(49 days)
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities, let alone AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No.
The device is a support catheter used for accessing vasculature, exchanging guidewires, and delivering solutions, but it does not directly treat a disease or condition.
No.
The device is described as a catheter used to access regions of the vasculature, exchange guidewires, and deliver saline solutions or diagnostic contrast agents. While it can deliver diagnostic contrast agents, its primary function is not to diagnose, but rather to facilitate other procedures.
No
The device description clearly details a physical, intravascular catheter and an advancing mechanism, which are hardware components. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in vivo (within the body) to access and navigate the vasculature, exchange guidewires, and deliver substances like saline or contrast agents. This is a procedural device used during a medical intervention.
- Device Description: The description details a physical catheter designed for insertion into the cardiovascular system. It mentions features like a lumen for guidewires and delivery, a radiopaque marker for visualization under fluoroscopy, and a mechanism for advancing a guidewire. These are all characteristics of an in vivo medical device.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any interaction with patient specimens or any diagnostic testing performed on samples.
In summary, the ILT Support Catheter is a medical device used for interventional procedures within the body, not for diagnostic testing of specimens outside the body.
N/A
Intended Use / Indications for Use
The ILT Support Catheter is indicated to be used in 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 ILT 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 ILT Support Catheter is a single-lumen intravascular catheter intended for percutaneous use. It is designed to be used in conjunction with a 0.014" steerable guidewire to gain access to locations within the cardiovascular system that are remote from the site of insertion. Once accessed, guidewires may be exchanged within the catheter. The ILT Support Catheter may also be used for The ILT 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 ILT Support Catheter is a nominal 135 cm. The nominal The enective longin of the 12 - Saffench (0.037"). The distal region incorporates a maximum outside diamotor to 210 fretton (onder fluoroscopy. The inside diameter of the ILT Support Catheter shaft will accommodate a commercially available 0.014" quidewire.
-The ILT-Support Catheter Advancing Mechanism is a handle with a connecting luer in The ILT Oupport Catholor nated to the ILT Support Catheter. The handle includes and advancing mochanism that allows for incremental advancement of the guidewire. This anovaning moonament the froo movements of the guidewire through the catheter shaft.
The ILT Support Catheter and the ILT-Support-Catheter-Advancing-Mechanism are packaged in a Tyvek® covered tray and heat-sealed to form a sterile barrier. The packaged catheter is sterilized by ethylene oxide gas. The ILT 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
fluoroscopy
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 (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 ILT 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.
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
AUG 3 0 2001
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: | ILT Support Catheter and ILT Support Catheter
Advancing Mechanism |
|----|----------------------|-----------------------------------------------------------------------------------------|
| B. | Catalog Number: | C114LW1 – ILT Support Catheter
A115AM1 – ILT Support Catheter Advancing
Mechanism |
| 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 ILT Support Catheter is a similar in design, materials, mode of operation and intended use to the IntraLuminal Therapeutics, Inc. ILT 0.014" Catheters cleared under 510(k) K001992. The modified device separates the catheter from the advancing mechanism.
DEVICE DESCRIPTION
The ILT Support Catheter is a single-lumen intravascular catheter intended for percutaneous use. It is designed to be used in conjunction with a 0.014" steerable guidewire to gain access to locations within the cardiovascular system that are remote from the site of insertion. Once accessed, guidewires may be exchanged within the catheter. The ILT Support Catheter may also be used for The ILT Support Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
046 ﺎ ﮨﺎ
1
The effective length of the ILT Support Catheter is a nominal 135 cm. The nominal The enective longin of the 12 - Saffench (0.037"). The distal region incorporates a maximum outside diamotor to 210 fretton (onder fluoroscopy. The inside diameter of the ILT Support Catheter shaft will accommodate a commercially available 0.014" quidewire.
-The ILT-Support Catheter Advancing Mechanism is a handle with a connecting luer in The ILT Oupport Catholor nated to the ILT Support Catheter. The handle includes and advancing mochanism that allows for incremental advancement of the guidewire. This anovaning moonament the froo movements of the guidewire through the catheter shaft.
The ILT Support Catheter and the ILT-Support-Catheter-Advancing-Mechanism are packaged in a Tyvek® covered tray and heat-sealed to form a sterile barrier. The packaged catheter is sterilized by ethylene oxide gas. The ILT Support Catheter is provided "STERILE" and "Non-pyrogenic", and is intended for single use only.
INTENDED USE
The ILT Support Catheter is indicated to be used in 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 ILT Support Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
TECHNOLOGICAL CHARACTERISTICS
The ILT Support Catheter is similar in basic materials, design, construction and mechanical performance to the previously cleared ILT .014" Catheter. The modification separates the advancing mechanism (handle) from the catheter and allows the ability to use the ILT Support Catheter with or without the advancing mechanism..
BIOCOMPATIBILITY AND PERFORMANCE DATA
Biocompatibility testing and in vitro bench studies were conducted to evaluate the biological and performance characteristics of the ILT 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 ILT Support Catheter with out the advancing mechanism is substantially equivalent to the predicate device and is capable of safely and accurately performing the stated intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the words "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.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2001
Ms. Pamela Misajon Vice President of Regulatory Affairs and Quality Assurance IntraLuminal Therapeutics, Inc. 6354 Corte Del Abeto, Suite A Carlsbad, CA 92009
K012169 Re:
ILT Support Catheter and ILT Support Catheter Advancing Mechanism Regulation Number: 870.1250 Regulatory Class: II (two) Product Code: DQY Dated: August 10, 2001 Received: August 13, 2001
Dear Ms. Misajon:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have teviewed your becally be is substantially equivalent (for the indications for use above and we nave determined the avveeted predicate devices marketed in interstate commerce Stated in the energiane) to legally manage of the Medical Device Amendments, or to devices that prof to May 20, 1970, the chassistence with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (11ct). Tournal) ; actives ; ; increases) ; ; } = } = = = include requirements for annual provisions of the rea. "The Prices, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remarket / pprovally, while Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Manancial ing Praval regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspoculity, the Read and may result in regulatory action. In addition, FDA may publish compry with the Original concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Pamela Misajon
This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will anow you to ocemanaling , quivalence of your device to a legally marketed noutication. The I Driving of vice in the 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 If you desire specific days of the stic devices), please contact the Office of Compliance at additionally 607.10 for in This chaghestions on the promotion and advertising of your device, (201) 594-4560. Runnenary, 2011 - 12:4639. Also, please note the regulation prease conder the Childer reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small information on your responsion.com Assistance at its toll-free number (800) 638-2041 or 1901) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
James E. Dillard III
Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
KO12169
510(k) Number: Device Name:
ILT Support Catheter (with or without Advancing Mechanism)
Indications For Use:The ILT Support Catheter with or without the advancing mechanism is indicated to be used in conjunction with a steerable guidewire in indicated to be access discreet regions of the vasculature. Once the order to accessed, an exchange of one guidewire for another can occur. The ILT Support Catheter may also be used another san occanduit 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
✓
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)
Division of Cardiovascular & Perinatal Services
510(k) Number K021669
016