(88 days)
Not Found
No
The summary describes a standard electrosurgical system and does not mention any AI or ML components or functionalities.
Yes
The device is described as an electrosurgical system intended for resection, ablation, excision of soft tissue, hemostasis, and coagulation during arthroscopic surgery, which are all therapeutic interventions.
No
The device is described as an electrosurgical system intended for resection, ablation, excision of soft tissue, hemostasis, and coagulation of soft tissue during arthroscopic surgery, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states the system includes a generator, electrodes, and accessories, which are hardware components. The performance studies also focus on the physical integrity and function of the electrodes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for procedures within the body (arthroscopic surgery of joints). IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Device Description: The description details an electrosurgical system and electrodes used for cutting, ablation, and coagulation of tissue during surgery. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical components or functions of an IVD.
The device is a surgical tool used directly on the patient's tissue during a procedure.
N/A
Intended Use / Indications for Use
The DePuy Mitek VAPR Electrodes for use with the VAPR 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
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, 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.
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)
Verification and Validation of the VAPR Electrodes included performance testing to demonstrate that the device is appropriate for hip arthroscopy.
Testing consisted of:
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.
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)
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.
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510(k) SUMMARY
.
| Date Prepared | August 8, 2012 |
|---|---|
| Submitter's Name and Address: | DePuy Mitek, Inc. |
| a Johnson & Johnson company | |
| 325 Paramount Drive | |
| Raynham, MA 02767 | |
| Contact Person | Yayoi Fujimaki |
| Senior Regulatory Affairs Associate | |
| DePuy Mitek, Inc. | |
| a Johnson & Johnson company | |
| 325 Paramount Drive | |
| Raynham, MA 02767, USA | |
| Telephone: 508-828-3541 | |
| Facsimile: 508-977-6911 | |
| e-mail: yfujima1@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 P50 Electrode | |
| VAPR S50 Electrode | |
| VAPR S90 Electrode | |
| VAPR P50 Electrode with Handcontrols | |
| VAPR S90 Electrode with Handcontrols | |
| FDA Classification: II | |
| FDA product code: GEI | |
| 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, 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. |
| Description of Change | This premarket notification is submitted to add HIP arthroscopy to the indication for use for the VAPR Electrodes listed in this section. |
DePuy Mitek, Premarket notification 510(k) 1DePuy Mitek, Premarket notification 510(k)
Hip Indication addition to VAPR Electrodes
1
1
| As a result, the Instructions for Use (IFU) will be updated to add the hip indication. | |
|---|---|
| Besides the HIP indication addition, electrode shaft design (S50, P50 and P50 w/Hndcontrols) has been changed to the same single-shaft design of the predicates. | |
| No other changes have been made to the devices covered by this submission. | |
| Indications for Use | VAPR Suction Electrodes (P50, S50, S90, P50 w/Handcontrols and S90 w/Handcontrols) |
| The DePuy Mitek VAPR Electrodes for use with the VAPR 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: |
| Product | 510K Number | |
|---|---|---|
| Electrode | VAPR LDS Electrode | K113545 |
| VAPR LPS Electrode | ||
| VAPR P90 Electrode | ||
| VAPR CP90 Electrode | ||
| VAPR CP90 Electrode w/Handcontrols | ||
| Associated | ||
| Generator | VAPR VUE Radiofrequency System | |
| VAPR II Electrosurgical System | ||
| VAPR 3 Electrosurgical System |
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.
| Table 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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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 Electrodes when used the VAPR system 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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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-002
DePuy Mitek, Incorporated a Johnson and Johnson Company % Yayoi Fujimaki Senior Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767
November 5, 2012
Re: K122425
Trade/Device Name: VAPR®P50 Electrode, VAPR® S50 Electrode, VAPR® S90 Electrode, VAPR®P50 Electrode with Handcontrols, VAPR® S90 Electrode with Handcontrols
Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 8, 2012 Received: August 9, 2012
Dear Yayoi Fujimaki:
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
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Page 2 - Yayoi Fujimaki
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Peter D. Rumm/-S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K122425
Device Name: VAPR® P50 Electrode, VAPR® S50 Electrode, VAPR® S90 Electrode, VAPR® P50 Electrode with Handcontrols, VAPR® S90 Electrode with Handcontrols
Indications for Use:
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 arthroscpic 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)
Yancy D. Payne
(Division Sign-Óff) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K12
umber K122425
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