MODIFICATION TO: T-PORT HP INFUSION PORT by PFM MEDICAL, INC

The T-Port HP Infusion 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 T-Port HP Infusion Port 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 non-coring power injectable needle.

Device Description

The T-Port HP Infusion 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 T-Port HP Infusion Port is offered with the polyurethane catheter either preattached by the manufacturer or attachable for application by the inserting physician. The port can be anchored with sutures in the port pocket for secure seating. 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.
The base of the port has the letters "CT" to signify that it can be used for power injection on contrast agents. The serial number is laser etched into the base of the port. The suture holes may contain clear silicone to prevent tissue in growth to the suture holes.
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 T-Port HP Infusion Port is packaged with the necessary accessories to facilitate catheter insertion.
The port and catheter are manufactured and sterilized at the same manufacturing and sterilization facilities as the predicate device cleared under K071993. .
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

This document is a 510(k) summary for the T-Port HP Infusion Port, which is an implantable device used to provide repeated access to the vascular system. It is important to note that this document is a 510(k) summary, not a detailed study report. Therefore, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive study with detailed acceptance criteria and performance data for a new AI or diagnostic device.

Based on the provided text, the device is a physical medical device (infusion port and catheter system), not an AI or imaging diagnostic device. As such, the information requested in your prompt (e.g., sample size for training/test sets, expert qualifications, MRMC study, standalone algorithm performance, AI vs. human improvement) are not applicable to this type of device and are not found in the document.

The document describes the device, its intended use, and its equivalence to a previously cleared device (K071993). The "acceptance criteria" here are tied to demonstrating substantial equivalence for regulatory clearance, primarily through material biocompatibility and functional specifications that match or are equivalent to the predicate device.

Here's an attempt to address your points based on the available information, with many points being "Not Applicable":

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

Acceptance Criteria (Inferred from substantial equivalence to predicate)	Reported Device Performance (Inferred from specifications and equivalence)
Biocompatibility: Materials used are safe for implantation.	Materials are the same as those used in legally marketed devices under comparable conditions of use.
Functional Equivalence: Provides repeated vascular access for infusion and blood withdrawal.	Functions as an implantable port and catheter system for repeated vascular access.
Power Injection Capability: Supports specified infusion rates and pressures for contrast media.	- Max infusion rate: 5 ml/sec with 19G/20G non-coring needle.- Max infusion rate: 2 ml/sec with 22G non-coring needle.- Max pressure: 300 psi.
Mechanical Integrity: Withstands specified infusion pressures without failure.	(Implicit in meeting power injection specifications and substantial equivalence to predicate)
Sterilization: Sterilized according to established practices.	Manufactured and sterilized at the same facilities as the predicate device (K071993).
Labeling/Instructions for Use (IFU): Provides clear and accurate information for safe use.	Provides necessary accessories (e.g., guide wire, dilator, Huber needle, IFU) and outlines intended use and power injection parameters.

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

Not Applicable. This is a physical medical device. The "test set" in the context of a 510(k) for such a device refers to bench testing, material testing, and potentially some animal studies (though not detailed here) comparing it to the predicate, rather than a clinical data set for an AI algorithm.
- No specific sample sizes for clinical data are mentioned, as the focus is on device specifications and equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not Applicable. Ground truth, in the context of expert consensus, is not relevant to demonstrating substantial equivalence for a physical medical device like an infusion port. The "ground truth" for this device would be its physical and mechanical properties, material safety, and functionality, verified through engineering and biocompatibility testing.

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

Not Applicable. Adjudication methods are relevant for subjective assessments, typically in diagnostic imaging or clinical trials. This document pertains to the regulatory clearance of a physical device based on objective specifications and equivalence.

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. MRMC studies are used for evaluating diagnostic performance, especially with AI assistance. This device is an infusion port, not a diagnostic tool where "human readers" would be involved in interpreting its output.

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

Not Applicable. The T-Port HP Infusion Port is a physical device, not an algorithm.

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

For physical device characteristics: The "ground truth" is established through engineering specifications, material standards, biocompatibility testing results (e.g., ISO standards), and verified manufacturing processes.
For performance claims (e.g., power injection rates): The ground truth would be volumetric and pressure measurements performed during bench testing, ensuring the device can safely handle the stated flow rates and pressures without failure.

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device. No "training set" in that sense exists.

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

Not Applicable. As above, no training set is involved.

Summary

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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

DEC 1 2 2007

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:
Trade Name:	T-Port HP Infusion Port
Common Name:	Port & Catheter Implanted, Subcutaneous, Intravascular
Classification Name:	Same

Equivalent Devices:
Manufacturer:	PFM Medical, Inc
Name:	T-Port HP Infusion Port
510(k) #:	K071993

Device Description:

The base of the port has the letters "CT" to signify that it can be used for power injection on contrast agents. The serial number is laser etched into the base of the port. The suture holes may contain clear silicone to prevent tissue in growth to the suture holes.

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 T-Port HP Infusion Port is packaged with the necessary accessories to facilitate catheter insertion.

The port and catheter are manufactured and sterilized at the same manufacturing and sterilization facilities as the predicate device cleared under K071993. .

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

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K03210 page 2 of 3

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:

When used with a power injectable needle, the T-Port HP Infusion Port 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 non-coring power injectable needle.

Biocompatibility:

The materials used to manufacture the T-Port HP Infusion Port are used in legally marketed devices under comparable conditions of use.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

DEC 1 2 2007

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

Rc: K073210

Trade/Device Name: T-Port HP Infusion Port Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: November 12, 2007 Received: November 16, 2007

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 mcan 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 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 Office of Compliance at (240) 276-0120. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Cve

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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510(k):

Device Name: T-Port HP Infusion Port

Indications for Use: The T-Port HP Infusion 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 T-Port HP Infusion Port 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 noncoring power injectable needle or 2 ml/sec with a 22G non-coring power injectable needle.

Concurrence of CDRH, Office of Device Evaluation (ODE)

ਮੇ Prescription Use Or Over the Counter Use (Per 21 CFR 801.109)

Antan v.n
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices

510(k) Number 1473214

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.