The devices are for use in patient therapy requiring repeated vascular access for infusion therapy, power injected diagnostic techniques using contrast media, and blood infusion/withdrawal. For the power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec using media with a maximum viscosity of 11.8 cP.

Device Description

The proposed device is exactly the same as the predicate devices.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Cook Vascular, Inc. Vital-Port Vascular Access System Power Injectable Port. This submission aims to establish a safe and effective way to conduct power injection studies using the device, which was previously marketed without specific claims or instructions for this procedure. The current submission focuses on demonstrating the device's suitability for power injectable diagnostic techniques using contrast media.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Parameters for Power Injection)	Reported Device Performance (Tested Limits)
Maximum recommended infusion rate	5 mL/sec
Maximum contrast media viscosity	11.8 cP
Maximum pressure limit	325 psi
Catheter length for testing	> 70 cm
Catheter length in assumed implanted range	20 cm - 50 cm
Contrast media pre-heating (clinical context)	Could reduce viscosity by nearly half (e.g., to 4.9 cP)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the numerical sample size for the "test set" in terms of how many individual devices were tested. It refers to "the flowing tests" implying multiple instances or scenarios were subjected to testing.

The data provenance is from Cook Vascular, Inc., a company based in Vandergrift, PA, USA. The tests described are prospective (laboratory testing performed for the purpose of this submission) and are likely simulated rather than using human or animal subjects, as they focus on physical performance under specific conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable in this context. The "ground truth" for this medical device submission is the physical performance and safety characteristics of the device under specific mechanical stress and fluid flow conditions. It's established through engineering tests, not through expert clinical consensus or interpretation of observational data. The tests are designed to measure objective physical properties of the device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies in expert interpretations of clinical data or images. Since the "test set" involves laboratory-based engineering parameter testing (e.g., flow rates, pressure limits, burst tests), there is no need for such adjudication. The results are objective measurements.

5. 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

An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI algorithms where human interpretation is involved. The Cook Vascular, Inc. Vital-Port is a physical vascular access system, not an imaging device or an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable. The device is not an algorithm or an AI system. Its performance is entirely mechanical and physical.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance related to power injection is established through physical and mechanical engineering tests. These tests evaluate:

Dynamic Failure Flow Test: Measures flow characteristics and potential failure modes under dynamic conditions.
Instantaneous Burst Test: Assesses the device's ability to withstand sudden, high-pressure events.
Static Burst Test: Determines the maximum pressure the device can tolerate under prolonged static conditions.
Puncture Life Test: Evaluates the number of times the septum can be punctured before degradation or failure.
Cyclic Test: Assesses durability under repeated stress cycles.
Life Cycle Power Injection Test: Simulates repeated power injection procedures to evaluate long-term performance and integrity.

The "ground truth" for the operational parameters (5 mL/sec, 11.8 cP, 325 psi) is derived directly from the results of these tests, confirming that the device can safely tolerate these conditions.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI or machine learning model. The device's performance is determined by its physical design and materials, which are verified through direct testing, not through training data.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for this type of device.

Summary

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1081425

SEP 3 0 2008

510(k) Summary

Submitted by:

Jim Ferguson Quality Systems Manager Cook Vascular, Incorporated 1186 Montgomery Lane Vandergrift, Pa 15690 724-845-8621, XT 2227 April 10, 2006

Device:

Trade name:	Cook Vascular, Inc. Vital-Port Vascular Access SystemPower Injectable Port
Proposed Classification:	Subcutaneous, implanted, intravascular infusion port andcatheter, 880.5965

Predicate Devices:

The Cook Vascular, Inc. Vital-Port Vascular Access System Power Injectable Port Set is similar in terms of intended use, and exactly the same as materials of construction and technology characteristics to the predicate devices that have been found substantially equivalent.

Device Description:

The proposed device is exactly the same as the predicate devices,

Substantial Equivalence:

This device will be manufactured to specified process controls and a Quality Assurance program. This device will undergo packaging exactly the same as the devices currently manufactured by Cook Vascular. This device will undergo sterilization exactly the same as the devices currently marketed and distributed. Being the same as the predicate devices in respect to indication for use, materials and physical construction, this device meets the requirements for section 510(k) substantial equivalence. It is to be noted that this device has not changed in design, materials and/or methods.

It has come to Cook Vascular's attention that ports have been and are being used for power injection studies. Cook Vascular currently makes no claims and provides no instruction for use for this procedure. The purpose for this 510(k) is to establish a safe and effective way to conduct a power injection study through ports which are deemed appropriate for this type of use.

When used for power injection, the port is accessed, using qualified power injectable infusion sets, in the standard fashion, per the standard instructions. The supplemental instructions will then be used for power injection. Power injection involves the luse of a power syringe to inject contrast media in order to complete a study.

· Cook Vascular, Inc. • Special 510(k) Premarket Submission • Vital-Port Vascular Access System Power Injectable Port •

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Test Data:

The Cook Vascular, Inc. Vital-Port Vascular Access System Power Injectable Port was subjected to the flowing tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:

Dynamic Failure Flow Test 1.
1. Instantaneous Burst Test
റ്റ് Static Burst Test
1. Puncture Life Test
1. Cyclic Test
1. Life Cycle Power Injection Test

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a Vital-Port Vascular Access System Power Injectable Port.

Based on empirical evidence, Cook Vascular, Inc. recommends for power injection of 9000 series models of Vital-Ports® with a maximum limit of 5mL/sec and 325psi. We reasonably assume that our testing provides "worst-case" scenarios for contrast media viscosity, catheter length and septum access. Our tested catheter length is greater than 70cm, while we assume the implanted length to be within a 20cm - 50cm range. Furthermore, our tested contrast media viscosity was at 11.8cP, while suggested usage for vendor supplied contrast media calls for pre-heating of the media prior to injection, this pre-heating could reduce viscosity by nearly half as some heated viscous contrast media could be as low as 4.9cP. Applying these expected clinical parameters would reduce overall system pressure and thereby increase the operational safety factor. Lastly, sufficient warnings against over pressurization of the silicone catheter systems are highly recommended as empirical evidence suggests that a catheter could fail prior to the injection machine depressurizing the system.

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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 & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

SEP 3 0 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jim Ferguson Quality System Manager Cook Vascular, Incorporated 1186 Montgomery Lane Vandergrift, Pennsylvania 15690

Re: K081425

Trade/Device Name: Cook Vascular, Inc. Vital-Port Vascular Access System Power Injectable Port Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Codc: LJT Dated: September 19, 2008 Received: September 22, 2008

Dear Mr. Ferguson:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Ferguson

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the elcctronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) promarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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

510(k) Number (if known): K081425

Cook Vascular Inc. Vital-Port Vascular Access System Device Name:_ Power Injectable Port

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

$\mathscr{A}$ for clu lin

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of 1

KO 1425 510(k) Number:

Regulation Number and Section

§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.

(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.