Steerable Introducer

K191190 · Freudenberg Medical, LLC · DYB · Aug 1, 2019 · Cardiovascular

Device Facts

• Record ID: K191190
• Device Name: Steerable Introducer
• Applicant: Freudenberg Medical, LLC
• Product Code: DYB · Cardiovascular
• Decision Date: Aug 1, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The 8.5F Steerable Introducer is intended to provide a conduit allowing introduction, removal, and exchange of compatible therapeutic and/or diagnostic tools into the cardiovascular system while maintaining hemostasis. The device facilitates access to the left and right sides of the heart, including left atrium and left ventricle access through the interatrial septum. It features a deflectable distal tip that enables guidance of compatible tools.

Device Story

Steerable introducer sheath with handle, hemostasis valve, sideport with 3-way stopcock, and tapered dilator; used in cardiovascular procedures to introduce/exchange diagnostic or therapeutic tools. Physician operates handle-mounted steering control to achieve 180° bi-directional distal tip deflection; radiopaque tip and dilator allow fluoroscopic visualization. Device provides conduit for fluid injection, sampling, infusion, pressure monitoring, flushing, and aspiration. Facilitates access to heart chambers, including transseptal access to left atrium/ventricle. Benefits patient by enabling precise placement of cardiovascular catheters.

Clinical Evidence

Bench testing only. Testing included shaft deflection, simulated use, torsional stiffness, radiopacity, hemostasis, leak testing, guidewire/transseptal needle compatibility, distribution tests, and usability studies. Biocompatibility testing performed per ISO 10993-1 for limited exposure (<24 hours). Shelf life verified via 13-month accelerated aging study.

Technological Characteristics

8.5F steerable sheath with 180° bi-directional deflection; handle-based rotating actuator; radiopaque distal tip and dilator; hemostasis valve; 3-way stopcock. Sterilized via ethylene oxide (SAL 10^-6). Compatible with 0.032in guidewires and standard 98cm transseptal needles. Materials compliant with ISO 10993-1.

Indications for Use

Indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Agilis NxT™ Steerable Introducer Large Curl (K081645)
• Agilis NxT™ Steerable Introducer Small/Medium Curl (K061363)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and 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.

August 1, 2019

Freudenberg Medical LLC Mary Prunty Regulatory Affairs Manager 2301 Centennial Boulevard Jeffersonville, Indiana 47130

Re: K191190

Trade/Device Name: Steerable Introducer 8.5F Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: May 1, 2019 Received: May 3, 2019

Dear Mary Prunty:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Rachel Neubrander Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular 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) K191190

Device Name

Indications for Use (Describe)

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------|----------------------------------------------------------------------|
| <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(K) SUMMARY

#### GENERAL INFORMATION

| Primary Submission Contact | Mary Prunty<br>Regulatory Affairs Manager<br>c/o Freudenberg Medical LLC<br>2301 Centennial Boulevard<br>Jeffersonville, IN 47130<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Secondary Submission Contact | Larry Bender<br>Director of Quality<br>Freudenberg Medical LLC<br>2301 Centennial Boulevard,<br>Jeffersonville, Indiana 47130<br>Tel: [phone]<br>Fax: [phone] |

Date of Summary

01 May 2019

Email: [e-mail]

#### DEVICE INFORMATION

| Device Information | |
|---------------------------|-----------------------------------------------------------------|
| Trade Name | Steerable Introducer |
| Common Name | 8.5F Steerable Introducer S/M/L |
| Classification Name | Catheter Introducer |
| Classification Regulation | 870.1340 |
| Class | II |
| Panel | Cardiovascular |
| Product Code | DYB |
| Predicate Device(s) | Agilis NxT™ Steerable Introducer<br>Large Curl (K081645) |
| | Agilis NxT™ Steerable Introducer<br>Small/Medium Curl (K061363) |

### 510(K) TYPE AND REASON FOR SUBMISSION

This is a traditional 510(k) and is submitted to obtain marketing clearance for a new device - the 8.5F Steerable Introducer, with small, medium and large curl.

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### DEVICE DESCRIPTION

The steerable introducer consists of a steerable sheath connected to a handle with steering controls, a hemostasis valve with sideport featuring a 3-way stopcock, and a tapered dilator. The device is provided sterile in a sealed Tyvek pouch and carton with IFU. The sheath distal tip and dilator shaft are radiopaque for visualization under fluoroscopy. The dilator is designed to accommodate a guidewire, with size compatibility as indicated on the product labels. A dilator hub is provided with a female luer tapered fitting for flushing (see illustration below). The device includes a side port with stopcock to allow fluid injection and sampling, drip infusion, pressure monitoring, flushing and aspiration.

The steerable introducer usable length, lumen length, outer diameter, curl size, and inner diameter/tool compatibility specifications are indicated on the product labels. The distal end of the steerable sheath features 180° bi-directional deflection to provide directional control to the compatible tools interacting with the device.

Image /page/4/Figure/5 description: The image shows a medical device with several labeled parts. The parts include the dilator hub (1), dilator (2), hemostatic valve (3), 3-way stopcock (4), steering control (5), device handle (6), introducer sheath (7), steerable section (8), and radiopaque marker (9). The device appears to be a type of catheter or endoscope used for medical procedures.

Image /page/4/Figure/6 description: This image shows a medical instrument with labels indicating its various dimensions. The top part of the image shows the instrument's handle, lumen length, usable length, inner diameter, and outer diameter. The bottom part of the image shows the dilator ID, dilator OD, and dilator usable length.

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## INTENDED USE

The 8.5F Steerable Introducer is intended to provide a conduit allowing introduction, removal, and exchange of compatible therapeutic and/or diagnostic tools into the cardiovascular system while maintaining hemostasis. The device facilitates access to the left and right sides of the heart, including left atrium and left ventricle access through the interatrial septum. It features a deflectable distal tip that enables guidance of compatible tools.

### INDICATIONS FOR USE

The Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

### TECHNOLOGICAL CHARACTERISTICS

The 8.5F Steerable Introducer (Small / Medium / Large Curl) are comparable to the predicate devices previously cleared under K061363 (Small / Medium Curl) & K081645 (Large Curl), with the following similarities:

- Indications for Use
- Fundamental scientific technology
- Basic sheath design (dimensions, tip shape)
- User interface with handle (rotating actuator for deflection)
- Materials ●
- . Sterilization process

The 8.5F Steerable Introducer distal tip is radiopaque for visualization under fluoroscopy to facilitate introduction into the cardiovascular system and features 180° bi-directional deflection to provide directional control to the compatible tools interacting with the device. A steering control knob is provided on the handle, along with a hemostasis valve and flush port with 3-way stop-cock to allow fluid injection and sampling, drip infusion, pressure monitoring, flushing and aspiration. The included dilator is radiopaque for visualization under fluoroscopy. It is sized for a close fit to the introducer sheath and accommodates insertion over the included 0.032in guidewire and standard 98cm transseptal needle. A proximal dilator hub includes a female luer tapered fitting for flushing.

### PERFORMANCE DATA

The 8.5F Steerable Introducer has been tested to meet the device intended use and to ensure conformance to the product specifications. The 8.5F Steerable Introducer has been tested and meets all its physical and performance specifications on the bench including, but not limited to:

- Shaft deflection
- Simulated Use
- Torsional stiffness ●
- Radiopacity visualization
- Hemostasis ●

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- Leak testing
- Guidewire compatibility ●
- Transseptal needle compatibility
- Distribution tests ●
- Usability studies

#### SHELF LIFE TESTING

Shelf life verification testing was completed with a 13 month accelerated age study to ensure that device specifications were met. All testing passed. Testing demonstrated the functional and mechanical characteristics of the device were not compromised post aging.

#### BIOCOMPATIBILITY

In addition, the 8.5F Steerable Introducer was tested for biocompatibility as per ISO 10993-1 for limited exposure (<24 hours) to circulating blood. The device is to be sterilized by ethylene oxide to a sterility assurance level (SAL) of 10th These performance requirements are similar to those described by the predicate device. The testing demonstrated the device satisfies ISO 10993-1 requirements, indicating the device is as safe and effective as the predicate device.

#### SUBSTANTIAL EQUIVALENCE

The 8.5F Steerable Introducer is substantially equivalent to the Agilis NxTTM Steerable Introducer Large Curl (K081645 Model G408324) and Agilis NxTTM Steerable Introducer Small/Medium Curl (K061363). The 8.5F Steerable Introducer has the same intended use for introducing compatible therapeutic / diagnostic tools into the chambers of the heart. Test data demonstrate the technological difference between the Steerable Introducer and its predicate do not raise any safety and efficacy issues.

#### CONCLUSION

Based on the test data and the same intended use, the 8.5F Steerable Introducer is found to be substantially equivalent to its predicate.