(151 days)
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.
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.
The provided text is a 510(k) summary for the Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter, a reprocessed medical device. It does not contain information about an AI/ML-driven device, nor does it specify "acceptance criteria" in the context of diagnostic performance metrics like sensitivity or specificity. Instead, the document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.
Therefore, many of the requested details, such as sample sizes for test/training sets, expert qualifications, adjudication methods, or effects of AI assistance, are not applicable or cannot be extracted from this particular document.
However, I can extract the "performance" details in the context of the non-clinical testing conducted to prove substantial equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Equivalence)
The document primarily focuses on demonstrating that the reprocessed device performs comparably to the original predicate device through various non-clinical tests. These tests effectively serve as the "acceptance criteria" for demonstrating substantial equivalence rather than diagnostic performance in an AI/ML context.
| Acceptance Criteria (Non-Clinical Test Category) | Reported Device Performance (as stated in the document) |
|---|---|
| Functional Performance | Evaluated and found to be substantially equivalent to the predicate device. Specific tests included: |
| - Simulated use and artificial soiling | Not explicitly detailed, but implied successful equivalence. |
| - Visual inspection | Not explicitly detailed, but implied successful equivalence. |
| - Mechanical characteristics | Not explicitly detailed, but implied successful equivalence. |
| - Ultrasound transducer testing | Not explicitly detailed, but implied successful equivalence. |
| - Dimensional analysis | Not explicitly detailed, but implied successful equivalence. |
| - Electrical Safety | Not explicitly detailed, but implied successful equivalence. |
| - Dielectric and current leakages | Not explicitly detailed, but implied successful equivalence. |
| Cleaning Validation | Not explicitly detailed, but implied successful validation for reprocessing. |
| Biocompatibility | Not explicitly detailed, but implied successful validation. |
| Sterilization Validation | Not explicitly detailed, but implied successful validation. Specific tests included: |
| - Bioburden testing | Not explicitly detailed, but implied successful validation. |
| - Ethylene oxide and ethylene chlorohydrin residuals testing | Not explicitly detailed, but implied successful validation. |
| - Bacteriostasis/fungistasis | Not explicitly detailed, but implied successful validation. |
| Packaging and shelf life validation | Not explicitly detailed, but implied successful validation. |
| Product stability | Not explicitly detailed, but implied successful validation. |
| Indications for Use | Same as the predicate device: "indicated for use in adult and adolescent pediatric patients to visualize cardiac structures; blood flow and other devices within the heart." |
| Technological Characteristics | Same as the predicate device: "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." |
2. Sample size used for the test set and the data provenance
Not applicable. This document describes a reprocessing approval based on non-clinical engineering and biological tests, not statistical analysis of patient data or diagnostic performance of an AI model. There is no "test set" in the sense of a dataset for an AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth in the context of AI/ML is not relevant here. The "ground truth" for this submission is established through validated scientific methods for medical device performance, safety, and equivalence.
4. Adjudication method for the test set
Not applicable. No adjudication method is described, as there is no "test set" requiring expert consensus.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
Not applicable. This applies to AI/ML devices that assist human readers in diagnostic tasks. The Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter is a reprocessed physical medical device, not an AI system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used
For this type of device (reprocessed catheter), the "ground truth" is established through:
- Validated engineering specifications: Proving the device meets its design requirements in terms of mechanical, electrical, and dimensional properties.
- Biological safety testing: Ensuring biocompatibility and effective sterilization.
- Functional performance testing: Demonstrating the device performs its intended function (e.g., ultrasound imaging capability) identically to the original device.
- Regulatory standards and guidelines: Adherence to established FDA regulations for reprocessing.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for an AI/ML model.
{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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{5}------------------------------------------------
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 MaysSenior Regulatory Affairs Specialist, Quality Assurance/Regulatory AffairsP: 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, reprocessed21 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 Company2374 Morse Ave., Irvine, CA 92614 | |
| Model intended for reprocessing | ViewFlex Xtra ICE Catheter D087031 | Transducer: 64 element phased arrayTip deflection: 120 degreeSize: 9 Fr x 90 cm |
| Device Description | The Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter isinserted into the heart via intravascular access. The reprocessedViewFlex Xtra is a sterile, single use, temporary, intracardiac catheterindicated for use in adult and adolescent pediatric patients. TheViewFlex catheter shaft is a 9 French catheter constructed withradiopaque tubing with a useable length of 90 cm. The shaft iscompatible with a 10 French or larger introducer for insertion into thefemoral or jugular veins. The catheter tip is a 64-element linear phasedarray 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. | |
| TechnologicalCharacteristics | 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-clinicalTestingSummary | 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 IceCatheter | Medline ReNewalReprocessed ViewFlexXtra Ice Catheter | As Stated | |
| 510(k) | K133853 | K232130 | N/A |
| Model Number | Not listed in K133853Summary | D087031 | As stated |
| Common Name | Diagnostic IntravascularCatheter | Diagnostic IntravascularCatheter, 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 IceCatheter | Medline ReNewalReprocessed ViewFlexXtra 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 Catheteris indicated for use in adultand adolescent pediatricpatients to visualize cardiacstructures; blood flow andother devices within theheart. | The Medline ReNewalReprocessed ViewFlexXtra ICE Catheter isindicated for use in adultand adolescent pediatricpatients to visualize cardiacstructures; blood flow andother devices within theheart. | Same |
| TechnologicalCharacteristicsª | To operate, the catheter isconnected to a compatibleintracardiac ultrasoundconsole (View Mate II,ViewMate Z and PhilipsCX50) via a compatibleViewFlex CatheterInterface Module. | To operate, the catheter isconnected to a compatibleintracardiac ultrasoundconsole (View Mate II,ViewMate Z and PhilipsCX50) via a compatibleViewFlex CatheterInterface Module. | Same |
| Reprocessing | Each catheter is reprocessed no more than two times. Medline ReNewaldoes not reprocess the catheters of other reprocessors. | ||
| Conclusion | The predicate and proposed devices in this application have the sameindications for use and technological characteristics. Based on this andthe non-clinical testing data presented in this 510(k) submission, theMedline ReNewal Reprocessed ViewFlex Xtra ICE Catheter device modellisted in this summary table is substantially equivalent to the predicatedevice. | ||
| a Neither K133853 nor the current submission included the interface module or generators aspart of their respective submissions. Only the catheter model is included in the projectscope. |
§ 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).