(267 days)
Not Found
No
The description focuses on the electrosurgical generator's function of delivering high-frequency current and controlling it via proprietary software, without mentioning any AI or ML capabilities for analysis, decision-making, or adaptation.
Yes.
The device's intended use is to deliver high-frequency electrical current for the cutting and/or coagulation of tissue, as well as for the removal of polyps and tissue from the GI tract, which are therapeutic actions.
No
The device is an electrosurgical system intended for therapeutic purposes (cutting and coagulation of tissue), not for diagnosing conditions.
No
The device description clearly outlines hardware components such as the Electrosurgical Generator, footswitch, bipolar connecting cable, power cord, polypectomy snare, and electrosurgical knife. While the generator incorporates proprietary software, the system is not solely 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 "cutting and/or coagulation of tissue" and the removal of polyps, tissue, and foreign bodies from the GI tract using high-frequency electrical current. This is a therapeutic and surgical function performed directly on the patient's body.
- Device Description: The description details an electrosurgical generator and accessories (snares and knives) that deliver electrical current for surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment decisions. IVDs are used in vitro (outside the body) to analyze biological samples.
The device described is an electrosurgical system used for surgical interventions in vivo (within the body).
N/A
Intended Use / Indications for Use
Electrosurgical Generator is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue.
Bipolar Polypectomy Snare Combination has been designed to be used with endoscope and electrosurgical unit for the removal of sessile polyps, pedunculated polyps, tissue and foreign bodies from within the GI tract using high-frequency current.
Single Use Electrosurgical Knife Combination has been designed to be used with endoscopes and electrosurgical units to cut tissue within the digestive tract using high-frequency current.
Product codes
KNS
Device Description
The Electrosurgical System comprises:
- Electrosurgical Generator;
- Bipolar polypectomy snare combination;
- Single use electrosurgical knife combination.
The Electrosurgical Generator is designed to deliver bipolar high-frequency current for the purpose of cutting and coagulating tissue. It consists of High frequency generator, footswitch, bipolar connecting cable and power cord. The Electrosurgical Generator output is actuated via a two-pedal Footswitch. One pedal activated the bipolar high-frequency current output for cut; the other pedal activates the bipolar high-frequency current output for coagulation. The Electrosurgical Generator incorporates proprietary software developed by AGS for generating and controlling the two energies delivered. The Bipolar connecting cable connects electrosurgical instruments to the Electrosurgical Generator, it transfer electrical energy - without changing the energy - from devices to instruments. The Electrosurgical Generator, Footswitch, Bipolar connecting cable and Power cord are non-sterile and reusable.
Bipolar polypectomy snare combination is an accessory to Electrosurgical Generator. It is a sterile device consists of Polypectomy snare (Bipolar) and Distal attachment. It is for endoscopic use. It is used for removal of polyps within the digestive tract using high-frequency current. EO sterilization and use for single use only.
Single use electrosurgical knife combination is an accessory to Electrosurgical Generator. It is a sterile device consists of Single use electrosurgical knife and Distal attachment. It is for endoscopic use. It is used for cutting tissues within the digestive tract using high-frequency current. EO sterilization and use for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI tract, digestive tract
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 Electrosurgical System meets all device standards for electrical safety and EMC (IEC 60601), biocompatibility (ISO 10993) and sterility (ISO 11135). The performance in ex-vivo and in-vivo meets the design specification and shows substantial equivalence to the predicated devices. No Clinical test is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K083452, K172729, K092309, K171158
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
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.
May 21, 2020
Hangzhou AGS MedTech Co., Ltd. Chunqi Han R&D Director Building 5, Building 6, No.597 Kangxin Road Yuhang District Hangzhou, Zhejiang, 311106 CHINA
Re: K192342
Trade/Device Name: Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories) Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KNS Dated: August 23, 2019 Received: August 28, 2019
Dear Chunqi Han:
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-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,
for
Shani P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K192342
Device Name
Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)
Indications for Use (Describe)
Electrosurgical Generator is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue.
Bipolar Polypectomy Snare Combination has been designed to be used with endoscope and electrosurgical unit for the removal of sessile polyps, pedunculated polyps, tissue and foreign bodies from within the GI tract using high-frequency current.
Single Use Electrosurgical Knife Combination has been designed to be used with endoscopes and electrosurgical units to cut tissue within the digestive tract using high-frequency current.
| 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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K192342 Page 1 of 10
Image /page/3/Picture/1 description: The image shows the logo for AGS Medtech. The logo consists of a circular design with three curved shapes in blue and green. To the right of the circular design, the text "AGS MEDTECH" is written in English, followed by the same text in Chinese characters. The logo appears to be for a medical technology company.
Section 5 510(k) Summary Electrosurgical System
510(k) Summary
We submit this 510(k) Summary as per 21 CFR 807.92, it meets the content and format regulatory requirements.
5.1 Submitter
| Submitted by/Owner: | Hangzhou AGS MedTech Co., Ltd.
Building 5, Building 6, NO.597 Kangxin Road Yuhang
District, Hangzhou, Zhejiang 311106 China |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration Number: | 3010288205 |
| Registration Status: | Active |
| Contact Person: | Yanping Fu
Phone: 0086-15958493282
Fax: 0086-0571-87671225
Email: fuyp@bioags.com |
| Date Prepared: | July 18, 2019 |
5.2 Proposed Device
| Trade Name: | Electrosurgical System (Electrosurgical Generator with
Bipolar polypectomy snare combination and Single use
electrosurgical knife combination accessories) |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Electrosurgical System (Electrosurgical Generator with
Bipolar polypectomy snare combination and Single use
electrosurgical knife combination accessories) |
| Common Name: | Electrosurgical System |
| Regulation class: | Class II |
| Regulation Number: | 876.4300 |
| Regulation Description: | Endoscopic electrosurgical unit and accessories |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | KNS |
| Product Code Name: | Unit, Electrosurgical, Endoscopic (With Or Without
Accessories) |
5.3 Predicate Device
| Trade Name: | ERBE ESU Model VIO 300D with Accessories |
|---|---|
| Device Name: | ERBE ESU Model VIO 300D with Accessories |
| Common Name: | Electrosurgical Unit (ESU/Generator) System |
| 510(k) Number: | K083452 |
| Regulation class: | Class II |
| Regulation Number: | 21 CFR 878.4400 |
| Regulation Description: | Electrosurgical cutting and coagulation device and accessories. |
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K192342 Page 2 of 10
Image /page/4/Picture/1 description: The image shows a logo for AGS Medtech. The logo consists of a circular design with three blue curved shapes forming a triangle, with a green triangle in the center. To the right of the circular design, the text "AGS MEDTECH" is written in English, followed by "安杰思医学" in Chinese.
Section 5 510(k) Summary Electrosurgical System
| Review Panel: | General & Plastic Surgery |
|---|---|
| Product Code: | GEI |
| Product Code Name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Trade Name: | Polypectomy snare |
|---|---|
| Device Name: | Polypectomy snare |
| Common Name: | Polypectomy snare |
| 510(k) Number: | K172729 |
| Regulation class: | Class II |
| Regulation Number: | 21 CFR 876.4300 |
| Regulation Description: | Endoscopic electrosurgical unit and accessories |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | FDI |
| Product Code Name: | Snare, Flexible |
| Trade Name: | Single use Electrosurgical Knife Series |
|---|---|
| Device Name: | Single use Electrosurgical Knife Series |
| Common Name: | Electrosurgical Knife |
| 510(k) Number: | K092309 |
| Regulation class: | Class II |
| Regulation Number: | 21 CFR 876.4300 |
| Regulation Description: | Endoscopic electrosurgical unit and accessories |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | KNS |
| Product Code Name: | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) |
| Trade Name: | Single use Electrosurgical knife |
|---|---|
| Device Name: | Single use Electrosurgical knife |
| Common Name: | Single use Electrosurgical knife |
| 510(k) Number: | K171158 |
| Regulation class: | Class II |
| Regulation Number: | 21 CFR 876.4300 |
| Regulation Description: | Endoscopic electrosurgical unit and accessories |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | KNS |
| Product Code Name: | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) |
5.4 Device Description
The Electrosurgical System comprises:
- ◆ Electrosurgical Generator;
- ◆ Bipolar polypectomy snare combination;
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K192342 Page 3 of 10
Image /page/5/Picture/1 description: The image shows the logo for AGS Medtech. The logo consists of a blue and green circular design on the left, with the text "AGS MEDTECH" and "安杰思医学" on the right. The circular design appears to be a stylized representation of three interconnected shapes, with the green shape in the center.
Section 5 510(k) Summary Electrosurgical System
Single use electrosurgical knife combination. �
The Electrosurgical Generator is designed to deliver bipolar high-frequency current for the purpose of cutting and coagulating tissue. It consists of High frequency generator, footswitch, bipolar connecting cable and power cord. The Electrosurgical Generator output is actuated via a two-pedal Footswitch. One pedal activated the bipolar high-frequency current output for cut; the other pedal activates the bipolar high-frequency current output for coagulation. The Electrosurgical Generator incorporates proprietary software developed by AGS for generating and controlling the two energies delivered. The Bipolar connecting cable connects electrosurgical instruments to the Electrosurgical Generator, it transfer electrical energy - without changing the energy - from devices to instruments. The Electrosurgical Generator, Footswitch, Bipolar connecting cable and Power cord are non-sterile and reusable.
Bipolar polypectomy snare combination is an accessory to Electrosurgical Generator. It is a sterile device consists of Polypectomy snare (Bipolar) and Distal attachment. It is for endoscopic use. It is used for removal of polyps within the digestive tract using high-frequency current. EO sterilization and use for single use only.
Single use electrosurgical knife combination is an accessory to Electrosurgical Generator. It is a sterile device consists of Single use electrosurgical knife and Distal attachment. It is for endoscopic use. It is used for cutting tissues within the digestive tract using high-frequency current. EO sterilization and use for single use only.
5.5 Indication for use statement
Electrosurgical Generator is intended to deliver High Frequency (HF)
electrical current for the cutting and/or coagulation of tissue.
Bipolar Polypectomy Snare Combination has been designed to be used with endoscope and electrosurgical unit for the removal of sessile polyps, pedunculated polyps, tissue and foreign bodies from within the GI tract using high-frequency current.
Single Use Electrosurgical Knife Combination has been designed to be used with endoscopes and electrosurgical units to cut tissue within the digestive tract using high-frequency current.
5.6 Comparison of Technology Characteristics
Our proposed device Electrosurgical System is substantially equivalent to the predicate devices. The differences between the Electrosurgical System and the predicate devices do not raise any questions regarding its safety and effectiveness. The differences are listed in the table below.
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Image /page/6/Figure/0 description: The image shows a logo for AGS Medtech. The logo consists of a blue circular design with a green triangle in the center. To the right of the logo, the text "AGS MEDTECH" is written in English, followed by the same name written in Chinese characters.
5.6.1 Electrosurgical Generator
| Difference | Proposed device | Predicate device
K083452 | Performance Testing |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Output parameters | CUT I:
Rated Output frequency: 460 kHz±10%;
Max. voltage output: 480Vp; | Bipolar CUT:
Rated Output frequency: 350kHz ±10%;
Max. voltage output: 740Vp; | Different rated output frequency, but in the range of
200k-500MHz;
Electrical safety reports.
Thermal Effect on Tissue study report;
The difference raises no new questions regarding
safety and efficacy. |
| | CUT II:
Working mode: Bipolar;
Rated Output frequency: 460 kHz±10%;
Rated Power: 120W±20%;
Max. voltage output: 650Vp;
Crest factor: 1.46.3 | ENDO CUT Q:7.6 | ENDO CUT I:
Working mode: Monopolar;
Rated Output frequency: 350kHz ±10%;
Rated Power: 400W+0%/-20%;
Max. voltage output: 770Vp;
Crest factor: 1.4 ( $RL=500Ω$ ) | Electrical safety reports.
Thermal Effect on Tissue study report;
Animal study report;
The difference raises no new questions regarding
safety and efficacy. |
| | CUT III:
Working mode:
Bipolar;
Rated Output frequency: 460kHz±10%;
Rated Power: 60W±20%;
Max. voltage output: 560Vp;
Crest factor: 1.9
Working mode:
Monopolar;
Rated Output frequency: 350kHz ±10%;
Rated Power: 170W±20%;
Max. voltage output: 550Vp;
Crest factor: 1.4 ( $RL=500Ω$ ) | Electrical safety reports.
Thermal Effect on Tissue study report;
Animal study report;
The difference raises no new questions regarding
safety and efficacy. |
| | COAG I:
Rated Output frequency: 460 kHz±10%;
Rated load: 100Ω; | Bipolar Soft COAG:
Rated Output frequency: 350kHz ±10%;
Rated load: 75Ω; | Different rated output frequency, but in the range of
200k-500MHz;
Electrical safety reports.
Thermal Effect on Tissue study report; |
| Difference | Proposed device | Predicate device
K083452 | Performance Testing |
| | | | The difference raises no new questions regarding
safety and efficacy. |
| | COAG II:
Rated Output frequency: 460 kHz±10%; | Bipolar Forced COAG:
Rated Output frequency: 350kHz±10%; | Different rated output frequency, but in the range of
200k-500MHz;
Electrical safety reports.
Thermal Effect on Tissue study report;
The difference raises no new questions regarding
safety and efficacy. |
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Image /page/7/Figure/0 description: The image shows the logo for AGS Medtech. The logo consists of a circular design with three blue curved shapes and a green shape in the center. To the right of the logo is the text "AGS MEDTECH" in English, followed by the same name in Chinese characters. The text is in a simple, sans-serif font.
5.6.2 For Bipolar polypectomy snare combination
| Difference | Proposed device | Predicate device
K172729 | Performance Testing |
|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Principles of
operation | Bipolar Polypectomy Snare Combination is an applied
part of electrosurgical generator, using bipolar
high-frequency current delivered by the
electrosurgical generator to cut and coagulate tissue
with the electrode.
We designed a diffusion electrode attached to the tip
of its sheath and an active electrode attached to the
electrode on the end of the sheath, and designed the
Distal Attachment to connect with the diffusion
electrode to provide a larger contact area. The
high-frequency electricity flows from the electrode to
the Distal Attachment. Distal Attachment provides a
return path for high-frequency current with a low | Monopolar Polypectomy Snare manufactured
is an applied part of electrosurgical generator,
using monopolar high-frequency current
delivered by the electrosurgical generator to
cut and coagulate tissue with the electrode.
The high-frequency electricity flows from the
active electrode to the neutral electrode placed
on patient skin. | Electrical safety reports.
Thermal effect on tissue study report.
The difference raises no new
questions regarding safety and
efficacy. |
| Difference | Proposed device | Predicate device
K172729 | Performance Testing |
| | current density and closer to the other electrode, to
reduce the area of human tissue where
high-frequency currents circulate and prevent the
occurrence of anticipated burns in human tissue. No
neutral electrode is needed. | | |
| Energy Use | Biopolar High-Frequency Current | Monopolar Radio Frequency Current | Electrical safety reports.
Thermal effect on tissue study report.
The difference raises no new
questions regarding safety and
efficacy. |
| Structure | Bipolar Polypectomy snare combination consists of
Polypectomy snare (Bipolar) and Distal Attachment.
Polypectomy snare (Bipolar) consists of Electrode,
External tube, Sheath tube, Base, Connector, Handle
and Conductor.
Distal Attachment consists of Plastic cap, Connect
piece, Metal tube and Connect tube. | Polypectomy snare consists of Electrode,
Sheath, Fixed/Rotary part, Sliding handle,
Connector plug and handle. | Bench testing report.
Thermal effect on tissue study report.
The difference raises no new
questions regarding safety and
efficacy. |
| Materials or
substances in
contact with the
same human tissue
or body fluids | 1. Polypectomy Snare (Bipolar):
Sheath: PTFE;
External tube:SUS304;
Electrode:SUS304;
2.Distal Attachment:
Plastic Cap: TPE;
Connect piece: SUS304; | Sheath: PTFE;
Electrode: SUS304; | Biocompatibility tests reports.
The difference raises no new
questions regarding safety and
efficacy. |
| Difference | Proposed device | Predicate device | Performance Testing |
| | | K172729 | |
| | Metal tube: SUS303; | | |
| | Connect tube:SUS304; | | |
| | 5.6.3 For Single use electrosurgical knife combination | | |
| Difference | Proposed device | Predicate device | Performance Testing |
| | | K171158; | |
| | | K092309; | |
| Principles of | AGS's Bipolar Electrosurgical Knife Combination is | Monopolar Single Use Electrosurgical Knife | Electrical safety reports. |
| operation | an applied part of electrosurgical generator, using | is an applied part of electrosurgical generator, | Thermal effect on tissue study report. |
| | bipolar high-frequency current delivered by the | using monopolar high-frequency current | difference raises no
The
new |
| | electrosurgical generator to cut and cauterize tissue | delivered by the | questions
regarding safety
and |
| | with the electrode. | electrosurgical generator to cut and cauterize | efficacy. |
| | The Bipolar Electrosurgical Knife Combination has | tissue with the electrode. The high-frequency | |
| | a diffusion electrode (named 'External tube') | electricity flows from the active electrode to | |
| | attached to the tip of its sheath and an active | the neutral electrode placed on patient skin. | |
| | electrode attached to the knife on the end of the | | |
| | sheath. The active electrode is used to perform cut | | |
| | and cauterize while the external tube provides a | | |
| | return path for bipolar high-frequency current. | | |
| | However, the contact area of External tube is so | | |
| | small, we design the Distal Attachment to provide a | | |
| | larger contact area. Distal Attachment is installed at | | |
| | the distal end of the endoscope, Bipolar Single Use | | |
| | Electrosurgical Knife pass through the channel of | | |
| | endoscope, connect tube of the Distal Attachment | | |
| Difference | Proposed device | Predicate device
K171158;
K092309; | Performance Testing |
| | connect with the External tube of the Bipolar Single
Use Electrosurgical Knife. The high-frequency
electricity flows from the knife to the Distal
Attachment. Distal Attachment provides a return
path for high-frequency current with a low current
density and closer to the other electrode, to reduce
the area of human tissue where high-frequency
| | |
| Energy Use | Biopolar High-Frequency Current | Monopolar Radio Frequency Current | Electric safety reports.
Thermal effect on tissue study report.
The difference raises no new
questions regarding safety and
efficacy. |
| Structure | Single use electrosurgical knife combination consists
of single use electrosurgical knife and distal
attachment. Single use electrosurgical knife consists
of electrode part, sheath part and handle part.
Distal Attachment consists of Plastic cap, Connect
piece, Metal tube and Connect tube. | Single use electrosurgical knife consists of
electrode part, sheath part and handle part. | Bench test report.
Thermal effect on tissue study report.
The difference raises no new
questions regarding safety and
efficacy. |
| Maximum insertion
portion diameter | $\Phi$ 2.4mm | KD-655 L: $\Phi$ 2.7mm;
KD-620LR: $\Phi$ 2.6mm; | Bench test report.
The difference raises no new
questions regarding safety and
efficacy. |
| Difference | Proposed device | Predicate device | Performance Testing |
| (mm) | | K171158;
K092309; | |
| Working Length | 5521: 1650mm,1950mm, 2300mm;
5522: 1650mm,1950mm;
5524: 1650mm,1950mm, 2300mm; | KD-612L: Φ2.6mm.
KD-655L: 1650mm;
KD-620LR: 1650mm;
KD-611IL: 1650mm; | questions regarding safety and efficacy. |
| Cutting knife length | 5521: 1.4mm, 2.1mm
5522: 4.0mm
5524: 3.0mm, 3.5mm | KD-655 L: 2.0mm;
KD-620LR: 4.5mm;
KD-611L: 4mm; | |
| Tip diameter | 5524: Ф1.2mm, Ф1.7mm | KD-612: Φ2.2mm | |
| Materials or
substances in
contact with the
same human tissue
or body fluids | PTFE, SUS304, SUS303 | No information. | Biocompatibility tests reports.
The difference raises no new
questions regarding safety and
efficacy. |
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Image /page/8/Picture/0 description: The image contains a logo with the text "AGS MEDTECH" and Chinese characters below it. The logo consists of three blue curved shapes forming a triangle with a green shape in the center. The text "AGS MEDTECH" is in a sans-serif font, and the Chinese characters appear to be a translation of the company name. The logo and text are positioned side by side, with the logo on the left and the text on the right.
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Image /page/9/Picture/0 description: The image contains a logo with the text "AGS MEDTECH" and Chinese characters below it. The logo consists of three blue curved shapes forming a triangle with a green shape in the center. The text "AGS MEDTECH" is in a sans-serif font, and the Chinese characters appear to be a translation of the company name. The logo and text are positioned side by side, with the logo on the left and the text on the right.
10
Image /page/10/Picture/0 description: The image contains a logo with a circular design on the left and text on the right. The circular design consists of three blue curved shapes that form a triangle, with a green shape in the center. To the right of the logo, there is the text "AGS MEDTECH" in English, followed by the same text in Chinese characters. The text is aligned to the right of the logo and appears to be the name of a company or organization.
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Image /page/11/Picture/0 description: The image shows the logo for AGS Medtech. The logo consists of a circular design with three blue curved shapes and a green shape in the center. To the right of the logo is the text "AGS MEDTECH" in English, followed by the same name in Chinese characters. The text is in a simple, sans-serif font.
5.7 Applicable Guidance Document
NA
5.8 Performance Data
The Electrosurgical System meets all device standards for electrical safety and EMC (IEC 60601), biocompatibility (ISO 10993) and sterility (ISO 11135). The performance in ex-vivo and in-vivo meets the design specification and shows substantial equivalence to the predicated devices.
5.9 Clinical Test
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Image /page/12/Picture/0 description: The image contains a logo for AGS Medtech. The logo consists of a circular design with three curved shapes in blue and green. To the right of the logo, the text "AGS MEDTECH" is written in English, followed by the same name written in Chinese characters. The logo and text are positioned side by side, creating a clear and concise brand representation.
K192342 Page 10 of 10
Section 5 510(k) Summary Electrosurgical System
No Clinical test is included in this submission.
5.10 Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Hangzhou AGS Medtech Co., Ltd has demonstrated that proposed device is substantially equivalent to the predicate devices.