The Medcomp® Gen III Power Injectable Port is indicated for 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.

When used with a power injectable needle, the power injectable infusion port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-coring power injectable needle.

Device Description

The Medcomp® Gen III Power Injectable Port includes the Dignity® Mini. Low Profile and Pro-Fuse® Low Profile and Standard are subcutaneously implantable single fluid reservoir port offered with a choice of a silicone or polyurethane cather either pre-attached by the manufacturer or attachable for application by the inserting physician. The Pro-Fuse® product line offers a round base while the Dignity® product line offers a shovel nose concaved sides and smooth contours. The Dignity® product line is offered in Midsize. which has a smaller base than the predicate, K070003. The Dignity® product line is offered in Low Profile, which is a smaller base than the Midsize therefore is smaller than predicate, K070003. The Dignity® product line is offered in Mini, it is the smallest offered profile.

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 catherer lock provides securement of the catheter to the port stem. The port is accessed by inserting needle through the skin into the self-sealing septum.

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.

Power injection of contrast media, can be safely administered with a 19 or 20 gauge power injectable infusion non-coming needle at a maximum recommended infusion rate of 5 ml/s.

The implantable infusion port is packaged with the necessary accessories to facilitate catheter insertion.

AI/ML Overview

The provided text describes the Medcomp® Gen III Power Injectable Port and its 510(k) submission (K132177). This document focuses on demonstrating substantial equivalence to a predicate device (K070003) rather than a standalone study proving device performance against specific novel acceptance criteria.

The acceptance criteria are implicitly defined by the safety and performance requirements for implantable infusion ports and are primarily demonstrated through comparison to the predicate and established international standards (ISO 10555-1, ISO 10993).

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with numerical targets and corresponding performance results for each criterion. Instead, it lists various "Bench / Performance Data" tests performed and states that the "results of these tests in conjunction with the substantial equivalence claims effectively demonstrate the proposed devices are equivalent to the predicate device. K070003."

Essentially, the acceptance criterion for each test is that the new device's performance is equivalent to, or meets the established safety and performance characteristics of, the predicate device and relevant ISO standards.

Acceptance Criterion (Implicit)	Reported Device Performance
Mechanical/Physical Performance equivalent to predicate and ISO 10555-1, including: - Power Injection Simulation - Elongation & Tensile - Priming Volume - Gravity Flow - Stem Break Force - Cap/Base Bond Integrity - Catheter Lock Integrity - Clearance Volume - Needle Insertion/Extraction Force - Reservoir Pressure - Static Burst Pressure	"In vitro testing was performed on the Power Injectable. Implantable Infusion Port 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." "The following testing was performed on all configurations Pro-Fuse Standard and Low Profile, Dignity Low Profile, Midsize and Mini. in accordance with requirements of ISO 10555-1 for all configurations listed in pursuant of this application to market." "The results of these tests in conjunction with the substantial equivalence claims effectively demonstrate the proposed devices are equivalent to the predicate device. K070003." No specific numerical performance values are provided, only an assertion of equivalence.
Biocompatibility in accordance with ISO 10993	"Testing for all materials used for the Power Iniectable Infusion Port has been submitted in previously cleared Medcomp device predicate K070003. All biocompaibility testing demonstrals used meet the requirements of ISO 10993."
Substantial Equivalence to Predicate K070003	"The proposed devices meet the performance criteria of design verification as specified by ISO standards, guidance documents and internal test protocols. The proposed device has the same intended use, operation and function as the predicates. There are no differences that raise of safety and effectiveness. The proposed device is substantially equivalent to the legally marketed predicate devices."

2. Sample sizes 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 sample sizes (number of units or batches tested) for the "Bench / Performance Data" tests. It mentions "all configurations Pro-Fuse Standard and Low Profile, Dignity Low Profile, Midsize and Mini" were tested, indicating multiple product variants were included.

The data provenance is implied to be from in vitro testing performed by the manufacturer (Medcomp®) in the US, as it's a submission to the FDA. It is prospective for the Gen III device, as these tests were conducted on the new device.

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)

This section is not applicable to this type of submission. This is a premarket notification for a medical device (implantable port) based on substantial equivalence and bench testing, not an algorithmic diagnostic device requiring expert interpretation of clinical images for ground truth establishment.

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

This is not applicable. Adjudication methods are typically used in studies involving human interpretation or performance, often for diagnostic accuracy, which is not the nature of this submission. The "ground truth" for the performance tests would be the measured physical properties of the device against engineering requirements or established standards.

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

This is not applicable. An MRMC comparative effectiveness study is specific to diagnostic imaging devices or AI algorithms where human reader performance is a key metric. This submission is for an implantable infusion port.

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

This is not applicable as this is a physical medical device, not an algorithm or AI system. The "standalone" performance here relates to the device's physical and mechanical properties, which were tested in a "standalone" manner (i.e., the device itself was subjected to bench tests).

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

The "ground truth" for the bench tests are:

Engineering specifications and measurements: For parameters like priming volume, burst pressure, tensile strength, etc.
Compliance with international standards: ISO 10555-1 for performance and ISO 10993 for biocompatibility.
Performance of the predicate device (K070003): The new device's performance is shown to be equivalent to the previously cleared predicate.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This is not applicable for the same reason as above.

Summary

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K132177
DEC 12 2013

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Section 5

510(k) SUMMARY

Traditional 510K

Submitter Information:

Submitter:	MEDCOMP®1499 Delp DriveHarleysville, PA 19438Tel: (215) 256-4201Fax: (215) 256-9191
Contact:	Rosanna SeveriniCompliance Manager
Date Prepared:	June 28, 2013
Trade Name:	Medcomp® Gen III Power Injectable Port
Common Name:	Power Injectable, Implantable, Infusion Port
Classification Name:	Subcutaneous, implanted, intravascular infusion port and catheter
C.F.R. Sections	§880.5965Product Code and Class: LJT, II
Predicate Devices:	K070003: Medcomp, Power Injectable Implantable Port, concurrence dateMay 15, 2007.

Device Description:

Power injection of contrast media, can be safely administered with a 19 or 20 gauge power injectable infusion non-coming needle at a maximum recommended infusion rate of 5 ml/s.

The implantable infusion port is packaged with the necessary accessories to facilitate catheter insertion.

Indications for Use:

The Medcomp® Gen III Power Injectable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infission of medications, I.V. Shuts, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.

When used with a power injectable the power injectable infusion port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-coring power injectable needle.

Medcomp® Gen III Power Injectable Port Summary .

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Comparison to Predicate Devices:

The implanted port is substantially equivalent to the predicate devices in K070003 in terms of intended use, anatomical location, basic design, materials, performance, labeling, manufacturing process and method of sterilization.

Port Types	Port Body and Catheter Options	Comparison to Predicate (K070003)
STANDARDPRO-FUSE ®	Purple plastic cap and base.	Inception design of Medcomp Infusion CT Ports. The line began with the Standard Pro-Fuse®.
	Catheters Offered:9.6F Silicone8F Polyurethane
	Purple plastic cap and base.
	LOW PROFILEPRO-FUSE®
		The base is smaller and smaller height than predicate, K070003.
Silicone Filled Suture Holes available.
MID-SIZEDIGNITY®		Purple plastic cap and base.
	Catheters Offered:9.6F Silicone8F Polyurethane6.6F Polyurethane5F Polyurethane

	Silicone Filled Suture Holes available.
	LOW PROFILEDIGNITY®	Purple plastic cap and base.
Catheters Offered:8F Polyurethane6.6F Polyurethane5F Polyurethane

Silicone Filled Suture Holes available.
MINIDIGNITY®		Purple plastic cap and base.
	Catheters Offered:8F Polyurethane6.6F Polyurethane5F Polyurethane
	Silicone Filled Suture Holes available.

The unique characteristic of the Gen 111 implanted port is a universal catherer lock. The new catherer lock is universal in form therefore eliminating the need for insertine which way the lock nust be connected to the port.

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Medcomp@ Gen III Power Injectable Port Summary :

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Bench / Performance Data:

In vitro testing was performed on the Power Injectable. Implantable Infusion Port 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.

The following testing was performed on all configurations Pro-Fuse Standard and Low Profile, Dignity Low Profile, Midsize and Mini. in accordance with requirements of ISO 10555-1 for all configurations listed in pursuant of this application to market.

Power Injection Simulation
Elongation & Tensile
Priming Volume
Gravity Flow
Stem Break Force
Cap/Base Bond Integrity
Catheter Lock Integrity
Clearance Volume
Needle Insertion/Extraction Force
Reservoir Pressure
Static Burst Pressure

The results of these tests in conjunction with the substantial equivalence claims effectively demonstrate the proposed devices are equivalent to the predicate device. K070003.

Biocompatibility:

Testing for all materials used for the Power Iniectable Infusion Port has been submitted in previously cleared Medcomp device predicate K070003. All biocompaibility testing demonstrals used meet the requirements of ISO 10993.

Technological Characteristics:

Technological similarities between the proposed devices remain the same. The primary difference between the predicate and Gen III implanted port is the universal lock is universal in form and capable of being placed bi-directionally. This provides a unique feature while maintaining the same functional characteristics of the predicate device.

Summary of Substantial Equivalence:

The proposed devices meet the performance criteria of design verification as specified by ISO standards, guidance documents and internal test protocols. The proposed device has the same intended use, operation and function as the predicates. There are no differences that raise of safety and effectiveness. The proposed device is substantially equivalent to the legally marketed predicate devices.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

December 12, 2013

Medical Components, Incorporated Ms. Rosanna Severini Regulatory Specialist 1499 Delp Drive HARLEYSVILLE PA 19438

Re: K132177

Trade/Device Name: Medcomp® Gen III Power Injectable Port Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: November 11, 2013 Received: November 12, 2013

Dear Ms. Severini:

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. Severini

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 (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,

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Erin I. Keith, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

、1765年、1994年、1987年、1985年)、1982年の2008年、19

Indications for Use

510(k) Number (if known) K132177

Device Name

Medcomp@ Gen III Power Injectable Port

Indications for Use (Describe)

The Medican po Gen III Power Injectable Por 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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)	Digitally signed by Richard C. ChapmanDate: 2013.12.12 10:16:39 -05'00'
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Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

FORM FDA 3881 (9/13)

PSC Publishmig Serviors ( JO1) +4 3-4740 EF

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.