(237 days)
Not Found
No
The summary describes a standard electrosurgical device for coagulation and hemostasis, with no mention of AI, ML, image processing, or data-driven decision-making. The performance studies focus on thermal effects, animal studies, and compliance with electrosurgical safety and biocompatibility standards, which are typical for this type of device and do not indicate AI/ML involvement.
Yes
The device is used to "cauterize and coagulate or to perform hemostasis," which are therapeutic actions designed to treat abnormal bleeding or tissue within the digestive tract.
No
The device is described as being used to "cauterize and coagulate or to perform hemostasis", which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is a physical device consisting of a handle, plug, sheath, and forceps part, and is used with endoscopes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The Bipolar Coagulation Forceps are used within the digestive tract to directly apply high-frequency current for cauterization, coagulation, and hemostasis. This is a therapeutic and procedural device, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly describes a procedure performed inside the body, not a laboratory test.
Therefore, the Bipolar Coagulation Forceps fall under the category of a therapeutic or surgical medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Bipolar Coagulation Forceps have been designed to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.
Product codes (comma separated list FDA assigned to the subject device)
KGE
Device Description
The Bipolar Coagulation Forceps described in this submission are a sterile, single use devices compatible with the working channel of endoscope. The device is used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.
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
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 Bipolar Coagulation Forceps meets all design specifications and medical device standards for electrosurgical safety (IEC 60601), biocompatibility (ISO 10993) and sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device.
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.
Not Found
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
§ 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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 5, 2021
Hangzhou AGS MedTech Co., Ltd. Yanping Fu RA Supervisor Building 5, Building 6, No. 597 Kangxin Road Yuhang District Hangzhou, Zhejiang 311106 CHINA
Re: K210406
Trade/Device Name: Bipolar Coagulation Forceps Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Code: KGE Dated: August 20, 2021 Received: August 26, 2021
Dear Yanping Fu:
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.
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
1
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 (OS) 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,
for
Shanil 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) / K210406
Device Name Bipolar Coagulation Forceps
Indications for Use (Describe)
Bipolar Coagulation Forceps have been designed to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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FORM FDA 3881 (6/20)
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K210406 Page 1 of 6
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 Bipolar Coagulation Forceps
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, 311106 Hangzhou, Zhejiang, 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: | Feb. 07, 2021 |
5.2 Proposed Device
| Trade Name: | / |
|---|---|
| Device Name: | Bipolar Coagulation Forceps |
| Common Name: | Bipolar Coagulation Forceps |
| Regulation class: | Class II |
| Regulation Number: | 876.4300 |
| Regulation Description: | Endoscopic electrosurgical unit and accessories. |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | KGE |
| Product Code Name: | Forceps, Biopsy, Electric |
5.3 Predicate Device
| Trade Name: | Coagrasper™ |
|---|---|
| Device Name: | Single-use Electrosurgical Hemostatic Forceps |
| Common Name: | Electrosurgical Hemostatic Forceps Series |
| 510(k) Number: | K062517 |
| Regulation class: | Class II |
| Regulation Number: | 876.4300 |
| Regulation Description: | Endoscopic electrosurgical unit and accessories. |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | KGE |
| Product Code Name: | Forceps, Biopsy, Electric |
5.4 Device Description
The Bipolar Coagulation Forceps described in this submission are a sterile, single use
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Image /page/4/Picture/0 description: The image shows the text "K210406" on the first line and "Page 2 of 6" on the second line. The text is in a simple, sans-serif font and is likely part of a document or report. The text suggests that this is page 2 of a 6-page document with the identifier K210406.
Image /page/4/Picture/1 description: The image contains the 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 a sans-serif font, with the Chinese characters for "Anjie Si Medical" written below.
Section 5 510(k) Summary Bipolar Coagulation Forceps
devices compatible with the working channel of endoscope. The device is used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.
5.5 Indication for use statement
Bipolar Coagulation Forceps have been designed to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.
5.6 Comparison of Technology Characteristics
Our proposed device Bipolar Coagulation Forceps is substantially equivalent to the predicate devices. The differences between the Bipolar Coagulation Forceps 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/5/Picture/0 description: The image shows a logo for AGS Medtech. The logo consists of a blue and green circular design on the left, with the text "AGS MEDTECH" in black on the right. Below the English text is the same company name in Chinese characters. The logo is simple and professional, and it is likely used to represent the company's brand.
K210406
Page 3 of 6
Section 5 510(k) Summary
Bipolar Coagulation Forceps
| Table 5.6 Comparison of technical characteristics | ||||
|---|---|---|---|---|
| Item | Proposed device | Predicate device | Comparison | |
| Common name | Bipolar Coagulation Forceps | Single-use electrosurgical hemostatic forceps | / | |
| Trade name | / | Coagrasper™ | / | |
| Model number | 5461, 5462, 5463, 5464 | KD-410LR | / | |
| 510(k) submitter | Hangzhou AGS MedTech | |||
| Co., Ltd. | Olympus Medical Systems | |||
| Corporation | / | |||
| 510(k) number | / | K062517 | / | |
| Technical | Principles of | |||
| operation | Bipolar Coagulation Forceps | |||
| is an applied part of | ||||
| electrosurgical generator, | ||||
| using bipolar high-frequency | ||||
| current delivered by the | ||||
| electrosurgical generator to | ||||
| cauterize and coagulate or to | ||||
| perform hemostasis within the | ||||
| digestive tract. We designed | ||||
| two electrodes (two forceps | ||||
| cup) of opposite polarity | ||||
| attached to the tip of its | ||||
| sheath. The high-frequency | ||||
| electricity flows from one | ||||
| forceps cup to another forceps | ||||
| cup. No neutral electrode is | ||||
| needed. | Monopolar Single-use electrosurgical hemostatic forceps is an applied part of electrosurgical generator, using monopolar high-frequency current delivered by the electrosurgical generator to cauterize and coagulate or to perform hemostasis within the digestive tract. The high-frequency electricity flows from the active electrode (forceps) to the neutral electrode placed on patient skin. | Similar. | ||
| Both Bipolar Coagulation Forceps and Monopolar Single-use Electrosurgical Hemostatic Forceps are applied part of electrosurgical generator. | ||||
| Bipolar Coagulation Forceps has two electrodes (two forceps cup) of opposite polarity attached to the tip of its sheath. | ||||
| Thermal effect study and animal study had been conducted to demonstrate substantial | ||||
| Bipolar Coagulation Forceps | ||||
| Item | Proposed device | Predicate device | Comparison | |
| equivalence, | ||||
| please refer to | ||||
| Section 18.2 | ||||
| Thermal Effect | ||||
| study and 19 | ||||
| Animal study of | ||||
| this submission. | ||||
| Structure | Bipolar Coagulation Forceps | |||
| consists of Handle part, plug, | ||||
| sheath and forceps part. | Electrosurgical | |||
| hemostatic | ||||
| forceps consists of handle | ||||
| part, plug, sheath, forceps | ||||
| part, and A cord. | Similar. | |||
| Electrosurgical | ||||
| hemostatic | ||||
| forceps has a A | ||||
| cord while | ||||
| Bipolar | ||||
| coagulation | ||||
| forceps don't | ||||
| have. | ||||
| Energy Use | Bipolar Radio Frequency | |||
| Current | Monopolar Radio | |||
| Frequency Current | Different. | |||
| Thermal effect | ||||
| study and | ||||
| animal study | ||||
| had been | ||||
| conducted to | ||||
| demonstrate | ||||
| substantial | ||||
| equivalence, | ||||
| please refer to | ||||
| Section 18.2 | ||||
| Thermal Effect | ||||
| study and 19 | ||||
| Animal study of | ||||
| this submission. | ||||
| Sheath tube | 2.5mm | 2.75mm | Similar. | |
| Span length | 4.0mm, 5.0mm, 6.5mm, | |||
| 7.0mm | 5.0mm | Similar. | ||
| The difference | ||||
| will not raise | ||||
| any question of | ||||
| safety and | ||||
| effectiveness. | ||||
| Our proposed | ||||
| device has more | ||||
| choice on span | ||||
| Item | Proposed device | Predicate device | Bipolar Coagulation Forceps | |
| Comparison | ||||
| length for | ||||
| operators, | ||||
| operators could | ||||
| choose based on | ||||
| their clinical | ||||
| needs. | ||||
| Minimum | ||||
| Working | ||||
| Channel: | 3.2mm | 2.8mm | Similar. | |
| Working length | 1650mm, 1950mm, 2300mm | 1650mm; | Similar. | |
| The difference | ||||
| will not raise | ||||
| any question of | ||||
| safety and | ||||
| effectiveness. | ||||
| Our proposed | ||||
| device has more | ||||
| choice on | ||||
| working length | ||||
| for operators, | ||||
| operators could | ||||
| choose based on | ||||
| their clinical | ||||
| needs. | ||||
| Biological | Materials or | |||
| substances in | ||||
| contact with the | ||||
| same human | ||||
| tissue or body | ||||
| fluids | Plastic PTFE, Stainless | |||
| Steel 304, Stainless Steel | ||||
| N, PEEK450-GL30, | ||||
| Ceramic, Stainless Steel |
-
| No exact information. | Different.
Biocompatibility
tests have been
done for the
difference.
Biological risks
are acceptable. |
| | Biocompatibility | In Vitro Cytotoxicity Test:
ISO 10993-5: 2009;
Skin sensitization Test: ISO
10993-10: 2010;
Intracutaneous Reactivity
Test: ISO 10993-10: 2010;
Acute Systemic Toxicity Test:
ISO 10993-11:2017;
Pyrogenicity: ISO
10993-11:2017; | No exact information. | |
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Image /page/6/Picture/0 description: The image shows 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 appears to represent a company in the medical technology field.
K210406
Page 4 of 6
Section 5 510(k) Summary
Bipolar Coagulation Forceps
7
K210406
Page 5 of 6
Image /page/7/Picture/1 description: The image contains 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 logo, the text "AGS MEDTECH" is written in English, followed by Chinese characters that translate to "Anjie Si Medical".
Section 5 510(k) Summary
Bipolar Coagulation Forceps
8
Image /page/8/Picture/0 description: The image shows a logo for AGS Medtech. The logo consists of a circular symbol with three curved shapes in blue and green. To the right of the symbol, the text "AGS MEDTECH" is written in English, followed by the same name written in Chinese characters. The logo appears to be for a medical technology company.
K210406 Page 6 of 6
Section 5 510(k) Summary Bipolar Coagulation Forceps
5.7 Applicable Guidance Document NA
5.8 Performance Data
The Bipolar Coagulation Forceps meets all design specifications and medical device standards for electrosurgical safety (IEC 60601), biocompatibility (ISO 10993) and sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device.
5.9 Clinical Test
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 Bipolar Coagulation Forceps is substantially equivalent to the predicate devices.