STERILEMED REPROCESSED IVUS IMAGING CATHETER

K043453 · Sterilmed, Inc. · OWQ · Mar 1, 2005 · Cardiovascular

Device Facts

• Record ID: K043453
• Device Name: STERILEMED REPROCESSED IVUS IMAGING CATHETER
• Applicant: Sterilmed, Inc.
• Product Code: OWQ · Cardiovascular
• Decision Date: Mar 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The SterilMed Reprocessed Imaging Catheter is intended for intravascular or intracardiac ultrasound imaging in order to provide visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart. This device is intended for use in the right heart only.

Device Story

SterilMed Reprocessed IVUS Imaging Catheter; steerable catheter; 90 cm length; 10 French diameter; distal ultrasonic phased array imaging transducer; frequency range 4.0-10.0 MHz. Used with compatible ultrasound imaging system for visualization of vascular/cardiac anatomy and physiology or other devices in heart; right heart use only. Reprocessed device; identical to predicate in design, materials, and construction. Clinical utility involves providing real-time ultrasound visualization to assist physicians during cardiac procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including design testing, process validation for cleaning and sterilization, and packaging validation.

Technological Characteristics

Steerable catheter; 90 cm length; 10 French diameter; distal ultrasonic phased array imaging transducer; 4.0-10.0 MHz frequency range. Reprocessed device; sterilization and cleaning validated.

Indications for Use

Indicated for intravascular or intracardiac ultrasound imaging to visualize vascular, cardiac, and great vessel anatomy and physiology, or other devices in the heart. Intended for use in the right heart only.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• AcuNav Diagnostic Ultrasound Catheter (K992631)

Submission Summary (Full Text)

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K043453
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## MAR 1 - 2065

#### SUMMARY AND CERTIFICATION SECTION 2.

### 2.A. 510(K) SUMMARY

f

| Submitter: | SterilMed, Inc. |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dr. Bruce R. Lester<br>SterilMed, Inc.<br>11400 73rd Avenue North<br>Minneapolis, MN 55369<br>Ph: 763-488-3409<br>Fax: [phone] |
| Date Prepared: | December 13, 2004 |
| Trade Name: | SterilMed Reprocessed IVUS Imaging Catheter |
| Classification Name:<br>and Number: | Angiography Catheter<br>Class II, 21 CFR 870.1200 |
| Product Code: | NLI |
| Predicate Device(s): | The SterilMed Reprocessed Imaging Catheter is<br>substantially equivalent to the AcuNav™ Diagnostic<br>Ultrasound Catheter Manufactured by Acuson Corp.<br>(K992631). |
| Device Description: | The SterilMed Reprocessed Imaging Catheter is intended to<br>be used with a compatible ultrasound imaging system. It is<br>steerable, has a useable length of 90 cm and a diameter of<br>10 French. The distal end of the catheter contains an<br>ultrasonic phased array imaging transducer. The transducer<br>offers imaging modes at frequencies between 4.0 and 10.0<br>MHz. |
| Intended Use: | The SterilMed Reprocessed Imaging Catheter is intended<br>for intravascular or intracardiac ultrasound imaging in<br>order to provide visualization of vascular anatomy, cardiac<br>and great vessel anatomy and physiology, or other devices<br>in the heart. This device is intended for use in the right<br>heart only. |
| Functional and<br>Safety Testing: | Representative samples of reprocessed imaging catheters<br>underwent design testing to demonstrate appropriate |

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functional characteristics. Process validation testing was done 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. Finally, testing to support the required Special 510(k) Report was successfully performed and provided to the Agency.

The imaging catheters reprocessed by SterilMed are Conclusion: substantially equivalent to the AcuNav™ Diagnostic Ultrasound Catheter Manufactured by Acuson Corp. (K992631). This conclusion is based upon the fact that this device is identical to the predicate device in terms of its design, materials, indications for usc, and construction.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight.

MAR 1 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SterilMed, Inc. c/o Bruce Lester, Ph.D. Vice President Research and Development 11400 73rd Avenue North Minneapolis, MN 55369

Re: K043453

1949139
Trade Name: Sterilmed Reprocessed IVUS Imaging Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: NLI Dated: December 13, 2004 Received: December 15, 2004

Dear Dr. Lester:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have teviewed your bocurer. 310(s) fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars actment date of the Medical Device Amendments, or to conninered provision to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). and Cosment Act (Act) that to not requent of the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of general controls profitive proctice, 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 If your device is crassimod (soc ac refrols. Existing major regulations affecting your device can may be subject to saen adonations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Coursements concerning your device in the Federal Register.

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Page 2 -- Bruce Lester, Ph.D.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issualites of a cases of the other requirements of the Act that I DA has made a dolorimiation administered by other Federal agencies. You must or any rederal statutes and regulations and limited to: registration and listing (21 Comply with an the Act 3 requirements, morealing, and manufacturing practice requirements as set CFK Part 807), adomig (21 CFRT art 820), good if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro risions (oveting your device as described in your Section 5 lo(k) This letter will anow you to begin maxicoling of substantial equivalence of your device to a legally premarket notheation. The PDA muding of backandar 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 If you titsire specific at 700-10-10-10-10-20 Also, please note the regulation entitled, Collider the Orifice of Councilication" (21CFR Part 807.97). You may obtain of Small other general information on your response Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Bhiminor for

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 -- Bruce Lester, Ph.D.

Enclosure - List of Devices Substantially Equivalent

:

| Orig Models found to be SE |
|----------------------------|
| Acuson (1) |
| 55790 |

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# Indications for Use

510(k) Number (if known):

K043457

Device Name:

Reprocessed Imaging Catheters

Indications For Use:

The SterilMed Reprocessed Imaging Catheter is intended for intravascular or intracardiac ultrasound imaging in order to provide visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart. This device is intended for use in the right-heart only.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blamminion

ision Sign-Off Division of Cardiovas 510(k) Number

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