TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088

K040447 · Boston Scientific Corp · LQC · Mar 12, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K040447
• Device Name: TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088
• Applicant: Boston Scientific Corp
• Product Code: LQC · Gastroenterology, Urology
• Decision Date: Mar 12, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.4500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Boston Scientific Lithotripter Compatible Basket is intended for the retrieval of stones from the biliary system and endoscopic crushing (lithotripsy) of biliary calculi.

Device Story

Trapezoid™ RX Lithotripter Compatible Basket is a mechanical retrieval device used for biliary stone management. Operated by physicians during endoscopic procedures, the device captures biliary calculi within a basket mechanism; it facilitates mechanical lithotripsy (crushing) of stones to enable removal. The device functions as a manual tool; it does not involve electronic processing, software, or automated analysis. It is used in clinical settings to assist in stone extraction, potentially reducing the need for more invasive surgical interventions.

Clinical Evidence

Bench testing only. Performance characteristics, biocompatibility, and functional testing support substantial equivalence to the predicate device.

Technological Characteristics

Mechanical stone retrieval and lithotripsy basket. Operates via manual mechanical actuation. No energy source, software, or electronic components. Materials and design are consistent with established lithotripter basket technology.

Indications for Use

Indicated for retrieval of stones from the biliary system and endoscopic crushing (lithotripsy) of biliary calculi in patients requiring such procedures.

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

• Boston Scientific Lithotripter Compatible Basket (LCB) (K964937)
• Cook® Memory Soft Wire Basket

Submission Summary (Full Text)

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Special 510(k) Premarket Notification I ithotripter Compatible Basket

MAR 1 2 2004

Boston Scientific Corporation February 19, 2004

K04047

## 510 (k) SUMMARY

| SPONSOR: | Boston Scientific Corporation<br>One Boston Scientific Place<br>Natick, MA 01760 |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | James D. McMahon<br>Senior Regulatory Affairs Specialist |
| DEVICE: | |
| Trade Name:<br>Common Name:<br>Classification: | Trapezoid™ RX Lithotripter Compatible Basket<br>Retrieval Basket / Lithotripsy Basket<br>Class II per 21 CFR Part 876, Section 4500 |
| PREDICATE DEVICE: | Boston Scientific Lithotripter Compatible Basket (LCB)<br>(K964937) and the Cook® Memory Soft Wire Basket |
| DESCRIPTION: | The Boston Scientific Lithotripter Compatible Basket is a stone<br>retrieval and lithotripter compatible basket used for calculi<br>crushing and biliary stone retrieval. |
| INTENDED USE: | The Boston Scientific Lithotripter Compatible Basket is intended<br>for the retrieval of stones from the biliary system and endoscopic<br>crushing (lithotripsy) of biliary calculi. |
| COMPARISON OF<br>CHARACTERISTICS: | The modified device is substantially equivalent to the predicate<br>device, as they have the same operating principal and intended<br>use. In addition, the results of design control activities do not<br>raise any new issues of safety or effectiveness. |
| PERFORMANCE DATA: | FDA's "Guidance for the Content of Premarket Notifications",<br>and the results of physical comparison and functional testing<br>support a determination of substantial equivalence for the<br>modified device when compared to the predicate device. The<br>modified device is substantially equivalent to the currently<br>marketed Boston Scientific Lithotripter Compatible Basket in<br>terms of performance characteristics, biocompatibility, and<br>intended use. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or waves.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 2004

Mr. James D. McMahon Senior Regulatory Affairs Specialist Boston Scientific Corporation, Endoscopy One Boston Scientific Place NATICK MA 01760-1537

Re: K040447 Trade/Device Name: Trapezoid™ RX Lithotripter Compatible Basket Models 1086, 1087 and 1088 Regulation Number: 21 CFR §876.4500 Regulation Name: Mechanical lithotriptor Regulatory Class: II Product Code: 78 LQC Dated: February 19, 2004 Received: February 20, 2004

Dear Mr. McMahon:

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 (PMA), it may be subject to 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) I mir letter will and my of substantial equivalence of your device of your device to a legally marketed predicated 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 If you destre spoolite daving at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. Ixxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small miormation on your responsible and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

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 STATEMENT

| 510(k)<br>Number | To be determined |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Trapezoid™ RX Lithotripter Compatible Basket |
| Indications For Use | The Boston Scientific Lithotripter Compatible Basket is indicated for use<br>in the retrieval of stones from the biliary system and endoscopic crushing<br>(lithotripsy) of biliary calculi. The Lithotripter Compatible Basket<br>should not be used for any purpose other than its intended application. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

Nancy C. Brogdon

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 51.0(k) Number

000036

Proprietary and Confidential Information of Boston Scientific Corporation