VANGUARD REPROCESSED INFLATION DEVICES

K012480 · Vanguard Medical Concepts, Inc. · MAV · Jan 22, 2002 · Cardiovascular

Device Facts

• Record ID: K012480
• Device Name: VANGUARD REPROCESSED INFLATION DEVICES
• Applicant: Vanguard Medical Concepts, Inc.
• Product Code: MAV · Cardiovascular
• Decision Date: Jan 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The inflation device is designed to inflate and deflate an angioplasty balloon or other interventional device and to monitor pressure within the balloon.

Device Story

Reprocessed sterile hand-held mechanical inflation device; includes 20 cc syringe, pressure gauge, plunger, connector tube, and male luer fitting. Used in angioplasty or interventional procedures to generate/monitor pressure within balloons. Operated by clinicians in healthcare facilities. Vanguard Medical Concepts collects used OEM devices; performs cleaning, inspection, functional testing, and sterilization; returns to facility for reuse. Output is visual pressure monitoring via gauge; assists clinician in controlled balloon inflation/deflation.

Clinical Evidence

Bench testing only. Evidence includes sterilization and packaging validation, functional/performance testing, and biocompatibility testing to demonstrate that reprocessed devices are equivalent to OEM predicates.

Technological Characteristics

Mechanical hand-held inflation device. Components: 20 cc syringe, pressure gauge, plunger, connector tube, male luer fitting. Materials and specifications identical to OEM predicates. Sterilization performed as part of the reprocessing cycle.

Indications for Use

Indicated for use in angioplasty or other interventional procedures to inflate/deflate balloons and monitor balloon pressure.

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

• ACS Inflation Devices
• Medtronic Everest 20/30 Inflation Devices
• Merit Medical Systems Monarch/IntelliSystem 25 Inflation Devices
• SCIMED Encore 26 Inflation Devices

Submission Summary (Full Text)

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K012480

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## 510(k) Summary of Safety & Effectiveness

| Submitter | Vanguard Medical Concepts, Inc.<br>5307 Great Oak Drive<br>Lakeland, FL 33815 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Mr. Mike Sammon, Ph.D.<br>Director, Research and Development<br>[phone], extension 228<br>[phone] (facsimile)<br>[e-mail] |
| Date | July 27, 2001 |
| Device | <ul><li>Trade Names: Vanguard Reprocessed Inflation Devices <ul><li>⇒ ACS Indeflator™ Inflation Devices</li><li>⇒ Medtronic Everest™ 20/30 Inflation Devices</li><li>⇒ Merit Medical Systems Monarch™/ IntelliSystem®25 Inflation Devices</li><li>⇒ SCIMED® Encore® 26 Inflation Devices</li></ul></li><li>Common Name: Inflation device or syringe</li><li>Classification: Class II - Syringe, Balloon Inflation</li><li>Product Code MAV</li></ul> |
| Predicate Devices | Respective ACS, Medtronic, Merit Medical, and SCIMED® legally marketed inflation devices under various 510(k) premarket notifications. |
| Indications for Use | The inflation device is designed to inflate and deflate an angioplasty balloon or other interventional device and to monitor pressure within the balloon. |

Continued on next pageContinued on next page

Indeflator is a trademark of Advanced Cardiovascular Systems, Inc.

Everest is a trademark of Medtronic, Inc.

Monarch and IntelliSystem are trademarks of Merit Mcdical Systems, Inc. Monarch and IntelliSystem are trademarks of Meril Wednesd bystenlific Scimed, Inc.

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## 510(k) Summary of Safety & Effectiveness, Continued

| Device<br>Description | An inflation device is designed to generate and monitor pressure and is used<br>in angioplasty or other interventional procedures. It is a sterile hand-held<br>mechanical device comprised of a 20 cc syringe, pressure gauge, plunger,<br>connector tube and a male luer fitting for connection to a catheter. The device<br>may be used in conjunction with other accessories such as a hemostatic valve<br>or stopcock, guide wire introducer or torque device.<br><br>Vanguard receives previously used inflation devices from healthcare<br>facilities; cleans, inspects, tests, repackages and sterilizes the devices; and<br>returns them to the healthcare facility. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | The Vanguard reprocessed inflation devices are essentially identical to<br>the currently marketed OEM devices. No changes are made to the currently<br>marketed device's specifications and they possess the same technological<br>characteristics. Biocompatibility and performance/functional testing<br>demonstrate that the devices are equivalent and continue to be safe and<br>effective for their intended use. |
| Test Data | Sterilization and packaging validations, and functional/performance, and<br>biocompatibility testing demonstrates that the reprocessed devices perform as<br>intended and are safe and effective. |
| Conclusion | Based on the information provided herein and the 510(k) "Substantial<br>Equivalence" Decision Making Process Chart, we conclude that the Vanguard<br>reprocessed inflation devices are substantially equivalent to the predicate<br>devices under the Federal Food, Drug and Cosmetic Act. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 2002

Mike Sammon, Ph.D. Director, Research and Development Vanguard Medical Concepts, Inc. 5307 Great Oak Drive Lakeland, FL 33815

K012480 Re:

Vanguard Reprocessed Inflation Devices Regulation Number: 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: 74 MAV Dated: November 25, 2001 Received: November 27, 2001

Dear Dr. Sammon:

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.

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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with

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Page 2 - Mike Sammon, Ph.D.

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.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Deeda Tiller

Bram Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

KO12480 510(k) Number:

Device Name: Vanguard Reprocessed Inflation Devices

Indications for Use:

The inflation device is designed to inflate and deflate an angioplasty balloon or other interventional device and to monitor pressure within the balloon.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

1 Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number

iv