A LITHOTRIPTER-COMPATIBLE BASKET

K964937 · Boston Scientific Corp · LQC · Jan 24, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K964937
• Device Name: A LITHOTRIPTER-COMPATIBLE BASKET
• Applicant: Boston Scientific Corp
• Product Code: LQC · Gastroenterology, Urology
• Decision Date: Jan 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Device is a mechanical lithotripter and retrieval basket used during endoscopic procedures to capture and crush biliary calculi. Operated by a physician, the device consists of a basket (stainless steel, octagonal shape, 4-wire configuration) and a sheath (2.3 mm diameter, 180 cm length) with a detachable three-ring handle featuring an injection port. The device is inserted endoscopically into the biliary system to entrap stones; mechanical force is applied to crush the calculi for subsequent removal. The device facilitates stone clearance, potentially preventing complications associated with stone impaction, such as cholangitis or pancreatitis.

Clinical Evidence

Bench testing only. Biocompatibility assessment performed on patient- and fluid-contact materials with satisfactory results. Laboratory testing verified safety and performance characteristics.

Technological Characteristics

Stainless steel 4-wire octagonal basket; 2.3 mm diameter, 180 cm length sheath; detachable three-ring handle with injection port. Sterilized via ethylene oxide gas per AAMI protocol. Packaged in PVC tray within Tyvek-Mylar pouch.

Indications for Use

Indicated for patients requiring retrieval of biliary stones and endoscopic crushing (lithotripsy) of biliary calculi.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Monolith Mechanical Lithotripter (K943191)
• Biliary Helical and Mini-Helical Baskets (K925495)

Submission Summary (Full Text)

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K964937
P193
SECTION 9
JAN 24 1997
510(K) SUMMARY

# 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)<br/>Urology/Lithotripsy (ULDB)
- **OWNER/OPERATOR:** Boston Scientific Corporation<br/>One Boston Scientific Place<br/>Natick, MA 01760<br/>Owner/Operator No. 9912058
- **CONTACT PERSON:** Daniel J. Dillon, Senior Regulatory Affairs Specialist

## INDICATIONS FOR USE

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.

## 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; perforation; hemorrhage; hematoma; septicemia/infection; pancreatitis; cholangitis; allergic reaction to contrast medium.

Premarket Notification, Lithotripter-Compatible Basket, December 9, 1996
Proprietary and Confidential Information of Boston Scientific Corporation
57

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# DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES

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.

Premarket Notification, Lithotripter-Compatible Basket, December 9, 1996
Proprietary and Confidential Information of Boston Scientific Corporation
58

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FIGURE 9-1: SIMILARITIES AND DIFFERENCES BETWEEN LITHOTRIPTER-COMPATIBLE BASKET, MONOLITH MECHANICAL LITHOTRIPTER, AND BILIARY HELICAL AND MINI-HELICAL BASKETS

| | Lithotripter-Compatible Basket (This 510(k)) | Monolith Mechanical Lithotripter (K943191) | Biliary Helical and Mini-Helical Baskets (K925495) |
| --- | --- | --- | --- |

USE

| Indication | Biliary stone retrieval, crushing and removal | Biliary stone crushing and removal | Biliary stone entrapment and removal |
| --- | --- | --- | --- |
| Route of Administration | Endoscopic | «— Same | «— Same |

BASKET

| Dimensions | 5.5 x 2.5 cm
4 x 2 cm
3 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

| Diameter | 2.3 mm | «— Same | 0.63 - 1.6 mm |
| --- | --- | --- | --- |
| Length | 180 cm | «— Same | 35 -240 cm |

HANDLE

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

Premarket Notification, Lithotripter-Compatible Basket, December 9, 1996
Proprietary and Confidential Information of Boston Scientific Corporation
59