soft tissue and control bleeding. It directly interacts with tissue within the body.
- Intended Use: The intended use clearly describes surgical procedures performed on the patient's body, not the analysis of samples outside the body.
Therefore, based on the provided information, the ArthroCare Coblator IQ ENT System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ArthroCare® Coblator IQTM ENT System is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:
- Adenoidectomy
- Head, Neck, Oral, and Sinus Surgery
- Myringotomy with Effective Hemorrhage Control
- Nasopharyngeal/Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
- Papilloma Keloids
- Submucosal Tissue Shrinkage
- Traditional Uvulopalatoplasty (RAUP)
- Tissue in the Uvula/Soft Palate for the treatment of Snoring
- Cysts
- Mastoidectomy
- Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
- Neck Mass
- Submucosal Palatal Shrinkage
- Tonsillectomy (including palatine tonsils)
- Tumors
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The ArthroCare Coblator IQ ENT System (CIQ System) is comprised of eight ArthroCare Coblator IQ ENT Plasma Wands (CIQ Wands) and the ArthroCare Coblator IQ Controller (CIQ Controller).
The CIQ Wands are bipolar, single use, radiofrequency-based electrosurgical devices designed for use with the CIQ Controller for specific indications in otorhinolaryngology (ENT) procedures.
The CIQ Controller is a bipolar, high frequency electrosurgical generator with an integrated peristaltic pump for saline delivery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue and blood vessels in otorhinolaryngology (ENT) surgery (e.g., adenoids, head, neck, oral, sinus, nasopharyngeal/laryngeal, mastoid, nasal turbinates, tonsils, uvula/soft palate)
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 - Bench: Bench testing was conducted to evaluate the performance of the Coblator IQ ENT System compared to the predicate devices. The test results demonstrate that the Coblator IQ ENT System meets all design and performance specifications.
Performance Testing - Animal: Pre-Clinical animal studies were conducted to compare the tissue effects using the Coblator IQ ENT System as compared to the predicate devices. Based on the test results, the proposed devices are substantially equivalent to the predicate devices.
Performance Testing - Clinical: No clinical data are included in this submission.
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, K063538, K033257, K014290, K091674
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
K123357
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510(k) Summary
ArthroCare® Corporation
COBLATOR IQTM ENT SYSTEM
APR 5 2013
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: | Mitchell Dhority |
| Vice President, Clinical and Regulatory Affairs | |
| Date Prepared: | October 29, 2012 |
Device System Names/Components
| Proprietary: | Coblator IQTM ENT System |
|---|---|
| Common: | ENT System |
| Classification: | Class II |
| Product Code: | GEI |
| CFR Section: | 21 CFR 878.4400 |
Predicate Device
| ArthroCare ENT Plasma Wands | K070374 (April 25, 2007) |
|---|---|
| K063538 (December 1, 2006) | |
| K033257 (October 29, 2003) | |
| K014290 (March 28, 2002) |
ArthroCare Coblator IQ System (Controller)
K091674 (January 15, 2010)
Description
The ArthroCare Coblator IQ ENT System (CIQ System) is comprised of eight ArthroCare Coblator IQ ENT Plasma Wands (CIQ Wands) and the ArthroCare Coblator IQ Controller (CIQ Controller).
The CIQ Wands are bipolar, single use, radiofrequency-based electrosurgical devices designed for use with the CIQ Controller for specific indications in otorhinolaryngology (ENT) procedures.
The CIQ Controller is a bipolar, high frequency electrosurgical generator with an integrated peristaltic pump for saline delivery.
1
Intended Use/Indications For Use
The ArthroCare® Coblator IQTM ENT System is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: 1 ... ..
- . Adenoidectomy
- 1 Head, Neck, Oral, and Sinus Surgery
- . Myringotomy with Effective Hemorrhage Control
- . Nasopharyngeal/Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
- 1 Papilloma Keloids
- Submucosal Tissue Shrinkage
- 1 Traditional Uvulopalatoplasty (RAUP)
- . Tissue in the Uvula/Soft Palate for the treatment of Snoring
Performance Testing - Bench
-
Cysts
123353 -
Mastoidectomy 트
-
l Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
-
l Neck Mass
-
Submucosal Palatal Shrinkage 트
-
Tonsillectomy (including palatine tonsils)
-
Tumors
Bench testing was conducted to evaluate the performance of the Coblator IQ ENT System compared to the predicate devices. The test results demonstrate that the Coblator IQ ENT System meets all design and performance specifications.
Performance Testing - Animal
Pre-Clinical animal studies were conducted to compare the tissue effects using the Coblator IQ ENT System as compared to the predicate devices. Based on the test results, the proposed devices are substantially equivalent to the predicate devices.
Performance Testing - Clinical
No clinical data are included in this submission.
Summary
The ArthroCare Coblator IQ ENT System (CIQ System) is comprised of eight ArthroCare Coblator IQ : ENT Wands (CIQ Wands) and the ArthroCare Coblator IQ Controller (CIQ Controller).
The modified CIQ Wands are substantially equivalent to the predicate ArthroCare ENT Plasma Wands. The modification to performance specifications, materials, and labeling are minor changes, and do not affect the safety or efficacy of the devices.
There have also been minor software changes to the CIQ Controller cleared in 2010. However, these changes do not affect the safety or efficacy of the device.
Page 2 of 2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: April 5, 2013
Arthrocare Corporation % Mr. Mitchell Dhority Vice President, Clinical and Regulatory Affairs 7000 West William Cannon Drive Austin, Texas 78735
Re: K123353 Trade/Device Name: ArthroCare® Coblator IQ™ ENT System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 12, 2013 Received: March 27, 2013
Dear Mr. Dhority:
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. Iisting 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
3
Page 2 - Mr. Mitchell Dhority
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for 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/cdrh/mdr/ 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 toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N.Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K123353 510(k) Number (if known):
Device Name: ArthroCare® Coblator IQTM ENT System
Indications for Use:
The ArthroCare® Coblator IQTM ENT System is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:
- Adenoidectomy
- Head, Neck, Oral, and Sinus Surgery
- Myringotomy with Effective Hemorrhage Control
- 다 Nasopharyngeal/Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
- Papilloma Keloids
- Submucosal Tissue Shrinkage
- Traditional Uvulopalatoplasty (RAUP)
- 트 Tissue in the Uvula/Soft Palate for the treatment of Snoring
- . Cysts
- Mastoidectomy 미
- l Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
- 0 Neck Mass
- 트 Submucosal Palatal Shrinkage
- 이 Tonsillectomy (including palatine tonsils)
- 트 Tumors
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) . Concurrence of CDRH. Office of Device Evaluation (ODE)
Joshua C.
Nipper -S
For
(Division Sign-Off) Division of Surgical Devices
K123353 510(k) Number
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