The TightRail Sub-C 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 Sub-C 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 The dilator sheath is advanced, withdrawn, and rotated about the lead, catheter or foreign object to be removed.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 Sub-C is 15.5 cm.

AI/ML Overview

The provided text describes a medical device, the "TightRail Sub-C Rotating Dilator Sheath," and its premarket notification (510(k)) to the FDA. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study that defines and meets specific acceptance criteria for a new, standalone device performance claim. Therefore, much of the requested information regarding algorithm performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment is not available in this document because it pertains to the evaluation of a software algorithm or AI, which is not the subject of this medical device submission.

Here's a breakdown of the available information:

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

The document lists various design verification and validation tests performed to ensure the subject device met specifications and was substantially equivalent to its predicate. These are not acceptance criteria in the sense of a clinical trial's primary endpoints and statistical measures, but rather engineering and safety parameters.

Acceptance Criteria (Test)	Reported Device Performance (Outcome)
Dimensional Verification	Met specifications (implied by "demonstrated that the subject device is as safe and clinically effective")
Tensile Test	Met specifications
Torque to Deform Test	Met specifications
Axial Load Test	Met specifications
Weld Integrity Test	Met specifications
Outer Sheath Axial Load Test	Met specifications
Radio-Detectability Test	Met specifications
Corrosion Resistance Characterization	Met specifications
Simulated Use Testing	Met specifications
Dimensional Verification at 2 years	Met specifications
Outer Sheath Axial Load Test at 2 years	Met specifications
Simulated Use Test at 2 years	Met specifications
Sterilization:
Product adoption equivalency per AAMI TIR:28-2009	Met specifications
Biocompatibility:
Cytotoxicity	Met specifications
Sensitization	Met specifications
Intracutaneous Reactivity	Met specifications
Acute Systemic Toxicity	Met specifications
C3a Complement Activation	Met specifications
SC5b-9 Complement Activation	Met specifications
Direct Hemolysis	Met specifications
Indirect Hemolysis	Met specifications
Thrombosis Partial Thromboplastin Time (PTT)	Met specifications
Material Mediated Pyrogenicity	Met specifications

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

Not Applicable. This document describes engineering and biocompatibility testing for a physical device, not an algorithm being tested on a "test set" of data. No clinical studies were required or performed to demonstrate substantial equivalence for this 510(k) submission.

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

Not Applicable. See point 2.

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

Not Applicable. See point 2.

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:

No. This is a physical medical device, not an AI or software algorithm requiring an MRMC study.

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

No. This is a physical medical device, not an algorithm.

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

Not Applicable. For the engineering tests, "ground truth" would be established by validated measurement techniques, standards, and established laboratory protocols, rather than expert consensus on medical images or pathology.

8. The sample size for the training set:

Not Applicable. This document describes a traditional 510(k) submission for a physical device, not an AI or machine learning model. There is no concept of a "training set" in this context.

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

Not Applicable. See point 8.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 08, 2016

Spectranetics, Inc. Stephanie Byrum Regulatory Affairs Associate 9965 Federal Drive Colorado Springs, Colorado 80921

Re: K161333

Trade/Device Name: TightRail Sub-C Rotating Dilator Sheath Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator for Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: May 11, 2016 Received: May 12, 2016

Dear Stephanie Byrum:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 yours,

M. G. Hilleman

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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Indications for Use

510(k) Number (if known) K161333

Device Name

TightRail Sub-C Rotating Dilator Sheath

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)|X 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 features the Spectranetics logo. On the left is a blue diamond shape with a white circle in the center. To the right of the diamond is the word "Spectranetics" in a bold, blue font. Below the company name is the tagline "Always Reaching Farther" in a smaller, lighter font.

510(k) Summary

This 510(k) summary was prepared in accordance with 21 CFR 807.92(c) Prepared on May 9, 2016.

510(k) Submitter / Holder:	Spectranetics9965 Federal DriveColorado Springs, CO 80921.3617
	Establishment Registration No: 3007284006
Contact:	Stephanie Byrum
	Regulatory Affairs Associate
	Office: 719.447.2671
	Mobile: 719.482-4765
	Fax: 719.447.2070
	Email: Stephanie.byrum@spnc.com

Subject Device

Device Trade Name:	TightRail Sub-C Rotating Dilator Sheaths
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:	560-009, 560-011, 560-013

Predicate Device

Predicate Device
The TightRail Sub-C Rotating Dilator Sheaths were compared to the following legally marketed predicate devices:
510(k) Number:	K142546 (cleared 25 September 2014) and K150360(cleared 4 March 2015)
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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Image /page/4/Picture/0 description: The image shows the Spectranetics logo. The logo consists of a blue diamond shape with a white circle inside, followed by the word "Spectranetics" in blue, and the tagline "Always Reaching Farther" in smaller, black font below. The logo is clean and modern, and the colors are bright and eye-catching.

Technological Characteristics

The TightRail Sub-C Rotating Dilator Sheath features the same performance characteristics as the predicate devices (K142546 and K150360). There are no significant changes to the function of the device. Changes have been made to the inner and outer shaft. The predicate devices featured a tri-coil design while the subject device features a laser-cut hypotube.

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
Tensile Test .
Torque to Deform Test
Axial Load Test ●
Weld Integrity Test ●
Outer Sheath Axial Load Test
. Radio-Detectability Test
. Corrosion Resistance Characterization
Simulated Use Testing
Dimensional Verification at 2 years
Outer Sheath Axial Load Test at 2 years ●
Simulated Use Test at 2 years ●

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 Hemolvsis ●
- Thrombosis Partial Thromboplastin Time (PTT) ●
- Material Mediated Pvrogenicity ●

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.

Substantial Equivalence

Based on the similarities in design between the subject and predicate devices, and the performance data, the TightRail Sub-C are substantially equivalent to the previously cleared versions of the TightRail and TightRail Mini (K142546 and K150360, 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).