(28 days)
Not Found
No
The device description focuses on mechanical and electrical components and their functions (motorized rotation, dilation, etc.). There is no mention of data processing, algorithms, or learning capabilities.
Yes
The device is intended for the percutaneous dilation of tissue to facilitate removal of cardiac leads, which is a therapeutic intervention.
No
The device description indicates its purpose is to "facilitate removal of cardiac leads" through "dilation of tissue." There is no mention of the device being used to identify, measure, or monitor a medical condition.
No
The device description clearly outlines multiple physical components (Drive Assembly, Dilation Extension Selection Assembly, Motor Drive Handle, Outer Sheath Accessory, Fish Tape Accessory) and describes mechanical actions (motor activation, rotation of inner shaft and cam blade, dilation of tissue). This 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 "for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads." This describes a surgical or interventional procedure performed directly on a patient's body.
- Device Description: The device description details a mechanical device with a motor, blades, and sheaths designed to physically interact with tissue. This is consistent with a surgical or interventional tool.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide diagnostic information about a patient's condition.
- Anatomical Site: The anatomical site is "tissue to facilitate removal of cardiac leads," which is a location within the body, not a sample taken from the body.
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 Guardian motorized dilator sheath is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads.
Product codes (comma separated list FDA assigned to the subject device)
DRE
Device Description
The TightRail Guardian motorized dilator sheath is a sterile, single use, prescription only device used for cardiac leads. The device is comprised of:
-
- Drive Assembly
-
- Dilation Extension Selection (DES) Assembly
-
- Motor Drive Handle
-
- Outer Sheath Accessory
-
- Fish Tape Accessory
The motorized dilator sheath is advanced or retracted along the target lead to be removed. Pulling the trigger on the handle of the TightRail Guardian device results in activation of the motor and subsequent rotation of the inner shaft and cam blade. Triager activation results in bidirectional rotation mechanism. Actuation of the distal dilation mechanism causes dilation of tissue and fibrous attachments surrounding the lead tarqeted for removal, thereby facilitating removal of said lead. The device has two modes of operation, providing dilation with the blades shielded or extended. The diameter sizes range from 9 French (F) to 13 F. The nominal effective length of the TightRail Guardian is 47.5 cm. The outer sheath accessory may be used for additional support by creating a conduit for the device's shaft assembly. The outer sheath may also be used to maintain venous access for quidewire placement, prior to implantation of a new lead. The fish tape accessory may be used to feed a target lead and locking stylet through the inner lumen of the device.
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:
Design Verification and Validation Testing
- Simulated Use Testing ●
- Simulated Environment Testing
- Human Factors Evaluation
- Linear and Radial Dimensional Testing ●
- Device Weight Measurement ●
- Blade Extension Testing ●
- Atraumatic Surface Testing
- Axial Load Testing
- Tensile Testing ●
- Flexibility Testing ●
- . Outer Sheath Compression Testing
- EMC/EMI and Electrical Medical Safety Testing
- . Radiopacity Evaluation
Sterilization
- Product adoption equivalency per AAMI TIR28:2016 ●
Biocompatibility
- Cytotoxicity
- Sensitization
- Irriation/Intracutaneous Reactivity ●
- Material Mediated Pyrogenicity
- Acute Systemic Toxicity ●
- Indirect and Direct Hemolysis ●
- Hemocompatibility ●
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 (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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The text is in blue, with "FDA" in a larger font size and enclosed in a blue square.
December 15, 2022
Spectranetics Inc. Jordan Baum Regulatory Affairs Specialist 9965 Federal Drive Colorado Springs, Colorado 80921
Re: K223472
Trade/Device Name: TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013) Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator For Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: November 17, 2022 Received: November 17, 2022
Dear Jordan Baum:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Hetal B. Patel -S
Hetal Odobasic Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
TightRail Guardian Motorized Dilator Sheath, 9 French (575-009);
TightRail Guardian Motorized Dilator Sheath, 11 French (575-011);
TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)
Indications for Use (Describe)
The TightRail Guardian motorized dilator sheath is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
Image /page/3/Picture/0 description: The image shows the Spectranetics logo. The logo consists of a blue geometric shape to the left of the word "Spectranetics" in blue, stylized font. Below the company name is the tagline "Always Reaching Farther" in a smaller, sans-serif font.
510(k) Summary
This 510(k) summary was prepared in accordance with 21 CFR 807.92(c) Prepared on 17 November 2022
| 510(k) Submitter / Holder: | Spectranetics
9965 Federal Drive
Colorado Springs, CO 80921.3617
Establishment Registration No: 3007284006 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Jordan Baum
Regulatory Affairs Specialist
Mobile: (719) 247-0183
Fax: (719) 447-2070
Email: Jordan.Baum@philips.com |
Subject Device
| Device Trade Name: | TightRail Guardian Motorized 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: | 575-009, 575-011, 575-013 |
Predicate Devices
The TightRail Guardian Motorized Dilator Sheath is being compared to the following legally marketed predicate devices:
TightRail Guardian Motorized Dilator Sheath
| 510(k) Number: | K212784 (cleared 24 August 2022) |
|---|---|
| Manufacturer: | The Spectranetics Corporation |
| Trade Name: | TightRail Guardian Motorized Dilator Sheath |
| Device Common Name: | Sheath |
Intended and Indications for Use
The TightRail Guardian Motorized Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads.
Device Description
The TightRail Guardian motorized dilator sheath is a sterile, single use, prescription only device used for cardiac leads. The device is comprised of:
-
- Drive Assembly
4
Image /page/4/Picture/0 description: The image shows the Spectranetics logo. The logo consists of a blue diamond shape with a white circle in the center, followed by the word "Spectranetics" in blue, and the tagline "Always Reaching Farther" in a smaller font size below the word "Spectranetics". The logo is clean and modern, and the blue color gives it a sense of trust and reliability.
-
- Dilation Extension Selection (DES) Assembly
-
- Motor Drive Handle
-
- Outer Sheath Accessory
-
- Fish Tape Accessory
The motorized dilator sheath is advanced or retracted along the target lead to be removed. Pulling the trigger on the handle of the TightRail Guardian device results in activation of the motor and subsequent rotation of the inner shaft and cam blade. Triager activation results in bidirectional rotation mechanism. Actuation of the distal dilation mechanism causes dilation of tissue and fibrous attachments surrounding the lead tarqeted for removal, thereby facilitating removal of said lead. The device has two modes of operation, providing dilation with the blades shielded or extended. The diameter sizes range from 9 French (F) to 13 F. The nominal effective length of the TightRail Guardian is 47.5 cm. The outer sheath accessory may be used for additional support by creating a conduit for the device's shaft assembly. The outer sheath may also be used to maintain venous access for quidewire placement, prior to implantation of a new lead. The fish tape accessory may be used to feed a target lead and locking stylet through the inner lumen of the device.
Technological Characteristics
The TightRail Guardian device features a battery powered dilation mechanism and two dilation modes (Shielded, Extended). The dilation mechanism is activated through a trigger on the device handle. The shaft of the dilator sheath is designed from laser-cut stainless steel hypotubes to provide columnar stability during device advancement and actuation. The laser-cuts are progressively increased across the shaft, to provide additional flexibility toward the distal tip of the dilator sheath.
The TightRail Guardian Motorized Dilator Sheath features the same performance characteristics and overall design as the predicate device (K212784). There are no changes to the principle of operation and no changes to the intended use.
5
Image /page/5/Picture/0 description: The image shows the Spectranetics logo. The logo consists of a blue diamond shape with a white center, followed by the word "Spectranetics" in blue, bold font. Below the company name is the tagline "Always Reaching Farther" in a smaller, lighter blue font. The logo is clean and modern, conveying a sense of innovation and progress.
Performance Data
The following testing was conducted to validate and verify that the subject device met all specifications:
Design Verification and Validation Testing
- Simulated Use Testing ●
- Simulated Environment Testing
- Human Factors Evaluation
- Linear and Radial Dimensional Testing ●
- Device Weight Measurement ●
- Blade Extension Testing ●
- Atraumatic Surface Testing
- Axial Load Testing
- Tensile Testing ●
- Flexibility Testing ●
- . Outer Sheath Compression Testing
- EMC/EMI and Electrical Medical Safety Testing
- . Radiopacity Evaluation
Sterilization
- Product adoption equivalency per AAMI TIR28:2016 ●
Biocompatibility
- Cytotoxicity
- Sensitization
- Irriation/Intracutaneous Reactivity ●
- Material Mediated Pyrogenicity
- Acute Systemic Toxicity ●
- Indirect and Direct Hemolysis ●
- Hemocompatibility ●
Pre-clinical 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 currently in use, and the performance data, the use of the TightRail Guardian device for the proposed indication does not raise new questions related to safety and effectiveness compared with the predicate. Therefore, TightRail Guardian is substantially equivalent to the TightRail Guardian device cleared under K212784.