The SpyScope Access and Delivery Catheter is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the biliary system including the hepatic ducts.

Device Description

The SpyScope Access and Delivery Catheter is a sterile, single-use device comprised of two main components: a flexible delivery catheter and a handle. The device is intended to be used to guide both the SpyGlass Direct Visualization Probe (K050403) or other visualization devices and accessory devices, (such as biopsy forceps, cytology brushes, stone retrieval baskets, etc.) during endoscopic retrograde cholangiopancreatography (ERCP) procedures. The SpyScope Access and Delivery Catheter is introduced to the desired anatomical location through a duodenoscope with a minimum working channel diameter of 4.2mm. The distal tip of the SpyScope Access and Delivery Catheter is designed to articulate in four directions.

AI/ML Overview

The provided text is a 510(k) summary for the Boston Scientific SpyScope Access and Delivery Catheter and generally contains information for regulatory clearance. It describes the device, its intended use, and substantial equivalence to predicate devices based on technological characteristics and performance data.

However, the document does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving device performance against those criteria in the way you've outlined for typical AI/ML device studies. This document predates the widespread use of AI/ML in medical devices and therefore doesn't address metrics like sensitivity, specificity, or reader studies.

Here's a breakdown of what can be extracted and what is missing:

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

The document implies that "bench testing was conducted to evaluate the design features... and establish specifications of the descriptive characteristics." However, it does not explicitly list these specifications (acceptance criteria) or the precise performance values measured against them.
The "performance data" section is very general, stating that these specifications "were used to demonstrate substantial equivalence."

Acceptance Criteria (Implied from text)	Reported Device Performance (Implied from text)
Design features and descriptive characteristics (e.g., articulation, working channel, control knobs, locking mechanism)	Met all established specifications, demonstrating substantial equivalence to predicate devices (Olympus SwingTip Cannula, Olympus CHF Type BP30 Choledochofiberscope).

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

Not present. The document states "bench testing was conducted," but provides no details on sample size for the test set or data provenance (e.g., simulated scenarios, actual device samples, number of cycles tested for durability, etc.).

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/Not present. This type of information is relevant for studies involving human interpretation (e.g., radiology images) or clinical outcomes where expert consensus or adjudication defines the "ground truth." For a mechanical device like a catheter, "ground truth" performance is typically established through engineering specifications and physical testing, not expert consensus on medical data.

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

Not applicable/Not present. Adjudication methods are used in reader studies or clinical trials to resolve discrepancies in expert opinions, which is not relevant for this type of bench testing.

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

Not applicable. This device is a catheter, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.

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

Not applicable. This device is purely mechanical and does not involve an algorithm.

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

The "ground truth" for this device's performance would be derived from engineering specifications and physical measurements obtained during bench testing. For example, testing the articulation range, working channel diameter, material strength, and durability against predefined engineering standards. The document only generally states that "specifications of the descriptive characteristics" were established.

8. The sample size for the training set

Not applicable/Not present. Since this device does not involve AI or machine learning, there is no "training set."

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

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

In summary:

The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the SpyScope Access and Delivery Catheter to predicate devices based on design and functional characteristics, supported by general bench testing. It does not provide the detailed performance metrics, study designs, expert involvement, or AI/ML-specific information that your request implies. This is typical for a 510(k) from 2005 for a mechanical device.

Summary

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JUN 1 6 2005

SECTION 10 510(K) SUMMARY

510(K) SUMMARY

1. Submitter:

Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760 Owner/operator #9912058

Contact: Jennifer Johnson Sr. Regulatory Specialist Boston Scientific Marlborough 100 Boston Scientific Way Marlborough, MA 01752 Phone: 508-683-4178, Fax: 508-683-5939 Date Prepared: May 16, 2005

2. Device:

Trade Name: SpyScope Access and Delivery Catheter Common Name: Catheter Classification Name: Endoscopes and Accessories

3. Predicate Device:

Olympus SwingTip Cannula, K011149 Olympus CHF Type BP30 Choledochofiberscope, K944473

4. Device Description:

5. Intended Use:

The SpyScope Access and Delivery Catheter will be intended to guide both optical and accessory type devices for diagnostic and therapeutic applications during endoscopic procedures in the biliary system including the hepatic ducts.

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6. Technological Characteristics:

Technological similarities between the SpyScope Access and Delivery Catheter and the Olympus SwingTip Cannula include the articulating tip and between the SpyScope Access and Delivery Catheter and the Olympus Choledochofiberscope includes the working channel, control knobs, and locking mechanism to hold tip in position. In instances where the technological characteristics may differ, it has been demonstrated that there are no new questions raised regarding safety and effectiveness of the SpyScope Access and Delivery Catheter.

7. Performance Data:

Bench testing was conducted to evaluate the design features of the SpyScope Access and Delivery Catheter and establish specifications of the descriptive characteristics for the proposed device. These specifications were used to demonstrate substantial equivalence of the proposed device to the predicate devices.

8. Conclusion:

BSC has demonstrated that the SpyScope Access and Delivery Catheter is substantially equivalent to Olympus's currently marketed SwingTip Cannula and Olympus's currently marketed CHF Type BP30 Choledochofiberscope.

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JUN 1 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MI) 20050

Boston Scientific Corporation c/o Mr. Neil E. Devine Sr. Staff Engineer Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719

Re: K051504

Trade/Device Name: SpyScope™ Access and Delivery Catheter Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: KOG Dated: June 2, 2005 Received: June 7, 2005

Dear Mr. Devine:

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 Aniendments, 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 531-542 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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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SECTION 3 INDICATIONS FOR USE

Indications for Use

510(k) Number (if known):	To be determined
Device Name:	SpyScope Access and Delivery Catheter

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K051504

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Premarket Notification, SpyScope Access and Delivery Catheter, May 16, 2005 Proprietary and Confidential Information of Boston Scientific Corporation

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.