(14 days)
Not Found
No
The description focuses on the electrosurgical and argon gas delivery mechanisms, with no mention of AI or ML capabilities. The device operation is based on manual control of RF current and gas flow.
Yes
The device is designed for cutting and coagulation of biological tissue during open surgical procedures, which are therapeutic interventions.
No
The device is described as a surgical tool for cutting and gas coagulation during open surgical procedures, primarily performing therapeutic actions rather than diagnostic ones.
No
The device is a physical handpiece with mechanical components (handle, telescoping nozzle, electrode, push buttons) and delivers RF current and argon gas, clearly indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "provides cutting and gas coagulation during open surgical procedure where monopolar electrosurgery (cutting and coagulation) is normally used." This describes a surgical tool used directly on tissue during a procedure.
- Device Description: The description details a "monopolar handpiece" that uses "radio frequency (RF) monopolar electrosurgical current to cut or coagulate biological tissue." This is a description of a surgical instrument, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on sample analysis
- Use in a laboratory setting
The device is a surgical tool used for cutting and coagulation during open surgical procedures.
N/A
Intended Use / Indications for Use
The Hybrid Plasma Scalpel provides cutting and gas coagulation during open surgical procedure where monopolar electrosurgery (cutting and coagulation) is normally used. The Hybrid Plasma Scalpel is a monopolar handpiece used with compatible electrosurgical units.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Canady Vieira Hybrid Plasma™ Scalpel is an accessory multi-functional electrosurgical handpiece used for open surgical procedures where monopolar radio frequency electrosurgical handpieces (cutting, coagulation) is normally used. The handpiece uses radio frequency (RF) monopolar electrosurgical current to cut or coagulate biological tissue. The handpiece can also combine argon gas with radio frequency monopolar cut or coagulation currents to produce a hybrid plasma cut, or argon plasma coagulation.
The handpiece consists of three major components: Handle, Telescoping Nozzle, and Electrode. The insulated handle encases the radio frequency (RF) current and gas tubing for controlling the flow of argon gas and activation of RF current for the device. RF current is activated by two push buttons yellow (standard CUT mode) and blue (standard COAG mode) which are top of the handle. Argon gas is delivered via the handle by activating a third push button (purple) which is also on top of the handle. The electrode tip has 4 modes of operation and as shown in the below table, this words appear depending on the mode of operation that is necessary.
Depending on the RF current mode (CUT or COAG), the handpiece can function in the following argon modes: HYBRID PLASMA CUT – Argon gas is delivered through the handpiece while the attached electrosurgical generator is set in the CUT mode. Hybrid Argon Plasma Cut mode will cut and coagulate the tissue at the same time. ARGON PLASMA COAGULATION – Argon gas is delivered through the handpiece while the attached electrosurgical generator is set in the COAG mode. Argon Plasma Coagulation will coagulate the tissue. The Canady Vieira Hybrid Plasma™ Scalpel is an accessory that is used with the Argon 2 (CPC2) and Argon 4 (CPC4) generators, previously cleared by FDA. These generators provide a controlled flow of argon to the electrosurgical handpiece during Hybrid Plasma Cutting or Argon Plasma Coagulation modes. The Physician manually sets the flow rate on the Plasma coagulator. The telescoping nozzle can be extended or shortened over the electrode as desired when the surgeon is performing argon procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / open surgical procedures
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)
Biocompatibility Testing:
Biocompatibility testing was performed to validate the patient contacting material used for the Canady Vieira Hybrid Plasma™ Scalpel. These tests were conducted to meet ISO 10993-1 and USP requirements.
Performance Testing - Bench Studies:
Testing was completed to ensure that the Canady Vieira Plasma™ Scalpel meets the requirements of IEC 60601-1-2 and IEC 60601-2-2 and to ensure that it is compatible with the Canady Plasma Argon 2 and Argon 4 Electrosurgical Generators SS-200-E and SS-601-MCa. Bench Testing was also performed to ensure cutting and coagulation using the device, as well as shelf life and sterility testing.
Performance Testing – Clinical Studies:
No Clinical studies were performed for the submission of this 510(k).
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
DEC - 9 2011
510(k) Summary
(per 21 CFR 807.92(c))
1. Applicant
US Medical Innovations, LLC 2940 Winter Lake Road Lakeland, Florida 33803
Contact Person: Jerome Canady, M.D. Tel: 863 667-1609 Fax: 863 667-1917
Date Prepared: October 11, 2011
2. Device Name and Classification
Trade Name(s): Canady Vieira Hybrid Plasma™ Scalpel, AW-422552
Common Name: Electrosurgical, cutting & coagulation & accessories
Classification Name: Electrosurgical cutting and coagulation device and accessories
Classification Regulation: 21 CFR 878.4400 Panel: General, Restorative, and Neurological Devices Product Code: GEI Class: Il
3. Predicate Devices
The Canady Vieira Hybrid Plasma'™ Scalpel is substantially equivalent to the following devices:
| 510(k) Number | Device | Manufacturer |
|---|---|---|
| K955020 | Telescoping Pen Evac ABC | I.C. Medical, Inc. |
| K964636 | Force Argon II Argon Enhanced | Valley Lab |
4. Description of the Device
The Canady Vieira Hybrid Plasma™ Scalpel is an accessory multi-functional electrosurgical handpiece used for open surgical procedures where monopolar radio frequency electrosurgical handpieces (cutting, coagulation) is normally used. The handpiece uses radio frequency (RF)
1
monopolar electrosurgical current to cut or coagulate biological tissue. The handpiece can also combine argon gas with radio frequency monopolar cut or coagulation currents to produce a hybrid plasma cut, or argon plasma coagulation.
The handpiece consists of three major components: Handle, Telescoping Nozzle, and Electrode. The insulated handle encases the radio frequency (RF) current and gas tubing for controlling the flow of argon gas and activation of RF current for the device. RF current is activated by two push buttons yellow (standard CUT mode) and blue (standard COAG mode) which are top of the handle. Argon gas is delivered via the handle by activating a third push button (purple) which is also on top of the handle. The electrode tip has 4 modes of operation and as shown in the below table, this words appear depending on the mode of operation that is necessary.
| Table 5- | 1 |
|---|---|
| ---------- | --- |
| Canady Vieira Hybrid Plasma™ Scalpel Mode | Operation being performed |
|---|---|
| CUT | Cuts Tissue |
| COAG | Coagulates Tissue |
| ARGON PLASMA COAG | Coagulates Tissue |
| CANADY VIEIRA HYBRID PLASMA CUT | Cuts Tissue |
Depending on the RF current mode (CUT or COAG), the handpiece can function in the following argon modes: HYBRID PLASMA CUT – Argon gas is delivered through the handpiece while the attached electrosurgical generator is set in the CUT mode. Hybrid Argon Plasma Cut mode will cut and coagulate the tissue at the same time. ARGON PLASMA COAGULATION – Argon gas is delivered through the handpiece while the attached electrosurgical generator is set in the COAG mode. Argon Plasma Coagulation will coagulate the tissue. The Canady Vieira Hybrid Plasma™ Scalpel is an accessory that is used with the Argon 2 (CPC2) and Argon 4 (CPC4) generators, previously cleared by FDA. These generators provide a controlled flow of argon to the electrosurgical handpiece during Hybrid Plasma Cutting or Argon Plasma Coagulation modes. The Physician manually sets the flow rate on the Plasma coagulator. The telescoping nozzle can be extended or shortened over the electrode as desired when the surgeon is performing argon procedures.
5. Indications for Use (IFU)
The Hybrid Plasma Scalpel provides cutting and gas coagulation during open surgical procedure where monopolar electrosurgery (cutting and coagulation) is normally used. The Hybrid Plasma Scalpel is a monopolar handpiece used with compatible electrosurgical units.
6. Summary of Performance Data
Biocompatibility Testing
Biocompatibility testing was performed to validate the patient contacting material used for the Canady Vieira Hybrid Plasma™ Scalpel. These tests were conducted to meet ISO 10993-1 and USP requirements.
Performance Testing - Bench Studies
2
Testing was completed to ensure that the Canady Vieira Plasma ™ Scalpel meets the requirements of IEC 60601-1-2 and IEC 60601-2-2 and to ensure that it is compatible with the Canady Plasma Argon 2 and Argon 4 Electrosurgical Generators SS-200-E and SS-601-MCa. Bench Testing was also performed to ensure cutting and coagulation using the device, as well as shelf life and sterility testing.
Performance Testing – Clinical Studies
No Clinical studies were performed for the submission of this 510(k).
7. Safety & Effectiveness
| Trade Name | Canady Vieira
Hybrid Plasma
Scalpel | Telescoping PenEvac ABC | Force Argon II Enhanced
Electrosurgical System | Significant
Difference |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Manufacturer | USMI | I.C. Medical, Inc. | ValleyLab, | N/A |
| 510(k) Number | TBD | K955020 | K964636 | N/A |
| Model | 422552 | N/A | E2520H | N/A |
| Indications for Use | Hybrid Plasma
provides cutting and
gas coagulation
during open surgical
procedure where
monopolar
electrosurgery
(cutting and
coagulation) is
normally used. | Electrosurgery cut and
coagulation / Argon Plasma
Coagulation during open
surgical procedures where
monopolar electrosurgery
(cutting, coagulation) is
normally used. | Argon Shrouded Cut/
Argon Enhanced Coagulation
Electrosurgery cut and
coagulation used in open,
surgical procedures where
monopolar electrosurgery
(cutting, coagulation) is normally
used | None |
| Handpiece, | Yes | Yes | Yes | None |
| Telescoping tip | Yes | Yes | Yes | None |
| Sterile | Yes | Yes | Yes | None |
| Disposable | Yes | Yes | Yes | None |
| Reusable | No | Yes | No | None |
| Sterilization
Method | EO | EO | EO | None |
| Needle tip length | 2.5cm | 2.5cm | 2.5cm | None |
| Buttons on scalpel | 3 buttons | 3 buttons | 3 buttons | None |
| Gas Flow Rate as
Defined | 0.1 to 10.0 l/min | 0.5 to 12.0 l/min | 0.5 to 12.0lmin | None |
| Bipolar/Monopolar | Monopolar | Monopolar | Monopolar | None |
| Meets IEC 60601-
1-2 | Yes | Yes | Yes | None |
| Meets IEC 60601-
2-2 | Yes | Yes | Yes | None |
| Probe Tip | Ceramic | CERAMIC | Ceramic | None |
| Electrode material | Tungsten | TUNGSTEN | Tungsten | None |
| Instrument
Recognition | Yes | Yes | Yes | None |
| Meets
Biocompatibility | Yes | Yes | Yes | None |
3
As demonstrated in the above table the Canady Vieira Hybrid Plasma™ Scalpel is substantially equivalent to the predicate devices listed in this 510(k) submission. The Canady Vieira Hybrid Plasma ™ Scalpel compared to the predicate devices does not raise issues with regards to safety and effectiveness.
.
4
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC - 9 2011
U.S. Medical Innovations, LLC % TUV SUD America, Inc. Mr. Alexander Schapovalov 1775 Old Highway 8 New Brighton, MN 55112-1891
Re: K113500
Trade/Device Name: Canady Vieira Hybrid Plasma™ Scalpel Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 22, 2011 Received: November 25, 2011
Dear Mr. Schapovalov:
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
5
Page 2 - Mr. Alexander Schapovalov
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/ReportalProblem/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 vour
sincerely yours,
for Duthm Mr. Lin Din
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): ____
Device Name: Canady Vieira Hybrid Plasma™ Scalpel
Indications for Use:
The Hybrid Plasma Scalpel provides cutting and gas coagulation during open surgical procedure where monopolar electrosurgery (cutting and coagulation) is normally used. The Hybrid Plasma Scale in a monopolar handpiece used with compatible electrosurgical units.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113500