(96 days)
No
The device description and performance studies focus on mechanical properties and physical performance, with no mention of AI or ML.
No.
The device is described as a percutaneous wire stylet used for the extraction of chronically implanted pacing or defibrillator leads, which is a procedural tool rather than a device that provides therapy for a medical condition.
No
Explanation: The device is used for the physical removal of chronically implanted leads, acting as a fixation mechanism to provide traction for lead extraction. It does not diagnose any condition or disease.
No
The device description clearly outlines physical components such as wire stylets, wire loop handles, a core mandrel, stainless steel mesh, a radiopaque marker, a proximal connector, a platinum/iridium coil, and tin/silver solder. The performance studies also describe bench testing of physical properties and mechanical joints. 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:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Spectranetics LLD E is a percutaneous wire stylet used inside a chronically implanted pacing or defibrillator lead within the patient's body. Its purpose is to provide fixation and traction for the physical removal of the lead.
- Intended Use: The intended use clearly describes a procedure performed in vivo (within the living body) for the removal of a medical device. It does not involve the analysis of biological specimens.
Therefore, the Spectranetics LLD E is a surgical/interventional device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Spectranetics LLD E is intended for use in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads having an inner lumen and using the superior venous approach. The lead inner lumen must have an inner diameter (ID) range from 0.015 -0.026 inches (0.38 - 0.66 mm) and a length less than 33.5 inches (85 cm).
Product codes
DRB
Device Description
The Spectranctics LI.D E is a percutaneous wire stylets that are placed inside the central lumen of a pacemaker or defibrillator lead as a fixation mechanism to provide traction for the extraction of the lead.
The Spectranctics LLD E is comprised of two (2) wire loop handles and a core mandrel that has a stainless steel mesh fixation mechanism. This mesh is attached at the distal end within a radiopaque marker for visibility under fluoroscopy. The proximal end of the mesh is attached to a proximal connector that is used to deploy and lock the device into the pacing or defibrillator lead.
The proximal connector is seated on a crimped section of the core mandrel until it is deployed. The connector slides from the crimped section and deploys the mesh inside the lead.
The tip of the LLD E is comprised of a platinum/iridium coil that is affixed to the tapered tip with the use of tin/silver solder. This coil allows the stylet better maneuverability around tight curves as compared to the predicate device. The platinum/iridium materials of the coil also allow for visualization of the stylet tip under fluoroscopy.
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)
Bench Testing:
Physical testing was performed on the mechanical joints and overall design of the LLD E stylet to verify the physical properties of the device. Testing consisted of the following: fatigue testing the locking and unlocking performance of the stylet, tensile strength of the solder joints. Test results indicate that the samples tested passed the fatigue and strength test for the LLD E design.
Performance testing was conducted to verify the performance properties of the LLD E stylet. Testing consisted of lead tracking capability, and lead locking and unlocking capability using an anatomical model. Test results indicate that the LLD E stylet tracked through an anatomical model very well through both a simulated 0.015 inch ID and a 0.026 inch ID lead inner lumen. Test results also indicated that the LLD E adequately locked and unlocked both sizes of leads.
Shelf Life testing was conducted to verify the performance of the LLD E design after accelerated aging and shipping distribution testing was conducted to verify the acceptable function and appearance of the device and its packaging after simulated shipping. Acceptable function and appearance of the LLD E stylet design was confirmed after accelerated aging and shipping distribution testing.
Testing was conducted to confirm that the biocompatibility of the LLD E stylet is substantially equivalent to the predicate device, the LLD stylet. Test results indicate that LLD E is substantially equivalent to the LLD stylet design in regards to device biocompatibility.
Radiopacity testing was conducted to verify the radiopacity of the LLD E stylets. Test results indicate that the LLD E is more visible that the LLD stylets.
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
§ 870.1380 Catheter stylet.
(a)
Identification. A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.(b)
Classification. Class II (performance standards).
0
MAR 1 6 2005
04 3401
page 1 of 4
510(k) Summary
1) Submitter Information
| Company Name: | The Spectranetics Corporation |
|---|---|
| Company Address: | 96 Talamine Court |
| Colorado Springs, CO 80907 | |
| Company Phone: | (719) 633-08333/(800) 633-0960 |
| Company Fax: | (719) 442-2481 |
| Contact Person: | Adrian Elfe |
| V.P. QA/RA | |
| Date Prepared: | 11 February 2005 |
| 2) Identification | |
| Device Trade Name: | Spectranetics Lead Locking Device E (LLD E). |
| Device Common Name: | Locking stylet |
| Classification Name: | Stylet, Catheter, CFR 870.1380 |
Class II Device Class:
Device Code: DRB
3) Identification of Predicate Devices
The Spectranetics LLD E stylets are similar in design, construction, indications, target population, risk analysis, performance, and materials to the predicate devices, the Spectranetics LLD stylets, K990713.
4) Device Description
The Spectranctics LI.D E is a percutaneous wire stylets that are placed inside the central lumen of a pacemaker or defibrillator lead as a fixation mechanism to provide traction for the extraction of the lead.
The Spectranctics LLD E is comprised of two (2) wire loop handles and a core mandrel that has a stainless steel mesh fixation mechanism. This mesh is attached at the distal end within a radiopaque marker for visibility under fluoroscopy. The proximal end of the mesh is attached to a proximal connector that is used to deploy and lock the device into the pacing or defibrillator lead.
1
043401
page 2 of 4
The proximal connector is seated on a crimped section of the core mandrel until it is deployed. The connector slides from the crimped section and deploys the mesh inside the lead.
The tip of the LLD E is comprised of a platinum/iridium coil that is affixed to the tapered tip with the use of tin/silver solder. This coil allows the stylet better maneuverability around tight curves as compared to the predicate device. The platinum/iridium materials of the coil also allow for visualization of the stylet tip under fluoroscopy.
5) Intended Use
The Spectranetics LLD E is intended for use in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads having an inner lumen and using the superior venous approach. The lead inner lumen must have an inner diameter (ID) range from 0.015 -0.026 inches (0.38 - 0.66 mm) and a length less than 33.5 inches (85 cm).
6) Comparison to Predicate Device
Substantial Equivalence Summary:
The Spectranetics LLD E stylet is equivalent to the predicate device, the current Spectranetics LLD stylets, in materials design, and configuration, except for the following minor enhancements to the LLD E:
Wire Loop Handles:
The Spectranetics LLD E is comprised of two (2) stainless steel wire loop handles. The predicate devices (LLD stylets) are comprised of one stainless steel wire hoop handle and a stainless steel suture cleat. The second wire hoop on the LLD E fulfills the same function (serves as a suture tie down point) as the suture cleat on the predicate devices.
Dimensions:
The maximum tip diameter for the LLD E is 0.015 inches whereas the maximum tip diameters for the LLD # 1 and LLD #2 (predicate devices) is 0.013 and 0.017 inches respectively. The maximum body diameter for the LLD E is 0.015 inches whereas the maximum body diameter for the LLD #1 and the LLD #2 is 0.0135 and 0.0175 inches respectively.
Length:
The has a minimum working length of 85 centimeters whereas the predicate LLD devices have a minimum working length of 65 centimeters. Working length refers to the length of the locking mesh. The overall length of the LLD E stylet is equivalent to the overall length of the LLD stylets, 135 cm.
2
K04 3401
page 3 of 4
Distal Tip:
The tip of the LLD E stylet has been designed for more flexibility so as to improve the tractability of the stylet in pacing and defibrillator leads.
Tin/silver solder is used to secure a platinum/iridium coil to the distal tip of the LLD E stylet. The platinum iridium coil is approximately 1 centimeter in length and is wound over the stainless steel core mandrel. The coil is secured on its other end to the distal marker band by another tin/silver solder joint. Tin/silver solder is used to secure the stainless steel mesh braid to the distal marker band. The distal marker band is approximately 1 centimeter from the proximal tip of the LLD E stylet.
In contrast an epoxy plug is used to secure the stainless steel mesh braid to the tip of the stylet for the LLD predicate devices. Directly behind the epoxy plug is the distal marker band that is also secured to the stainless steel mesh braid and core mandrel by the epoxy adhesive. This design makes for a stiffer tip (approximately 2 cm.) that can limit the tractability of the predicate devices.
Bench Testing:
Physical testing was performed on the mechanical joints and overall design of the LLD E stylet to verify the physical properties of the device. Testing consisted of the following: fatigue testing the locking and unlocking performance of the stylet, tensile strength of the solder joints. Test results indicate that the samples tested passed the fatigue and strength test for the LLD E design.
Performance testing was conducted to verify the performance properties of the LLD E stylet. Testing consisted of lead tracking capability, and lead locking and unlocking capability using an anatomical model. Test results indicate that the LLD E stylet tracked through an anatomical model very well through both a simulated 0.015 inch ID and a 0.026 inch ID lead inner lumen. Test results also indicated that the LLD E adequately locked and unlocked both sizes of leads.
Shelf Life testing was conducted to verify the performance of the LLD E design after accelerated aging and shipping distribution testing was conducted to verify the acceptable function and appearance of the device and its packaging after simulated shipping. Acceptable function and appearance of the LLD E stylet design was confirmed after accelerated aging and shipping distribution testing.
Testing was conducted to confirm that the biocompatibility of the LLD E stylet is substantially equivalent to the predicate device, the LLD stylet. Test results indicate that LLD E is substantially equivalent to the LLD stylet design in regards to device biocompatibility.
Radiopacity testing was conducted to verify the radiopacity of the LLD E stylets. Test results indicate that the LLD E is more visible that the LLD stylets.
3
01 3401
page Hof4
Conclusion:
The Spectranetics LLD E stylet is similar in basic design, construction, mechanical safety, indications, target population, risk analysis, performance, and materials to the predicate device. The Spectranetics New Product Introduction procedure has been faithfully followed in concert with the Quality System Regulations for new product introduction. The Company's design validation protocols, the Company's Risk Management System, and the Design Failure Mode Effects Analysis addressed all known risks associated with the device including tensile strength, bond joints, tracking, locking and unlocking, visibility, and biocompatibility. Testing performed for the LLD E provides reasonable assurance that the device will perform in a safe and effective manner when used as indicated.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
MAR 16 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
The Spectranetics Corp. c/o Mr. Michael J. Ryan RA Manager 96 Talamine Court Colorado Springs, CO 80907-5186
Re: K043401
Trade Name: Spectranetics LLD E stylet Regulation Number: 21 CFR 870.1380 Regulation Name: Catheter Stylet Regulatory Class: Class II Product Code: DRB Dated: February 15, 2005 Received: February 16, 2005
Dear Mr. Ryan:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we have reviewed your Section 910(t) premained is substantially equivalent (for the indications
referenced above and have determined the device is substanted in interests to referenced above and nave determined the acteded predicate devices marketed in interstate for use stated in the encrosule) to regally manative performedical Device Amendments, or to commerce prior to May 28, 1970, the charities with the provisions of the Federal Food, Drug.
devices that have been reclassified in accordance with the provisions of the Unit devices that have been recials in acceranted while a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act. The and Cosmelle Act (Act) that do not require approvate of the general controls provisions of the Act. The
You may, therefore, market the device, subject to the generation, l You may, therefore, market the devices, seeject to the more of the may be and general controls provisions of the Fiel merclass required.
devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FDA may be subject to such additional ochitorial Claims of the 21, Parts 800 to 898. In addition, FDA may be found in the Code of Peachar reegening your device in the Federal Register.
5
Page 2 -- Mr. Michael J. Ryan
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualities with other requirements of the Act
that FDA has made a determination that your device complies with other must that FDA has made a decommation that your as ross overprises. You must or any Federal statures and regulations damindered of registration and listing (21 )
comply with all the Act's requirements, including, but not limited to set comply with an the Act s requirements, newards, and many of the requirements as set CFR Part 807); labeling (21 CFR Part 801); good if applicable, the electronic forth in the quality systems (QD) regalized (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1 product radiation control provisions (occions 511 vize as described in your Section 510(k)
This letter will allow you to begin marketing your device as described in a logol I his letter will anow you to ocgin maneting your antial equivalence of your device to a legally premarket notification. The PDA inding of substantial organisand thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your ac-100 cm. Also, please note the regulation entitled, contact the Office of Complance at (210) 276-676-17 (21CFR Part 807.97). You may obtain "Misbranding by reference to promants notifican international the Act from the Division of Small other general Information on your responsible in to toll-free number (800) 638-2041 or and consectlingencertlingency btml Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bimmermanfor
B. R. Zimmerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K043401
Spectranetics LLD E Stylet Device Name:
Indications For Use:
The Spectranetics LLD E is intended for use in patients suitable for transvenous removal i he Spectrailences LLD E is micheed for ass having an inner lumen and using the of chromeany implained puoning of doner have an inner diameter (ID) range superior venous approach. "The fead Miror Al and a length less than 33.5 inches (85 cm).
Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blummenstiel
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number
Page 1 of