(29 days)
Not Found
No
The summary describes a standard electrosurgical generator with argon beam coagulation, focusing on hardware components, user interface for mode/setting selection, and safety/performance testing according to established standards. There is no mention of AI, ML, image processing, or data-driven decision-making within the device's operation.
Yes
The device is intended to deliver argon gas and high-frequency electrical current for the cutting and/or coagulation of tissue, which are direct medical interventions used for treatment.
No
The device is intended to deliver argon gas and high-frequency electrical current for cutting and coagulation of tissue, which are therapeutic functions, not diagnostic.
No
The device description explicitly states it is composed of an electrosurgical generator and a mobile pedestal, which are hardware components. The summary also mentions hardware-related testing like electrical safety and electromagnetic compatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver argon gas as well as high frequency electrical current for the cutting and/or coagulation of tissue." This describes a surgical procedure performed directly on a patient's tissue, not a test performed on a sample taken from the body.
- Device Description: The description details an electrosurgical generator and a mobile pedestal for delivering argon gas and electrical current. This aligns with surgical equipment, not diagnostic equipment used for analyzing samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates directly on the patient's tissue during a procedure.
N/A
Intended Use / Indications for Use
The CONMED HelixAR ABC System is intended to deliver argon gas as well as high frequency electrical current for the cutting and/or coagulation of tissue.
Product codes
GEI
Device Description
The HelixAR ABC System is composed of an electrosurgical generator with argon beam coagulation (ABC) and a mobile pedestal. The generator is designed with a graphic user interface (GUI) display which allows the user to select monopolar, bipolar, and ABC modes of operation, choose power and argon flow settings, adjust user settings options, and create, edit, or delete user programs. The HelixAR mobile pedestal (cart) houses two D-size argon gas cylinders and provides connection ports for the use of wired footswitches. The mobile pedestal is designed with an argon tank capacity monitor that provides the user with feedback on the argon gas cylinder pressure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Risk management activities in accordance with ISO 14971 demonstrate the risks associated with the use of the HelixAR ABC System are mitigated to an acceptable level. Design verification testing demonstrates the modified HelixAR ABC System complies with the electrical safety requirements of IEC 60601-1:2012 and IEC 60601-2-2:2009 and electromagnetic compatibility per IEC 60601-1-2:2007. Benchtop testing and software verification validation demonstrate the modified HelixAR ABC System meets design specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 4, 2017
ConMed Corporation Lisa Anderson Manager, Regulatory Affairs 525 French Road Utica, New York 13502
Re: K172671
Trade/Device Name: HelixAR ABC System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 1, 2017 Received: September 5, 2017
Dear Lisa Anderson:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820):
1
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 (DICE) 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. 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 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 (DICE) 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.
Sincerely, Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices
Center for Devices and Radiological Health
Office of Device Evaluation
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K172671
Device Name HelixAR ABC System
Indications for Use (Describe)
The CONMED HelixAR ABC System is intended to deliver argon gas as well as high frequency electrical current for the cutting and/or coagulation of tissue.
| 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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510(k) Summary of Safety and Effectiveness
CONMED HelixAR ABC System
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21CFR 807.92, ConMed Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) number
A. Submitter
ConMed Corporation 525 French Road Utica, NY 13502
Establishment Registration: 1320894
B. Company Contact
Lisa Anderson Manager, Requlatory Affairs T: (941) 713-2035 F: (315) 624-3225
C. Device Name
| Proprietary Name: | HelixAR |
|---|---|
| Common Name: | Electrosurgical Generator with Argon Beam Coagulation |
| Classification Name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Regulation Number: | 878.4400 |
| Product Code: | GEI |
| Regulatory Class: | II |
| Panel: | General and Plastic Surgery |
D. Predicate Device
| Primary Device Name: | HelixAR ABC System |
|---|---|
| Company Name: | CONMED Corporation |
| 510(k): | K152860 |
This predicate has not been subject to a design-related recall.
E. Device Description
The HelixAR ABC System is composed of an electrosurgical generator with argon beam coagulation (ABC) and a mobile pedestal. The generator is designed with a graphic user interface (GUI) display which allows the user to select monopolar, bipolar, and ABC modes of operation, choose power and argon flow settings, adjust user settings options, and create, edit, or delete user programs. The HelixAR mobile pedestal (cart) houses two D-size argon gas cylinders and provides connection ports for the use of wired footswitches. The mobile pedestal is designed with an argon tank
4
capacity monitor that provides the user with feedback on the argon gas cylinder pressure.
F. Intended Use / Indications for Use
The ConMed HelixAR ABC System is intended to deliver argon gas as well as high frequency electrical current for the cutting and/or coagulation of tissue.
G. Technological Characteristics
The modified HelixAR ABC System has similar technological characteristics as the predicate HelixAR ABC System cleared under K152860. Both systems include an electrosurgical generator used in conjunction with monopolar and bipolar handpieces and footswitches and an accessory cart. The HelixAR ABC System output panel provides receptacles for monopolar and bipolar hand- and foot-controlled devices. Footswitch receptacles for monopolar, bipolar, and ABC footswitches are provided on the accessory cart which also accommodates the use of a smoke evacuation system. The HelixAR ABC System provides Automatic Return Monitoring (ARM) for dual dispersive electrodes and includes the same visual and audible alerts as the predicate design. The HelixAR generator design includes the monopolar, bipolar, and ABC modes present in the predicate device. The modified HelixAR ABC System includes the following improvements:
- Wireless footswitch re-pairing capability; —
- -Improved flow control;
- Enabling Pulse mode in the ABC® Flex minor mode; —
- Updates to GUI, User Settings, and system start-up for improved user experience.
H. Performance Characteristics
Modifications to the HelixAR ABC System do not alter the safety or performance. Risk management activities in accordance with ISO 14971 demonstrate the risks associated with the use of the HelixAR ABC System are mitigated to an acceptable level. Design verification testing demonstrates the modified HelixAR ABC System complies with the electrical safety requirements of IEC 60601-1:2012 and IEC 60601-2-2:2009 and electromagnetic compatibility per IEC 60601-1-2:2007. Benchtop testing and software verification validation demonstrate the modified HelixAR ABC System meets design specifications.
-Substantial Equivalence
The differences between the predicate and modified device do not raise any new risks of safety or efficacy. Supporting information per this premarket submission confirms that the modified ConMed HelixAR ABC System is safe and effective for its intended use and is substantially equivalent in design, intended use, principals of operation, and technical characteristics to the CONMED HelixAR ABC System cleared under K152860.