📊 Evidence-Based Reference
Ball Tip Model 030-188
Med Telectronics
Summary: The ball tip model 030-188 by Med Telectronics is a Class 3 medical device used primarily in clinical settings for procedures involving IVC filters. Key evidence highlights its role in detecting bony pedicle defects.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K770285 ↗
Decision Date ?
February 24, 1977
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The ball tip model 030-188 was cleared through the FDA 510k pathway on February 24, 1977. It is manufactured by Med Telectronics and classified as a Class 3 device.
What It Is
The ball tip model 030-188 is a specialized medical device designed for use in procedures involving inferior vena cava (IVC) filters. It aids in the detection of anatomical defects, enhancing surgical precision.
FDA-Cleared Indications
- Use in procedures involving inferior vena cava filters, as described in the available device record.
- Detection of bony pedicle or other structural defects, as described in the available device record.
Clinical Applications
- Use during selected IVC-filter-related procedures when the device is included in the applicable cleared technique.
- Intraoperative or procedural assessment for bony pedicle defects.
- Identification of structural abnormalities when tactile or mechanical probing is part of the labeled procedure.
Evidence Summary
The available literature includes 10 studies, encompassing various types such as RCTs and case series, published between 2021 and 2025. These studies explore the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the ball tip model 030-188 effectively aids in the detection of bony pedicle defects, with outcomes varying based on the surgeon's experience. The device's role in enhancing palpation quality is noted in clinical settings.
Safety Profile
Reported complications include challenges in palpation quality depending on the user's experience level. No significant adverse events have been documented in the provided studies.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to establish standardized protocols and long-term outcomes.
Practical Considerations
- The available record does not provide the device's dimensions, working length, materials, or compatibility requirements; consult the original FDA 510(k) summary and manufacturer labeling.
- Use only with compatible instruments and according to the manufacturer's instructions for use.
- The available record does not establish MRI safety. Confirm MR Safe, MR Conditional, or MR Unsafe status before an MRI examination.
- Inspect the device before use and follow applicable sterilization, reprocessing, and single-use instructions.
- Contraindications, warnings, and procedural limitations should be taken from the original labeling; they cannot be reliably inferred from the product code alone.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for ball tip model 030-188?
The device is indicated for use in procedures involving IVC filters, particularly for detecting bony pedicle defects.
What outcomes have been reported in clinical studies?
Studies report effective detection of anatomical defects, with outcomes influenced by the clinician's experience.
What complications have been reported?
Safety data indicate challenges in palpation quality, with no major adverse events reported.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.