The CT Power Injectable Infusion Ports are indicated for pediatric patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications. I.V. fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.

The maximum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-coring power injectable needle. The maximum recommended infusion rate is 2 ml/s with a 22 gauge non-coring power injectable needle.

Device Description

The Dignity™ CT implantable infusion ports are subcutaneously implantable single fluid reservoir ports offered with a polyurethane (5F) catheter either preattached by the manufacturer or attachable for application by the inserting physician in a choice of two kit configurations. Placement of the port is determined by the inserting physician based on patient anatomy and medical judgment. 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 stem. The port is accessed by inserting a non-coring needle through the skin into the self-sealing septum. The ports are offered in a Mini or Low Profile design with power injection capabilities.

The base of the port is printed with the letters "CT" in reverse with radiopaque ink to signify that it can be used for power injection on contrast agents (orientation will appear correct under x-ray). Lot numbers are laser etched into the base of the port. The rigid top half of the port centers the silicone septum and aids in locating the implanted device under the skin.

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/s and a maximum pressure setting of 300 psi.

A 22 gauge needle can be used at 2 ml/sec with a maximum pressure setting of 300 psi.

The implantable infusion port is packaged with the necessary accessories to facilitate catheter insertion in either a standard or micro-puncture kit.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the Dignity™ CT implantable infusion port. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in the typical format of a clinical trial or performance study report with statistical outcomes.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through in vitro testing. This is a common approach for 510(k) clearances when clinical studies are not deemed necessary.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The text does not explicitly present a table of acceptance criteria with corresponding performance results in a quantitative manner. The acceptance is based on demonstrating that the new device performs reliably and safely, and is substantially equivalent to predicate devices.

Acceptance Criterion (Inferred)	Reported Device Performance
Mechanical Integrity/Reliability during Power Injection	Safe administration of contrast media at:
	- Up to 5 ml/s with 19 or 20 gauge non-coring needles (max 300 psi)
	- Up to 2 ml/s with a 22 gauge non-coring needle (max 300 psi)
Biocompatibility	Materials meet ISO 10993 for permanent implantable tissue and blood contact (under previously approved 510(k)s). No unusual or unacceptable risk.
Design and Performance Reliability	In vitro testing performed according to FDA guidance ("Guidance on 510(k) Submissions for Implanted Infusion Ports" dated October 1990) and in-house protocols.
Substantial Equivalence to Predicate Devices	Performance and materials are equivalent to K070003 Medcomp Power Injectable Port and K952435 Celsite® Pediatric Venous Port in terms of intended use, insertion method, anatomical location, design, performance, materials, labeling, and sterilization.

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

The text explicitly states:

"In vitro testing was performed on the ports to assure reliable design and performance..."
The testing was "according to the referenced standards as well as in-house protocols."
"Clinical studies were not deemed necessary since in vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate devices."

Therefore, there was no human "test set" or clinical data. The data provenance is from laboratory in vitro testing rather than human subjects. The sample size for these in vitro tests is not specified in the provided summary.

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

As no human "test set" or clinical study was conducted, there were no experts used to establish ground truth in the traditional sense of clinical trial adjudication. The "ground truth" for the device's performance was established through engineering and material science testing, aligned with regulatory standards and predicate device performance.

4. Adjudication Method for the Test Set

Since no human clinical test set was used, there was no adjudication method applied to clinical data. The assessment was based on compliance with in vitro test protocols and regulatory guidelines.

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

No MRMC comparative effectiveness study was done. This device is a physical medical implant (infusion port), not an imaging or diagnostic AI device that would involve human readers or AI assistance in interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

This question is not applicable to the device described. The device is a physical implant, not an algorithm. Therefore, no standalone algorithm performance study was done.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance and safety largely relies on:

Engineering specifications and performance standards: Demonstrated through in vitro testing.
Regulatory standards: Specifically, FDA's "Guidance on 510(k) Submissions for Implanted Infusion Ports" dated October 1990 and ISO 10993 for biocompatibility.
Performance of legally marketed predicate devices: The new device must demonstrate substantial equivalence to these.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical implant, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no "training set" for this type of medical device.

Summary

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K110424

NOV 3 0 2011

Section 5 510(k) SUMMARY Submitter Information: Submitter: MEDCOMP® 1499 Delp Drive Harleysville, PA 19438 (215) 256-4201 Telephone (215) 256-9191 Fax Contact: Jean Callow. Regulatory Specialist Date Prepared: February 11, 2011 Trade Names: Dignity™ Mini CT Port and Dignity™ Low Profile CT Port Common Name: Power Injectable, Implantable, Infusion Port Classification Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Long Term Classification: LJT

Device Classification: C. Predicate Devices: K070003 Power Injectable Port Medcomp, Concurrence date May 15, 2007 K952435, Celsite® Pediatric Venous Port, B. Braun Medical, Inc.
General Hospital

880.5965

D. Device Description:

C.F.R. Section:

Classification Advisory Committee:

CT Implantable Ports - Mini / Low Profile Page 1 of 2

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A 22 gauge needle can be used at 2 ml/sec with a maximum pressure setting of 300 psi.

The implantable infusion port is packaged with the necessary accessories to facilitate catheter insertion in either a standard or micro-puncture kit.

E. Intended Use:

The maximum recommended infusion rate is 5 ml/s with a 19 or 20 gauge noncoring power injectable needle. The maximum recommended infusion rate is 2 ml/s with a 22 gauge non-coring power injectable needle.

ட் Technological Comparison to Predicate Devices:

The ports are substantially equivalent to the predicate devices in terms of intended use, insertion method, anatomical location, design, performance, materials, labeling and method of sterilization.

G. Safety and Effectiveness / Performance Data:

In vitro testing was performed on the ports to assure reliable design and performance in accordance with the FDA's "Guidance on 510(k) Submissions for . Implanted Infusion Ports" dated October 1990. Verification testing and performance testing performed according to the referenced standards as well as in accordance with in-house protocols.

Clinical studies were not deemed necessary since in vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate devices. This device presents no known additional risks to the patient that are not well documented and for which there is already a prescribed therapy.

H. Biocompatibility:

Materials have been used under previously approved 510k's. Biocompatibility testing demonstrated that the materials used meet the requirements of ISO 10993 for a permanent implantable tissue and blood contact device. All materials present no unusual or unacceptable risk to the patient.

l. Summary of Substantial Equivalence:

Performance data indicated the performance and materials of the Mini CT Port is equivalent to the claims of the currently marketed K070003 Medcomp Power Injectable Port and K952435. Celsite® Pediatric Venous Port. B. Braun Medical. Inc.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Ms. Jean Callow Regulatory Specialist Medical Components, Incorporated 1499 Delp Drive Harleysville, Pennsylvania 19438

NOV 3 0 2011

Re: K110424

Trade/Device Name: CT Power Injectable Implantable Infusion Port Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutancous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: November 21, 2011 Received: November 22, 2011

Dear Ms. Callow:

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. Callow

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Anton V, Anton

Anthony D. Watson, B.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

510(k) Number (if known): K110424

Device Name: ___ CT Power Injectable Implantable Infusion Port

Indications for Use:

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Richard C. Chapman 11/29/4

Page_1 of 1

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

510(k) Number: K110424

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.