CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM

K062340 · Cardio-Optics, Inc. · LYK · Nov 30, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K062340
• Device Name: CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM
• Applicant: Cardio-Optics, Inc.
• Product Code: LYK · Gastroenterology, Urology
• Decision Date: Nov 30, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The CardioOptics Augmentative Cardiac Optical Imaging System is intended to image and onical structures within the chambers of the heart and great vessels. The system is to be used in conjunction with fluoroscopic imaging. The system is also indicated for accessing the coronary sinus for pacemaker lead implantation. The system includes visualization means to image anatomical structures to augment navigation into the coronary sinus.

Device Story

System comprises single-use catheter, accessories, and Image Acquisition System; utilizes infrared (IR) light technology to enable visualization through flowing blood. Operated by physicians in clinical settings; used alongside fluoroscopic imaging to navigate cardiac chambers, great vessels, and coronary sinus. Provides real-time visual feedback to assist in catheter placement and pacemaker lead implantation. Benefits include enhanced anatomical visualization during interventional procedures.

Technological Characteristics

System utilizes infrared (IR) light technology for optical imaging through blood. Components include a single-use catheter, accessories, and an Image Acquisition System. Designed for use in conjunction with fluoroscopic imaging systems.

Indications for Use

Indicated for patients requiring visualization of cardiac chambers and great vessels, and for patients undergoing pacemaker lead implantation requiring access to the coronary sinus. Used in conjunction with fluoroscopic imaging.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• CSATM System (K050808)
• FSEA Fiberscope (K011763)
• Olympus Angioscopes (K911278 & K860858)
• ACUSON AcuNav™ 8F-110 Ultrasound Catheter (K042593)
• EPMed Systems ViewFlex Catheter (K031066)

Submission Summary (Full Text)

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K062340

# ATTACHMENT 4

# 510(k) Summary

NOV 3 U 2006

# CardioOptics Augmentative Cardiac Optical Imaging System

| Applicant Name: | Cardio-Optics, Inc.<br>2425 55th St. Suite 100<br>Boulder, Colorado 80301 USA<br>Phone: [phone]<br>Fax: [phone] |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Larry O. Blankenship<br>Chief Operating Officer |
| Date Prepared: | November 3, 2006 |
| Device Trade Name: | CardioOptics Augmentative Cardiac Optical Imaging System |
| Common Name: | Angioscope |
| Classification Name: | Angioscope (21 CFR 876.1500 Product Code: LYK) |
| Predicate Devices: | CSATM System, K050808<br>FSEA Fiberscope, K011763<br>Olympus Angioscopes, K911278 & K860858<br>ACUSON AcuNav™ 8F-110 Ultrasound Catheter, K042593<br>EPMed Systems ViewFlex Catheter, K031066 |
| Device Description: | The CardioOptics Augmentative Cardiac Optical Imaging<br>System is composed of a single-use catheter, accessories,<br>and an Image Acquisition System. The system incorporates<br>infrared light (IR) technology to provide visualization<br>through flowing blood. This submission modifies the<br>indications for use originally cleared in 510(k) No. K050808<br>to include visualization of the cardiac chambers and great<br>vessels. |

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Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three tail feathers or streamers extending from its body. The bird is positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular fashion around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 3 0 2006

CardioOptics, Inc. c/o Larry Blankenship, Chief Operating Officer 2425 55th Street Suite 100 Boulder. CO 80301

Re: K062340

Trade/Device Name: CardioOptics Augmentative Cardiac Optical Imaging System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: LYK Dated: November 3, 2006 Received: November 6, 2006

Dear Mr. Blankenship:

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. Blankenship

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oe davinou mat i termination that your device complies with other requirements of the Act that I Drimas intatutes and regulations administered by other Federal agencies. You must or any I edital button as a sea step including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in also qualion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product raction of 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 premated 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 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,

Bermimor 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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#### ATTACHMENT 3

# INDICATIONS FOR USE STATEMENT

Page 1 of 1

# 510(k) Number (if known): K062340

Device Name: CardioOptics Augmentative Cardiac Optical Imaging System

#### Indications for Use:

The CardioOptics Augmentative Cardiac Optical Imaging System is intended to image and onical structures within the chambers of the heart and great vessels. The system is to be used in conjunction with fluoroscopic imaging.

The system is also indicated for accessing the coronary sinus for pacemaker lead implantation. The system includes visualization means to image anatomical structures to augment navigation into the coronary sinus.

Prescription Use X (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)

Duane R. La Hue

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K 662340