(87 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a microwire guide, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a microwire guide intended to facilitate the delivery of other catheters, not to provide therapy itself.
No
Explanation: The device is intended for facilitating the delivery of percutaneous catheters, which is a therapeutic rather than a diagnostic function. The description and performance studies focus on mechanical properties and biocompatibility relevant for a guidewire, not on detecting or characterizing medical conditions.
No
The device description clearly states it is a physical microwire guide made of nitinol with a polymer coating, indicating it is a hardware device. The performance studies also focus on physical properties like torque, flexibility, and tensile strength.
Based on the provided information, the Alight™ 16 Superselective Microwire Guides are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "facilitate delivery of percutaneous catheters into the peripheral vasculature." This describes a device used within the body for a procedural purpose, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details the physical characteristics of a wire guide used for navigation within blood vessels. This aligns with an interventional medical device, not an IVD.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Alight™ 16 Superselective Microwire Guides do not fit this description.
N/A
Intended Use / Indications for Use
Alight™ 16 Superselective Microwire Guides are intended for use in facilitating delivery of percutaneous catheters into the peripheral vasculature.
Product codes
DQX
Device Description
Alight™ 16 Superselective Microwire Guides are 0.016 inches (0.41 mm) in diameter and are available in a variety of lengths and configurations. The core mandril of the Alight Superselective Microwire Guides is made of nitinol with a polymer coating and spans the entire length of the device to help facilitate flexibility and torqueability. The distal length of the device is covered with a hydrophilic coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
The Alight™ 16 Superselective Microwire Guide was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:
- Torque Response ~ Testing shows that all test articles were successfully subjected to 1. rotational response testing. The predetermined acceptance criteria were met.
- Hydrated Lubricity Testing shows that the peak force of all test articles was less 2. than the predetermined acceptance criteria.
- Flexing Evaluation No flaking was witnessed after testing. The predetermined 3. acceptance criteria were met.
-
- Fracture Evaluation - Testing shows that all test articles underwent bending testing without showing signs of fracture. The predetermined acceptance criteria were met.
- Torque Strength Evaluation Testing verifies that the device is sufficiently strong to न. withstand normal rotational loading for intended use. The predetermined acceptance criteria were met.
- Tensile Evaluation Testing verifies that the wire guide is sufficiently strong to 6. withstand normal tensile loading for intended use in accordance with ISO 11070:2009. The predetermined acceptance criteria were met.
- Tip Flexibility Evaluation Testing was completed for characterization purposes only 7. and therefore did not have a set acceptance criterion. The testing showed that the wire guide is sufficiently strong to withstand normal tensile loading for its intended use.
- Biocompatibility Testing (i.e., cytotoxicity, sensitization, intracutaneous reactivity, 8. systemic toxicity, pyrogen, hemocompatibility, complement activation, partial thromboplastin time, and thromboresistance) shows the device is biocompatible. In conformance with the applicable sections of ISO 10993-1, the predetermined acceptance criteria were met.
In conclusion, the results of these tests provide reasonable assurance that the device is as safe and effective as the predicate device and support a determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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K123707
p. 1 of 2
Page 22
FEB 2 8 2013
Special 510(K) Premarket Notification Alight" 16 Superselective Microwire Guides Cook Incorporated 30 November 2012
510(k) Summary
Submitted By:
David Lehr Cook Incorporated 750 Daniels Way Bloomington, IN 47404
Device:
Trade Name: Proposed Classification:
Alight™ 16 Superselective Microwire Guides Wire, Guide, Catheter DQX (21 CFR §870.1330)
Indications for Use:
Alight" 16 Superselective Microwire Guides are intended for use in facilitating delivery of percutaneous catheters into the peripheral vasculature.
Predicate Device:
Cook Incorporated's Alight™ 16 Superselective Microwire Guide is identical in terms of intended use and similar in terms of principles of operation, materials of construction, and technological characteristics to the predicate device, subject of this submission, is substantially equivalent to the Roadrunner UniGlide Hydrophilic Wire Guide, manufactured by Cook Incorporated, which is cleared under 510(k) number K110009 (February 2, 2011).
Comparison to Predicate Device:
It has been demonstrated that the Alight™ 16 Superselective Microwire Guide is comparable to its predicate device in terms of design, intended use, materials, fundamental technology, and principle of operation.
Device Description:
Alight™ 16 Superselective Microwire Guides are 0.016 inches (0.41 mm) in diameter and are available in a variety of lengths and configurations. The core mandril of the Alight Superselective Microwire Guides is made of nitinol with a polymer coating and spans the entire length of the device to help facilitate flexibility and torqueability. The distal length of the device is covered with a hydrophilic coating.
1
K123707
P. 2 of 2
Page 23
Special 510(K) Premarket Notification . Alight™ 16 Superselective Microwire Guides Cook Incorporated 30 November 2012
Test Data:
The Alight" 16 Superselective Microwire Guide was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:
- Torque Response ~ Testing shows that all test articles were successfully subjected to 1 . rotational response testing. The predetermined acceptance criteria were met.
- Hydrated Lubricity Testing shows that the peak force of all test articles was less 2. than the predetermined acceptance criteria.
- Flexing Evaluation No flaking was witnessed after testing. The predetermined 3. acceptance criteria were met.
-
- Fracture Evaluation - Testing shows that all test articles underwent bending testing without showing signs of fracture. The predetermined acceptance criteria were met.
- Torque Strength Evaluation Testing verifies that the device is sufficiently strong to న. withstand normal rotational loading for intended use. The predetermined acceptance criteria were met.
- Tensile Evaluation Testing verifies that the wire guide is sufficiently strong to 6. withstand normal tensile loading for intended use in accordance with ISO 11070:2009. The predetermined acceptance criteria were met.
- Tip Flexibility Evaluation Testing was completed for characterization purposes only 7. and therefore did not have a set acceptance criterion. The testing showed that the wire guide is sufficiently strong to withstand normal tensile loading for its intended use.
- Biocompatibility Testing (i.e., cytotoxicity, sensitization, intracutaneous reactivity, 8. systemic toxicity, pyrogen, hemocompatibility, complement activation, partial thromboplastin time, and thromboresistance) shows the device is biocompatible. In conformance with the applicable sections of ISO 10993-1, the predetermined acceptance criteria were met.
In conclusion, the results of these tests provide reasonable assurance that the device is as safe and effective as the predicate device and support a determination of substantial equivalence.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
February 28. 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Public Health Service
Cook Incorporated c/o Mr. David Lehr, Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404
Re: K123707
Trade Name: Alight™ 16 Superselective Microwire Guides Regulation Number: 21 CFR 870.1330 Regulation Name: Wire, Guide, Catheter Regulatory Class: Class II Product Code: DOX Dated: January 31, 2013 Received: February 4, 2013
Dear Mr. Lehr:
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.
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 (reporting of medical device-related adverse events) (21 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.
3
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportaProblem/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,
Matthew G¶레illebrenner
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Special 510(K) Premarket Notification Alight™ 16 Superselective Microwire Guides Cook Incorporated 30 November 2012
510(k) Number (if known):
Device Name: Alight™ 16 Superselective Microwire Guides
Indications for Use:
Alight™ 16 Superselective Microwire Guides are intended for use in facilitating delivery of percutaneous catheters into the peripheral vasculature.
Prescription Use X (Per 21 CFR 801 Subpart D) 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)
Matthew G퀘訓lebrenner