(120 days)
No
The summary describes a visualization system for navigation but does not mention any AI/ML components for image analysis, decision support, or other functions.
No
The device is described as an access and visualization system to facilitate a procedure (pacemaker lead implantation), not to treat a condition itself.
No
The device is intended for providing access and visualization for lead implantation, not for diagnosing a condition. Its visualization component aids navigation rather than diagnosis.
No
The device description explicitly states the system includes hardware components such as a catheter, sheath system, guide sheath set, sterile sleeve, and an imaging acquisition system.
Based on the provided information, the CardioOptics Coronary Sinus Access (CSA™) System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The CSA™ System is a device used within the body (in vivo) to provide access and visualization for a surgical procedure (pacemaker lead implantation). It is not used to examine specimens outside the body to provide diagnostic information about a patient's condition.
- Intended Use: The intended use clearly states it's for providing subclavian access to the right heart for accessing the coronary sinus and placing a guide sheath for pacemaker lead implantation. This is a procedural device, not a diagnostic one.
- Device Description: The description details a catheter and sheath system for percutaneous access and visualization within the body.
Therefore, the CSA™ System falls under the category of an in vivo medical device used for a procedural purpose, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
LYK
Device Description
The Coronary Sinus Access (CSA™) System provides a catheter and sheath system for providing percutaneous access to the coronary sinus. In addition, the catheter provides visualization to augment the user's ability to locate the coronary sinus for placement of a guide sheath. The system includes a sterile, single use Coronary Sinus Access Kit, which includes a deflecting tip catheter with visualization capability (FLAIR™ CS Catheter), a Guide Sheath Set including a dilator and sheath slitters, and a Sterile Sleeve to drape over the camera pod. The system also includes an Imaging Acquisition System to collect and display video images present in front of the catheter tip.
Mentions image processing
The system also includes an Imaging Acquisition System to collect and display video images present in front of the catheter tip.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary sinus, right heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Device testing, including mechanical, functional, and animal, was performed to support substantial equivalence to the predicate devices.
Biocompatibility was performed on the blood and tissue contacting materials of the catheter, sheaths, and dilator. The testing was consistent with ISO 10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing." All specified biocompatibility requirements were met.
The components of the Coronary Sinus Access Kit will be sterilized using validated Ethylene Oxide (EtO) sterilization processes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Olympus Angioscopes, K911278 & K860858
Reference Device(s)
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
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.
0
JUL 28 2005
so 808
510(k) SUMMARY -- CardioOptics CSA™ System
.
| Applicant Name: | Cardio-Optics, Inc.
2477 55th St. Suite 120
Boulder, Colorado 80301 USA
Phone: (720) 406-1560
Fax: (720) 406-1562 |
|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Larry O. Blankenship
Chief Operating Officer |
| Date Prepared: | March 29, 2005, Revised July 26, 2005 |
| Device Trade Name: | CardioOptics Coronary Sinus Access (CSA™) System |
| Classification Name: | Angioscope
Product code LYK, CFR Section 876.1500 |
| Predicate Devices: | Primary Predicate Devices:
Olympus Angioscopes, K911278 & K860858
Product code LYK, CFR Section 876.1500
Additional Predicate Devices:
Biosense Webster CS Deflectable Catheter K955817
Product code DRF, CFR Section 870.1220
St. Jude Medical Apeel™ CS Guide Sheath K031906
Product code DYB, CFR Section 870.1340
Thomas Medical SafeSheath™ CS Sheaths K003731
Product code DYB, CFR Section 870.1340
Acumen Coronary Sinus Visualization System, K042381
Product code DQY, CFR Section 870.1250 |
| Device Description: | The Coronary Sinus Access (CSA™) System provides a
catheter and sheath system for providing percutaneous
access to the coronary sinus. In addition, the catheter
provides visualization to augment the user's ability to locate
the coronary sinus for placement of a guide sheath. The
system includes a sterile, single use Coronary Sinus Access
Kit, which includes a deflecting tip catheter with visualization
capability (FLAIR™ CS Catheter), a Guide Sheath Set
including a dilator and sheath slitters, and a Sterile Sleeve to
drape over the camera pod. The system also includes an
Imaging Acquisition System to collect and display video
images present in front of the catheter tip. |
| Intended 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 Technological
Characteristics and
Comparison to
Predicate Device(s): | The CSA™ System was shown to be substantially
equivalent to percutaneous catheter and guide sheath
devices cleared in previous 510(k) submissions. The
FLAIR™ CS Catheter with visualization was shown to be
substantially equivalent to angioscopes and associated
video display systems cleared in previous 510(k)
submissions. |
| Performance Data: | Device testing, including mechanical, functional, and animal,
was performed to support substantial equivalence to the
predicate devices.
Biocompatibility was performed on the blood and tissue
contacting materials of the catheter, sheaths, and dilator.
The testing was consistent with ISO 10993, "Biological
Evaluation of Medical Devices Part-1: Evaluation and
Testing." All specified biocompatibility requirements were
met.
The components of the Coronary Sinus Access Kit will be
sterilized using validated Ethylene Oxide (EtO) sterilization
processes. |
| Conclusion: | Based on the data and information presented, the CSA™ System is substantially equivalent to the identified predicate
devices in terms of intended use, safety, and effectiveness. |
1
:
:
:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES" written around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other. The profiles are stylized with curved lines, giving the impression of movement or flow.
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
3
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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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
4
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)
.
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
Page 1 of 1