The Lithotripter-Compatible Basket is indicated for the retrieval of stones from the biliary system and endoscopic crushing (lithotripsy) of biliary calculi. The Lithotripter-Compatible Basket should not be used for any purpose other than its intended application.

Device Description

Not Found

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics. It's a 510(k) premarket notification for a medical device (Lithotripter-Compatible Basket) seeking substantial equivalence to existing devices, not a clinical study report.

Here's a breakdown based on the information available and what is missing:

The document states: "Boston Scientific Corporation believes that Lithotripter-Compatible Basket is substantially equivalent to its currently-marketed Monolith Mechanical Lithotripter and Biliary Helical and Mini-Helical Baskets. ... Boston Scientific Corporation has presented laboratory testing and biocompatibility information. The information presented provides assurance that the Lithotripter-Compatible Basket will meet the minimum requirements that are considered acceptable for its intended use."

This indicates that substantial equivalence is the primary "acceptance criterion" in this context, rather than specific performance thresholds from a clinical trial. The "study" proving this is primarily the comparison to predicate devices and laboratory testing.

Here's an attempt to answer your questions based on the provided text, highlighting where information is absent:

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

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Devices (Monolith Mechanical Lithotripter & Biliary Helical/Mini-Helical Baskets) in:	Demonstrated through descriptive comparison (Figure 9-1) showing similarities in:
- Indications for Use (Biliary stone retrieval, crushing, removal)	- Matches (for retrieving, crushing, and removing biliary stones)
- Route of Admin (Endoscopic)	- Matches
- Basket Dimensions (5.5 x 2.5 cm; 4 x 2 cm; 3 x 1.5 cm)	- Matches Monolith; Different from Helical/Mini-Helical (22-37mm L, 8.5-20mm D) but still compatible for biliary stones
- Number of Wires (4)	- Matches Monolith; Different from Helical/Mini-Helical (3-5)
- Basket Shape (Octagonal)	- Matches Monolith; Different from Helical (Helical)
- Basket Material (Stainless Steel)	- Matches
- Sheath dimensions (O.D., I.D., Working Length)	- Not explicitly stated as matching in the snippet provided, but implied to be similar enough for substantial equivalence. The table is incomplete for sheath.
- Handle Mechanism (Three-Ring, Detachable)	- Different from Monolith (Trigger, Non-Detachable) and Helical (Three-Ring, Non-Detachable) but this difference is permissible as long as function is equivalent.
- Handle Injection Port (Present)	- Matches
Biocompatibility	- "Biocompatibility assessment was performed on the patient- and fluid-contact materials...with satisfactory results."
Safety and Performance (General)	- "Laboratory testing regarding characteristics was performed...to verify its safety and performance."
Packaging, Sterilization, Pyrogenicity	- Packaging in PVC tray, Tyvek-Mylar pouch. Sterilized by ethylene oxide gas (AAMI protocol). Pyrogenicity testing performed periodically.

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

Sample Size: Not applicable/Not provided. The document describes laboratory testing and a comparison to predicate devices, not a clinical trial with a "test set" of patients.
Data Provenance: Not applicable/Not provided. The data appears to be from internal laboratory testing and comparative analysis, not patient data from a specific country or study type (retrospective/prospective).

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. No "test set" requiring ground truth establishment by experts is described in this regulatory submission for substantial equivalence.

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

Not applicable/Not provided. No "test set" requiring adjudication 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 is a submission for a mechanical medical device (a lithotripter basket), not an AI diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant or mentioned.

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

No. This is a mechanical device, not an algorithm.

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

Not applicable/Not provided. For substantial equivalence of a mechanical device, device specifications and performance data (e.g., tensile strength, flexibility, material composition, functional testing in a lab setting) are the "ground truth" for comparison against predicate devices, rather than clinical ground truth from patient data.

8. The sample size for the training set

Not applicable/Not provided. No "training set" is described as this is not an AI/machine learning device.

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

Not applicable/Not provided. No "training set" is described.

Summary

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K964937

JAN 2 4 1997

FOI RELEASABLE

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification "... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness.

Common/Usual Names: Retrieval Basket, Mechanical Lithotripter
TRADE/PROPRIETARY NAME: The tradename of the device has not been finalized.
Classification Name &

DEVICE CLASSIFICATION:	Class II
	Name	Number	21 CFR Ref.
	Biliary Mechanical Lithotripter	78 LQC	876.4500
	Biliary Stone Dislodger	78 LQR	876.5010
> DEVICE PANEL/BRANCH:	Gastroenterology-Urology (GU)Urology/Lithotripsy (ULDB)
> OWNER/OPERATOR:	Boston Scientific CorporationOne Boston Scientific PlaceNatick, MA 01760Owner/Operator No. 9912058
> CONTACT PERSON:	Daniel J. Dillon, Senior Regulatory Affairs Specialist

INDICATIONS FOR USE

Contraindications

None known.

COMPLICATIONS

Possible complications that may result from endoscopic crushing (lithotripsy ) and retrieval of biliary calculi include, but may not be limited to: stone impaction; hemorrhage; hematoma; septicemia/infection: pancreatitis; cholangitis; allergic reaction to contrast medium.

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DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES

K964937 p 2073

Boston Scientific Corporation believes that the Lithotripter-Compatible Basket is substantially equivalent to the currently-marketed Monolith Mechanical Lithotripter. Figure 9-1 compares the descriptive characteristics of these products.

PERFORMANCE CHARACTERISTICS

Laboratory testing regarding characteristics was performed on Lithotripter-Compatible Basket to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluid-contact materials of the Lithotripter-Compatible Basket with satisfactory results.

PACKAGING, STERILIZATION, AND PYROGENICITY

The Lithotripter-Compatible Basket will be packaged in a PVC tray and placed inside a Tyvek-Mylar pouch. The Lithotripter-Compatible Basket will be sterilized using ethylene oxide gas using the AAMI protocol for ethylene oxide sterilization. Pyrogenicity testing will be performed on a periodic basis to monitor bacterial endotoxin levels.

CONCLUSION

」

Boston Scientific Corporation believes that Lithotripter-Compatible Basket is substantially equivalent to its currently-marketed Monolith Mechanical Lithotripter and Biliary Helical and Mini-Helical Baskets. Figure 9-1 compares the descriptive characteristics of these products. As demonstrated in Figure 9-1, the Lithotripter-Compatible Basket is equivalent in its indications for use, while being very similar in design and materials. In addition, Boston Scientific Corporation has presented laboratory testing and biocompatibility information. The information presented provides assurance that the Lithotripter-Compatible Basket will meet the minimum requirements that are considered acceptable for its intended use.

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14964937 8797

Figure 9-1: Simularities and Differences between Lithotripter-Compatible Basket, Monolith MECHANICAL LITHOTRIPTER, AND BILIARY HELICAL AND MINI-HELICAL BASKETS

Lithotripter-CompatibleBasket(This 510(k))	Monolith MechanicalLithotripter(K943191)	Biliary Helical and Mini-Helical Baskets(K925495)
----------------------------------------------------	--------------------------------------------------	-----------------------------------------------------------

USE

Indication	Biliary stone retrieval,	! Billiary stone crushing	: Biliary stone entrapment
	crushing and removal	! and removal	and removal
Route of Administration	Endoscopic	«-- Same	«-- Same

BASKET

Dimensions	5.5 x 2.5 cm4 x 2 cm3 x 1.5 cm	<-- Same	22 - 37 mm (Length)8.5 - 20 mm (Diameter)
Number of Wires	4	<-- Same	3 - 5
Shape	Octagonal	<-- Same	Helical
Material	Stainless Steel	<-- Same	<-- Same

SHEATH

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HANDLE

Mechanism	Three-Ring,Detachable	Trigger,Non-Detachable	Three-Ring,Non-Detachable
Injection Port	Present	Present	Present

Regulation Number and Section

§ 876.4500 Mechanical lithotriptor.

(a)
Identification. A mechanical lithotriptor is a device with steel jaws that is inserted into the urinary bladder through the urethra to grasp and crush bladder stones.(b)
Classification. Class II (special controls). The device, when it is a biliary mechanical lithotripter, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.