(27 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a catheter and does not mention any AI/ML capabilities.
No
The device is used for accessing regions of the vasculature and exchanging guidewires, or delivering solutions and contrast agents, not for treating a disease or condition.
No
The device is a support catheter used for accessing vasculature, exchanging guidewires, and delivering substances. While it can deliver "diagnostic contrast agents," its primary function is not to diagnose conditions itself but rather to facilitate procedures where diagnostic agents might be used by other means.
No
The device description clearly describes a physical catheter, a hardware component, intended for insertion into the vasculature. It is not solely software.
Based on the provided text, the Safe Cross® Support Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The intended use is to access regions of the vasculature, exchange guidewires, and deliver saline or contrast agents within the body. This is an in vivo application, not an in vitro (outside the body) diagnostic test.
- Device Description: The description details a catheter designed for percutaneous insertion into the cardiovascular system. This is consistent with an in vivo medical device.
- Lack of Diagnostic Testing: The description does not mention any components or functions related to analyzing samples (like blood, urine, tissue) or performing diagnostic tests outside the body.
- Delivery of Agents: While it can deliver diagnostic contrast agents, this is for visualization within the body using fluoroscopy, not for in vitro diagnostic testing of a sample.
In summary, the Safe Cross® Support Catheter is a medical device used for interventional procedures within the cardiovascular system, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
The Safe Cross® Support Catheter is indicated to be used in conjunction with a steerable quidewire in order to access discreet regions of the vasculature. Once the region has been accessed, an exchange of one quidewire for another can occur. The Safe Cross® Support 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® Support Catheter is a single-lumen intravascular catheter intended for percutaneous use. It is designed to use in conjunction with a .014" and .018" quide wire to gain access to locations within the cardiovascular system that are remote from the site of insertion. Once accessed, quide wires may be exchanged within the catheter. The Safe Cross® Support Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
The effective length of the Support Catheter is a nominal 135 cm. The nominal maximum outside diameter is 2.8 French (0.037"). The distal region incorporates a radiopaque material to aid in visualization under fluoroscopy. The inside diameter of the Support Catheter shaft will accommodate a commercially available .014" and .018" quide wire.
The Safe Cross® Support Catheter is packaged in a Tyvek® covered tray and heat-sealed to form a sterile barrier. The packaged catheter is sterilized by ethylene oxide gas. The Safe Cross Coated Support Catheter is provided "STERILE" and "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, cardiovascular system
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 in vitro bench studies were conducted to evaluate the biological and performance characteristics of the Support 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.
The results of testing demonstrate that the modifications to the Safe Cross Support Catheter are substantially equivalent to the predicate device and are capable of safely and accurately performing the stated intended use.
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
APR 2 4 2003
Special 510(k) Premarket Notification
ILT Safe Cross® Support Catheter
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. | Device Trade Name: | Safe Cross® Support Catheter |
|---|---|---|
| B. | Catalog Number: | C114AN1 – Safe Cross® .014" Angled Support Catheter |
| C114SN1 – Safe Cross® .014" Straight Support Catheter | ||
| C118AN1 – Safe Cross® .018" Angled Support Catheter | ||
| C118SN1 – Safe Cross® .018" Straight Support Catheter | ||
| C. | Device Common Name: | Percutaneous Catheter |
| D. | Classification Name: | Percutaneous Catheter |
| E. | Device Class: | Class II (per 21 CFR 870.1250) |
IDENTIFICATION OF MODIFIED DEVICE
The Safe Cross® Support Catheter is a similar in design, materials, mode of operation and intended use to the IntraLuminal Therapeutics, Inc. 0.014" Support Catheter cleared under 510(k) K012169. The device modification includes the devices to be coated with a hydrophilic coating and a new .018" Support Catheter Model. The new .018" Support Catheter is a single lumen intravascular catheter with same intended use. But will accommodate a .018" guide wire.
1
16030984
DEVICE DESCRIPTION
The Safe Cross® Support Catheter is a single-lumen intravascular catheter intended for percutaneous use. It is designed to use in conjunction with a .014" and .018" quide wire to gain access to locations within the cardiovascular system that are remote from the site of insertion. Once accessed, quide wires may be exchanged within the catheter. The Safe Cross® Support Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
The effective length of the Support Catheter is a nominal 135 cm. The nominal maximum outside diameter is 2.8 French (0.037"). The distal region incorporates a radiopaque material to aid in visualization under fluoroscopy. The inside diameter of the Support Catheter shaft will accommodate a commercially available .014" and .018" quide wire.
The Safe Cross® Support Catheter is packaged in a Tyvek® covered tray and heat-sealed to form a sterile barrier. The packaged catheter is sterilized by ethylene oxide gas. The Safe Cross Coated Support Catheter is provided "STERILE" and "Non-pyrogenic", and is intended for single use only.
INTENDED USE
The Safe Cross® Support Catheter is indicated to be used in conjunction with a steerable quidewire in order to access discreet regions of the vasculature. Once the region has been accessed, an exchange of one quidewire for another can occur. The Safe Cross® Support Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
TECHNOLOGICAL CHARACTERISTICS
The Safe Cross Support Catheter is similar in basic materials, design, construction and mechanical performance to the previously cleared .014" Catheter. The device modification includes the devices to be coated with a Bio-coat Hydak® hydrophilic coating and an additional .018" Support Catheter Model.
BIOCOMPATIBILITY AND PERFORMANCE DATA
Biocompatibility testing and in vitro bench studies were conducted to evaluate the biological and performance characteristics of the Support 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 modifications to the Safe Cross Support Catheter are substantially equivalent to the predicate device and are capable of safely and accurately performing the stated intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that suggest feathers or wings.
Public Health Service
APR 2 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
IntraLuminal Therapeutics, Inc. Ms. Pamela Misajon Vice President of Regulatory Affairs and Quality Assurance 6354 Corte Del Abeto - Suite A Carlsbad, CA 92009
Re: K030984
Trade/Device Name: Safe Cross® Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: April 15, 2003 Received: April 16, 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 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
3
Page 2 - Ms. Pamela Misajon
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. 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 entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information 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,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
1.6 INDICATIONS FOR USE FORM
INDICATIONS FOR USE
Kb30984 510(k) Number: Safe Cross® Support Catheter Device Name:
The Safe Cross® Support Catheter is indicated to be used in Indications For Use: conjunction with a steerable guidewire in order to access discreet regions of the vasculature. Once the region has been accessed, an exchange of one guidewire for another can occur. The Safe Cross Support 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 i
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _____________
N. Derler Th
510(k) Number K033482