(393 days)
Not Found
No
The summary describes a standard electrosurgical unit and plasma coagulator with various modes, but there is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended to cut and/or coagulate tissue during general surgery procedures, which are therapeutic actions to remove or modify diseased tissue.
No
The device is an electrosurgical unit and coagulator intended for cutting and coagulating tissue during general surgery procedures. It is mentioned to be used for "tissue removal and coagulation," not for diagnosing conditions or diseases.
No
The device description clearly outlines hardware components including Electrosurgery Units, Coagulators (gas units), and probes, which are physical devices used in surgical procedures.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the devices are for "gas-enhanced coagulation during general surgery procedures" and "to cut and/or coagulate tissue". This describes a surgical procedure performed directly on a patient's tissue, not a test performed on a sample taken from the body.
- Device Description: The description details how the device uses high-frequency voltage and plasma gas to interact with tissue for cutting and coagulation. This is a therapeutic/surgical function, not a diagnostic one.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue samples, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly intended for direct surgical intervention on a patient.
N/A
Intended Use / Indications for Use
The Canady Plasma Coagulator devices are intended to provide gas-enhanced coagulation during general surgery procedures. The Canady Plasma Coagulator devices are Argon Plasma Coagulation Unit designed for gas enhanced coagulation when used only with the Canady Plasma Electrosurgery Unit models and compatible monopolar and/or bipolar RF handpieces.
The Canady Electrosurgery Unit Generators are intended to cut and/or coagulate tissue when used with compatible monopolar and/or bipolar RF handpieces. The Canady Electrosurgery Unit Generators are capable of monopolar argon gas enhanced coagulation when used with Canady Plasma Coagulator and probes.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Canady Plasma"M Electrosurgical Unit Series with Accessories is an High Frequency (HF) Electrosurgery Unit (ESU) used in combination with Canady Plasma™ Coagulators (Argon 2 and Argon 4) gas units and probes (Canady Plasma™ GIT probe and Canady Plasma™ TBS probe). The Canady Plasma (ESU) series combines (HF) voltage to electrically enhanced plasma gas (i.e. Argon) to produce a plasma gas stream. Current density upon arrival at the tissue surface from Canady Plasma Probes causes coagulation of the tissue. Canady Plasma (ESU) series is also a monopolar and bipolar RF surgical device for cutting and coagulation. It is used for tissue removal and coagulation in accordance with the operative procedure performed by the physician. The unit provides various cutting and coagulation modes to meet the physician flexibility performing the specific procedure with the device.
The Canady Plasma Electrosurgery Unit Model SS-200E is to only be used with the Canady Plasma Coagulator Argon 2. The Canady Plasma Electrosurgery Unit Model SS-601 Mca is to only be used with the Canady Plasma Coagulator Argon 4.
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
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)
Not Found
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.
K052035, K933157, K023886, K024047, K013348, K944602, K022856
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
APR - 6 2011
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Submitter Information:
US Medical Innovations, LLC 2940 Winter Lake Road Lakeland, Florida 33803 Tel: 863 667-1609 Fax: 863-667-1917 Attn: Jerome Canady, M.D.
Date Summary Prepared: July 27, 2010
Application Correspondent:
Krista Oakes Senior Regulatory Consultant Emergo Group Inc. 611 West 5th Street Third Floor Austin, Texas 78701 Tel: 512-327-9997 Fax: 512-327-9998
Device Name:
Trade Name(s): Canady Plasma"" Electrosurgical Unit Series (SS-601 MCa, SS-200E)/ Canady Plasma™ Coagulator (Argon 2 and 4) with Accessories Canady Plasma™ Probes for Flexible Endoscopy
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: II
Predicate Device Information:
Canady Technology, LLC Canady Plasma Probes for Flexible Endoscopy - K052035 ERBE ICC 200 - K933157 ERBE VIO 300D - K023886 ERBE VIO APC2 - K024047 ERBE APC Applications - K013348 Valley Lab Force FX - K944602 BOVIE IDS-300 K022856
1
Device Description:
The Canady Plasma"M Electrosurgical Unit Series with Accessories is an High Frequency (HF) Electrosurgery Unit (ESU) used in combination with Canady Plasma™ Coagulators (Argon 2 and Argon 4) gas units and probes (Canady Plasma™ GIT probe and Canady Plasma™ TBS probe). The Canady Plasma (ESU) series combines (HF) voltage to electrically enhanced plasma gas (i.e. Argon) to produce a plasma gas stream. Current density upon arrival at the tissue surface from Canady Plasma Probes causes coagulation of the tissue. Canady Plasma (ESU) series is also a monopolar and bipolar RF surgical device for cutting and coagulation. It is used for tissue removal and coagulation in accordance with the operative procedure performed by the physician. The unit provides various cutting and coagulation modes to meet the physician flexibility performing the specific procedure with the device.
The Canady Plasma Electrosurgery Unit Model SS-200E is to only be used with the Canady Plasma Coagulator Argon 2. The Canady Plasma Electrosurgery Unit Model SS-601 Mca is to only be used with the Canady Plasma Coagulator Argon 4.
Intended Use:
The Canady Plasma Coagulator devices are intended to provide gas-enhanced coagulation during general surgery procedures. The Canady Plasma Coagulator devices are Argon Plasma Coagulation Unit designed for gas enhanced coagulation when used only with the Canady Plasma Electrosurgery Unit models and compatible monopolar and/or bipolar RF handpieces.
The Canady Electrosurgery Unit Generators are intended to cut and/or coagulate tissue when used with compatible monopolar and/or bipolar RF handpieces. The Canady Electrosurgery Unit Generators are capable of monopolar argon gas enhanced coagulation when used with Canady Plasma Coagulator and probes.
Comparison to Predicate Devices:
These devices are equivalent in intended use, technological characteristics, and performance characteristics to the named predicate devices.
Testing and Conclusions:
The devices comply with NBR IEC 60601-1 Standard, Electromedical equipment - Part 1 - General requirements for safety, NBR IEC 60601 - 2- 2 Electromedical equipment -Part 2 - 2: Particular requirements for the safety of high frequency surgical equipment, NBR IEC 60601 - 1 - 2, Electromedical equipment - Part 1 - 2: Collateral standard: Electromagnetic compatibility - Requirements and test.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
US Medical Innovations LLC % TUV SUD America, Inc. Ms. Dawn Tibodeau 1775 Old Highway 8 NW, Ste 104 New Brighton, Minnesota 55112-1891
APR - 6 2511
Re: K100669
Trade/Device Name: Canady Plasma Electrosurgical Unit Series & Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 29, 2011 Received: April 6, 2011
Dear Ms. Tibodeau:
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 10 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
3
Page 2 - Ms. Dawn Tibodeau
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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Alij B. Rute
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4 - Indications for Use '
510(k) Number (if known): K100669
Device Name: Canady Plasma™ Electrosurgical Unit Series with Accessory Probes
Indications for Use:
The Canady Plasma Coagulator devices are intended to provide gas-enhanced coagulation during general surgery procedures. The Canady Plasma Coagulator devices are Argon Plasma Coagulation Unit designed for gas enhanced coagulation when used only with the Canady Plasma Electrosurgery Unit models and compatible monopolar and/or bipolar RF handpieces.
The Canady Electrosurgery Unit Generators are intended to cut and/or coagulate tissue when used with compatible monopolar and/or bipolar RF handpieces. The Canady Electrosurgery Unit Generators are capable of monopolar argon gas enhanced coagulation when used with Canady Plasma Coagulator and probes.
Prescription Use _______________(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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Younes M. Elgayar
(Division Division of Surgical, Orthopedia and Restorative Devices
510(k) Number K100669