(67 days)
The Safe-Cross® .035" Support Catheter is indicated for use with a guide wire in order to access discreet regions of the vasculature. 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.
The ILT Safe-Cross® .035" Support Catheter is a single-lumen intravascular catheter coated with a Biocoat Hydak® hydrophilic coating intended for percutaneous use. It is designed to be used in conjunction with steerable wires to gain access to locations within the cardiovascular system that are remote from the site of insertion. Once accessed, guide wires may be exchanged within the catheter. The Safe-Cross® .035" 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 Safe-Cross® .035" Support Catheter is a nominal 135 cm. The nominal maximum outside diameter is 4.4 French (0.057"). The I.D. at the tip of the ILT Safe-Cross® .035" Support Catheter is a nominal 0.041" and the inside diameter will accommodate commercially available 0.035" quide wires.
The ILT Safe-Cross® .035" Support Catheter is packaged in a Tyvek® covered 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.
The provided text describes the 510(k) Premarket Notification for the ILT Safe-Cross® .035" Support Catheter. This document is for a medical device and therefore does not contain information about an AI/ML device or its associated studies. As a result, many of the requested sections regarding AI/ML device performance and study methodology cannot be answered from the provided text.
Specifically, there is no information about:
- Acceptance criteria and reported device performance for an AI/ML device.
- Sample size used for a test set, data provenance, or ground truth for AI/ML validation.
- Number/qualifications of experts or adjudication methods for AI/ML ground truth.
- MRMC comparative effectiveness studies or effect sizes for AI assistance.
- Standalone performance of an AI algorithm.
- Sample size for a training set or how ground truth for a training set was established.
This document focuses on the mechanical and biocompatibility performance of a physical medical device (a support catheter) and its substantial equivalence to predicate devices. The studies mentioned are "Biocompatibility testing and in vivo bench studies" to evaluate biological and performance characteristics. The conclusions state that "device materials are biocompatible" and "device satisfies functional performance requirements when used as indicated." These are qualitative summaries, not quantitative performance metrics as would be expected for an AI/ML device.
Therefore, I cannot provide the requested table and study details as they pertain to AI/ML devices, as this document is not about an AI/ML medical device.
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Original 510(k) Premarket Notification ILT Safe-Cross .035" Support Catheter
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
SUBMITTER INFORMATION
| A. | Company Name: | IntraLuminal Therapeutics, Inc |
|---|---|---|
| B. | Company Address: | 6354 Corte del AbetoSuite ACarlsbad, CA 92009 |
| C. | Company Phone: | (760) 918-1820 |
| D. | Company Facsimile: | (760) 918-1823 |
| E. | Contact Person: | Pamela MisajonVice President of Regulatory Affairs andQuality Assurance |
| DEVICE IDENTIFICATION | ||
| A. | Trade Name: | ILT Safe-Cross® .035" Support Catheter |
| B. | Catalog Number: | C135SN1 |
| C. | Common Name: | Support Catheter |
Classification Name: Percutaneous Catheter D. Device Class: Class II (per 21 CFR 870.1250) ய்
IDENTIFICATION OF PREDICATE DEVICE
The ILT Safe-Cross® .035" Support Catheter is similar in design, materials, mode of operation and intended use to the Spectranetics .035 Support Catheter cleared under 510(k) K022138 and the IntraLuminal Therapeutics, Inc. ILT Safe-Cross® Support Catheter cleared under 510(k) K030984.
DEVICE DESCRIPTION
The ILT Safe-Cross® .035" Support Catheter is a single-lumen intravascular catheter coated with a Biocoat Hydak® hydrophilic coating intended for percutaneous use. It is designed to be used in conjunction with steerable wires to gain access to locations within the cardiovascular system that are remote from the site of insertion. Once accessed, guide wires may be exchanged within the catheter. The Safe-Cross® .035" Support Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
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The effective length of the ILT Safe-Cross® .035" Support Catheter is a nominal 135 cm. The nominal maximum outside diameter is 4.4 French (0.057"). The I.D. at the tip of the ILT Safe-Cross® .035" Support Catheter is a nominal 0.041" and the inside diameter will accommodate commercially available 0.035" quide wires.
The ILT Safe-Cross® .035" Support Catheter is packaged in a Tyvek® covered 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 ILT Safe-Cross® .035" Support Catheter is indicated for use with a guide wire in order to access discreet regions of the vasculature. Once the region has been accessed, an exchange of one quide wire for another can occur. The Catheter mav also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
TECHNOLOGICAL CHARACTERISTICS
The ILT Safe-Cross® .035" Support Catheter is similar in basic materials, design, construction and mechanical performance to the predicate device.
BIOCOMPATIBILITY AND PERFORMANCE DATA
Biocompatibility testing and in vivo bench studies were conducted to evaluate the biological and performance characteristics of the ILT Safe-Cross® .035" 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 Safe-Cross® .035" Support Catheter is substantially equivalent to the predicate devices and is capable of safely and accurately performing the stated intended use.
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal are three stylized human profiles facing to the right, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 1 2003
Intraluminal Therapeutics c/o Ms. Pamela Misajon 6354 Corte Del Abeto, Suite A Carlsbad, CA 92009
Re: K031417
ILT Safe-Cross .035" Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter. Regulatory Class: Class II Product Code: DQY Dated: May 2, 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 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
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Page 2 - Ms. Pamela Misajon
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) 594-4646. 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,
N.O.e.d.Tu
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:
ILT Safe-Cross® .035" Support Catheter Device Name: The Safe-Cross® .035" Support Catheter is indicated for use Indications for Use: with a guide wire in order to access discreet regions of the vasculature. 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.
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
DeLattre
510(k) Num
§ 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).