(242 days)
No
The description focuses on mechanical and electrical components, fluid delivery control based on user input (adjustable flow rate), and standard performance testing. There is no mention of AI, ML, or any learning or adaptive capabilities.
Yes
The device is used for dissection, elevation, irrigation, and preparation of tissue layers in combination with monopolar cutting and coagulation within the digestive tract, which directly involves medical treatment and intervention.
No
The device is described for dissection, elevation, irrigation, preparation, cutting, and coagulation of tissue, as well as fluid delivery for tissue elevation. These are all therapeutic or surgical functions, not diagnostic ones.
No
The device description clearly outlines physical hardware components for both the electrosurgical knife and the fluid pump system, including a cutting knife, tubes, handle, foot pedal, console, pump cartridge, and tubing set. While the fluid pump system includes software, the device as a whole is not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this device is used within the digestive tract for surgical procedures (dissection, elevation, irrigation, cutting, coagulation). It is acting directly on tissue within the body, not analyzing samples taken from the body.
- The device performs surgical functions. The core functions are cutting, coagulation, dissection, and tissue elevation through fluid injection. These are all surgical interventions, not diagnostic tests performed on samples.
- The device is used with endoscopes and electrosurgical units. These are tools used for direct visualization and surgical manipulation within the body.
The device is a surgical instrument used for therapeutic purposes within the body, not for diagnosing conditions by analyzing samples.
N/A
Intended Use / Indications for Use
Single Use Electrosurgical Knife:
These instruments have been designed to be used with endoscopes and electrosurgical for dissection, elevation, irrigation and preparation of tissue layers in combination with monopolar cutting and coagulation within the digestive tract.
Fluid Pump System:
The Fluid Pump System is a fluid delivery device that can inject fluid with adjustable flow rate and can be used with the Single Use Electrosurgical Knife for elevation of tissue layers by injection into the submucosa.
Product codes (comma separated list FDA assigned to the subject device)
GEI, FQH
Device Description
The proposed device Single Use Electrosurgical Knife with Fluid Pump System includes Single Use Electrosurgical Knife and Fluid Pump System.
The Single Use Electrosurgical Knife is a sterile, single-use endoscopic device, intended to be used with endoscopes and electrosurgical units for dissection, irrigation and preparation of tissue layers in combination with monopolar cutting and coagulation within the digestive tract. The Fluid Pump System is a fluid delivery device that can inject fluid with adjustable flow rate and can be used with the Single Use Electrosurgical Knife for elevation of tissue layers by injection into the submucosa. The Fluid Pump System is included as an accessory to the Single Use Electrosurgical Knife.
The Single Use Electrosurgical Knife is used with the Electrosurgical Unit (ESU), the ESU supplies high frequency (HF) energy through a retractable electrode of the Single Use Electrosurgical Knife for the cutting and coagulation of tissue. The Single Use Electrosurgical Knife consists of Cutting Knife, outer tube assembly, Middle Tube assembly and handle assembly. The Single Use Electrosurgical Knife is divided into I type, T type, O type and IT type according to the Cutting Knife. The Single Use Electrosurgical Knife has twenty-two (22) specifications; the main differences of these specifications are Cutting Knife Shape, Cutting Knife Length, and Effective Working Length and with injection function or without injection function.
Physicians would attach it to the ESU. For endoscopic procedures, the Single Use Electrosurgical Knife is placed down the channel of an endoscope that has a working channel equal to or greater than 2.8mm. Upon the setup of the ESU, the Single Use Electrosurgical Knife is ready for use. To activate cautery, the Cutting Knife is extended out and the ESU's footswitch is depressed. The subject devices with injection models can supply fluid into the submucosa to supply liquid, use a syringe or pump to connect with luer tap on the hand components.
The Fluid Pump System included in the proposed device is a fluid delivery device that can inject fluid with adjustable flow rate and can be used with the Single Use Electrosurgical Knife for elevation of tissue layers by injection into the submucosa.
The Fluid Pump System consists of a Foot Pedal, a Fluid Pump Console (with a Power Cord and a Control Button Cord), a Disposable Pump Cartridge, a Disposable Tubing Set, and a Disposable Control Button. The Disposable Pump Cartridge adopts the structure of a reciprocating pump, and the purpose of conveying sterile fluid is achieved through the piston's reciprocating movement. The Disposable Tubing Set is used to connect the Disposable Pump Cartridge's fluid outlet and Single Use Electrosurgical Knife's fluid injection port. The Fluid Pump Console provides a drive the Disposable Pump Cartridge to achieve reciprocating motion. The user can set the Effect value via the touch button on the touch screen or the physical knob. The Effect setting value range is 10 to 40, where Effect 10 corresponds to the minimum flow rate of 25mL/min, and Effect 40 corresponds to the maximum flow rate of 100mL/min. When Fluid Pump System used with Single Use Electrosurgical Knife, the recommended Effect is 10-30. The user can control the fluid delivery through the Foot Pedal or the Disposable Control Button, stepping on the Foot Pedal or pressing the Disposable Control Button to start fluid delivery, releasing the Foot Pedal or the Disposable Control Button, and immediately stop the fluid delivery.
The Single Use Electrosurgical Knife are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of one year.
The Disposable Pump Cartridge, Disposable Tubing Set and Disposable Control Button of Fluid Pump System are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of one year. The Foot Pedal and Fluid Pump Console of Fluid Pump System are non-sterile and reusable, the service life of the Foot Pedal and Fluid Pump Console are 8 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
digestive tract, submucosa
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)
The following bench tests were performed:
- Dimension
- Actuation Performance
- Compatible Performance
- Sealing Performance
- Flowing Performance
- Mucosa Lift Performance
- Cutting Performance
- Connected Force Performance
Shelf-life testing and packaging integrity testing was conducted based on an accelerated aging test in accordance with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices and ISO 11607-1:2019: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2:2019: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes. One year aging test was performed to demonstrate the stability and support the results of the accelerated aging test.
Sterilization validation was carried out in accordance with ISO 11135:2014+A1:2018 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices".
Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO-10993-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" issued on September 4, 2020.
Electromagnetic compatibility, electric safety had been confirmed according to the following standards: - IEC 60601-1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Software of Fluid Pump System had been confirmed according to FDA guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "IEC 62304:2015 Medical device software - Software life cycle processes".
Key results: The results of all the performance testing demonstrated that the proposed device met the predetermined acceptance criteria and is substantial equivalence to the predicate device Single Use Electrosurgical Knife (K193601).
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 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 text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
December 17, 2021
Micro-Tech (Nanjing) Co., Ltd. Sally He RA Engineer No.10 Gaoke Third Road, Nanjing National Hi-Tech Industrial Development Zone Nanjing, Jiangsu Province China
Re: K211172
Trade/Device Name: Single Use Electrosurgical Knife with Fluid Pump System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, FQH Dated: November 3, 2021 Received: November 8, 2021
Dear Sally He:
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
Page 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 531-542 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 (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,
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K211172
Device Name
Single Use Electrosurgical Knife with Fluid Pump System
Indications for Use (Describe)
Single Use Electrosurgical Knife:
Tyne of Use (Select one or hoth, as annlicable)
These instruments have been designed to be used with endoscopes and electrosurgical for dissection, elevation, irrigation and preparation of tissue layers in combination with monopolar cutting and coagulation within the digestive tract.
Fluid Pump System:
The Fluid Pump System is a fluid delivery device that can inject fluid with adjustable flow rate and can be used with the Single Use Electrosurgical Knife for elevation of tissue layers by injection into the submucosa.
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------- | --------------------------------------------------------------------------- |
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3
Image /page/3/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional block font. The letters are interconnected, with the "M" on the left and the "T" on the right. A registered trademark symbol (®) is positioned in the upper right corner of the logo. The logo has a clean and modern design.
510K Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K211172
1. Date of Preparation: 2021-10-28
2. Sponsor Identification
Micro-Tech (Nanjing) Co., Ltd.
No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone, Nanjing, Jiangsu Province, PRC
Establishment Registration Number: 3004837686
Contact Person: Sally He
Position: RA Engineer
Tel: +86-25-58646395
Fax: +86-25-58350006
Email: RA.Micro-Tech@outlook.com
3. Identification of Proposed Device
Product Name: Single Use Electrosurgical Knife with Fluid Pump System
Trade Name: Single Use Electrosurgical Knife, Fluid Pump System
Common Name: Electrosurgical Knife; Jet
Regulatory Information
Classification Name: Electrosurgical cutting and coagulation device and accessories, Jet lavage.
Classification: 2
Product Code: GEI and FQH
Regulation Number: 878.4400 and 880.5475
Review Panel: General & Plastic Surgery, General Hospital
4
Image /page/4/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are bold and appear to be interconnected, creating a sense of unity and strength. A registered trademark symbol is visible in the upper right corner of the logo.
4. Identification of Predicate Device/Reference Device
Predicate Device
510(k) Number: K193601
Product Name: Single Use Electrosurgical Knife
Manufacturer: Micro-Tech (Nanjing) Co., Ltd
Reference Device
510(k) Number: K143306
Product Name: ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe
Manufacturer: ERBE USA, Inc
ട്. Indications for Use
Single Use Electrosurgical Knife:
These instruments have been designed to be used with endoscopes and electrosurgical for dissection, elevation, irrigation and preparation of tissue layers in combination with monopolar cutting and coagulation within the digestive tract.
Fluid Pump System:
The Fluid Pump System is a fluid delivery device that can inject fluid with adjustable flow rate and can be used with the Single Use Electrosurgical Knife for elevation of tissue layers by injection into the submucosa.
6. Device Description
The proposed device Single Use Electrosurgical Knife with Fluid Pump System includes Single Use Electrosurgical Knife and Fluid Pump System
The Single Use Electrosurgical Knife is a sterile, single-use endoscopic device, intended to be used with endoscopes and electrosurgical units for dissection, irrigation and preparation of tissue layers in combination with monopolar cutting and coagulation within the digestive tract. The Fluid Pump System is a fluid delivery device that can inject fluid with adjustable flow rate and can be used
5
Image /page/5/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are interconnected and appear to be angled slightly, giving them a dynamic look. A registered trademark symbol is visible in the upper right corner of the logo.
with the Single Use Electrosurgical Knife for elevation of tissue layers by injection into the submucosa. The Fluid Pump System is included as an accessory to the Single Use Electrosurgical Knife.
The Single Use Electrosurgical Knife is used with the Electrosurgical Unit (ESU), the ESU supplies high frequency (HF) energy through a retractable electrode of the Single Use Electrosurgical Knife for the cutting and coagulation of tissue. The Single Use Electrosurgical Knife consists of Cutting Knife, outer tube assembly, Middle Tube assembly and handle assembly. The Single Use Electrosurgical Knife is divided into I type, T type, O type and IT type according to the Cutting Knife. The Single Use Electrosurgical Knife has twenty-two (22) specifications; the main differences of these specifications are Cutting Knife Shape, Cutting Knife Length, and Effective Working Length and with injection function or without injection function.
Physicians would attach it to the ESU. For endoscopic procedures, the Single Use Electrosurgical Knife is placed down the channel of an endoscope that has a working channel equal to or greater than 2.8mm. Upon the setup of the ESU, the Single Use Electrosurgical Knife is ready for use. To activate cautery, the Cutting Knife is extended out and the ESU's footswitch is depressed. The subject devices with injection models can supply fluid into the submucosa to supply liquid, use a syringe or pump to connect with luer tap on the hand components.
The Fluid Pump System included in the proposed device is a fluid delivery device that can inject fluid with adjustable flow rate and can be used with the Single Use Electrosurgical Knife for elevation of tissue layers by injection into the submucosa.
The Fluid Pump System consists of a Foot Pedal, a Fluid Pump Console (with a Power Cord and a Control Button Cord), a Disposable Pump Cartridge, a Disposable Tubing Set, and a Disposable Control Button. The Disposable Pump Cartridge adopts the structure of a reciprocating pump, and the purpose of conveying sterile fluid is achieved through the piston's reciprocating movement. The Disposable Tubing Set is used to connect the Disposable Pump Cartridge's fluid outlet and Single Use Electrosurgical Knife's fluid injection port. The Fluid Pump Console provides a drive the Disposable Pump Cartridge to achieve reciprocating motion. The user can set the Effect value via the touch button on the touch screen or the physical knob. The Effect setting value range is 10 to 40, where Effect 10 corresponds to the minimum flow rate of 25mL/min, and Effect 40 corresponds to the
6
Image /page/6/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be leaning slightly to the left, giving the logo a dynamic feel. A circled "R" trademark symbol is positioned in the upper right corner of the logo.
maximum flow rate of 100mL/min. When Fluid Pump System used with Single Use Electrosurgical Knife, the recommended Effect is 10-30. The user can control the fluid delivery through the Foot Pedal or the Disposable Control Button, stepping on the Foot Pedal or pressing the Disposable Control Button to start fluid delivery, releasing the Foot Pedal or the Disposable Control Button, and immediately stop the fluid delivery.
The Single Use Electrosurgical Knife are EO sterilized to achieve the Sterility Assurance Level (SAL) of 106 and placed in a sterility maintenance package to ensure a shelf life of one year.
The Disposable Pump Cartridge, Disposable Tubing Set and Disposable Control Button of Fluid Pump System are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of one year. The Foot Pedal and Fluid Pump Console of Fluid Pump System are non-sterile and reusable, the service life of the Foot Pedal and Fluid Pump Console are 8 years.
7. Comparison of Technological Characteristics
The proposed device Single Use Electrosurgical Knife with Fluid Pump System includes Single Use Electrosurgical Knife and Fluid Pump System. The Single Use Electrosurgical Knife is identical to the current Single Use Electrosurgical Knife cleared under K193601. Compared with the predicate device Single Use Electrosurgical Knife cleared under K193601, the only difference of the proposed device is the addition of Fluid Pump System, which is included as accessory of Single Use Electrosurgical Knife.
For the difference, we cited a reference device ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe (K143306) to compare with the new added accessory Fluid Pump System.
| Characteristics | Fluid Pump System | Reference Device
ERBEJET® 2 System with
HybridAPC Probe
(K143306) | Remark |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Indications for Use | The Fluid Pump System is a
fluid delivery device that can
inject fluid with adjustable flow
rate and can be used with the | The ERBEJET 2 is intended
for lifting mucosal lesions by
injection into the submucosa as well
as the cutting and dissection of soft | The intended use
of the proposed
device Fluid
Pump System is |
| | | Reference Device | |
| Characteristics | Fluid Pump System | ERBEJET® 2 System with
HybridAPC Probe
(K143306) | Remark |
| | Single Use Electrosurgical
Knife for elevation of tissue
layers by injection into the
submucosa. | tissue in neurosurgery and soft
tissue such as the liver, kidney, etc.
within the abdomen, including Total
Mesorectal Excision (TME) in open
as well as endoscopic surgery.
The HybridAPC probe is indicated
for the induction of sterile normal
saline into the submucosa to lift
mucosal lesions using direct
visualization through an endoscope
and for HF ablation of the mucosal
lesion by Argon Plasma Coagulation
(APC). | included in the
reference device
ERBEJET® 2
System. |
| Energy Delivered | Pressurized sterile saline for
submucosa lifting | Pressurized sterile saline for cutting,
dissecting and submucosa lifting | The energy
delivered is
included in
ERBEJET® 2
System. |
| Power Input | 100-240 V | 100-240 V | Same |
| Frequency | 50/60 Hz | 50/60 Hz | Same |
| Nozzle Diameter | 0.15 mm | 0.12 mm | Similar |
| Flow Rate | 25100 mL/min75 mL/min
25
(Recommend value when used
with Single Use
Electrosurgical Knife) | 1~55 mL/min | Similar |
| Components | Fluid Pump Console
Connecting Cables
Foot Pedal
Disposable Pump Cartridge
Disposable Pump Tubing
Disposable Control Button | Unit
Connecting Cables
Foot Switch
Pump Cartridge
Applicators
Suction System | The proposed
device doesn't
include
Applicators and
Suction System |
| Main Material | Metal, Glass Display Screen,
Plastics, Wiring, Insulation
Plastic, Metal | Metal, Glass Display Screen,
Plastics, Wiring, Insulation Plastic,
Metal | SE |
| Mucosal Lift
Performance | Deliver flow liquid for mucosal
lifting | Deliver flow liquid for mucosal
lifting | SE |
| Characteristics | Fluid Pump System | Reference Device
ERBEJET® 2 System with
HybridAPC Probe
(K143306) | Remark |
| Connection
Performance | properly connect and detach
from designated
equipment/accessory. Once
connected, there are no water
leaks. | properly connect and detach from
designated equipment/accessory.
Once connected, there are no water
leaks, argon gas leakages, or leakage
currents above international
standards. | device doesn't
include a probe
subsystem,
without argon gas
or currents
delivered. |
| Electrical
Performance | Comply with
IEC 60601-1:2012;
IEC60601-1-2:2014;
IEC 60529 (Foot Pedal Only) | Comply with
IEC 60601-1:2012;
IEC60601-1-2:2014;
IEC 60529 (Foot Pedal Only) | SE |
| Usability | Comply with
IEC 60601-1-6:2013;
IEC 62366-1:2015; | Comply with
IEC 60601-1-6:2013;
IEC 62366-1:2015; | SE |
| Software | Comply with
IEC 62304:2015; | Comply with
IEC 62304:2015; | SE |
| Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 | SE |
| Shelf Life | Fluid Pump
Console (with
connecting
cables), Foot
Pedal | Unit
Connecting
cables,
Foot Pedal
Suction System | SE |
| | Reusable | Reusable | |
| | Disposable
Pump Cartridge,
Disposable
Pump Tubing,
Disposable
Control Button | Pump Cartridge,
Applicators | |
| | 1 Year
Comply
with ASTM
F1980-16 | 3 Years
Comply with
ASTM
F1980-16 | |
| | | | |
| Sterilization | Fluid Pump
Console (with
connecting
cables), Foot
Pedal | Unit
Connecting
cables,
Foot Pedal
Suction System | SE |
| | Non-Sterile | Non-Sterile | |
| | Disposable
Pump Cartridge,
Disposable
Tubing Set,
Disposable
Control Button: | Pump Cartridge,
Applicators | |
| | EO
Sterilization,
SAL: 10-6. | EO
Sterilization,
SAL: 10-6. | |
| | | | |
| | Section 5 510k summary | | |
| Characteristics | Fluid Pump System | Reference Device
ERBEJET® 2 System with
HybridAPC Probe
(K143306) | Remark |
| | Fluid Pump
Console (with
connecting
cables), Foot
Pedal
Reusable | Unit
Connecting
cables,
Foot Pedal
Suction System
Reusable | |
| Single Use | Disposable
Pump Cartridge,
Disposable
Pump Tubing,
Disposable
Control Button
Single Use | Pump Cartridge,
Applicators
Single Use | SE |
| Labeling | Comply with 21 CFR part 801 | Comply with 21 CFR part 801 | SE |
Comparison to Reference Devices
7
Image /page/7/Picture/1 description: The image shows a logo with the letters 'MT' in a stylized, three-dimensional design. The letters are primarily white against a blue background, giving them a bold and prominent appearance. A registered trademark symbol '®' is visible in the upper right corner of the logo, indicating that the design is legally protected.
8
Image /page/8/Picture/1 description: The image shows a logo with the letters 'MT' in a stylized, three-dimensional block font. The letters are white against a blue background, and there is a registered trademark symbol '®' in the upper right corner of the logo. The logo has a simple, modern design.
9
Image /page/9/Picture/1 description: The image shows a blue, stylized logo. The logo appears to be the letters 'M' and 'T' in a bold, sans-serif font. The letters are designed with a 3D effect, giving them a blocky, isometric appearance. The logo is simple and modern, with a clean design.
Compared with the reference device, the Fluid Pump System incorporates substantially equivalent device materials, design, configuration, packaging, sterilization process and intended use as those featured in the reference device ERBEJET® 2 System.
8. Performance Data
The following bench tests were performed:
-
Dimension
- A Actuation Performance
-
Compatible Performance
-
Sealing Performance
-
Flowing Performance
-
Mucosa Lift Performance
- ア Cutting Performance
-
Connected Force Performance
Shelf-life testing and packaging integrity testing was conducted based on an accelerated aging test in accordance with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices and ISO 11607-1:2019: Packaging for terminally sterilized medical devices - Part 1:
10
Image /page/10/Picture/1 description: The image shows a logo with the letters "MT" in a bold, sans-serif font. The letters are rendered in a dark blue color and have a three-dimensional effect, with the top and right sides appearing to extend back and to the right, creating a sense of depth. A circled "R" symbol, indicating a registered trademark, is positioned in the upper right corner of the logo.
Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2:2019: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes. One year aging test was performed to demonstrate the stability and support the results of the accelerated aging test.
Sterilization validation was carried out in accordance with ISO 11135:2014+A1:2018 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices".
Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO-10993-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" issued on September 4, 2020.
Electromagnetic compatibility, electric safety had been confirmed according to the following standards:
- A IEC 60601-1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Software of Fluid Pump System had been confirmed according to FDA guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "IEC 62304:2015 Medical device software - Software life cycle processes".
The results of all the performance testing demonstrated that the proposed device met the predetermined acceptance criteria and is substantial equivalence to the predicate device Single Use Electrosurgical Knife (K193601).
9. Animal Study
No animal study is included in this submission.
10. Clinical Study
No clinical study is included in this submission.
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Image /page/11/Picture/1 description: The image shows a logo with the letters 'MT' in a stylized, three-dimensional design. The letters are primarily white, with a blue outline and shading that gives them a sense of depth. The 'M' is positioned to the left and slightly behind the 'T', creating an overlapping effect. The overall design is simple yet modern, with a clean and professional appearance.
11. Substantially Equivalent (SE) Conclusion
Based on the indications for use, technological characteristics, and safety and performance testing, the Single Use Electrosurgical Knife with Fluid Pump System has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared predicate device Single Use Electrosurgical Knife (K193601).