INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5

K052908 · Infraredx, Inc. · DQO · Jun 23, 2006 · Cardiovascular

Device Facts

• Record ID: K052908
• Device Name: INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5
• Applicant: Infraredx, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Jun 23, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The InfraReDx Near Infrared (NIR) Imaging System is intended for the near infrared imaging of the coronary arteries.

Device Story

InfraReDx NIR Imaging System (Model MC-5) provides near-infrared imaging of coronary arteries. System components include catheter, catheter accessories, pull-back/rotation device, and laser console. Physician operates device in clinical setting; catheter tracks over existing guidewire via femoral or radial access during routine PCI. Device captures NIR signals to produce arterial images as adjunct to coronary angiography. Output assists clinicians in visualizing coronary vasculature; aids clinical decision-making during interventional procedures.

Clinical Evidence

Bench testing only. 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 contact. Preclinical testing confirmed device functions as intended and meets internal design specifications.

Technological Characteristics

System includes laser console, pull-back/rotation device, and catheter. Materials meet ISO 10993 for transient blood contact. Sensing principle: Near-infrared imaging. Connectivity: Standalone. Standards: ISO 60601-1, ISO 60601-2-22, CSA22.2 No.601.1, CSA Z386-01, IEC 60825-1, ANSI Z136.1-2000.

Indications for Use

Indicated for near infrared imaging of coronary arteries in patients undergoing coronary angiography.

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

• Boston Scientific Galaxy IVUS System (K052908)
• Boston Scientific Atlantis SR, SR Pro and SR Plus IVUS catheter (K052908)
• Volcano Revolution and Eagle Eye Gold IVUS catheter (K052908)
• Baxter Imagecath Coronary Angioscope (K052908)
• American Edwards Angioscopy catheter/system (K052908)
• Cardio-Optics CSA System (K052908)

Submission Summary (Full Text)

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## 510(K) SUMMARY K052908 InfraReDx Near Infrared (NIR) Imaging System

| Submitter Name: | InfraReDx JUN 2 3 2006 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 34 Third Avenue<br>Burlington, MA 01803 |
| Contact Person: | Nandini Murthy, V.P. Clinical and Regulatory Affairs |
| Phone Number: | [phone], Extn 221 |
| Fax Number: | [phone] |
| Date Prepared: | October 13, 2005 (Amended: June 8, 2006) |
| Device Trade Name: | InfraReDx Near Infrared (NIR) Imaging System, Model MC-5 |
| Device Common Name: | Near Infrared (NIR) Imaging System |
| Predicate Devices: | Boston Scientific Galaxy IVUS System, Boston Scientific<br>Atlantis SR, SR Pro and SR Plus IVUS catheter<br>Volcano Revolution and Eagle Eye Gold IVUS catheter, IVUS<br>system<br>Baxter Imagecath Coronary Angioscope<br>American Edwards Angioscopy catheter/system<br>Cardio-Optics CSA System |
| Device Description: | The InfraReDx Near Infrared (NIR) Imaging system is<br>comprised of the catheter, catheter accessories, pull-back and<br>rotation device and laser console with accessories. |
| Intended Use: | The InfraReDx Near Infrared (NIR) Imaging System is intended<br>for the near infrared imaging of the coronary arteries. |
| Performance Data: | The InfraReDx Near Infrared (NIR) Imaging System complies<br>with applicable safety and performance standards, ISO 60601-1,<br>ISO 60601-2-22, CSA22.2 No.601.1, CSA Z386-01, IEC 60825-<br>1, ANSI Z136.1-2000 and ISO 10993 (for transient blood<br>contacting devices). Further preclinical testing has shown that<br>the product can function as intended and meets all internal<br>design specifications. |
| Conclusion: | The InfraReDx Near Infrared (NIR) Imaging System has similar<br>indications statements as the predicate devices. All are used for<br>imaging of the coronary vasculature. The functionality of the<br>InfraReDx System and predicate devices is identical. The<br>catheter accesses the coronary vasculature via the femoral or<br>radial access site and tracks on the existing guidewire as used<br>during routine PCI. The device output is an image of the artery,<br>as an adjunct to coronary angiography, and is similar to the<br>predicate devices. Therefore the InfraReDx NIR Imaging System<br>is substantially equivalent to the predicate devices. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 2006

InfraReDx, Inc. Ms. Nandini Murthy Vice President, Clinical and Regulatory Affairs 34 Third Avenue Burlington MA 01803

Re: K052908

Trade/Device Name: InfraReDx NIR Imaging System, Model MC-5 Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II (performance standards) Product Code: DOO Dated: April 24, 2006 Received: April 25, 2006

Dear Ms. Murthy:

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. HDA way 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 aft the Act or any Federal statutes and regulations administered by other Federal agencies. Your must comply with all the Act s requirements, including, but not limited to: registration and listing (21

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Page 2 - Ms. Nandini Murthy

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, permitte vor 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,

Bymmerman 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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## Indications for Use

510(k) Number (if known): K052908

Device Name: InfraReDx Near Infrared (NIR) Imaging System

Indications For Use:

The InfraReDx NIR System is intended for the near infrared imaging of the coronary arteries.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

B. Bannister.

(División Sign-Off) Division of Cardiovascular Devices 510(k) Number_ KOS 290X

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