The Triple Lumen PFM PICC (CT Rated and Non-Rated) is indicated for short or long term peripheral access to the central venous system for infusion, intravenous therapy, blood sampling and power injection of contrast media. The Triple Lumen PFM PICC has a maximum recommended infusion rating of 5 ml/sec. The primary line of the Triple Lumen PFM PICC is also indicated for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter of lumen of 20 gauge or larger be used.

Device Description

The Triple Lumen PFM PICC is a 6F triple lumen peripherally inserted central venous catheter designed to perform infusion, intravenous therapy, blood sampling and also power injection of contrast media studies. The catheter is made of radiopaque polyurethane tubing are inserted peripherally. Each Triple Lumen PFM PICC has a kink resistant, reverse tapered catheter design. The Triple Lumen PFM PICC kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations. The Triple Lumen PFM PICC is indicated for dwell times shorter or greater than 30 days. The Triple Lumen PFM PICC can be used for venous pressure monitoring. The Triple Lumen PFM PICC catheter assembly has been tested to withstand power injection of worst-case viscosity injection media at 5 ml/sec with a maximum power injector pressure of 300 psi. The fully assembled Triple Lumen PFM PICC consists of an extruded triple lumen polyurethane catheter insert molded into an injection molded polyurethane hub (having integral suture tabs) that has extension leg tubing bonded to ISO standard Luer lock fittings for access attachment. The primary lumen is power injectable. The purple extension leg tubing from the hub has the words 'Power Injectable' and the gauge size printed on the tubing. The clamp ID ring on this extension states "5m/sec max' and 'Check Blood Return and Flush'. The two non-power injectable lumens are equivalent in size, but smaller than the power injectable lumen. The extension tubing legs are clear. The clamp ID ring on these extensions state "DO NOT POWER INJECT" on one side and the gauge size printed on the other. The catheter has depth indicating markings to assist in depth of insertion into the peripherally accessed vein. The device has no components made of natural rubber latex.

AI/ML Overview

The provided text is a 510(k) Summary Statement for a medical device called the "Triple Lumen PFM PICC." It details the device's description, intended use, technical characteristics, and safety and performance tests. However, it does not contain the specific information required to complete all sections of your request.

Here's an breakdown of what can and cannot be extracted from the document:

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

The document states: "The Triple Lumen PFM PICC met all established acceptance criteria. Verification and Validation testing conducted on the Triple Lumen PFM PICC yielded acceptable results."

However, it does not explicitly list the specific acceptance criteria or the reported performance metrics for each. It only lists the standards against which the device was tested.

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

This information is not provided in the document.

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 information is not provided as the type of study described does not involve expert image interpretation.

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

This information is not applicable as the described tests are technical performance tests, not studies requiring adjudication of results from experts.

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 information is not provided and is not applicable to this type of device (a physical catheter) or the tests described.

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

This is not applicable as the device is a physical medical catheter, not an algorithm. The tests conducted were on the physical properties and performance of the catheter itself.

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

For the performance tests mentioned, the "ground truth" would be established by the specified international standards and internal verification/validation protocols for medical device performance (e.g., measuring pressure, flow rates, material strength, biocompatibility, etc.). The document lists standards like ISO 10555-1, ISO 10993-1, etc., which define the methods and criteria for these types of "ground truth" measurements.

8. The sample size for the training set

This is not applicable as the device is a physical catheter, not an AI/ML algorithm. There is no "training set."

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

This is not applicable for the same reason as above.

Summary of available information:

Criteria / Information Request	Information from Document
1. Acceptance Criteria & Reported Performance	The document states: "The Triple Lumen PFM PICC met all established acceptance criteria. Verification and Validation testing conducted on the Triple Lumen PFM PICC yielded acceptable results." It also notes: "The Triple Lumen PFM PICC catheter assembly has been tested to withstand power injection of worst-case viscosity injection media at 5 ml/sec with a maximum power injector pressure of 300 psi." However, a comprehensive table of all acceptance criteria and their corresponding reported performance values is not provided.
2. Sample Size & Data Provenance	Not provided.
3. Number & Qualifications of Experts (Ground Truth)	Not applicable to this type of device/study.
4. Adjudication Method	Not applicable.
5. MRMC Comparative Effectiveness Study	Not applicable.
6. Standalone Algorithm Study	Not applicable.
7. Type of Ground Truth Used	For the performance tests, ground truth was established by adherence to and measurement against specified international standards for medical devices, particularly intravascular catheters (e.g., ISO 10555-1/-3, ISO 10993 for biocompatibility, ISO 14971 for risk management). These standards define test methods and acceptable limits for physical, chemical, and biological properties.
8. Training Set Sample Size	Not applicable.
9. Ground Truth for Training Set	Not applicable.

The document primarily focuses on establishing "substantial equivalence" of the Triple Lumen PFM PICC to predicate devices (K083873 and K071875) by demonstrating comparable technical characteristics and meeting established medical device safety and performance standards. The "study" referenced is a series of "Safety and Performance Tests" conducted in accordance with various international standards, rather than a clinical trial or an AI/ML validation study.

Summary

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K110914: Request for Additional Information Triple Lumen PFM PICC

ATTACHMENT G: 510K SUMMARY STATEMENT

SEP 2 1 2011

510(k) Summary of Safety and Effectiveness

The following section is included as required by the Safe Medical Device Act (SMDA) of 1990.

Date Prepared:	June 3, 2011
Name:	PFM Medical, Inc
Address:	1815 Aston AveSuite 106Carlsbad, CA 92008
CONTACT PERSON:	SALVADORE F. PALOMARES, RAC
PHONE No:	760.758.8749

510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:
Trade Name:	Triple Lumen PFM PICC
Common Name:	Catheter, Intravascular, Therapeutic, Long Term
Classification:	LJS

PFM Medical PFM PICC

Equivalent Devices: Manufacturer. Name: 510(k) #:

Manufacturer: Name:

510(k) #:

K083873 CR Bard POWERPICC, POLY PER-Q-CATH, 6FR TL POLY PER-Q-CATH, POWER HOHN, AND POWER LINE K071875

Device Description:

The catheter is made of radiopaque polyurethane tubing are inserted peripherally. Each Triple Lumen PFM PICC has a kink resistant, reverse tapered catheter design. The Triple Lumen PFM PICC kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations.

The Triple Lumen PFM PICC is indicated for dwell times shorter or greater than 30 days. The Triple Lumen PFM PICC can be used for venous pressure monitoring. The Triple Lumen PFM PICC catheter assembly has been tested to withstand power injection of worst-case viscosity injection media at 5 ml/sec with a maximum power injector pressure of 300 psi.

The fully assembled Triple Lumen PFM PICC consists of an extruded triple lumen polyurethane catheter insert molded into an injection molded polyurethane hub (having integral suture tabs) that has extension leg tubing bonded to ISO standard Luer lock fittings for access attachment.

The primary lumen is power injectable. The purple extension leg tubing from the hub has the words 'Power Injectable' and the gauge size printed on the tubing. The clamp ID ring on this extension states "5m/sec max' and 'Check Blood Return and Flush'. The two non-power injectable lumens are equivalent in size, but smaller than the power injectable lumen. The extension tubing legs are clear. The clamp ID ring on these extensions state "DO NOT POWER INJECT" on one side and the gauge size printed on the other.

COMPANY CONFIDENTIAL

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The catheter has depth indicating markings to assist in depth of insertion into the peripherally accessed vein. The device has no components made of natural rubber latex.

Intended Use;

The Triple Lumen PFM PICC has a maximum recommended infusion rating of 5 ml/sec.

The primary line of the Triple Lumen PFM PICC is also indicated for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter of lumen of 20 gauge or larger be used.

Technical Characteristics

The Triple Lumen PFM PICC has equivalent technological characteristics with respect to the basic catheter design and function of the predicate PFM PICC (SE-K083873) and the CR Bard PowerPICC (SE-K071875) catheters. The Triple Lumen PFM PICC's power injection capabilities are comparable to the predicate PFM PICC and the CR Bard PowerPICC catheters. Differences do not raise any new questions regarding safety and effectiveness.

Safety and Performance Tests

Performance testing of the Triple Lumen PFM PICC was conducted in accordance with the following international standards:

Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995
ISO 10555-1:2009, Sterile, single-use intravascular catheters, Part 1. General requirements
BS/EN/ISO 10555-3 -1996/Cor 1:2002, Sterile, single-use intravascular catheters, Part 3. Central venous catheters
AAMI/ANSI/ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and the FDA Modified Safety & ISO 10993 Test Profile
AAMI/ANSI/1SO 1 0993-7 2008, Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Results
AAMI/ANSI/ISO 11135:2007, Sterilization of Healthcare Products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 14971:2007, Medical Devices Risk Management for Medical Devices

The Triple Lumen PFM PICC met all established acceptance criteria. Verification and Validation testing conducted on the Triple Lumen PFM PICC yielded acceptable results. Risk Management analysis did not identify any new types of safety or efficacy questions for the Triple Lumen PFM PICC

The results of these tests, in conjunction with the substantial equivalence claims effectively demonstrate that the Triple Lumen PFM PICC is substantially equivalent to the cited predicate devices.

Summary of Substantial Equivalence

Based on the indications for use and safety and performance testing, the Triple Lumen PFM PICC meets the requirements that are considered for its intended use and is substantially equivalent in design materials, sterilization, and indications for use to the predicate devices

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Image /page/2/Picture/1 description: The image shows a logo with a stylized bird-like figure composed of three curved lines, suggesting movement or flight. The logo is encircled by text, which appears to be part of the organization's name or a related phrase. The text is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO65-G609 Silver Spring, MD 20993-0002

Mr. Salvadore F. Palomares Director of Regulatory Affairs PFM Medical, Incorporated 1815 Aston Avenue, Suite 106 Carlsbad. California 92008

SEP 2 1 201

Re: K110914

Trade/Device Name: Triple Lumen PFM PICC Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: July 26. 2011 Received: July 27, 2011

Dear Mr. Palomares:

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- Mr. Palomares

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/AboutlFDA/CentersOffices/CDRH/CDRHOffices/ uem115809.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 reparting 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/Industrv/default.htm.

Sincerely yours.

Charling ha

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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510(k):	K110914
Device Name:	Triple Lumen PFM PICC
Indications for Use:	The Triple Lumen PFM PICC (CT Rated and Non-Rated) is indicated for short or long term peripheral access to the central venous system for infusion, intravenous therapy, blood sampling and power injection of contrast media. The Triple Lumen PFM PICC has a maximum recommended infusion rating of 5 ml/sec. The primary line of the Triple Lumen PFM PICC is also indicated for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter of lumen of 20 gauge or larger be used.

510(k):

K110914

Device Name:

Triple Lumen PFM PICC

Indications for Use:

Prescription Use × (Per 21 CFR 801 Subpart D)

AND/OR

Over the Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rih C. Chyp

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

510(k) Number: K110914

COMPANY CONFIDENTIAL

سمبر آگر

Regulation Number and Section

§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.

(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”