INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5

K072932 · Infraredx, Inc. · OGZ · Apr 25, 2008 · Cardiovascular

Device Facts

• Record ID: K072932
• Device Name: INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5
• Applicant: Infraredx, Inc.
• Product Code: OGZ · Cardiovascular
• Decision Date: Apr 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The LipiScan Coronary Imaging System is intended for the near-infrared examination of coronary arteries. The System is intended for the detection of lipid-core-containing plaques of interest. The System is intended for the assessment of coronary artery lipid core burden.

Device Story

LipiScan Coronary Imaging System performs near-infrared (NIR) examination of coronary arteries. System components include catheter, pull-back/rotation device, and laser console. Catheter accesses coronary vasculature via femoral or radial site, tracking over existing guidewire during routine PCI. Device uses NIR light to detect lipid-core-containing plaques and assess lipid core burden. Output is an image of the artery wall, serving as an adjunct to coronary angiography. Used in clinical settings by physicians to visualize plaque composition; aids in clinical decision-making regarding coronary artery disease management. Benefits include improved identification of lipid-rich plaques.

Clinical Evidence

Ex vivo and in vivo data presented to support expanded indications for use. Device complies with safety and performance standards including ISO 60601-1, ISO 60601-2-22, CSA22.2 No.601.1, CSA Z386-01, IEC 60825-1, ANSI Z136.1-2000, and ISO 10993 for transient blood contacting devices. Preclinical testing confirmed device functions as intended and meets internal design specifications.

Technological Characteristics

Near-infrared imaging system; catheter-based; laser console; pull-back and rotation device. Materials compliant with ISO 10993 for transient blood contact. Standards: ISO 60601-1, ISO 60601-2-22, CSA22.2 No.601.1, CSA Z386-01, IEC 60825-1, ANSI Z136.1-2000. Connectivity: Standalone system. Sterilization: Not specified.

Indications for Use

Indicated for near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography to detect lipid-core-containing plaques and assess lipid core burden.

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

• InfraReDx NIR Imaging System (K052908)
• Boston Scientific Galaxy IVUS System (K980851)
• Boston Scientific Atlantis SR Pro (K050577)
• Volcano Eagle Eye Gold IVUS catheter (K051337)
• IVUS system (K042188)

Submission Summary (Full Text)

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| 510(K) SUMMARY<br>LipiScan Coronary Imaging System | | K072932<br>Pg 1 of 2 |
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| Submitter Name: | InfraReDx, Inc. | |
| Submitter Address: | 34 Third Avenue<br>Burlington, MA 01803 | APR 25 2008 |
| Contact Person: | Steven J. Chartier, Director, Clinical and Regulatory Affairs | |
| Phone Number: | [phone], ext. 349 | |
| Fax Number: | [phone] | |
| Date Prepared: | April 21, 2008 | |
| Device Trade Name: | LipiScan Coronary Imaging System | |
| Device Common Name: | Near Infrared Imaging System | |
| Predicate Devices: | InfraReDx NIR Imaging System (K052908)<br>Boston Scientific Galaxy IVUS System (K980851), Boston<br>Scientific Atlantis SR Pro (K050577)<br>Volcano Eagle Eye Gold IVUS catheter (K051337), IVUS<br>system (K042188) | |
| Device Description: | The LipiScan Coronary Imaging System is comprised of<br>the catheter, catheter accessories, pull-back and rotation<br>device and laser console with accessories. | |
| Intended Use: | The LipiScan Coronary Imaging System is intended for the<br>near-infrared examination of coronary arteries. The System<br>is intended for the detection of lipid-core-containing<br>plaques of interest. The System is intended for the<br>assessment of coronary artery lipid core burden. | |

## Device Technology Characteristics and Comparison to Predicate Device:

The LipiScan Coronary Imaging System utilizes the same basic catheter design as the predicate, the InfraReDx NIR Imaging System, cleared K052809. These devices have a similar intended use, use the same operating principal, incorporate the same basic catheter design, have the same shelf life, and are packaged using the same materials and processes. The modifications from the InfraReDx NIR Imaging System to the LipiScan Coronary Imaging System are the improved catheter design, improved user interface (including PBR and console), and the additional testing required to support an expanded indication for use.

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K072932
Pg. 2 of 2

The LipiScan Coronary Imaging System complies with Performance Data: applicable safety and performance standards, ISO 60601-1, ISO 60601-2-22, CSA22.2 No.601.1, CSA Z386-01, IEC 60825-1, ANSI Z136.1-2000 and ISO 10993 (for transient blood contacting devices). Further preclinical testing has shown that the product can function as intended and meets all internal design specifications.

Conclusion: The LipiScan Coronary Imaging System has similar indications statements as the predicate devices. All are used for imaging of the coronary vasculature. The functionality of the LipiScan Coronary Imaging System and predicate devices is identical. The catheter accesses the coronary vasculature via the femoral or radial access site and tracks on the existing guidewire as used during routine PCI. The device output is an image of the artery wall, as an adjunct to coronary angiography, and is similar to the predicate devices. Ex vivo and in vivo data is presented to support expanded indications for use. Therefore the LipiScan Coronary Imaging System is substantially equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 5 2008

InfraReDx, Inc. c/o Mr. Steven J. Chartier Director, Clinical and Regulatory Affairs 34 Third Ave. Burlington, MA 01803

Re: K072932

Trade/Device Name: LipiScan Coronary Imaging System Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: OGZ Dated: March 5, 2008 Received: March 6, 2008

Dear Mr. Chartier:

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.

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## Page 2 - Mr. Steven J. Chartier

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); 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

B.Bummeuraylor

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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## Indications for Use

510(k) Number: K072932

Device Name:

LipiScan Coronary Imaging System

Indications for Use:

The LipiScan Coronary Imaging System is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. The System is intended for the detection of lipid-core-containing plaques of interest. The System is intended for the assessment of coronary artery lipid core burden.

X Perscription Use (21 CFR 801 Subpart D) AND/OR

Over the Counter Use (21 CFR 801 Subpart C)

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| (Division Sign-Off) | |
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| | Division of Cardiovascular Devices |
| 510(k) Number | K072932 |
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