The primeMIDLINE™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling and power injection of contrast media. These catheters are indicated for patients older than 28 days and that weigh more than 10 kg, with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The primeMIDLINE™ Catheters are suitable for use with power injectors.

Device Description

The 4F DL primeMIDLINE™ Catheter is a peripherally placed midline catheter designed to provide access to the vascular system. The catheter lumen is an open-ended design comprised of radiopaque polyurethane. The 4F DL primeMIDLINE ™ Catheter is packaged sterile in a tray with the accessories necessary to establish short-term (less than 30 days) vascular access. The 4F DL primeMIDLINE Catheter is suitable for use with power injectors.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device (4F Dual Lumen primeMIDLINE™ Catheter) and focuses on demonstrating its substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria based on a study with a test set, expert ground truth, and statistical performance metrics commonly seen in studies for AI/ML-enabled devices.

Therefore, the requested information regarding a table of acceptance criteria and reported device performance, sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and training set ground truth establishment is not present in the provided document.

This document details the regulatory pathway for a conventional medical device, emphasizing its similarity to a previously cleared predicate device through comparisons of intended use, technological characteristics, and performance testing (e.g., tensile strength, flow rate). These tests are typically engineering/bench tests rather than clinical studies with human "ground truth" and reader performance metrics.

Here's a breakdown of what is provided and why it doesn't fit the requested AI/ML study format:

Acceptance Criteria and Reported Device Performance: Instead of performance in terms of diagnostic accuracy or reader improvement, the document lists various non-clinical performance tests conducted on the device (e.g., Visual Inspection, Tensile Strength, Catheter Elongation, Radiopacity, Lifecycle Performance, Static Burst Pressure, Power Injection Flowrate, Biocompatibility tests). The acceptance criteria for these tests are stated as having been "met all predetermined acceptance criteria as defined in the referenced Standards, FDA Guidance Document or PFM Medical, Inc. Internal Standards." Specific numerical results are not provided in this summary but would be in the full submission.
Sample Size for Test Set and Data Provenance: Not applicable in the context of the reported performance testing. These are bench tests on manufactured units, not a dataset of patient cases.
Number of Experts & Qualifications for Ground Truth: Not applicable. Ground truth for these tests would be objective measurements (e.g., a caliper for dimensional characteristics, a flow meter for flow rate).
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is for evaluating changes in human reader performance, typically with AI assistance.
Standalone Performance: Not applicable. This device is a physical catheter, not an algorithm.
Type of Ground Truth Used: For non-clinical tests, "ground truth" refers to the objectively measured values compared against specifications derived from standards or internal requirements.
Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable. This device does not involve machine learning or training a model.

In summary, the provided document describes the regulatory clearance of a physical medical device (a catheter) based on its substantial equivalence to an existing device and a series of engineering and biocompatibility tests. It does not contain information about an AI/ML-based device study with a "test set" in the diagnostic sense, expert ground truth, or human reader performance metrics.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

October 28, 2019

PFM Medical, Inc. Mina Jiang Associate Regulatory Affairs Specialist 1916 Palomar Oaks Way, Suite 150 Carlsbad, California 92008

Re: K192802

Trade/Device Name: primeMidline™ Catheters Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: PND Dated: September 27, 2019 Received: September 30, 2019

Dear Mina Jiang:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Geeta Pamidimukkala Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K192802

Device Name

4F Dual Lumen primeMidline™ Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary As required by section 807.92

General Information
510(k) Owner:	PFM Medical, Inc.
Submitter Address:	1916 Palomar Oaks Way, Suite 150Carlsbad, CA 92008
Contact Person:	Mina Jiang
Telephone Number:	760.758.8749
Fax Number:	760.758.1167
Date of Preparation:	October 25, 2019
Subject Device Information
Trade Name:	4F Dual Lumen primeMIDLINE™ Catheter
Premarket Notification:	K192802
Common Name:	Midline Catheter
Classification Name:	Intravascular Catheter
Product Code:	PND
Regulation Number:	21 CFR §880.5200
Predicate Device Information
Trade Name:	primeMIDLINE™ Catheters
Premarket Notification:	K173114
Classification:	PND, 21 CFR §880.5200
Manufacturer:	PFM Medical, Inc.

{4}------------------------------------------------

Device Description

Indications for Use

Technological Characteristics

The proposed 4F Dual Lumen primeMIDLINE™ Catheter is substantially equivalent to the primeMidline Catheters previously reviewed and cleared under K173114. When compared to the predicate, the proposed 4F Dual Lumen primeMIDLINE™ Catheter has identical intended use, materials, overall design, components, technological characteristics and Indications for Use. The minor differences between the subject 4F DL primeMIDLINE™ catheter and the predicate device do not change the intended use of the device and they do not raise different questions of safety and effectiveness.

	Subject Device: 4F DualLumen primeMIDLINECatheter	Predicate Device:primeMIDLINE Catheters	Comparison Discussion
Manufacturer	PFM Medical, Inc.	PFM Medical, Inc.	This attribute is identicalbetween the subject andpredicate device.
510(k) Number	K192802	K173114	N/A
FDA ProductCode	PND	PND	This attribute is identicalbetween the subject andpredicate device.
Intended Use	The primeMIDLINETMCatheters are intended toaccess the vascular system foradministration of fluidsintravenously, bloodsampling, and power injectionof contrast media.	The primeMIDLINETMCatheters are intended toaccess the vascular system foradministration of fluidsintravenously, bloodsampling, and power injectionof contrast media.	This attribute is identicalbetween the subject andpredicate device.

The following is a summary of the technological characteristics of the 4F Dual Lumen primeMIDLINE™ catheter as compared to the predicate and reference devices:

{5}------------------------------------------------

pfmmedical

Indications forUse	The primeMIDLINE™Catheters are indicated forshort term access to theperipheral venous system forselected intravenoustherapies, blood sampling andpower injection of contrastmedia. These catheters areindicated for patients olderthan 28 days and that weighmore than 10 kg, withconsideration given toadequacy of vascular anatomyand appropriateness of theprocedure. TheprimeMIDLINE™ Catheters aresuitable for use with powerinjectors.	The primeMIDLINE™Catheters are indicated forshort term access to theperipheral venous system forselected intravenoustherapies, blood sampling andpower injection of contrastmedia. These catheters areindicated for patients olderthan 28 days and that weighmore than 10 kg, withconsideration given toadequacy of vascular anatomyand appropriateness of theprocedure. TheprimeMIDLINE™ Catheters aresuitable for use with powerinjectors.	This attribute is identicalbetween the subject andpredicate device.
Duration of Use	Short term (<30 days)	Short term (<30 days)	This attribute is identicalbetween the subject andpredicate device.
Duration of Use	Short term (<30 days)	Short term (<30 days)	This attribute is identicalbetween the subject andpredicate device.
InsertionMethod	Percutaneous, using ModifiedSeldinger Technique andguidewire	Percutaneous, using ModifiedSeldinger Technique andguidewire	This attribute is identicalbetween the subject andpredicate device.
Tip PlacementLocation	Peripheral venous system,with catheter tip terminatingprior to the axilla	Peripheral venous system,with catheter tip terminatingprior to the axilla	This attribute is identicalbetween the subject andpredicate device.
Insertion Site	Peripheral	Peripheral	This attribute is identicalbetween the subject andpredicate device.
	Shaft TubingPolyurethaneCatheter JunctionPolyurethane	Shaft TubingPolyurethaneCatheter JunctionPolyurethane
Catheter BaseMaterials	Extension LegsPolyurethaneLuer HubsPolyurethaneExtension Leg ClampsAcetal Resin	Extension Leg(s)PolyurethaneLuer Hub(s)PolyurethaneExtension Leg Clamp(s)Acetal Resin	This attribute is identicalbetween the subject andpredicate device.
CatheterProximalConfiguration	Luer Connection	Luer Connection	This attribute is identicalbetween the subject andpredicate device.

{6}------------------------------------------------

pfmmedical

Catheter DistalConfiguration	Open Ended	Open Ended	This attribute is identicalbetween the subject andpredicate device.
CatheterDimensions	4F Dual Lumen x 20cm length	3F Single Lumen x 20cmlength4F Single Lumen x 20cmlength5F Single Lumen x 20cmlength5F Dual Lumen x 20cm length	The French size of thecatheter is reduced ascompared to the 5F DLprimeMidline configurationcovered under K173114.The reduction in the Frenchsize does not raise newquestions of safety andeffectiveness. Thefundamental operatingprincipals, materials andoverall design remain thesame between the subjectand predicate devices. The4F DL primeMidline doesnot increase the current riskprofile of or introduce newrisks to the primeMidlinefamily of catheters.
Number, Shapeof Lumens	Dual Lumen = Double D	Single Lumen = RoundDual Lumen = Double D	Identical to 5F Dual Lumenconfiguration.
DepthMarkings	Number every 5 cm and depthmark every cm	Number every 5 cm and depthmark every cm	This attribute is identicalbetween the subject andpredicate device.
StyletConfiguration	Pre-InsertedStiffening Stylet	Pre-InsertedStiffening Stylet	This attribute is identicalbetween the subject andpredicate device.

{7}------------------------------------------------

pfmmedical

Power InjectionMaximum FlowRate	4F DL: 4mL/sec	3F SL: 6mL/sec4F SL: 7mL/sec5F SL: 7mL/sec5F DL: 7mL/sec	The subject device has adifferent flowrate ascompared to the predicatedevices. This differencedoes not raise newquestions of safety andeffectiveness. Clinicians willdetermine which cathetersize, lumen configurationand performancecapabilities are appropriatebased on patient size andneed. The 4F DLprimeMidline catheterrepresents one size andperformance option in thefamily of primeMidlinecatheters. The differencesin flowrate do not increasethe current risk profile of orintroduce new risks to theprimeMidline family ofcatheters.
Sterility	100% Ethylene Oxide, SAL of10-6	100% Ethylene Oxide, SAL of10-6	This attribute is identicalbetween the subject andpredicate device.

{8}------------------------------------------------

Performance Testing

PFM Medical, Inc. conducted a risk analysis per ISO 14971: Medical devices – Application of risk management of medical devices to assess the risk profile of the 4F DL primeMIDLINE™ catheter. Control mechanisms, including design verification testing, were defined to mitigate the identified risks and to demonstrate that the devices perform as intended. Below is a listing of non-clinical testing that was conducted on the subject device:

Visual Inspection	Tensile Strength
Dimensional Characteristics	Catheter Elongation
Radiopacity	Lifecycle Performance
Catheter Collapse	Static Burst Pressure
Leak	Suture Wing Integrity
Priming Volume	Luer Testing
Gravity Flowrate	Power Injection Flowrate

The following standards and FDA guidance documents were utilized in the testing listed above:

ISO 10555-1:2013, Intravascular Catheters - Sterile and Single-Use Catheters
ASTM F640-12 – Standard Test Methods for Determining Radiopacity for Medical Use
ISO 80369-7:2016, Small-bore connectors for liquids and gases in healthcare applications -Part 7: Connectors for intravascular or hypodermic applications
FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters
PFM Medical Internal Standards

Additionally, the primeMIDLINE™ catheters were subjected to applicable biocompatibility testing as required per ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process:

Cytotoxicity	Sensitization
Irritation or IntracutaneousReactivity	Acute Systemic Toxicity
Material Mediated	Subacute/Subchronic Toxicity
Pyrogenicity
Genotoxicity	Carcinogenicity
Chronic Toxicity	Hemocompatibility
Implantation	Particulate
Complement Activation Assay

The subject device met all predetermined acceptance criteria as defined in the referenced Standards, FDA Guidance Document or PFM Medical, Inc. Internal Standards.

Conclusion

Based on detailed comparison of intended use, technological characteristics and performance testing of the subject and predicate device, the 4F DL primeMidline Catheter is substantially equivalent to the predicate primeMidline Catheters. Risk identification and validation activities ensure that the risk acceptability criteria have been met, and the risks have been mitigated.

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).