(99 days)
No
The document describes an electrosurgical system and electrodes for soft tissue procedures, with no mention of AI or ML capabilities.
Yes
The device is intended for "resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues," which are therapeutic functions.
No
The device is intended for surgical procedures like resection, ablation, excision, hemostasis, and coagulation of soft tissue, not for diagnosing conditions.
No
The device description explicitly states that the system consists of a high frequency Electrosurgical Generator, disposable Electrodes with integrated Handpiece, and a Footswitch, which are all hardware components.
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, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device description details an electrosurgical system used for surgical procedures, including electrodes and a generator. This aligns with surgical tools, not devices used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose diseases, monitor conditions, or screen for health issues. This device is a surgical tool used during a procedure.
N/A
Intended Use / Indications for Use
The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S20 and S50) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.
The VAPR TC Electrode with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, is intended for coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and wrist.
Product codes
GEI
Device Description
The device description of the VAPR 3.5 mm and 2.3 mm Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) with Integrated Handpiece is as follows. The DePuy Mitck VAPR System is designed for arthroscopic surgical procedures. The System consists of a high frequency Electrosurgical Generator, disposable Electrodes with integrated Handpiece, and a Footswitch. The components are designed and intended to be operated as a single unit. The device description of the VAPR TC Electrode with Integrated Handpiece is as follows. The VAPR Temperature Control Electrode is a soft tissue desiccation device intended for use with the VAPR Systems. Utilization with a VAPR System allows the tip temperature of the electrode to be indicated on the generator display. The device description of the VAPR Suction Electrodes (Sm and S60) is as follows. The VAPR Suction Electrodes are soft tissue ablation and desiccation devices intended for use with the VAPR System. Thev extend the utility of the system by removing bubbles created during activation from the operating site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder, ankle, elbow and wrist
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)
Mitek has provided certification of compliance to 21 CFR 820.30 Design Control requirements, descriptions of Mitek's subcontractor Design Control and Risk Analysis procedures, and the results of validation testing (performance testing) for the device modification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K041135, K963783, K974022, K000936, K992876, K992406, K002402
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.
0
DEC 1 9 2008
510(k) Summary
VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short), VAPR TC Electrode and VAPR Suction Electrodes (S00 and S50) with Integrated Handpiece
| Submitter's Name and
Address: | DePuy Mitek, Inc.
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767, USA | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Contact Person | Zheng Liu
Regulatory Affairs Specialist
DePuy Mitek, Inc.
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767, USA
Telephone: 508-977-3966
Facsimile: 508-977-6955
e-mail: zliu8@its.jnj.com | |
| Name of Medical Device | Classification Name: | Electrosurgical cutting and coagulating device
and accessories |
| | Common/Usual Name: | Electrosurgical System and Electrodes |
| | Proprietary Name: | VAPR S90 Electrode |
| | | VAPR 3.5 mm Side effect Electrode with
Integrated Handpiece |
| | | VAPR 3.5 mm Hook Electrode with
Integrated Handpiece |
| | | VAPR 3.5 mm Angled Side Effect Electrode
with Integrated Handpiece |
| | | VAPR 2.3 mm Wedge Electrode with
Integrated Handpiece |
| | | VAPR 2.3 mm Wedge Electrode (Short) with
Integrated Handpiece |
| | | VAPR S50 Electrode |
Premarket Notification: Special VAPR Electrode with Integrated Handpiece Confidential :
.
1
VAPR 3.5 mm Flex Side Effect Electrode with Integrated Handpiece
VAPR 2.3 Side Effect Electrode (Short) with Integrated Handpiece, 85 mm
VAPR 2.3 End Effect Electrode with Integrated Handpiece, 140 mm
VAPR Temperature Control (TC) End Effect Electrode with Integrated Handpiece, 2.3 mm x 140 mm
The VAPR S 00 Electrode is substantially equivalent to the VAPR LPS Substantial Equivalence (Low Profile Suction) Electrode (K041135, 05/10/2004).
The VAPR 3,5 mm Side effect Electrode with Integrated Handpiece is substantially equivalent to the Side Effect Electrode (K963783, 09/19/1996 & K974022, 01/12/1998).
The VAPR 3.5 mm Hook Electrode with Integrated Handpiece is substantially equivalent to the 90° Hook Electrode (K963783, 09/19/1996 & K974022, 01/12/1998).
The VAPR 3.5 mm Angled Side Effect Electrode with Integrated Handpiece is substantially equivalent to the Angled Side Effect Electrode (K963783, 09/19/1996 & K974022, 01/12/1998).
The VAPR 2.3 mm Wedge Electrode with Integrated Handpiece is substantially equivalent to the 2.3mm Wedge Electrode (K000936, 04/19/2000).
The VAPR 2.3 mm Wedge Electrode (Short) with Integrated Handpiece is substantially equivalent to the 2.3mm Wedge Electrode Short (K000936, 04/19/2000).
The VAPR S60 Electrode is substantially equivalent to the VAPR LPS (Low Profile Suction) Electrode (K041135, 05/10/2004).
The VAPR 3,5 mm Flex Side Effect Electrode with Integrated Handpiece is substantially equivalent to the Flex Side Effect Electrode (K963783, 09/19/1996 & K974022, 01/12/1998).
The VAPR 2.3 Side Effect Electrode (Short) with Integrated Handpiccc, 85 mm is substantially equivalent to the 2.3 VAPR Side Effect Electrode (Short) (K992876, 09/24/1999).
The VAPR 2,3 End Effect Electrode with Integrated Handpiece, 140 mm is substantially equivalent to the 2.3 VAPR End Effect
Premarket Notification: Special VAPR Electrode with Integrated Handpiece
2
Electrode (K992406, 08/06/1999). The VAPR Temperature Control (TC) End Effect Electrode with Integrated Handpiece, 2.3 mm x 140 mm is the VAPR TC Electrode (K002402, 08/31/2000). Device Classification Electrosurgical cutting and coagulating device and accessories have been classified as Class II, GEI (21 CFR 878.4400). Device Description The device description of the VAPR 3.5 mm and 2.3 mm Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) with Integrated Handpiece is as follows. The DePuy Mitck VAPR System is designed for arthroscopic surgical procedures. The System consists of a high frequency Electrosurgical Generator, disposable Electrodes with integrated Handpiece, and a Footswitch. The components are designed and intended to be operated as a single unit. The device description of the VAPR TC Electrode with Integrated Handpiece is as follows. The VAPR Temperature Control Electrode is a soft tissue desiccation device intended for use with the VAPR Systems. Utilization with a VAPR System allows the tip temperature of the electrode to be indicated on the generator display. The device description of the VAPR Suction Electrodes (Sm and S60) is as follows. The VAPR Suction Electrodes are soft tissue ablation and desiccation devices intended for use with the VAPR System. Thev extend the utility of the system by removing bubbles created during activation from the operating site. Indications for Use The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S20 and S50) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist. The VAPR TC Elcctrode with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgiçal System, is intended for coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and wrist.
Premarket Notification: Special VAPR Electrode with Integrated Handpiece
3
Safety and Performance
In support of the 510(k), Mitek has provided certification of compliance to 21 CFR 820.30 Design Control requirements, descriptions of Mitek's subcontractor Design Control and Risk Analysis procedures, and the results of validation testing (performance testing) for the device modification.
Based on the Indications for Use, technological characteristics and safety and performance testing, the VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short), VAPR TC Electrode and VAPR Suction Electrodes (S0 and S50) with Integrated Handpiece have been shown to be substantially cquivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
Premarket Notification: Special VAPR Electrode with Integrated Handpiece
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The logo is black and white.
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Depuy Mitek % Ms. Zheng Liu Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767
DEC 1 9 2008
Re: K082643
Trade/Device Name: VAPR Electrodes with Integrated Handpiece Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 24, 2008 Received: November 26, 2008
Dear Ms. Liu:
We have reviewed your Scction 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
Page 2 - Ms. Zheng Liu
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliary, at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Protmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M Millman
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):
Device Name: VAPR Electrodes with Integrated Handpiece
Indications For Use:
The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (Sº and S56) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.
The VAPR TC Electrode with Integrated Handpicce, when used with the DePuy Mitek VAPR Electrosurgical System, is intended for coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and wrist.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. Ogden Sir mkm
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K082643
Page 1 of 1
Premarket Notification: Special VAPR Electrode with Integrated Handpiece