(175 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical properties, with no mention of AI/ML or data processing for decision-making.
Yes
The device is used for the removal and/or cauterization of polyps and tissue, which are therapeutic interventions.
No
The device is described as a "Polypectomy Snare" used for the removal and/or cauterization of polyps and tissue. Its function involves delivering an electrical current to "cut and cauterize tissue." There is no mention of it collecting information for diagnosis or providing diagnostic output.
No
The device description clearly outlines physical components like a wire cable, loop, sheath, and handle, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the removal and/or cauterization of polyps and tissue from within the gastrointestinal tract. This is a therapeutic and surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical tool used for cutting and cauterizing tissue in vivo (within a living organism).
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is clearly a surgical instrument used for direct intervention within the body, not for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
The Polypectomy Snare is used endoscopically in the removal and/or and cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract.
Product codes
FDI
Device Description
The Polypectomy Snare consists of a flexible wire cable (core wire) and loop which can be extended and retracted from the Snare's flexible outer sheath using a threering handle. The flexible cable and loop can also be rotated 360° using the rotation actuator on the handle. The inner diameter of the sheath is PTFE to provide minimal friction during extension, rotation, and retraction of the loop from the sheath. When passed through an endoscope and activated, the Snare delivers a monopolar electrical current to cut and cauterize tissue with the loop.
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
In-vitro Testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests. A summary of the test results has been provided for Working Length, Tortuous Path Functionality, Rotation Capability, Handle to Core Wire Tensile Strength, Electrical Resistance, Electrical Safety and Snare Actuation.
The EO residual and ECH residual were measured after sterilization of the device to meet the criteria defined in ISO 11135 Second edition 2014 and ISO 10993-7 Second Edition 2008-10-15.
The shelf-life for three years had been validated in accelerated testing according to ASTM F1980-16 (2016) and the requirements on packaging for terminally sterilized medical device per ISO 11607-1 First Edition 2006-04-15 and ISO 11607-2 First Edition 2006-04-15 are also met. The testing successfully demonstrated essential performance is achieved before and after the shelf life test.
Biocompatibility testing was performed in accordance with the FDA Guidance," Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued on June 26, 2016. The cytotoxicity, sensitization, intracutaneous irritation, system toxicity pyrogen and endotoxin tests were performed to demonstrate the biocompatibility of the device.
Tests on Electromagnetic Compatibility and Electrical Safety were performed in accordance to requirements per AAMI/ANSI ES 60601-1:2005/(R)2012 and AAMI/ANSI/IEC 60601-2-2:2009.
No clinical study is included in this submission.
Key Metrics
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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March 7, 2018
Zhejiang Chuangxiang Medical Technology Co., LTD. Lucius Long Quality Supervisor 301B, No.22, XinYan Road Hangzhou, Zhejiang 311100 China
Re: K172758
Trade/Device Name: Rotatable Snares, Non-Rotatable Snares Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: II Product Code: FDI Dated: January 4, 2018 Received: January 4, 2018
Dear Lucius Long:
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,
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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) K172758
Device Name Rotatable Snares Non-Rotatable Snares
Indications for Use (Describe)
The Polypectomy Snare is used endoscopically in the removal and/or and cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract.
Type of Use (Select one or both, as applicable)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/1 description: The image contains a logo with a geometric shape on the left, transitioning from blue to green. To the right of the shape, there is text in blue that appears to be Chinese characters. Below the Chinese characters, the word "MEDNOVA" is written, with "MED" in blue and "NOVA" in green, matching the color gradient of the geometric shape.
Section 2 510(k) Summary( 21CFR 807.92)
1. Submitter's information
Name: Zhejiang Chuangxiang Medical Technology Co., LTD.
Address: 301B, No.22, XinYan Road Yuhang Economic And Technological Development Zone Hangzhou Zhejiang China
Contact person: Lucius.Long Telephone: 86-571-89167088 Fax: 86-571-89167086
2. Device
Trade Name: Rotatable Snares, Non-Rotatable Snares Common Name: Polypectomy Snare Classification name: Endoscopic electrosurgical unit and accessories Regulation class: 2 Regulation number:876.4300 Panel: Gastroenterology/Urology Product code: FDI
3. Predicative device
510(k) Number: K160637, Product Name: Rotatable Snares
4. Device description
The Polypectomy Snare consists of a flexible wire cable (core wire) and loop which can be extended and retracted from the Snare's flexible outer sheath using a threering handle. The flexible cable and loop can also be rotated 360° using the rotation actuator on the handle. The inner diameter of the sheath is PTFE to provide minimal friction during extension, rotation, and retraction of the loop from the sheath. When passed through an endoscope and activated, the Snare delivers a monopolar electrical current to cut and cauterize tissue with the loop.
For All models information in this submission, please refer to below table 1.
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Image /page/4/Picture/1 description: The image contains a logo with text. On the left side, there is a geometric shape with a gradient of green and blue. To the right of the shape, there is the text "MEDNOVA" in green and blue. Above the text, there are three Chinese characters in blue.
Table 1 List of models in this submission
| Model | Part Number | Max. OD
(mm)
≤ D (mm) | Snare Loop
Opening Width
(mm)
B +10%
-20% | Effective Length
(mm)
L (mm) ±100 | |
|-------------------|----------------|-----------------------------|-------------------------------------------------------|-----------------------------------------|------|
| E
Oval | MD-E-SNC181024 | Φ1.8 | 10 | 2400 | |
| | MD-E-SNC181524 | Φ1.8 | 15 | 2400 | |
| | MD-E-SNC181018 | Φ1.8 | 10 | 1800 | |
| | MD-E-SNC181518 | Φ1.8 | 15 | 1800 | |
| E
Oval | MD-E-SNC241024 | Φ2.4 | 10 | 2400 | |
| | MD-E-SNC241524 | Φ2.4 | 15 | 2400 | |
| | MD-E-SNC241018 | Φ2.4 | 10 | 1800 | |
| | MD-E-SNC241518 | Φ2.4 | 15 | 1800 | |
| | MD-E-SNC242516 | Φ2.4 | 25 | 1600 | |
| | MD-E-SNC242524 | Φ2.4 | 25 | 2400 | |
| | MD-E-SNC243224 | Φ2.4 | 32 | 2400 | |
| | MD-E-SNC242518 | Φ2.4 | 25 | 1800 | |
| Standard
(C) | MD-E-SNC243218 | Φ2.4 | 32 | 1800 | |
| | MD-H-SNC241024 | Φ2.4 | 10 | 2400 | |
| | MD-H-SNC241524 | Φ2.4 | 15 | 2400 | |
| H
Hexagonal | MD-H-SNC242224 | Φ2.4 | 22 | 2400 | |
| | MD-H-SNC243224 | Φ2.4 | 32 | 2400 | |
| | MD-H-SNC241018 | Φ2.4 | 10 | 1800 | |
| | MD-H-SNC241518 | Φ2.4 | 15 | 1800 | |
| H
Hexagonal | MD-H-SNC242218 | Φ2.4 | 22 | 1800 | |
| | MD-H-SNC243218 | Φ2.4 | 32 | 1800 | |
| | MD-C-SNC241524 | Φ2.4 | 15 | 2400 | |
| | MD-C-SNC242524 | Φ2.4 | 25 | 2400 | |
| C
Crescent | MD-C-SNC243224 | Φ2.4 | 32 | 2400 | |
| | MD-C-SNC241518 | Φ2.4 | 15 | 1800 | |
| | MD-C-SNC242518 | Φ2.4 | 25 | 1800 | |
| MD-C-SNC243218 | Φ2.4 | 32 | 1800 | | |
| | R | MD-R-SNC243224 | $Φ$ 2.4 | 32 | 2400 |
| | Round | MD-R-SNC243218 | $Φ$ 2.4 | 32 | 1800 |
| | E
Oval | MD-E-SNR181024 | $Φ$ 1.8 | 10 | 2400 |
| | | MD-E-SNR181524 | $Φ$ 1.8 | 15 | 2400 |
| | | MD-E-SNR181018 | $Φ$ 1.8 | 10 | 1800 |
| | | MD-E-SNR181518 | $Φ$ 1.8 | 15 | 1800 |
| | | MD-E-SNR241024 | $Φ$ 2.4 | 10 | 2400 |
| | | MD-E-SNR241524 | $Φ$ 2.4 | 15 | 2400 |
| | | MD-E-SNR241018 | $Φ$ 2.4 | 10 | 1800 |
| | | MD-E-SNR241518 | $Φ$ 2.4 | 15 | 1800 |
| | | MD-E-SNR242516 | $Φ$ 2.4 | 25 | 1600 |
| | | MD-E-SNR242524 | $Φ$ 2.4 | 25 | 2400 |
| | | MD-E-SNR243224 | $Φ$ 2.4 | 32 | 2400 |
| | | MD-E-SNR242518 | $Φ$ 2.4 | 25 | 1800 |
| | | MD-E-SNR243218 | $Φ$ 2.4 | 32 | 1800 |
| Rotational
(R) | H
Hexagonal | MD-H-SNR241024 | $Φ$ 2.4 | 10 | 2400 |
| | | | MD-H-SNR241524 | $Φ$ 2.4 | 15 |
| | | | MD-H-SNR242224 | $Φ$ 2.4 | 22 |
| | | | MD-H-SNR243224 | $Φ$ 2.4 | 32 |
| | | | MD-H-SNR241018 | $Φ$ 2.4 | 10 |
| | | | MD-H-SNR241518 | $Φ$ 2.4 | 15 |
| | | | MD-H-SNR242218 | $Φ$ 2.4 | 22 |
| | | | MD-H-SNR243218 | $Φ$ 2.4 | 32 |
| | C
Crescent | MD-C-SNR241524 | $Φ$ 2.4 | 15 | 2400 |
| | | | MD-C-SNR242524 | $Φ$ 2.4 | 25 |
| | | | MD-C-SNR243224 | $Φ$ 2.4 | 32 |
| | | | MD-C-SNR241518 | $Φ$ 2.4 | 15 |
| | | | MD-C-SNR242518 | $Φ$ 2.4 | 25 |
| | | | MD-C-SNR243218 | $Φ$ 2.4 | 32 |
| | R | MD-R-SNR243224 | $Φ$ 2.4 | 32 | 2400 |
| | Round | MD-R-SNR243218 | $Φ$ 2.4 | 32 | 1800 |
5
Image /page/5/Picture/1 description: The image contains a logo for a company called MEDNOVA. The logo consists of a green and blue shield with a white geometric shape inside. To the right of the shield is the company name, with "MED" in green and "NOVA" in blue. Above the company name are two Chinese characters in blue.
6
Image /page/6/Picture/1 description: The image shows the logo for MEDNOVA. The logo consists of a green and blue shield-like shape on the left, with the text "MEDNOVA" in green below it. To the right of the shield is the company name in Chinese, written in blue.
5. Indication for use
The Polypectomy Snare is used endoscopically in the removal and/or and cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract.
6. Technological Characteristics
The Polypectomy Snare incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the Boston Scientific Corporation predicate devices.
Comparison to predicate Devices:
| Item | Proposed device | Predicate device | Comparison to
Predicate
Devices |
|-------------------------------|---------------------------------------------------------|-------------------------------------|---------------------------------------|
| Device name | Polypectomy
Snare | Rotatable Snares | Similiar |
| 510(k)
number | NA, new
submission | K160637 | Different 510(k)
number |
| Manufacture
r | Zhejiang
Chuangxiang medical
technology Co., Ltd. | Boston Scientific
Corporation | Different
manufacturer |
| Product
Code | FDI | FDI, FGX | Same |
| Regulation
No. | 876.4300 | 876.4300 | Same |
| Class | 2 | 2 | Same |
| Supplied
Sterile | Yes | Yes | Same |
| Configuratio
n | Oval, Hexagonal,
Crescent, Round | Oval, Hexagonal,
Crescent, Round | Same |
| Minimal
working
channel | 2.8mm | 2.8mm | Same |
| Sheath OD | 2.4mm | 2.4mm | Same |
| Working
Length | 1600mm,1800m
m,2400mm | 2400mm | similar |
| Loop width | 10mm, 15mm, 22mm | 10mm, 11mm, 13mm, 15mm | similar |
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Image /page/7/Picture/1 description: The image shows the logo for MEDNOVA. The logo consists of a geometric shape in shades of green on the left, followed by the text "MEDNOVA" in green. To the right of the logo is Chinese text in blue.
| | mm,25mm,32mm, | mm,20mm,25mm,27mm,30
mm,33mm | |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Indications
for Use | The 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. | The Rotatable Snare is
used endoscopically in the
removal and/or
cauterization of diminutive
polyps, sessile polyps,
pedunculated polyps and
tissue from within the
gastrointestinal tract. | Same |
| Single Use | Yes | Yes | Same |
| Packaging | Single-use EO
sterilized pouch with
one device per pouch | Single-use EO sterilized
pouch with one device per
pouch | Same |
7. Performance data
In-vitro Testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests. A summary of the test results has been provided for Working Length, Tortuous Path Functionality, Rotation Capability, Handle to Core Wire Tensile Strength, Electrical Resistance, Electrical Safety and Snare Actuation.
The EO residual and ECH residual were measured after sterilization of the device to meet the criteria defined in ISO 11135 Second edition 2014 and ISO 10993-7 Second Edition 2008-10-15.
The shelf-life for three years had been validated in accelerated testing according to ASTM F1980-16 (2016) and the requirements on packaging for terminally sterilized medical device per ISO 11607-1 First Edition 2006-04-15 and ISO 11607-2 First Edition 2006-04-15 are also met. The testing successfully demonstrated essential performance is achieved before and after the shelf life test.
Biocompatibility testing was performed in accordance with the FDA Guidance," Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued on June 26, 2016. The cytotoxicity, sensitization, intracutaneous irritation, system toxicity pyrogen and endotoxin tests were performed to demonstrate the biocompatibility of the device.
8
Image /page/8/Picture/1 description: The image shows the logo for MEDNOVA. The logo consists of a blue and green hexagon shape on the left, with the text "MEDNOVA" in green and blue to the right of the shape. Above the text "MEDNOVA" are three blue Chinese characters.
Tests on Electromagnetic Compatibility and Electrical Safety were performed in accordance to requirements per AAMI/ANSI ES 60601-1:2005/(R)2012 and AAMI/ANSI/IEC 60601-2-2:2009.
8. Clinical Test Conclusion
No clinical study is included in this submission.
9. Conclusions
Chuangxiang medical has demonstrated that the proposed Polypectomy Snare are substantially equivalent to Boston Scientific Corporation's currently marketed Rotatable Snares(K160637).