The TightRail Guardian motorized dilator sheath is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads.

Device Description

The TightRail Guardian motorized dilator sheath is a sterile, single use, prescription only device used for cardiac leads. The device is comprised of:

Drive Assembly
Dilation Extension Selection (DES) Assembly
Motor Drive Handle
Outer Sheath Accessory
Fish Tape Accessory
The motorized dilator sheath is advanced or retracted along the target lead to be removed. Pulling the trigger on the handle of the TightRail Guardian device results in activation of the motor and subsequent rotation of the inner shaft and cam blade. Triager activation results in bidirectional rotation mechanism. Actuation of the distal dilation mechanism causes dilation of tissue and fibrous attachments surrounding the lead tarqeted for removal, thereby facilitating removal of said lead. The device has two modes of operation, providing dilation with the blades shielded or extended. The diameter sizes range from 9 French (F) to 13 F. The nominal effective length of the TightRail Guardian is 47.5 cm. The outer sheath accessory may be used for additional support by creating a conduit for the device's shaft assembly. The outer sheath may also be used to maintain venous access for quidewire placement, prior to implantation of a new lead. The fish tape accessory may be used to feed a target lead and locking stylet through the inner lumen of the device.

AI/ML Overview

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. As such, it does not contain the detailed information typically found in a clinical study report or a validation study for an AI-powered medical device.

Specifically, this document describes a mechanical device (a motorized dilator sheath) and its validation through engineering and performance testing, not an AI algorithm. Therefore, most of the requested information regarding AI device acceptance criteria, human reader studies, ground truth establishment, and training/test set details is not applicable to this submission.

The document states: "Preclinical and clinical data was not required to demonstrate substantial equivalence. The design characteristics of the subject device are similar to the predicate. The design verification and validation test results demonstrated that the subject device is as safe and clinically effective as the predicate device." This confirms that the approval was based on demonstrating equivalence in mechanical and performance characteristics to a previously cleared device, not on the performance of a novel AI algorithm.

However, I can extract the relevant "acceptance criteria" and "study" information that is present in the document, which pertains to the engineering and performance testing of this mechanical device.

Acceptance Criteria and Study for the TightRail Guardian Motorized Dilator Sheath (Mechanical Device)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific quantitative acceptance criteria or precise reported performance values in a table format. Instead, it lists the types of design verification and validation testing performed to ensure the device met its specifications and performed comparably to its predicate. The implicit acceptance criterion for all these tests is that the device demonstrated performance equivalent to or better than the predicate, and met all engineering specifications for safety and effectiveness.

Acceptance Criteria Category (Test Type)	Implicit Acceptance Criteria / Reported Performance Summary
Design Verification and Validation Testing	"The design verification and validation test results demonstrated that the subject device is as safe and clinically effective as the predicate device." (General summary of all tests)
Simulated Use Testing	Device performed as intended during simulated clinical procedures.
Simulated Environment Testing	Device maintained performance and integrity under various environmental conditions (e.g., temperature, humidity, storage, transport).
Human Factors Evaluation	Usability and safety aspects for human interaction were evaluated and found acceptable.
Linear and Radial Dimensional Testing	Dimensions met specified tolerances (e.g., French sizes 9F, 11F, 13F; nominal effective length 47.5 cm).
Device Weight Measurement	Device weight met specified limits.
Blade Extension Testing	Blades extended and retracted correctly in both shielded and extended modes, consistently meeting design specifications.
Atraumatic Surface Testing	Surfaces designed to contact tissue were smooth and non-damaging.
Axial Load Testing	Device maintained structural integrity under specified axial forces.
Tensile Testing	Device components withstood specified tensile forces without failure.
Flexibility Testing	Shaft demonstrated appropriate flexibility for navigation while maintaining necessary columnar stability.
Outer Sheath Compression Testing	Outer sheath maintained patency and structural integrity under compression, suitable for its intended use (additional support, maintaining venous access).
EMC/EMI and Electrical Medical Safety Testing	Device met relevant electromagnetic compatibility and electrical safety standards.
Radiopacity Evaluation	Device was sufficiently visible under fluoroscopy for clinical use.
Sterilization	"Product adoption equivalency per AAMI TIR28:2016" - Demonstrated that the sterilization process renders the device sterile as per AAMI TIR28:2016 standards, ensuring patient safety from microbiological contamination.
Biocompatibility	All tests (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Material Mediated Pyrogenicity, Acute Systemic Toxicity, Indirect and Direct Hemolysis, Hemocompatibility) demonstrated the device materials are biologically compatible with the human body for their intended use, without causing adverse biological responses. This implicitly means criteria for each test type (e.g., non-cytotoxic, non-sensitizing etc.) were met.

Since this is not an AI/software device, the following points are not applicable (N/A) based on the provided document:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): N/A (No test set of patient data/images for an AI algorithm). Testing was engineering-based on physical devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No ground truth established by experts for images/data for AI).
Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A.
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: N/A (No AI, no human reader study).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (No algorithm).
The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A (No ground truth as defined for diagnostic AI). The "ground truth" for this mechanical device is proper functioning according to engineering specifications and safety standards.
The sample size for the training set: N/A (No training set for an AI algorithm).
How the ground truth for the training set was established: N/A (No training set for an AI algorithm).

Summary

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December 15, 2022

Spectranetics Inc. Jordan Baum Regulatory Affairs Specialist 9965 Federal Drive Colorado Springs, Colorado 80921

Re: K223472

Trade/Device Name: TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013) Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator For Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: November 17, 2022 Received: November 17, 2022

Dear Jordan Baum:

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.

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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 (QS) 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.

Hetal B. Patel -S

Hetal Odobasic Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K223472

Device Name

TightRail Guardian Motorized Dilator Sheath, 9 French (575-009);

TightRail Guardian Motorized Dilator Sheath, 11 French (575-011);

TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)

Indications for Use (Describe)

The TightRail Guardian motorized dilator sheath is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads.

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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Image /page/3/Picture/0 description: The image shows the Spectranetics logo. The logo consists of a blue geometric shape to the left of the word "Spectranetics" in blue, stylized font. Below the company name is the tagline "Always Reaching Farther" in a smaller, sans-serif font.

510(k) Summary

This 510(k) summary was prepared in accordance with 21 CFR 807.92(c) Prepared on 17 November 2022

510(k) Submitter / Holder:	Spectranetics9965 Federal DriveColorado Springs, CO 80921.3617Establishment Registration No: 3007284006
Contact:	Mr. Jordan BaumRegulatory Affairs SpecialistMobile: (719) 247-0183Fax: (719) 447-2070Email: Jordan.Baum@philips.com

Subject Device

Device Trade Name:	TightRail Guardian Motorized Dilator Sheath
Device Common Name:	Sheath
Device Class:	II
Classification Regulation:	21 CFR 870.1310
Regulation Description:	Vessel dilator for percutaneous catheterization
Product Code:	DRE
510(k) Type:	Traditional
Model Numbers:	575-009, 575-011, 575-013

Predicate Devices

The TightRail Guardian Motorized Dilator Sheath is being compared to the following legally marketed predicate devices:

TightRail Guardian Motorized Dilator Sheath

510(k) Number:	K212784 (cleared 24 August 2022)
Manufacturer:	The Spectranetics Corporation
Trade Name:	TightRail Guardian Motorized Dilator Sheath
Device Common Name:	Sheath

Intended and Indications for Use

The TightRail Guardian Motorized Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads.

Device Description

The TightRail Guardian motorized dilator sheath is a sterile, single use, prescription only device used for cardiac leads. The device is comprised of:

1. Drive Assembly

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Image /page/4/Picture/0 description: The image shows the Spectranetics logo. The logo consists of a blue diamond shape with a white circle in the center, followed by the word "Spectranetics" in blue, and the tagline "Always Reaching Farther" in a smaller font size below the word "Spectranetics". The logo is clean and modern, and the blue color gives it a sense of trust and reliability.

1. Dilation Extension Selection (DES) Assembly
1. Motor Drive Handle
1. Outer Sheath Accessory
1. Fish Tape Accessory

The motorized dilator sheath is advanced or retracted along the target lead to be removed. Pulling the trigger on the handle of the TightRail Guardian device results in activation of the motor and subsequent rotation of the inner shaft and cam blade. Triager activation results in bidirectional rotation mechanism. Actuation of the distal dilation mechanism causes dilation of tissue and fibrous attachments surrounding the lead tarqeted for removal, thereby facilitating removal of said lead. The device has two modes of operation, providing dilation with the blades shielded or extended. The diameter sizes range from 9 French (F) to 13 F. The nominal effective length of the TightRail Guardian is 47.5 cm. The outer sheath accessory may be used for additional support by creating a conduit for the device's shaft assembly. The outer sheath may also be used to maintain venous access for quidewire placement, prior to implantation of a new lead. The fish tape accessory may be used to feed a target lead and locking stylet through the inner lumen of the device.

Technological Characteristics

The TightRail Guardian device features a battery powered dilation mechanism and two dilation modes (Shielded, Extended). The dilation mechanism is activated through a trigger on the device handle. The shaft of the dilator sheath is designed from laser-cut stainless steel hypotubes to provide columnar stability during device advancement and actuation. The laser-cuts are progressively increased across the shaft, to provide additional flexibility toward the distal tip of the dilator sheath.

The TightRail Guardian Motorized Dilator Sheath features the same performance characteristics and overall design as the predicate device (K212784). There are no changes to the principle of operation and no changes to the intended use.

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Image /page/5/Picture/0 description: The image shows the Spectranetics logo. The logo consists of a blue diamond shape with a white center, followed by the word "Spectranetics" in blue, bold font. Below the company name is the tagline "Always Reaching Farther" in a smaller, lighter blue font. The logo is clean and modern, conveying a sense of innovation and progress.

Performance Data

The following testing was conducted to validate and verify that the subject device met all specifications:

Design Verification and Validation Testing

Simulated Use Testing ●
Simulated Environment Testing
Human Factors Evaluation
Linear and Radial Dimensional Testing ●
Device Weight Measurement ●
Blade Extension Testing ●
Atraumatic Surface Testing
Axial Load Testing
Tensile Testing ●
Flexibility Testing ●
. Outer Sheath Compression Testing
EMC/EMI and Electrical Medical Safety Testing
. Radiopacity Evaluation

Sterilization

Product adoption equivalency per AAMI TIR28:2016 ●

Biocompatibility

Cytotoxicity
Sensitization
Irriation/Intracutaneous Reactivity ●
Material Mediated Pyrogenicity
Acute Systemic Toxicity ●
Indirect and Direct Hemolysis ●
Hemocompatibility ●

Pre-clinical and Clinical Data:

Preclinical and clinical data was not required to demonstrate substantial equivalence. The design characteristics of the subject device are similar to the predicate. The design verification and validation test results demonstrated that the subject device is as safe and clinically effective as the predicate device.

Substantial Equivalence:

Based on the similarities in design between the subject and predicate devices currently in use, and the performance data, the use of the TightRail Guardian device for the proposed indication does not raise new questions related to safety and effectiveness compared with the predicate. Therefore, TightRail Guardian is substantially equivalent to the TightRail Guardian device cleared under K212784.

Regulation Number and Section

§ 870.1310 Vessel dilator for percutaneous catheterization.

(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).