(81 days)
Not Found
No
The description focuses on the mechanical and material properties of a catheter and does not mention any computational or data-driven features indicative of AI/ML.
No.
The device facilitates access and delivery of other devices or substances but does not directly treat a condition itself.
No
The device is primarily intended for accessing regions of vasculature and facilitating the placement or exchange of guide wires and other interventional devices. While it can be used to deliver diagnostic contrast agents, its primary function is not to diagnose.
No
The device description clearly describes a physical catheter, which is a hardware component, not a software-only device.
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 within the body to access and navigate the vasculature, facilitate placement of other devices, and deliver substances like saline or contrast agents. This is an in vivo application.
- Device Description: The description details a catheter designed for percutaneous use within the vascular system. This further reinforces its use inside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnostic purposes.
IVD devices are specifically designed to perform tests on samples taken from the body, not to be used within the body for therapeutic or interventional purposes like this catheter.
N/A
Intended Use / Indications for Use
The Safe-Cross® Deflecting Catheter is indicated for use with a guide wire in order to access discreet regions of the peripheral vasculature and facilitate placement of the guide wire. Once the region has been accessed, an exchange of one guide wire for another can occur. The Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
Product codes
DQY
Device Description
The Safe-Cross® Deflecting Catheter is a coaxial lumen intravascular catheter coated with a Biocoat Hydak® hydrophilic coating intended for percutaneous use. It is designed to be used in conjunction with guide wires to gain access to and facilitate placement of the wires in locations within the vascular system that are remote from the site of insertion. Once accessed, guide wires may be exchanged within the catheter. The Safe-Cross® Deflecting Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
The effective length of the Safe-Cross® Deflecting Catheter is 135-140 cm. The shaft nominal outside diameter is 2.5 F (0.033") and the maximum outside diameter of the deflecting segment is 3.5 F (0.045") at a use pressure of 10 atm. The I.D. at the tip of the Safe-Cross® Deflecting Catheter is a nominal 0.016" and the inside diameter will accommodate commercially available 0.014" guide wires.
The Safe-Cross® Deflecting Catheter is packaged in a Tyvek® covered custom PETG trav that is heat-sealed to form a sterile barrier. The packaged units are sterilized with ethylene oxide gas. The device is provided "STERILE", "Non-Pyrogenic" and is intended for single use only.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing and bench studies were conducted to evaluate the biological and performance characteristics of the Safe-Cross® Deflecting Catheter. Biocompatibility test results indicate that the device materials are biocompatible. Performance test results indicate that the device satisfies functional performance requirements 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
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
SUBMITTER INFORMATION
| A. | Company Name: | IntraLuminal Therapeutics, Inc |
|---|---|---|
| B. | Company Address: | 6354 Corte del Abeto |
| Suite A | ||
| Carlsbad, CA 92009 | ||
| C. | Company Phone: | (760) 918-1820 |
| D. | Company Facsimile: | (760) 918-1823 |
| E. | Contact Person: | Pamela Misajon |
| Vice President of Regulatory Affairs and Quality | ||
| Assurance | ||
| DEVICE IDENTIFICATION | ||
| A. | Trade Name: | Safe-Cross® Deflecting Catheter |
| A. | Trade Name: | Safe-Cross® Deflecting Catheter |
| B. | Catalog Number: | C114ND1 |
| C. | Common Name: | Support Catheter |
| D. | Classification Name: | Percutaneous Catheter |
| E. | Device Class: | Class II (per 21 CFR 870.1250) |
IDENTIFICATION OF PREDICATE DEVICE
The Safe-Cross® Deflecting Catheter is similar in design, materials, and intended use to the IntraLuminal Therapeutics, Inc. ILT Deflecting Catheter cleared under 510(k) K010531.
DEVICE DESCRIPTION
The Safe-Cross® Deflecting Catheter is a coaxial lumen intravascular catheter coated with a Biocoat Hydak® hydrophilic coating intended for percutaneous use. It is designed to be used in conjunction with guide wires to gain access to and facilitate placement of the wires in locations within the vascular system that are remote from the site of insertion. Once accessed, guide wires may be exchanged within the catheter. The Safe-Cross® Deflecting Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ﺮﻧ
1
The effective length of the Safe-Cross® Deflecting Catheter is 135-140 cm. The shaft nominal outside diameter is 2.5 F (0.033") and the maximum outside diameter of the deflecting segment is 3.5 F (0.045") at a use pressure of 10 atm. The I.D. at the tip of the Safe-Cross® Deflecting Catheter is a nominal 0.016" and the inside diameter will accommodate commercially available 0.014" guide wires.
The Safe-Cross® Deflecting Catheter is packaged in a Tyvek® covered custom PETG trav that is heat-sealed to form a sterile barrier. The packaged units are sterilized with ethylene oxide gas. The device is provided "STERILE", "Non-Pyrogenic" and is intended for single use only.
INTENDED USE
The Safe-Cross® Deflecting Catheter is indicated for use with a guide wire in order to access discreet regions of the peripheral vasculature and facilitate placement of the guide wire. Once the region has been accessed, an exchange of one guide wire for another can occur. The Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
TECHNOLOGICAL CHARACTERISTICS
The Safe-Cross® Deflecting Catheter is similar in basic materials, design, construction and mechanical performance to the predicate device.
BIOCOMPATIBILITY AND PERFORMANCE DATA
Biocompatibility testing and bench studies were conducted to evaluate the biological and performance characteristics of the Safe-Cross® Deflecting Catheter. Biocompatibility test results indicate that the device materials are biocompatible. Performance test results indicate that the device satisfies functional performance requirements when used as indicated.
CONCLUSIONS DRAWN FROM STUDIES
The results of testing demonstrate that the Safe-Cross® Deflecting Catheter is substantially equivalent to the predicate devices and is capable of safely and accurately performing the stated intended use.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2003
IntraLuminal Therapeutics, Inc. c/o Ms. Pamela Misajon Vice President of Regulatory Affairs and Quality Assurance 6254 Corte del Abeto, Suite A Carlsbad, CA 92009
Re: K031692
Trade Name: Safe-Cross Deflecting Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: May 30, 2003 Received: June 27, 2003
Dear Ms. Misajon:
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.
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
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Page 2 – Ms. Pamela Misajon
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 systems (OS) 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) 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Arlene B. Brown
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
| 510(k) Number: | K031692 |
|---|---|
| Device Name: | ILT Safe-Cross® Deflecting Catheter |
| Indications for Use: | The Safe-Cross® Deflecting Catheter is indicated for use with a guide wire in order to access discreet regions of the vasculature. It may be used to facilitate placement of guide wires and other interventional devices. Once the region has been accessed, an exchange of one guide wire for another can occur. The Deflecting Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents. |
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Ashley B. Beams
(Division Sign Off)
(Division Sign-Off) (Division Sign-Qili)
Division of Cardiovascular Devices
510(k) Number K031692