(254 days)
Not Found
No
The device description and performance studies focus on the mechanical and electrical properties of a physical polyp snare, with no mention of AI or ML algorithms for image analysis, decision support, or automated control.
Yes.
The device is used to cut polyps or other redundant tissues in the digestive tract, which is a therapeutic intervention.
No
The device is described as a "Disposable Polyp Snare" intended for "cutting polyps or other redundant tissues in digestive tract." Its function is surgical removal (cutting/resection), not to identify or determine the nature of a disease or condition.
No
The device description clearly outlines physical components (handle section, tube section, loop section) and discusses performance testing related to physical properties (size, strength, maneuverability, rotation degree, cutting ability) and material properties (EO residual, ECH residual, biocompatibility). This indicates a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue samples) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Disposable Polyp Snare is a surgical tool used inside the body (in vivo) to physically cut and remove tissue (polyps or other redundant tissues) from the digestive tract. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states it's for "cutting polyps or other redundant tissues in digestive tract," which is a surgical procedure.
- Device Description: The description details a physical tool with a handle, tube, and loop for tissue resection.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis.
Therefore, based on the provided information, the Disposable Polyp Snare is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Disposable Polyp Snare is intended to be used in combination with endoscope for cutting polyps or other redundant tissues in digestive tract. The snare can be used with or without high-frequency current.
Product codes (comma separated list FDA assigned to the subject device)
FDI, FGX
Device Description
The subject device is intended to be used in combination with endoscope for cutting polyps or other redundant tissues in digestive tract.
The subject device consists of a handle section, a tube section and a loop section. The loop section is inserted into the tube section and is extended and retracted by operating the handle section.
The tube section and the loop section are inserted into the gastrointestinal tract through the endoscope. The loop is extended from the tube to resect the target tissue. The resection is performed with or without high-frequency current.
The shape of the loop includes oval, crescent, hexagonal, rhombus, dual-width oval, and polygonal. Users can choose the shape of the snare according to their preference and the characteristic of the lesion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
digestive tract (GI tract)
Indicated Patient Age Range
The subject device is intended for use in people other than infants and young children.
Intended User / Care Setting
Healthcare facility/hospital
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)
Performance testing was conducted on the following items to support the marketing claims and to confirm that the safety and effectiveness of the Disposable Polyp Snare is at least equivalent to the predicate device.
- Size
- Strength
- Maneuverability
- Rotation degree of snare loop
- Cold cutting ability
- Hot cutting ability
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 10993-7:2008.
The shelf-life for three years had been validated in accelerated testing according to ASTM F1980-16 and the requirements on packaging for terminally sterilized medical device per ISO 11607-1:2006 are also met. The testing successfully demonstrated essential performance is achieved before and after the shelf life test.
The biocompatibility evaluations were conducted in accordance with the 2020 FDA Guidance document Use of International Standard ISO-10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The cytotoxicity, sensitization, intracutaneous irritation, system toxicity and pyrogen 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 A1:2012 and IEC 60601-1-2 Edition 3: 2007-03, and in particular we also conducted tests on high frequency surgical equipment and accessories for endoscopes per IEC 60601-2-18:Edition 3.0 2009-08 and AAMI/ANSI/IEC 60601-2-2:2009.
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 in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.
September 22, 2022
Jiangsu Vedkang Medical Science and Technology Co.,Ltd. % Joyce Yang Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518000 China
Re: K220089
Trade/Device Name: Disposable Polyp Snare Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: II Product Code: FDI, FGX Dated: August 18, 2022 Received: August 18, 2022
Dear Joyce Yang:
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.
1
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 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 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
Indications for Use
510(k) Number (if known) K220089
Device Name Disposable Polyp Snare
Indications for Use (Describe)
The Disposable Polyp Snare is intended to be used in combination with endoscope for cutting polyps or other redundant tissues in digestive tract. The snare can be used with or without high-frequency current.
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)
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3
510(k) Summary
Date of Summary prepare: December 30, 2021
1. Submission Sponsor
| Applicant Name | Jiangsu Vedkang Medical Science &
Technology Co., Ltd. |
|----------------|---------------------------------------------------------------------------------------------------|
| Address | No.52, Guoxiang Road, Wujin Economic
Development Zone, Changzhou 213149,
Jiangsu, P.R.China |
| Contact person | Tang Ting |
| Phone | +86 519 69877755 |
2. Submission correspondent
| Name | Shenzhen Joyantech Consulting Co., Ltd |
|---|---|
| Address | 1713A, 17th Floor, Block A, Zhongguan Times |
| Square, Nanshan District, Shenzhen | |
| Post Code | 518000 |
| Phone No. | +86-755-86069197 |
| Contact Person | Joyce Yang |
| joyce@cefda.com |
3. Device Identification
| Type of 510(k) submission: Traditional | |
|---|---|
| Trade Name: Disposable Polyp Snare | |
| Classification name: | Endoscopic Electrosurgical |
| Unit and Accessories | |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | FDI |
| FGX | |
| Device Class: | 2 |
| Regulation Number: | 21 CFR § 876.4300 |
| 21 CFR § 876.4730 |
4. Legally Marketed Predicate Device
| Trade Name | Single Use Electrosurgical Snare SD-400 |
|---|---|
| Regulation number | 21 CFR § 876.4300 |
4
| 21 CFR § 876.4730 | |
|---|---|
| Regulation class | 2 |
| Regulation name | Endoscopic electrosurgical unit and |
| accessories | |
| Manual gastroenterology-urology surgical | |
| instrument and accessories | |
| 510(k) Number | K172734 |
| Product Code | FDI |
| FGX | |
| Manufacturer | Aomori Olympus Co., Ltd. |
Device Description 5.
The subject device is intended to be used in combination with endoscope for cutting polyps or other redundant tissues in digestive tract.
The subject device consists of a handle section, a tube section and a loop section. The loop section is inserted into the tube section and is extended and retracted by operating the handle section.
The tube section and the loop section are inserted into the gastrointestinal tract through the endoscope. The loop is extended from the tube to resect the target tissue. The resection is performed with or without high-frequency current.
The shape of the loop includes oval, crescent, hexagonal, rhombus, dual-width oval, and polygonal. Users can choose the shape of the snare according to their preference and the characteristic of the lesion.
6. Intended Use/ Indications for Use
The Disposable Polyp Snare is intended to be used in combination with endoscope for cutting polyps or other redundant tissues in digestive tract. The snare can be used with or without high-frequency current.
| Comparison
item | Subject Device: Disposable
Polyp Snare (K220089) | Predicate Device: Single Use
Electrosurgical Snare SD-
400(K172734) | Comments |
|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product
Code | FDI, FGX | FDI, FGX | Same |
| Regulation
Number | 21 CFR § 876.4300
21 CFR § 876.4730 | 21 CFR § 876.4300
21 CFR § 876.4730 | Same |
| Classificatio
n | Class II | Class II | Same |
| Comparison
item | Subject Device: Disposable
Polyp Snare (K220089) | Predicate Device: Single Use
Electrosurgical Snare SD-
400(K172734) | Comments |
| Type of use | Prescription Use | Prescription Use | Same |
| Intended
use &
Indication
s for Use | The Disposable Polyp Snare
is intended to be used in
combination with endoscope
for cutting polyps or other
redundant tissues in digestive
tract. The snare can be used
with or without high-frequency
current. | These instruments have been
designed to be used with an
Olympus endoscope for the
removal and/or cauterization
of diminutive polyps, sessile
polyps, pedunculated polyps
and tissue from within the Gl
tract. | Same |
| Applicable
user | The subject device is intended
for use in people other than
infants and young children. | The device is intended for use
in people other than infants
and young children. | Same |
| Environment
of use | Healthcare facility/hospital | Healthcare facility/hospital | Same |
| Single
/repeat use | Single use | Single use | Same |
| Sterile /non-
sterile | Marketed as a sterile device | Marketed as a sterile device | Same |
| Sterilization
method and
SAL | ETO sterile
SAL=10-6 | ETO sterile
SAL=10-6 | Same |
| Energy
source | With or without High-
frequency current | With or without High-
frequency current | Same |
| Materials | Loop: stainless steel
Tube sheath:
Polytetrafluoroethylene
(PTFE)
Handle: ABS
Protective sleeve:
Polyurethane (PU) | Loop: stainless steel
Tube: fluorocarbon polymer
Handle: ABS | Similar |
| Patient -
contact
potential
(Duration
and type of
contact) | Surface-contacting device in
contact with mucosal
membranes.
The contact duration is limited
exposure (i.e. contact is up to
24 hours) | Surface-contacting device in
contact with mucosal
membranes.
The contact duration is limited
exposure (i.e. contact is up to
24 hours) | Same |
| Configuratio
n | Oval, Crescent, Hexagonal,
Rhombus, Dual-width oval,
Polygonal | Hexagonal | Different |
| Loop Width | 6 mm, 10 mm, 15 mm, 20 mm,
25 mm, 30 mm, 35 mm, 40
mm, 45 mm, 50 mm | 10 mm, 15 mm | Different |
| Working
Length | 1200 mm,1600 mm, 1800 mm,
2300 mm, 2400 mm, 3000 mm | 2300 mm | Different |
| Comparison
item | Subject Device: Disposable
Polyp Snare (K220089) | Predicate Device: Single Use
Electrosurgical Snare SD-
400(K172734) | Comments |
| Tube sheath
O.D. | 1.8 mm, 2.3 mm | Unknown | Different |
| Minimal
working
channel | 2.0 mm, 2.8 mm | 2.8 mm | Different |
7. Technological characteristics comparison
5
6
8. Summary of non-clinical testing
Performance testing was conducted on the following items to support the marketing claims and to confirm that the safety and effectiveness of the Disposable Polyp Snare is at least equivalent to the predicate device.
- Size
- Strength
- Maneuverability
- Rotation degree of snare loop
- Cold cutting ability
- Hot cutting ability
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 10993-7:2008.
The shelf-life for three years had been validated in accelerated testing according to ASTM F1980-16 and the requirements on packaging for terminally sterilized medical device per ISO 11607-1:2006 are also met. The testing successfully demonstrated essential performance is achieved before and after the shelf life test.
The biocompatibility evaluations were conducted in accordance with the 2020 FDA Guidance document Use of International Standard ISO-10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The cytotoxicity, sensitization, intracutaneous irritation, system toxicity and pyrogen 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 A1:2012
7
and IEC 60601-1-2 Edition 3: 2007-03, and in particular we also conducted tests on high frequency surgical equipment and accessories for endoscopes per IEC 60601-2-18:Edition 3.0 2009-08 and AAMI/ANSI/IEC 60601-2-2:2009.
9. Brief discussion of clinical tests
No clinical tests were performed.
10. Conclusions
The conclusion drawn from the nonclinical tests demonstrates that the subject device, the Disposable Polyp Snares are as safe and effective, and performs as well as or better than the legally marketed predicate device cleared under K172734.