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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the SpyGlass™ Direct Visualization Probe, focusing on acceptance criteria and the supporting study:

No specific acceptance criteria or performance study proving the device meets them are explicitly detailed in the provided K050403 510(k) summary.

The document primarily focuses on establishing substantial equivalence to predicate devices rather than demonstrating performance against predefined acceptance criteria for clinical efficacy or specific performance metrics.

However, based on the information provided, we can infer some aspects:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Inferred)	Reported Device Performance	Comments
Optical Performance	"A comparison of the optical performance and image quality specifications was made between the proposed and predicate Visicath Imaging Catheter."	The document states a comparison was made, implying the SpyGlass™ device must have met or been equivalent to the predicate's optical performance. However, specific metrics (e.g., resolution, field of view, illumination) or quantitative results are not provided.
Image Quality Specifications	"A comparison of the optical performance and image quality specifications was made between the proposed and predicate Visicath Imaging Catheter."	Similar to optical performance, this suggests equivalence or non-inferiority to the predicate, but no detailed specifications or results are given.
Electrical Safety	"Electrical safety testing was performed in accordance with industry standards."	This indicates the device passed relevant electrical safety tests. Specific standards (e.g., IEC 60601-1) usually define pass/fail acceptance criteria, but these are not listed.
Intended Use Equivalence	"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."	The conclusion states substantial equivalence in terms of the proposed indication to the 5 Star Medical Saratoga Modular Miniature Endoscope, implying the device performs as intended for visualization in the specified anatomical areas.
Technological Characteristics Equivalence	"Essentially, the SpyGlass™ Direct Visualization Probe has the same technological characteristics as the predicate devices."	Not strictly a performance metric, but a fundamental criterion for substantial equivalence. It implies the underlying technology is comparable, suggesting similar performance.

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable. The provided text does not describe a clinical performance study with a "test set" in the sense of patient data. The performance evaluation cited ("comparison of the optical performance and image quality specifications") appears to be a benchtop or technical comparison against a predicate device, not a study involving human subjects or patient data.
Therefore, there's no information on data provenance (country of origin, retrospective/prospective) because human data was not used for this specific performance evaluation.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not Applicable. Since there was no clinical study involving interpretation of images or diagnoses from the device, there was no need for experts to establish ground truth for a test set. The "comparison" mentioned likely involved engineering or quality control personnel assessing technical specifications.

4. Adjudication Method:

Not Applicable. No adjudication method was mentioned as there was no clinical study requiring expert consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document does not mention an MRMC study. The focus was on demonstrating substantial equivalence through technical comparison and intended use, not on measuring improvements in human reader performance with the device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No. The SpyGlass™ Direct Visualization Probe is a physical endoscope, not an algorithm or AI system. Therefore, a standalone algorithm performance study is not applicable. The "performance data" refers to the physical device's characteristics.

7. Type of Ground Truth Used:

Not Applicable (for clinical ground truth). For the "comparison of optical performance and image quality specifications," the "ground truth" would likely be established technical specifications and measurements of the predicate device, against which the new device's measurements were compared. This is a technical, engineering-based ground truth, not a clinical one (like pathology or outcomes data).

8. Sample Size for the Training Set:

Not Applicable. There is no mention of a "training set" as this device is a hardware product, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. As there was no training set, this question is not relevant.

Summary of the K050403 Submission's Approach:

The K050403 submission for the SpyGlass™ Direct Visualization Probe relies entirely on demonstrating substantial equivalence to legally marketed predicate devices (Boston Scientific Visicath Imaging Catheter and 5 Star Medical Saratoga Modular Miniature Endoscope). This is a common pathway for medical devices seeking 510(k) clearance.

Instead of presenting novel clinical performance data against specific acceptance criteria, the manufacturer:

Compared the technological characteristics of the new device to the predicates.
Ensured the intended use was equivalent or very similar.
Provided performance data related to its optical characteristics and electrical safety, implying these met or were equivalent to the predicate's standards.

This approach means that the "acceptance criteria" for the SpyGlass™ device were largely framed by the established performance and safety profiles of the predicate devices. The study to prove it met these criteria was a technical comparison and electrical safety testing, not a human clinical trial.

Summary

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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:

5. Intended Use:

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 (240) 276-0115. 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 (800) 638-2041 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

000010

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.