(438 days)
No
The description focuses on the physical components and function of a microwave therapeutic antenna for tissue ablation, with no mention of AI or ML for analysis, control, or other functions.
Yes
The device is described as a "Disposable Microwave Therapeutic Antennas" used with a "Microwave Therapeutic System" for the "coagulation (ablation) of soft tissue," which is a therapeutic intervention.
No
The device is described as therapeutic, used for coagulation (ablation) of soft tissue, not for diagnosis.
No
The device description clearly details physical components like needles, cables, handles, and cooling tubes, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "coagulation (ablation) of soft tissue" using thermal energy. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a "puncture needle with microwave energy transmission" inserted into the human body to ablate tissue. This describes a surgical or interventional device.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
This device is clearly designed for a therapeutic intervention within the human body, not for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
Disposable Microwave Therapeutic Antennas is used with the Microwave Therapeutic System, which is indicated for the coagulation (ablation) of soft tissue. The Disposable Microwave Therapeutic Antennas is not intended for cardiac use.
Product codes (comma separated list FDA assigned to the subject device)
NEY
Device Description
Disposable Microwave Therapeutic Antennas is a puncture needle with microwave energy transmission. It is inserted into the human body through puncture, and the tissue is ablated by the thermal energy transformed by the needle tip.
Disposable Microwave Therapeutic Antennas is composed of radiator, handle, microwave cable with/without cooling tubes. The microwave cable connect the microwave ablation system to transmit microwaves to the ablation needle (radiator), a handle is set at the connection between the microwave cable and the ablation needle to facilitate the operator. The radiator is composed of a needle tip, a needle shaft, a cooling tube, and a coaxial cable. The metal parts are connected by a welding process, and the non-metal parts are connected by qlue. The needle and needle shaft are made of medical stainless steel, and the shape of the needle is a trianqular pyramid tip or pyramid type tip, which is mainly used for percutaneous puncture and microwave radiation; the handle is made of ABS material, the cooling tube is made of stainless steel to cool the needle bar all the way, the thermocouple is arranged in the handle to effectively monitor the temperature of the ablation needle not to exceed 45 degrees.
Disposable Microwave Therapeutic Antennas is provided sterile, for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
imaging techniques (such as CT, US, etc.)
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)
Clinical test:
Clinical testing is not required.
Non-clinical data:
- 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
- Shelf Life: Accelerated aging tests were conducted to confirm the validity of the 2 years shelf life for -Disposable Microwave Therapeutic Antennas.
- Thermal Effects test: -FDA Guidance Premarket Notification (510(K)) Submissions for Electrosurgical Devices for General Surgery
- Package Verification: ISO 11607-1:2016 Packaging for terminally sterilized medical devices Part 1: -Requirements for materials, sterile barrier systems and packaging systems.
- Sterilization validation: ISO 11135-1: 2014 Sterilization of health care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices.
- Biocompatibility: The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility. The Biological Evaluation Tests are in compliance with the standards of ISO 10993, "Biological Evaluation of Medical Devices".
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.
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 contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
May 18, 2022
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: K201265
Trade/Device Name: Disposable Microwave Therapeutic Antennas Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NEY
Dear Hong Wei:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 23, 2021. Specifically, FDA is updating this SE Letter due to a typo in the IFU Statement as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Long Chen, Ph.D., OHT4: Office of Surgical and Infection Control Devices, 301-796-6389, long.chen@fda.hhs.gov.
Sincerely,
Digitally signed by Long H. Chen
Long H. Chen -S-s
Date: 2022.05.18 12:57:58 -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
1
Image /page/1/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 23, 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: K201265
Trade/Device Name: Disposable Microwave Therapeutic Antennas 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.
2
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-continung-education/cdrl-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: 2021.07.23 14:07:05 -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) K201265
Device Name Disposable Microwave Therapeutic Antennas
Indications for Use (Describe)
Disposable Microwave Therapeutic Antennas is used with the Microwave Therapeutic System, which is indicated for the coagulation (ablation) of soft tissue. The Disposable Microwave Therapeutic Antennas 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) | ☐ |
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4
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 Manager | ||
| E-mail: | weihong@njeco.com.cn | ||
| Tel: | +86- 025-58872663 Ext: 8020 |
2. Device Identification
| Trade/Device Name: | Disposable Microwave Therapeutic Antennas |
|---|---|
| Models: | ECO-100AI1, ECO-100CL28C, ECO-100CL27C, ECO- |
| 100CL22C, ECO-100CL5, ECO-100CL5C, ECO-100AL23C, | |
| ECO-100AL13C, ECO-100CL11C, ECO-100CL10, ECO- | |
| 100CL10C, ECO-100CL8, ECO-100CL8C, ECO-100AI26, ECO- | |
| 100AI3, ECO-100AI18C, ECO-100AI25, ECO-100AI30, ECO- | |
| 100CL29, ECO-100AL29, ECO-100CL31 | |
| Device Common | |
| Name: | Microwave ablation system and accessories |
| Regulation Number: | 21 CFR 878.4400 |
| 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 |
5
510(k) Summary
| Regulation Class: | Class II |
|---|---|
| Product Code: | NEY |
| Reference device: | |
| 510(K) number: | K133821 |
| Device Name: | EmprintTM 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
Disposable Microwave Therapeutic Antennas is a puncture needle with microwave energy transmission. It is inserted into the human body through puncture, and the tissue is ablated by the thermal energy transformed by the needle tip.
Disposable Microwave Therapeutic Antennas is composed of radiator, handle, microwave cable with/without cooling tubes. The microwave cable connect the microwave ablation system to transmit microwaves to the ablation needle (radiator), a handle is set at the connection between the microwave cable and the ablation needle to facilitate the operator. The radiator is composed of a needle tip, a needle shaft, a cooling tube, and a coaxial cable. The metal parts are connected by a welding process, and the non-metal parts are connected by qlue. The needle and needle shaft are made of medical stainless steel, and the shape of the needle is a trianqular pyramid tip or pyramid type tip, which is mainly used for percutaneous puncture and microwave radiation; the handle is made of ABS material, the cooling tube is made of stainless steel to cool the needle bar all the way, the thermocouple is arranged in the handle to effectively monitor the temperature of the ablation needle not to exceed 45 degrees.
Disposable Microwave Therapeutic Antennas is provided sterile, for single use.
5. Indication for use
Disposable Microwave Therapeutic Antennas is used with the Microwave Therapeutic System, which is indicated for the coaqulation (ablation) of soft tissue. The Disposable Microwave Therapeutic Antennas 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
K201265 | Predicate device
K183153 | Reference device
K133821 | Comments |
|--------------|----------------------------------------------|-------------------------------------------------------------|-----------------------------|----------|
| Manufacturer | Nanjing ECO
Microwave System
Co., Ltd. | Surgnova Healthcare
Technologies
(Zhejiang) Co., Ltd. | Covidien LLC | -- |
6
| Trade name | Disposable
Microwave
Therapeutic
Antennas | Microwave ablation
system
Model: M150E | Emprint™ Ablation
System | -- | | microwave
antenna and
absorbed by water
molecules in the
tumor tissue. The
microwave energy
transform into heat,
and the | microwave antenna
and
absorbed by water
molecules in the
tumor tissue. The
microwave energy
transform into heat,
and the temperature | microwave antenna
and absorbed by
water molecules in
the tumor tissue. The
microwave energy
transform into heat,
and the
temperature
rises | |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 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 | Electrosurgical
cutting and
coagulation device
and accessories
Class : II
Product code : NEY | Same | | temperature
rises rapidly result
in tumor tissue
losing bioactivity. | rises rapidly result in
tumor tissue losing
bioactivity. | rapidly result in
tumor tissue losing
bioactivity. | |
| Indications
for use | Disposable
Microwave
Therapeutic
Antennas is used
with the Microwave
Therapeutic
System, which is
indicated for the
coagulation
(ablation) of
soft tissue.
The
Disposable
Microwave
Therapeutic
Antennas 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 Emprint™
Ablation System is
intended for use in
percutaneous,
laparoscopic, and
intraoperative
coagulation
(ablation) of soft
tissue, including
partial or complete
ablation of non-
resectable liver
tumors.
The
EmprintTM 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. | AC input
Voltage | AC100-240V,
50/60Hz | 100-240VAC 50-60
Hz | 100-240VAC 50-60
Hz | Same |
| Intended
purpose | coagulation and
ablation of tissue | coagulation and
ablation of tissue | coagulation and
ablation of tissue | Same | Output
Impedance | 50Ω nominal | 50Ω nominal | 50Ω nominal | Same |
| Operating
principle | 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 | 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 | 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 | Same | Output
parameters | 2450MHz±20MHz,
0-100W | 2450MHz±10MHz,
0-100W | 2450MHz±50MHz,
0-100W | Equivalent |
| Applicator
Patient
Contacting
Materials | 1. Ceramics
2. SUS 304 with
double teflon
coating
3. US 304 with
single teflon
coating
4. Nylon
5.
Polytetrafluoroethyl
ene | 304SS, polyethlene
terephthalate,
ceramics | fiberglass, resin,
ceramics | Different, The main
structure of the
needle is composed
of 304SS stainless
steel and Ceramics.
It is the same as the
predicate device,
except that the
external insulator
and coating are
different, these
differences do not
affect the
performance of
product, but only
affect the
biocompatibility of
the material.
The material used in
the ablation needle
has been performed
biocompatibility test
according to the ISO
10993-1, the results
shows that the
material is
biocompatibility, the
difference of material
does not raise the
new safety and
effective risk. | | | | | |
| Applicators | ECO-100AI1:100 | SS-MWA-1526C: 150 | CA15L1: 150 | Different, The | | | | | |
7
8
| | ECO-100AI3:100
ECO-100AI18C:150
ECO-100CL8C:150
ECO-100CL8:150
ECO-100AL13C:150
ECO-100CL5C:150
ECO-100CL5:150
ECO-100CL27C:150
ECO-100CL28C:200
ECO-100CL22C:200
ECO-100AL23C:200
ECO-100CL10:200
ECO-100CL10C:200
ECO-100AI25:200
ECO-100CL11C:250
ECO-100CL29:1000
ECO-100AL29:1000
ECO-100CL31:1000
ECO-100AI30:1200 | SS-MWA-1531C: 150
SS-MWA-2026C: 200
SS-MWA-2031C: 200
SS-MWA-2526C: 250
SS-MWA-2531C: 250
(mm) | CA20L1: 200
CA30L1: 300 | length of the
proposed device is
different from that of
the predicate
device, but
this difference is
only reflected in the
depth of the position
of the tumor to be
ablated and does
not
affect the product's
safety
and
performance. |
|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicators
Outer
Diameter
(18G=1.3m
m
17G=1.4mm
16G=1.6mm
15G=1.8mm
14G=2.0mm
8G=3.2mm) | ECO-100AI1:17G
ECO-100AI26:18G
ECO-100AI3:16G
ECO-100AI18C:8G
ECO-100CL8C:14G
ECO-100CL8:14G
ECO-100AL13C:15G
ECO-100CL5C:16G
ECO-100CL5:16G
ECO-100CL27C:18G
ECO-100CL28C:18G
ECO-100CL22C:16G
ECO-100AL23C:15G
ECO-100CL10:14G
ECO-100CL10C:14G
ECO-100AI25:8G
ECO-100CL11C:14G
ECO-100CL29:14G
ECO-100AL29:14G
ECO-100CL31:11G
ECO-100AI30:14G | OD(mm):2.08 | OD(mm):2.4 | Different, According
to different human
tissues
and
Expected ablation
volume,
the
applicators diameter
range is wider than
that of predicate
devices. The only
effect of different OD
is that the trauma
caused by punctures
is smaller or bigger,
based on the
affecting the area of
the ablation, the
different applicator
length does not raise
new safety and
performance risks. |
| Emission
area length
(exposed
length) (mm) | ECO-100AI1:3.5
ECO-100AI26:3.5
ECO-100AI3:3.5
ECO-100AI18C:12
ECO-100CL8C:12
ECO-100CL8:11
ECO-100AL13C:18
ECO-100CL5C:12
ECO-100CL5:12
ECO-100CL27C:12
ECO-100CL28C:12
ECO-100CL22C:12
ECO-100AL23C:18
ECO-100CL10:11
ECO-100CL10C:12
ECO-100AI25:11
ECO-100CL11C:12
ECO-100CL29:6
ECO-100AL29:6 | SS-MWA-1526C: 26
SS-MWA-1531C: 31
SS-MWA-2026C: 26
SS-MWA-2031C: 31
SS-MWA-2526C: 26
SS-MWA-2531C: 31 | CA15L1: 28
CA20L1: 28
CA30L1: 28 | Different, The internal
design details
difference will affect the
microwave emission
area, resulting in a
different ablation range
and microwave
radiation area. Our
product has conduct
ablation studies of in
vitro tissues in
accordance with FDA
guidelines, and the
study results support
the intended use of our
products, it does not
raise new safety
issues. |
| | ECO-100CL31:6
ECO-100AI30:6 | | | |
| Max power
(W) | ECO-100AI1:30
ECO-100AI26:30
ECO-100AI3:40
ECO-100AI18C:100
ECO-100CL8C:80
ECO-100CL8:80
ECO-100AL13C:60
ECO-100CL5C:60
ECO-100CL5:50
ECO-100CL27C:50
ECO-100CL28C:50
ECO-100CL22C:60
ECO-100AL23C:60
ECO-100CL10:80
ECO-100CL10C:100
ECO-100AI25:100
ECO-100CL11C:100
ECO-100CL29:50
ECO-100AL29:50
ECO-100CL31:50
ECO-100AI30:60 | 100 | 100 | Different, the max
power of subject
devices was less
than or equal to the
predicate device's,
the difference of Max
power will affect the
microwave emission
area, resulting in a
different ablation range
and microwave
radiation area. Our
product has conduct
ablation studies of in
vitro tissues in
accordance with FDA
guidelines, and the
study results support
the intended use of our
products, it does not
raise new safety
issues. |
| Disposable
/Single use
Device | The antennas are
disposable and are
to be used within a
single patient
procedure only. | The antennas are
disposable and are to
be used within a
single patient
procedure only. | The antennas are
disposable and are
to be used within a
single patient
procedure only. | Same |
| Sterility | The accessories
are sterilized with
EO(SAL: 10-6) | The accessories are
sterilized with
EO(SAL: 10-6) | The accessories are
sterilized with
EO(SAL: 10-6) | Equivalent |
| Biocompatibi
lity | Patient-contacting
materials are
biocompatible. | Patient-contacting
materials are
biocompatible. | Patient-contacting
materials are
biocompatible. | Equivalent |
| Device
Temperature
Monitoring | Temperature
monitoring features
used to ensure
system safety | Temperature
monitoring features
used to ensure
system safety | Temperature
monitoring features
used to ensure
system safety | Equivalent |
| Device
cooling | Pumped, normal
saline is used to
cool the antenna. | Pumped, normal
saline is used to cool
the antenna. | Pumped, normal
saline is used to cool
the antenna. | Equivalent |
9
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
10
510(k) Summary
Disposable Microwave Therapeutic Antennas comply 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
Shelf Life: -
Accelerated aging tests were conducted to confirm the validity of the 2 years shelf life for -Disposable Microwave Therapeutic Antennas.
Thermal Effects test: -
-FDA Guidance Premarket Notification (510(K)) Submissions for Electrosurgical Devices for General Surgery
Package Verification: -
ISO 11607-1:2016 Packaging for terminally sterilized medical devices Part 1: -Requirements for materials, sterile barrier systems and packaging systems. Sterilization validation:
-
ISO 11135-1: 2014 Sterilization of health care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices. Biocompatibility:
- The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility. The Biological Evaluation Tests are in compliance with the standards of ISO 10993, "Biological Evaluation of Medical Devices".
8. SE Conclusion
The proposed device is equivalent with respect to the basic design and function to that of the predicate device. It doesn't have new intended purposed, new target populations, and new users. The differences between the predicate, reference device and proposed device do not raise new questions of safety or effectiveness. The proposed device is substantial equivalence to predicate device (K183153).