(232 days)
No
The summary describes a mechanical device (wire stylet) for lead extraction and does not mention any AI/ML terms or functionalities.
No
The device is used for the "transvenous removal of chronically implanted pacing or defibrillator leads" which is a surgical or procedural tool for extraction, not for treating a disease or condition itself.
No
Explanation: The device is described as a "percutaneous wire stylet" used as a "fixation mechanism to provide traction for the extraction of the lead." Its purpose is to aid in the removal of existing leads, not to diagnose a condition or disease.
No
The device description clearly states it is a "percutaneous wire stylet," which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (inside the body) for the physical removal of implanted leads. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to diagnose or monitor medical conditions.
- Device Description: The description details a "percutaneous wire stylet" placed inside a lead within the body. This is a surgical or interventional device, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis.
Therefore, the Spectranetics Lead Locking Devices, LLD™, are medical devices used for a therapeutic procedure, not IVDs.
N/A
Intended Use / Indications for Use
The Spectranetics Lead Locking Devices, LLD™, are intended for use in patients suitable for transvernous removal of chronically implanted pacing or defibrillator leads having an inner lumen and using a superior venous approach. The lead inner lumen must have an inner diameter (ID) range from 0.013 - 0.032 inches (0.33 - 0.81 mm) and a length less than 25.6 inches (65 cm).
Product codes
DRB
Device Description
Lead Locking Devices are percutaneous wire stylets which 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.
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 design validation protocols and the Design Failure Mode, Effect and Criticality Analysis (FMECA), addressed all known risks associated with the device including tensile strength, bond joints, tracking, locking and unlocking, visibility, trackability and biocompatibility. Testing performed for the Lead Locking Device provides reasonable assurance that the devices will perform in a safe and effective manner when used as indicated.
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).
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OCT 22 1999
Image /page/0/Picture/2 description: The image shows the word "Spectranetics" in a bold, sans-serif font. The letters are black and the background is white. The word is centered and takes up most of the image.
BRILLIANCE IN INTERVENTIONAL THERAPY
Submitted By:
Michael J. Quinn Director of Regulatory Affairs Spectranetics Corporation 96 Talamine Court Colorado Springs, CO 80907 Signature and Date:
510(k) Summary
Device Trade Name:
Spectranetics Lead Locking Device is referred to as "LLD™." The generic name for this device is locking stylet.
Lead Locking Devices are percutaneous wire stylets which 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. Predicate devices of this type with similar intended uses have been classified into Class I or Class II.
Substantial Equivalence:
This product is similar in design, composition, and function to the Wilkoff Locking Stylet, 510(k) Number K970690.
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA1990 and 21 CFR 807.92.
The Spectranetics LLD devices are similar in basic design, construction, mechanical safety, indications, target population, risk analysis, performance and materials to the predicate device. Spectranetics New Product Introduction procedure has been faithfully followed in concert with the quality systems requlations for new product introduction. The design validation protocols and the Design Failure Mode, Effect and Criticality Analysis (FMECA), addressed all known risks associated with the device including tensile strength, bond joints, tracking, locking and unlocking, visibility, trackability and biocompatibility. Testing performed for the Lead Locking Device provides reasonable assurance that the devices will perform in a safe and effective manner when used as indicated.
THE SPECTRANETICS CORPORATION 201 · COLORADO SELLIB SELLING . 8623 - 5 - 3 - 3 33 8333 · 800 632 9260 · 7 : 0 : 0 2 9 9 2 8
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure or a bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 22 1999
Mr. Michael J. Quinn Director of Regulatory Affairs Spectranetics Corporation 96 Talamine Court Colorado Springs, CO 80907
Re : K990713
Spectranetics Lead Locking Device (LLD™) and Trade Name: Accessories Regulatory Class: II Product Code: DRB Dated: July 23, 1999 Received: July 26, 1999
Dear Mr. Quinn:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements concerning action. your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation
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Page 2 - Mr. Quinn
you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) Additionally, for questions on the promotion and advertising 594-4586. of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Ath. A. Ciarkowski.
J. Wolf Sapirstein, M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/3 description: The image shows the word "Spectranetics" in a bold, sans-serif font. The letters are black and appear to be slightly distressed, giving them a textured look. The word is the main focus of the image and is prominently displayed.
BRILLIANCE IN INTERVENTIONA! THERAPY
510(k) Number: K990713
Device Name:
Spectranetics Lead Locking Device
The Spectranetics Lead Locking Devices, LLD™, are intended for use in patients suitable for transvernous removal of chronically implanted pacing or defibrillator leads having an inner lumen and using a superior venous approach. The lead inner lumen must have an inner diameter (ID) range from 0.013 - 0.032 inches (0.33 - 0.81 mm) and a length less than 25.6 inches (65 cm).
Christopher to Sapirstein
THE SPECTRANETICS CORPORATION 96 TALAMINE COURT · COLORADO SFRINGS, CCLORACO 80907-5186 11 710 672 0229 . 000 123 0040 . 1