JET PORT PLUS HP CATHETER SYSTEM by PFM MEDICAL, INC

The Jet Port Plus HP Catheter System is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, IV fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.

When used with a power injectable needle, the Jet Port Plus HP Catheter System is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec with a 19G or 20G non-coring power injectable needle or 2 ml/sec with a 22G noncoring power injectable needle.

Device Description

The Jet Port Plus HP Catheter System is an implantable device designed to provide repeated access to the vascular system without the trauma associated with multiple vena puncture. The system consists of a self-sealing injection port and a delivery catheter for the receipt and delivery of medications to the selected body site.

The Jet Port Plus HP Catheter System port is available in various profiles The Jet Port Plus HP II has a polyoxymethylene body with a silicone septum The Tita Jet Light HP has a polyoxymethylene body containing a titanium insert with a silicone septum

The base of the port has the letters "CT" to signify that it can be used for power injection on contrast agents. These letters can be visualized through a Scout CT. The serial number is laser etched into the base of the port. The port can be anchored with sutures in the port pocket for secure seating. The suture holes may contain clear silicone to prevent tissue in growth to the suture holes.

The Jet Port Plus HP Catheter System is offered with the polyurethane catheter either pre-attached by the manufacturer or attachable for application by the inserting physician. The catheter lock provides securement of the catheter to the port. I Introduction into the implanted port and catheter system is through a non-coring needle.

Power injection of contrast media, can be safely administered with a 19 or 20 gauge power injectable infusion non-corning needle at a maximum recommended infusion rate of 5 ml/sec or a 22 gauge power injectable non-coring needle at a maximum recommended infusion rate of 2 ml/sec. Maximum pressure should not exceed 300 psi.

The Jet Port Plus HP Catheter System is packaged with the necessary accessories to facilitate catheter insertion.

The port and catheter uses the same components and are manufactured and sterilized at the same manufacturing and sterilization facilities as the predicate device cleared under K000125. The addition of power injection capability is comparable to the currently marketed Power Injectable Infusion Port cleared under K070003.

Components will be assembled into standard configurations specified by the customer and packaged.

The device includes the following components:

Implantable Port
. Click Connector
Guide Wire ●
Dilator ●
Tunneling Needle
Vein Lifter .
. Nurses Guide
Companion Checklist
Catheter .
Huber Needle
. Introducing Needle
. Peel Away Sheath
. Syringe
Instructions for Use ●
Patient Guide .
Patient ID Card & Key Ring Card .

AI/ML Overview

The provided text is a 510(k) Summary for the Jet Port Plus HP Catheter System, which is an implantable medical device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and ground truth analysis as typically seen in AI/ML device submissions.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance from a clinical study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details for training or testing sets.

The relevant information from the document is summarized below based on what is available:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in terms of specific performance metrics for the device (e.g., accuracy, sensitivity, specificity, or device failure rates over time from a clinical study). The acceptance for this 510(k) is based on demonstrating substantial equivalence to predicate devices, particularly regarding power injection capability.
Reported Device Performance: The document describes the intended function of the device and its specifications for power injection but does not report performance data from a study against specific acceptance criteria.
- Power Injection: Maximum recommended infusion rate of 5 ml/sec with a 19G or 20G non-coring power injectable needle, or 2 ml/sec with a 22G non-coring power injectable needle. Maximum pressure should not exceed 300 psi.
- Biocompatibility: Stated that materials are "used in legally marketed devices under comparable conditions of use," implying a regulatory acceptance based on prior use and material safety, not a specific study with performance metrics in this summary.

The following information is NOT available in the provided text:

Sample size used for the test set and the data provenance: Not applicable or provided. This is a device requiring substantial equivalence, not a performance study as described for AI/ML.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
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: Not applicable. This device is not an AI/ML diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary of the Study (as described in the 510(k) context):

The "study" in this context is the process of demonstrating substantial equivalence to legally marketed predicate devices, rather than a clinical performance study with defined acceptance criteria and statistical analysis.

Comparison to Predicate Devices: The Jet Port Plus HP Catheter System is compared to:
- pfm Medical, Inc.'s Jet Port Plus Catheter System (K000125): For the basic port and catheter system components and overall function. The document states, "The port and catheter uses the same components and are manufactured and sterilized at the same manufacturing and sterilization facilities as the predicate device cleared under K000125."
- MedComp's Power Injectable, Implantable Infusion Port (K070003): Specifically for the added power injection capability. The document states, "The addition of power injection capability is comparable to the currently marketed Power Injectable Infusion Port cleared under K070003."

The 510(k) summary explains the device's design, components, and intended use, asserting that its materials and general function are equivalent to K000125, and its power injection capabilities are comparable to K070003. This is the basis for FDA's substantial equivalence determination, not a clinical trial demonstrating performance against specific numerical acceptance criteria.

Summary

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K072481

510(k) Summary of Safety and Effectiveness

The following section is included as required by the Safe Medical Device Act (SMDA) of 1990.

Name:	PFM Medical, Inc
Address:	2605 Temple Heights DriveOceanside, CA 92056
CONTACT PERSON:	SALVADORE F. PALOMARES, RAC

510(k) Summary of Safety and Effectiveness

MAR - 7 2008

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:
Trade Name:	Jet Port Plus HP Catheter System
Common Name:	Port & Catheter Implanted, Subcutaneous, Intravascular
Classification Name:	Same

Equivalent Devices:

Manufacturer:	pfm Medical, Inc	MedComp
Name:	Jet Port Plus Catheter System	Power Injectable, Implantable Infusion Port
510(k) #:	K000125	K070003

Device Description:

The Jet Port Plus HP Catheter System is packaged with the necessary accessories to facilitate catheter insertion.

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Karate

power injection capability is comparable to the currently marketed Power Injectable Infusion Port cleared under K070003.

Components will be assembled into standard configurations specified by the customer and packaged.

The device includes the following components:

Implantable Port
. Click Connector
Guide Wire ●
Dilator ●
� Tunneling Needle
Vein Lifter .
. Nurses Guide
Companion Checklist
Catheter .
Huber Needle �
. Introducing Needle
. Peel Away Sheath
. Syringe
Instructions for Use ●
Patient Guide .
Patient ID Card & Key Ring Card .

Intended Use:

Biocompatibility:

The materials used to manufacture the Jet Port Plus HP Catheter System are used in legally marketed devices under comparable conditions of use.

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MENT OF HEALT

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Salvadore F. Palomares, RAC Director of Regulatory Affairs PFM Medical, Incorporated 2605 Temple Heights Drive, Suite A Oceanside, California 92056

MAR - 7 2008

Re: K072481

Trade/Device Name: Jet Port Plus HP Catheter System Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: February 29, 2008 Received: March 4, 2008

Dear Mr. Palomares:

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. Palomares

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 electronic 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) premarket 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 vour 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Chris Lins, Ph.D.

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):

Jet Port Plus HP Catheter System Device Name:

Indications For Use:

When used with a power injectable needle, the Jet Port Plus HP Catheter System is indicated for power injection of contrast media. For injection of contrast media, the maximum recommended infusion rate is 5 ml/sec with a 19G or 20G non-coring power injectable needle or 2 ml/sec with a 22G non-coring power injectable needle.

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anthony D. Anater
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devicess

510(k) Number: _ )< Φワコ48

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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.