(53 days)
Not Found
No
The summary describes a reprocessed ultrasound catheter and its physical characteristics and performance testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is used to visualize cardiac structures and blood flow, not to treat a disease or condition.
Yes.
This device is designed to visualize cardiac structures and blood flow within the heart using ultrasound, which is a diagnostic function.
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:
- Intended Use: The intended use is to "visualize cardiac structures, blood flow and other devices within the heart." This is a direct visualization and imaging function performed in vivo (within the living body).
- Device Description: The device is an "intracardiac ultrasound catheter" that is "inserted into the heart via intravascular access." This confirms its use within the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices and accessories used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
This device operates in vivo to provide real-time imaging, which falls outside the scope of IVD devices.
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 (comma separated list FDA assigned to the subject device)
OWO, 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 left-to-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. The model number included in the scope of this submission is D087031.
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 the Reprocessed ViewFlex Xtra ICE Catheter, including:
- Biocompatibility
- Cleaning Validation
- Sterilization Validation
- Functional Performance Testing
- Visual Inspection
- Simulated Use
- Dimensional Verification
- Ultrasound Transducer Testing
- Image Quality Testing
- Acoustic Output Testing
- Mechanical Characteristics
- EMC and Electrical Safety Testing
The performance testing demonstrates that reprocessed devices are as safe and effective as the predicate and operate 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).
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July 25, 2023
Stryker Sustainability Solutions Mia Brown Staff Regulatory Affairs Specialist 1810 West Drake Drive Tempe, Arizona 85283
Re: K231621
Trade/Device Name: Reprocessed ViewFlex Xtra ICE Catheter (D087031) Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OWO Dated: June 2, 2023 Received: June 2, 2023
Dear Mia Brown:
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,
Marco-Cannella -S
for
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
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K231621 - Mia Brown
| Model Number | Description | Usable length | French size |
|---|---|---|---|
| D087031 | Reprocessed ViewFlex Xtra ICE Catheter | 90cm | 9F |
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Reprocessed ViewFlex Xtra ICE Catheter (D087031)
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)
| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the Stryker logo, with the words "Sustainability Solutions" written below it. The word "Stryker" is in a bold, sans-serif font, and the words "Sustainability Solutions" are in a smaller, sans-serif font. The logo is black and white. The logo is simple and modern.
510(k) Summary
| Submitter Name and Address: | Stryker Sustainability Solutions
1810 W. Drake Drive
Tempe, Arizona 85283 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------|
| Contact Name and Address: | Mia Brown
Staff Regulatory Affairs Specialist
480-343-1855 (c)
480-763-2965 (f)
mia.brown1@stryker.com |
| Date of Preparation: | June 2, 2023 |
| Device Information: | |
| Trade/Proprietary Name: | Reprocessed ViewFlex Xtra ICE Catheter |
| Common Name: | Diagnostic Intravascular Catheter |
| Classification Name: | Reprocessed Intravascular Ultrasound Catheter |
| Regulation Number: | Cardiovascular (21 CFR § 870.1200, Class II) |
| Product Code: | OWQ |
| Model Number: | D087031 |
Predicate Devices:
| Model Number | 510(k) Number | 510(k) Title | Original Manufacturer |
|---|---|---|---|
| D087031 | K182238 | Reprocessed ViewFlex Xtra | |
| ICE Catheter | Stryker Sustainability | ||
| Solutions | |||
| D087031 | K133853 | ViewFlex Xtra ICE Catheter | Irvine Biomedical, Inc. |
| a St. Jude 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 left-to-right and anteriorto-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.
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Image /page/5/Picture/0 description: The image shows the Stryker logo, with the words "Sustainability Solutions" written below it. The Stryker logo is in a bold, sans-serif font. The words "Sustainability Solutions" are in a smaller, sans-serif font. The logo is black and the background is white. The registered trademark symbol is present to the right of the logo.
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.
The model number included in the scope of this submission is as follows:
| Model Number | Description | Usable length | French size |
|---|---|---|---|
| D087031 | Reprocessed ViewFlex Xtra ICE Catheter | 90cm | 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.
Technological Comparison:
The design, materials, and intended use of the Reprocessed ViewFlex Xtra ICE Catheter are equivalent to the predicate and reference devices. The mechanism of action 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 the device 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. This 510(k) adds a second reprocessing cycle to the same device cleared under K182238.
Functional and Safety Testing:
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed ViewFlex Xtra ICE Catheter, including:
- Biocompatibility ●
- Cleaning Validation
- Sterilization Validation ●
- . Functional Performance Testing
- Visual Inspection o
- Simulated Use O
- Dimensional Verification o
- Ultrasound Transducer Testing o
- Image Quality Testing O
- Acoustic Output Testing O
- Mechanical Characteristics O
- EMC and Electrical Safety Testing ●
The performance testing demonstrates that reprocessed devices are as safe and effective as the predicate and operate as originally intended.
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Image /page/6/Picture/0 description: The image contains the Stryker logo, with the words "Sustainability Solutions" written below it. The Stryker logo is in a bold, sans-serif font. The words "Sustainability Solutions" are in a smaller, sans-serif font. The logo and text are black against a white background. The logo also contains the registered trademark symbol.
The Reprocessed ViewFlex Xtra ICE Catheter is reprocessed no more than two (2) times. Each reprocessed device is tracked with a serial number label which is affixed to the catheter shaft. Once the device reaches the maximum number or 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.
Conclusion:
The results of bench and laboratory testing demonstrate that the subject device is at least as safe and effective as the predicate device.