(22 days)
No
The description focuses on mechanical and material properties, with no mention of AI or ML.
No.
The device facilitates the removal of objects by dilating tissue, which is a procedural aid, not a treatment or therapy for a disease or condition itself.
No
The device is intended for the percutaneous dilation of tissue to facilitate the removal of cardiac leads, indwelling catheters, and foreign objects. It is a tool for physical intervention, not for identifying a condition or disease.
No
The device description clearly outlines a physical, intra-operative device with a handle, sheath, and mechanical components for dilation, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the percutaneous dilation of tissue to facilitate the removal of cardiac leads, indwelling catheters, and foreign objects. This is a surgical or interventional procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as an "intra-operative device" that physically interacts with tissue to dilate it. This aligns with a surgical tool, not a diagnostic device.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the mechanical and physical properties of the device (tensile strength, torsional strength, axial load, etc.) and its biocompatibility, which are typical for surgical or interventional devices. There are no studies related to diagnostic accuracy (sensitivity, specificity, etc.).
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
DRE
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").
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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* .
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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
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").
1
Intended and Indications for Use
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
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* .
2
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).
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human services.
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.
4
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,
Image /page/4/Picture/8 description: The image shows a logo with the letters FDA. The letters are stylized and overlapping. The logo is black and white and appears to be a vectorized image.
forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
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)
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.
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)
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,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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