AUTOTOME RX MODEL # 4515, 4516

K013153 · Boston Scientific Corp · KNS · Oct 19, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K013153
• Device Name: AUTOTOME RX MODEL # 4515, 4516
• Applicant: Boston Scientific Corp
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Oct 19, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Autotome™ RX is indicated for use in transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. This device can also be used to cannulate and inject contrast medium.

Device Story

Autotome™ RX is a triple-lumen sphincterotome designed for use with the Rapid Exchange™ platform. It facilitates transendoscopic sphincterotomy of the Papilla of Vater and Sphincter of Oddi; enables simultaneous contrast medium injection via an adjacent lumen while accommodating a .035" guidewire. Operated by physicians during endoscopic procedures; provides controlled orientation and rotation features to assist in ductal access and tissue cutting. Benefits include improved procedural efficiency and access to biliary/pancreatic systems.

Clinical Evidence

Bench testing only.

Technological Characteristics

Triple-lumen sphincterotome; compatible with Rapid Exchange™ platform; accommodates .035" guidewire; features controlled orientation and rotation mechanisms. Mechanical device; no software or electronic components.

Indications for Use

Indicated for patients requiring transendoscopic sphincterotomy of the Papilla of Vater or Sphincter of Oddi, and for cannulation and contrast medium injection into biliary and pancreatic ductal systems.

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

• Rapid Exchange™ Cannulating Sphincterotome (K970053, Ultratome RX)

Submission Summary (Full Text)

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**OCT 1 9 2001**

KD13153

## Section 9 510(K) SUMMARY

| SPONSOR: | Boston Scientific Corporation (BSC)<br>Microvasive Endoscopy Division<br>One Boston Scientific Place<br>Natick, MA 01760 |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Lisa Quaglia<br>Regulatory Affairs Manager<br>Tel: [phone] |
| DATE OF SUBMISSION: | September 19, 2001 |
| DEVICE: | Autotome™ RX |
| Trade Name:<br>Common Name:<br>Classification: | Autotome™ RX<br>Sphincterotome<br>Endoscope and Accessories<br>Classified Under 21 CFR Part 876, §4300.<br>Classified as a Class II Device. |
| PREDICATE DEVICE: | Rapid Exchange™ Cannulating Sphincterotome<br>(K970053, Ultratome RX) |
| DEVICE DESCRIPTION: | The proposed Autotome™ RX is a triple lumen<br>sphincterotome with controlled orientation and rotation<br>features. It is compatible with the Boston Scientific<br>Microvasive® Endoscopy's Rapid Exchange™ platform,<br>and is capable of accommodating a .035" guidewire<br>while allowing simultaneous injection through an<br>adjacent lumen. |
| INTENDED USE: | The Autotome™ RX is indicated for use in<br>transendoscopic sphincterotomy of the Papilla of Vater<br>and/or the Sphincter of Oddi. This device can also be<br>used to cannulate and inject contrast medium. |
| COMPARISON OF<br>CHARACTERISTICS: | The proposed device is substantially equivalent to<br>currently marketed devices used for transendoscopic<br>sphincterotomy of the Papilla of Vater and/or the<br>Sphincter of Oddi, and for injection of contrast media<br>into the biliary and pancreatic ductal systems. |
| PERFORMANCE DATA: | The proposed device is substantially equivalent to<br>currently marketed Rapid Exchange™ Cannulating<br>Sphincterotome in terms of performance characteristics<br>tested and biocompatibility. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 1 9 2001

Ms. Lisa M. Quaglia Regulatory Affairs Manager Microvasive Endoscopy Boston Scientific Corporation One Boston Scientific Place NATICK MA 01760-1537

Re: K013153 Trade/Device Name: Ultratome™ RX Model # 4515, 4516 Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: 78 KNS Dated: September 19, 2001

Received: September 20, 2001

Dear Ms. Quaglia:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your been wined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the enorment date of 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, do nees that have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, arores, many of the Act include requirements for annual registration, listing of Econoral ocurrities profice, labeling, and prohibitions against misbranding and adulteration.

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 r read o a nove 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 or any r subtal butter equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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 (scctions 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number (if known)

K013153

Page 1 of 1

Device Name

Autotome™ RX

Indications for Use

The Autotome™ RX is indicated for use in transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The device can also be used to cannulate and inject contrast medium.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

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OR

Over the Counter Use _

Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013153