(284 days)
Not Found
No
The description focuses on real-time visual navigation using a near-infrared light source and optical stylet. There is no mention of AI, ML, or image processing that would suggest the use of these technologies for analysis or decision-making. The performance studies focus on safety and effectiveness compared to predicate devices, not on the performance of any AI/ML algorithms.
No.
The device is intended to aid in the placement of catheters by providing real-time visual navigation of the catheter tip, not to treat or diagnose a disease or condition.
No
This device is intended to aid in the placement of catheters by providing real-time visual navigation of the catheter tip, which is a procedural guidance function, not a diagnostic one.
No
The device description explicitly lists hardware components such as a control box, display screen, camera, and sterile optical stylet.
No, 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.
- LumenVu™ Function: The LumenVu™ Catheter Guidance System is used during a medical procedure (PICC placement) to provide real-time visual guidance of a catheter tip within the body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "aiding in the placement of peripherally inserted central catheters (PICC) by providing real-time visual navigation of the catheter tip." This is a procedural guidance tool, not a diagnostic test.
Therefore, based on the provided information, the LumenVu™ Catheter Guidance System is a medical device used for procedural guidance, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LumenVu™ Catheter Guidance System is intended to aid in the placement of peripherally inserted central catheters (PICC) by providing real-time visual navigation of the catheter tip. The system may be used by trained caregivers in hospitals or other healthcare facilities.
Product codes (comma separated list FDA assigned to the subject device)
OMF
Device Description
The SonoSite LumenVu™ Catheter Guidance System consists of a control box, a display screen, a camera, and a sterile optical stylet. The system uses a near-infrared light source to provide immediate visual feedback to the user on the location of a peripherally inserted central catheter tip. The optical stylet replaces traditional stiffening wire and provides a path for NIR light to its tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Near-infrared light source
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained caregivers in hospitals or other healthcare facilities.
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)
Performance testing and engineering analysis was performed and submitted to characterize the components of the SonoSite LumenVu™ Catheter Guidance System. Test results demonstrated that the LumenVu™ System functioned as intended. The observed test results demonstrate that the Lumen Vu™ System is as safe and effective as the predicate devices. Testing demonstrated that the system meets the requirements of IEC 60601-1 for electrical safety, IEC 60601-1-2 for electromagnetic compatibility, and IEC 60825-1 for laser safety.
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.
NEO MAPcath Sensor Stylet (Corpak MedSystem) - K083121, FlowPICC Stylet (VasoNova, Inc.) – K081625, InfraReDx NIR Imaging System (InfraReDx, Inc.) - K052908
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
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
0
Koa 3510
AUG 2 3 2010
:
.
510(k) SUMMARY
SonoSite LumenVu™ Catheter Guidance System
Submitter Information
| Name and Address: | SonoSite, Inc. |
|---|---|
| 21919 30th Drive SE | |
| Bothell, WA 98021 | |
| Contact Person: | Mary K. Moore, V.P. of Regulatory Affairs |
| Date Prepared: | November 10, 2009 |
Device Identification
| Proprietary Name: | LumenVu™ Catheter Guidance System |
|---|---|
| Common Name: | Percutaneous, Implanted, Long-Term Intravascular |
| Catheter: | Accessory for Catheter Position |
| Classification: | General Hospital and Personal Use Therapeutic |
| Devices | |
| 21 C.F.R. § 880.5970 |
Product Codes: OMF
Predicate Device Information
NEO MAPcath Sensor Stylet (Corpak MedSystem) - K083121
FlowPICC Stylet (VasoNova, Inc.) – K081625
InfraReDx NIR Imaging System (InfraReDx, Inc.) - K052908
Intended Use / Indications for Use
The LumenVu™ Catheter Guidance System is intended to aid in the placement of peripherally inserted central catheters (PICC) by providing real-time visual navigation of the catheter tip. The system may be used by trained caregivers in hospitals or other healthcare facilities.
1
Technological Characteristics
The SonoSite LumenVu™ Catheter Guidance System consists of a control box, a display screen, a camera, and a sterile optical stylet. The system uses a near-infrared light source to provide immediate visual feedback to the user on the location of a peripherally inserted central catheter tip. The optical stylet replaces traditional stiffening wire and provides a path for NIR light to its tip.
Performance Data
Performance testing and engineering analysis was performed and submitted to characterize the components of the SonoSite LumenVu™ Catheter Guidance System. Test results demonstrated that the LumenVu™ System functioned as intended. The observed test results demonstrate that the Lumen Vu™ System is as safe and effective as the predicate devices. Testing demonstrated that the system meets the requirements of IEC 60601-1 for electrical safety, IEC 60601-1-2 for electromagnetic compatibility, and IEC 60825-1 for laser safety.
Substantial Equivalence
The SonoSite LumenVu™ Catheter Guidance System has the same intended use and similar indications as the predicate devices. Any minor differences in technological characteristics and principles of operation do not raise any new issues of safety or effectiveness. Thus, the SonoSite LumenVuTM Catheter Guidance System is substantially equivalent to the predicate devices.
39
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of three curved lines that converge at the bottom.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Mary K. Moore Vice President of Regulatory Affairs SonoSite, Incorporated 21919 30th Drive SE Bothell, WA 98021
AUG 2 3 2010
Re: K093510
Trade/Device Name: Lumen Vu™ Catheter Guidance System Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: OMF Dated: August 19, 2010 Received: August 20, 2010
Dear Ms. Moore:
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. 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.
3
Page 2- Ms. Moore
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Pearce
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
14093510
36
Indications for Use Statement
510(k) Number (if known):
LumenVu™ Catheter Guidance System Device Name:
Indications for Use:
The LumenVu™ Catheter Guidance System is intended to aid in the placement of peripherally inserted central catheters (PICC) by providing real-time visual navigation of the catheter tip. The system may be used by trained caregivers in hospitals or other healthcare facilities.
Prescription Use X
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
5-510(k) Number: K093510