(683 days)
The Medi-Globe Balloon Dilatation Catheters are intended to be used for Endoscopic Dilation of Biliary Tract, Esophageal or Shincter Stenosis.
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.
The provided document is a 510(k) summary for a medical device (Medi-Globe Balloon Dilatation Catheter) seeking substantial equivalence to existing devices. It focuses on device description, intended use, and comparison to predicate devices, and refers to biological and bench testing.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a quantitative manner as one might find for diagnostic accuracy. Instead, it demonstrates equivalence to predicate devices and safety through testing. The reported performance is primarily focused on physical characteristics and safety margins.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence: Similar intended use, design, and materials to predicate devices (Boston Scientific K974788 and K973113). | Intended Use: Endoscopic dilation of biliary tract, esophageal, or sphincter stenosis (identical to predicates).Design: Nylon balloon mounted on double lumen catheter with luer fittings.Materials: Primarily similar, except for balloon material (Nylon 11 vs. Polyurethane).Specifications: Diameters, lengths, and max recommended pressures are within ranges comparable to or overlapping with predicates. |
| Biocompatibility/Safety: Materials must be safe for intended use. | Biologic Testing: Independent toxicology, chemical analysis, and cytotoxicity testing performed on the completed catheter (including balloon) found all material to be safe (Attachment E). |
| Mechanical Integrity/Safety: Balloon must withstand pressures significantly higher than recommended clinical use. | Bench Testing: Balloon's burst pressure is significantly higher than the maximum recommended balloon pressures provided to clinicians (Attachment G). |
| Sterility & Packaging: Sterile, single-patient use, individually packed. | Sterilization: Sterile Packed, Single Patient Use.Packaging: Individual Packed, Peel-open Pouches (Same as predicates). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical study or a "test set" in the context of device performance evaluation against a gold standard for accuracy or diagnostic capability. The "testing" mentioned refers to:
- Biologic testing: on materials for safety.
- Bench testing: on the device (balloon) for mechanical integrity (burst pressure).
Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable in this context, as there isn't a patient-centric "test set" described.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
As there is no "test set" evaluated against a ground truth in the context of diagnostic accuracy, this information is not applicable. The safety and mechanical testing would have been conducted by qualified laboratory personnel, but not "experts" establishing a clinical ground truth for a test set.
4. Adjudication Method for the Test Set
This is not applicable as there is no clinical "test set" or adjudication process described.
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
This is not applicable. The device is a balloon dilatation catheter, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI assistance effect size are irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical medical instrument, not an algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The concept of "ground truth" as typically used for diagnostic or screening devices is not applicable here. The "ground truth" for this device's evaluation is based on:
- Predicate device characteristics: Demonstrating similar physical and functional properties to already approved devices.
- Biocompatibility standards: Evaluating material safety against established biological safety standards.
- Mechanical engineering principles: Testing burst pressure against design specifications and safety margins.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" for an algorithm or a dataset in the context of this physical device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as #8.
{0}------------------------------------------------
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 Corporation6202 South Maple Avenue #131Tempe, Arizona 85283 | JAN 21 2001 | ||
|---|---|---|---|---|
| Telephone: (480) 897-2772Fax: (480) 897-2878 | ||||
| Contact Person: | Steven F. McLaughlinOperations ManagerMedi-Globe CorporationMedi-Globe Strasse 1-583101 AchenmuehleGermany | |||
| Telephone:Fax:E-mail: | +49 8032 973 380+49 8032 973 399mclaughlin@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 issubstantially equivalent to the balloon catheters manufacturedand sold by Boston Scientific (K974788 and K973113). | |||
| Device Description: | The balloon dilatation catheter is a nylon balloon mounted on adouble lumen catheter. Proximately the device is fitted witheither one or two luer fittings. The balloon dilatation catheterswith balloon diameters larger than 12 millimeters have onlyone luer fitting that allows for balloon inflation. Balloondilatation 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.
{2}------------------------------------------------
K010714 Page 3 of 3
| Characteristics | Medi-Globe | Boston Scientific | Boston Scientific |
|---|---|---|---|
| 510 (k) number | this application | K974788 | K973113 |
| Application | ofdilatationEndoscopic | &Same | &Same |
| esophagealandbiliary, | |||
| 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 | <=Same |
| Single Patient Use | |||
| Packaging | Individual Packed | &Same | &Same |
| Peel-open Pouches |
*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.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 25, 2015
Medi-Globe Corporation Gerhardt Seiwerth Product Specialist Medi-Globe Strasse 1-5 D-83101 Achenmühle Germany
Re:
K010714 Trade/Device Name: Balloon Dilatation Catheter Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE, KNO Dated (Date on orig SE ltr): October 17, 2002 Received (Date on orig SE Itr): October 23, 2002
Dear Gerhardt Seiwerth,
This letter corrects our substantially equivalent letter of January 21, 2003.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
{4}------------------------------------------------
Page 2 -
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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
for Benjamin R. Fisher, Ph.D.
Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
510 (k) NUMBER (IF KNOWN) : __________________________________________________________________________________________________________________________________________________
POEVICE NAME : Balloon Dilatation Catheter
INDICATIONS FOR USE:
来说说说
. •
The Medi-Globe Balloon Dilatation Catheters are intended to be used for Endoscopic Dilation of Biliary Tract, Esophageal or Shincter Stenosis.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE. ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ાર
Prescription Use (Per 2) CFR 001.109) Over - The - Counter - Use er - The - Councer 1 - 2
Nancy C Hogdon
(Division Sign-off)
Division of Reproducti and Parlining car Devices 510(k) Number
§ 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.