(252 days)
Not Found
No
The device description and performance studies focus on the mechanical and electrical properties of a traditional polypectomy snare, with no mention of AI or ML capabilities.
No.
The device is used to remove polyps and tissue but does not treat a disease or condition.
No
The device is used for the removal of polyps and tissue within the GI tract, and does not perform any diagnostic function.
No
The device description clearly outlines physical components such as a handle, sheath, flexible wire, and electrode, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is done outside the body (in vitro).
- Device Function: The Polypectomy Snare is a surgical instrument used inside the body (in vivo) to physically remove polyps and tissue from the GI tract. It uses mechanical action and electrical energy, not laboratory analysis of specimens.
- Intended Use: The intended use clearly states "used endoscopically in the removal of diminutive polyps, pedunculated polyps and tissue from within the GI tract." This describes a therapeutic procedure, not a diagnostic test performed on a sample.
The device is a surgical tool used during an endoscopic procedure, not a diagnostic test performed on a sample in a lab.
N/A
Intended Use / Indications for Use
Polypectomy Snare is used endoscopically in the removal of diminutive polyps, pedunculated polyps and tissue from within the GI tract.
Product codes (comma separated list FDA assigned to the subject device)
FDI
Device Description
The polypectomy snare consists of handle, sheath, flexible wire and electrode that is used to remove polys utilizing monopolar RF energy under endoscopic visualization.
The rotary snares' cable and polypectomy can be rotated using the rotation actuator on the handle.
Polypectomy snare is sterile for single use with no delayed hypersensitivity and no intracutaneous reactivity, have no animal or human origin substance.
The electrode of polypectomy snare has five shapes to be used in clinical practice: Oval, Polygon, Duck Bill, Hexagonal and Round, and the electrode can extend, retract from the snare's flexible outer sheath.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI 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)
No Clinical Study is included in this submission.
The following bench tests were performed on Polypectomy snare: Appearance, Size, Material, Usability, Electric property. The results of all testing were passing.
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 contains 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, 2018
Hangzhou AGS MedTech CO., Ltd % Ethan Liu RA Specialist Shanghai Thinkwell Consulting Co., Ltd. Xin Ling Road, 211/6F Shanghai, 201100 China
Re: K172729
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: April 13, 2018 Received: April 20, 2018
Dear Ethan Liu:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joyce M. Whang -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Polypectomy Snare
Indications for Use (Describe)
Polypectomy Snare is used endoscopically in the removal of diminutive polyps, pedunculated polyps and tissue from within the GI tract.
| 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) |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
d a person is espon دائل الملك ال ી । ઉપ information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image contains a logo for AGS MEOTECH. The logo consists of a circular design with three curved shapes in blue and green. To the right of the circular design is the text "AGS MEOTECH" in English, followed by the same name in Chinese characters. The logo appears to be for a medical technology company.
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
5.1 Submitter
| Submitted by: | Hangzhou AGS MedTech CO., Ltd.
Building 6, Kangxin Road No.597, Qianjiang
Economic Development Area , Hangzhou ,
Zhejiang , 311106, China |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration Number: | 3010288205 |
| Owner/Operator
Number: | 10052959 |
| Contact Person: | Ethan Liu
Phone:0086-15216699240
Fax: 0086-21-60732022
Email:xtdeepwater@126.com |
| Date Prepared: | Jan 18, 2017 |
5.2 Device
| Device Name: | Polypectomy Snare |
|---|---|
| Common Name: | Polypectomy Snare |
| Regulatory Class: | Class II |
| Regulation Number | 876.4300 |
| Product Code Name: | Snare, Flexible |
| Regulation Name: | Endoscopic electrosurgical unit and accessories |
| Product Code: | FDI |
5.3 Predicate Device
| Device Name: | Single Use Polypectomy Snares
Captivator II, Single-Use Polypectomy Snares
K133987 |
|--------------------|------------------------------------------------------------------------------------------|
| Common Name: | Polypectomy Snare |
| Regulatory Class: | Class II |
| Regulation Number | 876.4300 |
| Product Code Name: | Snare, Flexible |
| Regulation Name: | Endoscopic electrosurgical unit and accessories |
| Product Code: | FDI |
5.4 Device Description
The polypectomy snare consists of handle, sheath, flexible wire and electrode that is used to remove polys utilizing monopolar RF energy under endoscopic visualization.
4
Image /page/4/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 curved shapes in blue and green, arranged in a triangular pattern. To the right of the logo, there is text in two lines, with the first line reading "AGS MEDTECH" in English. The second line contains Chinese characters, which translate to "An Jie Si Medical".
K172729 Page 2 of 3
The rotary snares' cable and polypectomy can be rotated using the rotation actuator on the handle.
Polypectomy snare is sterile for single use with no delayed hypersensitivity and no intracutaneous reactivity, have no animal or human origin substance.
The electrode of polypectomy snare has five shapes to be used in clinical practice: Oval, Polygon, Duck Bill, Hexagonal and Round, and the electrode can extend, retract from the snare's flexible outer sheath.
5.5 Indication for Use:
Polypectomy Snare is used endoscopically in the removal of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.
5.6 Technology Characteristics
The polypectomy snare consists of handle, sheath, flexible wire and electrode, which are used endoscopically in the removal 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.
The proposed device contain both rotary and non-rotary specifications, the rotary snares' cable and polypectomy can be rotated using the rotation actuator on the handle, the main differences of these specifications are dimension.
5.7 Applicable Guidance Document
Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology
5.8 Substantial Equivalence
Captivator II, Single-Use Polypectomy Snare(Boston Scientific Corporation, K133987) is used as predicate device compared to proposed device Polypectomy Snare manufactured by Hangzhou MedTech Co., Ltd.
5.9 Performance Data
5.9.1 Biocompatibility Testing
The biocompatibility evaluation for this device was conducted in accordance with the FDA Bluebook Memorandum G95-1 "Use Of International Standard ISO-10993, 'Biological Evaluation Of Medical Devices Part 1: Evaluation And Testing.'" and the International Standard ISO 10993-1 Fourth Edition 2009-10-15, Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process [Including: Technical Corrigendum 1 (2010)], as recognized by FDA.
| Biocompatibility
| Test | Standards | Test Result | Verdict |
|---|---|---|---|
| -------------------------- | ----------- | ------------- | --------- |
5
Image /page/5/Picture/0 description: The image contains a logo with a blue circular design on the left and text on the right. The circular design consists of three curved shapes that form a triangular pattern with a green center. To the right of the logo, the text "AGS MEDTECH" is written in a simple, sans-serif font. Below "AGS MEDTECH", there are three Chinese characters, which appear to be a translation or alternative name for the company.
Section 5 510(k) Summary Polynectomy Snari
| In
| Cytotoxicity | Vitro ISO 10993-5:2009 | No cytotoxicity observed. | Pass |
|---|---|---|---|
| Delayed-type | |||
| Hypersensitivity | ISO 10993-10:2010 | No hypersensitivity observed | Pass |
| Irritation | ISO 10993-10:2010 | No irritation observed | Pass |
5.8.2 Performance Testing
The following bench tests were performed on Polypectomy snare: Appearance, Size, Material, Usability, Electric property. The results of all testing were passing.
5.9 Clinical Test Conclusion
No Clinical Study is included in this submission.
5.11 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 Boston Scientific Corporation's currently marketed Captivator II, Single-Use Polypectomy Snares(K133987).