(85 days)
Not Found
No
The description focuses on the addition of hand controls and compatibility with an existing generator, with no mention of AI or ML technologies.
Yes
The device is used for medical procedures (resection, ablation, excision, hemostasis, coagulation) which aim to treat medical conditions, fitting the definition of a therapeutic device.
No
The device is intended for "resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue," which are therapeutic functions, not diagnostic ones.
No
The device description clearly details physical components (electrodes, handles, buttons, plug) and performance testing related to these physical components (handle separation, handle retention, fluid ingress). It is an electrosurgical device with hardware.
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." This describes a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details an electrosurgical electrode used in conjunction with a generator. This is a surgical tool, not a diagnostic test kit or instrument used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to perform surgical procedures.
N/A
Intended Use / Indications for Use
The DePuy Mitek VAPR Electrodes for use with the VAPR System are 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 knee, shoulder, ankle, elbow, and wrist.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The VAPR Electrodes with Handcontrol are similar in technological characteristics, geometry and materials, as their predicated except they will now be available with integrated handcontrol capabilities via three buttons mounted on the existing one-piece handles.
These buttons control ablation, coagulation and the generator mode functions. The plug of the electrode is designed to fit the VAPR VUE generator (K100638: June 18, 2010) socket only and houses the components for ID recognition. They are intended to be run only off the VAPR VUE platform at pre-determined default settings specific for the device. If required, the settings for the device can be modified within safe pre-determined limits by accessing the generator or footswitch control in addition to the buttons on the handpiece.
There are no changes being made to the fundamental technology of the electrode with the exception of the addition of handcontrol functionality.
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)
Verification of the VAPR Electrodes with handcontrols includes performance testing to show that the device meets its product specifications. Results of performance testing are summarized in Table 1.
Table 1.
| Test | Results |
|---|---|
| One Piece Cantilever Handle Separation Test | Pass |
| One Piece Handle Retention Test | Pass |
| Fluid Ingress Test for Finger switches | Pass |
| System Compatibility Test | Pass |
| Capacitance Test | Pass |
Clinical Testing
Safety and Performance
No clinical studies are required to demonstrate safety and efficacy of the device in support of an application for premarket clearance. The VAPR Electrodes with handcontrols do not differ from the predicate device in fundamental scientific technology or 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.
K002422, K082643, K100638, K041135, K963783
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
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APR - 6 2012
મુ
510(k) SUMMARY
| Date Prepared | January 11, 2012 |
|---|---|
| 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 | |
| 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: Side Effect with Hand controls
Hook Electrode with Hand controls
2.3 Wedge Electrode with Hand controls
S90 with Hand controls
P50 with Hand controls
FDA Classification: II
FDA product code: GEI |
| Predicate
Device(s) | The proposed P50 Electrode with Handcontrols is substantially
equivalent to: |
- K002422: VAPR 90º Suction Electrode (August 31, 2000) ■
- K082643: VAPR Electrodes with Handpieces (December 19, 2008) .
- K100638: VAPR VUE including CP90 Handcontrol (June 18, 2010) ■
Premarket Notification: Traditional 510(k) VAPR Electrodes with Handcontrols
ﻤﺴﺮ . "
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The proposed S90 Electrode with Handcontrols is substantially equivalent to:
- 1 K041135: VAPR LPS Electrode (May 10, 2004)
- K082643: VAPR Electrodes with Handpieces (December 19, 2008) 트
- 피 K100638: VAPR VUE including CP90 Handcontrol (June 18, 2010)
The proposed Side Effect, Hook and Wedge Electrode with Handcontrols are substantially equivalent to:
- K963783 Mitek Electrosurgical System (December 25, 1996) 트
- . K082643 VAPR Electrode with Integrated Electrode (December 19, 2008)
- : K100638 VAPR VUE including CP90 with handcontrols (June 18, 2010)
Device Description
The VAPR Electrodes with Handcontrol are similar in technological characteristics, geometry and materials, as their predicated except they will now be available with integrated handcontrol capabilities via three buttons mounted on the existing one-piece handles.
These buttons control ablation, coagulation and the generator mode functions. The plug of the electrode is designed to fit the VAPR VUE generator (K100638: June 18, 2010) socket only and houses the components for ID recognition. They are intended to be run only off the VAPR VUE platform at pre-determined default settings specific for the device. If required, the settings for the device can be modified within safe pre-determined limits by accessing the generator or footswitch control in addition to the buttons on the handpiece.
There are no changes being made to the fundamental technology of the electrode with the exception of the addition of handcontrol functionality.
Indications for Use
The DePuy Mitek VAPR Electrodes for use with the VAPR System are 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 knee, shoulder, ankle, elbow, and wrist.
Comparison to Predicate Device This submission is intended to demonstrate that the VAPR Electrodes with handcontrols are substantially equivalent to their legally marketed devices.
The Electrodes have been carefully compared to legally marketed devices with respect to intended use, essential components and material, performance specifications and technology characteristics.
Premarket Notification: Traditional 510(k) VAPR Electrodes with Handcontrols
2
All of the electrodes which are the subject of this submission have the same Indications for Use and technology characteristics. The change to these electrodes is the addition of handcontrol capability which uses the same fundamental technology as the CP90 Electrode and VAPR footswitch.
In addition, safety and performance testing have been done to validate the performance and safety of the device. It has been demonstrated that the addition of handcontrol capability to their predicate electrodes will not affect safety and effectiveness of the subject devices.
Verification of the VAPR Electrodes with handcontrols includes performance testing to show that the device meets its product specifications. Results of performance testing are summarized in Table 1.
Table 1.
| Test | Results |
|---|---|
| One Piece Cantilever Handle Separation Test | Pass |
| One Piece Handle Retention Test | Pass |
| Fluid Ingress Test for Finger switches | Pass |
| System Compatibility Test | Pass |
| Capacitance Test | Pass |
Clinical Testing
Safety and Performance
No clinical studies are required to demonstrate safety and efficacy of the device in support of an application for premarket clearance. The VAPR Electrodes with handcontrols 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 VAPR Electrodes with handcontrols which are the subject of this submission are shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act.
Premarket Notification: Traditional 510(k) VAPR Electrodes with Handcontrols
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DEPARTMENT OF HEALTH & HUMAN SERVICES .
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. The symbol on the right is a stylized representation of a human figure, with three curved lines forming the body and head.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR - 6 2012
DePuy Mitek % Ms. Susan Kagan 325 Paramount Drive Raynham, MA 02767
Re: K120095
Trade Name: VAPR electrodes with Hand Controls Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 22, 2012 Received: March 23, 2012
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. 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 corply 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 Of K F at 607), aboning (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Susan Kagan
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark A. Millkus
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
· Enclosure
5
Indications for Use
510(k) Number (if known): K120095
Device Name: VAPR Electrodes with Handcontrols
Indications for Use:
The DePuy Mitek VAPR Electrodes for use with the VAPR System are 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 knee, shoulder, 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)
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signature
(Division ign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120095