(683 days)
Not Found
No
The description focuses on the mechanical aspects of a balloon catheter and does not mention any AI/ML components or functions.
Yes
The device is used for the "Endoscopic Dilation of Biliary Tract, Esophageal or Shincter Stenosis," which is a therapeutic intervention aimed at treating medical conditions.
No
The device is described as a balloon dilatation catheter used for endoscopic dilation of stenosis, which is a therapeutic rather than a diagnostic function. Its purpose is to treat existing conditions, not to identify or diagnose them.
No
The device description clearly describes a physical catheter with a balloon, luer fittings, and a guide wire lumen, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Endoscopic Dilation of Biliary Tract, Esophageal or Shincter Stenosis." This is a therapeutic procedure performed in vivo (within the body) to treat a physical condition (stenosis).
- Device Description: The device is a physical catheter with a balloon designed for mechanical dilation. It does not involve the analysis of biological samples in vitro (outside the body).
- No mention of IVD activities: The description does not mention any activities related to diagnosing diseases or conditions by examining samples like blood, urine, or tissue.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical and therapeutic.
N/A
Intended Use / Indications for Use
The Medi-Globe Balloon Dilatation Catheters are intended to be used for Endoscopic Dilation of Biliary Tract, Esophageal or Shincter Stenosis.
Product codes (comma separated list FDA assigned to the subject device)
FGE, KNO
Device Description
The balloon dilatation catheter is a nylon balloon mounted on a double lumen catheter. Proximately the device is fitted with either one or two luer fittings. The balloon dilatation catheters with balloon diameters larger than 12 millimeters have only one luer fitting that allows for balloon inflation. Balloon dilatation catheters with balloon diameters smaller than 12 millimeters have two luer fittings, one for passage of a guide wire and the other for balloon inflation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary tract, esophageal, sphincter
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)
Additionally, Medi-Globe Corporation has provided laboratory testing demonstrating the product can be safely used for its intended purposes.
*The only technologic difference between the Medi-Globe and Boston Scientific devices is the material used for the balloon. Medi-Globe's use of nylon 11 for the balloon material has been shown to be safe through both biologic and bench testing studies. Independent toxicology, chemical analysis and cytotoxicity testing has been performed on the completed catheter, including the balloon. This testing found all material to be safe. Testing data can be found in attachment E. Bench testing data demonstrates the balloon's burst pressure is significantly higher than the maximum recommended balloon pressures provided to clinicians. This testing data is found in attachment G.
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
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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Page 1 of 3
510(k) Summary
: r
ﺮﺯ
Medi-Globe Balloon Dilatation Catheter
This 510(k) summary of safety and effectiveness is being submitted in accordance
with the requirements of SMDA 1190 and 21 CFR, Section 807.92.
| Submitter: | Medi-Globe Corporation
6202 South Maple Avenue #131
Tempe, Arizona 85283 | | | JAN 21 2001 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|--|-------------|
| | Telephone: (480) 897-2772
Fax: (480) 897-2878 | | | |
| Contact Person: | Steven F. McLaughlin
Operations Manager
Medi-Globe Corporation
Medi-Globe Strasse 1-5
83101 Achenmuehle
Germany | | | |
| | Telephone:
Fax:
E-mail: | +49 8032 973 380
+49 8032 973 399
mclaughlin@gip-med.de | | |
| Date Submitted: | March 2, 2001 | | | |
| Device Name: | Balloon Dilatation Catheter | | | |
| Trade Name: | Expander | | | |
| Common Name: | Dilation Balloon | | | |
| Classification Name: | Esophageal Dilator, Biliary Catheter, Endoscopic Accessory | | | |
| Substantial Equivalence: | The Medi-Globe balloon dilatation catheter is
substantially equivalent to the balloon catheters manufactured
and sold by Boston Scientific (K974788 and K973113). | | | |
| Device Description: | The balloon dilatation catheter is a nylon balloon mounted on a
double lumen catheter. Proximately the device is fitted with
either one or two luer fittings. The balloon dilatation catheters
with balloon diameters larger than 12 millimeters have only
one luer fitting that allows for balloon inflation. Balloon
dilatation catheters with balloon diameters smaller than 12 | | | |
1
millimeters have two luer fittings, one for passage of a guide wire and the other for balloon inflation.
The Medi-Globe balloon dilatation catheters are intended to be Intended Use: used for endoscopic dilation of biliary tract, esophageal or sphincter stenosis.
Comparison to Predicate Device: Please see table on following page.
ﮨﮯ -
ン・・
Medi-Globe Corporation believes its balloon dilatation catheter Conclusion: is substantially equivalent to the currently marketed predicate devices. The table on the following page compares the characteristics of the products and demonstrates equivalence in intended use, design and materials. Additionally, Medi-Globe Corporation has provided laboratory testing demonstrating the product can be safely used for its intended purposes.
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K010714 Page 3 of 3
| Characteristics | Medi-Globe | Boston Scientific | Boston Scientific |
|---|---|---|---|
| 510 (k) number | this application | K974788 | K973113 |
| Application | of | ||
| dilatation | |||
| Endoscopic | &Same | &Same | |
| esophageal | |||
| and | |||
| biliary, | |||
| sphincter stenosis. | |||
| Balloon Specifications | |||
| Diameter | 4 – 18 mm | 6 - 25 mm | 4 - 14 mm |
| Length | 2.0 - 8.0 cm | 5.5 - 8.0 cm | 2.5 - 4.0 cm |
| Max. Recommended Pressure | 3 - 18 atm | 2 - 6 atm | 9 - 12 atm |
| Catheter Specifications | |||
| Diameter | 5.7 Fr. Tapers to 3 Fr. | 7 Fr. Tapers to 5 Fr. | 5.8 - 7.8 Fr. |
| Length | 200 cm | 180 - 240 cm | 180 cm |
| Balloon Material* | Nylon 1 l | Polyurethane | Polyurethane |
| Sterilization | Sterile Packed | &Same |