ENTERYX INJECTION CATHETER

K042882 · Boston Scientific Corp · FBK · Nov 9, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K042882
• Device Name: ENTERYX INJECTION CATHETER
• Applicant: Boston Scientific Corp
• Product Code: FBK · Gastroenterology, Urology
• Decision Date: Nov 9, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indicated for use in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varicies and for submucosal dye marking in the upper GI tract. The Enteryx® Injection Catheter is also a component of the Enteryx® Procedure Kit.

Device Story

Enteryx® Injection Catheter is a manual endoscopic accessory used by physicians to deliver injections into the upper GI tract. Device consists of a needle, catheter shaft, and handle. Handle includes a luer connector for injection and a locking mechanism to secure the needle position relative to the catheter shaft. Used in conjunction with an endoscope to facilitate targeted delivery of therapeutic agents or dyes. Benefits include precise submucosal placement for variceal treatment or tissue marking.

Clinical Evidence

Bench testing only. Performance characteristics and biocompatibility were evaluated via physical comparison and functional testing to support substantial equivalence.

Technological Characteristics

Manual injection catheter consisting of a needle, catheter shaft, and handle with luer connector and locking mechanism. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients requiring endoscopic injections for treatment of esophageal and gastric varices or submucosal dye marking in the upper GI tract.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Boston Scientific Enteryx® Injection Catheter

Submission Summary (Full Text)

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NOV - 9 2004

## 510 (k) SUMMARY

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| SPONSOR: | Boston Scientific Corporation<br>One Boston Scientific Place<br>Natick, MA 01760 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Lisa M. Quaglia<br>Regulatory Affairs Manager |
| DEVICE: | |
| Trade Name: | Enteryx® Injection Catheter |
| Common Name: | Endoscope and Accessories |
| Classification: | Class II per 21 CFR Part 876, Section 1500 |
| PREDICATE DEVICE: | Boston Scientific Enteryx® Injection Catheter |
| DESCRIPTION: | The Enteryx® Injection Catheter is an injection needle<br>consisting of a needle, catheter shaft and a handle. The handle<br>incorporates a luer for injection capabilities and offers a locking<br>mechanism to lock the needle in place with respect to the<br>catheter shaft. |
| INTENDED USE: | Indicated for use in conjunction with an endoscope to perform<br>endoscopic injections, such as for the treatment of esophageal<br>and gastric varicies and for submucosal dye marking in the upper<br>GI tract. The Enteryx® Injection Catheter is also a component<br>of the Enteryx® Procedure Kit. |
| COMPARISON OF<br>CHARACTERISTICS: | The modified device is substantially equivalent to the predicate<br>device, as they have the same operating principal and intended<br>use. In addition, the results of design control activities do not<br>raise any new issues of safety or effectiveness. |
| PERFORMANCE DATA: | FDA's "Guidance for the Content of Premarket Notifications",<br>and the results of physical comparison and functional testing<br>support a determination of substantial equivalence for the<br>modified device when compared to the predicate device. The<br>modified device is substantially equivalent to the currently<br>marketed Boston Scientific Enteryx® Injection Catheter in terms<br>of performance characteristics, biocompatibility, and intended<br>use. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three lines representing the human form. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 9 2004

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

Re: K042882

Trade/Device Name: Enteryx® Injection Catheter Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FBK Dated: October 18, 2004 Received: October 19, 2004

Dear Ms. Quaglia:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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 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 (Sections 531-5.42 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 Section 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:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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/cdrh/dsmadsmain.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 | To be determined K042882 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Enteryx® Injection Catheter |
| Indications For Use | Indicated for use in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varicies and for submucosal dye marking in the upper GI tract. The Enteryx® Injection Catheter is also a component of the Enteryx® Procedure Kit. |

Prescription Use X (Per 21 CFR 801.109)

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Over the Counter Use _________________________________________________________________________________________________________________________________________________________

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OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | |
|------------------------------------------|--|
|------------------------------------------|--|

OR

| Over the Counter Use | |
|----------------------|--|
|----------------------|--|

*Nancy C Brogdon*

(Division Sign-Off)

Division of Reproductive, Abdominal,

and Radiological Devices

| 510(k) Number | K042882 |
|---------------|---------|
|---------------|---------|

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