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 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.

AI/ML Overview

The provided document is a 510(k) summary for a reprocessed medical device, specifically the Reprocessed Agilis NxT Steerable Introducer. The focus of the acceptance criteria and study is on demonstrating that the reprocessed device is substantially equivalent to the predicate (original) device, meaning it is as safe and effective.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document describes several types of testing performed to demonstrate that the reprocessed device is equivalent to the original, but it does not provide a table with specific quantitative acceptance criteria or reported numerical performance data for the reprocessed device. Instead, it lists the categories of tests conducted.

The general acceptance criterion is that the reprocessed device must perform equivalently to the predicate and meet established safety and effectiveness standards for reprocessed medical devices.

Acceptance Criteria Category	Reported Device Performance (Summary)
Biocompatibility	Testing conducted to demonstrate safety.
Cleaning Validation	Testing conducted to demonstrate effectiveness of cleaning.
Sterilization Validation	Testing conducted to demonstrate effectiveness of sterilization.
Physical and Mechanical Testing
- Visual Inspection	Testing conducted to ensure visual integrity.
- Dimensional Verification	Testing conducted to ensure dimensions are within specifications.
- Tensile	Testing conducted to ensure tensile strength.
- Deflection	Testing conducted to ensure proper deflection.
- Simulated Use	Testing conducted to simulate clinical performance.
- Leak	Testing conducted to ensure no leaks.
- Radiopacity	Testing conducted to ensure proper radiopacity.
Packaging Validation	Testing conducted to ensure proper packaging integrity.
Overall	Device is concluded to be as safe and effective as predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for any of the described tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective. The studies described are bench and laboratory tests, not clinical studies involving patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information is not applicable to this submission. The studies described are physical, mechanical, and sterilization validations, which rely on established engineering and scientific testing methodologies and standards rather than expert clinical interpretation for establishing ground truth. There is no mention of human experts evaluating the "ground truth" in the context of diagnostic interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This detail is not applicable to the type of bench and laboratory testing described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for diagnostic accuracy, where multiple readers evaluate cases and discrepancies are resolved.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There was no Multi-Reader Multi-Case (MRMC) comparative effectiveness study done. This submission is for a reprocessed physical medical device (a steerable introducer), not an AI/imaging diagnostic device. Therefore, questions about human readers or AI assistance are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a physical medical instrument, not an algorithm, so the concept of "standalone algorithm performance" does not apply.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the types of tests performed:

Biocompatibility, Cleaning, Sterilization: The ground truth is established through adherence to recognized standards and validated scientific methods for assessing these parameters (e.g., ISO standards for biocompatibility, validated cleaning protocols, sterilization cycle validation to achieve sterility assurance levels).
Physical and Mechanical Testing: The ground truth is established by comparing the reprocessed device's performance against the original equipment manufacturer's specifications for the predicate device, or relevant industry standards. This includes objective measurements of dimensions, tensile strength, deflection, leak integrity, and radiopacity.
Simulated Use: The ground truth is success in performing the intended function without failure or compromise in a simulated environment, based on pre-defined performance metrics.

8. The sample size for the training set

This question is not applicable. The device is a physical medical instrument, not a machine learning or AI model. Therefore, there is no "training set" in the context of algorithm development.

9. How the ground truth for the training set was established

This question is not applicable as there is no training set for this type of device submission.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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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 (480) 525-5972 (office) (888) 965-7705 (fax) astoklas-oakes@innovative-health.com

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:

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	ITEMNUMBER	FRENCH SIZE		USEABLELENGTH(cm)	CURVE TYPE	CURVEREACH(mm)
AGILIS NxTSTEERABLEINTRODUCER	408309	8.5F	11.5F	71	SMALL CURLDUAL REACHBI-DIRECTIONAL	16.8
AGILIS NxTSTEERABLEINTRODUCER	408310	8.5F	11.5F	71	MEDIUM CURLDUAL REACHBI-DIRECTIONAL	22.4
AGILIS NxTSTEERABLEINTRODUCER	G408324	8.5F	11.5F	71	LARGE CURLDUAL REACHBI-DIRECTIONAL	50.0
AGILIS NxTSTEERABLEINTRODUCER	G408318	8.5F	11.5F	61	SMALL CURLDUAL REACHBI-DIRECTIONAL	16.8
AGILIS NxTSTEERABLEINTRODUCER	G408319	8.5F	11.5F	61	MEDIUM CURLDUAL REACHBI-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.

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).