(261 days)
No
The summary describes a reprocessed ultrasound catheter and its functional performance testing, with no mention of AI or ML capabilities.
No
The device is indicated for visualization of cardiac structures and blood flow, which is a diagnostic purpose, not a therapeutic one.
Yes
The device's intended use is to "visualize cardiac structures, blood flow and other devices within the heart," which is a diagnostic purpose to understand the condition or presence of structures within the heart.
No
The device description clearly details a physical catheter with a transducer, shaft, and handle, 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:
- 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 ViewFlex™ Xtra ICE Catheter is an intracardiac ultrasound catheter. It is inserted directly into the heart to visualize structures and blood flow within the body. It does not analyze samples taken from the body.
- Intended Use: The intended use is to "visualize cardiac structures, blood flow and other devices within the heart," which is a diagnostic imaging function performed in vivo (within the living body).
Therefore, this device falls under the category of a medical device used for diagnostic imaging in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Reprocessed ViewFlex™ Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.
Product codes
OWQ
Device Description
The Reprocessed ViewFlex Xtra ICE Catheter is a temporary intracardiac ultrasound catheter intended for use in patients to visualize cardiac structures and blood flow within the heart. The Reprocessed ViewFlex Xtra ICE Catheter is inserted into the heart via intravascular access. The Reprocessed ViewFlex Xtra ICE Catheter shaft is a 9 French catheter with a useable length of 90 cm. The shaft is compatible with a 10 French or larger introducer for insertion into the femoral or jugular veins. The catheter tip is a 64- element linear phased array transducer housed in silicone. The distal portion of the shaft is deflectable in four directions allowing for leftto-right and anterior-to-posterior deflection. The handle of the catheter has two deflection mechanisms that correspond with movement of the distal shaft in the four planes of movement. The Reprocessed ViewFlex Xtra Ice Catheter is compatible with ViewMate Z or ViewMate and Philips CX50 ultrasound consoles via the use of a compatible ViewFlex Catheter interface module.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac structures within the heart
Indicated Patient Age Range
adult and adolescent pediatric patients
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 ViewFlex Xtra ICE Catheter. This included the following tests: Biocompatibility, Validation of Reprocessing, Sterilization Validation, Functional Performance Tests, Acoustic Testing, Electrical Safety Testing, Electromagnetic Compatibility Testing, Packaging Validation. The functional performance testing demonstrates that Reprocessed ViewFlex device perform as originally intended.
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
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May 8, 2019
Stryker Sustainability Solutions Ramona Kulik Staff Specialist Regulatory Affairs 1810 West Drake Drive Tempe. Arizona 85283
Re: K182238
Trade/Device Name: Reprocessed ViewFlex Xtra ICE Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OWQ Dated: April 3, 2019 Received: April 4, 2019
Dear Ramona Kulik:
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/cfpmp/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 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
1
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/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,
Bram Zuckerman, M.D. Director Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
The following device model is included in the scope of this 510(k) submission:
| Model Number | Description | Useable Length | French Size |
|---|---|---|---|
| D087031 | Reprocessed ViewFlex Xtra ICE | ||
| Catheter | 90 cm | 9F |
3
Indications for Use
510(k) Number (if known) K182238
Device Name
Reprocessed ViewFlex™ Xtra ICE Catheter
Indications for Use (Describe)
The Reprocessed ViewFlex™ Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.
Type of Use (Select one or both, as applicable)
XJ 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
Submitter:
Stryker Sustainability Solutions 1810 W. Drake Drive Tempe, Arizona 85283
Contact:
Ramona Kulik Staff Regulatory Affairs Specialist 480-763-2952 (o) 480-763-2965 (f) ramona.kulik@stryker.com
August 17, 2018 Date of Preparation:
Name of Device:
| Trade/Proprietary Name: | Reprocessed ViewFlex™ Xtra ICE Catheter |
|---|---|
| Common Name: | Diagnostic Intravascular Catheter |
| Classification Information: | Class: II |
| Regulation Number: 21 CFR 870.1200 | |
| Product Code: OWO |
Predicate Devices:
| Model | 510(k) | 510(k) Title | Original |
|---|---|---|---|
| Number | Number | Manufacturer | |
| D087031 | K133853 | VIEWFLEX XTRA ICE CATHETER | Irvine |
| Biomedical | |||
| Inc. A St. Jude | |||
| Medical | |||
| Company |
Device Description:
The Reprocessed ViewFlex Xtra ICE Catheter is a temporary intracardiac ultrasound catheter intended for use in patients to visualize cardiac structures and blood flow within the heart. The Reprocessed ViewFlex Xtra ICE Catheter is inserted into the heart via intravascular access. The Reprocessed ViewFlex Xtra ICE Catheter shaft is a 9 French catheter with a useable length of 90 cm. The shaft is compatible with a 10 French or larger introducer for insertion into the femoral or jugular veins. The catheter tip is a 64- element linear phased array transducer housed in silicone. The distal portion of the shaft is deflectable in four directions allowing for leftto-right and anterior-to-posterior deflection. The handle of the catheter has two deflection mechanisms that correspond with movement of the distal shaft in the four planes of movement. The Reprocessed ViewFlex Xtra Ice Catheter is compatible with ViewMate Z or ViewMate and Philips CX50 ultrasound consoles via the use of a compatible ViewFlex Catheter interface module.
5
The model number included in the scope of this submission is as follows:
| Model
| Number | Description | Useable Length | French Size |
|---|---|---|---|
| D087031 | Reprocessed ViewFlex Xtra ICE | ||
| Catheter | 90 cm | 9F |
Intended Use:
The Reprocessed ViewFlex™ Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.
Summary of Technological Characteristics:
The design, materials, and intended use of Reprocessed ViewFlex Xtra ICE Catheter are equivalent to the predicate device. The mechanism of the reprocessed device is identical to the predicate device 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 ViewFlex Xtra ICE Catheter includes removal of adherent 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 ViewFlex Xtra ICE Catheter. This included the following tests:
- Biocompatibility .
- Validation of Reprocessing
- Sterilization Validation
- . Functional Performance Tests
- Acoustic Testing
- . Electrical Safety Testing
- Electromagnetic Compatibility Testing
- Packaging Validation .
The functional performance testing demonstrates that Reprocessed ViewFlex device perform as originally intended.
The Reprocessed ViewFlex Xtra ICE Catheter is reprocessed no more than one (1) time. Each reprocessed device is tracked with a serial number label which is affixed to the cable. Once the device reaches the maximum number of reprocessing cycles, it is rejected and taken out of service. Reprocessing is conducted only by Stryker Sustainability Solutions. Stryker Sustainability Solutions restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.
6
Conclusion:
Stryker Sustainability Solutions concludes that the Reprocessed ViewFlex Xtra ICE Catheter is at least as safe and effective as the predicate device as described herein.