(151 days)
Not Found
No
The summary describes a reprocessed intracardiac ultrasound catheter and its functional performance testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is solely indicated for visualization, which is a diagnostic function, not a therapeutic one.
Yes
This device is a diagnostic device because its intended use is "to visualize cardiac structures; blood flow and other devices within the heart," 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 diagnostic imaging procedure performed in vivo (within the living body), not in vitro (outside the body, typically on biological samples).
- Device Description: The device is a catheter inserted into the heart for ultrasound imaging. This is consistent with an in vivo imaging device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or performing tests on them outside the body.
Therefore, the Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Medline ReNewal 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)
OWQ
Device Description
The Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter is inserted into the heart via intravascular access. The reprocessed ViewFlex Xtra is a sterile, single use, temporary, intracardiac catheter indicated for use in adult and adolescent pediatric patients. The ViewFlex catheter shaft is a 9 French catheter constructed with radiopaque tubing 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 device has two deflection mechanisms that correspond with the movement of the distal shaft in the four planes of movement. The ViewFlex Xtra is compatible with ViewMate II, ViewMate Z and Philips CX50 ultrasound consoles. Each device is marked and tracked and taken out of service once the maximum number of cycles has been reached.
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)
The functional characteristics of the subject device have been evaluated and found to be substantially equivalent to the predicate device based on the following tests:
Functional performance:
• simulated use and artificial soiling;
• visual inspection;
• mechanical characteristics;
• ultrasound transducer testing
• dimensional analysis
• Electrical Safety
• Dielectric and current leakages
• Cleaning Validation:
• Biocompatibility:
• Sterilization Validation
• Packaging and shelf life validation; sterilization validation:
• bioburden testing; and
• ethylene oxide and ethylene chlorohydrin residuals testing
• bacteriostasis/fungistatis
• Product stability
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.
December 15, 2023
Surgical Instrument Services and Savings, Inc. Stephanie Mays Senior Regulatory Affairs Specialist (dba Medline ReNewal) 1500 NE Hemlock Ave. Redmond, Oregon 97756
Re: K232130
Trade/Device Name: Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OWQ Dated: November 15, 2023 Received: November 15, 2023
Dear Stephanie Mays:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Aneesh S. Deoras -S
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology,
2
Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
The item numbers included in the scope of this submission are as follows:
| OEM Model No. | Transducer | Tip Deflection | Size |
|---|---|---|---|
| ViewFlex Xtra ICE Catheter | |||
| D087031 | 64 element phased array | 120 degree | 9 Fr X 90 cm |
4
Indications for Use
510(k) Number (if known) K232130
Device Name
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter
Indications for Use (Describe)
The Medline ReNewal 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/5/Picture/0 description: The image shows the logo for "ReNewal Full Circle Reprocessing". The logo consists of two parts: a blue square on the left with a white star-like symbol and the word "MEDLINE" written vertically, and the word "ReNewal" in green and blue on the right, with the words "Full Circle Reprocessing" written in smaller font below it. The "TM" symbol is located at the top right of the word "ReNewal".
K232130 510(k) Summary
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR § 807.92.
| Submitter/ Owner | Surgical Instrument Service and Savings (dba Medline ReNewal)
1500 NE Hemlock Ave., Redmond, OR 97756 | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Contact/ Prepared by | Stephanie Boyle Mays
Senior Regulatory Affairs Specialist, Quality Assurance/Regulatory Affairs
P: 541-516-4205 • F: 541-923-3375 • smays@medline.com | |
| Date Prepared | July 17, 2023 | |
| | Proprietary/Trade Name: | Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter |
| | Common or Usual Name | ICE Catheter, Reprocessed |
| Device Name and Classification | Regulatory Name/Reference | Diagnostic intravascular catheter, reprocessed
21 CFR § 870.1200 |
| | Regulatory Class | 2 |
| | Product Code | OWQ |
| | Panel | Cardiovascular |
| | 510(k) Number | K133853 |
| Predicate Device | Proprietary or Trade Name | ViewFlex Xtra ICE Catheter |
| | Common or Usual Name | ICE Catheter |
| | Regulatory Name/Reference | Diagnostic intravascular catheter, 21 CFR § 870.1200 |
| | Regulatory Class | 2 |
| | Product Code | OBJ |
| | Panel | Cardiovascular |
| | Manufacturer | Irvine Biomedical, Inc. a St. Jude Medical Company
2374 Morse Ave., Irvine, CA 92614 |
| Model intended for reprocessing | ViewFlex Xtra ICE Catheter D087031 | Transducer: 64 element phased array
Tip deflection: 120 degree
Size: 9 Fr x 90 cm |
| Device Description | The Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter is
inserted into the heart via intravascular access. The reprocessed
ViewFlex Xtra is a sterile, single use, temporary, intracardiac catheter
indicated for use in adult and adolescent pediatric patients. The
ViewFlex catheter shaft is a 9 French catheter constructed with
radiopaque tubing 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 device has two deflection mechanisms that correspond with the movement of the distal shaft in the four planes of movement. The ViewFlex Xtra is compatible with ViewMate II, ViewMate Z and Philips CX50 ultrasound consoles. Each device is marked and tracked and taken out of service once the maximum number of cycles has been reached. | |
| Intended Use | The Medline ReNewal 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
Characteristics | The technological characteristics, materials, and the fundamental scientific technology of the subject device is equivalent to the predicate device. The proposed device is a reprocessed version of the predicate device. K133853 ViewFlex Xtra ICE Catheter was used as the primary predicate to support intended use, technological characteristics, and functional performance specifications. | |
| Non-clinical
Testing
Summary | The functional characteristics of the subject device have been evaluated and found to be substantially equivalent to the predicate device based on the following tests:
Functional performance:
• simulated use and artificial soiling;
• visual inspection;
• mechanical characteristics;
• ultrasound transducer testing
• dimensional analysis
• Electrical Safety
• Dielectric and current leakages
• Cleaning Validation:
• Biocompatibility:
• Sterilization Validation
• Packaging and shelf life validation; sterilization validation:
• bioburden testing; and
• ethylene oxide and ethylene chlorohydrin residuals testing
• bacteriostasis/fungistatis
• Product stability | |
6
Image /page/6/Picture/0 description: The image is a logo for "ReNewal Full Circle Reprocessing" by Medline. The logo has the word "ReNewal" in green and blue, with the "Re" in green and the "Newal" in blue. Below the word "ReNewal" is the phrase "Full Circle Reprocessing" in blue. To the left of the word "ReNewal" is the Medline logo, which is a blue square with a white star in the center and the word "MEDLINE" in white text.
Summary Table: Predicate and Medline ReNewal Reprocessed ViewFlex Xtra ICE
Catheter comparison chart.
| View | Predicate | Proposed | Comparison |
|---|---|---|---|
| ViewFlex Xtra Ice | |||
| Catheter | Medline ReNewal | ||
| Reprocessed ViewFlex | |||
| Xtra Ice Catheter | As Stated | ||
| 510(k) | K133853 | K232130 | N/A |
| Model Number | Not listed in K133853 | ||
| Summary | D087031 | As stated | |
| Common Name | Diagnostic Intravascular | ||
| Catheter | Diagnostic Intravascular | ||
| Catheter, Reprocessed | As stated |
7
Image /page/7/Picture/0 description: The image contains the logo for Medline Renewal Full Circle Reprocessing. The Medline logo is on the left side of the image and consists of a blue square with the word "MEDLINE" in white text and a white star-like symbol. To the right of the Medline logo is the word "Renewal" in a combination of green and blue text, with "Re" in green and "Newal" in blue. Below "Renewal" is the phrase "Full Circle Reprocessing" in blue text.
Summary table concluded
| Predicate | Proposed | Comparison | |
|---|---|---|---|
| View | ViewFlex Xtra Ice | ||
| Catheter | Medline ReNewal | ||
| Reprocessed ViewFlex | |||
| Xtra Ice Catheter | As Stated | ||
| Regulation No. | 21 CFR § 870.1200 | 21 CFR § 870.1200 | Same |
| Regulatory Class | 2 | 2 | Same |
| Product Code | OBJ | OWQ | As stated |
| Indications for Use | |||
| (Intended Use) | 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. | The Medline ReNewal | ||
| 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. | Same | ||
| Technological | |||
| Characteristicsª | To operate, the catheter is | ||
| connected to a compatible | |||
| intracardiac ultrasound | |||
| console (View Mate II, | |||
| ViewMate Z and Philips | |||
| CX50) via a compatible | |||
| ViewFlex Catheter | |||
| Interface Module. | To operate, the catheter is | ||
| connected to a compatible | |||
| intracardiac ultrasound | |||
| console (View Mate II, | |||
| ViewMate Z and Philips | |||
| CX50) via a compatible | |||
| ViewFlex Catheter | |||
| Interface Module. | Same | ||
| Reprocessing | Each catheter is reprocessed no more than two times. Medline ReNewal | ||
| does not reprocess the catheters of other reprocessors. | |||
| Conclusion | The predicate and proposed devices in this application have the same | ||
| indications for use and technological characteristics. Based on this and | |||
| the non-clinical testing data presented in this 510(k) submission, the | |||
| Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter device model | |||
| listed in this summary table is substantially equivalent to the predicate | |||
| device. | |||
| a Neither K133853 nor the current submission included the interface module or generators as | |||
| part of their respective submissions. Only the catheter model is included in the project | |||
| scope. |