(263 days)
Not Found
No
The description focuses on the hardware (transducer, catheter design) and basic image generation from ultrasound echoes. There is no mention of AI/ML terms, image processing beyond basic generation, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as an imaging catheter for evaluating vascular morphology and providing cross-sectional images, which indicates a diagnostic rather than therapeutic purpose.
Yes
The device is described as being used for the "evaluation of vascular morphology in blood vessels" and provides "a cross-sectional image of such vessels" to "provide an image of the vessel lumen and wall structures and dimensional measurements from the image," which are all diagnostic functions.
No
The device description clearly details a physical catheter with a digital ultrasound transducer, body markers, and a hydrophilic coating, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The Reprocessed Visions PV .035 catheter is an intravascular imaging catheter. It is introduced into the body (in vivo) to visualize the inside of blood vessels using ultrasound. It provides images and measurements of the vessel lumen and wall structures.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It directly interacts with the internal anatomy to generate images.
Therefore, based on the provided information, the Reprocessed Visions PV .035 catheter is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Reprocessed Visions PV .035 catheter is designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The Visions PV .035 ultrasound imaging catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.
Product codes
OWQ
Device Description
The Reprocessed Visions PV .035 catheter is an over-the-wire intravascular imaging catheter with a digital ultrasound transducer at the distal end. The transducer utilizes a 64-element cylindrical array that 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 peripheral vessels.
The catheter is introduced percutaneously or via surgical cutdown into the vascular system, and it is designed to track over 0.035"-.038" (0.89-0.97mm) guide wires.
The catheter has body markers 1 cm apart along the working length. There are 25 radiopaque markers on the distal end of the catheter, starting 1cm from the imaging plane, with the 25th RO marker overlapping the distal most wide inked marker. Inked markers (non-radiopaque) continue along the shaft, spaced 1 cm apart, middle-tomiddle, with wider marks indicating 5 cm intervals.
The Visions PV .035 catheters may only be used with Volcano s5 Series and CORE Series of Systems.
A hydrophilic coating is applied externally to a distal portion of the catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
blood vessels of the 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Visions PV .035 Catheter. This included the following:
- Biocompatibility
- Cleaning Validation
- Sterilization Validation
- Functional testing
- Visual Inspection.
- Dimensional Verification
- Simulated Use
- Mechanical Characteristics.
- Hydrophilic Coating
- System Compatibility
- Packaging Validation
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 contains 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.
January 18, 2019
Innovative Health, LLC Amanda Babcock Principal Regulatory Affairs Specialist 1435 North Hayden Road, Suite 100 Scottsdale, Arizona 85257
Re: K181126
Trade/Device Name: Reprocessed Visions PV .035 Digital IVUS Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OWQ Dated: December 17, 2018 Received: December 19, 2018
Dear Amanda Babcock:
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 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica E. Paulsen -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
The item numbers included in the scope of this submission are as follows:
| Description | Item
Number | French
Size | Guide Wire | Minimum
Sheath | Length
(cm) |
|------------------------------------------|----------------|----------------|-----------------|-------------------|----------------|
| Visions PV .035
Digital IVUS Catheter | 88901 | 7 | 0.035" - 0.038" | 8.5 F | 90 |
Table 1: Device Scope
3
Indications for Use
510(k) Number (if known)
K181126
Device Name
Reprocessed Visions PV .035 Digital IVUS Catheter
Indications for Use (Describe)
The Reprocessed Visions PV .035 catheter is designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The Visions PV .035 ultrasound imaging catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.
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) |
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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:
Amanda Babcock Principal Requlatory Affairs Specialist Innovative Health, LLC. (480) 525-5911 (office) (888) 965-7705 (fax) ababcock@innovative-health.com
Date prepared:
April 26, 2018
Device Information:
Trade/Proprietary Name: Common or Usual Name: Classification Name: Classification Number: Product Code:
Reprocessed Visions PV .035 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 |
|---|---|---|
| K153094 | Visions PV .035 Digital IVUS Catheter | Volcano Corporation |
Device Description:
The Reprocessed Visions PV .035 catheter is an over-the-wire intravascular imaging catheter with a digital ultrasound transducer at the distal end. The transducer utilizes a 64-element cylindrical array that 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 peripheral vessels.
The catheter is introduced percutaneously or via surgical cutdown into the vascular system, and it is designed to track over 0.035"-.038" (0.89-0.97mm) guide wires.
The catheter has body markers 1 cm apart along the working length. There are 25 radiopaque markers on the distal end of the catheter, starting 1cm from the imaging plane, with the 25th RO marker overlapping the distal most wide inked marker. Inked markers (non-radiopaque) continue along the shaft, spaced 1 cm apart, middle-tomiddle, with wider marks indicating 5 cm intervals.
The Visions PV .035 catheters may only be used with Volcano s5 Series and CORE Series of Systems.
A hydrophilic coating is applied externally to a distal portion of the catheter.
5
The item numbers in scope of this submission are as follows:
| Description | Item
Number | French
Size | Guide Wire | Minimum
Sheath | Length
(cm) |
|------------------------------------------|----------------|----------------|-----------------|-------------------|----------------|
| Visions PV .035
Digital IVUS Catheter | 88901 | 7 | 0.035" – 0.038" | 8.5 F | 90 |
Table 5.1: Device Scope
Indications for Use:
The Reprocessed Visions PV .035 catheter is designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels. The Visions PV .035 ultrasound imaging catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.
Technological Characteristics:
The purpose, design, materials, function, and intended use of the Reprocessed 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, Innovative Health's 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 to demonstrate performance (safety and effectiveness) of Reprocessed Visions PV .035 Catheter. This included the following:
- Biocompatibility
- Cleaning Validation
- Sterilization Validation ●
- Functional testing ●
- Visual Inspection .
- . Dimensional Verification
- . Simulated Use
- Mechanical Characteristics .
- . Hydrophilic Coating
- . System Compatibility
- Packaging Validation ●
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 cvcles, the device is reiected from further reprocessing. Reprocessing is performed only by Innovative Health. Innovative Health restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.
Conclusion:
Innovative Health concludes that the Reprocessed Visions PV .035 Catheter is as safe and effective as the predicate devices described herein.