(102 days)
Not Found
No
The description focuses solely on the mechanical and physical characteristics of the polypectomy snares and their intended use with or without diathermic energy. There is no mention of any software, algorithms, or data processing that would indicate the presence of AI or ML.
Yes
The device is used for the removal of polyps and tissue from the GI tract, which is a therapeutic intervention.
No
This device is used for the removal of polyps and tissue from the GI tract (therapeutic), not for identifying or diagnosing a medical condition.
No
The device description clearly details physical components such as cutting wires, catheters, and snare shapes, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the removal of polyps and tissue from within the GI tract using endoscopy and diathermic energy. This is a therapeutic or surgical procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a physical tool (a snare) designed to physically interact with tissue inside the body.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples in vitro), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used to remove tissue from the body, which is a treatment or intervention.
N/A
Intended Use / Indications for Use
Disposable Polynectomy Snare, Disposable Polypectomy Hybrid Snare is used endoscopically in the removal of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract. Disposable Polypectomy Snare shall be used with monopolar diathermic energy. Disposable Polypectomy Hybrid Snare shall be used with or without monopolar diathermic energy.
Product codes
FDI
Device Description
The Disposable Polypectomy Snare is available in two different types with rotating snare and non-rotating snare. The cutting wire diameter of the snares is 0.4mm. The catheter diameters are 1.8mm and 2.4mm the depending on the version. The snares are available in different forms, lengths and openings depending on the type.
- Non-rotating snares: The non-rotating snare is available in six different loop shape: Oval, Hexagon, Lune, Combination, Multiple and Composite. The snares are available in the opening widths 10mm, 15mm, 20mm, 25mm,30mm, 35mm. The snares are available in the working lengths 1800mm and 2300mm.
- Rotatable snares: The rotary snare is available in six different loop shape: Oval, Hexagon, Lune, Combination, Multiple and Composite. The opening widths are 10mm, 15mm, 20mm, 25mm, 30mm, 35mm, depending on the version. The snares are available in the working lengths 1800mm and 2300mm.
The Disposable Polypectomy Hybrid Snare is available in two different types with rotating snare and non-rotating snare. Only one available loop shape is Hybrid. The cutting wire diameter of the snares is 0.4mm. The catheter diameters is 2.4mm. The snares are available in different forms, lengths and openings depending on the type.
- Non-rotating snares: The non-rotating snare is available in the opening widths 10mm, 15mm, depending on the version. The snares are available in the working lengths 1800mm and 2300mm.
- Rotatable snares: The rotary snares are available 10mm, 15mm, depending on the version. The snares are available in the working lengths 1800mm and 2300mm.
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)
The following bench tests were performed on Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare: Appearance, Physical properties. The results of all testing were passing.
No Clinical Study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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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: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of human services. The right side of the logo features the FDA acronym in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
June 27, 2022
Yangzhou Fartley Medical Instrument Technology Co., Ltd. % Ethan Liu, RA Specialist Shanghai Thinkwell Consulting Co., Ltd Room 211/6F, Xinling Road, Minhang District Shanghai, Shanghai 201100 CHINA
K220790 Re:
Trade/Device Name: Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Code: FDI Dated: May 17, 2022 Received: May 23, 2022
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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 medical devices and radiation-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,
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
510(k) Number (if known) K220790
Device Name
Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare
Indications for Use (Describe)
Disposable Polynectomy Snare, Disposable Polypectomy Hybrid Snare is used endoscopically in the removal of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract. Disposable Polypectomy Snare shall be used with monopolar diathermic energy. Disposable Polypectomy Hybrid Snare shall be used with or without monopolar diathermic energy.
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| 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 "ARTLEY UNIQUE ENDOSCOPY". The word "ARTLEY" is in a stylized, bold, blue font with a yellow accent on the "Y". Below "ARTLEY" is the phrase "UNIQUE ENDOSCOPY" in a smaller, sans-serif font, also in blue. The logo appears to be for a company specializing in endoscopy equipment.
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: | Yangzhou Fartley Medical Instrument Technology Co., Ltd. |
|---|---|
| Address:Beizhou Road, Lidian Town, Guangling District, | |
| Yangzhou 225106 Jiangsu, China | |
| Contact | |
| Person: | Ethan Liu |
| RA Specialist | |
| Shanghai Thinkwell Consulting Co., Ltd | |
| Address: Room 211/6F, Xinling Road, Minhang Districtt, | |
| Shanghai, China. | |
| Phone: 0086-15216699240 | |
| Email: xtdeepwater@126.com | |
| Date | |
| Prepared: | May 17, 2022 |
5.2 Device
| Device Name: | Disposable Polypectomy Snare,
Disposable Polypectomy Hybrid Snare |
|----------------------|----------------------------------------------------------------------|
| Classification Name: | Endoscopic electrosurgical unit and accessories |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 876.4300 |
| Product Code: | FDI |
5.3 Predicate Device
| Device Name: | Polypectomy Snare
K172729 | |
|----------------------|-------------------------------------------------|--|
| Manufacturer: | Hangzhou AGS MedTech CO., Ltd. | |
| Classification Name: | Endoscopic electrosurgical unit and accessories | |
| Regulatory Class: | II | |
| Regulation Number: | 21 CFR 876.4300 | |
| Product Code: | FDI | |
5.4 Device Description
Disposable Polypectomy Snare
The Disposable Polypectomy Snare is available in two different types with rotating snare and non-rotating snare.
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Image /page/4/Picture/0 description: The image shows the logo for ARTLEY. The logo is in blue and yellow. The text "UNIQUE ENDOSCOPY" is below the main logo.
The cutting wire diameter of the snares is 0.4mm. The catheter diameters are 1.8mm and 2.4mm the depending on the version. The snares are available in different forms, lengths and openings depending on the type.
- Non-rotating snares
The non-rotating snare is available in six different loop shape: Oval, Hexagon, Lune, Combination, Multiple and Composite. The snares are available in the opening widths 10mm, 15mm, 20mm, 25mm,30mm, 35mm.The snares are available in the working lengths 1800mm and 2300mm.
- Rotatable snares
The rotary snare is available in six different loop shape: Oval, Hexagon, Lune, Combination, Multiple and Composite. The opening widths are 10mm, 15mm, 20mm.25mm. 30mm. 35mm. depending on the version. The snares are available in the working lengths 1800mm and 2300mm.
Disposable Polypectomy Hybrid Snare
The Disposable Polypectomy Hybrid Snare is available in two different types with rotating snare and non-rotating snare. Only one available loop shape is Hybrid.
The cutting wire diameter of the snares is 0.4mm. The catheter diameters is 2.4mm. The snares are available in different forms, lengths and openings depending on the type.
-
Non-rotating snares
The non-rotating snare is available in the opening widths 10mm, 15mm,depending on the version.The snares are available in the working lengths 1800mm and 2300mm. -
Rotatable snares
The rotary snares are available 10mm, 15mm, depending on the version. The snares are available in the working lengths 1800mm and 2300mm.
5.5 Indication for Use:
Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare is used endoscopically in the removal of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract. Disposable Polypectomy Snare shall be used with monopolar diathermic energy. Disposable Polypectomy Hybrid Snare shall be used with or without monopolar diathermic energy.
5.6 Comparison of Technological Characteristics
The Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare has substantially equivalent device design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device Hangzhou AGS MedTech CO., Ltd's Polypectomy Snare, K172729. The
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Image /page/5/Picture/0 description: The image shows the logo for ARTLEY UNIQUE ENDOSCOPY. The logo is in blue, except for the "Y" in ARTLEY, which is in yellow. The word "UNIQUE" is stacked on top of the word "ENDOSCOPY".
differences between the proposed device and the predicate devices do not raise any questions regarding its safety and effectiveness. The differences are listed in the table below.
| Item | Disposable
Polypectomy Snare,
Disposable
Polypectomy Hybrid
Snare(Proposed Device) | Polypectomy Snare,
K172729 | Discussion |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Indication for
Use | Disposable Polypectomy
Snare, Disposable
Polypectomy Hybrid
Snare is used
endoscopically in the
removal of diminutive
polyps, sessile polyps,
pedunculated polyps and
tissue from within the GI
tract. Disposable
Polypectomy Snare shall
be used with monopolar
diathermic energy.
Disposable Polypectomy
Hybrid Snare shall be
used with or without
monopolar diathermic
energy. | Polypectomy Snare is
used endoscopically
in the removal
and/or cauterization
of diminutive polyps,
sessile polyps,
pedunculated polyps
and tissue from within
the GI tract. | Substantially
equivalent |
| Product Code | FDI | FDI | Same |
| Energy Use | Monopolar Radio
Frequency Current | Monopolar Radio
Frequency Current | Same |
| Loop Shape | Disposable
Polypectomy
Snare:Oval, Hexagon,
Lune, Combination,
Multiple and Composite
Disposable
Polypectomy Hybrid
Snare:Hybrid | Hexagonal, Polygon ,
Oval, Round, Duck
Bill | Substantially
equivalent |
| Loop Width | Disposable
Polypectomy
Snare:10mm, 15mm,
20mm,25mm, 30mm,
35mm | Hexagonal: 10mm,
15mm, 25mm, 32mm
Polygon:10mm,
15mm, 25mm, 32mm
Oval:10mm, 15mm, | Similar |
| Item | Disposable
Polypectomy Snare,
Disposable
Polypectomy Hybrid
Snare(Proposed Device) | Polypectomy Snare,
K172729 | Discussion |
| | Disposable
Polypectomy Hybrid
Snare:10mm, 15mm | 25mm, 32mm
Round: 10mm,
15mm, 25mm, 32mm
Duck Bill: 10mm,
15mm, 25mm, 32mm | |
| Out tube
diameter | Disposable
Polypectomy
Snare:1.8mm, 2.4mm
Disposable
Polypectomy Hybrid
Snare:2.4mm | 1.8mm, 2.4mm | Same |
| Working
Length | 1800mm, 2300mm | 1800mm, 2300mm | Same |
| Sterilization | EO Sterilization;
SAL:10-6 | EO Sterilization;
SAL:10-6 | Same |
| Single Use | Yes | Yes | Same |
| Shelf Life | 3 years | 3 years | Same |
| Biocompatibility | Comply with ISO
10993-1 | Comply with ISO
10993-1 | Same |
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Image /page/6/Picture/0 description: The image shows the logo for "ARTLEY UNIQUE ENDOSCOPY". The word "ARTLEY" is in large, bold, blue font, with a yellow streak on the right side of the "Y". Below "ARTLEY" is the phrase "UNIQUE ENDOSCOPY" in a smaller, blue font. The logo appears to be for a medical device company.
5.7 Non-clinical Performance Data
The proposed device meets the requirements of ISO 10993 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing", ISO 11135-1 "Sterilization of Health Care products Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices", and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals" .
The following bench tests were performed on Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare: Appearance, Physical properties. The results of all testing were passing.
5.8 Clinical Test Data
No Clinical Study is included in this submission.
5.9 Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Yangzhou Fartley
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Image /page/7/Picture/0 description: The image shows the "ARTLEY UNIQUE ENDOSCOPY" logo. The word "ARTLEY" is in large, bold, blue font. Below that, the words "UNIQUE ENDOSCOPY" are in a smaller, blue font. There is a yellow line above the "EY" in "ARTLEY".
Medical Instrument Technology Co., Ltd. has demonstrated that proposed device Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare is substantially equivalent to Hangzhou AGS MedTech CO., Ltd's currently marketed Polypectomy Snare, K172729.