Reprocessed Agilis NxT Steerable Introducer

K170311 · Innovative Health, LLC · PNE · Jun 2, 2017 · Cardiovascular

Device Facts

• Record ID: K170311
• Device Name: Reprocessed Agilis NxT Steerable Introducer
• Applicant: Innovative Health, LLC
• Product Code: PNE · Cardiovascular
• Decision Date: Jun 2, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Reprocessed Agilis NxT Steerable Introducing various cardiovascular cardiovascular catheters into the heart including the left side of the heart through the interatrial septum.

Device Story

Reprocessed steerable introducer system; includes steerable sheath, dilator, and off-the-shelf guidewire. Used by physicians in cardiovascular procedures to facilitate flexible catheter positioning within cardiac anatomy. Features hemostasis valve to minimize blood loss; sideport with three-way stopcock for aspiration, infusion, sampling, and pressure monitoring. Handle includes rotating collar for bi-directional tip deflection (clockwise ≥ 180°, counterclockwise ≥ 90°). Distal vent holes minimize cavitation; radiopaque tip marker aids fluoroscopic visualization. Device is reprocessed once by Innovative Health, involving cleaning, decontamination, inspection, and functional testing. Provides stable access for catheters; assists in navigating complex cardiac structures.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included biocompatibility, cleaning validation, sterilization validation, and physical/mechanical testing (visual inspection, dimensional verification, tensile, deflection, simulated use, leak, and radiopacity).

Technological Characteristics

Steerable sheath and dilator system. Features include hemostasis valve, sideport with three-way stopcock, rotating handle for bi-directional deflection, distal vent holes, and radiopaque tip marker. Reprocessed via cleaning and decontamination. Single-use limit (max 1 cycle).

Indications for Use

Indicated for patients requiring introduction of cardiovascular catheters into the heart, including the left side via 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 (K081645)
• Agilis NxT Steerable Introducer (K061363)

Reference Devices

• Guidewire (K935170)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -WO66-G609 Silver Spring, MD 20993-0002

June 2, 2017

Innovative Health, LLC. Ms. Amy Stoklas-Oakes Sr. Quality and Regulatory Manager 1435 North Hayden Road, Suite 100 Scottsdale, Arizona 85257

Re: K170311

Trade/Device Name: Reprocessed Agilis NxT Steerable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Reprocessed Catheter Introducer Regulatory Class: Class II Product Code: PNE Dated: April 28, 2017 Received: May 1, 2017

Dear Ms. Amy Stoklas-Oakes,

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. 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

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

M.A. Hillemann

for
Bram Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Attachment

The following models are included in the clearance of K170311:

- 408309
- 408310
- o G408324
- . G408318
- G408319 ●

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## Indications for Use

510(k) Number (if known) K170311

Device Name

Reprocessed Agilis NxT Steerable Introducer

Indications for Use (Describe)

The Reprocessed Agilis NxT Steerable Introducing various cardiovascular cardiovascular catheters into the heart including the left side of the heart through the interatrial septum.

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

| <div> <span> <svg height="16" width="16"> <path d="M2 2 L14 14 M2 14 L14 2" stroke="black" stroke-width="2"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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### SECTION 5: 510(k) SUMMARY

As required by 21 CFR 807.92(c)

### Submitter's Name and Address:

Innovative Health, LLC. 1435 N. Hayden Road, Suite 100 Scottsdale, AZ 85257

### Contact Name and Information:

Amy Stoklas-Oakes Innovative Health. LLC. Sr. Quality and Regulatory Manager [phone] (office) [phone] (fax) [e-mail]

### Date prepared:

January 31, 2017

## Device Information:

Trade/Proprietary Name: Common Name: Classification Name: Classification Number: Product Code:

Reprocessed Aqilis NxT Steerable Introducer Steerable Introducer Reprocessed Catheter Introducer Class II, 21 CFR 870.1340 PNE

### Predicate Device:

| 510(k) Number | Device | Manufacturer |
|---------------|---------------------------------|------------------|
| K081645 | Agilis NxT Steerable Introducer | St. Jude Medical |
| K061363 | Agilis NxT Steerable Introducer | St. Jude Medical |

### Device Description:

The reprocessed Agilis NxT steerable introducer consists of a steerable sheath, dilator, and guidewire which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. The handle is equipped with a rotating collar to deflect the tip clockwise ≥ 180° and counterclockwise ≥ 90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.

Note: Only the steerable sheath and dilator are subject of this submission. The guidewire is purchased off-the shelf (K935170) and packaged with the reprocessed devices.

The item numbers included in the scope of this submission are as follows:

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| DESCRIPTION | ITEM<br>NUMBER | FRENCH SIZE | | USEABLE<br>LENGTH<br>(cm) | CURVE TYPE | CURVE<br>REACH<br>(mm) |
|---------------------------------------|----------------|-------------|-------|---------------------------|---------------------------------------------|------------------------|
| AGILIS NxT<br>STEERABLE<br>INTRODUCER | 408309 | 8.5F | 11.5F | 71 | SMALL CURL<br>DUAL REACH<br>BI-DIRECTIONAL | 16.8 |
| AGILIS NxT<br>STEERABLE<br>INTRODUCER | 408310 | 8.5F | 11.5F | 71 | MEDIUM CURL<br>DUAL REACH<br>BI-DIRECTIONAL | 22.4 |
| AGILIS NxT<br>STEERABLE<br>INTRODUCER | G408324 | 8.5F | 11.5F | 71 | LARGE CURL<br>DUAL REACH<br>BI-DIRECTIONAL | 50.0 |
| AGILIS NxT<br>STEERABLE<br>INTRODUCER | G408318 | 8.5F | 11.5F | 61 | SMALL CURL<br>DUAL REACH<br>BI-DIRECTIONAL | 16.8 |
| AGILIS NxT<br>STEERABLE<br>INTRODUCER | G408319 | 8.5F | 11.5F | 61 | MEDIUM CURL<br>DUAL REACH<br>BI-DIRECTIONAL | 22.4 |

Table 5.1: Item Numbers

#### Indications for Use:

The Reprocessed Agilis NxT 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 purpose, design, materials, function, and intended use of the Reprocessed Steerable Introducer are identical to the predicate devices. There are no changes to the claims, clinical applications, patient population, performance specifications, or method of operation. In addition, Innovative Health's reprocessing of these devices includes removal of visible soil and decontamination. Each device is inspected and function tested prior to packaging and labeling.

### Functional and Safety Testing:

Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Agilis NxT Steerable Introducer. This included the following:

- Biocompatibility ●
- Cleaning Validation ●
- Sterilization Validation ●
- Physical and Mechanical Testing ●
- Visual Inspection
- Dimensional Verification ●
- Tensile ●
- Deflection ●
- Simulated Use
- . Leak
- . Radiopacity
- Packaging Validation .

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The Reprocessed Agilis NxT Steerable Introducer are reprocessed no more than one (1) time. Each device is marked and tracked. After the device has reached the maximum number of reprocessing cycles, the device is rejected from further reprocessing. Reprocessing is performed only by Innovative Health. Innovative Health restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.

### Conclusion:

Innovative Health concludes that the Reprocessed Agilis NxT Steerable Introducers are as safe and effective as the predicate devices described herein.