(267 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical safety and performance, with no mention of AI/ML or image processing capabilities.
Yes
The device is used to remove and cauterize polyps, which are therapeutic interventions.
No
Explanation: The device is described as being used for the "removal and cauterization of sessile polyps and pedunculated polyps," which are therapeutic actions, not diagnostic ones. It performs resection with a high-frequency current.
No
The device description clearly outlines physical components (handle, sheath, snare head) and mentions mechanical actions (extended and retracted) and the use of high-frequency current for cauterization, indicating it is a hardware device. The performance studies also focus on physical and electrical testing of these components.
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, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is used endoscopically to remove and cauterize polyps directly within the gastrointestinal tract. It is a surgical tool used for intervention and treatment, not for analyzing samples in a lab setting.
The description clearly indicates a device used for a surgical procedure performed inside the body, which is the opposite of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
This device is used endoscopically in the removal and cauterization of sessile polyps and pedunculated polyps from within the gastrointestinal tract.
Product codes
FDI
Device Description
The subject device consists of a handle section, a sheath section. The snare head section. The snare head section is inserted into the sheath section and is extended and retracted by operating the three-ring handle section.
The sheath section and the snare head section are inserted in the gastrointestinal tract through an endoscope. The snare head is extended from the sheath to resect target polyps. This resection is performed with high-frequency current.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following non-clinical testing was conducted to demonstrate the performance of the subject device and confirmed that the subject device performs as intended.
- Shelf Life Testing
- Package Integrity Testing
- Tensile test snare to catheter
- Tensile test catheter to handle
- Snare head to drive cable joint
- Snare wire to cannula joint
- Handle/Cannula/Drive Cable joint
- Pin to Handle Joint
- IEC 60601-1: 2006 + A12: 2014- Medical electrical equipment – Part 1: General requirements for basic safety and essential performance of High Frequency Surgical Equipment and High frequency Surgical Accessories
- IEC 60601-2-2: 2017 - Medical Electrical Equipment - Part 2-2: Particular Requirements For The Basic Safety And Essential Performance Of High Frequency Surgical Equipment And High Frequency Surgical Accessories
- IEC 60601-2-18: 2009 Medical electrical equipment Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
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" and per ISO 10993-1:2009, Biological evaluation of medical devices-Evaluation and testing within risk management process.
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).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a square and the name in a sans-serif font. The logo is simple and professional, and it is easily recognizable.
August 24, 2018
Wilson-Cook Medical, Inc Theresa de Prat Global Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, North Carolina 27105
Re: K173673
Trade/Device Name: AcuSnare Polypectomy Snare Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Code: FDI Dated: July 10, 2018 Received: July 11, 2018
Dear Theresa de Prat:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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,
Glenn B. Bell -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) K173673
Device Name AcuSnare Polypectomy Snare
Indications for Use (Describe)
This device is used endoscopically in the removal and cauterization of sessile polyps and pedunculated polyps 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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3
510(k) Summary
| Name: | Wilson-Cook Medical, Inc. /Cook Endoscopy |
|---|---|
| Address: | 4900 Bethania Station Road |
| Winston-Salem, North Carolina 27105 | |
| Phone: | (336) 744-0157 |
| Fax: | (336) 201-5994 |
| Contact: | Theresa de Prat, Regulatory Affairs Specialist I |
| Date: | November 30, 2017 |
| Device Identification | |
|---|---|
| Trade Name: | AcuSnare Polypectomy Snare |
| Common Name: | Polypectomy Snare |
| Regulation Number: | 876.4300 |
| Classification Name: | Endoscopic electrosurgical unit and accessories. |
| Product Code: | FDI |
| Regulatory Class: | Class II |
| Classification Panel: | Gastroenterology and urology |
| Classification Name: | snare, flexible |
| Predicate Devices: | Rotatable Polypectomy Snare (POS-1) K851958; cleared July 25, 1985 |
| Single Use Electrosurgical Snare (SD-400) K172734; cleared December 7, 2017 |
Intended Use:
This subject device is used endoscopically in the removal and cauterization of sessile polyps and pedunculated polyps from within the gastrointestinal tract.
Device Description:
The subject device consists of a handle section, a sheath section. The snare head section. The snare head section is inserted into the sheath section and is extended and retracted by operating the three-ring handle section.
The sheath section and the snare head section are inserted in the gastrointestinal tract through an endoscope. The snare head is extended from the sheath to resect target polyps. This resection is performed with high-frequency current.
Substantial Equivalence:
Minor changes were made to the first predicate device Rotatable Polypectomy Snare (K851958) and second predicate Single Use Electrosurgical Snares SD-400(K172734). These changes include updating the intended use to the removal and cauterization of sessile polyps and pedunculated polyps from within the gastrointestinal tract, adding additional stainless-steel types to snare head materials of construction,
4
and a new snare head shape configuration ("needle-tip"), and a different thermoplastic for the handle of the subject device.
| | (Subject Device)
AcuSnare Polypectomy
Snare | (1st Predicate K851958)
Wilson-Cook Medical
Rotatable Polypectomy
Snare | (2nd Predicate
K172734)
Single Use
Electrosurgical Snare
SD-400. |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | This device is used
endoscopically in the
removal and cauterization
of sessile polyps and
pedunculated polyps from
within the gastrointestinal
tract. | To snare and remove
polyps from the colon. | 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 GI tract. |
| Classification Name: | Snare Flexible | Same | Same |
| Common/Usual Name: | Polypectomy Snare | Polypectomy Snare | Snares |
| Trade/or Proprietary
Name | AcuSnare Polypectomy
Snare | Rotatable Polypectomy
Snare (POS-1) | Single Use
Electrosurgical Snares
(SD-400) |
| Class: | Class II | Same | Same |
| Product Code | FDI | FGX | FGX |
| Configuration: | Oval, hexagon, needle-tip | Oval, crescent and
hexagon | Hexagon |
| Snare Material: | #304 /#302 / #303
Stainless Steel | #304 Stainless Steel | Stainless Steel |
| Sheath Material: | Teflon (PTFE) | Teflon (PTFE) | Fluorocarbon polymer |
| Handle Material: | PC | Unknown | ABS |
| Length: | 240 cm | 240 cm | 230 cm |
| Catheter FR Size: | 7 FR | 7 FR | Unknown |
| Sterile/non-sterile: | Sterile | Sterile | Sterile |
| Sterilization method: | Ethylene Oxide | Same | Same |
| Reusable/Single Use: | Single Use | Reusable | Single Use |
| Used with
Electrosurgical Unit: | Yes | Yes | Yes |
Comparison table of subject device and predicate device:
Summary of non-clinical testing:
The following non-clinical testing was conducted to demonstrate the performance of the subject device and confirmed that the subject device performs as intended.
- Shelf Life Testing ●
- Package Integrity Testing ●
- Tensile test snare to catheter ●
5
- Tensile test catheter to handle
- Snare head to drive cable joint
- Snare wire to cannula joint
- . Handle/Cannula/Drive Cable joint
- . Pin to Handle Joint
- . IEC 60601-1: 2006 + A12: 2014- Medical electrical equipment – Part 1: General requirements for basic safety and essential performance of High Frequency Surgical Equipment and High frequency Surgical Accessories
- . IEC 60601-2-2: 2017 - Medical Electrical Equipment - Part 2-2: Particular Requirements For The Basic Safety And Essential Performance Of High Frequency Surgical Equipment And High Frequency Surgical Accessories
- IEC 60601-2-18: 2009 Medical electrical equipment Part 2-18: Particular requirements for the ● basic safety and essential performance of endoscopic equipment
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" and per ISO 10993-1:2009, Biological evaluation of medical devices-Evaluation and testing within risk management process.
Conclusion:
We believe that the subject device is substantially equivalent to the predicate device in terms of intended use, key operating principles, materials and technological characteristics. We consider the risks associated with the modifications to the subject device to have been adequately addressed through our Design Control Processes and do not affect safety or effectiveness of the device.