(88 days)
Not Found
No
The summary describes a standard electrosurgical system using bipolar technology for arthroscopic procedures, with no mention of AI or ML capabilities in the intended use, device description, or performance studies.
Yes.
The device is intended for resection, ablation, excision, hemostasis, and coagulation of soft tissues, which are all therapeutic interventions during arthroscopic surgery.
No
The device is an electrosurgical system intended for therapeutic actions like resection, ablation, excision, hemostasis, and coagulation of soft tissues, not for diagnosing a condition.
No
The device description explicitly states the system includes a generator, electrodes, and accessories, indicating it is a hardware-based electrosurgical system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system 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 is described as an "electrosurgical system" that utilizes bipolar technology for surgical treatments. This further reinforces its use in a surgical setting.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any interaction with patient specimens or diagnostic purposes.
The device is a surgical tool used for treating tissues within the body, not for analyzing samples outside the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Mitek VAPR VUE Radiofrequency System is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery.
The Mitek VAPR II Electrode System, when used with a VAPR™ Electrode, is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery.
The VAPR 3 Electrode System, when used with a VAPR™ Electrode, is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery.
The DePuy Mitek VAPR Electrodes for use with the VAPR VUE Radiofrequency 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 LD and LP Suction Electrodes, when used with the VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissues, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, elbow and wrist.
Product codes
GEI, HRX
Device Description
The VAPR system is electrosurgical system that utilizes bipolar technology specifically designed to provide a range of arthroscopic surgical treatments including soft tissue ablation, contouring, cutting and coagulation and temperature control. The VAPR system includes a generator, electrodes which facilitate access and control the delivery of energy to the joint space. and accessories such as a footswitch and electrodes. This premarket notification is submitted to add HIP arthroscopy to the Description of indication for use for the VAPR Generators and VAPR Electrodes listed in this section. As a result, the Instructions for Use (IFU) will be updated to add the hip indication. In addition the following modifications have also been made to the VAPR system Manuals and Electrode IFU's: . Removing Arthroscopic joint surgery examples from VAPR VUE, VAPR II and VAPR III manuals. Add an electrode shaft bending caution. There have been no changes to the devices which are the subject of this submission. The purpose of this submission is to evaluate the performance testing to support the addition of hip indication.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder, hip, 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)
Testing: Device Insertion, Results: Pass: No visible cracks or missing portions at the distal tip of the electrodes.
Testing: Shaft Bending, Results: Pass: No visible splitting of heatshrink after one cycle of bending and straightening of the electrode handle and shaft.
Testing: Active Tip Engagement, Results: Pass: The electrodes withstood with no breakage at the active tip.
No clinical studies are required to demonstrate safety and efficacy of the device in support of an application for premarket clearance.
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.
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
| FEB 27 2012 K113545 | ||
|---|---|---|
| Pg 1 of 4 | ||
| Date Prepared | November 30, 2011 | |
| Submitter's Name and Address: | DePuy Mitek, Inc. | |
| a Johnson & Johnson company | ||
| 325 Paramount Drive | ||
| Raynham, MA 02767 | ||
| Contact Person | Susan Kagan | |
| Project Manager, Regulatory Affairs | ||
| DePuy Mitek, Inc. | ||
| a Johnson & Johnson company | ||
| 325 Paramount Drive | ||
| Raynham, MA 02767, USA | ||
| Telephone: 508-880-8097 | ||
| Facsimile: 508-977-6911 | ||
| e-mail: skagan@its.jnj.com | ||
| Name of Medical Device | Classification Name: Electrosurgical cutting and coagulation device and accessories: 21 CFR 878.4400 | |
| Common/Usual Name: Electrosurgical cutting and coagulation device and accessories: Arthroscope | ||
| Proprietary Name: VAPR® VUE™ Radiofrequency System | ||
| VAPR III Electrode Surgical System | ||
| VAPR II Electrode Surgical System | ||
| P90 Electrode | ||
| CP90 Electrode | ||
| CP90 Electrode with Handcontrol | ||
| LDS Electrode | ||
| LPS Electrode | ||
| FDA Classification: II | ||
| FDA product code: GEI |
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The VAPR system is electrosurgical system that utilizes bipolar technology Device Description specifically designed to provide a range of arthroscopic surgical treatments including soft tissue ablation, contouring, cutting and coagulation and temperature control. The VAPR system includes a generator, electrodes which facilitate access and control the delivery of energy to the ioint space. and accessories such as a footswitch and electrodes. This premarket notification is submitted to add HIP arthroscopy to the Description of indication for use for the VAPR Generators and VAPR Electrodes listed in Change this section. As a result, the Instructions for Use (IFU) will be updated to add the hip indication. In addition the following modifications have also been made to the VAPR system Manuals and Electrode IFU's: . Removing Arthroscopic joint surgery examples from VAPR VUE, VAPR II and VAPR III manuals. Add an electrode shaft bending caution. � There have been no changes to the devices which are the subject of this submission. The purpose of this submission is to evaluate the performance testing to support the addition of hip indication. Indications for Use VAPR VUE Radiofrequency system The Mitek VAPR VUE Radiofrequency System is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery. VAPR II Electrosurgical system The Mitek VAPR II Electrode System, when used with a VAPR™ Electrode, is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery. VAPR 3 Electrosurgical system The VAPR 3 Electrode System, when used with a VAPR™ Electrode, is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery.
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K113545
Pg 3 of 4
VAPR CoolPluse Electrodes
The DePuy Mitek VAPR Electrodes for use with the VAPR VUE Radiofrequency 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.
VAPR Suction Electrodes (P90, CP90, CP90 with Handcontrol) The DePuy Mitek VAPR Electrodes for use with all VAPR Electrosurgical Systems 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.
VAPR Suction Electrodes (LDS and LPS Electrode)
The VAPR LD and LP Suction Electrodes, when used with the VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissues, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, elbow and wrist.
Substantial Equivalence
With the addition of the Hip indication, the VAPR Systems and electrodes which are the subject of this submission will have the same indication as the following electrodes currently on the market:
- A Serfas RF System: K041810
Safety and Performance Verification and Validation of the VAPR Electrodes included performance testing to demonstrate that the device is appropriate for hip arthroscopy. A summary of testing is provided in Table 1.
| T | able | 1 |
|---|---|---|
| --- | ------ | --- |
| Testing | Results |
|---|---|
| Device Insertion | Pass: No visible cracks or missing portions at the |
| distal tip of the electrodes. | |
| Shaft Bending | Pass: No visible splitting of heatshrink after one cycle |
| of bending and straightening of the electrode handle | |
| and shaft. | |
| Active Tip Engagement | Pass: The electrodes withstood with no breakage at |
| the active tip. |
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3
| Pg 4 of 4 | |
|---|---|
| Clinical Testing | No clinical studies are required to demonstrate safety and efficacy of the |
| device in support of an application for premarket clearance. The VAPR | |
| System and Electrodes, when used for hip arthroscopic surgeries, do not | |
| differ from the predicate devices in fundamental scientific technology. | |
| Conclusion | Results of safety and performance and testing have demonstrated that the |
| modified device is suitable for its intended use. |
Based on the indications for use and fundamental scientific technology, the
VAPR System, along with the VAPR Electrodes are shown to be appropriate
for arthroscopy of the hip as well as substantially equivalent to the
predicate devices under the Federal Food, Drug and Cosmetic Act. |
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દ્વાર (1135.45
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 2 7 2012
Depuy Mitek, a Johnson & Johnson Company % Ms. Susan Kagan Project Manager, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767
Re: K113545
Trade/Device Name: VAPR VUE Radiofrequency System
VAPR II Electrosurgical System
VAPR III Electrosurgical System
VAPR CoolPulse Electrodes (CP90, CP90 with Handcontrol)
VAPR Suction Electrodes (PD90, LDS, and LPS Electrode)
Regulation Number: 21 CFR 878.4400
Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, HRX
Dated: November 30, 2011
Received: December 1, 2011
Received. December 1, 2011
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. Iisting 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.
5
Page 2 - Ms. Susan Kagan
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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K 113545
Pg 1. of 2
Indications for Use
510(k) Number (if known):
Device Name: VAPR Generator
Indications for Use:
VAPR VUE Radiofrequency system
VAN TV CE Radionequency System is intended for resection, ablation, excision of soft tissue, r ne micel v .. 11 10 U nearly and coagulation of soft tissue in patients requiring arthroscopic surgery.
VAPR II Electrosurgical system
VAPR'II Liectrode System, when used with a VAPR™ Electrode, is intended for resection, r he miles will in it it it it is a coasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery.
VAPR III Electrosurgical system
VAPR 3 Electrode System, when used with a VAPR™ Electrode, is intended for resection, ablation, rne VAI it 3 Licetious bystems of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
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Page 1 of 1
(Division Sign-O Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113545
7
Indications for Use
K113545
PS 2 of 2
510(k) Number (if known):
Device Name: VAPR Electrodes
Indications for Use:
VAPR CoolPulse Electrodes (CP90, CP90 with Handcontrol)
The DePuy Mitek VAPR Electrodes for use with the VAPR VUE Radiofrequency 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.
VAPR Suction Electrodes (P90, LDS and LPS Electrode)
The VAPR LD and LP Suction Electrodes, when used with the VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissues, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, elbow and wrist.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
signature
Page 1 of 1
(Division Sign-Oir)
Division of Surgical, Orthopedic, Division of Restorative Devices
510(k) Number K113545