The TightRail and TightRail Mini Rotating Dilator Sheaths are intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters, and foreign objects.

Device Description

The TightRail and TightRail Mini Rotating Dilator Sheaths are mechanical, intra- operative devices. The devices consist of a proximal handle drive mechanism with a distal dilation catheter. The sheaths are packaged with an optional outer support sheath. The dilator sheath is advanced, withdrawn, and rotated about the lead, catheter or foreign object to be removed. Actuating the trigger on the proximal handle activates a rotary dilation mechanism sheathed at the distal terminus of the catheter. Rotation of the inner shaft is translated to axial actuation of the dilation mechanism via a cam path contained within the distal components. Actuation of the distal dilation mechanism causes dilation of tissue and fibrous attachments surrounding the object targeted for removal, thereby facilitating removal of said object. The diameter sizes range from 9 French (F) to 13 F. The nominal effective length of the TightRail is 47.5 cm. The nominal effective length of the TightRail Mini is 15.5 cm.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the TightRail and TightRail Mini Rotating Dilator Sheaths, focusing on establishing substantial equivalence to previously cleared predicate devices. The information provided does not align with the typical structure of reporting acceptance criteria and a study proving device performance in the context of AI/ML devices or diagnostic accuracy studies. This document pertains to a physical medical device and its mechanical/material performance, not an AI system.

However, interpreting the request in the context of physical medical device validation as presented, here's an attempt to extract relevant information, acknowledging the limitations for your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state acceptance criteria in a strict pass/fail quantifiable manner for each test. Instead, it lists types of tests conducted to ensure safety and effectiveness, and then broadly states that the device "met all specifications" and was "substantially equivalent." Therefore, the table below will generalize the 'acceptance criteria' based on the purpose of each test.

Acceptance Criteria (Inferred)	Reported Device Performance
Mechanical/Physical Performance:
Dimensional Verification (Initial & at 24 months)	Met all specifications
Tri Coil Tensile Test	Met all specifications
Tri Coil Torsional Test	Met all specifications
Axial Load Test	Met all specifications
Outer Sheath Axial Load Test (Initial & at 24 months)	Met all specifications
Rotation Mechanism Functionality (Simulated Use Testing, Initial & at 24 months)	Met all specifications
Material/Durability Performance:
Radio-Detectability Test	Met all specifications
Corrosion Resistance Test	Met all specifications
Package Integrity (at 24 months)	Met all specifications
Simulated Distribution (Shipping and Environmental Conditioning)	Met all specifications
Sterilization:
Product adoption equivalency per AAMI TIR:28-2009	Met all specifications
Biocompatibility:
Cytotoxicity	Met all specifications
Sensitization	Met all specifications
Intracutaneous Reactivity	Met all specifications
Acute Systemic Toxicity	Met all specifications
C3a Complement Activation	Met all specifications
SC5b-9 Complement Activation	Met all specifications
Direct Hemolysis	Met all specifications
Indirect Hemolysis	Met all specifications
In Vivo Thrombogenicity-Ovine Model	Met all specifications
Genotoxicity - Ames Test	Met all specifications
Material Mediated Pyrogenicity	Met all specifications

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated for any of the individual tests. The document only lists the types of tests performed.
Data Provenance: The document does not specify the country of origin for any test data. The tests are "Design Verification and Validation Testing" and "Biocompatibility" tests, which are typically conducted in a laboratory setting by the manufacturer or a contracted lab. It does not mention retrospective or prospective studies in the typical clinical trial sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable in the context of this device and testing. The tests described are primarily engineering, mechanical, and material science evaluations, along with biocompatibility assessments. They do not involve human interpretation of clinical data or images that would require expert consensus for "ground truth."

4. Adjudication method for the test set:

Not applicable. There's no indication of clinical data interpretation requiring adjudication. Performance is assessed against defined engineering and biological standards.

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:

Not applicable. This is a physical medical device (dilator sheath), not an AI/ML diagnostic or assistive device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. (See point 5).

7. The type of ground truth used:

The "ground truth" for this type of device and its mechanical/biocompatibility testing would be established by:

Engineering specifications and standards: For dimensional, tensile, torsional, axial, and durability tests.
International standards (e.g., AAMI TIR:28-2009): For sterilization validation.
ISO standards for biocompatibility: For cytotoxicity, sensitization, hemolysis, etc.
Pre-defined pass/fail criteria: Based on the device's intended use and safety profile.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no concept of a "training set" in the machine learning sense. The "training" for the device would be its manufacturing process.

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

Not applicable. (See point 8).

Summary of what's not in the document but relevant to your questions:

The provided document describes a traditional 510(k) for a physical medical device that facilitates percutaneous dilation. The validation focuses on engineering specifications, material compatibility, and sterilization efficacy to demonstrate substantial equivalence to predicate devices, especially after a change in the drive mechanism for rotation. It does not involve AI/ML technology, diagnostic image interpretation, or clinical efficacy studies that would require expert ground truth, MRMC studies, or training/test sets in the computational sense. The document explicitly states: "Preclinical and clinical data was not required to demonstrate substantial equivalence."

Summary

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Public Health Service

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

September 25, 2014

Spectranetics, Inc. Christopher McLellan Sr. Regulatory Affairs Specialist 9965 Federal Drive Colorado Springs, Colorado 80921

Re: K142546

Trade/Device Name: TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator for Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: September 9, 2014 Received: September 10, 2014

Dear Christopher McLellan,

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 yours,

M.A. Hillebrenner
for

for

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K142546

Device Name

TightRail and TightRail Mini Rotating Dilator Sheaths

Indications for Use (Describe)

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

ال Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

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510(k) Summary – K142546: TightRail & TightRail Mini

510(k) Submitter / Holder:	Spectranetics9965 Federal DriveColorado Springs, CO 80921.3617Establishment Registration No: 3007284006
Contact:	Christopher McLellanSenior Regulatory SpecialistOffice: 719.447.2475Mobile: 719.314.8561Fax: 719.447.2040Email: christopher.mclellan@spnc.com

Subject Device

Device Trade Name:	TightRail and TightRail Mini Rotating 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:	TightRail: 545-509, 545-511, 545-513
	TightRail Mini: 540-009, 540-011

Predicate Device

The TightRail and TightRail Mini Rotating Dilator Sheaths were compared to the following legally marketed predicate devices:

510(k) Number:	K140047 (cleared 9 April 2014)K141131 (cleared 23 May 2014)
Manufacturer:	Spectranetics
Trade Name:	TightRail and TightRail Mini Rotating Dilator Sheaths
Device Common Name:	Sheath

Device Description

Intended and Indications for Use

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Technological Characteristics

The TightRail and TightRail Mini Rotating Dilator Sheaths feature the same performance characteristics as the predicate devices (K140047 and K141131). There are no significant changes to the function of the device. Changes have been made to the drive mechanism which imparts rotation to the dilatation catheter portion of the device. Whereas the predicate device features a barrel cam that imparts both clockwise and counterclockwise dilation in a single trigger pull, the subject device only rotates in a single direction during a trigger pull. The subject device changes rotation with each subsequent trigger pull.

Performance Data

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

Design Verification and Validation Testing

Dimensional Verification
Tri Coil Tensile Test
Tri Coil Torsional Test1 ●
Axial Load Test '
Outer Sheath Axial Load Test ●
Radio-Detectability Test '
Corrosion Resistance Test ●
Simulated Use Testing
Dimensional Verification at 24 months 1 ●
Outer Sheath Axial Load Test at 24 months 1 ●
. Simulated Use Test at 24 months '
. Package Integrity at 24 months '
Simulated Distribution (Shipping and Simulated Environmental Conditioning) Test ●

Sterilization

Product adoption equivalency per AAMI TIR:28-2009 '

Biocompatibility:

. Cytotoxicity
Sensitization1 ●
Intracutaneous Reactivity ●
Acute Systemic Toxicity ●
C3a Complement Activation1 ●
SC5b-9 Complement Activation1 .
Direct Hemolysis
Indirect Hemolysis 1 .
In Vivo Thrombogenicity-Ovine Model ' ●
. Genotoxicity - Ames Test '
Material Mediated Pyrogenicity ' ●

Preclinical 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.

1 Leveraged from previous submissions

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Substantial Equivalence

Based on the similarities in design between the subject and predicate devices, and the performance data, the TightRail and TightRail Mini are substantially equivalent to the
previously cleared versions of the TightRail and TightRail Mini (K140047 and K141131, respectively).

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).