(447 days)
No
The summary describes a standard IVUS catheter and its reprocessing. There is no mention of AI/ML in the intended use, device description, or performance studies. The focus is on the physical characteristics, imaging modality, and compatibility with existing systems.
No.
This device is for diagnostic imaging (Intravascular Ultrasound - IVUS) to evaluate vascular morphology, not to treat a medical condition.
Yes
The device is described as providing "real-time images of the coronary and peripheral vessels" and is used "in the evaluation of vascular morphology in blood vessels...by providing a cross-sectional image of such vessels," which are diagnostic functions.
No
The device description clearly details a physical catheter with an ultrasound transducer array, radiopaque markers, and a hydrophilic coating. It is a hardware device used for imaging.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is a device that is inserted directly into blood vessels to create images of the vessel's internal structure using ultrasound. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "evaluation of vascular morphology in blood vessels... by providing a cross-sectional image." This is an imaging procedure performed in vivo (within the living body), not in vitro (in a lab setting).
Therefore, this device falls under the category of a medical device used for imaging and diagnosis in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Reprocessed Eagle Eye Platinum RX Digital IVUS Catheters are designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels. The Reprocessed Eagle Eye Platinum RX Digitial IVUS Catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
Product codes
OWO
Device Description
The Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter incorporates a cylindrical ultrasound transducer array. The array radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the coronary and peripheral vessels.
The Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter utilizes an internal lumen that allows the catheter to track over the 0.014" (0.36 mm) guide wire. The guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter tip. The catheter is introduced percutaneously or via surgical cut down into the vascular system.
Three 1 mm-long radiopaque markers are incorporated on the internal lumen positioned 10 mm apart from distal edge to distal edge. starting 10 mm from the proximal edge of the portion of the scanner marker tube normally visible under fluoroscopy.
The Eagle Eye Platinum RX Digital IVUS Catheters are exclusive use with Volcano s5 Series and CORE Series of Systems. This catheter will not operate if connected to any other imaging system.
A hydrophilic coating is applied externally to a distal portion of the catheter.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
coronary and peripheral vasculature
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
Bench and laboratory testing was conducted by reference to demonstrate performance (safety and effectiveness) of Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter. This included the following:
- Biocompatibility
- Cleaning Validation
- Sterilization Validation
- Functional testing
- Visual Inspection
- Dimensional Verification
- Simulated Use
- Mechanical Characteristics
- Hydrophilic Coating
- System Compatibility
- Drying Validation
- Packaging Validation
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 25, 2022
Innovative Health, LLC. Christina Fleming VP, Compliance and Regulatory Affairs 1435 North Hayden Road, Suite 100 Scottsdale, Arizona 85257
Re: K210655
Trade/Device Name: Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: OWO Dated: April 23, 2022 Received: April 25, 2022
Dear Christina Fleming:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
K210655 - Christina Fleming
The item number included in the scope of this submission is as follows:
| Description | Item
Number | French
Size | Guide Wire | Minimum
Sheath | Length
(cm) |
|---------------------------------------------------------------|----------------|----------------|------------|-------------------|----------------|
| Reprocessed Eagle
Eye Platinum RX
Digital IVUS Catheter | 85900P | 3.5F | 0.014" | 0.056" | 150 |
3
Indications for Use
510(k) Number (if known) K210655
Device Name
Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
Indications for Use (Describe)
The Reprocessed Eagle Eye Platinum RX Digital IVUS Catheters are designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels. The Reprocessed Eagle Eye Platinum RX Digital IVUS Catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
SECTION 5: 510(k) SUMMARY
As required by 21 CFR 807.92(c)
Submitter's Name and Address:
Innovative Health, LLC. 1435 N. Hayden Road, Suite 100 Scottsdale, AZ 85257
Contact Name and Information:
Christina Fleming VP. Compliance and Requlatory Affairs Innovative Health, LLC. (480) 525-5972 (office) (888) 965-7706 (fax) tfleming@innovative-health.com
Date prepared:
March 3, 2021
Device Information:
Trade/Proprietary Name: Common or Usual Name: Classification Name: Classification Number: Product Code:
Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter Ultrasonic Imaging Catheter Diagnostic Intravascular Catheter Class II, 21 CFR 870.1200 owq
Predicate Device:
| 510(k) Number | 510(k) Title | Manufacturer |
|---|---|---|
| K143701 | Eagle Eye Platinum Digital IVUS Catheter | Volcano/Phillips |
| Corporation |
Reference Device:
| 510(k) Number | 510(k) Title | Manufacturer |
|---|---|---|
| K200195 | NES Reprocessed Visions PV .014P RX | |
| Digital IVUS Catheter | Northeast Scientific, Inc. | |
| 510(k) Number | 510(k) Title | Manufacturer |
| K181126 | Reprocessed Visions PV .035 Digital IVUS | |
| Catheter | Northeast Scientific, Inc. |
Device Description:
The Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter incorporates a cylindrical ultrasound transducer array. The array radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the coronary and peripheral vessels.
The Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter utilizes an internal lumen that allows the catheter to track over the 0.014" (0.36 mm) guide wire. The guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter tip. The catheter is introduced percutaneously or via surgical cut down into the vascular system.
5
Three 1 mm-long radiopaque markers are incorporated on the internal lumen positioned 10 mm apart from distal edge to distal edge. starting 10 mm from the proximal edge of the portion of the scanner marker tube normally visible under fluoroscopy.
The Eagle Eye Platinum RX Digital IVUS Catheters are exclusive use with Volcano s5 Series and CORE Series of Systems. This catheter will not operate if connected to any other imaging system.
A hydrophilic coating is applied externally to a distal portion of the catheter.
The item numbers in scope of this submission are as follows:
| Description | Item
Number | French
Size | Guide Wire | Minimum
Sheath | Length
(cm) |
|---------------------------------------------------------------|----------------|----------------|------------|-------------------|----------------|
| Reprocessed Eagle
Eye Platinum RX
Digital IVUS Catheter | 85900P | 3.5F | 0.014" | 0.056" | 150 |
Table 1: Device Scope
Indications for Use:
The Reprocessed Eagle Eye Platinum RX Digital IVUS Catheters are designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels. The Reprocessed Eagle Eye Platinum RX Digitial IVUS Catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
Technological Characteristics:
The purpose, design, materials, function, and intended use of the Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter are identical to the predicate devices. There are no changes to the claims, clinical applications, patient populations, performance specifications, or method of operation. In addition, the reprocessing of the Catheter includes removal of visible soil and decontamination. Each device is inspected and function tested prior to packaging and labeling.
Functional and Safety Testing:
Bench and laboratory testing was conducted by reference to demonstrate performance (safety and effectiveness) of Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter. This included the following:
- Biocompatibility .
- Cleaning Validation .
- Sterilization Validation
- Functional testing ●
- Visual Inspection .
- . Dimensional Verification
- . Simulated Use
- . Mechanical Characteristics
- . Hydrophilic Coating
- System Compatibility .
- Drying Validation .
- Packaging Validation ●
6
The catheter is reprocessed no more than one (1) time. Each device is marked and tracked. After the device has reached the maximum number of reprocessing cycles, the device is rejected from further reprocessing. Innovative Health restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.
Conclusion:
Innovative Health concludes that the Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is as safe and effective as the predicate devices described herein.