(90 days)
Not Found
No
The description focuses on the mechanical operation of the device and does not mention any AI or ML components or functionalities.
Yes
The device is used for the percutaneous dilation of tissue to facilitate the removal of cardiac leads, indwelling catheters, and foreign objects, which is a therapeutic intervention.
No
The device is described as a "Mechanical Dilator Sheath" intended for "percutaneous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters and foreign objects." This describes a therapeutic, interventional function, not a diagnostic one.
No
The device description explicitly states it is a "mechanical, intra-operative device" consisting of a "proximal handle drive mechanism with a distal dilation catheter" and "outer support sheath." It also describes the physical actuation of a "rotary dilation mechanism." This clearly indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate removal of cardiac leads, indwelling catheters and foreign objects" by mechanically dilating tissue. This is a direct intervention on the patient's body.
- Device Description: The description details a mechanical device with a handle, catheter, and a rotary dilation mechanism. This is a surgical/interventional tool.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition. IVDs are used in vitro (outside the body) to diagnose diseases or conditions.
The device is clearly an interventional medical device used for a therapeutic procedure (removing objects from the body).
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DRE
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 The dilator sheath is advanced, withdrawn and rotated about the lead, catheter or foreign object to be removed.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.
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 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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
APR 0 9 2014
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
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.
1
Traditional 510(k) - TightRail ™ Mechanical Dilator Sheath Set
Intended and Indications for Use
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.
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
- Shelf Life Verification Testing (6=months)
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
2
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),
3
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.
4
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
5
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)