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 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.

AI/ML Overview

The provided document is a 510(k) summary for the Boston Scientific SpyGlass™ Direct Visualization Probe. It details a submission for substantial equivalence to a predicate device, not a study performing comparative effectiveness or standalone performance with specific acceptance criteria in the typical sense of a novel algorithm or AI device.

Therefore, many of the requested elements (like sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance with acceptance criteria, ground truth types for training) are not applicable or cannot be extracted from this type of FDA submission.

Here's a breakdown of what can be extracted based on the document:

1. A table of acceptance criteria and the reported device performance:

The document states: "A comparison of the optical performance and image quality specifications was made between the proposed and predicate SpyGlass™ Direct Visualization Probe." It also mentions "Electrical safety testing was performed in accordance with industry standards."

This indicates that the acceptance criteria were based on:

Equivalence in optical performance and image quality to the predicate device (K050403). Specific quantitative metrics for these "specifications" are not provided in this summary.
Compliance with industry standards for electrical safety. The specific standards are not listed.

Since this is a submission for substantial equivalence to an existing device, the "reported device performance" is essentially that it met these equivalence and safety benchmarks, making it like the predicate. No specific performance metrics (e.g., sensitivity, specificity, accuracy) are reported because it's not a new performance claim but an equivalence claim.

Acceptance Criteria Category	Reported Device Performance
Optical Performance & Image Quality	Found to be comparable to the predicate SpyGlass Direct Visualization Probe.
Electrical Safety	Performed in accordance with industry standards.

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Not Applicable. This 510(k) does not describe a clinical study with a test set of data (e.g., patient cases) to evaluate an algorithm's performance. Instead, it describes a technical comparison of the physical device and its components to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not Applicable. No ground truth establishment by experts for a test set of data is described in this submission. The comparison is technical.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. No test set or associated adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This document describes a traditional medical device (a mini-endoscope), not an AI or imaging diagnostic algorithm requiring an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is not an algorithm, but a physical medical device. Standalone performance as described (algorithm only) is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not Applicable. No "ground truth" in the context of diagnostic accuracy against a reference standard is used or described. The "ground truth" for this submission would be the verifiable specifications and performance of the predicate device and relevant industry safety standards.

8. The sample size for the training set:

Not Applicable. No training set, as would be relevant for an AI/ML model, is described.

9. How the ground truth for the training set was established:

Not Applicable. No training set or associated ground truth establishment is described.

Summary

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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: (508) 683-4356 Fax: (508) 683-5939 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:

5. Intended Use:

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

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of three human profiles facing to the right, with flowing lines suggesting movement or connection. The profiles are arranged in a row, with each one slightly overlapping the previous one. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the profiles.

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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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

000007

510(k) Number K052194

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.