SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR

K052194 · Boston Scientific Corp · ODF · Aug 24, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K052194
• Device Name: SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR
• Applicant: Boston Scientific Corp
• Product Code: ODF · Gastroenterology, Urology
• Decision Date: Aug 24, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The proposed SpyGlass Direct Visualization Probe is intended to provide direct visualization for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.

Device Story

SpyGlass Direct Visualization Probe is a fiberoptic mini-endoscope; used in conjunction with SpyScope Access and Delivery Catheter and a duodenoscope. Device inserted into working channel of duodenoscope to access pancreatico-biliary system. Provides direct visualization for clinicians during diagnostic and therapeutic endoscopic procedures. Enables real-time visual assessment of anatomy; assists in guiding therapeutic interventions. Used in clinical settings by physicians; output viewed directly via optical system. Benefits include improved visualization of biliary/pancreatic ducts compared to standard fluoroscopy alone.

Clinical Evidence

Bench testing only. Comparison of optical performance and image quality specifications between subject and predicate devices. Electrical safety testing performed per industry standards.

Technological Characteristics

Fiberoptic mini-endoscope. Designed for use with a mother scope (duodenoscope) and delivery catheter. No electronic processing or software algorithms described. Electrical safety testing conducted per industry standards.

Indications for Use

Indicated for patients undergoing endoscopic procedures in the pancreatico-biliary system, including the hepatic ducts, requiring direct visualization for diagnostic or therapeutic applications.

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

• SpyGlass Direct Visualization Probe (K050403)

Reference Devices

• SpyScope Access and Delivery Catheter (K051504)

Submission Summary (Full Text)

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Boston
Scientific

K052194 pg. 1 of 2

AUG 2 4 2005

Endoscopy SECTION 11 510(K) SUMMARY

#### 510(K) SUMMARY

#### 1. Submitter:

Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537

Contact: Allyson Barford Regulatory Affairs Specialist Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: [phone] Fax: [phone] Date Prepared: July 8, 2005

### 2. Device:

Trade Name: SpyGlass™ Direct Visualization Probe Common Name: Mini-Endoscope Classification Name: Flexible Endoscope

#### 3. Predicate Devices:

Boston Scientific. SpyGlass Direct Visualization Probe - K050403

#### 4. Device Description:

The proposed SpyGlass Direct Visualization Probe a fiberoptic endoscope. The proposed device is used through the SpyScope Access and Delivery Catheter (K051504) which provides stability for steering the device. The delivery catheter/probe is inserted into the working channel of a duodenoscope for entry into the duodenum for access to the indicated site.

#### 5. Intended Use:

The proposed SpyGlass Direct Visualization Probe is intended to provide direct visualization for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.

#### 6. Technological Characteristics:

The SpyGlass Direct Visualization Probe is a modification to the predicate device and has the same technological characteristics as the predicate device. The proposed device and predicate device are fiberoptic mini-scopes used in conjunction with a mother scope to access and visualize an indicated location.

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052194 pg. 2 of 2

## 7. Performance Data:

A comparison of the optical performance and image quality specifications was made between the proposed and predicate SpyGlass™ Direct Visualization Probe. Electrical safety testing was performed in accordance with industry standards.

## 8. Conclusion:

Boston Scientific Corporation has demonstrated that the proposed SpyGlass Direct Visualization Probe is substantially equivalent to the predicate SpyGlass Direct Visualization Probe.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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AUG 2 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Boston Scientific Corporation c/o Mr. Daniel W. Lehtonen Intertek Testing Services NA, Inc. 70 Codman Hill Road Boxborough, Massachusetts 01719

Re: K052194

K052194
Trade/Device Name: SpyGlass™ Direct Visualization Probe Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: KOG Dated: August 10, 2005 Received: August 11, 2005

Dear Mr. Lehtonen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(a) peace is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreatives of the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1978, in ecordance with the provisions of the Federal Food, Drug, ue necs that have been receire approval of a premarket approval application (PMA). allu Cosmeter Act (1 tel) that to neview, subject to the general controls provisions of the Act. The I ou may, therefore, market the Act include requirements for annual registration, listing of general controls provisions of practice, 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 If your device to such additional controls. Existing major regulations affecting your device can may be subject to saterial Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oour of concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase oe advisou that I Dri bream that your device complies with other requirements of the Act that I DA has made a sond regulations administered by other Federal agencies. You must of any I odelui statutes and states and the because to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It in the quality systems (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quarty byesells (Sections 531-542 of the Act); 21 CFR 1000-1050.

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# Page 2- Mr. Daniel W. Lehtonen

This letter will allow you to begin marketing your device as described in your Section 510(k) This ictier will anow you'ts begin maing of substantial equivalence of your device to a legally prematice noticated. The PDF intelligention 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 If you desire specific acrisously at [phone]. Also, please note the regulation entitled, Comaon the Office of Count of County of CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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 vours.

eubais Bachell

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## SECTION 4 INDICATIONS FOR USE

K052194 P

510(k) Number:

To Be Determined

SpyGlass™ Direct Visualization Probe Device Name:

Indication for Use:

The proposed SpyGlass Direct Visualization Probe is intended to provide direct The proposed Spy Grass Direct Tisameutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.

Prescription Use ど (Per 21 CFR 801.1091) (Optional Format 1-2-96) Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Janbare bus for MYM

(Division Sign-Division of General, Restorative, and Neurological Devices

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510(k) Number K052194