(161 days)
Not Found
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 described as "for imaging guidance only not treatment delivery," indicating it is for diagnostic visualization rather than therapeutic intervention.
Yes
The "Intended Use" explicitly states that the device is for "visualization of cardiac and great vessel anatomy and physiology," and the "Device Description" states its optimized use for "intracardiac scanning," which are functions of a diagnostic device. Additionally, the "Device Description" directly refers to the device as "AcuNav Diagnostic Ultrasound Catheters."
No
The device description clearly states it is a physical catheter with a transducer at the tip, which is a hardware component. The summary focuses on the reprocessing and functional performance of this physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Function: The description clearly states the device is an "Ultrasound Catheter" intended for "intra-cardiac and intra-luminal visualization." This means it is used inside the body to create images.
- Intended Use: The intended use is for "imaging guidance only not treatment delivery." This reinforces its role as an imaging tool used directly within the patient.
The device is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Medline ReNewal Reprocessed Siemens ACUSON AcuNav Ultrasound Catheter 10F is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients. The catheter is intended for imaging guidance only not treatment delivery, during cardiac interventional percutaneous procedures.
Product codes (comma separated list FDA assigned to the subject device)
OWQ
Device Description
The Medline ReNewal Reprocessed Siemens AcuNav Diagnostic Ultrasound Catheters 10F are licensed for single use only. The catheter is optimized for intracardiac scanning. With the catheter, the physician can maneuver the imaging plane located inside the catheter tip to see the region of interest. The physician can steer the catheter to optimize tissue visualization. The catheters are to be used only on systems with which they have been tested and found compatible.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology
Indicated Patient Age Range
adult 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)
Functional performance: simulated use and artificial soiling; visual inspection; mechanical characteristics; ultrasound transducer testing; dimensional analysis; and device functionality Electrical Safety dielectric and current leakage Cleaning Validation Biocompatibility Sterilization Validation bioburden testing; ethylene oxide and ethylene chlorohydrin residuals testing; and bacteriostasis/fungistasis Packaging and shelf life validation 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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 10, 2025
Surgical Instrument Service and Savings Inc. (dba Medline ReNewal) Stephanie Boyle Mays Senior Regulatory Affaiirs Specialst, QA/RA 1500 NE Hemlock Ave. Redmond, Oregon 97756
Re: K243101
Trade/Device Name: Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342) Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OWQ Dated: February 12, 2025 Received: February 12, 2025
Dear Stephanie Boyle 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 (OS) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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-regulatory
2
assistance/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, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
| The following devices are included in the scope of this 510(k) premarket notification: | ||||
|---|---|---|---|---|
| OEM Model No. | Transducer | Curve | Size
(cm) |
|-----------------------------------------------|---------------------------------------------|------------------------------------------------------------|--------------|
| Siemens ACUSON AcuNav Ultrasound Catheter 10F | | | |
| 08255790 | Siemens Systems, 64 element
phased array | Four-way tip deflection,
anterior/posterior, left/right | 10F x 90 |
| 10043342 | GE Systems, 64 element phased
array | Four-way tip deflection,
anterior/posterior, left/right | 10F x 90 |
4
Indications for Use
Submission Number (if known)
Device Name
Medline ReNewal Reprocessed Siemens ACUSON AcuNav Ultrasound Catheter 10F (for Siemens Systems) (08255790);
Medline ReNewal Reprocessed Siemens ACUSON AcuNav Ultrasound Catheter 10F (for GE Systems) (10043342)
Indications for Use (Describe)
The Medline ReNewal Reprocessed Siemens ACUSON AcuNav Ultrasound Catheter 10F is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients. The catheter is intended for imaging guidance only not treatment delivery, during cardiac interventional percutaneous procedures.
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/5/Picture/1 description: The image shows the Medline Renewal logo. The word "Renewal" is written in a combination of green and blue colors, 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 consists of a blue square with a white star-like symbol and the word "MEDLINE" in white.
Traditional 510(k) Notification
Medline ReNewal Reprocessed Siemens ACUSON AcuNav Ultrasound Čatheter 10F
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 Inc. (dba Medline
ReNewal) 1500 NE Hemlock Ave., Redmond, OR 97756 | | | |
|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--|
| Contact/
Prepared by | Stephanie Boyle Mays
Senior Specialist, Regulatory Affairs Quality Assurance
P: 541-516-4205 • F: 541-923-3375 • smays@medline.com | | | |
| Date Prepared | September 27, 2024 | | | |
| Device Name
and | Proprietary/Trade
Name: | Medline ReNewal Reprocessed Siemens ACUSON
AcuNav Ultrasound Catheter 10F (for Siemens
Systems) (08255790); Medline ReNewal Reprocessed
Siemens ACUSON AcuNav Ultrasound Catheter 10F
(for GE Systems) (10043342) | | |
| Classification | Common or Usual
Name | Ultrasound catheter, reprocessed | | |
| | Regulatory
Name/Reference | Reprocessed intravascular, ultrasound catheter,
21 CFR § 870.1200 | | |
| | Regulatory Class | 2 | | |
| | Product Code | OWQ | | |
| | Panel | Cardiovascular | | |
| | Predicate
selection rationale | The predicate models in K170263 include the subject
device models of this submission. The predicate devices
and subject devices are the same except the subject
devices have been reprocessed. | | |
| | 510(k) Number | K170263 | | |
| Predicate
Device | Proprietary or
Trade Name | AcuNav Diagnostic Ultrasound Catheter 8F, 10F | | |
| | Common or Usual
Name | Ultrasound catheter | | |
| | Regulatory
Name/Reference | Catheter, ultrasound, intravascular
21 CFR § 870.1200 | | |
| | Regulatory Class | 2 | | |
| | Product Code | OBJ | | |
| | Panel | Cardiovascular | | |
| | 510(k) applicant | Siemens Medical Solutions, 685 E. Middlefield Rd.,
Mountain View, CA 94043 | | |
| Device
Description | The Medline ReNewal Reprocessed Siemens AcuNav Diagnostic Ultrasound
Catheters 10F are licensed for single use only. The catheter is optimized for
intracardiac scanning. With the catheter, the physician can maneuver the | | | |
| | imaging plane located inside the catheter tip to see the region of interest. The
physician can steer the catheter to optimize tissue visualization.
The catheters are to be used only on systems with which they have been
tested and found compatible. | | | |
| Technological
Characteristics | The technological characteristics, materials, and the fundamental scientific
technology of the subject device is equivalent to the predicate device. The
subject device is a reprocessed version of the predicate device. Each device
is marked, tracked, and taken out of service once the maximum number of
cycles has been reached. K170263 AcuNav Diagnostic Ultrasound Catheter
was used as the primary predicate to support intended use, technological | | | |
| Non-clinical
Testing
Summary | characteristics, and functional performance specifications.
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; and device functionality Electrical Safety dielectric and current leakage Cleaning Validation Biocompatibility Sterilization Validation bioburden testing; ethylene oxide and ethylene chlorohydrin residuals testing; and bacteriostasis/fungistasis Packaging and shelf life validation Product stability | | | |
| Summary Table: Predicate and Medline ReNewal Reprocessed Siemens ACUSON AcuNav
Diagnostic Ultrasound Catheter comparison chart. | | | | |
| | Predicate | Proposed | Comparison | |
| Device
Characteristics | Siemens Medical Solutions
AcuNav Diagnostic
Ultrasound Catheter | Medline ReNewal
Reprocessed Siemens
ACUSON AcuNav
Diagnostic Ultrasound
Catheter 10F | As Stated | |
| 510(k) | K170263 | K243101 | N/A | |
| Model Numbers | 10135936 and 10135910, 8F
08255790 and 10043342, 10F | 08255790 and 10043342, 10F | As stated | |
| Common Name | Ultrasound catheter | Ultrasound catheter
Reprocessed | As stated | |
| Regulation No. | 21 CFR § 870.1200 | 21 CFR § 870.1200 | Same | |
6
Image /page/6/Picture/1 description: The image shows the Medline Renewal Full Circle Reprocessing logo. The Medline logo is on the left side of the image and is a blue square with a white cross inside. The Renewal logo is on the right side of the image and is green and blue. Underneath the Renewal logo is the text "Full Circle Reprocessing".
Traditional 510(k) Notification
Medline ReNewal Reprocessed ACUSON AcuNav 10F Ultrasound Catheter
7
Image /page/7/Picture/1 description: The image contains the Medline Renewal logo. The Medline logo is on the left side of the image and consists of a blue square with a white cross inside. The word "MEDLINE" is written in white letters inside the blue square. To the right of the Medline logo is the word "Renewal" in green and blue letters. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in blue letters.
Traditional 510(k) Notification Medline ReNewal Reprocessed ACUSON AcuNav 10F Ultrasound Catheter
| Regulatory
| Class | 2 | 2 | Same |
|---|---|---|---|
| Product Code | OBJ | OWQ | As stated |
| Indications for | |||
| Use | The catheter is intended for | ||
| intra-cardiac and intra-luminal | |||
| visualization of cardiac and | |||
| great vessel anatomy and | |||
| physiology as well as | |||
| visualization of other devices | |||
| in the heart of adult and | |||
| pediatric patients. The catheter | |||
| is intended for imaging | |||
| guidance only, not treatment | |||
| delivery, during cardiac | |||
| interventional percutaneous | |||
| procedures. | The Medline ReNewal | ||
| Reprocessed Siemens | |||
| ACUSON AcuNav Diagnostic | |||
| Ultrasound Catheter is | |||
| intended for intra-cardiac and | |||
| intra-luminal visualization of | |||
| cardiac and great vessel | |||
| anatomy and physiology as | |||
| well as visualization of other | |||
| devices in the heart of adult | |||
| patients. The catheter is | |||
| intended for imaging guidance | |||
| only, not treatment delivery, | |||
| during cardiac interventional | |||
| percutaneous procedures. | Same | ||
| Technological | |||
| Characteristics | |||
| a | To operate, the device is | ||
| connected to a compatible | |||
| console (ACUSON, Vivid I, | |||
| Vivid q) via a compatible | |||
| module interface. | To operate, the device is | ||
| connected to a compatible | |||
| console (ACUSON, Vivid I, | |||
| Vivid q) via a compatible | |||
| module interface. | Same | ||
| Reprocessing | Each catheter is reprocessed no more than one time. Medline ReNewal does | ||
| not reprocess the catheters of other reprocessors. | |||
| Conclusion | The predicate and subject 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 AcuNav Ultrasound Catheter 10F models 08255790 and | |||
| 10043342 are substantially equivalent to the predicate device. | |||
| a | |||
| Neither K170263 nor the current submission included the consoles or any other system | |||
| components as part of their respective submissions. Only devices 08255790 and 10043342 are | |||
| included in the project scope. |