(21 days)
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.
The Boston Scientific Lithotripter Compatible Basket is a stone retrieval and lithotripter compatible basket used for calculi crushing and biliary stone retrieval.
This document is a 510(k) summary for a medical device called the Trapezoid™ RX Lithotripter Compatible Basket. The purpose of a 510(k) summary is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective.
Here's an analysis of the provided text to extract the requested information regarding acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, specific numerical acceptance criteria (e.g., minimum tensile strength, specific flexibility range) and corresponding reported device performance values are not explicitly stated. The document focuses on demonstrating "substantial equivalence" through comparison to a predicate device and general functional testing.
Instead of a table of specific criteria, the document states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device in performance characteristics, biocompatibility, and intended use. | "The results of design control activities do not raise any new issues of safety or effectiveness.""The modified device is substantially equivalent to the currently marketed Boston Scientific Lithotripter Compatible Basket in terms of performance characteristics, biocompatibility, and intended use.""Functional testing" was conducted. |
| Compliance with general controls and relevant regulations. | The FDA reviewed the 510(k) and determined the device is substantially equivalent. |
Explanation: The document emphasizes "substantial equivalence" as the primary "acceptance criterion" in the context of a 510(k) submission. This means the new device performs as safely and effectively as a legally marketed predicate device. The performance data section vaguely mentions "physical comparison and functional testing" which "support a determination of substantial equivalence," implying these tests confirmed the device's performance aligned with the predicate. However, detailed quantifiable results or specific acceptance thresholds are not provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a sample size for any test set or provide details on data provenance (country of origin, retrospective/prospective). It generally refers to "functional testing."
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)
The document does not mention the involvement of external experts to establish a "ground truth" for a test set. This type of device (a mechanical basket) does not typically utilize expert-reviewed imaging or diagnostic data in the same way an AI diagnostic tool would. The "ground truth" for this device would be its mechanical and functional performance, which is presumably evaluated through engineering tests rather than expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for a test set. As noted above, the evaluation seems to focus on engineering and functional testing rather than subjective human interpretation needing adjudication.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is a mechanical surgical tool, not an AI diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical instrument, not an algorithm, so "standalone" algorithm performance is not a concept that applies here. The performance is inherently "human-in-the-loop" as it is operated by a clinician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's evaluation is implied to be its functional performance and mechanical properties when compared to the predicate device. This would likely involve:
- Engineering specifications and measurements: Comparing dimensions, material properties, and mechanical characteristics against the predicate.
- Functional testing: Evaluating its ability to retrieve stones and perform lithotripsy in a simulated or benchtop environment, similar to how the predicate device performs.
- Biocompatibility testing: Ensuring the materials are safe for internal use.
It is not based on expert consensus on images, pathology, or clinical outcomes data in the way an AI diagnostic device would be.
8. The sample size for the training set
Not applicable. This device is a mechanical surgical instrument, not an AI model. Therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI model, the concept of establishing ground truth for it does not apply to this device.
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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 CorporationOne Boston Scientific PlaceNatick, MA 01760 |
|---|---|
| CONTACT PERSON: | James D. McMahonSenior Regulatory Affairs Specialist |
| DEVICE: | |
| Trade Name:Common Name:Classification: | Trapezoid™ RX Lithotripter Compatible BasketRetrieval Basket / Lithotripsy BasketClass 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 stoneretrieval and lithotripter compatible basket used for calculicrushing and biliary stone retrieval. |
| INTENDED USE: | The Boston Scientific Lithotripter Compatible Basket is intendedfor the retrieval of stones from the biliary system and endoscopiccrushing (lithotripsy) of biliary calculi. |
| COMPARISON OFCHARACTERISTICS: | The modified device is substantially equivalent to the predicatedevice, as they have the same operating principal and intendeduse. In addition, the results of design control activities do notraise 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 testingsupport a determination of substantial equivalence for themodified device when compared to the predicate device. Themodified device is substantially equivalent to the currentlymarketed Boston Scientific Lithotripter Compatible Basket interms of performance characteristics, biocompatibility, andintended 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 | (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
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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 usein the retrieval of stones from the biliary system and endoscopic crushing(lithotripsy) of biliary calculi. The Lithotripter Compatible Basketshould 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
§ 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.