(45 days)
Not Found
No
The 510(k) summary describes a mechanical device for stone retrieval and lithotripsy and contains no mention of AI, ML, image processing, or data-driven performance metrics.
No.
The device is indicated for the retrieval and crushing of stones, which are interventional procedures rather than therapeutic.
No
Explanation: The device is indicated for the retrieval and crushing of stones, which are therapeutic procedures, not diagnostic ones.
No
The device description and performance studies clearly indicate a physical device (basket) used for stone retrieval and lithotripsy, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the retrieval and crushing of stones within the biliary system. This is a therapeutic and interventional procedure performed directly on the patient's body.
- Device Description (or lack thereof): While the description is "Not Found," the intended use clearly describes a physical device used for mechanical manipulation within the body.
- No mention of in vitro testing: There is no indication that this device is used to examine specimens (like blood, urine, or tissue) outside of the body to provide diagnostic information.
- Anatomical Site: The device operates within the "biliary system," which is an internal anatomical site.
- Performance Studies: The performance studies mentioned relate to the device's physical characteristics, biocompatibility, safety, and performance in use, not its ability to diagnose a condition based on in vitro analysis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens and provide diagnostic information about a patient's health. This device's function is clearly therapeutic and interventional, not diagnostic in the IVD sense.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
78 LQC, 78 LQR
Device Description
The Lithotripter-Compatible Basket is designed for retrieval of stones from the biliary system and endoscopic crushing of biliary calculi. It features a three-ring, detachable handle with an injection port. The basket itself is octagonal in shape, made of stainless steel, and comes in dimensions of 5.5 x 2.5 cm, 4 x 2 cm, and 3 x 1.5 cm with 4 wires. The device will be packaged in a PVC tray, placed inside a Tyvek-Mylar pouch, and sterilized using ethylene oxide gas.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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.
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Common/Usual Names: Retrieval Basket, Mechanical Lithotripter
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TRADE/PROPRIETARY NAME: The tradename of the device has not been finalized.
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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 Corporation | ||
| One Boston Scientific Place | |||
| Natick, MA 01760 | |||
| 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; hemorrhage; hematoma; septicemia/infection: pancreatitis; cholangitis; allergic reaction to contrast medium.
1
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.
2
14964937 8797
Figure 9-1: Simularities 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, | ! 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 cm
4 x 2 cm
3 x 1.5 cm |