(21 days)
Not Found
No
The summary describes a mechanical device for stone retrieval and crushing, with no mention of AI, ML, image processing, or data-driven algorithms.
No
The device is used for the retrieval of stones and crushing of biliary calculi, which are procedures to remove or break down existing issues rather than to directly treat a disease or condition for therapeutic effect.
No
The device is described as a stone retrieval and crushing basket, indicating a therapeutic rather than diagnostic function. Its intended use is for actual stone removal and crushing, not for identifying or diagnosing conditions.
No
The device description clearly states it is a "stone retrieval and lithotripter compatible basket," which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "retrieval of stones from the biliary system and endoscopic crushing (lithotripsy) of biliary calculi." This is a therapeutic and interventional procedure performed directly on the patient's body.
- Device Description: The device is described as a "stone retrieval and lithotripter compatible basket." This further reinforces its role in a physical procedure within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of this device does not involve the analysis of such specimens.
Therefore, the Boston Scientific Lithotripter Compatible Basket is a medical device used for a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Boston Scientific Lithotripter Compatible Basket is indicated for use in 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.
Product codes
78 LQC
Device Description
The Boston Scientific Lithotripter Compatible Basket is a stone retrieval and lithotripter compatible basket used for calculi crushing and biliary stone retrieval.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
FDA's "Guidance for the Content of Premarket Notifications", and the results of physical comparison and functional testing support a determination of substantial equivalence for the modified device when compared to the predicate device. The modified device is substantially equivalent to the currently marketed Boston Scientific Lithotripter Compatible Basket in terms of performance characteristics, biocompatibility, and intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
One Boston Scientific Place
Natick, MA 01760 |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | James D. McMahon
Senior Regulatory Affairs Specialist |
| DEVICE: | |
| Trade Name:
Common Name:
Classification: | Trapezoid™ RX Lithotripter Compatible Basket
Retrieval Basket / Lithotripsy Basket
Class II per 21 CFR Part 876, Section 4500 |
| PREDICATE DEVICE: | Boston Scientific Lithotripter Compatible Basket (LCB)
(K964937) and the Cook® Memory Soft Wire Basket |
| DESCRIPTION: | The Boston Scientific Lithotripter Compatible Basket is a stone
retrieval and lithotripter compatible basket used for calculi
crushing and biliary stone retrieval. |
| 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. |
| COMPARISON OF
CHARACTERISTICS: | The modified device is substantially equivalent to the predicate
device, as they have the same operating principal and intended
use. In addition, the results of design control activities do not
raise any new issues of safety or effectiveness. |
| PERFORMANCE DATA: | FDA's "Guidance for the Content of Premarket Notifications",
and the results of physical comparison and functional testing
support a determination of substantial equivalence for the
modified device when compared to the predicate device. The
modified device is substantially equivalent to the currently
marketed Boston Scientific Lithotripter Compatible Basket in
terms of performance characteristics, biocompatibility, and
intended use. |
1
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.
2
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
3
INDICATIONS FOR USE STATEMENT
| 510(k)
| Number | To be determined |
|---|---|
| Device Name | Trapezoid™ RX Lithotripter Compatible Basket |
| Indications For Use | The Boston Scientific Lithotripter Compatible Basket is indicated for use |
| in 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. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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