The NexSite 9Fr Dual Lumen Critical Care Central Venous Catheter is indicated for long-term access to the Central Venous System. It is designed for administering IV fluids, blood products, drugs, and parenteral nutrition as well as blood withdrawal and power injection of contrast media. The maximum pressure of power injectors used with the NexSite device may not exceed 300psi.

Device Description

The NexSite 9Fr Dual Lumen Catheter is a long-term central venous catheter. The polyurethane Catheter is 55.5cm in length, and has a Dacron cuff distal to the bifurcation hub. A Polyurethane/Dacron Port supplied with the Catheter is implanted subcutaneously, and is intended to minimize Catheter movement. The Catheter and Port are packaged with accessories that are used to facilitate Catheter and Port insertion.

AI/ML Overview

The provided text describes the 510(k) summary for the NexSite 9Fr Dual Lumen Critical Care Central Venous Catheter.

Acceptance Criteria and Device Performance

The acceptance criteria for the NexSite 9Fr Dual Lumen Critical Care Central Venous Catheter were established based on ISO 10555-1 and ISO 10555-3 standards and by demonstrating substantial equivalence to legally marketed predicate devices.

Acceptance Criteria Category	Reported Device Performance
Visual and dimensional	Testing performed; results "meet the requirements in the applicable standards and specifications."
Catheter leakage	Testing performed; results "meet the requirements in the applicable standards and specifications."
Catheter joint strength	Testing performed; results "meet the requirements in the applicable standards and specifications."
Catheter pressure	Testing performed; results "meet the requirements in the applicable standards and specifications."
Radiopacity	Testing performed; results "meet the requirements in the applicable standards and specifications."
Corrosion resistance	Testing performed; results "meet the requirements in the applicable standards and specifications."
Catheter high pressure injection	Testing performed; results "meet the requirements in the applicable standards and specifications." The device is intended for power injection of contrast media with a maximum pressure of 300psi.
In vivo performance	In vivo testing was performed to demonstrate that the device would perform as intended. The sponsor states that clinical studies were not deemed necessary.

Study Details:

Sample size used for the test set and the data provenance:
- The document primarily describes in vitro testing. No specific sample sizes for each test are provided, but the testing was conducted on samples of the NexSite 9Fr Dual Lumen Critical Care Central Venous Catheter.
- Data Provenance: The testing was performed by Marvao Medical Devices, Ltd. in Ireland (GMIT Innovation in Business Centre, Dublin Road Galway, Ireland), indicating the data is from the manufacturer's internal testing program. The document does not explicitly state if it's retrospective or prospective for the in vitro tests but implies prospective testing conducted for the 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the studies described are primarily in vitro performance tests (e.g., strength, leakage, radiopacity) against engineering standards (ISO 10555-1 and ISO 10555-3) rather than clinical studies requiring expert ground truth for patient outcomes or diagnoses. The "ground truth" for these tests would be the established benchmark values from the relevant ISO standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable as the studies are engineering performance tests, not clinical studies requiring human adjudication of outcomes or diagnoses.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not performed, nor is it relevant to this medical device submission. The device is a physical central venous catheter, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not performed, nor is it relevant. The device is a physical central venous catheter.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the in vitro tests, the "ground truth" or acceptance criteria are derived from international standards (ISO 10555-1 and ISO 10555-3) and comparison to the performance of legally marketed predicate devices.
- For the in vivo testing, the "ground truth" was a demonstration that the "device would perform as intended," which implies meeting functional objectives in a living system (likely animal models, though not explicitly stated). No clinical outcomes data or pathology was used as "ground truth" for this submission as clinical studies were not deemed necessary.
The sample size for the training set:
- This information is not applicable as this submission is for a physical medical device, not an AI/machine learning algorithm that requires a training set.
How the ground truth for the training set was established:
- This information is not applicable as this submission is for a physical medical device, not an AI/machine learning algorithm.

Summary

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K 110627

2011

5. 510(k) Summary

General Information

March 3, 2011 Date Compiled

Class II. 21 CFR § 880.5970, Percutaneous, implanted, long-term Classification intravascular catheter, Product code LJS NexSite 9Fr Dual Lumen Critical Care Central Venous Catheter Trade Name

Marvao Medical Devices, Ltd. Submitter GMIT Innovation in Business Centre, Dublin Road Galway, Ireland Marybeth Gamber Contact Boston Biomedical Associates Phone: (508) 351-8632

Fax: (508) 351-8637

Intended Use

Predicate Devices

PowerHickman® Central Venous CatheterManufactured by Bard Access Systems	K061179
Medcomp® PRO-LINE™ CT Power Injectable CVCManufactured by Medcomp®	K053345

Device Description

Materials

The NexSite Catheter assembly is comprised of materials that are commonly used in medical device applications. Materials for the Catheter and Port include polyurethane, polycarbonate and Dacron.

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Testing

In vitro testing was performed on the NexSite 9Fr Dual Lumen Critical Care Central Venous Catheter to assure reliable design and performance in accordance with ISO 10555-1 and ISO 10555-3. The non-clinical tests performed by the company include visual and dimensional, catheter leakage, catheter joint strength, catheter pressure, radiopacity, corrosion resistance, and catheter high pressure injection. The test results demonstrate that the NexSite Catheter meets the requirements in the applicable standards and specifications, and is substantially equivalent to legally marketed predicate devices.

In vivo testing was also performed to demonstrate that the device would perform as intended. Clinical studies were not deemed necessary since in vitro testing were sufficient to demonstrate safety and effectiveness by way of comparison to a legally marketed predicate device.

Guidance

The FDA Guidance on Premarket Notification [(510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95, was utilized in order to meet the FDA requirements for content and organization of this submission.

Summary of Substantial Equivalence

Marvao Medical believes the NexSite 9Fr Dual Lumen Critical Care Central Venous Catheter is substantially equivalent to the predicate products. The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to existing legally marketed predicate products.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is smaller than the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MID 20993-0002

Marvao Medical Devices, Limited C/O Ms. Marybeth Gamber Principal Regulatory Consultant Boston Biomedical Associates 368 West Main Street, Suite 7 Northboro, Massachusetts 01532

AUG 1 2 2011

Re: K110627

Trade/Device Name: NexSite 9Fr Dual Lumen Critical Care Central Venous Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted long-term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: July 14, 2011 Received: July 15, 2011

Dear Ms. Gamber:

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.

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Page 2- Ms. Gamber

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 (OS) 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/ ucm 1 1 5809.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,

Cintrony D. nut

Anthony D. Watson, B.S., M.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

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Indications for Use Statement 4.

This application 510(k) Number (if known):

NexSite 9Fr Dual Lumen Critical Care Central Venous Catheter Device Name:

The NexSite 9Fr Dual Lumen Critical Care Central Venous Catheter is indicated Indications for for long-term access to the Central Venous System. It is designed for Use: administering IV fluids, blood products, drugs, and parenteral nutrition as well as blood withdrawal and power injection of contrast media. The maximum pressure of power injectors used with the NexSite device may not exceed 300psi.

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Per 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

Confidential

011

510(k) Number: K110627

Regulation Number and Section

§ 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.”