The SpyCatch™ Stone Retrieval Basket is used endoscopically to entrap and remove stones from the biliary system. The SpyCatch Stone Retrieval Basket is designed to be used through the working channel of a delivery device accessing the biliary system.

Device Description

The proposed SpyCatch is a stone retrieval device designed to pass through the working channel of a scope with a working channel of >1.1mm and retrieve stones inside the biliary duct.

AI/ML Overview

The provided text is a 510(k) summary for the SpyCatch™ Stone Retrieval Basket. It addresses a medical device, not a an AI/ML device, and therefore the acceptance criteria and study information typically sought for AI/ML devices (e.g., sample sizes of test/training sets, ground truth establishment, expert qualifications, MRMC studies) are not applicable or available in this document.

The 510(k) process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device through engineering and performance testing.

Here's a breakdown of the information that is available, and why certain AI/ML-specific questions cannot be answered from this document:

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

The document states:

"Design Verification testing has been conducted to confirm that the proposed basket meets its intended use."
"The SpyCatch™ Stone Retrieval Basket represents the same fundamental scientific technology as the currently marketed Biliary Flat Wire Baskets, K925879."

This implies that the acceptance criteria are likely related to standard engineering performance specifications for stone retrieval baskets (e.g., basket strength, flexibility, deployment/retraction reliability, stone capture effectiveness in a benchtop model, biocompatibility). However, the specific acceptance criteria and the numerical results of these tests are not detailed in this 510(k) summary. These details would typically be found in the full 510(k) submission, not the publicly available summary.

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 / Not provided. For a mechanical device like a stone retrieval basket, "test sets" in the AI/ML sense (e.g., a set of patient images) are not relevant. Testing would involve benchtop simulations, material testing, and potentially animal or cadaver studies, but the sample sizes for these types of engineering tests are not disclosed in this summary. Data provenance is also not applicable for this type of device submission.

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 provided. Ground truth, in the context of expert consensus, is not relevant for the performance evaluation of a mechanical stone retrieval basket. Device performance is assessed against engineering specifications, often validated by engineers or technicians, rather than clinical experts establishing a "ground truth."

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

Not applicable / Not provided. Adjudication methods are typically associated with resolving discrepancies in expert interpretations (e.g., in an AI/ML study). This concept does not apply to the performance testing of a mechanical device.

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. MRMC studies are specific to evaluating diagnostic or screening devices (often AI-powered) where human readers are interpreting cases. This device is a surgical tool, not a diagnostic one, and does not involve human "readers" or AI assistance in interpretation.

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

Not applicable. This question pertains to AI algorithms. The SpyCatch™ is a physical surgical tool; it does not have an "algorithm" component.

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

Not applicable / Engineering Specifications. As explained above, for a mechanical device, ground truth as clinical data is not the primary assessment. The device's "truth" is its ability to meet predefined engineering and functional specifications (e.g., ability to deploy, capture, and retrieve a stone in a simulated environment).

8. The sample size for the training set

Not applicable. This question is specific to AI/ML models. There is no "training set" for a mechanical device.

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

Not applicable. See point 8.

Summary for the SpyCatch™ Stone Retrieval Basket:

The K071066 submission for the SpyCatch™ Stone Retrieval Basket is for a Class II mechanical medical device. The regulatory pathway is a 510(k), which requires demonstration of "substantial equivalence" to a predicate device (Boston Scientific Corporation's Biliary Flat Wire Baskets, K925879).

The "study" referenced in the document is Design Verification testing. This testing is conducted to "confirm that the proposed basket meets its intended use." The basis for equivalence is the "same fundamental scientific technology" as the predicate device.

To reiterate, the questions regarding AI/ML device evaluation criteria (sample sizes, ground truth establishment by experts, adjudication, MRMC studies, standalone performance, training sets) are not applicable to this type of device submission. The 510(k) summary provides evidence of substantial equivalence through technological characteristics and design verification testing, rather than clinical efficacy trials or AI performance metrics.

Summary

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K071066

510(k) Summary - SpyCatch™ Stone Retrieval Basket

1. Submitter:

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752

Contact: Neil Kelly Regulatory Affairs Specialist Date Prepared: March 19, 2007

2. Device:

Trade Name: SpyCatch™ Stone Retrieval Basket Common Name: Dislodger, Stone, Biliary Regulation Number: 876.5010 Regulation Name: Biliary catheter and accessories Classification: Class II Product Code: LQR

3. Predicate Device:

Boston Scientific Corporation's Biliary Flat Wire Baskets, K925879

4. Device Description:

The proposed SpyCatch is a stone retrieval device designed to pass through the working channel of a scope with a working channel of >1.1mm and retrieve stones inside the biliary duct.

5. Indications for Use:

The SpyCatch Stone Retrieval Basket is used endoscopically to entrap and remove stones from the Biliary system. The SpyCatch Stone Retrieval Basket is designed to be used through the working channel of a delivery device accessing the Biliary system.

JUN 2 9 2007

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6. Technological Characteristics:

The SpyCatch™ Stone Retrieval Basket represents the same fundamental scientific technology as the currently marketed Biliary Flat Wire Baskets, K925879.

7. Performance Data:

Design Verification testing has been conducted to confirm that the proposed basket meets its intended use.

8. Conclusion:

Boston Scientific Corporation has demonstrated that proposed SpyCatch Stone Retrieval Basket is substantially equivalent to the currently marketed Biliary Flat Wire Baskets, K925879.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUN 2 9 2007

Mr. Neil Kelly Regulatory Affairs Specialist Endoscopy Boston Scientific Corporation 100 Boston Scientific Way MARLBOROUGH MA 01752

Re: K071066

Trade/Device Name: SpyCatch™ Stone Retrieval Basket Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: LQR Dated: May 25, 2007 Received: May 29, 2007

Dear Mr. Kelly:

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 Amendments, 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.

Image /page/2/Picture/10 description: The image is a circular seal with the letters "FDA" in large, bold font in the center. Above the letters, the numbers "1906-2006" are printed. Below the letters, the word "Centennial" is written in a cursive font. The seal is surrounded by stars and text, which appears to be the full name of the organization. The seal is black and white and has a slightly distressed look.

Promoting and Promoting Public Health

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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.

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.xxxxx 21 CFR 884.xxxx 21 CFR 892 xxxxx Other

(Gastroenterology/Renal/Urology) 240-276-0115 (Obstetrics/Gynecology) 240-276-0115 (Radiology); 240-276-0120 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 vours.

Nancy C Brogdon

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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INDICATIONS FOR USE

510(k) Number (if known): _ Ko 7 / 066

Device Names:

SpyCatch Stone Retrieval Basket

Indications for Use:

노사

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)
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K071046

000024

Regulation Number and Section

§ 876.5010 Biliary catheter and accessories.

(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.