(94 days)
Not Found
No
The summary describes a standard microwave ablation generator with software control for energy delivery and temperature monitoring. There is no mention of AI/ML in the device description, intended use, or performance studies.
Yes
The device is clearly indicated for the "coagulation (ablation) of soft tissue" and is used for "soft tissue ablation therapy" to treat conditions by inducing "tissue necrosis," which are all therapeutic actions.
No
Explanation: The device is described as a Microwave Ablation Generator intended for the "coagulation (ablation) of soft tissue" and to "produce tissue-heating effects" for treatment. While it monitors temperature, this is part of the therapeutic process to achieve necrosis and protect surrounding tissues, not to diagnose a condition. The "Coagulated zones are monitored during treatment using appropriate imaging techniques," but these imaging techniques are separate from the device itself and are used to observe the effects of the treatment.
No
The device description explicitly lists hardware components such as "microwave source, pump, foot pedal etc." and mentions delivering energy through "Microwave Ablation Antennas" and "Microwave Ablation Cable". While it is software-controlled, it is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The description clearly states that the Microwave Ablation Generator is used for the coagulation (ablation) of soft tissue within the body. It delivers microwave energy directly to the target tissue to cause necrosis. This is an in vivo procedure.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is to deliver energy for therapeutic purposes.
Therefore, based on the provided information, the Microwave Ablation Generator is a therapeutic device used for soft tissue ablation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Microwave Ablation Generator is indicated for the coagulation (ablation) of soft tissue. The device is not intended for cardiac use.
Product codes (comma separated list FDA assigned to the subject device)
NEY
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 Generator consists of microwave source, pump, foot pedal etc. It is a software-controlled microwave generator that delivers the microwave energy at a working frequency of 2450 MHz and can meet various clinical needs of soft tissue ablation therapy. Microwave Ablation Generator delivers microwave energy to Microwave Ablation Antennas into the target tissue through Microwave Ablation Cable(sterile or non-sterile cable). When reaching the target temperature, the soft tissue will be damaged, leading to irreversible necrosis. The Microwave Ablation Temperature Probe is applied to monitor the temperature of the target location and to protect important organs and tissues in the periphery of the lesion from unexpected damage by microwave energy. Coagulated zones are monitored during treatment using appropriate imaging techniques.
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
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)
Non-clinical performance data is provided in support of the substantial equivalence determination:
- Electrical Safety as per IEC 60601-1
- Electromagnetic Compatibility as per IEC 60601-1-2
- Specific Performance as per IEC 60601-2-6
- Software validation as per IEC 62304 and FDA Guidance: Content of Premarket Submissions for Device Software Functions.
- Thermal Effects Test and Temperature Monitoring Test
FDA Guidance: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery
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 and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 26, 2024
Canyon Medical Inc. Huigi Jiang RA Manager Building 3, Phase 2 Accelerator, No. 11 Yaogu Avenue Jiangbei New Area Nanjing, Jiangsu Province 210032 China
Re: K241827
Trade/Device Name: Microwave Ablation Generator (KY-2000A, KY-2100A) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: NEY Dated: August 29, 2024 Received: August 30, 2024
Dear Huiqi 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.
1
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" (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 QS 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-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 medical devices and radiation-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-regulatory
2
assistance/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,
Long H. Chen -- S Digitally signed by Long H. Chen-S
Date: 2024.09.26 Date: 2024.09.26 15:18:55 -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) K241827
Device Name
Microwave Ablation Generator (KY-2000A, KY-2100A)
Indications for Use (Describe)
Microwave Ablation Generator is indicated for the coagulation (ablation) of soft tissue. The device is not intended for cardiac use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image contains a logo for Canyon, which is a blue and yellow design. Next to the logo is the text "510(k) Summary". The text is in a simple, sans-serif font and is aligned to the right of the logo. The image is likely a document header or title page for a medical device submission.
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 25, 2024
4. Subject Device(s) Information
| Common Name: | Microwave Ablation Generator | ||
|---|---|---|---|
| Trade Name: | Microwave Ablation Generator (KY-2000A, KY-2100A) | ||
| Review Panel: | General & Plastic Surgery | ||
| Regulation Number: | 21 CFR 878.4400 | ||
| Regulation Description: | Electrosurgical cutting and coagulation device and | ||
| accessories | |||
| Classification Name: | System, Ablation, Microwave and Accessories | ||
| Device Class: | II | ||
| Product Code: | NEY |
5. Predicate Device(s) Information
| Manufacturer: | Nanjing ECO Microwave System Co., Ltd. |
|---|---|
| 510(K) Number: | K201262 |
| Trade Name: | Microwave Therapeutic System |
| Review Panel: | General & Plastic Surgery |
| Regulation Number: | 21 CFR 878.4400 |
| Regulation Description: | Electrosurgical cutting and coagulation device and |
| accessories | |
| Classification Name: | System, Ablation, Microwave and Accessories |
| Device Class: | II |
| Product Code: | NEY |
5
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 Generator consists of microwave source, pump, foot pedal etc. It is a software-controlled microwave generator that delivers the microwave energy at a working frequency of 2450 MHz and can meet various clinical needs of soft tissue ablation therapy. Microwave Ablation Generator delivers microwave energy to Microwave Ablation Antennas into the target tissue through Microwave Ablation Cable(sterile or non-sterile cable). When reaching the target temperature, the soft tissue will be damaged, leading to irreversible necrosis. The Microwave Ablation Temperature Probe is applied to monitor the temperature of the target location and to protect important organs and tissues in the periphery of the lesion from unexpected damage by microwave energy. Coagulated zones are monitored during treatment using appropriate imaging techniques.
7. Indications for Use
Microwave Ablation Generator is indicated for the coagulation (ablation) of soft tissue.
The 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:
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Image /page/6/Picture/0 description: The image shows the Canyon logo on the left and the text "510(k) Summary" on the right. The Canyon logo is a stylized heart shape with the word "CANYON" below it. The text "510(k) Summary" is in a simple, sans-serif font. A horizontal line is present below the text.
| ltem | Subject Device - K241827 | Predicate Device - K201262 | |
|---|---|---|---|
| Device | Microwave Ablation Generator | ||
| Model: KY-2000A | Microwave Ablation Generator | ||
| Model: KY-2100A | Microwave Therapeutic System | ||
| Model: SABERWAVE ECO-200G | |||
| Classification | Class II | Class II | Class II |
| Product Code | NEY | NEY | NEY |
| Regulation Number | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 |
| Indications for Use | Microwave Ablation Generator is | ||
| indicated for the coagulation | |||
| (ablation) of soft tissue. The device | |||
| is not intended for cardiac use. | Microwave Ablation Generator is | ||
| indicated for the coagulation | |||
| (ablation) of soft tissue. The device is | |||
| not intended for cardiac use. | The Microwave Therapeutic System is | ||
| indicated for the coagulation (ablation) | |||
| of soft tissue. The Microwave | |||
| Therapeutic System is not intended for | |||
| cardiac use. | |||
| Operating Principle | Microwave Ablation Generator with | ||
| frequency of 2450MHz delivers | |||
| microwave energy to Microwave | |||
| Ablation Antennas into the target | |||
| tissue through Microwave Ablation | |||
| Cable(sterile or non-sterile cable). | |||
| When reaching the target | |||
| temperature, the soft tissue will be | |||
| damaged, leading to irreversible | |||
| necrosis. | Microwave Ablation Generator with | ||
| frequency of 2450MHz delivers | |||
| microwave energy to Microwave | |||
| Ablation Antennas into the target | |||
| tissue through Microwave Ablation | |||
| Cable(sterile or non-sterile cable). | |||
| When reaching the target | |||
| temperature, the soft tissue will be | |||
| damaged, leading to irreversible | |||
| necrosis. | Microwave oscillating signals are | ||
| qenerated by a microwave transistor | |||
| and amplified by a microwave power | |||
| amplifier. Generator delivers | |||
| microwave energy to the applicator tip | |||
| to thermally target tissue, resulting in | |||
| coagulation and ablation. | |||
| A microwave therapeutic system refers | |||
| to equipment for treating diseases with | |||
| microwave energy at a working | |||
| frequency of 2450 MHz. | |||
| The liquid in the silicone tube is driven | |||
| by the rotation of the motor to flow | |||
| through the radiator to realize the | |||
| purpose of radiator cooling. | |||
| AC input Voltage | AC100-240V, 50/60Hz | AC100-240V, 50/60Hz | AC100-240V, 50/60Hz |
| Frequency | 2450MHz | 2450MHz | 2450MHz |
| Item | Subject Device - K241827 | Predicate Device - K201262 | |
| Device | Microwave Ablation Generator | ||
| Model: KY-2000A | Microwave Ablation Generator | ||
| Model: KY-2100A | Microwave Therapeutic System | ||
| Model: SABERWAVE ECO-200G | |||
| Output Impedance | 50Ω | 50Ω | 50Ω |
| Output power | |||
| parameter | Up to 100W | Up to 150W | Up to 100W |
| Device | |||
| Temperature | |||
| Monitoring | Temperature monitoring features | ||
| used to ensure safety | Temperature monitoring features | ||
| used to ensure safety | Temperature monitoring features used | ||
| to ensure safety | |||
| Device Cooling | Pumped, coolant is used to cool the | ||
| antenna. | Pumped, coolant is used to cool the | ||
| antenna. | Pumped, normal saline is used to cool | ||
| the antenna. | |||
| Operational Mode | Three modes: continuous mode, | ||
| pulse mode, foot pedal mode | Three modes: continuous mode, | ||
| pulse mode, foot pedal mode | Three modes: continuous mode, pulse | ||
| mode, foot pedal mode | |||
| Electricity safety | Meet requirements of IEC 60601-1 | Meet requirements of IEC 60601-1 | Meet requirements of IEC 60601-1 |
| Electromagnetic | |||
| compatibility | Meet requirements of IEC 60601-1-2 | Meet requirements of IEC 60601-1-2 | Meet requirements of IEC 60601-1-2 |
| Software | Embedded software which meets | ||
| requirements of IEC 62304 | Embedded software which meets | ||
| requirements of IEC 62304 | Embedded software which meets | ||
| requirements of IEC 62304 | |||
| Particular | |||
| requirement for | |||
| microwave therapy | |||
| safety | Meet requirements of IEC 60601-2-6 | Meet requirements of IEC 60601-2-6 | Meet requirements of IEC 60601-2-6 |
7
Image /page/7/Picture/0 description: The image shows the Canyon logo on the left and the text "510(k) Summary" on the right. The Canyon logo is a stylized heart shape with the word "CANYON" below it. The text "510(k) Summary" is in a larger font size than the word "CANYON". A horizontal line is present below the text.
8
Image /page/8/Picture/0 description: The image shows the Canyon logo on the left and the text "510(k) Summary" on the right. The Canyon logo is a stylized heart shape with the word "CANYON" below it. The heart shape is made up of two interlocking curves, one blue and one yellow. The text "510(k) Summary" is in a simple, sans-serif font. The image is clean and professional, and the text is easy to read.
The technological characteristics of the subject device are identical to those of predicate devices. The subject devices have the same basic design as the predicate device. The comparison between the subject and predicate devices is based on the following:
- Same indications for use
- Same fundamental technology
There is no significant risk raised by the difference.
9. Non-Clinical Test Summary
Non-clinical performance data is provided in support of the substantial equivalence determination:
- Electrical Safety as per IEC 60601-1
-
- Electromagnetic Compatibility as per IEC 60601-1-2
-
Specific Performance as per IEC 60601-2-6
-
Software validation as per IEC 62304 and FDA Guidance: Content of
Premarket Submissions for Device Software Functions.
- Thermal Effects Test and Temperature Monitoring Test
FDA Guidance: Premarket Notification (510(k)) Submissions for Electrosurgical
Devices for General Surgery
10. Conclusion
The conclusions drawn from the comparison, analysis, and 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.