FlowGuide (FG60F); GuidionShort (GS60F)

K242337 · Imds Operations B.V. · DQY · Apr 17, 2025 · Cardiovascular

Device Facts

• Record ID: K242337
• Device Name: FlowGuide (FG60F); GuidionShort (GS60F)
• Applicant: Imds Operations B.V.
• Product Code: DQY · Cardiovascular
• Decision Date: Apr 17, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Guide extension family catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guide wires and other interventional devices. The Guide extension family catheters are contraindicated in vessels less than 2.5mm in diameter, vessels in the neurovasculature, and the venous system.

Device Story

Single lumen rapid exchange guide extension catheters; used in conjunction with 6F or larger guide catheters; facilitates guide wire/interventional device placement in coronary/peripheral vasculature. Device features stainless-steel shaft; 15cm distal lumen section; radiopaque distal end for fluoroscopic visualization; positioning marks at 95cm and 105cm. FlowGuide model includes 9 perfusion holes in distal shaft to reduce pressure dampening. Operated by physicians in clinical/interventional settings. Output is visual confirmation via fluoroscopy; assists in navigating complex vascular anatomy; benefits patient by enabling access to discrete vascular regions.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including visual inspection, kink resistance, bond strength, crossing profile, deployment/retraction, end stop strength, tip length, coating lubricity/integrity/particulates, perfusion flow, corrosion resistance, torque strength, and packaging integrity. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility).

Technological Characteristics

Single lumen rapid exchange catheter; stainless steel proximal shaft; distal shaft features stainless steel coiling embedded in polymer; radiopaque markers (TPE/Tungsten); hydrophilic coating. FlowGuide includes 9 distal perfusion holes. Compatible with 6F guide catheters (1.78mm ID). Sterilization method not specified.

Indications for Use

Indicated for patients requiring coronary or peripheral vascular access via guide catheter to facilitate guide wire or interventional device placement. Contraindicated for vessels <2.5mm diameter, neurovasculature, and venous system.

Regulatory Classification

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.

Predicate Devices

• Guidion Rapid Exchange Guide Extension Catheter (K210110)

Reference Devices

• TrapLiner (K212211)

Submission Summary (Full Text)

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FDA U.S. FOOD &amp; DRUG ADMINISTRATION

April 17, 2025

IMDS Operations B.V.
Edwin Schulting
CEO
Ceintuurbaan Noord 150
Roden, NL9301NZ
Netherlands

Re: K242337
Trade/Device Name: FlowGuide (FG60F); GuidionShort (GS60F)
Regulation Number: 21 CFR 870.1250
Regulation Name: Percutaneous Catheter
Regulatory Class: Class II
Product Code: DQY
Dated: March 17, 2025
Received: March 17, 2025

Dear Edwin Schulting:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

U.S. Food &amp; Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K242337 - Edwin Schulting
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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K242337 - Edwin Schulting
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Sincerely,

Brian D. Pullin -S

for Lydia Glaw
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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K242337 | |
| Device Name FlowGuide (FG60F), GuidionShort (GS60F) | |
| Indications for Use (Describe) The Guide extension family catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guide wires and other interventional devices. The Guide extension family catheters are contraindicated in vessels less than 2.5mm in diameter, vessels in the neurovasculature, and the venous system. | |
| 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 [e-mail] | |
| "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." | |

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005 510(k) Summary Guidion 510(k) Submission

IMDS

# 510(k) Summary

[As required by 21 CFR 807.92]

Date Prepared: August 5th, 2024

## Submitter's Name / Contact Person

**Manufacturer**

IMDS Operations BV

Ceintuurbaan Noord 150

9301 NZ Roden, The Netherlands

Establishment Registration #3007740583

**Contact Person**

Aljosja Kot

Director of Quality and Regulatory

Tel: [phone]

Fax: [phone]

## General Information

**Trade Name**

FlowGuide and GuidionShort

**Common/Usual Name**

Rapid Exchange Guide Extension Catheter

**Classification Name**

Catheter, percutaneous

**Product Code**

DQY

**Predicate Device**

K210110, Guidion Rapid Exchange Guide Extension Catheter, IMDS Operations B.V.

**Reference Device**

K212211, TrapLiner, Vascular Solutions, LLC

## Device Description

The FlowGuide and GuidionShort are single lumen rapid exchange catheters being compatible with 6F and larger guide catheters and may be placed over either an exchange length or 180cm guide wire. The 150cm long device has a stainless-steel shaft section. The stainless-steel shaft is followed distally by a 15 cm lumen section.

The catheters have a radiopaque distal end which enables visibility while using standard fluoroscopic methods. The device has two positioning marks located at 95cm and 105cm from the distal tip, respectively.

The catheters are delivered through a guiding catheter resulting in an inner diameter that is approximately 1 French smaller than the guide catheter. The catheters have a proximal hub which indicates guide catheter compatibility.

The FlowGuide has 9 perfusion holes in the distal shaft intended to reduce pressure dampening.

## Intended Use

FlowGuide and GuidionShort catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guide wires and other interventional devices. The Guide extension family catheters are contraindicated in vessels less than 2.5mm in diameter, vessels in the neurovasculature, and the venous system.

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005 510(k) Summary Guidion 510(k) Submission

IMDS

# Technological Characteristics Comparison

The FlowGuide and GuidionShort are similar in design to the predicate device and both are Rapid Exchange Guide Extension Catheters intended to be used to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guide wires and other interventional devices.

| # | Item | FlowGuide and GuidionShort catheter | Guidion Catheter |
| --- | --- | --- | --- |
| | Model number (s) | FG60F, GS60F | G60F25150 |
| 1 | Type clinically based | Guide Extension catheter | Guide Extension catheter |
| 2 | Design construction | Rx, single lumen | Rx, single lumen |
| 3 | Distal shaft material | Stainless steel coiling embedded in a polymer shaft | Stainless steel coiling embedded in a polymer shaft |
| 4 | Proximal shaft | Stainless steel | Stainless steel |
| 5 | Distal radiopaque markers | 1 | 1 |
| 6 | Proximal radiopaque marker distal shaft | 1 | 0 |
| 7 | Radiopaque marker material | TPE/ Tungsten | TPE/ Tungsten |
| 8 | Effective length | 150 (cm) | 150 (cm) |
| 9 | Length distal shaft | 15 (cm) | 25 (cm) |
| 10 | Required guide catheter ID | 6F 1.78 (mm) | 6F 1.78 (mm) |
| 11 | Tip design shape | Straight | Straight |
| 12 | Inner diameter distal shaft | 6F 1.42 (mm) | 6F 1.42 (mm) |
| 13 | Distal shaft perfusion holes | Yes, FG60F only | No |
| 14 | Product coating | Hydrophilic | Hydrophilic |

With the exception of a shorter distal shaft length and perfusion holes for the FlowGuide the products are similar in design and technological characteristics to the predicate device. The shorter distal shaft length and perfusion holes are known features as evaluated from the reference device and were successfully evaluated in performance tests.

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005 510(k) Summary Guidion 510(k) Submission

IMDS

# Substantial Equivalence and Summary of Studies

The technological differences between the subject and predicate devices have been evaluated through performance and biocompatibility tests and results did not raise new questions of safety or effectiveness. The FlowGuide and GuidionShort Guide Extension catheters are substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use.

The device design has been verified through the following tests:

1) Visual inspection
2) Kink resistance/ flexibility
3) Radiopacity
4) Catheter bond strength
5) Crossing profile
6) Catheter preparation, deployment &amp; retraction
7) End stop strength
8) Tip length
9) Coating lubricity
10) Perfusion flow
11) Corrosion resistance
12) Torque strength
13) Effective length
14) Length distal shaft
15) Inner diameter
16) Coating Particulate Evaluation
17) Coating integrity
18) Packaging integrity

FlowGuide and GuidionShort are meeting the requirements for biocompatibility in accordance with ISO 10993-1:

- Cytotoxicity
- Sensitization
- Irritation
- Systemic toxicity
- Pyrogenicity
- Hemocompatibility

The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the FlowGuide and GuidionShort Rapid Exchange Guide Extension catheters are substantially equivalent to the predicate device.

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