CORONARY SINUS ACCESS KIT, MODEL KCS8F-01

K050808 · Cardio-Optics, Inc. · LYK · Jul 28, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K050808
• Device Name: CORONARY SINUS ACCESS KIT, MODEL KCS8F-01
• Applicant: Cardio-Optics, Inc.
• Product Code: LYK · Gastroenterology, Urology
• Decision Date: Jul 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

The CardioOptics Coronary Sinus Access (CSA™) System is intended to provide subclavian access to the right heart for accessing the coronary sinus and placing a guide sheath suitable for pacemaker lead implantation into the coronary sinus. The system includes visualization means to image anatomical structures to augment navigation.

Device Story

System provides percutaneous access to coronary sinus; includes deflecting tip catheter (FLAIR™ CS), guide sheath set (dilator/slitters), sterile sleeve, and imaging acquisition system. Catheter captures video images of anatomical structures at tip; displays via imaging acquisition system to augment navigation. Used in clinical setting by physicians to facilitate pacemaker lead implantation. Visualization aids in locating coronary sinus for guide sheath placement; improves navigation accuracy; potentially reduces procedure time/complications.

Clinical Evidence

Bench testing only. Included mechanical and functional testing. Biocompatibility testing performed on blood and tissue-contacting materials per ISO 10993. Animal testing performed to support substantial equivalence.

Technological Characteristics

System includes deflecting tip catheter, guide sheath, dilator, and imaging acquisition system. Materials are biocompatible per ISO 10993. Sterilization via Ethylene Oxide (EtO).

Indications for Use

Indicated for patients requiring subclavian access to the right heart for coronary sinus access and guide sheath placement for pacemaker lead implantation.

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

• Olympus Angioscopes (K911278 & K860858)
• Biosense Webster CS Deflectable Catheter (K955817)
• St. Jude Medical Apeel™ CS Guide Sheath (K031906)
• Thomas Medical SafeSheath™ CS Sheaths (K003731)
• Acumen Coronary Sinus Visualization System (K042381)

Submission Summary (Full Text)

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JUL 28 2005

so 808

## 510(k) SUMMARY -- CardioOptics CSA™ System

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| Applicant Name: | Cardio-Optics, Inc.<br>2477 55th St. Suite 120<br>Boulder, Colorado 80301 USA<br>Phone: [phone]<br>Fax: [phone] |
|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Larry O. Blankenship<br>Chief Operating Officer |
| Date Prepared: | March 29, 2005, Revised July 26, 2005 |
| Device Trade Name: | CardioOptics Coronary Sinus Access (CSA™) System |
| Classification Name: | Angioscope<br>Product code LYK, CFR Section 876.1500 |
| Predicate Devices: | Primary Predicate Devices:<br>Olympus Angioscopes, K911278 & K860858<br>Product code LYK, CFR Section 876.1500<br>Additional Predicate Devices:<br>Biosense Webster CS Deflectable Catheter K955817<br>Product code DRF, CFR Section 870.1220<br>St. Jude Medical Apeel™ CS Guide Sheath K031906<br>Product code DYB, CFR Section 870.1340<br>Thomas Medical SafeSheath™ CS Sheaths K003731<br>Product code DYB, CFR Section 870.1340<br>Acumen Coronary Sinus Visualization System, K042381<br>Product code DQY, CFR Section 870.1250 |
| Device Description: | The Coronary Sinus Access (CSA™) System provides a<br>catheter and sheath system for providing percutaneous<br>access to the coronary sinus. In addition, the catheter<br>provides visualization to augment the user's ability to locate<br>the coronary sinus for placement of a guide sheath. The<br>system includes a sterile, single use Coronary Sinus Access<br>Kit, which includes a deflecting tip catheter with visualization<br>capability (FLAIR™ CS Catheter), a Guide Sheath Set<br>including a dilator and sheath slitters, and a Sterile Sleeve to<br>drape over the camera pod. The system also includes an<br>Imaging Acquisition System to collect and display video<br>images present in front of the catheter tip. |
| Intended Use: | The CardioOptics Coronary Sinus Access (CSA™) System<br>is intended to provide subclavian access to the right heart<br>for accessing the coronary sinus and placing a guide sheath<br>suitable for pacemaker lead implantation into the coronary<br>sinus. The system includes visualization means to image<br>anatomical structures to augment navigation. |
| Device Technological<br>Characteristics and<br>Comparison to<br>Predicate Device(s): | The CSA™ System was shown to be substantially<br>equivalent to percutaneous catheter and guide sheath<br>devices cleared in previous 510(k) submissions. The<br>FLAIR™ CS Catheter with visualization was shown to be<br>substantially equivalent to angioscopes and associated<br>video display systems cleared in previous 510(k)<br>submissions. |
| Performance Data: | Device testing, including mechanical, functional, and animal,<br>was performed to support substantial equivalence to the<br>predicate devices.<br><br>Biocompatibility was performed on the blood and tissue<br>contacting materials of the catheter, sheaths, and dilator.<br>The testing was consistent with ISO 10993, "Biological<br>Evaluation of Medical Devices Part-1: Evaluation and<br>Testing." All specified biocompatibility requirements were<br>met.<br><br>The components of the Coronary Sinus Access Kit will be<br>sterilized using validated Ethylene Oxide (EtO) sterilization<br>processes. |
| Conclusion: | Based on the data and information presented, the CSA™ System is substantially equivalent to the identified predicate<br>devices in terms of intended use, safety, and effectiveness. |

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 8 2005

Cardio-Optics c/o Mr.Larry Blankenship Chief Operating Officer 2477 55th Street, Ste. 120 Boulder, CO 80301

Re: K050808

Trade/ Name: Coronary Sinus Access System Regulation Number: 21 CFR 876.1500 Regulation Name: Angioscope Regulatory Class: Class II (two) Product Code: LYK Dated: July 19, 2005 Received: July 20, 2005

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.

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

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Page 2 Mr. Larry Blankenship

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 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,

Blommer 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): k050008

Device Name: CardioOptics Coronary Sinus Access (CSA™) System

Indications for Use:

The CardioOptics Coronary Sinus Access (CSA™) System is intended to provide subclavian access to the right heart for accessing the coronary sinus and placing a quide sheath suitable for pacemaker lead implantation into the coronary sinus. The system includes visualization means to image anatomical structures to augment navigation.

Prescription Use X (Part 21 CFR 801 Subpart D)

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AND/OR

Over-The-Counter Use (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)

B. Zimmerman
(Division Sign-Off)

(Division Sign-Off) Division of Cardlovascular Devices 510(k) Number

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