The PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.

When used with a GRIPPER PLUS® POWER P.A.C. Safety Huber Needle or other power injectable Huber needle, the PORT-A-CATH® POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media.

The P.A.S Port® T2 POWER P.A.C. Implantable Venous Access Systems are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.

When used with a GRIPPER PLUS® POWER P.A.C. Safety Huber Needle or other power injectable Huber needle, the P.A.S. Port® POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media. For power injections of contrast media, the maximum recommended infusion rate is 5 ml/sec.

Device Description

The PORT-A-CATH® POWER P.A.C and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems are totally implantable venous access systems designed to permit repeated access to the venous system for the parenteral delivery of medications, fluids, nutritional solutions, and for the sampling of venous blood. When used with a power indicated Huber needle, the PORT-A-CATH® POWER P.A.C. and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems are indicated for power injection of contrast media.

The PORT-A-CATH® POWER P.A.C. and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems can be placed in the chest or arm, are supplied sterile, are non-pyrogenic and intended for single patient use only. The PORT-A-CATH® POWER P.A.C and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems consists of a portal with one or two self-sealing septa, and catheter connector that are assembled during implantation. The systems are offered in either a kit or a tray configuration.

AI/ML Overview

The provided text describes a 510(k) premarket notification for implantable venous access systems. It does not describe an AI device, therefore, many of the requested criteria (like ground truth, training/test sets, expert consensus, MRMC studies) are not applicable.

Here's the relevant information based on the provided text:

Device: PORT-A-CATH® POWER P.A.C. Implantable Venous Access Systems, PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems, and P.A.S. Port® T2 POWER P.A.C. Implantable Venous Access Systems.

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

Acceptance Criteria	Reported Device Performance
Physical Properties Suitability	Bench testing of the device confirmed the suitability of the device for its intended use. This implies that the device satisfied established criteria for its physical characteristics (e.g., strength, durability, patency, self-sealing septum integrity, catheter connector assembly).
Biocompatibility	Biocompatibility was established based on the similarity of the materials of construction to the predicate devices commercially marketed by Smiths Medical ASD, Inc. This indicates that the device's materials were deemed safe for implantation and did not elicit adverse biological responses, consistent with the predicate.
MR Safety	MR safety testing was performed on selected ports in accordance with established American Society for Testing and Materials (ASTM) standards. The devices were determined to be MR Conditional according to the terminology specified in ASTM Designation F2503-05. Testing was performed in the presence of a 3 Tesla MR imaging device. This means the devices meet specific conditions for safe use in an MRI environment (e.g., specific field strength, SAR limits, orientation) and do not pose an unacceptable risk when those conditions are met.
Substantial Equivalence to Predicate Port-A-Cath® Power P.A.C. (K070116) and Port-A-Cath® II Power P.A.C. (K072657)	The device is substantially equivalent to the currently marketed Power PAC Implantable Venous Access System based on a comparison of the indications for use and the technological characteristics of the device. Bench tests confirmed the suitability of the device for its intended use. This means the device performs as safely and effectively as a legally marketed device that it is compared against, without raising different questions of safety and effectiveness. The FDA concurred with this determination. This is the overarching "acceptance criterion" for a 510(k) submission.

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 for bench testing or biocompatibility. "Selected ports" were used for MR safety testing, but the exact number is not provided.
Data Provenance: The studies were non-clinical (bench testing, biocompatibility, MR safety). There is no mention of country of origin or whether clinical data was retrospective or prospective, as human clinical studies were deemed not necessary.

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 is not applicable as the studies were non-clinical bench tests and did not involve expert-reviewed data for ground truth establishment in the context of an AI device.

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

Not applicable as this was not a study involving human interpretation or AI adjudication.

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 study was done. This is not an AI device.

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

Not applicable as this is not an AI device.

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

For the non-clinical tests:
- Physical Properties: Engineering specifications and performance standards (e.g., pressure limits, flow rates, durability metrics).
- Biocompatibility: ASTM/ISO standards for material safety by comparison to predicate devices and likely material property data sheets.
- MR Safety: ASTM F2503-05 standard criteria for MR compatibility, which dictates specific parameters (e.g., temperature rise, artifact size, displacement force) under specific MR conditions (e.g., 3 Tesla field strength).

8. The sample size for the training set

Not applicable as this is not an AI device.

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

Not applicable as this is not an AI device.

Summary

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smiths medical

bringing technology to life

510(k) Number: Ko 934/ 4

Page 1 of 3

Date Prepared October 29, 2009

Submitter Information

MAR - 1 2010

Submitter's Name:	Smiths Medical ASD, Inc.
Address:	1265 Grey Fox RoadSt. Paul, MN 55112

Establishment Registration: 2183502

Contact Person:	Rachelle Parsons, RACSr. Regulatory Affairs Associate
	Phone: (651) 628-7018Fax: (651) 628-7457

Device Information

Trade Name:	PORT-A-CATH® POWER P.A.C. Implantable VenousAccess Systems
Common Name:	Subcutaneously Implanted Intravascular Infusion Port andCatheter
Classification Name:	Port and Catheter, Implanted, Subcutaneous, Intravascular
Product Code:	LJT
Regulation:	21 CFR §880.5965

Trade Name:	PORT-A-CATH® II POWER P.A.C. Implantable VenousAccess Systems
Common Name:	Subcutaneously Implanted Intravascular Infusion Port andCatheter
Classification Name:	Port and Catheter, Implanted, Subcutaneous, Intravascular
Product Code:	LJT
Regulation:	21 CFR §880.5965

Submission Page 19

:" ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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510(k) Summary

Page 2 of 3

Predicate Device(s)

The predicate devices are the above currently marketed devices. The reference 510(k) numbers for these devices are as follows:

Device	510(k)
PORT-A-CATH® POWER P.A.C. Implantable Venous Access Systems	K070116
PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems	andK072657

Device Descriptions

PORT-A-CATH®, PORT-A-CATH® II POWER P.A.C. line of Access Ports

Intended Use/Indications for Use

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510(k) Summary

Page 3 of 3

Summary of Non-Clinical Testing

The non-clinical testing included assessment of the physical properties of the PORT-A-CATH® POWER P.A.C. Implantable Venous Access System and its ability to achieve its intended use. Bench testing of the device confirmed the suitability of the device for its intended use.

Biocompatibility assessment of the device was performed. The purpose of the biocompatibility assessment was to ensure that biocompatibility had been established for the device. The device is biocompatible based on the similarity of the materials of construction to the predicate devices commercially marketed by Smiths Medical ASD, Inc.

MR safety testing was performed on selected ports in accordance with established American Society for Testing and Materials (ASTM) standards. This testing was performed to establish the safety of the listed medical devices in the MR environment. The devices selected represent the entire product line of the devices listed. Testing was performed in the presence of a 3 Tesla MR imaging device.

The devices listed were determined to be MR Conditional according to the terminology specified in the ASTM Designation F2503-05 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.

Summary of Clinical Testing

Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the PORT-A-CATH® POWER P.A.C. Implantable Venous Access Systems.

Statement of Equivalence

The PORT-A-CATH® POWER P.A.C. Implantable Venous Access System is substantially equivalent to the currently marketed Power PAC Implantable Venous Access System based on a comparison of the indications for use and the technological characteristics of the device.

Conclusion

The PORT-A-CATH® POWER P.A.C. Implantable Venous Access System is substantially equivalent to the currently marketed Power PAC Implantable Venous Access System based on the technological characteristics of the device. Bench tests confirmed the suitability of the device for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

Ms. Rachelle Parsons Senior, Regulatory Affairs Specialist Smiths Medical ASD, Incorporated 1265 Grev Fox Road Saint Paul, Minnesota 55112

MAR - 1 2010

Re: K093414

Trade/Device Name: PORT-A-CACH® II POWER P.A.C. Implantable Venous Access Systems, PORT-A-CATH® POWER P.A.C. Implantable Venous Access Systems, P.A.S. Port® T2 POWDER PAC Implantable Venous Access Systems Regulation Number: 21CFR 880.5965

Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT

Dated: February 17, 2010 Received: February 18, 2010

Dear Ms. Parsons:

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 practive, 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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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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

h for

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:

Device Name: PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems

Indications for Use:

"The PORT-A-CATH" II POWER P.A.C. Implantable Venous Access Systems are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.

When used with a GRIPPER PLUS® POWER P.A.C. Safety Huber Needle or other power injectable Huber needle, the PORT-A-CATH® II POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media. For power injections of contrast media, the maximum recommended infusion rate is 5 ml/sec."

Prescription Use X (Per 21 CFR 801.109)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: K093414

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Indications for Use

510(k) Number:

Device Name: PORT-A-CATH® POWER P.A.C. Implantable Venous Access Systems

Indications for Use:

"The PORT-A-CATH" POWER P.A.C. Implantable Venous Access Systems are indicated when patient therapy requires repeated vascular access for infusion therapy and/or venous blood sampling.

Prescription Use X (Per 21 CFR 801.109)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: K093414

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Indications for Use

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: P.A.S. Port® T2 POWER.P.A.C. Implantable Venous Access Systems

Indications for Use:

"The P.A.S Port® T2 POWER P.A.C. Implantable Venous Access Systems are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.

Prescription Use >< (Per 21 CFR 801.109)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clas

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

510(k) Number: K093414

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.