K Number

Device Name

PG Pro Microcatheter

Manufacturer

MicroVention, Inc., A Terumo Group Company

Date Cleared

2019-11-21

(59 days)

Product Code

DQY KRA

Regulation Number

870.1250

Intended Use

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

Device Description

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K142449

Reference Devices

K101542

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical microcatheter and does not mention any AI or ML components or functions.

Therapeutic

Yes
The device is intended for the infusion of "therapeutic agents", indicating its use in delivering therapies.

Diagnostic

Yes

The device is intended for the "infusion of diagnostic and therapeutic agents," indicating its use in diagnostic procedures.

SaMD (Software as a Medical Device)

The device description clearly describes a physical catheter with a lumen, guidewire compatibility, radiopaque markers, hydrophilic coating, and a luer fitting. The performance studies also focus on physical and material properties of the catheter.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the "infusion of diagnostic and therapeutic agents" within the peripheral vasculature. This describes a device used in vivo (within the living body) for delivering substances, not for testing samples in vitro (outside the living body).
Device Description: The description details a catheter designed for accessing and navigating blood vessels, which is an in vivo application.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This microcatheter's function is to deliver substances into the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

DQY, KRA

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral vasculature

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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 (

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).

Summary

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

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

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.

TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE

Table 1: Headway Microcatheters and PG Pro Comparison table
Property	Headway 17
Microcatheter
Reference Device	Headway 27
Microcatheter
Predicate Device	PG Pro Microcatheter
Subject Device	Differences
	(K101542)	(K142449)
Indication For
Use	The Headway 17
Microcatheter is
intended for general
intravascular use,
including the peripheral,
coronary and
neurovasculature for the
infusion of diagnostic
agents, such as contrast
media, and therapeutic
agents, such as occlusion
coils.	The Headway 27
Microcatheter is intended
for general intravascular
use, including the
peripheral, coronary and
neurovasculature for the
infusion of diagnostic
agents, such as contrast
media, and therapeutic
agents, such as occlusion
coils.	The PG Pro
microcatheter is
intended for the
peripheral vasculature
for the infusion of
diagnostic and
therapeutic agents.	The PG Pro
Microcatheter is
intended only
for the
peripheral
vasculature.
Principle of
Operation	The principle of
operation incorporates
various design features
that allow it to achieve
its intended use. A semi-
rigid proximal section
allows for steerability.
Progressively softer
durometer distal
segments and flexible tip
allow for atraumatic
navigation through the
vasculature. Radiopaque
markers allow for
fluoroscopic
visualization.
Hydrophilic polymer
coating reduces friction	The principle of operation
incorporates various
design features that allow
it to achieve its intended
use. A semi-rigid
proximal section allows
for steerability.
Progressively softer
durometer distal segments
and flexible tip allow for
atraumatic navigation
through the vasculature.
Radiopaque markers
allow for fluoroscopic
visualization.
Hydrophilic polymer
coating reduces friction
during navigation through
the vasculature.	The principle of
operation incorporates
various design features
that allow it to achieve
its intended use. A semi-
rigid proximal section
allows for steerability.
Progressively softer
durometer distal
segments and flexible
tip allow for atraumatic
navigation through the
vasculature. Radiopaque
markers allow for
fluoroscopic
visualization.
Hydrophilic polymer
coating reduces friction	Identical
Table 1: Headway Microcatheters and PG Pro Comparison table
Property	Headway 17
Microcatheter
Reference Device
(K101542)	Headway 27
Microcatheter
Predicate Device
(K142449)	PG Pro Microcatheter
Subject Device	Differences
	during navigation
through the vasculature.		during navigation
through the vasculature.
Material(s)	Catheter body: Pebax,
stainless steel, Grilamid,
inner liner of PTFE and
barium sulfate
incorporated in distal
Pebax segment.	Catheter body: Pebax,
stainless steel, Grilamid,
inner liner of PTFE	Catheter body: Pebax,
Tungsten, Grilamid,
inner liner of PTFE	PG Pro has a
Tungsten coil
versus a
Stainless-steel
coil for the
Headway 27 and
Headway 17
Microcatheters.
	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 not
come with a
Shaping
mandrel.
Proximal
ID/OD	ID = .0170" min
OD = .031"	ID = .027" min
OD = .040"	ID = .027" min
OD = .038"MAX	PG Pro has a
Max Proximal
O.D of .038"
which is in-
between
Headway 17 and
Table 1: Headway Microcatheters and PG Pro Comparison table
Property	Headway 17
Microcatheter
Reference Device
(K101542)	Headway 27
Microcatheter
Predicate Device
(K142449)	PG Pro Microcatheter
Subject Device	Differences
Distal ID/OD	ID = .0170" min
OD = .022"	ID = .027" min
OD = .034"	ID = .027" min
OD = .038" MAX	27
Microcatheter
proximal OD.
PG Pro has a
Max Distal O.D
of .038"
No. of Marker
bands	2	2	2	Identical
Coating	Hydrophilic Coating	Hydrophilic Coating	Hydrophilic Coating	Identical
Effective
Length	150 cm	150 cm and 156 cm	140 cm and 165 cm	PG Pro comes in
two lengths –
140 and 165 cm.
Tip
Configuration	Preshaped tips – with the
option of secondary
shaping for proper
adjustment to the
anatomy prior to use.	Straight - Steam
Shapeable by physician
prior to use	Straight configuration	PG Pro is
available only in
the straight
configuration.
Guidewire
Compatibility	0.014 "wires or smaller	0.014 "wires or smaller	0.021 "wires or smaller	PG Pro is
compatible with
0.021" wires or
smaller
Method of
supply	Sterile and single use	Sterile and single use	Sterile and single use	Identical
Accessories	Shaping mandrel and
Introducer sheath	Shaping mandrel and
Introducer sheath	Introducer sheath	PG Pro does not
include shaping
mandrel

K192625
Page 3 of 6

K192625
Page 4 of 6

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 (