(30 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a guidewire, with no mention of AI or ML technology. The navigation system mentioned uses an embedded magnet, which is a different technology.
No.
The device description and intended use indicate it is used to introduce and position catheters and interventional devices, rather than directly treating a condition.
No
The device is a steerable guidewire used for introducing and positioning catheters and interventional devices, which are therapeutic or interventional actions, not diagnostic ones. Its description focuses on its physical characteristics and navigation rather than diagnostic capabilities.
No
The device description clearly details physical components like a guidewire, radiopaque tip, embedded magnet, and coatings, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "introducing and positioning catheters and interventional devices within the coronary and peripheral vasculature." This is an in vivo procedure, meaning it's used within a living organism.
- Device Description: The description details a physical guidewire used for navigation within blood vessels. This is a surgical/interventional tool, not a device used to test samples of bodily fluids or tissues outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing chemical or biological tests, or providing diagnostic information based on laboratory analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a tool used directly within the body for a procedural purpose.
N/A
Intended Use / Indications for Use
Titan ™ steerable guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
74HAP, 74DQX, 74JAJ, DQX
Device Description
The Titan M steerable quidewires have a nominal diameter of 0.014" and nominal lengths of 185 cm and 300cm. The wire is configured with a radiopaque distal tip and an embedded magnet used with a navigation system to navigate the wire through vasculature. The distal tip can either be straight or angled. A hydrophilic coating covers the distal portion of the wire and a PTFE coating covers the proximal end of the wire.
The quidewires will be packaged in the standard Lake Region single pack packaging configuration (one wire in a dispenser, placed in a pouch, labeled and then placed in individual cartons). There will be no changes to the sterilization process for these guidewires.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral vasculature
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)
Non-Clinical Tests:
In order to demonstrate equivalence of the Titan™ iterations, LRM and Stereotaxis performed testing to established requirements. Test pieces were tested and inspected according to established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes. The results of these tests demonstrated the functionality and performance characteristics of these guidewires are comparable to the currently marketed devices.
Biocompatibility Testing:
Biocompatibility testing has been performed on the predicate device and has been found to be applicable to the modified 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
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
MAR 2 4 2006
SECTION 2.0 - SUMMARY OF SAFETY AND EFFECTIVENESS
February 20, 2006
This summary is being included in the Premarket Notification submission in lieu of a statement of availabilitv.
| Company Name, Address, and Telephone Number: |
|---|
| Lake Region Manufacturing, Inc. (LRM) |
| 340 Lake Hazeltine Drive |
| Chaska, MN 55318 |
| Telephone: (952) 448-5111 Fax: (952) 448-3441 |
| Contact Name: Karen Mortensen |
| Manager, Regulatory Affairs |
| Establishment Registration Number: 2126666 |
Device Trade Name/Proprietary Name: Titan 100 Guidewire (Soft Support, Assert, Super Support)
Device Common Names/Usual Names and Classification Names:
These devices are commonly known as guides, guidewires, or spring guidewires. The current classification names, and product codes are Angiographic Guidewire (74HAP), Catheter Guidewire (74DQX), and Radiological Catheter Guidewire (74JAJ).
Classification of Devices:
The classification names listed above were originally classified as Class II devices by the Neurology (84HAD), Cardiovascular (74DQX), and Radiology (90JAJ) Review Panels, respectively.
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SECTION 2.0 - SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
Applicability of Performance Standards:
LRM has determined that no mandatory performance standards have been established for these devices under Section 514 of the Medical Amendments to Federal Food, Drug, and Cosmetic Act or by any subsequent regulatory action. LRM has also determined that there are no applicable voluntary standards.
Device Description:
The Titan M steerable quidewires have a nominal diameter of 0.014" and nominal lengths of 185 cm and 300cm. The wire is configured with a radiopaque distal tip and an embedded magnet used with a navigation system to navigate the wire through vasculature. The distal tip can either be straight or angled. A hydrophilic coating covers the distal portion of the wire and a PTFE coating covers the proximal end of the wire.
The quidewires will be packaged in the standard Lake Region single pack packaging configuration (one wire in a dispenser, placed in a pouch, labeled and then placed in individual cartons). There will be no changes to the sterilization process for these guidewires.
Technological Characteristics:
The design specifications are the same for these Titan ™ iterations as they a e for the Titan™ Soft Support predicate device with the exception of tip flexibility variations.
Quality System Controls:
Design Control:
LRM is in conformance with the design control procedure requirements as specified in 21 CFR 820.30. Risk analysis was completed by means of a Failure Mode and Effect Analysis (FMEA) and all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria were met.
Material/Supplier/Product/Process Controls:
LRM has formal quality systems in place to assure that each product manufactured remains equivalent to the predicate products, and that the changes will not have an adverse affect on the safe and effective use of the product. The quality systems include Engineering Change Order Review Material Qualification, Supplier Qualification, Product Qualification, and Process Qualification. These controls are applied to each product size/group.
2
Qualification Testing:
Non-Clinical Tests:
In order to demonstrate equivalence of the Titan™ iterations, LRM and Stereotaxis performed testing to established requirements. Test pieces were tested and inspected according to established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes. The results of these tests demonstrated the functionality and performance characteristics of these guidewires are comparable to the currently marketed devices.
Biocompatibility Testing:
Biocompatibility testing has been performed on the predicate device and has been found to be applicable to the modified device.
Substantial Equivalence Data:
Lake Region believes these Titan™ iterations are substantially equivalent to the Titan'™ Soft Support predicate device cleared under 510(k) K052347. Performance specification changes to the Titan™ iterations are directly related to the varying tip flexibilities of the distal end. All non-clinical test results support the claim of substantial equivalence to the predicate devices.
Intended Use Statement:
Titan ™ steerable guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
NOTE: The modification of this device does not alter its intended use.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".
Public Health Service
MAR 2 4 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lake Region Manufacturing, Inc. c/o Ms. Karen Mortensen Manager, Regulatory Affairs 340 Lake Hazeltine Drive Chaska, MN 55318
Re: K060454 Titan™ Steerable Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: II Product Code: DQX Dated: February 20, 2006 Received: February 22, 2006
Dear Ms. Mortensen:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 – Ms. Karen Mortensen
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I Dri 3 issuance or our device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any I cuttar surates und regaraments, including, but not limited to: registration and listing (21 Comply with an the Not 870 cart 801); good manufacturing practice requirements as set CFN in the quality systems (21 OFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product tastation control pro herems (seting your device as described in your Section 510(k) I mis letter will anow you we connelling of substantial equivalence of your device to a legally prematication: "The PDF intemsg sification for your device and 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 acriver 10- 9 at (240) 276-0120. Also, please note the regulation entitled, Connact the Office of Comparket notification" (21CFR Part 807.97). You may obtain Missualling by reference to premaintentibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Donna R. Lachner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
K06.454
Steerable Guidewire (Trade Name: Titan TM) Device Name:
ﻧﮯ
Indications For Use:
For use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
sumar R. V. Aunes
Sio-om
(Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K060454
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