The TightRail Mechanical 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 Mechanical Dilator Sheaths are mechanical, intra-operative devices consist of a proximal handle drive mechanism with a distal dilation catheter. The sheaths are 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 The dilator sheath is advanced, withdrawn and rotated about the lead, catheter or foreign object to be removed.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 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.

AI/ML Overview

The provided text describes a 510(k) summary for the "TightRail™ Mechanical Dilator Sheath Set." This premarket notification asserts that the device is substantially equivalent to a legally marketed predicate device, focusing on design verification and validation testing rather than presenting formal acceptance criteria with specific performance metrics.

Here's an analysis of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria or specific performance metrics in a tabular format as would be typical for independent studies. Instead, it lists various "Design Verification and Validation Testing" categories, implying that the device was tested to "meet all specifications" and "demonstrated that the subject device is as safe and clinically effective as the predicate device."

No explicit table of acceptance criteria or quantitative performance is provided in the document. The acceptance is based on demonstrating substantial equivalence to a predicate device through a series of verification and validation tests.

Study Details:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The "Simulated Use Bench Top" test would have involved a certain number of devices or iterations, but the specific sample size is not detailed for any of the listed tests.
- Data Provenance: The tests are described as "Design Verification and Validation Testing" and "Simulated Use Bench Top," implying in-house laboratory testing. There is no mention of country of origin for data or whether it was retrospective or prospective in a clinical sense. These are engineering and performance tests, not clinical data from patients.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a study involving expert assessment of medical images or patient outcomes to establish ground truth. The "ground truth" for these engineering tests would be the established performance specifications for the device itself and comparison to the predicate.
- "Physician Simulated Use" is mentioned, which implies input from physicians, but the number or specific qualifications are not detailed, nor is it a method for establishing "ground truth" in the typical sense of a diagnostic study.
Adjudication method for the test set:
- Not applicable. This is not a clinical study involving human readers or interpretation where adjudication methods (like 2+1 or 3+1) would be used. The tests described are engineering and performance validation tests.
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:
- No. This is a medical device for percutaneous dilation, not a diagnostic imaging AI device. Therefore, MRMC studies and AI-assisted human reader improvement are not relevant to this submission.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a mechanical medical device, not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the engineering and performance testing, the "ground truth" would be established engineering specifications, industry standards (e.g., AAMI TIR:28-2009 for sterilization), and the performance characteristics of the legally marketed predicate device. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these tests.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary of Device Acceptance Criteria and Study:

The acceptance criteria for the TightRail Mechanical Dilator Sheath Set were met through a series of Design Verification and Validation Tests. These tests aimed to demonstrate that the device met all its specifications and was substantially equivalent to the predicate device (Cook® Medical Evolution® Mechanical Dilator Sheath Set, K061000).

The types of tests conducted included:

Dimensional Verification
Axial Loading of Tip Assembly and Outer Sheath
Tensile and Torsional Testing on the Tri-Coil
Simulated Use Bench Top
Radiopacity
Corrosion Resistance
Physician Simulated Use
Simulated Distribution (Shipping and Environmental Conditioning)
Shelf Life Verification Testing (6 months, including Dimensional Verification, Axial Loading, Simulated Use Bench Top, Package Integrity)
Sterilization (Product adoption equivalency per AAMI TIR:28-2009)
Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, C3a and SC5b-9 Complement Activation, Direct Hemolysis, Indirect Hemolysis, In Vivo Thrombogenicity-Ovine Model, Genotoxicity Ames Test, Material Mediated Pyrogenicity)

The submission explicitly states, "Preclinical and clinical data were 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 acceptance of this device was based purely on non-clinical, engineering, and laboratory performance testing, establishing equivalence to a previously cleared device.

Summary

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APR 0 9 2014

K140047

510(k) Summary

This 510(k) summary was prepared in accordance with 21 CFR 807.92(c)

Prepared on March 20, 2014

510(k) Submitter / Holder:

Spectranetics 9965 Federal Drive Colorado Springs, CO 80921.3617

Establishment Registration No: 3007284006

Contact:

Pharoah Garma Regulatory Affairs Manager Office: 719.447.2358 Fax: 719.447.2040 Email: Pharoah.Garma@SPNC.com

Subject Device

510(k) Number: Device Trade Name: Device Common Name: Device Class: Classification Requlation: Regulation Description: Product Code: 510(k) Type: Model Numbers:

K140047 TightRail™ Mechanical Dilator Sheath Set Sheath 21 CFR 870.1310 Vessel dilator for percutaneous catheterization DRE Traditional 545-509, 545-511, 545-513

Predicate Device

The TightRail Mechanical Dilator Sheath Sets were compared to the following legally marketed predicate device:

510(k) Number: K061000 (cleared on May 10, 2006) Manufacturer: Cook® Medical Evolution® Mechanical Dilator Sheath Set Trade Name: Device Common Name: Sheath

Device Description

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Traditional 510(k) - TightRail ™ Mechanical Dilator Sheath Set

Intended and Indications for Use

Technological Characteristics

The TightRail Mechanical Dilator Sheaths have similar performance characteristics as the predicate device. However, the design of the dilatation mechanism between the subject and predicate device differ. The predicate device features a single rotating outer shaft that includes an extended radial dilation blade. The cutting edges of their dilatation blade are on the exterior circumference. The subject device includes a stationary outer shaft, a rotating inner shaft, and an un-exposed dilation blade at rest. The TightRail dilatation blade extends and retracts along the inner shaft axis once the trigger is actuated. Lastly, the predicate device shaft is designed as a metal braid reinforced polymer, while the subject device shaft is composed of tri-coils. The tri-coil design increases the shaft flexibility of the subject device.

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 .
Axial Loading of Tip Assembly and Outer Sheath .
Tensile and Torsional Testing on the Tri-Coil ●
Simulated Use Bench Top .
. Radiopacity
Corrosion Resistance .
. Physician Simulated Use
Simulated Distribution (Shipping and Simulated Environmental Conditing) . .
- Shelf Life Verification Testing (6=months)
  - o Dimensional Verification
  - Axial Loading of Outer Sheath o
  - Simulated Use Bench Top ୍
  - Package Integrity o

Sterilization

Product adoption equivalency per AAMI TIR:28-2009 .
Biocompatibility
- Cytotoxicity �
- Sensitization .
- Intracutaneous Reactivity ●
- Acute Systemic Toxicity .
- C3a and SC5b-9 Complement Activation .
- Direct Hemolysis .
- Indirect Hemolysis .
- In Vivo Thromobogenicity-Ovine Model .
- Genotoxicity Ames Test
- Material Mediated Pyrogenicity

K140047

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Traditional 510(k) – TightRail™ Mechanical Dilator Sheath Set

Preclinical and Clinical Data:

Preclinical and clinical data were 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 device, and the performance data, the TightRail is substantially equivalent to the Evolution Mechanical Dilator Sheaths (K061000),

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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

April 9, 2014

Spectranetics Corp. Pharoah Garma 9665 Federal Drive Colorado Springs, CO 80921 US

Re: K140047

Trade/Device Name: Tight Rail Mechanical Dilator Sheath Set Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator for Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: March 10, 2014 Received: March 12, 2014

Dear Pharoah Garma:

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 - Pharoah Garma

Please be advised that I'DA'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} (2) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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.

Linda J. Ricci -S

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

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K 140047

Device Name

TightRail™ Mechanical Dilator Sheath Set

Indications for Use (Describe)

The TightRail Mechanical Dilator Sheath is intended for use percutancous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters and foreign objects.

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)

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

FOR FDA USE ONLY

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

Linda J. Ricci -S

FORM FDA 3881 (9/13)

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).