(214 days)
No
The description focuses on the mechanical and electrical functions of the device and its interaction with an electrosurgical unit. There is no mention of AI or ML in the intended use, device description, or performance studies.
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 are therapeutic interventions.
No
Explanation: The device is a surgical tool designed for dissection, elevation, irrigation, and preparation of tissue layers using monopolar cutting and coagulation, not for diagnosing medical conditions.
No
The device is a physical, single-use endoscopic instrument with various components (cutting knife, tubes, handle) made of materials like stainless steel and plastic, designed to be used with an electrosurgical unit and endoscope. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "dissection, elevation, irrigation and preparation of tissue layers in combination with monopolar cutting and coagulation within the digestive tract." This describes a surgical tool used on the body, not a device used to test samples from the body.
- Device Description: The description details a physical instrument with a cutting knife, tubes, and a handle, designed to be used with an endoscope and electrosurgical unit to apply energy for cutting and coagulation of tissue. This is consistent with a surgical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to perform a surgical procedure directly on tissue within the digestive tract.
N/A
Intended Use / Indications for Use
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.
Product codes
KNS
Device Description
The proposed device Single Use Electrosurgical Knife is a sterile, single-use endoscopic device, intended to be used with endoscopes and electrosurgical units for dissection, elevation, irrigation and preparation of tissue layers in combination with monopolar cutting and coagulation within the digestive tract.
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. 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 Single Use Electrosurgical Knife is divided into I type, T type, O type and IT type according to the shape of the Cutting Knife. The main materials include ABS, Stainless Steel, PTFE, Zirconia, TPU and Gold. The physical and chemical performances of the device are stable. The proposed devices 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 3 years.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
digestive tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians / 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)
Performance testing was conducted to demonstrate the essential performance of the proposed device and confirmed that the proposed device works as intended with the compatible devices. Additionally, the results of the tests below were evaluated as substantially equivalent to the predicate device.
- Dimension
- Actuation Performance
- Compatible Performance
- Sealing Performance
- Flowing Performance
- Mucosa Lift Performance
- Cutting Performance
- Connected Force Performance
The bench testings performed demonstrated that the proposed device and predicate device are substantially equivalent.
Shelf-life 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. Three-year aging test will be performed to demonstrate longer stability and support the results of the accelerated aging test. Sterilization validation was carried out in accordance with ISO 11135:2014 "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, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" issued on June 16,2016.
Electromagnetic compatibility, electric safety, and thermal safety had been confirmed according to the following standards:
IEC60601-1:2005+A1:2012 Medical Electrical Equipment - Part 1: Medical electrical equipment - general requirements for the basic safety and essential performance
IEC 60601-2-2:2017 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the safety of endoscopic equipment
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
No animal study is included in this submission.
No clinical study is included in this submission.
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.
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Image /page/0/Picture/0 description: The image shows 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 24, 2020
Micro-Tech (Nanjing) Co., Ltd. Sally He, RA Engineer No.10 Gaoke Third Road Nanjing National Hi-Tech, Industrial Development Zone Nanjing, Jiangsu Province 210032 China
Re: K193601
Trade/Device Name: Single Use Electrosurgical Knife Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: Class II Product Code: KNS Dated: December 19, 2019 Received: December 23, 2019
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/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
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 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.
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)
K193601
Device Name Single Use Electrosurgical Knife
Indications for Use (Describe)
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.
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/3/Picture/2 description: The image shows a blue logo with the letters 'MT' in a stylized, blocky font. The letters are interconnected and appear to be in a three-dimensional perspective. To the upper right of the letters, there is a small 'R' in a circle, indicating a registered trademark symbol.
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: K193601
1. Date of Preparation: 2020-05-28
-
- 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
Trade Name: Single Use Electrosurgical Knife
Common Name: Electrosurgical Knife
Regulatory Information
Classification Name: Endoscopic electrosurgical unit and accessories
Classification: 2
Product Code: KNS
Regulation Number: 876.4300
Review Panel: Gastroenterology/Urology
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Image /page/4/Picture/2 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, with the "M" on the left and the "T" on the right. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.
4. Identification of Predicate Device
Predicate Device 510(k) Number: K171158 Product Name: Single Use Electrosurgical Knife Manufacturer: Olympus Medical Systems Corporation
Reference device 510(k) Number: K083608 Product Name: ERBE Hybrid Knife™ Manufacturer: ERBE USA, Inc
5. Indications for Use
These instruments have been designed to be used with endoscopes and electrosurgical units for dissection, elevation, irrigation and preparation of tissue layers in combination with monopolar cutting and coagulation within the digestive tract.
6. Device Description
The proposed device Single Use Electrosurgical Knife is a sterile, single-use endoscopic device, intended to be used with endoscopes and electrosurgical units for dissection, elevation, irrigation and preparation of tissue layers in combination with monopolar cutting and coagulation within the digestive tract.
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. 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.
2/7
5
Image /page/5/Picture/2 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 made of solid blocks. A small registered trademark symbol is located in the upper right corner of the logo.
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 Single Use Electrosurgical Knife is divided into I type, T type, O type and IT type according to the shape of the Cutting Knife. The main materials include ABS, Stainless Steel, PTFE, Zirconia, TPU and Gold. The physical and chemical performances of the device are stable. The proposed devices 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 3 years.
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.
7. Comparison of Technological Characteristics
The Single Use Electrosurgical Knife incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device Single Use
| Electrosurgical Knife (K171158): | |||
|---|---|---|---|
| Proposed Device |
| ltem | Proposed Device
Single Use Electrosurgical
Knife | Predicate Device
Single Use
Electrosurgical Knife
(K171158) | Remark |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Product Code | KNS | KNS | Same |
| Requlation No. | 878.4300 | 878.4300 | Same |
| Class | 2 | 2 | Same |
| Supplied in Sterile | Yes | Yes | Same |
| Main Material | PTFE, ABS, SUS304 | Polymer materials,
Stainless Steel | Similar |
| Configuration | Cutting Knife, Tube, and | Distal end, Tube, and | Same |
| Item | Proposed Device
Single Use Electrosurgical
Knife | Predicate Device
Single Use
Electrosurgical Knife
(K171158) | Remark |
| Handle | Handle | Handle | |
| Injection | With/Without Injection | With Injection | Similar |
| Cutting Knife
Shape | I,T,O,IT | T | Similar |
| Cutting Knife
length | 1.5mm,2mm,4mm | 2mm,1.5mm | Similar |
| Working Length | 1950mm,2350mm | 1650mm,1950mm,2300mm | Similar |
| Compatible
endoscopy
working channel | ≥2.8mm | ≥2.8mm | Same |
| Energy used/
Delivered | Monopolar Radio Frequency
Current | Monopolar Radio
Frequency Current | Same |
| Rated
High-Frequency
Voltage | CUT/COAG:2400Vp-p | CUT: 3200Vp-p
COAG: 5800Vp-p | Similar |
| Indications for Use | 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. | These instruments have
been designed to be used
with Olympus endoscopes,
electrolsurgical units to cut
tissue and coagulate or to
perform hemostasis using
high-frequency current and
flushing devices for
submucosal injection in the
digestive tract. | Substantial
same |
| Single Use | Yes | Yes | Same |
| Packaging | Single-use EO sterilized
pouch with one device per
pouch | Single-use EO sterilized
pouch with one device per
pouch | Same |
| Shelf Life | Three years | Three years | Same |
| Biocompatibility | Conform to ISO 10993-1 | Conform to ISO 10993-1 | Same |
| Item | Proposed Device
Single Use Electrosurgical
Knife | Predicate Device
Single Use
Electrosurgical Knife
(K171158) | Remark |
| Sterilization | EO Sterilized, SAL: $10^{-6}$ | EO Sterilized, SAL: $10^{-6}$ | Same |
| Labeling | Conform to 21 CFR part 801 | Conform to 21 CFR part 801 | Same |
| Electrical Safety
and
Electromagnetic
compatibility | Conform to:
IEC60601-1
IEC 60601-1-2
IEC 60601-2-2
IEC 60601-2-18 | Conform to:
IEC60601-1
IEC 60601-1-2
IEC 60601-2-2
IEC 60601-2-18 | Same |
6
Image /page/6/Picture/2 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional design. The letters are bold and appear to be interconnected, with the "M" slightly overlapping the "T". A registered trademark symbol is visible in the upper right corner of the logo.
7
Image /page/7/Picture/2 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional design. The letters are connected and appear to be angled slightly, giving the logo a sense of depth. A registered trademark symbol is present in the upper right corner of the logo.
8. Performance Data
Performance testing was conducted to demonstrate the essential performance of the proposed device and confirmed that the proposed device works as intended with the compatible devices. Additionally, the results of the tests below were evaluated as substantially equivalent to the predicate device.
-
Dimension
- レ Actuation Performance
-
Compatible Performance
-
Sealing Performance
-
Flowing Performance
-
Mucosa Lift Performance
-
Cutting Performance
- ♪ Connected Force Performance
The bench testings performed demonstrated that the proposed device and predicate device are substantially equivalent.
Shelf-life testing was conducted based on an accelerated aging test in accordance with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems
8
Image /page/8/Picture/2 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are interconnected, with the "M" appearing to be in front of the "T". A small registered trademark symbol is located in the upper right corner of the logo. The logo has a clean and modern design.
for Medical Devices. Three-year aging test will be performed to demonstrate longer stability and support the results of the accelerated aging test. Sterilization validation was carried out in accordance with ISO 11135:2014 "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, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" issued on June 16,2016.
Electromagnetic compatibility, electric safety, and thermal safety had been confirmed according to the following standards:
IEC60601-1:2005+A1:2012 Medical Electrical Equipment - Part 1: Medical electrical equipment - general requirements for the basic safety and essential performance IEC 60601-2-2:2017 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular
requirements for the safety of endoscopic equipment
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
9. Animal Study
No animal study is included in this submission.
Clinical Study 10.
No clinical study is included in this submission.
9
Image /page/9/Picture/2 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are interconnected, with the "M" appearing to be in front of the "T". A small registered trademark symbol is located in the upper right corner of the logo. The logo has a clean and modern design.
Substantially Equivalent (SE) Conclusion 11.
Based on the indications for use, technological characteristics, and safety and performance testing, the Single Use Electrosurgical Knife 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 (K171158).