(92 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts. The device description focuses on the electrosurgical generator and its function.
Yes
The device is indicated for the gas enhanced ablation of soft tissue, which is a therapeutic intervention.
No
The device is described as an "Ablation System" used for "ablation of soft tissues" via a cold plasma spray. This indicates a therapeutic, not diagnostic, function.
No
The device description explicitly lists multiple hardware components including a generator, ablators, foot pedal, and trolley cart, indicating it is a hardware-based system with integrated software.
Based on the provided information, the Canady Helios Cold Plasma™ XL-1000CP™ Ablation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "gas enhanced ablation of soft tissue using helium-based plasma." This describes a therapeutic procedure performed directly on a patient's tissue, not a test performed on a sample taken from the body.
- Device Description: The device is described as an "Ablation System" that produces a plasma spray to deliver energy for "ablation of soft tissues." This is consistent with a surgical or therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue samples, etc.) or providing diagnostic information.
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. The Canady Helios Cold Plasma™ XL-1000CP™ Ablation System is clearly intended for direct therapeutic intervention on the patient's tissue.
N/A
Intended Use / Indications for Use
The Canady Helios Cold Plasma™ XL-1000CP™ Ablation System is indicated for the gas enhanced ablation of soft tissue using helium-based plasma.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Canady Helios Cold Plasma™ XL-1000CP™ Ablation System produces a Helium-based cold plasma spray to deliver high frequency low energy current intended for the ablation of soft tissues.
The Canady Helios Cold Plasma™ XL-1000CP Ablation System includes the following items:
- Canady Helios Cold Plasma™ XL-1000CP SMART Electrosurgical Generator
- Canady Helios™ Cold Plasma Ablators
- Foot Pedal
- Trolley Cart
The Canady Helios Cold Plasma™ XL-1000CP™ SMART Electrosurgical Generator is a transportable nonsterile electrical device compatible for use in the operating room environment. The Canady Helios Cold Plasma™ XL-1000CP SMART Electrosurgical Generator creates high frequency, short duration energy pulses with regulated Helium gas, which is delivered to the target tissue via the Canady Helios™ Cold Plasma Ablators. The Canady Helios™ Cold Plasma Ablators are sterile monopolar electrosurgical instruments intended for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room environment
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)
The following tests were conducted to confirm that the Canady Helios Cold Plasma™ XL-1000CP™ Ablation System meets specifications and that it performs equivalently to the predicate Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories.
Tests conducted (all met criteria):
Electrical Safety Testing
High Frequency Testing
Electromagnetic Compatibility Testing
Electromechanical Safety Testing
Package Integrity
Shelf Life
Sterilization
Software and System Verification / Validation
Cybersecurity
Biological Safety
Ablation Effectiveness
Thermal Effect
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
May 3, 2024
US Medical Innovations, LLC % Audrey Swearingen Sr. Regulatory Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, Texas 78746
Re: K240297
Trade/Device Name: Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: February 1, 2024 Received: February 1, 2024
Dear Audrey Swearingen:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.05.03 11:01:07 -04'00
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
K240297
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Submission Number (if known)
Device Name
Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)
Indications for Use (Describe)
The Canady Helios Cold Plasma™ XL-1000CP™ Ablation System is indicated for the gas enhanced ablation of soft tissue using helium-based plasma.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary Canady Helios Cold Plasma™ XL-1000CP™ Ablation System
The following information is provided in accordance with 21 CFR 807.92.
Submission Sponsor:
US Medical Innovations LLC 6930 Carroll Avenue, Suite 1000 Takoma Park, MD 20912 Contact: Jerome Canady, MD., FACS Title: CEO Phone: (301) 270-0147
Submission Correspondent:
Emergo by UL 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 Contact: Ms. Audrey Swearingen Senior Regulatory Consultant Title: Phone: (512) 327-9997 LST.AUS.ProjectManagement@ul.com Email:
Date: April 18, 2024
Device Identification:
| Trade or Proprietary Name: | Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS |
|---|---|
| Common or Usual Name: | Surgical ablation system |
| Regulation Number: | 21 CFR 878.4400 |
| Regulation Name: | Electrosurgical cutting and coagulation device and accessories |
| Product Code: | GEI |
| Device Class: | II |
| Panel: | General & Plastic Surgery |
Legally Marketed Predicate Device:
| Trade Name: | Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories |
|---|---|
| 510(k) Number: | K192124 |
| Manufacturer: | US Medical Innovations LLC |
| Regulation Number: | 21 CFR 878.4400 |
| Regulation Name: | Electrosurgical cutting and coagulation device and accessories |
| Product Code: | GEI |
Intended Use/Indications for Use:
The Canady Helios Cold Plasma™ XL-1000CP™ Ablation System is indicated for the gas enhanced ablation of soft tissue using helium-based plasma.
5
Device Description:
The Canady Helios Cold Plasma™ XL-1000CP™ Ablation System produces a Helium-based cold plasma spray to deliver high frequency low energy current intended for the ablation of soft tissues.
The Canady Helios Cold Plasma™ XL-1000CP Ablation System includes the following items:
- Canady Helios Cold Plasma™ XL-1000CP SMART Electrosurgical Generator
- Canady Helios™ Cold Plasma Ablators
- Foot Pedal
- Trolley Cart
The Canady Helios Cold Plasma™ XL-1000CP™ SMART Electrosurgical Generator is a transportable nonsterile electrical device compatible for use in the operating room environment. The Canady Helios Cold Plasma™ XL-1000CP SMART Electrosurgical Generator creates high frequency, short duration energy pulses with regulated Helium gas, which is delivered to the target tissue via the Canady Helios™ Cold Plasma Ablators. The Canady Helios™ Cold Plasma Ablators are sterile monopolar electrosurgical instruments intended for single use.
Substantial Equivalence:
The following table compares the proposed Canady Helios Cold Plasma™ XL-1000CP™ Ablation System to the Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories predicate device, with respect to intended use and technological characteristics.
| Trade Name | Canady Helios Cold Plasma™ XL-
1000CP™ SMART Ablation
System | Canady Plasma SMART XL-1000
Electrosurgical Generator with
Accessories System (K192124) | Significant Difference |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Manufacturer | US Medical Innovations, LLC | US Medical Innovations, LLC | N/A |
| Product code(s)/
Regulation No. | GEI /
878.4400 | GEI /
878.4400 | Both are under the
same regulation |
| Intended Use | Gas enhanced ablation of soft
tissue. | Gas enhanced ablation of soft
tissue. | None |
| Indications for Use | The Canady Helios Cold Plasma™
XL-1000CP™ SMART Ablation
System is indicated for gas
enhanced ablation of soft tissue
using helium based plasma. | The Canady Plasma® SMART XL-
1000™ Electrosurgical Generator
with Accessories is intended to
provide gas-enhanced
coagulation during general
surgery procedures. The Canady
Plasma® SMART XL-1000™
Electrosurgical Generator with
Accessories is designed for gas
enhanced coagulation when
used only with the Canady
Plasma Electrosurgery Unit and
compatible monopolar and/or
bipolar handpieces.
The Canady Electrosurgery Unit
Generators are intended to cut
and/or coagulate tissue when
used with compatible
monopolar and/or bipolar RF | The XL-1000CP uses a
subset of the
Indications for use
defined for the
predicate device. |
| System Components | • Canady Helios Cold Plasma™
XL-1000CP™ SMART
Electrosurgical Generator
• Canady Helios™ Cold Plasma
Ablators
• Footswitch
• Power Supply Cord
• XL-1000/XL-1000CP Trolley
Cart | handpieces. The Canady
Electrosurgery Unit Generators
are capable of monopolar
argon gas enhanced
coagulation when used with
Canady Plasma Coagulator and
probes.
• Canady Plasma® SMART XL-
1000™ Electrosurgical
Generator
• Canady Plasma Hybrid Scalpel
(K113500)
• Canady Plasma Probes for
Flexible Endoscopy
(K100669)
• Footswitch
• Power Supply Cord
• XL-1000/XL-1000CP Trolley
Cart | Same. The subject
Ablators are identical
to the predicate's
handpieces. |
| Generator Type | High Frequency | High Frequency | None |
| Inert Gas Type | Helium | Argon | The XL-1000CP uses
the inert gas Helium
instead of Argon. |
| Frequency | 390 kHz | 390 kHz | None |
| Peak to Peak Voltage | 4kV (1000 Ω) | 4kV (1000 Ω) | None |
| Main CPU Type | FPGA | FPGA | None |
| Display Type | LED with backlight | LED with backlight | None |
| Monopolar | Yes, insulated | Yes, insulated | None |
| Bipolar | No | Yes | The XL-1000CP
generator only
supports monopolar
ablation. |
| Monopolar Modes | Canady Helios Cold Plasma
Ablation Mode (equivalent to
Fulgurate High on the XL-1000) | Argon Plasma - Cut (Pure, Blend
I,II,III, Pure High Cut, Blend High
Cut I,II), E-Cut, Argon Plasma
(Spray, Fulgurate High,
Fulgurate Low, Desiccate I,II,III) | Cold Plasma ablation
mode is the same as
the Argon Plasma
Fulgurate High mode
of the XL-1000. |
| Gas Flow Rate | 0.0 - 5.0 L/min | 0.0 - 5.0 L/min | None |
| Power Setting Shown | Yes | Yes | None |
| Cooling Type | Convection | Convection | None |
| Input Voltage, VAC | 100 – 240 | 100 - 240 | None |
| Performance | Shown to ablate soft tissue at
specified parameters. | Shown to ablate soft tissue at
specified parameters. | Both perform as
intended to ablate
soft tissue. |
6
Performance Testing:
The following tests were conducted to confirm that the Canady Helios Cold Plasma™ XL-1000CP™ Ablation System meets specifications and that it performs equivalently to the predicate Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories.
7
| Electrical Safety Testing | Met criteria |
|---|---|
| High Frequency Testing | Met criteria |
| Electromagnetic Compatibility Testing | Met criteria |
| Electromechanical Safety Testing | Met criteria |
| Package Integrity | Met criteria |
| Shelf Life | Met criteria |
| Sterilization | Met criteria |
| Software and System Verification / Validation | Met criteria |
| Cybersecurity | Met criteria |
| Biological Safety | Met criteria |
| Ablation Effectiveness | Met criteria |
| Thermal Effect | Met criteria |
The device complies with the following applicable test standards:
| ANSI/AAMI/ISO 11135:
2014/AMD 2018 | Sterilization of health-care products — Ethylene oxide — Requirements for the
development, validation and routine control of a sterilization process for medical
devices |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ANSI/AAMI/ISO 11737-
1:2018 | Sterilization of health care products — Microbiological methods — Part 1:
Determination of a population of microorganisms on products |
| ANSI/AAMI/ISO 11737-2
2019 | Sterilization of medical devices — Microbiological methods — Part 2: Tests of
sterility performed in the definition, validation and maintenance of a sterilization
process |
| AAMI/ANSI ES 60601-
1:2005/2012 | Medical Electrical Equipment - Part 1 General Requirements for Basic Safety and
Essential Performance |
| IEC 60601-1-2:2020 | Medical Electrical Equipment - Part 1-2: General Requirements for Basic Satety and
Essential Performance - Collateral Standard: Electromagnetic Compatibility -
Requirements and Tests |
| IEC 60601-2-2:2017
Edition 6.0 | Medical electrical equipment - Part 2-2: Particular requirements for the basic safety
and essential performance of high frequency surgical equipment and high frequency
surgical accessories |
| IEC 60601-1-
6:2010+AMD1:2013 | Medical electrical equipment - Part 1-6: General requirements for basic safety and
essential performance - Collateral standard: Usability |
| IEC 62304 Ed 1.1 2015-06,
Consol. version | Medical device software - Software life cycle processes |
Conclusion:
The Canady Helios Cold Plasma™ XL-1000CP™ Ablation System has the same intended use and the same or similar technological characteristics as the predicate device. Testing to recognized consensus standards and internal performance testing has demonstrated the device is as safe and effective for requested intended use, as the predicate device. The minor technological differences compared to the predicate do not raise different types of questions of safety and effectiveness. Therefore, the Canady Helios Cold Plasma™ XL-1000CP™ Ablation System is substantially equivalent to the predicate device.