The VAPR® ARCTIC™ Suction Electrode for use with the VAPR VUE® RF System is intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery of the hip.

Device Description

The VAPR® ARCTIC™ Electrode is a single use, one-piece bipolar suction articulating electrode for use in arthroscopic surgery of the hip. The electrode has a hand-controlled articulating tip to improve access and suction capabilities. This will enhance the efficiency of the electrode and extend the utility of the system by assisting in the removal of bubbles and debris created during activation within the operating site.

The ARCTIC Electrode has been designed to facilitate access and control the delivery of RF energy to the joint space. The plug of the ARCTIC Electrode is designed to fit the VAPR VUE® generator socket only. It has an internal identification capacitor code which automatically adjusts the VAPR VUE Generator to the optimal default and accessible powers and waveforms. If required, the settings for the device can be modified within safe pre-determined limits by accessing the generator or footswitch control. It is intended to be run only off the VAPR VUE electrosurgical generator at pre-determined default settings specific for the device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the VAPR® ARCTIC™ Suction Electrode. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information about acceptance criteria, detailed study design, and AI performance is not explicitly available in the provided text.

However, I can extract information about the types of tests performed to ensure safety and performance, which can be seen as meeting product specifications and user needs.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of quantitative acceptance criteria and their corresponding reported performance values. Instead, it lists various verification and validation tests performed to ensure the device meets its specifications and user needs. The conclusion states that the "Results of performance and safety testing have demonstrated that the modified device is suitable for its intended use."

Here's a summary of the types of tests conducted:

Test Category	Specific Tests Mentioned
Verification	Electrical and performance tests (to meet product specifications over a range of operating conditions). Conformity to standards: EN 60601-1:2010 (General safety), EN 60601-2-2:2009 (Safety of HF surgical equipment), EN 60601-1-2:2007 (EMC), ISO 10993-1:2009 (Biological evaluation), ISO 11137-1:2013 (Gamma radiation and shelf life), and Software Guidance Document (for moderate level of concern software).
Validation	Tests to show the device meets user needs, including: Shaft bending, Articulation durability, Hipot (High Potential Test), Activation, Polyurethane durability, Cable tensile, Suction tube pull, Fluid ingress, Distal tip and suction tube sealing, Active tip and shroud retention, Lever actuation force, Articulation angle measurement, System compatibility, Dielectric strength, Suction flow, Articulation wire pull force, Lever strength, Thermal shock, Thermal margin assessment, Temperature rise, Clogging frequency.
Overall Outcome	"Results of performance and safety testing have demonstrated that the modified device is suitable for its intended use." (Implied acceptance that it meets unspecified criteria from these tests).

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 does not specify the sample size for individual tests, nor does it provide details about data provenance (e.g., country of origin, retrospective/prospective nature). The tests appear to be laboratory or bench-top tests of the device components and functionality.

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 applicable. The device is an electrosurgical tool, and its performance is evaluated against engineering specifications and functional requirements, not through expert-labeled diagnostic data. Therefore, there's no "ground truth" in the clinical imaging or diagnostic sense being established by experts for a test set in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are typically used in clinical studies or studies involving expert interpretation of data (e.g., medical images). This document describes device performance and safety testing, not diagnostic performance.

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 is not applicable. The VAPR® ARCTIC™ Suction Electrode is an electrosurgical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related effectiveness metrics are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. As stated above, this device is a surgical instrument, not an algorithm, and the concept of "standalone" performance for an algorithm is not relevant here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established by engineering specifications, industry standards (listed in Table 2), and functional requirements for surgical tools. This includes measurements of physical properties (e.g., articulation angle, tensile strength), electrical properties, biological compatibility, and demonstration of proper function (e.g., activation, suction flow, non-clogging). It does not involve clinical "ground truth" in the diagnostic sense.

8. The sample size for the training set

This is not applicable. This device is not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

This is not applicable. This device is not an AI algorithm that requires a training set or ground truth establishment for a training set.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a stylized human figure, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 5, 2014

Depuy Mitek, A Johnson & Johnson Company % Susan Kagan Project Manager Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767

Re: K140896

Trade/Device Name: VAPR® ARCTICTM Suction Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: June 13, 2014 Received: June 16, 2014

Dear Ms. Kagan,

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 (reporting of medical devicerelated 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 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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Indications for Use

510(k) Number (if known)

Device Name

VAPR® ARCTIC™ Suction Electrode

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X 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)

FORM FDA 3881 (1/14)

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	DePuy
Mitek Inc.a Johnson Johnson company	never stop moving™

510(k) SUMMARY

Date Prepared April 7, 2014 Submitter's Name DePuy Mitek, Inc. a Johnson & Johnson company and Address: 325 Paramount Drive

Contact Person Susan Kaqan Project Manager, Regulatory Affairs DePuy Mitek, Inc. a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767, USA Telephone: 508-880-8097 Facsimile: 508-977-6955 e-mail: skagan@its.jnj.com
Raynham, MA 02767
Name of Medical Classification Name: Electrosurqical cutting and coagulation device and accessories: 21 CFR 878.4400 Deice Common/Usual Name: Electrosurgical cutting and coagulation device and accessories VAPR® ARCTIC™ Suction Electrode Proprietary Name: FDA Classification: 11 FDA product code: GEI Predicate The proposed VAPR ARCTIC Electrode is substantially Device(s) equivalent to:
- CP90 Electrode: K113545/ K100638 트
  - o (November 11, 2012/ June 18, 2010)
- 트 P50 Electrode: K122425/ K100638/K082643: (November 11, 2012/June 18, 2010) o
- 트 Smith and Nephew Eflex Ablator K000691 o (May 4, 2000)
- . Arthrocare Hip ArthroWand: 510(k) # Not Known

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DeviceDescription	The VAPR® ARCTIC™ Electrode is a single use, one-piece bipolarsuction articulating electrode for use in arthroscopic surgery of thehip. The electrode has a hand-controlled articulating tip to improveaccess and suction capabilities. This will enhance the efficiency ofthe electrode and extend the utility of the system by assisting inthe removal of bubbles and debris created during activation withinthe operating site.
	The ARCTIC Electrode has been designed to facilitate access andcontrol the delivery of RF energy to the joint space. The plug of theARCTIC Electrode is designed to fit the VAPR VUE® generatorsocket only. It has an internal identification capacitor code whichautomatically adjusts the VAPR VUE Generator to the optimaldefault and accessible powers and waveforms. If required, thesettings for the device can be modified within safe pre-determinedlimits by accessing the generator or footswitch control. It isintended to be run only off the VAPR VUE electrosurgical generatorat pre-determined default settings specific for the device.
Indications forUse	The VAPR® ARCTIC™ Suction Electrode for use with the VAPRVUE® RF System is intended for resection, ablation and excision ofsoft tissue, hemostasis of blood vessels and coagulation of softtissue in patients requiring arthroscopic surgery of the hip.
Comparison toPredicate Device	This submission is intended to demonstrate that the ARCTICElectrode is substantially equivalent to its legally marketed devices.The Electrode has been carefully compared to legally marketeddevices with respect to intended use, essential components andmaterial, performance specifications and technologycharacteristics.
	Comparison to Predicate Devices provided in Table 1.

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Component/ Feature	VAPR CP90Electrode	VAPR P50Electrode	VAPR ARCTICSuctionElectrode	ArthroCareHipArthroWand	Eflex Ablator
Manufacturer	DePuy Mitek	DePuy Mitek	DePuy Mitek	ArthrocareSportsMedicine	Smith andNephew
510(k)	K113545 K100638	K122425 K100638 K082643	ProposedDevice	Not Known	K000691
Indication forUse Statement	The DePuy Mitek VAPRElectrodes for use with theVAPR System are intendedfor resection, ablation,excision of soft tissue,hemostasis of blood vesselsand coagulation of soft tissuein patients requiringarthroscopic surgery of theknee, shoulder, hip, ankle,elbow and wrist.		The VAPR®ARCTIC™SuctionElectrode foruse with theVAPR VUE RFSystem isintended forresection,ablation andexcision ofsoft tissue,hemostasis ofblood vesselsandcoagulationof soft tissuein patientsrequiringarthroscopicsurgery ofthe hip.	The hipArthroWandwithintegratedcable isindicated forresection,ablation andcoagulation ofsoft tissue,andhemostasis ofblood vesselsinarthroscopicprocedures	The VULCANEFLEX AblatorElectrosurgicalProbes, incombinationwith theVULCANgenerator Isintended forgeneralsurgical use,includingorthopedic andarthroscopicapplications,for resection,ablation,excision of softtissue,hemostatis ofblood vesselsand incoagulatingsoft tissues injoints includingbut not limitedto the knee,shoulder,wrist, hip,etc.
Fixed vs.ArticulatingTip	Fixed	Fixed	Articulating	Articulating	Articulating
Degree ofTip Flexion	N/A	N/A	110 degrees	90 degrees	100 degrees
Rotating Shaft	No	No	No	Yes	No

Table 1: Comparison to Predicate Devices

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TipConfiguration	90 degreeside effect	End Effect	End EffectDome Shape	Chisel	End EffectDome Shape
RF Energy	Bipolar	SAME	SAME	SAME	Monopolar
WorkingLength	160mm	SAME	220mm	235mm	240mm
ShaftDiameter	3.7mm	SAME	3.4mm	2.95mm	3.50mm

Safety and Performance

Verification of the ARCTIC Electrode includes electrical and performance tests to show that the device meets its product specifications over a range of operating conditions. Validation testing includes testing to show the device meets user needs.

Verification testing conforms to the Standards listed in Table 2.

Standard/Guidance	Description
EN 60601-1:2010	Medical electrical equipment – Part 1:General requirements for safety
EN 60601-2-2:2009	Medical electrical equipment – Part 2-2:Particular requirements for the safety ofhigh frequency surgical equipment
EN 60601-1-2:2007	Medical electrical equipment – Part 1-2:Collateral standards for Electromagneticcompatibility
ISO 10993-1:2009	Biological evaluation of medical devices – Part 1: Evaluation and testing basedon externally communicating devicewith limited contact with tissue/bonedentin
ISO 11137-1:2013	Gamma radiation and shelf life testing
Software GuidanceDocument(5/11/2005)	Guidance for the content of 510(k) forsoftware contained in medicaldevices for a MODERATE level ofconcern

TABLE 2: Standards

Validation testing includes testing to show the device meets user needs are:

Shaft bending ●
Articulation durability ●
. Hipot
Activation ●

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Polyurethane durability ●
Cable tensile ●
Suction tube pull ●
Fluid ingress
Distal tip and suction tube sealing ●
Active tip and shroud retention ●
Lever actuation force ●
Articulation angle measurement ●
System compatibility ●
Dielectric strength ●
Suction flow
Articulation wire pull force
Lever strength ●
Thermal shock ●
Thermal margin assessment ●
Temperature rise ●
Clogging frequency

Clinical Testing No clinical studies are required to demonstrate safety and efficacy of the device in support of an application for premarket clearance. The ARCTIC Electrodes do not differ from the predicate device in fundamental scientific technology or intended use.

Conclusion Results of performance and safety testing have demonstrated that the modified device is suitable for its intended use.

Based on the indications for use, fundamental scientific technology, and comparison to the predicate devices, the ARCTIC Electrode is shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act.

Regulation Number and Section

§ 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.