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

Device Description

The P.A.S. PORT® Elite System is similar to the current commercially available P.A.S. PORT System. The systems have the identical outlet tube, catheter connector and catheter. The P.A.S. PORT® Elite System differs from the current commercially available P.A.S. PORT System as follows: modified portal shape, increased septum diameter, new portal housing material, and a pierceable rear suture hole. The P.A.S. PORT® Elite System will be made available with a sensor assembly and/or introducer set.

AI/ML Overview

The provided text describes a 510(k) submission for the P.A.S. PORT® Elite Implantable Venous Access System. This is a medical device, not a diagnostic AI/ML algorithm. Therefore, the questions related to AI/ML specific criteria (such as MRMC studies, standalone algorithm performance, number of experts for ground truth, sample sizes for training/test sets in the context of AI, data provenance for AI) are not applicable to this document.

However, I can extract the acceptance criteria and the study that proves the device meets those criteria, based on the information provided for this medical device.

Acceptance Criteria and Device Performance for P.A.S. PORT® Elite Implantable Venous Access System

The submission indicates that the P.A.S. PORT® Elite System is a modification of an existing device and is compared to two predicate devices. The acceptance criteria are largely implied by the functional and biocompatibility testing performed.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly Met)	Reported Device Performance
Functional Performance	Device functions according to specifications for an implanted infusion port.	Septum Puncture: Testing conducted in accordance with FDA "Guidance on 510(k) Submissions for Implanted Infusion Ports," dated October 1990. Results indicated functionality according to specification.
	System Leakage: Testing conducted in accordance with FDA "Guidance on 510(k) Submissions for Implanted Infusion Ports," dated October 1990. Results indicated functionality according to specification.
	Clearance Testing: Testing conducted in accordance with FDA "Guidance on 510(k) Submissions for Implanted Infusion Ports," dated October 1990. Results indicated functionality according to specification.
Biocompatibility	System components are biocompatible for human implantation.	Biocompatibility Testing: Conducted on system components. Results indicated materials used in the system are biocompatible.

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

Sample Size: Not specified. The studies were in-vitro (laboratory) functional and biocompatibility tests, not studies involving human or animal subjects that typically have "sample sizes" in this context.
Data Provenance: Not specified, but the testing was "in-vitro," meaning in a controlled laboratory environment, likely at the manufacturer's facility. The country of origin of the data is not mentioned, but the manufacturer is SIMS Deltec, Inc. based in St. Paul, MN, USA.
Retrospective or Prospective: Not applicable, as these were laboratory tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth for in-vitro functional and biocompatibility tests is typically established by engineering and materials science standards and measurements, not by expert consensus from medical professionals in a diagnostic context.

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

Not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth in AI/ML performance evaluations involving human interpretation. This submission describes engineering verification and validation testing.

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 not an AI/ML algorithm. No MRMC comparative effectiveness study was performed.

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

Not applicable. This device is not an AI/ML algorithm.

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

The "ground truth" for the functional tests was compliance with the FDA "Guidance on 510(k) Submissions for Implanted Infusion Ports" (October 1990), implying established engineering and performance specifications.
For biocompatibility, the ground truth was meeting established biocompatibility standards for materials used in implantable devices.

8. The sample size for the training set

Not applicable. There is no "training set" for this type of medical device submission, as it does not involve AI/ML.

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

Not applicable, as there is no training set.

Summary

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K99 2880

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

P.A.S. PORT® Elite Implantable Venous Access System

August 25, 1999

GENERAL INFORMATION 1.

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 IntravascularInfusion Port and Catheter
Proprietary Name:	P.A.S. PORT® Elite Implantable VenousAccess System
Equivalence Device Comparison:	P.A.S. PORT® Implantable Venous Access System(manufactured by SIMS Deltec, Inc.)M.R.I.® Low Profile Implanted Port(manufactured by Bard Access Systems)

II. DEVICE DESCRIPTION

The P.A.S. PORT® Elite System is similar to the current commercially available P.A.S. PORT System. The systems have the identical outlet tube, catheter connector and catheter.

The P.A.S. PORT® Elite System differs from the current commercially available P.A.S. PORT System as follows: modified portal shape, increased septum diameter, new portal housing material, and a pierceable rear suture hole.

The P.A.S. PORT® Elite System will be made available with a sensor assembly and/or introducer set.

III. INTENDED USE OF DEVICE

A P.A.S. 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 3

IV. DEVICE COMPARISON

	P.A.S. PORT® EliteSystems	P.A.S. PORT®Systems	M.R.L. Low ProfileImplanted Port
MANUFACTURER	SIMS Deltec, Inc.	SIMS Deltec, Inc.	Bard Access Systems
510(K) NUMBER	Subject Device	K875276	—
INDICATION FORUSE	A P.A.S. PORT® systemis indicated when patienttherapy requiresrepeated venous accessfor injection or infusiontherapy and/or venousblood sampling.	A system is indicatedwhen patient therapyrequires repeated venousaccess for injection orinfusion therapy and/orvenous blood sampling.	The M.R.I. Low ProfileImplanted Port is indicatedfor patient therapy requir-ingrepeated access to thevascular system in pedia-triccases or where a small portprofile is desired or required.The port system can be usedfor infusion of medications,parenteral nutrition solution,blood products or imagingsolutions and for thewithdrawal of blood samples.
PORTALDIMENSIONS(Nominal)
HeightLengthWidthSeptum Diameter	9.5 mm25 mm17.2 mm9.7 mm	10.0 mm26.7 mm16.5 mm6.6 mm	10.0 mm24.8 mm (diameter)—10.8 mm
CATHETERDIMENSIONS(Nominal)
I.D.O.D.Length	1.0 mm1.9 mm76 cm	1.0 mm1.9 mm76 cm	1.0 mm—76 cm
MATERIALS
Portal HousingSeptumConnectorCatheter	Acetal and TitaniumSiliconeTitaniumPolyurethane	TitaniumSiliconeTitaniumPolyurethane	AcetalSilicone—Silicone
CATHETERCONNECTOR	ULTRA-LOCK®Connector	ULTRA-LOCK®Connector	Strain relief connection

--- Information is unknown.

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

SUMMARY OF STUDIES V.

Functional Testing A.

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 septum puncture, system leakage and clearance testing.

Biocompatibility testing was conducted on system components.

B. Clinical Studies

Clinical studies were not deemed necessary regarding the P.A.S. PORT® Elite Implantable Venous Access System due to its similarity in materials, design and function to current SIMS Deltec systems and other commercially available systems.

C. Conclusions Drawn from the Studies

The results of the testing indicated that the P.A.S. PORT® Elite Implantable Venous Access System functions according to specification and the materials used in the system are biocompatible. Therefore, the system is considered acceptable for human use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The caduceus is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 1999

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

Re : K992880

Trade Name: P.A.S.PORT® Elite Implantable Venous Access System Class: Unclassified Product Code: LJT August 25, 1999 Dated: Received: August 27, 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, Druq, 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbrandinq 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 - Ms. Stone

the Federal Register. Please note: this response to your premarket notification submission does not affect any 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 diaqnostic 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,

Kollatrik

Timothy A. Ulatowski

hy A. Ulatowski Timot Diredtor 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): _ K 992880

Device Name: P.A.S. PORT® Elite Implantable Venous Access System

Indications for Use:

"A P.A.S. PORT® 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_ OR (Per 21 CFR 801.109) (Division Sign-Off) Division of Dental, Infection C ntrol/

510(k) Number

and General Hospital Devices

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

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.