SPYGLASS DIRECT VISULATION PROBE

K050403 · Boston Scientific Corp · ODF · Mar 4, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K050403
• Device Name: SPYGLASS DIRECT VISULATION PROBE
• Applicant: Boston Scientific Corp
• Product Code: ODF · Gastroenterology, Urology
• Decision Date: Mar 4, 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 pancreaticobiliary system including the hepatic ducts.

Device Story

SpyGlass Direct Visualization Probe is a fiberoptic miniscope used for direct visualization of the pancreaticobiliary system. The device features a distal glass lens and a proximal adapter with a bayonet fitting and light post for connection to an external light source. It is designed to be used in conjunction with an ERCP cannula for steering stability and is inserted through the working channel of a duodenoscope. Operated by a physician during endoscopic procedures, the probe provides real-time visual feedback to the clinician, facilitating diagnostic and therapeutic interventions within the hepatic ducts and pancreaticobiliary tree. The device benefits patients by enabling direct visualization of the target anatomy, potentially improving the accuracy and efficacy of endoscopic procedures.

Clinical Evidence

Bench testing only. Evidence includes a comparison of optical performance and image quality specifications against the Visicath Imaging Catheter, and electrical safety testing performed in accordance with industry standards.

Technological Characteristics

Fiberoptic miniscope; distal glass lens; proximal adapter with bayonet fitting and light post; used with ERCP cannula and duodenoscope; electrical safety per industry standards.

Indications for Use

Indicated for patients undergoing endoscopic procedures in the pancreaticobiliary system, including the hepatic ducts, for diagnostic and therapeutic visualization.

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

• Visicath Imaging Catheter (K850393)
• Saratoga Modular Miniature Endoscope (K963354)

Submission Summary (Full Text)

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KOSd403

# MAR 4 - 2005

SECTION 11 510(K) SUMMARY

#### 510(K) SUMMARY

## 1. Submitter:

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

Contact: Kathleen Morahan Regulatory Affairs Manager Date Prepared: January 7, 2005

#### 2. Device:

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

## 3. Predicate Devices:

Boston Scientific, Visicath Imaging Catheter - K850393 5 Star Medical, Saratoga Modular Miniature Endoscope - K963354

#### 4. Device Description:

The proposed SpyGlass™ Direct Visualization Probe a fiberoptic endoscope. There is a glass fens at the distal end of the probe, and an adapter at the proximal end. The adapter has a bayonet fitting and a light post. An ocular lens connects to the bayonet fitting and the light post provides a connection for a light source. The proposed device is used with an ERCP cannula that provides stability for steering the device. The canula/probe is inserted into the working channel of a duodenoscope for entry into the duodenum and access to the pancreatico-biliary system.

#### 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 pancreaticobiliary system including the hepatic ducts.

## 6. Technological Characteristics:

Essentially. the SpyGlass™ Direct Visualization Probe has the same technological characteristics as the predicate devices. The proposed device and both predicate devices are fiberoptic miniscopes used in conjunction with a mother scope to access and visualize an indicated location.

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## 7. Performance Data:

A comparison of the optical performance and image quality specifications was made between the proposed and predicate Visicath Imaging Catheter. Electrical safety testing was performed in accordance with industry standards.

## 8. Conclusion:

Boston Scientific Corporation has demonstrated that the proposed SpyGlass™ Direct 170ston Scientifie Corporation to the Boston Scientific Visicath Imaging Catheter and in terms of the proposed indication, to the 5 Star Medical Saratoga Modular Miniature Endoscope.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of an eagle or bird with three stylized wings or feathers.

Public Health Service

MAR 4 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Boston Scientific Corporation c/o Mr. Daniel W. Lehtonen Intertek Testing Services 70 Codman Hill Road Boxborough, Massachusetts 01779

Re: K050403

K050405
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: February 15, 2005 Received: February 17, 2005

Dear Mr. Lehtonen:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) premaince is substantially equivalent (for the indications
referenced above and have determined the device is substantially equivale referenced above and have delemined the devices marketed in interstate
for use stated in the enclosure) to legally marketed prodicate device Amendments for use stated in the enclosure) to legally manced provice Amendical Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Eederal Food. Drug commerce prior to May 28, 1970, the chacanent with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with spersonal application (PMA devices that have been reclassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval assured assuredicoss of the Act. The and Cosmetic Act (Act) that do not require approvate of the general controls of the Act. The Act. The
You may, therefore, market the device, subject to the generation, li You may, therefore, market the device, subject or the general morements for annual registration, listing of general controls provisions of the rectments.
devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into ether class II (Special Controls) or class III (PMA), it If your device is classified (See above) mito caso i percentations affecting your device can
may be subject to such additional controls. Existing may on 808 - In addition F may be subject to such additional controls. Extrong may --------------------------------------------------------------------------------------------------------------------be found in the Code on Pederal Regarations, our device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a substition with other requirements of the Act
that FDA has made a determination that your device complies. You must that FDA has made a decermination that your accred by other Federal agencies. You must on or any Federal statutes and regulations administered or registration and listing (21
comply with all the Act's requirements, including, but not is set comply with an the Act s requirements, n.c. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CFR Part 807), labeling (21 CFR Part 801), good manat 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 (1050 forth in the quality systems (Q5) regalation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000

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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)
Children and contraction TRA to for lies of unstance of your device to a legally This letter will allow you to begin marketing your device of your device of your device of your device to a legally
premarket notification. The FDA inding of substantial cap premarket notification. The FDA Inding of substantial equive 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 advice for your device on our nasemato the regulation cuitiled,
contact the Office of Compliance at [phone]. Also, please note 207-07. You ma contact the Office of Compliance at (240) 270 - 19. 13. FR Part 807.97). You nay obtain
"Misbranding by reference to premarket notification of Single of Small "Misbranding by reference to premiers nonitication " (270) At then the Division of Small
other general information on your responsibilities under the Act from the Division of other general information on your responsibility of the envires mumber [phone] or 1988)
Manufacturers, International and Consumer Assistance at iss toll-free/support/i Manufacturers, International and Consumer Assistance at les con Products/Jsupport/index.html.

Sincerely yours,
Mark A. Millbern

Celia M. Witten, Ph.D., M.D. 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

510(k) Number:

To Be Determined

KUFO403

SpyGlass Direct Visualization Probe Device Name:

Indication for Use:

The proposed SpyGlass Direct Visualization Probe is intended to provide direct I he proposed Dpy Stato Direct + sexapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.

Prescription Use X (Per 21 CFR 801.1091) (Optional Format 1-2-96) OR

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (

vision of General, Restorative
& Neurological Devices

050403

Premarket Notification, SpyGlass™ Direct Visualization Probe, January 7, 2005 Proprietary and Confidential Information of Boston Scientific Corporation

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