Plastic Port Implantable Venous Access Systems consist of a plastic portal (standard or Low Profile™ size), silicone or polyurethane catheter connector, PORT-A-CATH® access needle, blunt needle, and vein pick. The systems will be made available with and without introducer sets.

AI/ML Overview

The provided 510(k) summary (K994216) describes the "Plastic Port Implantable Venous Access Systems" and evaluates their safety and effectiveness through in-vitro functional testing and biocompatibility testing. It explicitly states that clinical studies were not deemed necessary due to the device's similarity to existing, legally marketed predicate devices. Therefore, the device performance is primarily assessed against functional specifications and material properties rather than clinical outcomes or diagnostic accuracy.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Catheter to port connection functionality	Functioned according to specifications (implied by "function according to specifications")
Septum puncture performance	Functioned according to specifications (implied by "function according to specifications")
System leakage	Functioned according to specifications (implied by "function according to specifications")
Clearance testing	Functioned according to specifications (implied by "function according to specifications")
Biocompatibility of system components	Materials used in the system are biocompatible

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

Sample Size for Test Set: The document does not specify a numerical sample size for the in-vitro functional tests. It generally refers to "In-vitro testing" and "Biocompatibility testing."
Data Provenance: The data provenance is from "In-vitro testing" and refers to laboratory tests, not human or animal subjects. As it's in-vitro testing performed by the manufacturer, it's considered retrospective in the sense that the test results would be analyzed after the experiments were conducted. There is no country of origin specified for the testing data itself, assumed to be internal to the manufacturer (SIMS Deltec, Inc. in St. Paul, MN, USA).

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

Not applicable. This study primarily involved in-vitro functional testing and biocompatibility testing, not diagnostic or clinical accuracy evaluations requiring expert interpretation of ground truth. The "ground truth" for these tests would be established by engineering specifications and established material testing standards, not by human experts interpreting clinical data.

4. Adjudication Method for the Test Set

Not applicable. As described above, this study focused on in-vitro functional and biocompatibility testing, which typically relies on objective measurements against predefined specifications rather than expert adjudication of interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical studies were not deemed necessary regarding Plastic Port Implantable Venous Access Systems due to their similarity in materials, design and function to current SIMS Deltec systems and other commercially available systems." Therefore, there is no information on human reader improvement with or without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a standalone performance study was done in the form of in-vitro functional testing and biocompatibility testing. This assessment was purely on the device's physical and material properties against specifications without any human-in-the-loop interaction for performance evaluation.

7. Type of Ground Truth Used

Engineering specifications and material science standards. For functional testing (catheter to port connection, septum puncture, system leakage, clearance), the ground truth is defined by the device's design specifications and industry standards for performance. For biocompatibility testing, the ground truth is established by recognized biocompatibility standards and material properties deemed safe for human contact.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm requiring a training set. The performance evaluation was based on traditional in-vitro testing.

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

Not applicable. As mentioned above, there is no training set as this is not an AI/ML device.

Summary

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'JAN 2 7 2000

K994216

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Plastic Port Implantable Venous Access Systems

December 14, 1999

I. GENERAL INFORMATION

Applicant's Name and Address:	SIMS Deltec, Inc.1265 Grey Fox RoadSt. Paul, MN 55112
Contact Person:	Lisa StoneManager, Regulatory Affairs
Common/Usual Name:	Subcutaneously Implanted Intravascular InfusionPort and Catheter
Proprietary Name:	Plastic Port Implantable Venous Access System
Equivalence Device Comparison:	PORT-A-CATH® Implantable Venous AccessSystems(manufactured by SIMS Deltec, Inc.)M.R.I.® Implanted Ports(manufactured by Bard Access Systems)

IL DEVICE DESCRIPTION

III. INTENDED USE OF DEVICE

A Plastic Port System is indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

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510(k) Summary of Safety and Effectiveness Page 2 of 4

	Plastic Port Systems	PORT-A-CATH®Systems	M.R.I.® ImplantedPort
MANUFACTURER	SIMS Deltec, Inc.	SIMS Deltec, Inc.	Bard Access System
510(K) NUMBER	Subject Device	K830730BK875276 K932840 K942024	Unknown
INDICATION FOR USE	A system is indicatedwhen patient therapyrequires repeated venousaccess for injection orinfusion therapy and/orvenous blood sampling.	A system is indicatedwhen patient therapyrequires repeated venousaccess for injection orinfusion therapy and/orvenous blood sampling.	The BardPort ImplantedPorts are indicated forpatient therapiesrequiring repeated accessto the vascular system.The port system can beused for infusion ofmedications, I.V. fluids,parenteral nutritionsolutions, blood productsand for the withdrawal ofblood samples.
PORTAL ANDCONNECTORMATERIALS
Housing	Acetal	Polysulfone/Titanium orTitanium	Acetal
Septum	Silicone	Silicone	Silicone
Connector	Polypropylene/Acetal orSilicone	Polypropylene/Titaniumor Titanium	Unknown
PORTAL DIMENSIONS- STANDARD SIZE(Nominal)
HeightPortal BaseSeptum Diameter	14.0 mm30.5 mm12.7 mm	14.7 mm30.5 mm11.4 mm	13.5 mm32.0 mm12.7 mm
PORTAL DIMENSIONS- LOW PROFILE SIZE(Nominal)
HeightPortal BaseSeptum Diameter	10.0 mm25.0 mm10.5 mm	11.5 mm25.0 mm9.5 mm	10.0 mm24.8 mm10.8 mm
	Plastic Port Systems	PORT-A-CATH®Systems	M.R.I.® ImplantedPort
CATHETERMATERIAL ANDDIMENSIONS(Nominal)
SILICONEI.D.O.D.Length	1.0 mm2.8 mm76 cm	1.0 mm2.8 mm76 cm	1.0 mmUnknown76 cm
POLYURETHANEI.D.O.D.Length	1.0 mm1.9 mm76 cm	1.0 mm1.9 mm76 cm	n/a1n/an/a
I.D.O.D.Length	1.6 mm2.6 mm76 cm	1.6 mm2.6 mm76 cm	n/an/an/a
CATHETERCONNECTOR	SLIDE-LOCK® orCATH-SHIELD®Connector	CATH-SHIELD® orULTRA-LOCK®Connector	Strain relief connection

IV. DEVICE COMPARISON

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510(k) Summary of Safety and Effectiveness Page 3 of 4

III. SUMMARY OF STUDIES

A. Functional Testing

In-vitro testing was conducted in accordance with the FDA "Guidance on 510(k) Submissions for Implanted Infusion Ports," dated October 1990. The testing included catheter to port connection, septum puncture, system leakage and clearance testing.

Biocompatibility testing was conducted on system components.

Clinical Studies B.

Clinical studies were not deemed necessary regarding Plastic Port Implantable Venous Access Systems due to their similarity in materials, design and function to current SIMS Deltec systems and other commercially available systems.

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C. Conclusions Drawn from the Studies

The results of the testing indicated that the Plastic Port Implantable Venous Access Systems function according to specifications and the materials used in the system are biocompatible. Therefore, these systems are considered acceptable for human use.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 7 2000

Ms. Lisa J. Stone Manager, Regulatory Affairs Smiths Industries Medical Systems Deltec 1265 Grey Fox Road St. Paul, Minnesota 55112

Re : K994216 Deltec Plastic Port Implantable Venous Trade Name: Access System Requlatory Class: Unclassified Product Code: LJT December 14, 1999 Dated: Received: December 15, 1999

Dear Ms. Stone:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਬ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Ms. Stone

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Plastic Port Implantable Venous Access Systems

Indications for Use:

" A system is indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling."

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

Patricio Guereida

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 1: 0(k) Number_K 99 4-210

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.