SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES

K131700 · Boston Scientific Corp · FDI · Nov 4, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K131700
• Device Name: SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES
• Applicant: Boston Scientific Corp
• Product Code: FDI · Gastroenterology, Urology
• Decision Date: Nov 4, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Polypectomy Snares and Rotatable Snares are used endoscopically in the removal and /or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.

Device Story

Single-use polypectomy snares (rotatable and non-rotatable) consist of flexible wire cable and loop; operated via three-ring handle passed through endoscope. Device delivers monopolar electrical current to cut and cauterize GI tract tissue; rotatable models include rotation actuator for loop positioning. Used by physicians in clinical endoscopic settings. Output is physical tissue resection; clinical benefit is removal of polyps and tissue lesions.

Clinical Evidence

Bench testing only. In-vitro testing confirmed all components and subassemblies met specifications. Comparative testing against Olympus SnareMaster assessed physical dimensions and mechanical properties (length, OD, loop width/shape, deflection, tensile strength).

Technological Characteristics

Flexible wire cable and loop; three-ring handle; rotation actuator (rotatable models). Monopolar electrosurgical energy source. Single-use. Design, materials, and manufacturing identical to predicate devices.

Indications for Use

Indicated for endoscopic removal and/or cauterization of diminutive, sessile, and pedunculated polyps and tissue within the GI tract.

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

• Sensation Short Throw, Single-Use Polypectomy Snares, Captiflex, Single-Use Polypectomy Snares, Captivator, Single-Use Polypectomy Snares, Captivator II, Single-Use Polypectomy Snares, Profile, Single-Use Polypectomy Snares (K941750)
• Single-Use Rotatable Snare (K992477)
• SnareMaster (K955650)

Submission Summary (Full Text)

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SECTION 5 510(k) SUMMARY

#### 1. Submitter

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: [phone] Fax: [phone]

Contact: Janis F. Taranto M.S., RAC Sr. Regulatory Affairs Specialist Date Prepared: June 10, 2013

NOV 0 4 2013

## 2. Device

Trade Name: Sensation Short Throw, Single-Use Polypectomy Snares Captiflex, Single-Use Polypectomy Snares Captivator, Single-Use Polypectomy Snares Captivator II, Single-Use Polypectomy Snares Profile, Single-Use Polypectomy Snares Common Name: Polypectomy Snare Family Classification Name: 1) Snare, Flexible, 2) Snare, Non-Electrical Regulation Number: 1) 876.4300, 2) 876.4730 Product Code: 1) FDI, 2) FGX Classification: Class II

Trade Name: Rotatable Snare, Single-Use Polypectomy Snare Common Name: Rotatable Snare Classification Name: Snare, Flexible Regulation Number: 876.4300 Product Code: FDI Classification: Class II

#### 3. Predicate Devices

Trade Name: Sensation Short Throw, Single-Use Polypectorny Snares Captiflex, Single-Use Polypectomy Snares Captivator, Single-Use Polypectomy Snares Captivator II, Single-Use Polypectomy Snares Profile, Single-Use Polypectomy Snares Manufacturer and Clearance Number: Boston Scientific Corporation, K941750 Classification Name: Snare, Flexible Regulation Number: 876.4300 Product Code: FDI Classification: Class II

Premarket Notification, Polypectorny and Rotatable Snares: Tissue Resection

000072

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Trade Name: Single-Use Rotatable Snare Manufacturer and Clearance Number: Boston Scientific Corporation, K992477 Classification Name: Snare, Flexible Regulation Number: 876.4300 Product Code: FDI Classification: II

Trade Name: SnareMaster Manufacturer and Clearance Number: Olympus, K955650 Classification Name: 1) Snare, Flexible, 2) Electrode, electrosurgical, active, urological Regulation Number: 876.4300 Product Code: 1) FDI, 2) FAS Classification: II

## 4. Device Description

Both the rotatable and non-rotatable snares consists of a flexible wire cable and loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop. For the rotatable snares, the snare can be rotated by using the rotation actuator.

## 5. Indication for Use:

The Polypectorny Snares and Rotatable Snares are used endoscopically in the removal and for cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.

## 6. Technological Characteristics:

This is a change to the device indication only. The proposed Polypectorny Snares and Rotatable Snares are identical in design, materials, and manufacturing processes to the predicate Polypectorny Snares and Rotatable Snares (K941750 and K992477). The proposed Polypectomy Snares and Rotatable Snares are similar in design to the Olympus SnareMaster (K955650).

## 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.

Comparative testing was performed to assess similarities between the Boston Scientific Corporation Polypectorny Snares and Rotatable Snares and the Olympus SnareMaster.

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Specifications tested included length, OD, loop width and shape, loop plane deflection and tensile strength.

# 8. Conclusion:

Boston Scientific Corporation has demonstrated that the proposed Polypectomy Snares and Rotatable Snares are substantially equivalent to Boston Scientific Corporation's currently marketed Polypectomy Snares and Rotatable Snares (K941750 and K992477) and the Olympus SnareMaster (K955650).

Premarket Notification, Polypectorny and Rotatable Snares: Tissue Resection

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#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 4, 2013

Boston Scientific Corporation Janis F. Taranto, M.S., RAC Senior Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752

Re: K131700

> Trade/Device Name: Single Use Polypectomy Snares and Rotatable Snares; Sensation Short Throw. Single-Use Polypectomy Snares Captiflex; Single-Use Polypectomy Snares, Captivator, Single-Use Polypectomy Snares; Captivator II, Single-Use Polypectomy Snares; Profile, Single-Use Polypectomy Snares; Rotatable Snare, Single-Use Polypectomy Snares Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Il Product Code: FDI Dated: October 11, 2013 Received: October 15, 2013

Dear Janis F. Taranto,

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. Ilsting 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.

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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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours,

Image /page/4/Picture/7 description: The image shows the name "Benjamin R. Fisher -S" in a bold, sans-serif font. The letters "R" and "F" are stylized with a geometric pattern, creating a unique visual element within the name. The text is horizontally oriented and appears to be a signature or title. The overall impression is clean and professional, with a touch of artistic flair in the letter design.

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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## SECTION 4 INDICATIONS FOR USE STATEMENT

Indications for Use:

510(k) Number (if known): 131700

Device Name: Single use Polypectomy Snares and Rotatable Snares Sensation Short Throw, Single-Use Polypectomy Snares Captiflex, Single-Use Polypectomy Snares Captivator, Single-Use Polypectomy Snares Captivator II. Single-Use Polypectomy Snares Profile, Single-Use Polypectomy Snares Rotatable Snare, Single-Use Polypectomy Snares

Indications for Use:

The Polypectomy Snares and Rotatable Snares are used endoscopically in the removal and /or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.

Prescription Use X (Part 21 CFR 801 Part D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Beniamin 2013.1

Premarket Notification, Polypectomy and Rotatable Snares: Tissue Resection