Polypectomy Snare
Device Facts
| Record ID | K221713 |
|---|---|
| Device Name | Polypectomy Snare |
| Applicant | Hangzhou AGS MedTech Co., Ltd. |
| Product Code | FDI · Gastroenterology, Urology |
| Decision Date | Mar 3, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.4300 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Polypectomy Snare is used endoscopically in the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract.
Device Story
Polypectomy Snare; sterile, single-use endoscopic accessory; compatible with endoscope working channels. Device consists of handle, sheath, flexible wire, and electrode. Operation: user inserts device through endoscope; sliding handle extends electrode from sheath to trap target tissue; handle retraction secures tissue. Hot mode: delivers high-frequency monopolar current for cutting/coagulation. Cold mode: mechanical cutting without electrical activation. Also functions to remove previously released Hemoclips (K211787) by engaging locking hooks to release clip buckles. Used by physicians in clinical settings. Benefits: enables tissue resection and retrieval of misplaced clips, reducing need for repeat procedures.
Clinical Evidence
No clinical data. Substantial equivalence supported by non-clinical bench testing, including mechanical resection durability, snare loop extension/retraction, rotation, tilting, loop width stability, service life, disassembly, and mechanical cutting force.
Technological Characteristics
Sterile, single-use endoscopic snare. Materials: flexible wire, sheath, handle. Energy: monopolar electrosurgical current. Standards: IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, ISO 10993 (biocompatibility), ISO 11135 (EO sterilization). Dimensions: loop widths 10-32mm; loop lengths 16-60mm. Mechanical actuation via sliding handle.
Indications for Use
Indicated for endoscopic removal and/or cauterization of diminutive, sessile, and pedunculated polyps and tissue within the gastrointestinal tract.
Regulatory Classification
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.
Predicate Devices
- Polypectomy Snare (K172729)
Reference Devices
- Hemoclip (K211787)
Submission Summary (Full Text)
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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 in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
March 3. 2023
Hangzhou AGS MedTech Co., Ltd. Jiayuan Zhang RA Specialist Building 5, Building 6, No. 597 Kangxin Road Yuhang District Hangzhou, Zhejiang 311106 China
Re: K221713
> Trade/Device Name: Polypectomy Snare Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: II Product Code: FDI Dated: January 30, 2023 Received: January 31, 2023
Dear Jiayuan Zhang:
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.
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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-regulatoryinformation/postmarketing-safety-reporting-combination-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,
### Sivakami Venkatachalam -S
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
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### Indications for Use
510(k) Number (if known) K221713
Device Name Polypectomy Snare
Indications for Use (Describe)
Polypectomy Snare is used endoscopically in the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract.
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/0 description: The image contains a logo for AGS Medtech. The logo consists of a blue and green circular design on the left, with the text "AGS MEDTECH" in English and Chinese characters on the right. The Chinese characters are arranged vertically below the English text.
#### 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
| | Hangzhou AGS MedTech Co., Ltd. | |
|---------------------------------------|--------------------------------------------------------------------------------------------------|--|
| Submitted by/Owner: | Building 5, Building 6, No.597 Kangxin Road Yuhang<br>District, 311106 Hangzhou, Zhejiang, China | |
| Establishment<br>Registration Number: | 3010288205 | |
| Registration Status: | Active | |
| Contact Person: | Jiayuan Zhang<br>Phone: 0086-18668235131<br>Fax: 0086-0571-87671225<br>Email: zhangjy@bioags.com | |
| Date Prepared: | March 3, 2023 | |
#### 5.2 Proposed Device
| Trade Name: | Polypectomy Snare |
|-------------------------|--------------------------------------------------|
| Device Name: | Polypectomy Snare |
| Common Name: | Polypectomy Snare |
| Regulation class: | Class II |
| Regulation Number: | 876.4300 |
| Regulation Description: | Endoscopic electrosurgical unit and accessories. |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | FDI |
| Product Code Name: | Snare, Flexible |
#### 5.3 Predicate Device
| Trade Name: | Polypectomy Snare |
|-------------------------|--------------------------------------------------|
| Device Name: | Polypectomy Snare |
| Common Name: | Polypectomy Snare |
| 510(k) Number: | K172729 |
| Regulation class: | Class II |
| Regulation Number: | 876.4300 |
| Regulation Description: | Endoscopic electrosurgical unit and accessories. |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | FDI |
| Product Code Name: | Snare, Flexible |
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Image /page/4/Picture/0 description: The image shows a 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, the text "AGS MEDTECH" is written in English, followed by Chinese characters below.
#### 5.4 Device Description
Polypectomy Snare described in this submission is a sterile, single use devices compatible with the working channel of endoscope. The device is used endoscopically in the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract. The device can remove the specified released Hemoclip. EO sterilization and use for single use only.
#### 5.5 Indication for use statement
Polypectomy Snare is used endoscopically in the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract.
#### 5.6 Comparison of Technology Characteristics
Our proposed device Polypectomy Snare is substantially equivalent to the predicate device. The differences between the Polypectomy Snare and the predicate device 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 gray on the right. Below the English text is the same text in Chinese.
Section 5 510(k) Summary Polypectomy Snare
| Table 5.6 Comparison of technical characteristics | | | | |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Item | Proposed device | Predicate device (K172729) | Comparison |
| | Common name | Polypectomy Snare | Polypectomy Snare | / |
| | Trade name | / | / | / |
| | Model number | 5071, 5072, 5073, 5074, 5075,<br>5076, 5077, 5078, 5079, 50710<br>series | 5071, 5072, 5073, 5074, 5075,<br>5076, 5077, 5078, 5079, 50710<br>series | / |
| | 510(k) submitter | Hangzhou AGS MedTech Co.,<br>Ltd. | Hangzhou AGS MedTech Co.,<br>Ltd. | / |
| | 510(k) number | / | K172729 | / |
| Technical | Principles<br>of operation | The polypectomy snare is intended<br>to pass through the endoscope via<br>working channel. When the<br>electrode appears in the<br>endoscopic view, push the sliding<br>handle forward to extend the<br>electrode from the sheath tube.<br>The electrode can be extended to a<br>certain open width in order to trap<br>the target tissue. Pull the sliding<br>handle back to hold the target<br>tissue within the electrode loop.<br>For hot indication, activate the<br>electrode. The snare electrode<br>delivers a high frequency current<br>to cut and cauterize tissue, and<br>then achieves separation and<br>coagulation of the tissue.<br>For cold indication, pull the<br>sliding handle back and without<br>activating the electrode.<br>Continually pull the sliding handle<br>and cut the tissue mechanically<br>with the electrode.<br>For remove indication, the device<br>can remove the specified released<br>Hemoclip (manufactured by<br>Hangzhou AGS, K211787). There | The polypectomy snare consists<br>of handle, sheath, flexible wire<br>and electrode, which is used<br>endoscopically in the removal of<br>diminutive and/or cauterization<br>of diminutive polyps, sessile<br>polyps, pedunculated polyps and<br>tissue from within the GI tract.<br>When passed through an<br>endoscope and activated, the<br>snare delivers a monopolar<br>electrical current to cut and<br>cauterize tissue with the<br>electrode. | Similar.<br>For proposed device,<br>add the cold indication<br>and the remove<br>indication. Bench test<br>has been conducted to<br>demonstrate substantial<br>equivalence, please refer<br>to Section 18 bench<br>performance testing. |
| Item | Proposed device | Predicate device (K172729) | Comparison | |
| | is a locking hook at the end of the<br>Hemoclip's clips, when the clip<br>part released after the closing<br>movement, the locking hook forms<br>a buckle with the groove at the<br>lower end of the frap tube, making<br>the two clips self-locking and<br>closing, so as to achieve<br>mechanical suture of the tissue at<br>the lesion. Intraoperative, when<br>operators find close position is not<br>ideal, need to be adjusted to<br>remove the released and closed<br>clip head, they could take a snare<br>product, since the endoscopic<br>clamp inserts, in the perspective of<br>endoscopic, the snare loop goes<br>into the grooves, gradually<br>tightening the snare loop, apply a<br>pressure to the locked hook, press<br>the hooks in, release the lock<br>buckle, so that the two closed clips<br>open, and the closed clip head<br>leave the original lesion site; The<br>snare loop tightens the opened clip<br>head and exits from the human<br>digestive tract together with the<br>endoscope. Then the endoscope<br>was reintroduced into the human<br>digestive tract and the operation<br>continued. | | | |
| Snare open<br>width | 10mm, 15mm, 25mm, 32mm | 10mm, 15mm, 25mm, 32mm | Substantial equivalence.<br>We conducted bench test<br>on our proposed device<br>in comparison with our<br>chosen predicate. All the<br>test results show that the<br>proposed device is as<br>safe and effective as our<br>predicate device. For<br>bench tests reports,<br>please refer to Section | |
| | | | | Polypectomy Snare |
| Item | Proposed device | Predicate device (K172729) | Comparison | |
| | | | 18 of this submission. | |
| Electrode<br>shape | Oval, shield, diamond, hexagon,<br>polygon, round, crescent | Oval, hexagon, polygon, round,<br>duck bill | Different.<br>Bench test has been<br>conducted to<br>demonstrate substantial<br>equivalence, please refer<br>to Section 18 bench<br>performance testing. | |
| Loop length | 16mm, 22mm, 30mm, 31mm,<br>45mm, 50mm, 52mm, 60mm; | 28mm, 32mm, 50mm, 63mm | Different.<br>Bench test has been<br>conducted to<br>demonstrate substantial<br>equivalence, please refer<br>to Section 18 bench<br>performance testing. | |
| Loop area | 130mm², 135mm², 140mm²,<br>210mm², 245mm², 250mm²,<br>400mm², 650mm², 790mm²,<br>830mm², 1050mm², 1250mm² | 225mm², 330mm², 850mm²,<br>1335mm² | Different.<br>Bench test has been<br>conducted to<br>demonstrate substantial<br>equivalence, please refer<br>to Section 18 bench<br>performance testing. | |
| Usability<br>performance | 1. Durability of mechanical<br>resection;<br>2. Extension and retraction of<br>snare loop;<br>3. Rotation degree of snare loop;<br>4. Tilting length;<br>5. Change of loop width;<br>6. Durability of snare loop<br>wire-Pull force of keeping<br>required width;<br>7. Durability of snare loop<br>wire-Service life of snare loop;<br>8. Disassembly performance;<br>9. Mechanical cutting force. | 1. Durability of mechanical<br>resection;<br>2. Extension and retraction of<br>snare loop;<br>3. Rotation degree of snare loop;<br>4. Tilting length;<br>5. Change of loop width;<br>6. Durability of snare loop<br>wire-Pull force of keeping<br>required width;<br>7. Durability of snare loop<br>wire-Service life of snare loop; | Substantial equivalence.<br>We conducted usability<br>performance test on our<br>proposed device in<br>comparison with our<br>chosen predicate. All the<br>test results show that the<br>proposed device is as<br>safe and effective as our<br>predicate device. For<br>bench tests reports,<br>please refer to Section<br>18 of this submission. | |
| Electrical safety | The electrical safety performance<br>of the polypectomy snare should<br>meet the requirements of IEC<br>60601-1: 2005+A1:2012, IEC<br>60601-2-2:2017 and IEC | The electrical safety<br>performance of the polypectomy<br>snare should meet the<br>requirements of IEC 60601-1:<br>2005+A1:2012 IEC | Similar.<br>We conducted Electrical<br>safety on our proposed<br>device, for test reports,<br>please refer to Section | |
| Item | Proposed device | Predicate device (K172729) | Comparison | |
| | 60601-2-18. | 60601-2-2:2009 and IEC<br>60601-2-18. | 17 of this submission. | |
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Image /page/6/Picture/0 description: The image shows a logo with a circular design on the left and text on the right. The circular design consists of three curved shapes in blue and green, arranged in a triangular pattern. To the right of the design, the text "AGS MEDTECH" is written in a smaller font size above the Chinese characters "
安杰思医学".
# Section 5 510(k) Summary
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Image /page/7/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 is the text "AGS MEDTECH" in English, followed by the same name in Chinese characters. The logo appears to represent a medical or technological company with a global presence.
# Section 5 510(k) Summary
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Image /page/8/Picture/0 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" in black to the right of the design. Below the English text is the same company name in Chinese characters.
Section 5 510(k) Summary
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### 5.7 Applicable Guidance Document
NA
#### 5.8 Performance Data
The Polypectomy Snare 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. Following tests were conducted in our non-clinical bench test: Durability of mechanical resection; Extension and retraction of snare loop; Rotation degree of snare loop; Tilting length; Change of loop width; Durability of snare loop wire-Pull force of keeping required width; Durability of snare loop wire-Service life of snare loop; Disassembly performance; Mechanical cutting force.
#### 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 Polypectomy Snare is substantially equivalent to the predicate device.
