AcuSnare Polypectomy Snare

K173673 · Wilson-Cook Medical, Inc. · FDI · Aug 24, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K173673
• Device Name: AcuSnare Polypectomy Snare
• Applicant: Wilson-Cook Medical, Inc.
• Product Code: FDI · Gastroenterology, Urology
• Decision Date: Aug 24, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is used endoscopically in the removal and cauterization of sessile polyps and pedunculated polyps from within the gastrointestinal tract.

Device Story

AcuSnare Polypectomy Snare is a single-use endoscopic instrument used for polyp resection. The device consists of a handle, a sheath, and a snare head. The clinician inserts the sheath and snare head through an endoscope into the gastrointestinal tract. The snare head is extended from the sheath to capture target polyps. High-frequency electrosurgical current is applied to the snare to perform resection and cauterization. The device is operated by a clinician in a clinical setting. The output is the physical removal of the polyp, which aids in diagnostic or therapeutic management of gastrointestinal lesions.

Clinical Evidence

No clinical data. Bench testing only. Testing included shelf life, package integrity, and mechanical tensile testing of joints (snare to catheter, catheter to handle, snare head to drive cable, snare wire to cannula, pin to handle). Electrical safety and performance testing conducted per IEC 60601-1, IEC 60601-2-2, and IEC 60601-18. Biocompatibility testing performed per ISO 10993-1.

Technological Characteristics

Materials: Snare head (#304, #302, #303 stainless steel), sheath (PTFE), handle (polycarbonate). Energy: High-frequency electrosurgical current. Dimensions: 240 cm length, 7 FR catheter. Configuration: Oval, hexagon, needle-tip. Sterilization: Ethylene Oxide. Connectivity: None (standalone accessory).

Indications for Use

Indicated for the endoscopic removal and cauterization of sessile and pedunculated polyps from the gastrointestinal tract in patients requiring polypectomy.

Regulatory Classification

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.

Predicate Devices

• Rotatable Polypectomy Snare (POS-1) (K851958)
• Single Use Electrosurgical Snare (SD-400) (K172734)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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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# 510(k) Summary

| Name: | Wilson-Cook Medical, Inc. /Cook Endoscopy |
|----------|--------------------------------------------------|
| Address: | 4900 Bethania Station Road |
| | Winston-Salem, North Carolina 27105 |
| Phone: | [phone] |
| Fax: | [phone] |
| 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<br>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,

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and a new snare head shape configuration ("needle-tip"), and a different thermoplastic for the handle of the subject device.

| | (Subject Device)<br>AcuSnare Polypectomy<br>Snare | (1st Predicate K851958)<br>Wilson-Cook Medical<br>Rotatable Polypectomy<br>Snare | (2nd Predicate<br>K172734)<br>Single Use<br>Electrosurgical Snare<br>SD-400. |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | This device is used<br>endoscopically in the<br>removal and cauterization<br>of sessile polyps and<br>pedunculated polyps from<br>within the gastrointestinal<br>tract. | To snare and remove<br>polyps from the colon. | These instruments have<br>been designed to be<br>used with an Olympus<br>endoscope for the<br>removal and/or<br>cauterization of<br>diminutive polyps,<br>sessile polyps,<br>pedunculated polyps<br>and tissue from within<br>the GI tract. |
| Classification Name: | Snare Flexible | Same | Same |
| Common/Usual Name: | Polypectomy Snare | Polypectomy Snare | Snares |
| Trade/or Proprietary<br>Name | AcuSnare Polypectomy<br>Snare | Rotatable Polypectomy<br>Snare (POS-1) | Single Use<br>Electrosurgical Snares<br>(SD-400) |
| Class: | Class II | Same | Same |
| Product Code | FDI | FGX | FGX |
| Configuration: | Oval, hexagon, needle-tip | Oval, crescent and<br>hexagon | Hexagon |
| Snare Material: | #304 /#302 / #303<br>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<br>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 ●

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- 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.