REPROCESSED BALOON INFLATION DEVICE

K053188 · Sterilmed, Inc. · NKU · May 4, 2006 · Cardiovascular

Device Facts

• Record ID: K053188
• Device Name: REPROCESSED BALOON INFLATION DEVICE
• Applicant: Sterilmed, Inc.
• Product Code: NKU · Cardiovascular
• Decision Date: May 4, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The reprocessed Balloon Inflation Device is intended for use with balloon dilatation catheters to create and monitor pressure in the balloon and to deflate the balloon.

Device Story

Reprocessed manual balloon inflation device; used with balloon dilatation catheters. Components include threaded plunger, locking mechanism, pressure gauge, and connecting tube. Finger latch controls locking mechanism; allows advancement/withdrawal of plunger when unlocked. Device generates and monitors pressure in atmospheres (atm) and pounds per square inch (psi). Used by clinicians to inflate/deflate balloons during interventional procedures. Benefits include controlled balloon expansion for therapeutic catheterization.

Clinical Evidence

Bench testing only. Representative samples underwent functional performance testing. Process validation performed for cleaning, sterilization, and packaging. Manufacturing process includes 100% visual and functional testing.

Technological Characteristics

Manual inflation device consisting of threaded plunger, locking mechanism, pressure gauge, and connecting tube. Mechanical operation. No software or electronic components.

Indications for Use

Indicated for use with balloon dilatation catheters to create, monitor, and deflate pressure in the balloon during clinical procedures.

Regulatory Classification

Special Controls

*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Encore 26 Inflation Device (K955869)

Submission Summary (Full Text)

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K053188

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### 510(K) SUMMARY

| Submitter: | SterilMed, Inc. |
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| | Contact Person:<br>Dr. Bruce Lester<br>SterilMed, Inc.<br>11400 73rd Avenue North<br>Minneapolis, MN 55369 |
| Date Prepared: | November 14, 2005 |
| Trade Name: | Reprocessed Balloon Inflation Device |
| Classification Name: | Injector and Device, Angiographic, Balloon<br>Inflation, Reprocessed |
| Classification Number: | Class II; 870 1650 |
| Product Code: | NKU |
| Predicate Device(s): | The SterilMed Reprocessed Balloon Inflation Device is<br>substantially equivalent to the Encore 26 Inflation<br>Device manufactured by Boston Scientific (K955869<br>cleared March 22, 1996). |
| Device Description: | The Reprocessed Balloon Inflation Device consists of a<br>threaded plunger, locking mechanism, pressure gauge,<br>Device and connecting tube. A finger latch controls the<br>locking mechanism on the device. When the device is<br>unlocked the threaded plunger may be advanced or<br>withdrawn. Locking of the device allows for generation<br>and monitoring of pressure in atmospheres (atm) and<br>pounds per square inch (psi). |

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SterilMed Inc 510(k) Premarket Notification Reprocessed Balloon Inflation Device

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11/14/2005

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| Intended Use: | The reprocessed Balloon Inflation Device is intended for use with balloon dilatation catheters to create and monitor pressure in the balloon and to deflate the balloon. |
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| Functional and Safety Testing: | Representative samples of reprocessed Balloon Inflation Devices underwent bench testing to demonstrate appropriate functional performance. Process validation testing was performed to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced. |
| Conclusion: | The Reprocessed Balloon Inflation Device is substantially equivalent to the Encore 26 Inflation Device manufactured by Boston Scientific (K955869 cleared March 22, 1996). This conclusion is based upon the devices' similarities in functional design, materials, indications for use and methods of construction. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling three wavy lines or stripes, possibly representing a flag or banner.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 4 2006

SterilMed, Inc c/o Mr. Dennis Toussaint Regulatory Affairs Director 11400 73rd Avenue North, Suite 100 Maple Grove, Minnesota 55369

Re: K053188

Trade/Device Name: Reprocessed Balloon Inflation Device Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: Class II Product Code: NKU Dated: April 25, 2006 Received: April 26, 2006

Dear Mr. Toussaint:

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, Or to and Cosmetic Act (Act) that do not require approval of a premarket approval application (DMA). 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misburanding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be 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 not 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); 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.

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Page 2 - Mr. Dennis Toussaint

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html .

Sincerely yours,

Duna R. lochner

A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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## Page 3 – Mr. Dennis Toussaint

# List of Model(s): Boston Scientific Encore 26 Inflation Device

11 - 12 - 12 - 12 - 12 ..

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#### INDICATIONS FOR USE

K053188

Device Name: Reprocessed Balloon Inflation Device

Indications for Use:

The reprocessed Balloon Inflation Device is intended for use with balloon dilatation catheters to create and monitor pressure in the balloon and to deflate the balloon.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Number_Kos 3188