(281 days)
The Safe-Steer™ Guide Wire System is indicated for use in facilitating the placement of catheters used in percutaneous interventions in native coronary arteries with total occlusions.
The IntraLuminal Therapeutics, Inc. SAFE-STEER™ Guide Wire System is comprised of a sterile single-use guide wire with an integrated optical fiber. The guide wire is used with a support catheter of choice that will accommodate a .014" guidewire. The optical fiber in the guide wire is connected to a reusable Optical Coherence Reflectometry (OCR). The guide wire core has an embedded optical fiber that transmits near infrared light and the reflection is relayed back to the OCR unit and then a unique intensity versus distance measurement is exhibited on the OCR display. The trace of the slope on the OCR display distinguishes the distance from the tip of the wire and the vessel wall. The display output exhibits the relative distance between the wire tip and vessel wall. The guide wire is provided in lengths of 175 cm and 275 cm long and has a diameter of 0.014" with a lubricious hydrophilic coating in the distal region. The guide wire is sterilized by ethylene oxide and packaged to maintain the sterile barrier.
The provided document is a 510(k) premarket notification for the SAFE-STEER™ Guide Wire System. It details the device, its intended use, and claims substantial equivalence to predicate devices, but it does not contain acceptance criteria or a study designed to prove the device meets specific performance criteria.
Instead, the document states that "Safety and performance testing was performed to demonstrate that the IntraLuminal Therapeutics SAFE-STEER™ Guide Wire System is substantially equivalent to the predicate devices." It then broadly lists the types of testing conducted: "software, performance, biocompatibility, packaging, clinical and comparative tests."
Therefore, I cannot extract the requested information as it is not present in the provided text. The document concludes with a claim of substantial equivalence and meeting internal product specifications, rather than reporting against specific, publicly available acceptance criteria.
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APR 0 3 2002
6.0 Summary of Safety and Effectiveness for the SAFE-STEER™ Guide Wire System
| 6.1 | Trade Name: | SAFE-STEER™ Guide Wire System |
|---|---|---|
| Common Name: | Guide Wire, Cardiovascular or Peripheral | |
| Classification: | DQX, Title 21 CFR Section: 870.1330 | |
| 6.2 | Manufacturer: | IntraLuminal Therapeutics, Inc.6354 Corte Del AbetoCarlsbad, CA 92009Phone: (760) 918-1820Fax: (760) 918-1823 |
Pamela L. Misajon Contact: Vice President of Regulatory Affairs and Quality Assurance
Date of Preparation: March 28, 2002
Substantially Equivalent Legally Marketed Devices: 6.3
| Product Name | 510(k) Numbers |
|---|---|
| 1. ACS Hi-Torque Cross-it Guide Wire | K981381 & K990639 |
| 2. ACS Hi-Torque Standard Guide Wire | K881897 & K881787 |
Device Description: 6.4
The IntraLuminal Therapeutics, Inc. SAFE-STEER™ Guide Wire System is comprised of a sterile single-use guide wire with an integrated optical fiber. The guide wire is used with a support catheter of choice that will accommodate a .014" guidewire. The optical fiber in the guide wire is connected to a reusable Optical Coherence Reflectometry (OCR). The guide wire core has an embedded optical fiber that transmits near infrared light and the reflection is relayed back to the OCR unit and then a unique intensity versus distance measurement is exhibited on the OCR display. The trace of the slope on the OCR display distinguishes the distance from the tip of the wire and the vessel wall. The display output exhibits the relative distance between the wire tip and vessel wall. The guide wire is provided in lengths of 175 cm and 275 cm long and has a diameter of 0.014" with a lubricious hydrophilic coating in the distal region. The guide wire is sterilized by ethylene oxide and packaged to maintain the sterile barrier.
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6.0 Summary of Safety and Effectiveness for the SAFE-STEER™ Guide Wire System (continued)
6.5 Intended Use
The Safe-Steer™ Guide Wire System is indicated for use in facilitating the placement of catheters used in percutaneous interventions in native coronary arteries with total occlusions.
Technological Characteristics of Substantial Equivalence 6.6
The IntraLuminal Therapeutics SAFE-STEER™ Guide Wire System is comprised of a guide wire used with a support catheter of choice to facilitate the placement of catheters used in percutaneous interventions in native coronary arteries with total occlusions.
The indications for use are similar to both the ACS Hi-Torque Standard and the ACS Hi-Torque Cross-It guide wires. The models and sizes are similar to commercially distributed quide wires.
Performance Data 6.7
Safety and performance testing was performed to demonstrate that the IntraLuminal Therapeutics SAFE-STEER™ Guide Wire System is substantially equivalent to the predicate devices.
The testing included software, performance, biocompatibility, packaging, clinical and comparative tests.
- Conclusion: In conclusion, the IntraLuminal Therapeutics SAFE-STEER™ Guide 6.8 Wire System meets the requirements for being substantially equivalent to predicate devices and meets internal product specifications.
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Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Pamela L. Misajon Vice President of Regulatory Affairs and Quality Assurance IntraLuminal Therapeutics, Inc. 6354 Corte Del Abeto Carlsbad, CA 92009
APR 0 3 2002
Re: K011986
Trade Name: SAFE-STEER™ Guide Wire System Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II (two) Product Code: DQX Dated: January 28, 2001 Received: January 29, 2001
Dear Ms. Misajon:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your bocuse of to the device is substantially equivalent (for the indications for referenced above and have to legally marketed predicate devices marketed in interstate commerce use stated in the energiant date of the Medical Device Amendments, or to devices that provision in the Provisions with the provisions of the Federal Food, Drug, and Cosmetic nu v och roendomics and 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 therers, manions of the Act include requirements for annual registration, listing of devices, good connolor provizion, 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 n your de foo to such additional controls. Existing major regulations affecting your device can be finer of babyer to easil 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); good manufacturing practice requirements as set forth in the quality
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Page 2. - Ms. Pamela L. Misajon
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) rins letter will anow your to ough finding of substantial equivalence of your device to a legally premaince noutheation - The 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation en itled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Toganation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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/dsma/dsmamain.html
Sincerely yours,
Koda Tellh
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number: K011986 IntraLuminal Therapeutics, Inc. SAFE-STEER™ Guide Wire Device Name: System
Indications For Use:
The Safe-Steer™ Guide Wire System is indicated for use in facilitating the placement of catheters used in percutaneous interventions in native coronary arteries with total occlusions.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use __ V (Per 21 CFR 801.109) OR Over-The-Counter Use
ill
Division of Cardiovascular & Respiratory Devices
510(k) Number K011906
vascular & Respiratory
§ 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.