The TightRail Mini Rotating Dilator Sheath is 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 Mini Rotating Dilator Sheaths is an intra-operative device. The device consists of a proximal handle drive mechanism with a distal dilation sheath. The sheath is packaged with an 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 The dilator sheath is advanced, withdrawn and rotated about the lead, catheter or foreign object to be removed.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 sheath. 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 11 F. The nominal effective length of the effective length of the TightRail Mini is 15.5 cm (6.1").

AI/ML Overview

The provided text describes a 510(k) submission (K141131) for the Spectranetics TightRail Mini Rotating Dilator Sheath. This is a medical device for percutaneous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters, and foreign objects. The device is a modification of an existing predicate device (TightRail Device K140047), with the primary change being a shorter working length.

Given that this is a 510(k) submission for a Class II device that is substantially equivalent to a predicate device, the regulatory pathway relies heavily on demonstrating performance through design verification and validation testing, not necessarily clinical studies with human subjects or a direct measure of AI performance.

Therefore, many of the requested categories for AI-based device evaluations (such as sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone AI performance) are not applicable or not explicitly detailed in this type of submission. The "acceptance criteria" here relate to engineering and performance specifications for the device itself, rather than diagnostic accuracy or AI algorithmic performance metrics.

I will populate the table and answer the questions based on the information available and note when information is not provided due to the nature of the device and submission type.

Acceptance Criteria and Device Performance

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

Acceptance Criteria Category	Specific Test / Requirement	Reported Device Performance / Outcome
Mechanical Performance	Dimensional Verification (Working Length)	Met requirements; working length verified at 15.5 cm (6.1").
	Dimensional Verification*	Met requirements (leveraged from K140047).
	Tri Coil Tensile Test*	Met requirements (leveraged from K140047).
	Tri Coil Torsional Test*	Met requirements (leveraged from K140047).
	Axial Load Test*	Met requirements (leveraged from K140047).
	Outer Sheath Axial Load Test*	Met requirements (leveraged from K140047).
	Outer Sheath Axial Load Test at 2 years*	Met requirements (leveraged from K140047 and demonstrated long-term stability).
Material & Safety	Radio-Detectability Test*	Met requirements (leveraged from K140047).
	Corrosion Resistance Test*	Met requirements (leveraged from K140047).
Functional Performance	Simulated Use Testing*	Met requirements (leveraged from K140047).
	Simulated Use Test at 2 years*	Met requirements (leveraged from K140047 and demonstrated long-term stability).
Packaging & Sterilization	Package Integrity at 2 years*	Met requirements (leveraged from K140047 and demonstrated long-term stability).
	Simulated Distribution (Shipping and Simulated Environmental Conditioning) Test*	Met requirements.
	Sterilization	Product adoption equivalency per AAMI TIR:28-2009.
Biocompatibility	Cytotoxicity*	Met requirements (leveraged from K140047).
	Sensitization*	Met requirements (leveraged from K140047).
	Intracutaneous Reactivity*	Met requirements (leveraged from K140047).
	Acute Systemic Toxicity*	Met requirements (leveraged from K140047).
	C3a Complement Activation*	Met requirements (leveraged from K140047).
	SC5b-9 Complement Activation*	Met requirements (leveraged from K140047).
	Direct Hemolysis*	Met requirements (leveraged from K140047).
	Indirect Hemolysis*	Met requirements (leveraged from K140047).
	In Vivo Thrombogenicity-Ovine Model*	Met requirements (leveraged from K140047).
	Genotoxicity Ames Test*	Met requirements (leveraged from K140047).
	Material Mediated Pyrogenicity*	Met requirements (leveraged from K140047).

Note: All tests marked with an asterisk () are leveraged from the predicate device K140047, indicating the subject device is considered to have the same performance characteristics for these aspects.*

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

This document describes technical and biological verification testing for a physical medical device, not a software algorithm or AI. Therefore, there isn't a "test set" in the context of data used for an algorithm. The testing described (e.g., dimensional verification, tensile tests, biocompatibility tests) would involve physical samples of the device components or final product. The document does not specify the number of samples used for each test individually or their geographical origin, but rather states that these tests were conducted to validate and verify the device. These are generally prospective tests conducted by the manufacturer.

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 is not applicable. This is a physical medical device, not an AI or diagnostic imaging device that relies on expert interpretation to establish ground truth for a test set. Ground truth for these tests would be objective measurements against engineering specifications (e.g., dimension, force, chemical analysis).

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

Not applicable for this type of physical device testing. Adjudication methods are typically used in clinical studies or studies involving human interpretation of data for diagnostic purposes.

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 not an AI-assisted diagnostic device. A comparative effectiveness study against human readers would not be relevant.

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

Not applicable. This is a standalone physical medical device, not an algorithm.

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

For the listed design verification and validation tests, the "ground truth" would be established by:

Engineering specifications and standards: For dimensional verification, tensile/torsional/axial load tests, corrosion resistance, radio-detectability.
Established biological testing protocols: For biocompatibility tests (cytotoxicity, sensitization, hemolysis, thrombogenicity, etc.), adherence to defined test methods and acceptance criteria from standards (e.g., ISO 10993 series).
Simulated conditions: For simulated use testing, package integrity, and simulated distribution, performance is assessed against defined environmental stresses and functional requirements.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is a comprehensive set of Design Verification and Validation testing. This testing demonstrates that the TightRail Mini Rotating Dilator Sheath performs as intended and is as safe and effective as its predicate device (TightRail Device K140047).

The core of the "proof" for this 510(k) submission lies in demonstrating substantial equivalence to the predicate device. This was achieved by:

Identifying the technological characteristics of the predicate device and confirming the subject device shares these, with the only significant change being the shorter working length.
Performing new tests specific to the subject device (e.g., Dimensional Verification of TightRail Mini Working Length).
Leveraging existing test data from the predicate device (K140047) for a wide range of tests including mechanical properties (tensile, torsional, axial load tests), material characteristics (radio-detectability, corrosion resistance), functional performance (simulated use testing), long-term stability (2-year tests), packaging, sterilization equivalency, and extensive biocompatibility testing. The justification for leveraging this data is that the subject and predicate devices are otherwise identical in technological characteristics.

The conclusion drawn from this combination of new and leveraged testing was that "The design verification and validation test results demonstrated that the subject device is as safe and clinically effective as the predicate device." This formed the basis for the FDA's determination of substantial equivalence.

Summary

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K141131 Summary

510(k) Submitter / Holder:

Spectranetics 9965 Federal Drive Colorado Springs, CO 80921-3617

Establishment Registration No: 3007284006

Contact:

Christopher S. McLellan Sr. Regulatory Specialist Office: 719-447-2475 Fax: 719-447-2040 Email: christopher.mclellan@spnc.com

Subject Device

Device Trade Name:	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:	Special
Model Numbers:	540-009, 540-011

Predicate Device

The TightRail Mini was compared to the following legally marketed predicate device:

510(k) Number:	K140047
Manufacturer:	Spectranetics
Trade Name:	TightRail Device
Common Name:	Sheath
Model Numbers:	545-009, 545-011, 545-013

Device Description

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Intended and Indications for Use

Technological Characteristics

The TightRail Mini Rotating Dilator Sheaths features the same performance characteristics as the predicate device (K140047 - TightRail® Rotating Mechanical Dilator Sheath). There are no significant changes to the function of the device. Changes have been made to length of the distal dilation sheath. The predicate device features a working length of 47.5cm (18.7") whereas the subject device features a working length of 15.5cm (6.1"). The subject and predicate are otherwise identical with regards to technological characteristics.

Performance Data -

The following testing was conducted to validate and verify that the subject device met all requirements of as identified in the risk analysis that was performed.

Design Verification and Validation Testing

Dimensional Verification of TightRail Mini Working Length .
. Dimensional Verification*
Tri Coil Tensile Test* .
Tri Coil Torsional Test* .
Axial Load Test* .
Outer Sheath Axial Load Test* .
. Radio-Detectability Test*
. Corrosion Resistance Test*
. Simulated Use Testing*
. Dimensional Verification at 2 years*
Outer Sheath Axial Load Test at 2 years* .
. Simulated Use Test at 2 years*
. Package Integrity at 2 years*

Simulated Distribution (Shipping and Simulated Environmental Conditioning) Test* Sterilization:

Product adoption equivalency per AAMI TIR:28-2009* .

Biocompatibility:

Cytotoxicity* .
Sensitization* .
Intracutaneous Reactivity* .
Acute Systemic Toxicity* .
C3a Complement Activation* .
. SC5b-9 Complement Activation*
Direct Hemolysis* .
Indirect Hemolysis* .
In Vivo Thrombogenicity-Ovine Model* .
Genotoxicity Ames Test* .
Material Mediated Pyrogenicity* .

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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 All testing marked with an * is leveraged from K140047. Additional testing required is summarized within this submission

Substantial Equivalence:

Based on the similarities in design between the subject and predicate device, and the performance testing performed, the TightRail Mini is substantially equivalent to the TightRail Rotating Mechanical Dilator Sheath (K140047).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

May 23, 2014

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

Re: K141131

Trade/Device Name: TightRail Mini Rotating Dilator Sheath Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator for Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: April 29, 2014 Received: May 1, 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.

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Page 2 - Christopher Mcleilan

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 (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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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forBram 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) K141131

Device Name

TightRail Mini Rotating Dilator Sheath

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

,通勤的投稿次 FOR FDA USE ONLY BES ONLY BES

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Date: 2014.05.23
09:49:20 -04'00'

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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).