(15 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML terms or functionalities.
Yes
The device is intended to facilitate the removal of cardiac leads, indwelling catheters, and foreign objects by dilating tissue, which is a therapeutic intervention.
No
This device is described as a mechanical, intra-operative device for the percutaneous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters, and foreign objects. Its function involves physical dilation, not the identification or assessment of a medical condition.
No
The device description clearly states it is a "mechanical, intra-operative device" consisting of a "proximal handle drive mechanism with a distal dilation catheter" and an "optional outer support sheath." The performance studies also detail physical testing like "Dimensional Verification," "Tri Coil Tensile Test," and "Corrosion Resistance Test," indicating a hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "percutaneous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters, and foreign objects." This is a surgical/interventional procedure performed directly on a patient's body.
- Device Description: The description details a mechanical device with a handle, catheter, and a rotating dilation mechanism. This is consistent with a surgical tool used for physical manipulation of tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for a therapeutic/interventional purpose.
N/A
Intended Use / 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.
Product codes
DRE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Design Verification and Validation Testing: 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 24 months, Outer Sheath Axial Load Test at 24 months, 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, 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.
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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.
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)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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3
510(k) Summary – K142546: TightRail & TightRail Mini
| 510(k) Submitter / Holder: | Spectranetics
9965 Federal Drive
Colorado Springs, CO 80921.3617
Establishment Registration No: 3007284006 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Christopher McLellan
Senior Regulatory Specialist
Office: 719.447.2475
Mobile: 719.314.8561
Fax: 719.447.2040
Email: 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
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.
4
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).