(119 days)
Not Found
No
The summary describes a standard electrosurgical electrode with mechanical articulation and pre-set electrical parameters. There is no mention of AI or ML in the device description, intended use, or performance studies. The "internal identification capacitor code" is a simple mechanism for the generator to recognize the electrode type and set default parameters, not an AI/ML function.
Yes
The VAPR® ARCTIC™ Suction Electrode is intended for medical procedures such as "resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery of the hip," indicating its use in treating medical conditions.
No
Explanation: The device is intended for "resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue" during arthroscopic surgery, and it does not mention any function related to diagnosing a condition.
No
The device description and performance studies clearly indicate this is a physical electrode with mechanical and electrical components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is 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." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a surgical electrode used for delivering RF energy and suction during arthroscopic surgery. This is consistent with a surgical tool, not a diagnostic device that analyzes biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, the VAPR® ARCTIC™ Suction Electrode is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VAPR® ARCTICTM 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The VAPR® ARCTICTM 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip
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)
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.
Validation testing includes testing to show the device meets user needs are:
- Shaft bending
- Articulation durability
- Hipot
- 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
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.
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.
K113545, K100638, K122425, K082643, K000691
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
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.
1
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
2
Indications for Use
510(k) Number (if known)
Device Name
VAPR® ARCTIC™ Suction Electrode
Indications for Use (Describe)
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.
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)
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
| 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:
5
| 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. |
| Indications for
Use | 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. |
| Comparison to
Predicate Device | This submission is intended to demonstrate that the ARCTIC
Electrode is substantially equivalent to its legally marketed devices.
The Electrode has been carefully compared to legally marketed
devices with respect to intended use, essential components and
material, performance specifications and technology
characteristics. |
| | Comparison to Predicate Devices provided in Table 1. |
6
| Component
/ Feature | VAPR CP90
Electrode | VAPR P50
Electrode | VAPR ARCTIC
Suction
Electrode | ArthroCare
Hip
ArthroWand | Eflex Ablator |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | DePuy Mitek | DePuy Mitek | DePuy Mitek | Arthrocare
Sports
Medicine | Smith and
Nephew |
| 510(k) | K113545
K100638 | K122425
K100638
K082643 | Proposed
Device | Not Known | K000691 |
| Indication for
Use Statement | The DePuy Mitek VAPR
Electrodes for use with the
VAPR System are intended
for resection, ablation,
excision of soft tissue,
hemostasis of blood vessels
and coagulation of soft tissue
in patients requiring
arthroscopic surgery of the
knee, shoulder, hip, ankle,
elbow and wrist. | | 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. | The hip
ArthroWand
with
integrated
cable is
indicated for
resection,
ablation and
coagulation of
soft tissue,
and
hemostasis of
blood vessels
in
arthroscopic
procedures | The VULCAN
EFLEX Ablator
Electrosurgical
Probes, in
combination
with the
VULCAN
generator Is
intended for
general
surgical use,
including
orthopedic and
arthroscopic
applications,
for resection,
ablation,
excision of soft
tissue,
hemostatis of
blood vessels
and in
coagulating
soft tissues in
joints including
but not limited
to the knee,
shoulder,
wrist, hip,
etc. |
| Fixed vs.
Articulating
Tip | Fixed | Fixed | Articulating | Articulating | Articulating |
| Degree of
Tip Flexion | N/A | N/A | 110 degrees | 90 degrees | 100 degrees |
| Rotating Shaft | No | No | No | Yes | No |
Table 1: Comparison to Predicate Devices
7
| Tip
Configuration | 90 degree
side effect | End Effect | End Effect
Dome Shape | Chisel | End Effect
Dome Shape |
|----------------------|--------------------------|------------|--------------------------|--------|--------------------------|
| RF Energy | Bipolar | SAME | SAME | SAME | Monopolar |
| Working
Length | 160mm | SAME | 220mm | 235mm | 240mm |
| Shaft
Diameter | 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 of | |
| high frequency surgical equipment | |
| EN 60601-1-2:2007 | Medical electrical equipment – Part 1-2: |
| Collateral standards for Electromagnetic | |
| compatibility | |
| ISO 10993-1:2009 | Biological evaluation of medical devices – Part 1: Evaluation and testing based |
| on externally communicating device | |
| with limited contact with tissue/bone | |
| dentin | |
| ISO 11137-1:2013 | Gamma radiation and shelf life testing |
| Software Guidance | |
| Document | |
| (5/11/2005) | Guidance for the content of 510(k) for |
| software contained in medical | |
| devices for a MODERATE level of | |
| concern |
TABLE 2: Standards
Validation testing includes testing to show the device meets user needs are:
- Shaft bending ●
- Articulation durability ●
- . Hipot
- Activation ●
8
- 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.