(171 days)
Not Found
No
The description focuses on the physical construction and basic functionality of an ultrasound catheter and its compatibility with specific systems. There is no mention of AI, ML, or advanced image processing that would suggest the use of these technologies.
No.
The device is indicated for "enhanced ultrasonic visualization of intracardiac structures," which is a diagnostic purpose, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" statement explicitly calls the device a "Diagnostic Ultrasound rounded tip catheter" and states its purpose is "for enhanced ultrasonic visualization of intracardiac structures," which is a diagnostic function.
No
The device description clearly details a physical catheter with a transducer, driveshaft, and connector, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "enhanced ultrasonic visualization of intracardiac structures." This describes a device used in vivo (within the body) for imaging, not a device used in vitro (outside the body) to examine specimens like blood, urine, or tissue.
- Device Description: The description details a catheter designed to be inserted into the heart for ultrasound imaging. This is consistent with an in vivo diagnostic imaging device.
- Input Imaging Modality: "Ultrasonic Pulsed Echo Imaging" is a technique used for in vivo imaging.
- Anatomical Site: "Intracardiac structures" are within the body.
IVD devices are specifically designed to examine specimens obtained from the human body to provide information for diagnostic purposes. This device is used to directly visualize structures within the body using ultrasound.
N/A
Intended Use / Indications for Use
The Reprocessed Ultra IntraCardiac Echo Diagnostic Ultrasound rounded tip catheter is indicated for enhanced ultrasonic visualization of intracardiac structures.
Product codes (comma separated list FDA assigned to the subject device)
OWQ
Device Description
The Reprocessed Ultra IntraCardiac Echo Diagnostic Ultrasound Catheter is a 9F (3mm) diameter and 9 MHz frequency IntraCardiac Echocardiography Catheter which is 110cm in lenath.
The Ultra IntraCardiac Echo Catheter is constructed with an inner core and proximal connector. The catheter has a distal imaging window and an inserted rotatable imaging core with a distal ultrasound transducer.
The 9F (3mm)/9MHz Ultra IntraCardiac Echo Catheter can be used with the ClearView Ultra™ DSP system only after implementation of version 4.22 software or higher, or the Galaxy™ system.
Ultra IntraCardiac Echo Catheters rely on the rotational fidelity of the internal transducer and driveshaft assembly to accurately coincide with the position sensing electronics located in the Motordrive Unit (MDU). This arrangement is necessary in order to reduce the overall diameter of the catheter and to ensure that image information is displayed correctly on the screen. Although the transducer and driveshaft assembly is relatively rugged, its performance depends on free rotation of the shaft within the catheter body. Pinching, crushing, and extremely sharp bends are to be avoided during use and handling.
Although the catheter body will adequately protect and guide the internal rotating assembly, care should be taken so that the catheter body is not abraded, cut or used to pull the motor assembly into position. The catheter body is formed at its distal tip so that the ultrasound energy is efficiently emitted and received. Design and functional constraints require that the distal tip be less strong, rendering it more susceptible to crushing and bending than the proximal portions. For this reason, it is strongly recommended that the tip be carefully inspected visually prior to use and after removal.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
intracardiac structures
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 Ultra ICE™ IntraCerdiac Echo Catheter. This included the following tests:
- Biocompatibility
- Validation of reprocessing
- Sterilization Validation
- Function test(s)
- Packaging Validation
Performance testing demonstrates that Reprocessed Ultra ICE™ IntraCardiac Echo Catheter perform as originally intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K121913 pg. 1 of 2
SECTION 5: 510(K) SUMMARY
Submitter:
Stryker Sustainability Solutions 1810 W Drake Dr Tempe, Arizona 85283
DEC 2 0 2012
Contact: Moira Barton-Varty Senior Director Regulatory Affairs (480) 763-5300 (o) (863) 904-2312 (f) moira.barton@stryker.com
Date of preparation: 29-JUN-2012
Name of device: Ultra ICE™ IntraCardiac Echo Catheter
Trade/Proprietary Name: Reprocessed Ultra ICE™ IntraCardiac Echo Catheter
Classification Name: Ultrasonic Pulsed Echo Imaging Catheter
| Predicate Device | 510(k) Title | Manufacturer |
|---|---|---|
| K980851 | Galaxy Intravascular Ultrasound System | Boston Scientific |
Device Description:
The Reprocessed Ultra IntraCardiac Echo Diagnostic Ultrasound Catheter is a 9F (3mm) diameter and 9 MHz frequency IntraCardiac Echocardiography Catheter which is 110cm in lenath.
The Ultra IntraCardiac Echo Catheter is constructed with an inner core and proximal connector. The catheter has a distal imaging window and an inserted rotatable imaging core with a distal ultrasound transducer.
The 9F (3mm)/9MHz Ultra IntraCardiac Echo Catheter can be used with the ClearView Ultra™ DSP system only after implementation of version 4.22 software or higher, or the Galaxy™ system.
Ultra IntraCardiac Echo Catheters rely on the rotational fidelity of the internal transducer and driveshaft assembly to accurately coincide with the position sensing electronics located in the Motordrive Unit (MDU). This arrangement is necessary in order to reduce the overall diameter of the catheter and to ensure that image information is displayed correctly on the screen. Although the transducer and driveshaft assembly is relatively rugged, its performance depends on free rotation of the shaft within the catheter body. Pinching, crushing, and extremely sharp bends are to be avoided during use and handling.
Although the catheter body will adequately protect and guide the internal rotating assembly, care should be taken so that the catheter body is not abraded, cut or used to pull the motor
1
assembly into position. The catheter body is formed at its distal tip so that the ultrasound energy is efficiently emitted and received. Design and functional constraints require that the distal tip be less strong, rendering it more susceptible to crushing and bending than the proximal portions. For this reason, it is strongly recommended that the tip be carefully inspected visually prior to use and after removal.
Indications for Use:
The Reprocessed Ultra IntraCardiac Echo Diagnostic Ultrasound rounded tip catheter is indicated for enhanced ultrasonic visualization of intracardiac structures.
Technological Characteristics:
The design, materials, and intended use of Reprocessed Ultra IntraCardiac Echo Catheter are identical to the predicate devices. The mechanism of action of the reprocessed device is identical to the predicate devices in that the same standard mechanical design, materials, and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. In addition, Stryker Sustainability Solutions' reprocessing of Ultra ICE™ IntraCardiac Echo Catheter includes removal of adbrent visible soil and decontamination. Each individual device is tested for appropriate function of its components prior to packaging and labeling operations
Performance data:
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Ultra ICE™ IntraCerdiac Echo Catheter. This included the following tests:
- Biocompatibility �
- Validation of reprocessing �
- � Sterilization Validation
- B Function test(s)
- . Packaging Validation
Performance testing demonstrates that Reprocessed Ultra ICE™ IntraCardiac Echo Catheter perform as originally intended.
Conclusion:
Stryker Sustainability Solutions concludes that the modified devices (Reprocessed Ultra ICE™ IntraCardiac Echo Catheter) are safe, effective, and substantially equivalent to the predicate devices as described herein.
2
Image /page/2/Picture/0 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 "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles a caduceus or a staff with a serpent entwined around it, representing health and medicine.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
DEC 2 0 2012
Stryker Sustainability Solutions c/o: Moira Barton-Varty Senior Director Regulatory Affairs 1810 W Drake Dr Tempe, Arizona 85283
Re: K121913
Trade Name: Reprocessed Ultra IntraCardiac Echo Diagnostic Ultrasound Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: OWQ Dated: November 18, 2012 Received: November 19, 2012
Dear Ms. Barton-Varty:
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.
3
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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
for
Sincerely vours.
Owen P. Faris -S
Bram D. Zuckerman, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K121913
SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K121913
Device Name: Reprocessed Ultra IntraCardiac Echo Diagnostic Ultrasound Cathefer
Indications For Use: The Reprocessed Ultra IntraCardiac Echo Diagnostic Ultrasound rounded tip catheter is indicated for enhanced ultrasonic visualization of intracardiac structures.
Prescription Use × (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Owen P. Faris -S
2012.12.20
13:51:32 -05'00'
Stryker Sustalnability Solutions Reprocessed Ultra IntraCardiac Echo Diagnostic Ultrasound Catheter Traditional 510(k)