(424 days)
No
The description focuses on standard medical device components and functions (microwave generation, control system, display, temperature measurement) and does not mention any AI/ML-specific terms or capabilities. The performance studies listed are standard device validations, not AI/ML model performance evaluations.
Yes
The device is explicitly named "Microwave Therapeutic System" and its intended use is for coagulation (ablation) of soft tissue, which is a therapeutic intervention.
No
The device is described as a "Microwave Therapeutic System" used for the "coagulation (ablation) of soft tissue." Its purpose is therapeutic (ablation), not diagnostic.
No
The device description explicitly lists multiple hardware components including a microwave source, control system, display system, temperature measurement system, casing, power module, microwave transmitting module, and water circulation module. It is described as a "software-controlled microwave generator," indicating software is a component of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "coagulation (ablation) of soft tissue." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a "Microwave Therapeutic System" that delivers microwave energy for ablation. This is a treatment device, not a device used to examine specimens from the body to diagnose or monitor a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device performs a therapeutic action directly on the patient.
N/A
Intended Use / Indications for Use
The Microwave Therapeutic System is indicated for the coagulation (ablation) of soft tissue. Therapeutic System is not intended for cardiac use.
Product codes
NEY
Device Description
The Microwave Therapeutic System is a host machine will be used together with Disposable Microwave Ablation Needle for ablation of soft tissue. The Microwave Therapeutic System consists of microwave source, control system, display system and temperature measurement system. It is a software-controlled microwave generator that deliver the microwave energy at a working frequency of 2450 MHz.
The generator of the microwave therapeutic system is composed of a casinq, a power module, a control feedback unit, a display module, a microwave transmitting module, a water circulation module, and a temperature measurement module.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Clinical test:
Clinical testing is not required.
Non-clinical data:
Microwave Therapeutic System and predicate device are substantially equivalent in design concepts, technologies, which have been designed and tested in accordance with:
Electrical Safety:
- ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
Electromagnetic Compatibility:
- IEC 60601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances --Requirements and tests
Performance:
- IEC 60601-2-6 Medical electrical equipment Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment
Software validation:
- Software validation is in compliance with FDA guidance for the content of premarket submissions for software contained in Medical devices.
Shelf Life:
- Accelerated aging tests were conducted to confirm the validity of the 8 years shelf life for l machine.
Thermal Effects test and Temperature monitoring test:
- FDA Guidance Premarket Notification (510(K)) Submissions for Electrosurgical Devices for -General Surgery
The test results prove that single needle ablation can also achieve the intended use, the performance meet the requirements of IEC 60601-2-6, the temperature measurement accuracy meet the requirements of intended use, the difference does not affect the product's safety and performance.
The software verification according to the FDA software quidance, the test result proves the functions in each operational mode can be achieved. This difference does not raise a new risk.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 9, 2021
Nanjing ECO Microwave System Co., Ltd Hong Wei. RA Manager Third & Fourth Floors, J5 Building, No. 15 Wanshou Road, Pukou District Nanjing, Jiangsu 211800 China
Re: K201262
Trade/Device Name: Microwave Therapeutic System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: NEY Dated: July 1, 2021 Received: July 6, 2021
Dear Hong Wei:
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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/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
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 53 1 -542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 Long H. Chen
Long H. Chen -S-s
Date: 2021.07.09 08:54:29 -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
2
Indications for Use
510(k) Number (if known) K201262
Device Name Microwave Therapeutic System
Indications for Use (Describe)
The Microwave Therapeutic System is indicated for the coagulation (ablation) of soft tissue. Therapeutic System 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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3
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: July 8, 2021
1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | Nanjing ECO Microwave System Co., Ltd. | ||
|---|---|---|---|
| Address: | Third & Fourth Floors, J5 Building, NJUT Science & Technology | ||
| Industrial Park, No.15 Wanshou Road, Pukou District, 211800, | |||
| Nanjing, Jiangsu, P.R.China. | |||
| Contact person: | Hong Wei | ||
| Title: | RA | ||
| E-mail: | weihong@njeco.com.cn | ||
| Tel: | +86-025-58872663 Ext: 8020 |
2. Device Identification
| Trade/Device Name: | Microwave Therapeutic System |
|---|---|
| Models: | SABERWAVE ECO-200G |
| Regulation Number: | 21 CFR 878.4400 |
| Device Common | |
| Name: | Microwave ablation system and accessories |
| Regulation Name: | Electrosurgical cutting and coagulation device and |
| accessories | |
| Regulation Class: | Class II |
| Product Code: | NEY |
3. Predicate Device
| Predicate device: | |
|---|---|
| 510(K) number: | K183153 |
| Device Common | |
| Name: | Microwave ablation system and accessories |
| Device Trade | |
| /Proprietary Name: | Microwave Ablation System |
| Model: | M150E |
| Manufacturer: | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. |
| Regulation Number: | 21 CFR 878.4400 |
| Regulation Name: | Electrosurgical cutting and coagulation device and accessories |
| Regulation Class: | Class II |
| Product Code: | NEY |
4
| Reference device: | |
|---|---|
| 510(K) number: | K133821 |
| Device Name: | Emprint™ Ablation System |
| Manufacturer: | Covidien LLC |
| Regulation Number: | 21 CFR 878.4400 |
| Regulation Name: | Electrosurgical cutting and coagulation device and accessories |
| Regulation Class: | Class II |
| Product Code: | NEY |
4. Device Description
The Microwave Therapeutic System is a host machine will be used together with Disposable Microwave Ablation Needle for ablation of soft tissue. The Microwave Therapeutic System consists of microwave source, control system, display system and temperature measurement system. It is a software-controlled microwave generator that deliver the microwave energy at a working frequency of 2450 MHz.
The generator of the microwave therapeutic system is composed of a casinq, a power module, a control feedback unit, a display module, a microwave transmitting module, a water circulation module, and a temperature measurement module.
5. Indication for use
The Microwave Therapeutic System is indicated for the coagulation (ablation) of soft tissue. The Microwave Therapeutic System is not intended for cardiac use.
6. Comparison to Predicate Device
Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following table.
| Feature | Subject device
K201262 | Predicate device
K183153 | Comments |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/K# | Nanjing ECO
Microwave System Co.,
Ltd. | Surgnova Healthcare
Technologies (Zhejiang)
Co., Ltd. | -- |
| Trade name | Microwave Therapeutic
System
Model: SABERWAVE
ECO-200G | Microwave ablation
system
Model: M150E | -- |
| Classification name and
Regulation Name | Electrosurgical cutting
and coagulation device
and accessories
Class : II
Product code : NEY | Electrosurgical cutting
and coagulation device
and accessories
Class : II
Product code : NEY | Same |
| Indications for use | The
Microwave
Therapeutic System is
indicated for the
coagulation (ablation) of
soft tissue. The
Microwave Therapeutic
System is not intended
for cardiac use. | The Microwave Ablation
System is intended for
the coagulation
(ablation) of soft tissues.
The MW Ablation
System is not intended
for use in cardiac
procedures. | The microwave
generator instrument
and antenna of the
predicate device are
combined to submit
510k together, the
microwave generator
instrument and antenna
of subject device are
submitted 510k
separately. The intended
use description is the
same. |
| Intended purpose | coagulation and ablation
of tissue | coagulation and ablation
of tissue | Same |
| Operating principle | Microwave oscillating
signals are generated
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. | During the surgery, the
microwave ablation
antenna is accurately
placed in the tumor
target area by imaging
techniques (such as CT,
US, etc.). The
microwave energy
generated by the
microwave generator
transmits to the
microwave ablation
antenna through the
coaxial cable, and then
it is radiated out through
the microwave
antenna and absorbed
by water molecules in
the tumor tissue. The
microwave energy
transform into heat, and
the temperature
rises rapidly result in
tumor tissue losing
bioactivity. | Equivalent.
The microwave
generator instrument
and antenna of the
predicate device are
combined to submit
510k together, the
subject device only
include generator
instrument, the principle
of generator instrument
is equivalent. |
| Design | Single channel | Double channels | Different, please refer to
comment 1. |
| | cooling-water cycle,
thermal ablation,
the probe of TEMP, foot
switch | cooling-water cycle,
thermal ablation,
the probe of TEMP, foot
switch | Same |
| | AC input Voltage | AC100-240V, 50/60Hz | 100-240VAC 50-60 Hz |
| Output Impedance | 50Ω nominal | 50Ω nominal | Same |
| Output parameters | 2450MHz±20MHz, | 2450MHz±10MHz, | Same |
| | 0-100W | 0-100W | |
| Device
Temperature
Monitoring | Temperature monitoring
features used to ensure
system safety | Temperature monitoring
features used to ensure
system safety | Same |
| Device cooling | Pumped, normal saline
is used to cool the
antenna. | Pumped, normal saline
is used to cool the
antenna. | Same |
| Operational mode | Three modes can be
selected by the user. | Only one operational
mode | Different, please refer to
comment 2. |
5
6
Comment 1: Different, predicate device support double channels and two ablation needles can be inserted at the same time for tissue ablation. Our product only supports single channel and only one ablation needle for tissue ablation, Double-needle ablation speeds up the time of a single ablation, but there are injury and risks due to multiple punctures to patient. Single-needle ablation can also achieve the intended use and reduce the injury and risk of multiple punctures to the patient. The subject device has performed the Thermal effects test, performance test according to IEC 60601-2-6, temperature measurement accuracy test, the test result prove that single needle ablation can also achieve the intended use, the performance meet the requirements of IEC 60601-2-6, the temperature measurement accuracy meet the requirements of intended use, the difference does not affect the product's safety and performance.
Comment 2: Different, predicate devices have only a single operation mode. We have designed three modes according to the expected usage scenarios, which are convenient for users to operate according to different tissue types and sizes. The main difference between these three modes is that timing method is countdown or forward timing, foot switch control or manual control, output is continuous or intermittent, these are just to give users more operating options, and do not change the intended use and function of the product, the subject device has been conducted software verification according to the FDA software quidance, the test result proves the functions in each operational mode can be achieved. This difference does not raise a new risk.
All the differences don't affect the safety and effectiveness which is concluded after all the required testing, so no safety and effectiveness issues relating to the system come into conclusion.
7. Performance Data
Clinical test:
Clinical testing is not required.
Non-clinical data
Microwave Therapeutic System and predicate device are substantially equivalent in design concepts, technologies, which have been designed and tested in accordance with:
Electrical Safety:
-
-ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
Electromagnetic Compatibility: -
-IEC 60601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances --Requirements and tests
Performance:
7
510(k) Summary
- IEC 60601-2-6 Medical electrical equipment Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment
Software validation:
- Software validation is in compliance with FDA guidance for the content of premarket submissions for software contained in Medical devices.
Shelf Life:
-
Accelerated aging tests were conducted to confirm the validity of the 8 years shelf life for l machine.
Thermal Effects test and Temperature monitoring test: -
FDA Guidance Premarket Notification (510(K)) Submissions for Electrosurgical Devices for -General Surgery
8. Conclusion
The proposed device is equivalent with respect to the basic system design and function to that of the predicate device. The proposed device isn't the implants and high-risk device. And it doesn't have new intended purposes, new medical, new target populations, and new users and so on. What's more. The differences between the predicate and proposed device do not raise new questions of safety or effectiveness.