Polypectomy Snare

• K Number: K221713
• Device Name: Polypectomy Snare
• Manufacturer: Hangzhou AGS MedTech Co., Ltd.
• Date Cleared: 2023-03-03 ( 263 days)
• Product Code: FDI
• Regulation Number: 876.4300

Intended 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 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.

Predicate Devices

K172729

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical and electrosurgical function of a physical device (polypectomy snare) and does not mention any software, algorithms, or data processing related to AI/ML.

Therapeutic

Yes
The device is used for the removal and/or cauterization of polyps and tissue, which is a therapeutic intervention within the gastrointestinal tract.

Diagnostic

No

The device is described as being used for the "removal and/or cauterization" of polyps and tissue, which are interventional or therapeutic actions, not diagnostic ones. Performance studies mention mechanical and durability tests, not diagnostic accuracy metrics.

SaMD (Software as a Medical Device)

No

The device description clearly indicates it is a physical, sterile, single-use device used endoscopically, not a software-only product.

IVD (In Vitro Diagnostic)

No, 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 of the body.
• Device Function: The Polypectomy Snare is a surgical instrument used inside the body (endoscopically within the gastrointestinal tract) to physically remove or cauterize tissue. It does not perform any diagnostic tests on samples.

The description clearly indicates a device used for a therapeutic procedure (tissue removal and cauterization) performed directly on the patient's anatomy.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

FDI

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

gastrointestinal 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

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. No Clinical test is included in this submission.

Key Metrics

Not Found

Predicate Device(s)

K172729

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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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.

1

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 ([e-mail]) or phone [phone] 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
District, 311106 Hangzhou, Zhejiang, China
Establishment
Registration Number:	3010288205
Registration Status:	Active
Contact Person:	Jiayuan Zhang
Phone: [phone]
Fax: [phone]
Email: [e-mail]
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, 50710
series	5071, 5072, 5073, 5074, 5075,
5076, 5077, 5078, 5079, 50710
series	/
	510(k) submitter	Hangzhou AGS MedTech Co.,
Ltd.	Hangzhou AGS MedTech Co.,
Ltd.	/
	510(k) number	/	K172729	/
Technical	Principles
of operation	The polypectomy snare is intended
to pass through the endoscope via
working channel. When the
electrode appears in the
endoscopic view, push the sliding
handle forward to extend the
electrode from the sheath tube.
The electrode can be extended to a
certain open width in order to trap
the target tissue. Pull the sliding
handle back to hold the target
tissue within the electrode loop.
For hot indication, activate the
electrode. The snare electrode
delivers a high frequency current
to cut and cauterize tissue, and
then achieves separation and
coagulation of the tissue.
For cold indication, pull the
sliding handle back and without
activating the electrode.
Continually pull the sliding handle
and cut the tissue mechanically
with the electrode.
For remove indication, the device
can remove the specified released
Hemoclip (manufactured by
Hangzhou AGS, K211787). There	The polypectomy snare consists
of handle, sheath, flexible wire
and electrode, which is used
endoscopically in the removal of
diminutive and/or cauterization
of diminutive polyps, sessile
polyps, pedunculated polyps and
tissue from within the GI tract.
When passed through an
endoscope and activated, the
snare delivers a monopolar
electrical current to cut and
cauterize tissue with the
electrode.	Similar.
For proposed device,
add the cold indication
and the remove
indication. Bench test
has been conducted to
demonstrate substantial
equivalence, please refer
to Section 18 bench
performance testing.
Item	Proposed device	Predicate device (K172729)	Comparison
	is a locking hook at the end of the
Hemoclip's clips, when the clip
part released after the closing
movement, the locking hook forms
a buckle with the groove at the
lower end of the frap tube, making
the two clips self-locking and
closing, so as to achieve
mechanical suture of the tissue at
the lesion. Intraoperative, when
operators find close position is not
ideal, need to be adjusted to
remove the released and closed
clip head, they could take a snare
product, since the endoscopic
clamp inserts, in the perspective of
endoscopic, the snare loop goes
into the grooves, gradually
tightening the snare loop, apply a
pressure to the locked hook, press
the hooks in, release the lock
buckle, so that the two closed clips
open, and the closed clip head
leave the original lesion site; The
snare loop tightens the opened clip
head and exits from the human
digestive tract together with the
endoscope. Then the endoscope
was reintroduced into the human
digestive tract and the operation
continued.
Snare open
width	10mm, 15mm, 25mm, 32mm	10mm, 15mm, 25mm, 32mm	Substantial equivalence.
We conducted bench test
on our proposed device
in comparison with our
chosen predicate. All the
test results show that the
proposed device is as
safe and effective as our
predicate device. For
bench tests reports,
please refer to Section
				Polypectomy Snare
Item	Proposed device	Predicate device (K172729)	Comparison
			18 of this submission.
Electrode
shape	Oval, shield, diamond, hexagon,
polygon, round, crescent	Oval, hexagon, polygon, round,
duck bill	Different.
Bench test has been
conducted to
demonstrate substantial
equivalence, please refer
to Section 18 bench
performance testing.
Loop length	16mm, 22mm, 30mm, 31mm,
45mm, 50mm, 52mm, 60mm;	28mm, 32mm, 50mm, 63mm	Different.
Bench test has been
conducted to
demonstrate substantial
equivalence, please refer
to Section 18 bench
performance testing.
Loop area	130mm², 135mm², 140mm²,
210mm², 245mm², 250mm²,
400mm², 650mm², 790mm²,
830mm², 1050mm², 1250mm²	225mm², 330mm², 850mm²,
1335mm²	Different.
Bench test has been
conducted to
demonstrate substantial
equivalence, please refer
to Section 18 bench
performance testing.
Usability
performance	1. Durability of mechanical
resection;

2. Extension and retraction of
   snare loop;
3. Rotation degree of snare loop;
4. Tilting length;
5. Change of loop width;
6. Durability of snare loop
   wire-Pull force of keeping
   required width;
7. Durability of snare loop
   wire-Service life of snare loop;
8. Disassembly performance;
9. Mechanical cutting force. | 1. Durability of mechanical
   resection;
10. Extension and retraction of
    snare loop;
11. Rotation degree of snare loop;
12. Tilting length;
13. Change of loop width;
14. Durability of snare loop
    wire-Pull force of keeping
    required width;
15. Durability of snare loop
    wire-Service life of snare loop; | Substantial equivalence.
    We conducted usability
    performance test on our
    proposed device in
    comparison with our
    chosen predicate. All the
    test results show that the
    proposed device is as
    safe and effective as our
    predicate device. For
    bench tests reports,
    please refer to Section
    18 of this submission. | |
    | Electrical safety | The electrical safety performance
    of the polypectomy snare should
    meet the requirements of IEC
    60601-1: 2005+A1:2012, IEC
    60601-2-2:2017 and IEC | The electrical safety
    performance of the polypectomy
    snare should meet the
    requirements of IEC 60601-1:
    2005+A1:2012 IEC | Similar.
    We conducted Electrical
    safety on our proposed
    device, for test reports,
    please refer to Section | |
    | Item | Proposed device | Predicate device (K172729) | Comparison | |
    | | 60601-2-18. | 60601-2-2:2009 and IEC
    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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Section 5 510(k) Summary

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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.