TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath

K142546 · Spectranetics, Inc. · DRE · Sep 25, 2014 · Cardiovascular

Device Facts

• Record ID: K142546
• Device Name: TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath
• Applicant: Spectranetics, Inc.
• Product Code: DRE · Cardiovascular
• Decision Date: Sep 25, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Mechanical intra-operative device for percutaneous tissue dilation. Consists of proximal handle drive mechanism and distal dilation catheter; optional outer support sheath included. Physician operates device by advancing, withdrawing, and rotating sheath about target object (cardiac lead, catheter, or foreign object). Trigger actuation on handle translates rotation to axial movement of distal dilation mechanism via internal cam path. Distal mechanism dilates fibrous tissue attachments surrounding target, facilitating removal. Used in clinical settings. Benefits patient by enabling removal of indwelling objects through minimally invasive percutaneous approach.

Clinical Evidence

No clinical data required. Substantial equivalence demonstrated via bench testing, including dimensional verification, tensile/torsional testing, axial load testing, radio-detectability, corrosion resistance, simulated use, and package integrity. Biocompatibility testing included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, complement activation, hemolysis, ovine thrombogenicity model, genotoxicity, and material-mediated pyrogenicity.

Technological Characteristics

Mechanical vessel dilator. Sizes 9F to 13F. Effective lengths: 47.5 cm (TightRail), 15.5 cm (TightRail Mini). Features proximal handle with trigger-actuated rotary dilation mechanism and distal cam path. Sterilization per AAMI TIR:28-2009. No software or electronic components.

Indications for Use

Indicated for patients requiring percutaneous tissue dilation to facilitate removal of cardiac leads, indwelling catheters, and foreign objects.

Regulatory Classification

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.

Predicate Devices

• TightRail and TightRail Mini Rotating Dilator Sheaths (K140047)
• TightRail and TightRail Mini Rotating Dilator Sheaths (K141131)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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

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

See PRA Statement below.

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

| 510(k) Submitter / Holder: | Spectranetics<br>9965 Federal Drive<br>Colorado Springs, CO 80921.3617<br>Establishment Registration No: 3007284006 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Christopher McLellan<br>Senior Regulatory Specialist<br>Office: 719.447.2475<br>Mobile: [phone]<br>Fax: [phone]<br>Email: [e-mail] |

#### 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)<br>K141131 (cleared 23 May 2014) |
|---------------------|-----------------------------------------------------------------|
| Manufacturer: | Spectranetics |
| Trade Name: | TightRail and TightRail Mini Rotating Dilator Sheaths |
| Device Common Name: | Sheath |

#### 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.

#### Intended and Indications for Use

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.

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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).