EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830

K010714 · Medi-Globe Corp. · FGE · Jan 21, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K010714
• Device Name: EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830
• Applicant: Medi-Globe Corp.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Jan 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medi-Globe Balloon Dilatation Catheters are intended to be used for Endoscopic Dilation of Biliary Tract, Esophageal or Shincter Stenosis.

Device Story

Balloon dilatation catheter used for endoscopic dilation of biliary tract, esophageal, or sphincter stenosis. Device consists of nylon 11 balloon mounted on double lumen catheter. Models with balloon diameter >12mm feature one luer fitting for inflation; models <12mm feature two luer fittings (one for guide wire, one for inflation). Operated by clinicians in endoscopic settings. Inflation of balloon provides mechanical dilation of stenotic areas. Device is single-patient use and sterile packed.

Clinical Evidence

Bench testing only. Testing included biologic evaluation, toxicology, chemical analysis, cytotoxicity, and mechanical burst pressure testing to confirm safety and performance equivalence to predicate devices.

Technological Characteristics

Nylon 11 balloon; double lumen catheter; 4-18 mm balloon diameter; 2.0-8.0 cm balloon length; 5.7 Fr catheter tapering to 3 Fr; 200 cm length; 3-18 atm max recommended pressure; sterile, single-patient use.

Indications for Use

Indicated for endoscopic dilation of biliary tract, esophageal, or sphincter stenosis in patients requiring such procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Boston Scientific (K974788)
• Boston Scientific (K973113)

Submission Summary (Full Text)

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K010714

Page 1 of 3

## 510(k) Summary

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## 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<br>6202 South Maple Avenue #131<br>Tempe, Arizona 85283 | | | JAN 21 2001 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|--|-------------|
| | Telephone: [phone]<br>Fax: [phone] | | | |
| Contact Person: | Steven F. McLaughlin<br>Operations Manager<br>Medi-Globe Corporation<br>Medi-Globe Strasse 1-5<br>83101 Achenmuehle<br>Germany | | | |
| | Telephone:<br>Fax:<br>E-mail: | [phone]<br>[phone]<br>[e-mail] | | |
| 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<br>substantially equivalent to the balloon catheters manufactured<br>and sold by Boston Scientific (K974788 and K973113). | | | |
| Device Description: | The balloon dilatation catheter is a nylon balloon mounted on a<br>double lumen catheter. Proximately the device is fitted with<br>either one or two luer fittings. The balloon dilatation catheters<br>with balloon diameters larger than 12 millimeters have only<br>one luer fitting that allows for balloon inflation. Balloon<br>dilatation catheters with balloon diameters smaller than 12 | | | |

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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.

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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<br>dilatation<br>Endoscopic | &Same | &Same |
| | esophageal<br>and<br>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 | <=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.

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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510 (k) NUMBER (IF KNOWN) : __________________________________________________________________________________________________________________________________________________

POEVICE NAME : Balloon Dilatation Catheter

INDICATIONS FOR USE:

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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)

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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