(263 days)
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.
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.
The provided text describes a 510(k) summary for the Polypectomy Snare, which is submitted to demonstrate substantial equivalence to a predicate device. This document does not detail acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device. Instead, it focuses on the substantial equivalence of the new Polypectomy Snare to an existing one based on technical characteristics, performance data (bench tests), and compliance with medical device standards.
However, I can extract information related to the device attributes and how its performance was evaluated against a predicate device, which can be adapted to the structure of your request if we interpret "acceptance criteria" as meeting or being equivalent to the predicate device's performance, and "study" as the bench testing conducted.
Based on the provided text, here's an attempt to answer your questions by interpreting "acceptance criteria" as the performance of the predicate device and "study" as the bench testing performed for substantial equivalence:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission for a traditional medical device (Polypectomy Snare, not an AI/ML device), the "acceptance criteria" are implied by the performance of the predicate device (K172729) and compliance with relevant standards. The "reported device performance" refers to the results of bench tests conducted on the proposed Polypectomy Snare to demonstrate it is "as safe and effective as our predicate device."
| Metric / Characteristic | Acceptance Criteria (Predicate Device K172729) | Reported Device Performance (Proposed Polypectomy Snare) |
|---|---|---|
| Principles of Operation | Snare delivers monopolar electrical current to cut and cauterize tissue. | Same, plus cold indication (mechanical cutting) and removal of specified Hemoclip. Bench tests conducted to demonstrate substantial equivalence for these additions. |
| Snare Open Width | 10mm, 15mm, 25mm, 32mm | 10mm, 15mm, 25mm, 32mm |
| Electrode Shape | Oval, hexagon, polygon, round, duck bill | Oval, shield, diamond, hexagon, polygon, round, crescent |
| Loop Length | 28mm, 32mm, 50mm, 63mm | 16mm, 22mm, 30mm, 31mm, 45mm, 50mm, 52mm, 60mm |
| Loop Area | 225mm², 330mm², 850mm², 1335mm² | 130mm², 135mm², 140mm², 210mm², 245mm², 250mm², 400mm², 650mm², 790mm², 830mm², 1050mm², 1250mm² |
| Usability Performance | 7 specific tests (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). | 9 specific tests (includes all 7 from predicate, plus Disassembly performance; Mechanical cutting force). All test results show the proposed device is as safe and effective as the predicate. |
| Electrical Safety | Meets requirements of IEC 60601-1:2005+A1:2012, IEC 60601-2-2:2009, and IEC 60601-2-18. | Meets requirements of IEC 60601-1:2005+A1:2012, IEC 60601-2-2:2017, and IEC 60601-2-18. |
| Biocompatibility | Complies with ISO 10993 | Complies with ISO 10993 |
| Sterility | Complies with ISO 11135 | Complies with ISO 11135 |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "bench tests" and "non-clinical performance tests."
- Sample Size: Not specified in the provided text for any of the individual bench tests. The text mentions "All the test results show that the proposed device is as safe and effective as our predicate device," implying sufficient testing was done, but specific sample numbers are absent.
- Data Provenance: The tests were conducted by Hangzhou AGS MedTech Co., Ltd., which is based in Hangzhou, Zhejiang, China. The data is prospective, generated specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the submission is for a physical medical device (Polypectomy Snare) and relies on performance bench tests against engineering specifications and predicate device performance, not expert-labeled ground truth like in AI/ML studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML study involving human readers or interpretation of results where adjudication would be necessary. The evaluation is based on objective measurements from bench testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This is not an AI/ML device, and no MRMC comparative effectiveness study was performed. The device is a surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to the Polypectomy Snare, as it is a physical medical instrument requiring human operation, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for demonstrating substantial equivalence for this device is based on:
- Engineering Specifications: Meeting design specifications for various physical and functional parameters (e.g., snare open width, loop length, usability performance tests like durability, extension/retraction, cutting force).
- Compliance with Standards: Meeting recognized international standards for medical devices (IEC 60601 for electrical safety, ISO 10993 for biocompatibility, ISO 11135 for sterility).
- Predicate Device Performance: Demonstrating performance "as safe and effective as" the legally marketed predicate device (K172729) through comparative bench testing.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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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 YuhangDistrict, 311106 Hangzhou, Zhejiang, China | |
| EstablishmentRegistration Number: | 3010288205 | |
| Registration Status: | Active | |
| Contact Person: | Jiayuan ZhangPhone: 0086-18668235131Fax: 0086-0571-87671225Email: 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, 5075,5076, 5077, 5078, 5079, 50710series | 5071, 5072, 5073, 5074, 5075,5076, 5077, 5078, 5079, 50710series | / | |
| 510(k) submitter | Hangzhou AGS MedTech Co.,Ltd. | Hangzhou AGS MedTech Co.,Ltd. | / | |
| 510(k) number | / | K172729 | / | |
| Technical | Principlesof operation | The polypectomy snare is intendedto pass through the endoscope viaworking channel. When theelectrode appears in theendoscopic view, push the slidinghandle forward to extend theelectrode from the sheath tube.The electrode can be extended to acertain open width in order to trapthe target tissue. Pull the slidinghandle back to hold the targettissue within the electrode loop.For hot indication, activate theelectrode. The snare electrodedelivers a high frequency currentto cut and cauterize tissue, andthen achieves separation andcoagulation of the tissue.For cold indication, pull thesliding handle back and withoutactivating the electrode.Continually pull the sliding handleand cut the tissue mechanicallywith the electrode.For remove indication, the devicecan remove the specified releasedHemoclip (manufactured byHangzhou AGS, K211787). There | The polypectomy snare consistsof handle, sheath, flexible wireand electrode, which is usedendoscopically in the removal ofdiminutive and/or cauterizationof diminutive polyps, sessilepolyps, pedunculated polyps andtissue from within the GI tract.When passed through anendoscope and activated, thesnare delivers a monopolarelectrical current to cut andcauterize tissue with theelectrode. | Similar.For proposed device,add the cold indicationand the removeindication. Bench testhas been conducted todemonstrate substantialequivalence, please referto Section 18 benchperformance testing. |
| Item | Proposed device | Predicate device (K172729) | Comparison | |
| is a locking hook at the end of theHemoclip's clips, when the clippart released after the closingmovement, the locking hook formsa buckle with the groove at thelower end of the frap tube, makingthe two clips self-locking andclosing, so as to achievemechanical suture of the tissue atthe lesion. Intraoperative, whenoperators find close position is notideal, need to be adjusted toremove the released and closedclip head, they could take a snareproduct, since the endoscopicclamp inserts, in the perspective ofendoscopic, the snare loop goesinto the grooves, graduallytightening the snare loop, apply apressure to the locked hook, pressthe hooks in, release the lockbuckle, so that the two closed clipsopen, and the closed clip headleave the original lesion site; Thesnare loop tightens the opened cliphead and exits from the humandigestive tract together with theendoscope. Then the endoscopewas reintroduced into the humandigestive tract and the operationcontinued. | ||||
| Snare openwidth | 10mm, 15mm, 25mm, 32mm | 10mm, 15mm, 25mm, 32mm | Substantial equivalence.We conducted bench teston our proposed devicein comparison with ourchosen predicate. All thetest results show that theproposed device is assafe and effective as ourpredicate device. Forbench tests reports,please refer to Section | |
| Polypectomy Snare | ||||
| Item | Proposed device | Predicate device (K172729) | Comparison | |
| 18 of this submission. | ||||
| Electrodeshape | Oval, shield, diamond, hexagon,polygon, round, crescent | Oval, hexagon, polygon, round,duck bill | Different.Bench test has beenconducted todemonstrate substantialequivalence, please referto Section 18 benchperformance testing. | |
| Loop length | 16mm, 22mm, 30mm, 31mm,45mm, 50mm, 52mm, 60mm; | 28mm, 32mm, 50mm, 63mm | Different.Bench test has beenconducted todemonstrate substantialequivalence, please referto Section 18 benchperformance testing. | |
| Loop area | 130mm², 135mm², 140mm²,210mm², 245mm², 250mm²,400mm², 650mm², 790mm²,830mm², 1050mm², 1250mm² | 225mm², 330mm², 850mm²,1335mm² | Different.Bench test has beenconducted todemonstrate substantialequivalence, please referto Section 18 benchperformance testing. | |
| Usabilityperformance | 1. Durability of mechanicalresection;2. Extension and retraction ofsnare loop;3. Rotation degree of snare loop;4. Tilting length;5. Change of loop width;6. Durability of snare loopwire-Pull force of keepingrequired width;7. Durability of snare loopwire-Service life of snare loop;8. Disassembly performance;9. Mechanical cutting force. | 1. Durability of mechanicalresection;2. Extension and retraction ofsnare loop;3. Rotation degree of snare loop;4. Tilting length;5. Change of loop width;6. Durability of snare loopwire-Pull force of keepingrequired width;7. Durability of snare loopwire-Service life of snare loop; | Substantial equivalence.We conducted usabilityperformance test on ourproposed device incomparison with ourchosen predicate. All thetest results show that theproposed device is assafe and effective as ourpredicate device. Forbench tests reports,please refer to Section18 of this submission. | |
| Electrical safety | The electrical safety performanceof the polypectomy snare shouldmeet the requirements of IEC60601-1: 2005+A1:2012, IEC60601-2-2:2017 and IEC | The electrical safetyperformance of the polypectomysnare should meet therequirements of IEC 60601-1:2005+A1:2012 IEC | Similar.We conducted Electricalsafety on our proposeddevice, for test reports,please refer to Section | |
| Item | Proposed device | Predicate device (K172729) | Comparison | |
| 60601-2-18. | 60601-2-2:2009 and IEC60601-2-18. | 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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Image /page/9/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 a sans-serif font to the right. Below the English text is the same company name in Chinese characters.
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.
§ 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).