(171 days)
Not Found
No
The device description and performance studies focus on the mechanical and electrical aspects of a traditional polypectomy snare, with no mention of AI or ML capabilities.
Yes
The device is used to remove polyps from the GI tract, delivering an electrical current to cut and cauterize tissue, which directly treats a medical condition.
No
The device is used for the removal of polyps and not for diagnostic purposes; it is a therapeutic device.
No
The device description clearly states it is a physical, sterile, single-use endoscopic device with a wire cable, loop, sheath, and handle, designed to deliver electrical current for cutting and cauterization. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Polypectomy Snare is a surgical instrument used within the body (in the GI tract) to physically remove polyps. It uses mechanical action (snaring) and electrical current (cutting and cauterization) directly on the tissue.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. It interacts directly with the tissue in situ.
The description clearly indicates the device's purpose is the physical removal of polyps during an endoscopic procedure, which is a surgical intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Polypectomy Snares are used endoscopically in the removal of diminutive polyps, and pedunculated polyps within the GI tract.
The Polypectomy Snares are used endoscopically in the removal of diminutive polyps, sessile polyps, and pedunculated polyps from within the GI tract.
Product codes (comma separated list FDA assigned to the subject device)
FDI
Device Description
The proposed device Polypectomy Snare is a sterile, single-use endoscopic device, intended to be used endoscopically in the removal diminutive polyps, sessile polyps, and pedunculated polyps from within the GI tract.
The Polypectomy Snares consists of a flexible wire cable and loop which can be extended and retracted from the snare's flexible outer sheath using a handle. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop. The proposed device has eighteen (18) specifications; the main differences of these specifications are dimension and if the loop can be rotatable with the rotation of the handle.
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ASTM F88/F88M-09, Standard Test Method For Seal Strength Of Flexible Barrier Materials.
ASTM F1929-12, Standard Test Method For Detecting Seal Leaks In Porous Medical Packaging By Dye Penetration.
ASTM F1140/F1140M-13, Standard Test Methods For Internal Pressurization Failure Resistance Of Unrestrained Packages.
IEC60601-2-18:2009 Medical electrical equipment Part 2-18: Particular requirements for the safety of endoscopic equipment
ANSI/AAMI HF18:2001 Electrosurgical devices
AAMI ANSI ES60601-1:2005/(R)2012 And C1:2009/(R)2012 Medical Electrical
Equipment Part 1: General requirements for safety
IEC60601-2-2:2009 Medical electrical equipment Part 2-2: Particular requirements for the safety of high frequency surgical equipment
ISO 11737-1 Second Edition 2006-04-01 Sterilization of medical devices -
Microbiological methods—Part 1: Determination of a population of microorganisms on products
ASTM F1886/F1886M - 09 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
ASTM F1929-12, Standard Test Method For Detecting Seal Leaks In Porous Medical Packaging By Dye Penetration
ASTM F1980 - 07:2011 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
AAMI ANSI ST72:2011 bacterial endotoxins - test methods, routine monitoring, and alternatives to batch testing.
ASTM F88/F88M-09, Standard Test Method For Seal Strength Of Flexible Barrier Materials.
ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
ISO 10993-7:2008(R) 2012, Biological Evaluation Of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals.
ISO 10993-10:2010, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
USP Sterility Tests.
USP 37-NF 32: 2014 BACTERIAL ENDOTOXINS TEST.
No clinical study is included in this submission.
Based on the comparison and analysis from the nonclinical tests, the proposed devices is safe and effective, perform is as well as the predicate devices. It determined to be Substantially Equivalent (SE) to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Electrode contact impedance: 13.46 +/- 0.68
Cutting: 23.75 +/- 1.14
Pushability: 3.08 +/- 0.64
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 30, 2015
Micro-Tech (Nanjing) Co., Ltd. Becky Li Manager of Quality Department No. 10 Gaoke Third Road Nanjing, Jiangsu 210032 China
Re: K150316
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: June 15, 2015 Received: June 22, 2015
Dear Becky Li,
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. 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 (reporting of medical device
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher, Ph.D. for 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) K150316
Device Name Polyhpectomy Snare
Indications for Use (Describe)
The Polypectomy Snares are used endoscopically in the removal of diminutive polyps, and pedunculated polyps within the GI 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)
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 PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/1 description: The image shows the logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, three-dimensional font, with the words "MICRO-TECH" written to the right of the letters. Below the words "MICRO-TECH" are two Chinese characters. The logo is blue and white.
510K Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K150316
1. Date of Preparation: 01/16/2015
2. Sponsor Identification
Micro-Tech (Nanjing) Co., Ltd.
No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone, Nanjing, Jiangsu Province, PRC Establishment Registration Number: 3004837686 Contact Person: Becky Li Position: Manager of Quality Department Tel: +86-25-58646378 Fax: +86-25-58744269 Email: In@micro-tech.com.cn
3. Identification of Proposed Device
Product Name: Polypectomy Snare Common Name: Snare, Flexible Regulatory Information Classification Name: Endoscopic electrosurgical unit and accessories Classification: 2 Product Code: FDI Subsequent Product Code: FDI Regulation Number: 876.4300 Review Panel: Gastroenterology/Urology
4. Predicate Devices:
GIP/MEDI-GLOBE POLYPECTOMY SNARES cleared under K943935
5. Indications for Use
The Polypectomy Snares are used endoscopically in the removal of diminutive polyps, sessile polyps, and pedunculated polyps from within the GI tract.
4
Image /page/4/Picture/1 description: The image shows the logo for MICRO-TECH. The logo consists of a blue stylized "MT" on the left, followed by the text "MICRO-TECH" in a sans-serif font. There is a thin line underneath the text, and below that are two Chinese characters. The logo is simple and modern, with a focus on the company's name.
6. Device Description
The proposed device Polypectomy Snare is a sterile, single-use endoscopic device, intended to be used endoscopically in the removal diminutive polyps, sessile polyps, and pedunculated polyps from within the GI tract.
The Polypectomy Snares consists of a flexible wire cable and loop which can be extended and retracted from the snare's flexible outer sheath using a handle. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop. The proposed device has eighteen (18) specifications; the main differences of these specifications are dimension and if the loop can be rotatable with the rotation of the handle.
7. Identification of Predicate Device
510(k) Number: K943935 Product Name: GIP/MEDI-GLOBE POLYPECTOMY SNARES
8. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ASTM F88/F88M-09, Standard Test Method For Seal Strength Of Flexible Barrier Materials.
ASTM F1929-12, Standard Test Method For Detecting Seal Leaks In Porous Medical Packaging By Dye Penetration.
ASTM F1140/F1140M-13, Standard Test Methods For Internal Pressurization Failure Resistance Of Unrestrained Packages.
IEC60601-2-18:2009 Medical electrical equipment Part 2-18: Particular requirements for the safety of endoscopic equipment
ANSI/AAMI HF18:2001 Electrosurgical devices
AAMI ANSI ES60601-1:2005/(R)2012 And C1:2009/(R)2012 Medical Electrical
Equipment Part 1: General requirements for safety
IEC60601-2-2:2009 Medical electrical equipment Part 2-2: Particular requirements for the safety of high frequency surgical equipment
ISO 11737-1 Second Edition 2006-04-01 Sterilization of medical devices -
Microbiological methods—Part 1: Determination of a population of microorganisms on products
ASTM F1886/F1886M - 09 Standard Test Method for Determining Integrity of Seals for
5
Image /page/5/Picture/1 description: The image shows the logo for Micro-Tech. The logo consists of the letters "MT" in a stylized, three-dimensional font on the left. To the right of the letters is the text "MICRO-TECH" in a sans-serif font, with a thin line underneath. Below the line are two Chinese characters.
Flexible Packaging by Visual Inspection
ASTM F1929-12, Standard Test Method For Detecting Seal Leaks In Porous Medical Packaging By Dye Penetration
ASTM F1980 - 07:2011 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
AAMI ANSI ST72:2011 bacterial endotoxins - test methods, routine monitoring, and alternatives to batch testing.
ASTM F88/F88M-09, Standard Test Method For Seal Strength Of Flexible Barrier Materials.
ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
ISO 10993-7:2008(R) 2012, Biological Evaluation Of Medical Devices - Part 7:
Ethylene Oxide Sterilization Residuals.
ISO 10993-10:2010, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
USP Sterility Tests.
USP 37-NF 32: 2014 BACTERIAL ENDOTOXINS TEST
9. Clinical Test Conclusion
No clinical study is included in this submission.
10. Substantially Equivalent (SE) Comparison
6
Image /page/6/Picture/0 description: The image contains a logo for MICRO-TECH. The logo consists of a stylized blue "MT" monogram on the left, followed by the text "MICRO-TECH" in blue. Below the text, there are two Chinese characters in a lighter shade of blue.
510K Summary
| Item | Proposed Device | Predicate Device | Substantial Equivalence |
|---|---|---|---|
| Product Code | FDI | FDI | Same |
| Regulation No. | 876.4300 | 876.4300 | Same |
| Class | 2 | 2 | Same |
| Indications for Use | The Polypectomy Snares are used | ||
| endoscopically in the removal diminutive | |||
| polyps, sessile polyps, and pedunculated | |||
| polyps from within the GI tract. | The Polypectomy snare is intended to | ||
| remove polyps and small tumors from | |||
| the gastrointestinal tract with high | |||
| frequency current. | Similar | ||
| Single Use | Yes | Yes | Same |
| Configuration | Configuration Loop, outer tube, | ||
| High-Frequency, and Handle | Loop, outer tube, High-Frequency, | ||
| and Handle | Same | ||
| Energy used/ Delivered | Monopolar Radio Frequency Current | Monopolar Radio Frequency Current | Same |
| Loop Shape | Oval | Oval, Hexagonal, Asymmetric | Similar |
| Loop Diameter | Oval: 10mm, 15mm, 20mm, 24mm, 30mm, | ||
| 36mm | Oval: 15mm, 20mm, 25mm, 35mm, | ||
| 50mm; | |||
| Hexagonal: 15mm, 25mm, 35mm; | |||
| Asymmetric: 15mm, 25mm | Similar | ||
| Outer Tube Diameter | 2.3mm | 2.5mm | Similar |
| Minimal Working Channel | 2.8mm | 2.8mm | Same |
| Working Length | 2300mm | 1800mm, 2300mm | Similar |
Table 1 Comparison of Technology Characteristics
7
Image /page/7/Picture/0 description: The image shows the logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, three-dimensional font. Below the word MICRO-TECH is the Chinese characters "微 创".
510K Summary
| 510K Summary | |||
|---|---|---|---|
| Electrode contact impedance | $13.46\pm0.68$ | $13.64\pm0.90$ | Similar |
| Cutting | $23.75\pm1.14$ | $23.42\pm1.62$ | Similar |
| Pushability | $3.08\pm0.64$ | $3.38\pm0.81$ | Similar |
| Performance | Electrode contact impedance, Cutting, Pushability and Tensile Strength | Electrode contact impedance, Cutting, Pushability and Tensile Strength | Same |
| Patient-contact Material | Stainless steel SUS304 (With Dow Corning® MDX4-4159, 50% Medical Grade Dispersion) and Polytetrafluoroethylene (PTFE) | Stainless steel SUS304 (With Dow Corning® MDX4-4159, 50% Medical Grade Dispersion) and Polytetrafluoroethylene (PTFE) | Same |
| Biocompatibility | Comply with ISO 10993-5, ISO 10993-10 and USP . | Comply with ISO 10993-5, ISO 10993-10, and USP . | Same |
| Sterilization | EO Sterilized, SAL: 10-6 | EO Sterilized, SAL: 10-6 | Same |
| Shelf Life | Three years | Five years | Similar |
| Labeling | Conforms to 21 CFR part 801 | Conforms to 21 CFR part 801 | Same |
8
Image /page/8/Picture/1 description: The image shows the logo for MICRO-TECH. The logo consists of a blue stylized "MT" on the left, followed by the words "MICRO-TECH" in blue, with a line underneath. Below the line are two Chinese characters, also in blue.
Substantially Equivalent (SE) Conclusion 11.
Based on the comparison and analysis from the nonclinical tests, the proposed devices is safe and effective, perform is as well as the predicate devices. It determined to be Substantially Equivalent (SE) to the predicate devices.