(88 days)
Microwave Ablation Antennas, in conjunction with the compatible Microwave Ablation Generator, is intended for coagulation (ablation) of soft tissue. This device is not intended for cardiac use.
Microwave ablation is a kind of thermal ablation technology used in the treatment of soft tissue, utilizing electromagnetic waves in the microwave energy spectrum (300 MHz to 300 GHz) to produce tissue-heating effects. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis. Microwave Ablation Antennas generally consist of the Microwave Ablation Antennas, Microwave Ablation Cable. This device is single-use and sterilized by EO. During ablation, Microwave Ablation Antennas will be punctured into the target tissue of the patients. In order to achieve the intended use, Microwave Ablation Antennas shall be connected with Microwave Ablation Generator which deliver microwave energy to Microwave Ablation Antennas through Microwave Ablation Cable (sterile or non-sterile cable). When reaching the target temperature, the soft tissue will be damaged leading to irreversible necrosis. Coagulated zones are monitored during treatment using appropriate monitoring techniques.
The provided text is a 510(k) summary for the Canyon Medical Inc. Microwave Ablation Antennas (K241825). This document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, rather than presenting a clinical study to prove device performance against specific acceptance criteria in a human clinical trial setting.
Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in this type of regulatory submission. These details are typically found in clinical study reports.
However, based on the non-clinical test summary, we can infer some "acceptance criteria" related to the device's engineering performance and safety.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria for clinical performance and corresponding device performance data from a clinical study. Instead, it lists non-clinical tests and states that the "results from testing performed confirm the design requirements." This implies that the device met the acceptance criteria for each listed non-clinical test.
| Aspect | Acceptance Criteria (Implied from tests) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 standards for medical electrical equipment. | "Results from testing performed confirm the design requirements." (i.e., Met criteria) |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 standards for EMC of medical electrical equipment. | "Results from testing performed confirm the design requirements." (i.e., Met criteria) |
| Specific Performance | Compliance with IEC 60601-2-6 standards specific to Microwave Ablation Equipment. | "Results from testing performed confirm the design requirements." (i.e., Met criteria) |
| Thermal Effects & Temp. Monitoring | Performance as per FDA Guidance: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery. (Implies achieving expected thermal ablation zones and accurate temperature monitoring). | "Results from testing performed confirm the design requirements." (i.e., Met criteria) |
| Biocompatibility | Compliance with ISO 10993 series standards for biological evaluation of medical devices (for an externally communicating device with tissue for limited duration < 24h). | "Relevant tests are conducted as per ISO 10993 series standards." and "meet ISO 10993 biocompatibility requirements." (i.e., Met criteria) |
| Package Validation | Maintenance of sterility and integrity per ISO 11607-1 and ISO 11607-2. | "The integrity performance as per ISO 11607-1 and ISO 11607-2 is carried out." (Implies Met criteria, as no issues are reported). |
| Transport | Packaging integrity maintained after compression, vibration, and shock tests. | "The result indicates that packaging is not damaged." (i.e., Met criteria) |
| Shelf Life | Device functionality and safety maintained after accelerated aging equivalent to 3 years. | "The test results demonstrate that the aged samples complied with the pre-determined acceptance criteria." (i.e., Met criteria) |
| EO/ECH Residual | Compliance with allowable limits for Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) residuals as per ISO 10993-7. | "The results meet the requirements." (i.e., Met criteria) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of a clinical test set. The reported tests are non-clinical (laboratory/bench testing). The sample sizes for these non-clinical tests (e.g., number of antennas tested for electrical safety) are not specified in this summary.
- Data Provenance: The listed tests are non-clinical, conducted by the manufacturer (Canyon Medical Inc.) or authorized testing facilities, likely in the People's Republic of China, where the company is based. The data is thus internal, prospective non-clinical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a non-clinical submission. Ground truth, in a clinical sense (e.g., disease presence), is not established for this type of testing. The "ground truth" for non-clinical tests is adherence to established engineering and safety standards.
4. Adjudication Method for the Test Set
Not applicable. This is a non-clinical submission, not involving human readers or clinical endpoints requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This submission is for a medical device (Microwave Ablation Antennas), not an AI/software device intended for diagnostic interpretation or to assist human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This submission is for a medical device (Microwave Ablation Antennas), not an AI/software device.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is typically defined by:
- Compliance with recognized consensus standards: (e.g., IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility).
- Pre-determined design specifications and requirements: The device's performance is measured against its own established engineering specifications (e.g., for power delivery, temperature profile, mechanical integrity).
8. The Sample Size for the Training Set
Not applicable. This is a medical device, not a machine learning or AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is a medical device, not an AI algorithm.
{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" followed by the words "U.S. Food & Drug Administration".
September 20, 2024
Canyon Medical Inc. Huiqi Jiang RA Manager Building 3, Phase 2 Accelerator, No. 11 Yaogu Avenue, Jiangbei New Area Nanjing, Jiangsu 210032 China
Re: K241825
Trade/Device Name: Microwave Ablation Antennas Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: NEY Dated: June 21, 2024 Received: June 24, 2024
Dear Huigi Jiang:
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
{2}------------------------------------------------
Sincerely,
Long H. Chen --S Digitally signed by Long H.Chen -S
Date: 2024.09.20 Date: 2024.09.20 06:10:53 -04'00'
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K241825
Device Name Microwave Ablation Antennas
Indications for Use (Describe)
Microwave Ablation Antennas, in conjunction with the compatible Microwave Ablation Generator, is intended for coagulation (ablation) of soft tissue.
This device is not intended for cardiac use.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
510(k) Summary
510(k) Summary
1. 510(k) Owner
Canyon Medical Inc.
2. Submission Correspondent
Submitter Name: Canyon Medical Inc.
Address: Building 3, Phase 2 Accelerator, No. 11 Yaogu Avenue, Jiangbei New Area,
210032, Nanjing, Jiangsu Province, People's Republic of China
Official Correspondent: Ms. Huiqi Jiang
Position: RA Manager
E-mail: jhq@canyonmedical.com.cn
Telephone: +86-13241196637
3. Date of Preparation: September 19, 2024
4. Subject Device(s) Information
| Common Name: | Microwave Ablation Antennas |
|---|---|
| Trade Name: | Microwave Ablation Antennas |
| Regulation Number: | 21 CFR 878.4400 |
| Classification Name: | System, Ablation, Microwave and Accessories |
| Device Class: | II |
| Product Code: | NEY |
| Review Panel: | General & Plastic Surgery |
5. Predicate Device(s) Information
| Manufacturer: | Nanjing ECO Microwave System Co., Ltd. |
|---|---|
| 510(K) Number: | K201265 |
| Trade Name: | Disposable Microwave Therapeutic Antennas |
| Regulation Number: | 21 CFR 878.4400 |
| Classification Name: | System, Ablation, Microwave and Accessories |
| Device Class: | II |
| Product Code: | NEY |
| Review Panel: | General & Plastic Surgery |
{5}------------------------------------------------
510(k) Summary
6. Device Description
Microwave ablation is a kind of thermal ablation technology used in the treatment of soft tissue, utilizing electromagnetic waves in the microwave energy spectrum (300 MHz to 300 GHz) to produce tissue-heating effects. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis.
Microwave Ablation Antennas generally consist of the Microwave Ablation Antennas, Microwave Ablation Cable. This device is single-use and sterilized by EO.
During ablation, Microwave Ablation Antennas will be punctured into the target tissue of the patients. In order to achieve the intended use, Microwave Ablation Antennas shall be connected with Microwave Ablation Generator which deliver microwave energy to Microwave Ablation Antennas through Microwave Ablation Cable (sterile or non-sterile cable). When reaching the target temperature, the soft tissue will be damaged leading to irreversible necrosis. Coagulated zones are monitored during treatment using appropriate monitoring techniques.
7. Indications for Use
Microwave Ablation Antennas, in conjunction with the compatible Microwave Ablation Generator, is intended for coagulation (ablation) of soft tissue.
This device is not intended for cardiac use.
8. Summary and Comparison of Technological Characteristics
Equivalence comparison has been identified with following summary of technical characteristics:
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image contains a logo on the left and the text "510(k) Summary" on the right. The logo consists of a stylized, intertwined design in blue and yellow, with the word "CANYON" written below it in blue. The text "510(k) Summary" is positioned to the right of the logo, with a horizontal line underneath it.
| ltem | Subject Device-K241825 | Predicate Device-K201265 |
|---|---|---|
| Device | Microwave Ablation Antennas | Disposable Microwave TherapeuticAntennas |
| Classification | Class II | Class II |
| Product Code | NEY | NEY |
| RegulationNumber | 21 CFR 878.4400 | 21 CFR 878.4400 |
| Indications forUse | Microwave Ablation Antennas, inconjunction with the compatibleMicrowave Ablation Generator, isintended for coagulation (ablation) ofsoft tissue. This device is not intendedfor cardiac use. | Disposable Microwave TherapeuticAntennas is used with the MicrowaveTherapeutic System, which isindicated for the coagulation (ablation)of soft tissue. The DisposableMicrowave Therapeutic Antennas isnot intended for cardiac use. |
| OperatingPrinciple | During the surgery, the MicrowaveAblation Antennas is accurately placedin the target area by imagingtechniques (such as CT, US, etc.).The microwave energy generated bythe microwave generator transmits tothe Microwave Ablation Antennasthrough Microwave Ablation Cable.When reaching the target temperature,the soft tissue will be damaged leadingto irreversible necrosis. Coagulatedzones are monitored during treatmentusing appropriate monitoringtechniques. | During the surgery, the microwaveablation antenna is accurately placedin the tumor target area by imagingtechniques (such as CT, US, etc.).The microwave energy generated bythe microwave generator transmits tothe microwave ablation antennathrough the coaxial cable, and then itis radiated out through the microwaveantenna and absorbed by watermolecules in the tumor tissue. Themicrowave energy transform into heat,and the temperature rises rapidlyresult in tumor tissue losing bioactivity. |
| Shaftlength(mm) | 70, 80, 100, 130, 150, 180, 200, 250,300, 1200mm | 100, 150, 200, 250, 1000,1200mm |
| Antennaouterdiameter(G) | 13G, 14G, 15G, 16G, 17G, 18G, 19G,20G | 8G, 11G, 14G, 15G, 16G, 17G, 18G |
| Antennaactivetip(mm) | 3, 5, 11, 25, 28mm | 3.5, 6, 8, 11, 12, 18mm |
| Max tolerablepower | Up to 150W | Up to 100W |
| Sterilizationmethod | EO gas | EO gas |
| Single Use | Yes | Yes |
| DeviceTemperatureMonitoring | Temperature monitoring features usedto ensure safety | Temperature monitoring features usedto ensure safety |
| Device Cooling | Pumped, coolant is used to cool theantenna. | Pumped, coolant is used to cool theantenna. |
| CANYON510(k) Summary | K241825 | Page 4 of 5 |
| Item | Subject Device-K241825 | Predicate Device-K201265 |
| Device | Microwave Ablation Antennas | Disposable Microwave TherapeuticAntennas |
| Patient-contactinginformation | Externally communicating device, incontact with the patient for a limitedduration (no more than 24 hours) | Externally communicating device, incontact with the patient for a limitedduration (no more than 24 hours) |
| Biocompatibility | Biocompatible according to ISO 10993 | Biocompatible according to ISO 10993 |
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image contains a logo with the word "CANYON" in blue, stylized with a design that resembles two interlocking letter C's. Above the word "CANYON" is a yellow shape that mirrors the design of the blue letters. The logo is positioned to the left of the number "510".
Biocompatibility
The technological characteristics of the subject device are similar to those of predicate device. The subject device has the same basic design as the predicate device. The comparison between the subject and predicate devices is based on the following:
applicable parts
- Same indications for use
- Same technological characteristics
- Same material types that meet ISO 10993 biocompatibility requirements
- · Same sterilization methods
- Same fundamental technology
There is no significant risk raised by the difference.
applicable parts
9. Non-Clinical Test Summary
Non-clinical performance data is performed to evaluate the performance and functionality of the subject device against requirement specification. The subject device has been subjected to compliance testing according to, by FDA, recognized consensus standards IEC 60601-1, IEC 60601-1-2, IEC 60601-2-6, ISO 10993 series standards, ISO 11607-1, ISO 11607-2, ASTM F 1980, and specific FDA guidance etc. Results from testing performed confirm the design requirements.
-
- Electrical Safety as per IEC 60601-1
-
- Electromagnetic Compatibility as per IEC 60601-1-2
-
- Specific Performance as per IEC 60601-2-6
-
- Thermal Effects Test and Temperature Monitoring Test:
{8}------------------------------------------------
510(k) Summary
K241825
FDA Guidance: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery
- Biocompatibility
The subject devices are externally communicating medical devices with tissue less than 24h which means limited duration. Relevant tests are conducted as per ISO 10993 series standards.
6) Package Validation
Primary package of the proposed device is intended to maintain the sterility of the product during its claimed shelf life. The integrity performance as per ISO 11607-1 and ISO 11607-2 is carried out.
- Transport
Subject devices are processed by compression, first vibration, shock and second vibration, and then check. The result indicates that packaging is not damaged.
- Shelf Life
Accelerated aging was used to simulate the storage of 3 years and the test results demonstrate that the aged samples complied with the pre-determined acceptance criteria.
- EO/ECH Residual
Examination of the EO and ECH residuals have been conducted in accordance with ISO 10993-7 to evaluate whether the sterilized proposed device comply with the above selected allowable limits, and the results meet the requirements.
10. Conclusion
The conclusions drawn from the comparison, analysis, nonclinical testing above demonstrate that the proposed subject devices raise no new questions of safety or effectiveness, and are as safe, as effective, and performs as well as the legally marketed predicate devices for proposed indications for use.
5
§ 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.