(205 days)
Empty
No
The document describes a reprocessed ultrasound catheter and its basic imaging and mechanical functions. There is no mention of AI, ML, or advanced image processing that would suggest the use of such technologies. The performance studies listed are standard tests for medical devices, not indicative of AI/ML evaluation.
No
The device is described as a "Diagnostic Ultrasound Catheter" and its intended use is for "intracardiac and intraluminal visualization," which indicates it is used for imaging and diagnosis, not for treating a condition.
Yes
The device's Intended Use explicitly states it is for "intracardiac and intraluminal visualization" to aid in diagnosis. Additionally, the device name itself includes "Diagnostic Ultrasound Catheter."
No
The device description explicitly details a physical catheter with an ultrasound transducer and steering mechanism, indicating it is a hardware device, not software-only. The performance studies also include hardware-specific testing like mechanical characteristics and electrical safety.
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. They are used to examine these samples outside of the body.
- Device Function: The description clearly states the device is an "intracardiac and intraluminal visualization" tool. It uses ultrasound to image structures inside the body (heart and great vessels).
- No Sample Analysis: There is no mention of the device analyzing any biological samples taken from the patient. Its function is purely for real-time imaging within the body.
Therefore, the Reprocessed Acunav Diagnostic Ultrasound Catheter is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Reprocessed Acunav Diagnostic Ultrasound Catheter is intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients.
The reprocessed device is not indicated for use with pediatric patients.
Product codes
OWO
Device Description
The Reprocessed AcuNav Diagnostic Ultrasound Catheters distal end has an ultrasound transducer providing 2-D imaging. A steering mechanism controls the image plane orientation through four-way articulation of the tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Intracardiac and intraluminal visualization of cardiac and great vessel anatomy
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Prescription Use
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 Diagnostic Ultrasound Catheters. This included the following:
- Biocompatibility
- Cleaning Validation
- Sterilization Validation
- Functional testing
- . Visual Inspection
- . Dimensional Verification
- . Ultrasound Transducer Testing
- . Simulated Use
- Mechanical Characteristics
- . Electrical Safety Testing
- . Dielectric and Current Leakage
- . 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 shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three heads in profile, facing right. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 12, 2017
Innovative Health, LLC. Rafal Chudzik VP. R&D and Operations 1435 North Hayden Road Suite 100 Scottsdale, Arizona 85257
Re: K163560
Trade/Device Name: Reprocessed AcuNav Diagnostic Ultrasound Catheter (see Enclosed Model List) Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OWO Dated: July 7, 2017 Received: July 10, 2017
Dear Rafal Chudzik:
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. 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
M.A. Wilhelmsson
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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Table 1: K163560 List of Models in Scope
| ltem Number | Description | Sheath
Usable
Length
(cm) | French
Size | System Compatibility |
|-------------|------------------------------------------|------------------------------------|----------------|-------------------------------------------|
| 10135936 | AcuNav Diagnostic Ultrasound
Catheter | 90 | 8F | Acuson/Siemens |
| 10135910 | AcuNav Diagnostic Ultrasound
Catheter | 90 | 8F | GE Vivid i & Vivid q
Ultrasound System |
The item numbers included in the scope of this submission are as follows:
Table 1: Devices in Scope
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Indications for Use
510(k) Number (if known)
Device Name
Reprocessed AcuNav Diagnostic Ultrasound Catheter
Indications for Use (Describe)
The Reprocessed Acunav Diagnostic Ultrasound Catheter is intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients.
The reprocessed device is not indicated for use with pediatric patients.
| 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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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:
Rafal Chudzik Innovative Health, LLC. VP. R&D and Operations (480) 525-6006 (office) (844) 965-9359 (fax) rchudzik@innovative-health.com
Date prepared:
December 16, 2016
Device Information:
| Trade/Proprietary Name: | Reprocessed AcuNav Diagnostic Ultrasound Catheters |
|---|---|
| Common Name: | Diagnostic Ultrasound Catheters |
| Classification Name: | Reprocessed Intravascular Ultrasound Catheter |
| Classification Number: | Class II, 21 CFR 870.1200 |
| Product Code: | OWQ |
Predicate Device:
| 510(k) Number | 510(k) Title | Manufacturer |
|---|---|---|
| K153090 | Reprocessed AcuNav Diagnostic Ultrasound | |
| Catheters | Innovative Health, LLC. | |
| K071234 | AcuNav Diagnostic Ultrasound Catheter 8F | |
| and 10F | Siemens Medical Solutions |
Device Description:
The Reprocessed AcuNav Diagnostic Ultrasound Catheters distal end has an ultrasound transducer providing 2-D imaging. A steering mechanism controls the image plane orientation through four-way articulation of the tip.
| Item
Number | Description | Sheath
Usable
Length
(cm) | French
Size | System
Compatibility |
|----------------|------------------------------------------|------------------------------------|----------------|-------------------------------------------|
| 10135936 | AcuNav Diagnostic
Ultrasound Catheter | 90 | 8F | Acuson/Siemens |
| 10135910 | AcuNav Diagnostic
Ultrasound Catheter | 90 | 8F | GE Vivid i & Vivid q
Ultrasound System |
5
Indications for Use:
The Reprocessed AcuNav Diagnostic Ultrasound Catheter is intended for intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the hearts of adult patients.
The reprocessed device is not indicated for use with pediatric patients.
Technological Characteristics:
The purpose, design, materials, function, and intended use of the Reprocessed Diagnostic Ultrasound Catheters are identical to the predicate devices. There are no changes to the claims. clinical applications, performance specifications, or method of operation. In addition, Innovative Health's reprocessing of the Diagnostic Ultrasound 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 Diagnostic Ultrasound Catheters. This included the following:
- Biocompatibility ●
- Cleaning Validation ●
- Sterilization Validation
- Functional testing
- . Visual Inspection
- . Dimensional Verification
- . Ultrasound Transducer Testing
- . Simulated Use
- Mechanical Characteristics
- . Electrical Safety Testing
- . Dielectric and Current Leakage
- . Packaging Validation
The Reprocessed Diagnostic Ultrasound Catheters are reprocessed no more than three (3) times. Each device is marked and tracked. After the device has reached the maximum number of reprocessing cycles, the device is rejected 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 Diagnostic Ultrasound Catheter is as safe and effective as the predicate devices described herein.