(112 days)
No
The document describes an optical imaging system using infrared light for visualization and navigation. There is no mention of AI, ML, image processing beyond basic visualization, or any data processing/analysis that would suggest the use of these technologies. The focus is on the hardware and the optical imaging principle.
No
The device is an imaging system used to visualize anatomical structures, not to treat a disease or condition.
No
The device is described as an optical imaging system intended to visualize anatomical structures within the heart chambers and great vessels, and assist in navigation for lead implantation. Its purpose is to provide visualization, not to diagnose a condition or disease.
No
The device description explicitly states the system is composed of a single-use catheter, accessories, and an Image Acquisition System, indicating it includes hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- CardioOptics System Function: The CardioOptics Augmentative Cardiac Optical Imaging System is used to directly image anatomical structures within the heart and great vessels in vivo (within the living body). It uses optical imaging technology to visualize these structures during procedures.
The key difference is that IVDs analyze samples outside the body, while this device is used for direct visualization inside the body.
N/A
Intended Use / 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.
Product codes
LYK
Device Description
The CardioOptics Augmentative Cardiac Optical Imaging System is composed of a single-use catheter, accessories, and an Image Acquisition System. The system incorporates infrared light (IR) technology to provide visualization through flowing blood. This submission modifies the indications for use originally cleared in 510(k) No. K050808 to include visualization of the cardiac chambers and great vessels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical imaging, fluoroscopic imaging
Anatomical Site
chambers of the heart and great vessels, coronary sinus
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
CSATM System, K050808, FSEA Fiberscope, K011763, Olympus Angioscopes, K911278 & K860858, ACUSON AcuNav™ 8F-110 Ultrasound Catheter, K042593, EPMed Systems ViewFlex Catheter, K031066
Reference Device(s)
Not Found
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
ATTACHMENT 4
510(k) Summary
NOV 3 U 2006
CardioOptics Augmentative Cardiac Optical Imaging System
| Applicant Name: | Cardio-Optics, Inc.
2425 55th St. Suite 100
Boulder, Colorado 80301 USA
Phone: (720) 406-1560
Fax: (720) 406-1562 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Larry O. Blankenship
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
FSEA Fiberscope, K011763
Olympus Angioscopes, K911278 & K860858
ACUSON AcuNav™ 8F-110 Ultrasound Catheter, K042593
EPMed Systems ViewFlex Catheter, K031066 |
| Device Description: | The CardioOptics Augmentative Cardiac Optical Imaging
System is composed of a single-use catheter, accessories,
and an Image Acquisition System. The system incorporates
infrared light (IR) technology to provide visualization
through flowing blood. This submission modifies the
indications for use originally cleared in 510(k) No. K050808
to include visualization of the cardiac chambers and great
vessels. |
1
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.
2
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 (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 (240) 276-3150 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
3
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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duane R. La Hue
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K 662340