The PG Pro Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the catheter hub is used for the attachment of accessories.

AI/ML Overview

The provided text is for a 510(k) premarket notification for the "PG Pro Microcatheter". This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance acceptance criteria for an AI/ML type of medical device through a clinical study.

Therefore, the text does not contain the information requested regarding:

A table of acceptance criteria and reported device performance for an AI/ML device.
Sample size and data provenance for a test set.
Number of experts and their qualifications for ground truth establishment.
Adjudication method for a test set.
MRMC comparative effectiveness study results.
Standalone performance of an algorithm.
Type of ground truth used (expert consensus, pathology, outcomes data).
Sample size for a training set.
How ground truth for the training set was established.

Instead, the document describes:

Device Description: The PG Pro Microcatheter is a single lumen catheter designed for introducing over a guidewire to access small, tortuous vasculature for infusing diagnostic and therapeutic agents in the peripheral vasculature.
Predicate Device: Headway 27 Microcatheter (K142449). A reference device (Headway 17 Microcatheter, K101542) is also listed.
Comparisons: The document includes a detailed "TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE" (Table 1) comparing the PG Pro Microcatheter to its predicate and reference devices across properties like Indications For Use, Principle of Operation, Material(s), Proximal ID/OD, Distal ID/OD, Number of Marker bands, Coating, Effective Length, Tip Configuration, Guidewire Compatibility, Method of Supply, and Accessories. The table highlights differences such as the PG Pro being intended only for peripheral vasculature, using a Tungsten coil vs. stainless steel, having a different range of effective lengths, being straight configuration only, being compatible with larger guidewires, and not including a shaping mandrel.
Performance Data (Non-Clinical):
- Biocompatibility testing: Conducted according to ISO10993-1, including cytotoxicity, sensitization, irritation, acute systemic toxicity, and hemocompatibility, as it is considered a limited (<24 hour) circulating blood contacting device.
- Bench testing: A comprehensive list of tests was performed, including surface contamination, physical attributes, force at break, leakage (liquid, air), static and dynamic burst, durability and lubricity of hydrophilic coating, simulated use in flow model, catheter flow rate, kink resistance, stiffness, flexural fatigue, particulate testing, catheter dead space, torque strength, hub testing, corrosion testing, and radio detectability.
- Animal Study: An acute large animal study was conducted with n=3 animals. The study assessed the device's safety profile, compatibility with therapeutic agents, and tissue response, concluding that the PG Pro Microcatheter performed similarly to the predicate device (Headway 27 Microcatheter).
Conclusion: The PG Pro Microcatheter is considered substantially equivalent to the identified predicate based on performance, intended use, design, materials, principle of operation, and overall technological characteristics. The nonclinical data, verification, and validation testing support this conclusion and demonstrate the device should perform as intended.

In summary, this document is a 510(k) submission for a physical medical device (microcatheter) and relies on benchmarking against a predicate device, along with non-clinical (bench and animal) testing to demonstrate substantial equivalence, not the evaluation of an AI algorithm against specific performance criteria.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 21, 2019

MicroVention, Inc., Mr. Ganesh Balachandar Regulatory Affairs Specialist 35 Enterprise Aliso Viejo, California 92656

Re: K192625

Trade/Device Name: PG Pro Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, KRA Dated: September 20, 2019 Received: September 23, 2019

Dear Mr. Balachandar:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192625

Device Name PG Pro Microcatheter

Indications for Use (Describe)

The PG Pro microcatheter is intended for the peripheral vasculature for the infusion of diagnostic and therapentic agents.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) SUMMARY

SUBMITTER

MicroVention Inc. 35 Enterprise, Aliso Viejo, CA 92656 Phone: 714-247-8000 Contact Person: Ganesh Balachandar Date Prepared: 20th, September 2019

DEVICE

Name of the Device: PG Pro Microcatheter Common Name: Percutaneous Catheter Classification Name: Device, Percutaneous Catheter Regulatory Class: Class II, 21 CFR 870.1250 Product Code: DQY Additional Product Code: KRA

PREDICATE DEVICE

Headway 27 Microcatheter (K142449)

REFERENCE DEVICE

Headway 17 Microcatheter (K101542)

DEVICE DESCRIPTON

INDICATION FOR USE

The PG Pro Microcatheter is intended for the peripheral vasculature for the infusion of diagnostic and therapeutic agents.

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TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE

Table 1: Headway Microcatheters and PG Pro Comparison table
Property	Headway 17MicrocatheterReference Device	Headway 27MicrocatheterPredicate Device	PG Pro MicrocatheterSubject Device	Differences
	(K101542)	(K142449)
Indication ForUse	The Headway 17Microcatheter isintended for generalintravascular use,including the peripheral,coronary andneurovasculature for theinfusion of diagnosticagents, such as contrastmedia, and therapeuticagents, such as occlusioncoils.	The Headway 27Microcatheter is intendedfor general intravascularuse, including theperipheral, coronary andneurovasculature for theinfusion of diagnosticagents, such as contrastmedia, and therapeuticagents, such as occlusioncoils.	The PG Promicrocatheter isintended for theperipheral vasculaturefor the infusion ofdiagnostic andtherapeutic agents.	The PG ProMicrocatheter isintended onlyfor theperipheralvasculature.
Principle ofOperation	The principle ofoperation incorporatesvarious design featuresthat allow it to achieveits intended use. A semi-rigid proximal sectionallows for steerability.Progressively softerdurometer distalsegments and flexible tipallow for atraumaticnavigation through thevasculature. Radiopaquemarkers allow forfluoroscopicvisualization.Hydrophilic polymercoating reduces friction	The principle of operationincorporates variousdesign features that allowit to achieve its intendeduse. A semi-rigidproximal section allowsfor steerability.Progressively softerdurometer distal segmentsand flexible tip allow foratraumatic navigationthrough the vasculature.Radiopaque markersallow for fluoroscopicvisualization.Hydrophilic polymercoating reduces frictionduring navigation throughthe vasculature.	The principle ofoperation incorporatesvarious design featuresthat allow it to achieveits intended use. A semi-rigid proximal sectionallows for steerability.Progressively softerdurometer distalsegments and flexibletip allow for atraumaticnavigation through thevasculature. Radiopaquemarkers allow forfluoroscopicvisualization.Hydrophilic polymercoating reduces friction	Identical
Table 1: Headway Microcatheters and PG Pro Comparison table
Property	Headway 17MicrocatheterReference Device(K101542)	Headway 27MicrocatheterPredicate Device(K142449)	PG Pro MicrocatheterSubject Device	Differences
	during navigationthrough the vasculature.		during navigationthrough the vasculature.
Material(s)	Catheter body: Pebax,stainless steel, Grilamid,inner liner of PTFE andbarium sulfateincorporated in distalPebax segment.	Catheter body: Pebax,stainless steel, Grilamid,inner liner of PTFE	Catheter body: Pebax,Tungsten, Grilamid,inner liner of PTFE	PG Pro has aTungsten coilversus aStainless-steelcoil for theHeadway 27 andHeadway 17Microcatheters.
	Marker band: Pt/Ir	Marker band: Pt/Ir	Marker band: Pt/Ir	Identical
	Hub: Nylon	Hub: Nylon	Hub: Nylon	Identical
	Strain relief: Pebax	Strain relief: Pebax	Strain relief: Pebax	Identical
	Introducer: Pebax	Introducer: Pebax	Introducer: Pebax	Identical
	Shaping mandrel:Stainless steel	Shaping mandrel:Stainless steel	Shaping mandrel: N/A	PG Pro does notcome with aShapingmandrel.
ProximalID/OD	ID = .0170" minOD = .031"	ID = .027" minOD = .040"	ID = .027" minOD = .038"MAX	PG Pro has aMax ProximalO.D of .038"which is in-betweenHeadway 17 and
Table 1: Headway Microcatheters and PG Pro Comparison table
Property	Headway 17MicrocatheterReference Device(K101542)	Headway 27MicrocatheterPredicate Device(K142449)	PG Pro MicrocatheterSubject Device	Differences
Distal ID/OD	ID = .0170" minOD = .022"	ID = .027" minOD = .034"	ID = .027" minOD = .038" MAX	27Microcatheterproximal OD.PG Pro has aMax Distal O.Dof .038"
No. of Markerbands	2	2	2	Identical
Coating	Hydrophilic Coating	Hydrophilic Coating	Hydrophilic Coating	Identical
EffectiveLength	150 cm	150 cm and 156 cm	140 cm and 165 cm	PG Pro comes intwo lengths –140 and 165 cm.
TipConfiguration	Preshaped tips – with theoption of secondaryshaping for properadjustment to theanatomy prior to use.	Straight - SteamShapeable by physicianprior to use	Straight configuration	PG Pro isavailable only inthe straightconfiguration.
GuidewireCompatibility	0.014 "wires or smaller	0.014 "wires or smaller	0.021 "wires or smaller	PG Pro iscompatible with0.021" wires orsmaller
Method ofsupply	Sterile and single use	Sterile and single use	Sterile and single use	Identical
Accessories	Shaping mandrel andIntroducer sheath	Shaping mandrel andIntroducer sheath	Introducer sheath	PG Pro does notinclude shapingmandrel

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K192625
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PERFORMANCE DATA

Biocompatibility testing

Biocompatibility evaluation for the PG Pro Microcatheter was conducted in accordance with ISO10993-1 Biological Evaluation of Medical Devices-Part 1: Guidance on Selection of Tests. The microcatheter is considered a limited (<24hour) circulating blood contacting device.

The battery of testing for the device included the following tests:

Cytotoxicity ●
Sensitization
Irritation or Intracutaneous Reactivity ●
Acute Systemic Toxicity
Hemocompatibility

Bench testing

Bench testing conducted for the PG Pro Microcatheter included the following:

Surface Contamination ●
Physical Attributes ●
Force at break (Hub and distal portion of the catheter) ●
Liquid leakage
Air leakage
Static burst
Durability and lubricity of hydrophilic coating
Simulated use in flow model ●
Dynamic burst
Catheter flow rate
Kink resistance
Stiffness testing
Catheter flexural fatigue
Particulate testing
Catheter dead space ●
Torque strength
Hub testing
Corrosion testing ●
Radio detectability ●

Animal Study

The PG Pro Microcatheter was evaluated in an acute large animal study (n=3) The safety profile as assessed through device safety, compatibility with therapeutic agents and tissue response showed that the PG Pro Microcatheter performed similar to the predicate device. Headway 27 Microcatheter.

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CONCLUSION

The PG Pro Microcatheter is substantially equivalent to the identified predicate regarding performance, intended use, design, materials, principle of operation and overall technological characteristics. The nonclinical data supports the substantial equivalence of the subject device and the verification and validation testing demonstrate that the subject device should perform as intended when used as instructed in the instructions for use.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).