A PORT-A-CATH® II Trans-Arterial Percutaneous System consists of a portal with a self-sealing silicone septum, accessible by percutaneous needle puncture, and single lumen catheter. The following accessories are provided with the portal and catheter: PORT-A-CATH® access needle, blunt needle, extra-thin wall introducer needle, dilator/sheath assembly, guidewire and syringe.

AI/ML Overview

The provided text describes a 510(k) submission for the PORT-A-CATH® II Trans-Arterial Percutaneous System. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical trials with specific acceptance criteria as would be the case for novel devices.

Therefore, the requested information on acceptance criteria and a study proving those criteria are met for this specific device is largely not applicable in the traditional sense of a performance study. Instead, the submission argues that the device's similarity to existing, legally marketed devices implies its safety and effectiveness.

Here's how to address the request based on the provided text:

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

Since no specific performance acceptance criteria or direct performance data for the PORT-A-CATH® II Trans-Arterial Percutaneous System is reported for this 510(k), we can infer the "acceptance criteria" were related to demonstrating substantial equivalence.

Acceptance Criteria (Inferred for 510(k) Substantial Equivalence)	Reported Device Performance
Similarity in Materials	The PORT-A-CATH® II Trans-Arterial Percutaneous System uses Polysulfone/Titanium for the Portal, Silicone for the Septum, and Polyurethane for the Catheter, which are the same materials as the predicate PORT-A-CATH® II Low Profile™ System.
Similarity in Design	The submission states the device has "similarity in materials, design and function" to the predicate device. The dimensions (Height, Base, Septum Diameter for Portal; I.D., O.D., Length for Catheter) are identical or very similar to the predicate devices.
Similarity in Function	The submission states the device is "functionally the same as the PORT-A-CATH® II Low Profile™ Venous System."
Similarity in Intended Use (for relevant aspects)	The intended use ("A system is indicated when a patient requires prolonged or repeated intra-arterial infusion") is a variation of the predicate devices' broader "repeated vascular access for injection or infusion therapy and/or venous blood sampling."
Biocompatibility	Biocompatibility testing was conducted on the device, and the conclusion was that "the device materials were biocompatible," rendering the device "acceptable for human use."
No new safety/effectiveness concerns	The FDA's substantial equivalence determination implies that no new questions of safety or effectiveness were raised compared to the predicate devices.

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 for the test set: Not applicable. No clinical or functional performance test set was used for this device as part of the 510(k) submission. The submission relied on the established safety and effectiveness of the predicate devices and biocompatibility testing of the materials.
Data provenance: Not applicable.

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. No ground truth was established by experts for a test set for this device in this submission, as no new performance study was conducted.

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

Not applicable. No test set requiring adjudication was used.

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 is a medical device, not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device, not an algorithm.

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

Not applicable for performance evaluation in this 510(k). The "ground truth" for the submission's approval was essentially the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. No training set was used for this device in this submission.

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

Not applicable. No training set was used.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

PORT-A-CATH® II Trans-Arterial Percutaneous System

K 992697

August 9, 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:	Implantable Access System
Proprietary Name:	PORT-A-CATH® II Trans-Arterial PercutaneousSystem
Equivalence Device Comparison:	PORT-A-CATH® II Low Profile™ VenousImplantable Access SystemPORT-A-CATH® Arterial Implantable AccessSystem

II. DEVICE DESCRIPTION

III. INTENDED USE OF DEVICE

A system is indicated when a patient requires prolonged or repeated intra-arterial infusion.

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DEVICE COMPARISON IV.

	PORT-A-CATH® IITrans-ArterialPercutaneous System	PORT-A-CATH® IILow Profile™ System	PORT-A-CATH®Arterial System
MANUFACTURER	SIMS Deltec, Inc.	SIMS Deltec, Inc.	SIMS Deltec. Inc.
510(K) NUMBER	Subject Device	K942024	K830730B
INDICATIONS FORUSE	A system is indicatedwhen a patient requiresprolonged or repeatedintra-arterial infusion.	A system is indicatedwhen a patient requiresrepeated vascular accessfor injection or infusiontherapy and/or venousblood sampling.	A system is indicatedwhen a patient requiresrepeated vascular accessfor injection or infusiontherapy and/or venousblood sampling.
PORTALDIMENSIONS(nominal)
HeightBaseSeptum Diameter	11.5 mm25.0 mm9.5 mm	11.5 mm25.0 mm9.5 mm	13.5 mm25.4 mm11.4 mm
CATHETERDIMENSIONS(nominal)
I.D.O.D.Length	1.9 mm1.0 mm100 cm	1.9 mm1.0 mm76 cm	2.3 mm0.8 mm76 cm
MATERIALS
PortalSeptumCatheter	Polysulfone/TitaniumSiliconePolyurethane	Polysulfone/TitaniumSiliconePolyurethane	TitaniumSiliconeSilicone
CATHETERCONNECTOR	ULTRA-LOCK®Connector	ULTRA-LOCK®Connector	CATH-SHIELD®Connector

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V. SUMMARY OF STUDIES

Functional Testing A.

Functional testing was not performed because the PORT-A-CATH® II Trans-Arterial Percutaneous System is functionally the same as the PORT-A-CATH® II Low Profile™ Venous System.

Biocompatibility testing was conducted on the device.

B. Clinical Studies

Clinical studies were not deemed necessary regarding the PORT-A-CATH® II Trans-Arterial Percutaneous System due to its similarity in materials, design and function to the current PORT-A-CATH® II Low Profile™ Venous System.

C. Conclusion Drawn from the Studies

As noted above, no functional testing or clinical studies were deemed necessary regarding the PORT-A-CATH® II Trans-Arterial Percutaneous System. Biocompatibility testing showed that the device materials were biocompatibile. Therefore, the device is considered acceptable for human use.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three curved lines representing the bird's head and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 1999

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

K992697 Re :

PORT-A-CATH® II Trans-Arterial Percutaneous Trade Name: System Unclassified Requlatory Class: Product Code: LJT Dated: October 18, 1999 Received: October 19, 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 Requlations, Title 21, Parts 800 to 895. A 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 requlatory 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 regulation (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

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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K992697 wmo
K442647

510(k) Number (if known):

Device Name: PORT-A-CATH® II Trans-Arterial Percutaneous System

Indications for Use:

" A system is indicated when a patient requires prolonged or repeated intra-arterial infusion. "

(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 __________

Patric Cucenti

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.