(71 days)
Not Found
No
The description focuses on the mechanical and material properties of a catheter and does not mention any computational or analytical functions that would suggest AI/ML.
No
The device is described as a catheter used for accessing vasculature, exchanging guidewires, and delivering fluids/contrast agents, not directly treating a disease or condition.
No.
The device is described as a catheter used to access the vasculature and provide a conduit for the delivery of saline solutions or diagnostic contrast agents. While it can deliver diagnostic agents, the device itself is not performing the diagnostic function; it is merely facilitating the delivery of a substance that aids in diagnosis.
No
The device description clearly details a physical catheter with specific dimensions, materials, and packaging, indicating it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to access and facilitate placement of guidewires within the vascular system, exchange guidewires, and deliver saline or contrast agents. These are all in vivo procedures, meaning they are performed within the living body.
- Device Description: The description details a catheter designed for percutaneous (through the skin) use within the vascular system. This further confirms its use within 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 diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to be used outside the body to analyze samples. This device is clearly designed for use inside the body.
N/A
Intended Use / Indications for Use
The Safe-Cross® Deflecting Catheter is indicated to be used in conjunction with a steerable guidewire in order to access discrete regions of the vasculature. Once the region has been accessed, an exchange of one guidewire for another can occur. The Safe-Cross® Deflecting 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 guidewires 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, guidewires 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" guidewires.
The Safe-Cross Deflecting Catheter is packaged in a Tyvek® covered custom PETG tray 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
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
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
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
NOV 1 8 2003
510(k) SUMMARY
SUBMITTER INFORMATION
| A. | Company Name: | IntraLuminal Therapeutics, Inc. |
|---|---|---|
| ---- | --------------- | --------------------------------- |
B. Company Address:
C. Company Phone:
Company Facsimile: D.
- ய் Contact Person:
nc
6354 Corte del Abeto Suite A Carlsbad, CA 92009
(760) 918-1820
(760) 918-1823
Pamela Misajon Vice President of Requlatory Affairs and Quality Assurance
DEVICE IDENTIFICATION
- A. Trade Name: B. Catalog Number: C114ND1 C. Support Catheter Common Name: D. Classification Name: Percutaneous Catheter
- Device Class: E.
ILT Safe-Cross® Deflecting Catheter
Class II (per 21 CFR 870.1250)
IDENTIFICATION OF MODIFIED DEVICE
The ILT Safe-Cross® Deflecting Catheter is identical in design, materials and mode of operation to the IntraLuminal Therapeutics, Inc. ILT Safe-Cross Deflecting Catheter cleared under 510(k) K031692.
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 guidewires 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, guidewires 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.
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" guidewires.
The Safe-Cross Deflecting Catheter is packaged in a Tyvek® covered custom PETG tray 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 to be used with a steerable guidewire in order to access discrete regions of the vasculature. Once the region has been accessed, an exchange of one guidewire for another can occur. The Safe-Cross Deflecting 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 identical 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
Image /page/2/Picture/11 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem is a stylized representation of a bird or eagle, with three curved lines forming its body and wings, symbolizing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 2003
IntraLuminal Therapeutics, Inc. c/o Pamela Misajon Vice President of Regulatory Affairs and Quality Assurance 6354 Corte del Abeto, Suite A Carlsbad, Ca 92009
Re: K032784
ILT Safe-Cross® Deflecting Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: October 17, 2003 Received: October 20, 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.
3
Page 2 -- Ms. Pamala Misajon
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 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) 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) 594-4648. 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,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices ,Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number: K032784
ILT Safe-Cross® Deflecting Catheter Device Name:
The Safe-Cross® Deflecting Catheter is indicated to Indications for Use: be used in conjunction with a steerable guidewire in order to access discrete regions of the vasculature. Once the region has been accessed, an exchange of one guidewire for another can occur. The Safe-Cross® Deflecting Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
Division of Cardiovascular & Respiratory Devices
510(k) Number K032784