(90 days)
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.
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.
This document describes the CONMED HelixAR ABC System, an electrosurgical generator with argon beam coagulation (ABC). The information provided is primarily for a 510(k) premarket notification, focusing on demonstrating substantial equivalence to predicate devices, rather than a detailed clinical study demonstrating specific performance metrics against pre-defined acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding detailed acceptance criteria and a study proving those specific criteria cannot be fully extracted.
However, based on the provided text, here's an attempt to answer the questions within the context of substantial equivalence:
1. A table of acceptance criteria and the reported device performance
The document does not present explicit, quantifiable acceptance criteria with corresponding device performance values for specific clinical outcomes (e.g., coagulation time, depth of penetration, adverse event rates). Instead, the "acceptance" is focused on demonstrating that the device is substantially equivalent to predicate devices. The performance testing section mentions compliance with several standards.
| Acceptance Criteria (Implied by Substantial Equivalence and Standards Compliance) | Reported Device Performance (Summary) |
|---|---|
| Safety and Effectiveness (equivalent to predicate devices) | "CONMED HelixAR ABC System is safe and effective for its intended use" |
| Intended Use (equivalent to predicate devices) | "Substantially equivalent in design, intended use, principals of operation, and technical characteristics to the CONMED System 7550 and CONMED System 5000." |
| Materials (equivalent to predicate devices) | Demonstrated to be substantially equivalent. |
| Technology (equivalent to predicate devices) | Demonstrated to be substantially equivalent. |
| Performance (equivalent to predicate devices) | "Performance testing ... demonstrate the HelixAR ABC System is substantially equivalent" |
| Compliance with AAMI/ANSI ES60601-1 (General requirements for basic safety and essential performance of medical electrical equipment) | Devices comply with applicable sections. |
| Compliance with IEC 60601-2-2 (Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories) | Devices comply with applicable sections. |
| Compliance with IEC 60601-1-2 (Electromagnetic compatibility - Requirements and tests) | Devices comply with applicable sections. |
| Risk Mitigation (ISO 14971) | "Risks associated with the use of the HelixAR ABC System are mitigated to an acceptable level. Analyses ... conclude the benefits ... outweigh the residual risks." |
| Generation of New Risks | "The differences between the predicate devices and the proposed device do not raise any new risks of safety or efficacy." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Benchtop and ex-vivo comparison testing as well as in-vivo simulated use testing." However, it does not specify sample sizes for these tests (e.g., number of ex-vivo tissue samples, number of in-vivo simulated use observations) nor does it provide details on the data provenance (country of origin, retrospective/prospective). The focus is on the equivalence rather than a clinical trial with a defined test set sample size.
3. 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 provided in the document. Given that the testing appears to be primarily benchtop, ex-vivo, and simulated in-vivo, it's unlikely that external medical experts were used to establish a "ground truth" in the way they would be for image-based diagnostic devices or clinical outcomes. The "ground truth" for electrosurgical performance would typically be based on quantifiable physical measurements and established scientific principles rather than expert consensus on subjective observations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials, especially for endpoints requiring subjective assessment, to resolve discrepancies among multiple reviewers. Since no such clinical test set or expert review process is described, an adjudication method is not mentioned.
5. 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
This information is not applicable/provided. The HelixAR ABC System is an electrosurgical device, not a diagnostic imaging device with an AI component for interpretation. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The HelixAR ABC System is a physical electrosurgical device that requires human operation. It does not have a standalone algorithm for performance assessment in the way AI/ML software devices do.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the performance testing mentioned (benchtop, ex-vivo, in-vivo simulated use), the "ground truth" would likely be based on:
- Physical measurements: For parameters like power output, argon flow rates, temperature, current, etc.
- Observed tissue effects: For ex-vivo and in-vivo tests, comparison to known and accepted electrosurgical tissue effects validated by established scientific methods.
- Compliance with standards: Verification against the requirements of AAMI/ANSI ES60601-1, IEC 60601-2-2, and IEC 60601-1-2.
The document does not explicitly state the type of ground truth used, but it would not be expert consensus, pathology, or outcomes data in the context of a clinical trial.
8. The sample size for the training set
This information is not applicable/provided. The HelixAR ABC System is a hardware medical device; it is not an AI/ML device that requires a training set in the computational sense. The "training" for such a device would involve engineering design, prototyping, and iterative testing, not a dataset for algorithm training.
9. How the ground truth for the training set was established
This information is not applicable/provided for the reasons stated in point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 29, 2015
CONMED Corporation Ms. Lisa Anderson Manager, Regulatory Affairs 525 French Road Utica, New York 13502
Re: K152860
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 29, 2015 Received: September 30, 2015
Dear Ms. 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
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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/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 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 yours,
David Krause -S
- for 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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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152860
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)
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)
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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 K152860 as of December 2, 2015.
A. Submitter
ConMed Corporation 525 French Road Utica, NY 13502
Establishment Registration: 1320894
B. Company Contact
Lisa Anderson Manager, Regulatory Affairs T: (315) 624-3371 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: | System 7500-B (currently System 7550) |
|---|---|
| Company Name: | CONMED Corporation |
| 510(k): | K050161 |
This predicate has not been subject to a design-related recall.
| Secondary Device Name: | System 5000 |
|---|---|
| Company Name: | CONMED Corporation |
| 510(k): | K020186 |
This predicate has not been subject to a design-related recall.
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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 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 HelixAR ABC System is similar to the predicate devices in that the system includes 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 footcontrolled 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 as well as visual and audible alerts similar to those used in the predicate designs. The HelixAR ABC System differs from the predicate devices in that the generator is designed with a GUI display and is compatible with the CONMED Wireless Footswitch Kit. The Wireless Footswitch Kit provides the same functionality as corded footswitches and the convenience of wireless devices. The HelixAR generator design includes the monopolar, bipolar, and ABC modes present in the predicate devices plus the addition of ABC pulse modes. The ABC pulse modes provide the same output characteristics of the other ABC modes with a pulsed application of energy.
H. Performance Testing
Benchtop and ex-vivo comparison testing as well as in-vivo simulated use testing demonstrate the HelixAR ABC System is substantially equivalent to the ConMed System 7550 and System 5000 with regard to intended use, materials, technology, and performance. Mechanical, electrical, and ex-vivo tissue verification activities and software validation testing demonstrate the devices comply with design requirements and the applicable sections of AAMI/ANSI ES60601-1. IEC 60601-2-2, and IEC 60601-1-2. Risk management activities in accordance with ISO 14971 demonstrate the risks associated with the use of the HelixAR ABC System are mitigated to an
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acceptable level. Analyses of these activities conclude the benefits associated with the use of the HelixAR ABC System outweigh the residual risks.
Substantial Equivalence -
The differences between the predicate devices and the proposed device do not raise any new risks of safety or efficacy. Supporting information per this premarket submission confirms that the 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 System 7550 and CONMED System 5000.
§ 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.