(184 days)
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Not Found
No
The provided 510(k) summary describes a physical device (sheath catheter) and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is described as an access sheath catheter designed to facilitate the entry of other interventional devices, rather than directly providing therapy itself.
No
The device is designed to facilitate the entry of interventional devices, not to diagnose a condition.
No
The intended use clearly describes a "Sheath Catheter," which is a physical, hardware medical device used to facilitate entry into blood vessels. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the entry of interventional devices into the vessels of the cardiovascular system." This describes a device used in vivo (within the body) for a procedural purpose, not for testing samples in vitro (outside the body) to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
The Pathway™ Access Sheath Catheter is clearly an interventional medical device used during procedures within the cardiovascular system.
N/A
Intended Use / Indications for Use
The Pathway™ Access Sheath Catheter is designed to facilitate the entry of interventional devices into the vessels of the cardiovascular system.
Product codes
DYB
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
vessels of the cardiovascular system
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image contains the text "Public Health Service". The text is in a bold, sans-serif font. The text is black and the background is white.
Image /page/0/Picture/2 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 2003
Vertelink Corporation c/o Mr. Samuel M. Shaolian 30 Hughes, Suite 206 Irvine, CA 92618
Re: K030734
Pathway Access Sheath Catheter Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: Class II Product Code: DYB Dated: June 25, 2003 Received: June 26, 2003
Dear Mr. Shaolian:
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.
1
Page 2 - Mr. Samuel Shaolian
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
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Page 1 of 1
510(k) Number (if known): K030734
Device Name: Pathway™ Access Sheath Catheter
Indications For Use: The Pathway™ Access Sheath Catheter is designed to facilitate the entry of interventional devices into the vessels of the cardiovascular system.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Deleth
510(k) Numbe
(Optional Format 3-10-98)
Prescription Use Only