The Low Profile Port 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 Low Profile Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 3 ml/sec with a 19G or 20G non-coring power injectable needle or 2 ml/sec with a 22G non-coring power injectable needle.

Device Description

The Low Profile Port 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 Low Profile Port has a polyoxymethylene body, with or without a titanium insert and 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 lot 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 Low Profile Port 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. Introduction of solution 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 3ml/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 Low Profile Port 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 K072481. The power injection capability is comparable to the currently marketed Jet Port Plus HP Catheter cleared under K072481.

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

• Implantable Port
• Click Connector
• Guide Wire
• Dilator
• Tunneling Needle
• Vein Lifter
• Introducing Needle
• Peel Away Sheath
• Syringe
• Catheter
• Huber Needle
• Instructions for Use
• Nurses' Guide
• Companion Checklist
• Patient Guide
• Patient Chart Sheet
• Patient ID Card and Key Ring Card

AI/ML Overview

The provided text describes the Low Profile Port, an implantable device designed for vascular access. The device's acceptance criteria and the study proving its compliance are detailed in the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that the Low Profile Port "met all established acceptance criteria for performance testing and design verification testing." While specific numerical acceptance criteria values are not explicitly stated in this document, the performance data demonstrated equivalence to the predicate device, the Jet Port Plus HP Catheter System (K072481). The key performance aspect highlighted is the power injection capability.

Acceptance Criteria Category	Reported Device Performance (Low Profile Port)
Material & Design	Identical to Jet Port Plus HP Catheter System (Predicate Device K072481). Polyoxymethylene body, with or without titanium insert and silicone septum.
Power Injection Rate (Contrast Media)	- Max 3 ml/sec with 19G or 20G non-coring power injectable needle. - Max 2 ml/sec with 22G non-coring power injectable needle. - Maximum pressure should not exceed 300 psi.
Sterilization	Met requirements of ISO 11135:2007 (Ethylene Oxide Sterilization).
Biocompatibility	Met requirements of ISO-10993, Part 1: Evaluation and Testing for externally communicating, blood-contacting, long-term devices.
Overall Safety & Effectiveness	Demonstrated to be safe and effective for its intended use through performance testing and design verification, substantiating equivalence to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

The document states that "Verification testing was performed according to protocols." However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This document does not mention the use of experts to establish a ground truth for a test set. The evaluation relies on design verification and performance testing against established standards and comparison to a predicate device.

4. Adjudication Method for the Test Set:

Not applicable as there is no mention of expert consensus or a specific adjudication method for a test set in this document.

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:

Not applicable. This device is an implantable medical device (port and catheter), not an artificial intelligence (AI) or imaging analysis device that would typically involve a multi-reader multi-case comparative effectiveness study with human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" in this context is established through compliance with recognized standards and direct comparison of physical and performance characteristics to a legally marketed predicate device.

Performance data: Direct measurements and tests to ensure the device meets specified functional requirements (e.g., flow rates, pressure limits, material properties).
Compliance with International Standards: ISO 11135:2007 for sterilization and ISO 10993-1 for biocompatibility.
Guidance Documents: FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95.
Equivalence to Predicate Device: The Jet Port Plus HP Catheter System (K072481) serves as the primary "ground truth" for demonstrating substantial equivalence in terms of technology, safety, and effectiveness.

8. The Sample Size for the Training Set:

Not applicable. This document describes a physical medical device, not an AI or machine learning model that would require a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As above, there is no training set for this type of device.

Summary

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JUL 1 6 2013

510(k) Summary of Safety and Effectiveness

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

Date Prepared:	July 15, 2013
Name:	PFM Medical, Inc.
Address:	1815 Aston Ave, Suite 106Carlsbad, CA 92008
CONTACT PERSON:	SALVADORE F. PALOMARES, RAC
PHONE NO:	760.758.8749

510(k) Summary of Safety and Effectiveness

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: K122402 Trade Name: Low Profile Port Port & Catheter, Implanted, Subcutaneous, Intravascular, Common Name: Classification: LJT 21 CFR 880.5965

Equivalent Device:

Manufacturer:	PFM Medical, Inc.
Name:	Jet Port Plus HP Catheter System
510(k) #:	K072481

Device Description:

The Low Profile Port has a polyoxymethylene body, with or without a titanium insert and a silicone septum.

The Low Profile Port is offered with the polyurethane catheter either pre-attached by the manufacturer or attachable for application by the inserting physician. The catheter

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lock provides securement of the catheter to the port. Introduction of solution into the implanted port and catheter system is through a non-coring needle.

The Low Profile Port is packaged with the necessary accessories to facilitate catheter insertion.

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

• Implantable Port	• Catheter
• Click Connector	• Huber Needle
• Guide Wire	• Instructions for Use
• Dilator	• Nurses' Guide
• Tunneling Needle	• Companion Checklist
• Vein Lifter	• Patient Guide
• Introducing Needle	• Patient Chart Sheet
• Peel Away Sheath	• Patient ID Card and Key Ring Card
• Syringe

The device includes the following components:

Intended Use:

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Technological Comparison to Predicate Devices:

New device is compared to Marketed Device?

Yes. It is compared to predicate PFM Jet Port Plus HP Catheter System (PFM Medical, SE-K072481)

Does the new device have the same indication statements?

Yes; but the Low Profile Port has a lower maximum profile infusion rate of 3ml/sec. vs. 5ml/sec. maximum flow rate for the Jet Port Plus HP Catheter System.

Do the differences alter the intended therapeutic/diagnosticletc. effect (i.e. deciding may consider impact on safety and effectiveness)?

No, the differences do not alter the intended use of the device.

Does the new device have the same technological characteristics, e.g. design, material, etc.?

Yes. The Low Profile Port is identical to that of the Jet Port Plus HP Catheter System (SE-K072481). The devices are made by the same company PFM Medical CPP SA. The Low Profile Port is substantially equivalent to the predicate device, Jet Port Plus HP Catheter System (SE-K072481). The basic fundamental scientific technology of the device has not changed.

Could the new characteristics affect safety or effectiveness?

No.

Do the new characteristics raise new types of safety and effectiveness questions?

No.

There are no new types of safety and effectiveness questions.

Do accepted scientific methods exist for assessing effects of the new characteristics?

Yes. The FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95 was used to determine the appropriate methods for evaluating the device's performance.

Sterilization requirements of ISO 11135:2007, Sterilization of Health Care 0 Products - Requirements for Validation and Routine Control -- Ethylene Oxide Sterilization were met.

Biocompatibility requirements according to of ISO-10993, Biological Evaluation . of Medical Devices Part 1: Evaluation and Testing. Test profiles for externally communicating, blood-contacting, long-term devices were met.

These and other standards were used to determine the appropriate methods for evaluating the device's performance.

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Are performance data available to assess effects of new characteristics?

Yes. Verification testing was performed according to protocols based on the abovereferenced guidance document recommendations and additional standards.

Do performance data demonstrate equivalence?

Yes. Performance data gathered in design verification testing demonstrated that the Low Profile Port is substantially equivalent to the noted predicate device.

CONCLUSION:

The Low Profile Port met all established acceptance criteria for performance testing and design verification testing. This testing demonstrated that the Low Profile Port is safe and effective for its intended use, and based on FDA's decision tree is substantially equivalent to the following predicate devices: Jet Port Plus HP Catheter System (PFM Medical, SE-K072481)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle.

Public Health Service

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

July 16, 2013

PFM Medical, Incorporated Mr. Salvadore F. Palomares, RAC Director of Regulatory Affairs 1815 Aston Avenue, Suite 106 CARLSBAD California 92008

Re: K122402

Trade/Device Name: Low Profile Port Regulation Number: 21 CFR 880.5965 Regulation Name: Port & Catheter, Implanted, Subcutancous & Intravascular Infusion Regulatory Class: II Product Code: LJT Dated: June 21, 2013 Received: July 12, 2013

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. 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 - 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); 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,

Image /page/5/Picture/7 description: The image shows the name "Mary S. Bunner -S" in a bold, sans-serif font. The text is black against a white background. The letters are clearly legible, and the name appears to be a signature or label.

Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k): K122402

Device Name:

Low Profile Port

Indications for Use:

When used with a power injectable needle, the Low Profile Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 3 ml/sec with a 19G or 20G noncoring power injectable needle or 2 ml/sec with a 22G non-coring power injectable needle.

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use(Per 21 CFR 801.109)Salia	Over the Counter Use
Syed
(Division Sign-Off)
Division of Dental, Infection Control, and GeneralHospital Devices
KI22402510(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.