LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70

K093993 · Infraredx, Inc. · OGZ · Jun 30, 2010 · Cardiovascular

Device Facts

• Record ID: K093993
• Device Name: LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70
• Applicant: Infraredx, Inc.
• Product Code: OGZ · Cardiovascular
• Decision Date: Jun 30, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The LipiScan™ IVUS Imaging System is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. The System is intended for ultrasound examination of coronary intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

Device Story

System combines near-infrared (NIR) spectroscopy and intravascular ultrasound (IVUS) imaging; catheter tracks over existing guidewire via femoral or radial access during coronary angiography. NIR component detects lipid-core-containing plaques and assesses lipid core burden; IVUS component provides ultrasound imaging of coronary artery wall and pathology. Console processes signals to produce real-time images of artery wall as adjunct to angiography. Used in clinical settings by physicians to visualize coronary vasculature; output aids in identifying plaques and assessing vessel pathology, supporting clinical decision-making during interventional procedures.

Clinical Evidence

Ex vivo and in vivo data presented to support expanded indications. Bench testing included hardware, software, and system-level tests. Electrical safety verified per EN 60601-1 and EN 60601-1-2. Acoustic output testing performed per FDA 1997 guidance.

Technological Characteristics

System integrates NIR spectroscopy and 40 MHz IVUS transducer. Catheter design based on predicate K072932. Connectivity includes pull-back and rotation device with laser console. Complies with EN 60601-1 (electrical safety) and EN 60601-1-2 (EMC). Software verified and validated per FDA guidance.

Indications for Use

Indicated for patients undergoing invasive coronary angiography or candidates for transluminal coronary interventional procedures requiring examination of coronary arteries and intravascular pathology.

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 LipiScan™ IVUS Imaging System (K072932)
• Boston Scientific iLab Ultrasound Imaging System (K051679)
• Boston Scientific Atlantis SR Pro Catheter (K050577)

Submission Summary (Full Text)

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K093993 pg. 1 of 3

### Premarket Notification

# 510(K) SUMMARY

JUN 3 0 2010

| Submitter Name: | InfraReDx, Inc. |
|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 34 Third Avenue<br>Burlington, MA 01803 |
| Contact Person: | Steven J. Chartier, Vice President, Clinical & Regulatory Affairs |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Date Prepared: | December 23, 2009 |
| Device Trade Name: | InfraReDx LipiScan™ IVUS Imaging System |
| Device Common Name: | Near Infrared/IVUS Imaging System |
| Predicate Devices: | InfraReDx LipiScan™ IVUS Imaging System (K072932)<br>Boston Scientific iLab Ultrasound Imaging System<br>(K051679), Boston Scientific Atlantis SR Pro Catheter<br>(K050577) |
| Device Description: | The InfraReDx LipiScan™ IVUS Imaging System is<br>comprised of the catheter, catheter accessories, pull-back<br>and rotation device and laser console with accessories. |
| Intended Use: | The LipiScan™ IVUS Imaging System is intended for the<br>near-infrared examination of coronary arteries in patients<br>undergoing invasive coronary angiography.<br>a. The System is intended for the detection of lipid-<br>core-containing plaques of interest.<br>b. The System is intended for the assessment of<br>coronary artery lipid core burden.<br>The System is intended for ultrasound examination of<br>coronary intravascular pathology. Intravascular ultrasound<br>imaging is indicated in patients who are candidates for<br>transluminal coronary interventional procedures. |
| Device Technology Characteristics and Comparison to Predicate Device: | The InfraReDx LipiScan™ IVUS Imaging System utilizes<br>the same basic catheter design as the predicate, the<br>InfraReDx LipiScan™ Coronary Imaging System, Gen. 1.0<br>cleared K072932. These devices have a similar intended<br>use, use the same operating principal, incorporate the<br>same basic catheter design, have the same shelf life, and<br>are packaged using the same materials and processes.<br>The modifications from the InfraReDx LipiScan™ Coronary |

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Section 5: Page 1 of 3

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#### Premarket Notification

Koszari 3 pa 2013

Imaging System, Gen. 1.0 to the InfraReDx LipiScan™ IVUS Imaging System are the inclusion of ultrasound imaging within the same dimensions of the catheter, and the additional testing required to support an expanded indication for use. The ultrasound capabilities are functionally equivalent to the Boston Scientific iLab System (K051679).

#### Performance Data:

#### Non-clinical Test Results

Bench, electrical safety and acoustic output safety testing demonstrate that the LipiScan™ IVUS System and its accessories meet or exceed performance requirements and is safe and effective for its intended use.

#### Bench Testing

Bench testing was performed to evaluate the performance and functionality of the LipiScan™ IVUS System. This testing included hardware unit-level tests, software unitlevel test, and system level tests. The results demonstrate that the device satisfies all performance and functional requirements.

#### Electrical Safety Testing

The LipiScan™ IVUS System complies with EN 60601-1 and EN 60601-1-2 standards as verified by independent test facilities. The LipiScan™ IVUS System software was verified and validated in accordance with applicable FDA guidance documents.

#### Acoustic Output Testing

Acoustic output testing for the LipiScan™ IVUS System has been performed in accordance with FDA Guidance, "Information for Manufactures Seeking Market Clearance of Diagnostic Ultrasound Systems and Transducers", issued September 30, 1997.

The InfraReDx LipiScan™ IVUS Imaging System has similar indications statements as the predicate devices. All are used for imaging of the coronary vasculature. The functionality of the InfraReDx LipiScan™ IVUS System and predicate devices is equivalent. 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

#### Conclusion:

Confidential

Section 5: Page 2 of 3

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K0939913 pg 3 of 3

## InfraReDx LipiScan™ IVUS Imaging System

:

#### Premarket Notification

InfraReDx LipiScan™ IVUS Imaging System is substantially equivalent to the predicate devices.

Confidential

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread. The eagle is facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

#### JUN 3 0 2010

InfraReDx, Inc. C/O Steven J. Chartier Vice President, Clinical and Regulatory Affairs 34 Third Avenue Burlington, MA 01803-4414

Re: K093993

Trade/Device Name: LipiScan IVUS Imaging System Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OGZ, OBJ, IYO Dated: May 21, 2010 Received: May 24, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Steven J. Chartier

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely your

Bram D. Zucke 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: K093993

InfraReDx LipiScan™ IVUS Imaging System Device Name:

Indications for Use:

- 1. The LipiScan™ IVUS Imaging System is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography.
- a. The System is intended for the detection of lipid-core-containing plaques of interest.
- b. The System is intended for the assessment of coronary artery lipid core burden.
- 2. The System is intended for ultrasound examination of coronary intravascular pathology.
- a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

× Prescription 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 ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.M. Wood

vaccilar Do

510(k) Number K061399

Section 4: Page 1 of 2

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## Indications for Use Table

| System: | LipiScan™ IVUS Imaging System |
|-------------------|-------------------------------|
| System Model: | MC7 |
| Transducer Model: | 40 MHz IVUS |

| Clinical Application | | Mode of Operation | | | | | | | |
|-----------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|--|
| General | Specific | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging &<br>Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-Operative<br>(Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify) | | | | | | | | |
| | Neonatal | | | | | | | | |
| | Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-<br>Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other | | | | | | | | |
| Cardiac | Cardiac Adult | X | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | X | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-Cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (Specify) | | | | | | | | |

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