(62 days)
Not Found
No
The document describes a mechanical catheter and does not mention any AI or ML components or functionalities.
No
The device is described as a "support catheter" intended to access regions of the vasculature in conjunction with a guidewire. Its function is to facilitate access rather than directly treat a condition. It is compared to a predicate "Support Catheter," reinforcing its role as an access tool, not a therapeutic one.
No
The device description indicates it is a support catheter used to access regions of the vasculature with a guidewire, which is an interventional/delivery function, not a diagnostic one.
No
The device description clearly describes a physical catheter with a shaft, coils, handle, and strain relief, all constructed from stainless steel wire. This indicates a hardware medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used "in conjunction with a steerable guidewire in order to access discreet regions of the vasculature." This describes a device used within the body for a procedural purpose (accessing blood vessels), not for testing samples outside the body to diagnose a condition.
- Device Description: The description details the physical construction of a catheter designed for insertion into the vasculature.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
This device is a medical device used for interventional procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Xtrak Support catheter is intended to be used in conjunction with a steerable guidewire in order to access discreet regions of the vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Xtrak Support catheter shaft consists of a flexible, distal section made of closely-wound coils, and a stiffer and more torqueable mid-section coupled to a proximal handle through a short length of spiraled strain relief. The distal and mid-shaft sections, and the strain relief are constructed from a continuous length of stainless steel wire to maximize catheter integrity. The catheter is provided in various sizes to accommodate .014" and .018" quidewires.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Xtrak Support catheter components have been tested to assess compliance with their specifications and to support claims of substantial equivalence to the predicate devices. This testing includes the following:
- . Mechanical Strength Testing
- Biocompatibility Testing .
Test results demonstrate conformance of the Xtrak Support catheter components to their specification requirements, and that the Xtrak Support catheter is as safe and effective as the legally marketed predicated devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
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
032660
Xtrak Support Catheter Pre-Market Notification [510(k)]
OCT 2 9 2003
510(k) Summary
General Information Classification:
Class II (per 21 CFR 870.1250)
Trade Name:
Sponsor:
Xtrak Support Catheter
Xtrak Medical, Inc. 26H Keewaydin, Dr. Salem. NH 03079 (603) 896-6416 Tel: Fax: (603) 893-7708 Gary Boseck, Ph.D.
Contact:
Identification of Predicate or Legally Marketed Devices: ILT Safe Cross Support Catheter (K030984) manufactured by Intraluminal Therapeutics, Inc.
Intended Use:
The Xtrak Support catheter is intended to be used in conjunction with a steerable guidewire in order to access discreet regions of the vasculature.
Device Description:
The Xtrak Support catheter shaft consists of a flexible, distal section made of closely-wound coils, and a stiffer and more torqueable mid-section coupled to a proximal handle through a short length of spiraled strain relief. The distal and mid-shaft sections, and the strain relief are constructed from a continuous length of stainless steel wire to maximize catheter integrity. The catheter is provided in various sizes to accommodate .014" and .018" quidewires.
Materials:
All materials used in the manufacture of the Xtrak Support catheter are suitable for their intended use and are used commonly in the manufacture of previously cleared products.
Performance Testing:
The Xtrak Support catheter components have been tested to assess compliance with their specifications and to support claims of substantial equivalence to the predicate devices. This testing includes the following:
- . Mechanical Strength Testing
- Biocompatibility Testing .
Test results demonstrate conformance of the Xtrak Support catheter components to their specification requirements, and that the Xtrak Support catheter is as safe and effective as the legally marketed predicated devices.
Summary of Substantial Equivalence:
Xtrak Medical believes that the Xtrak Support catheter is substantially equivalent to the legally marketed predicate devices. This claim of equivalence is supported by the identical intended use of the devices and their common technological characteristics.
1
Public Health Service
Image /page/1/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird, with three lines representing the body and wings. The image is simple and clean, with a focus on the text and the bird symbol.
OCT 2 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Xtrak® Medical, Inc. c/o Ms. Debbie Iampietro ORC Consulting 26H Keewaydin Dr. Salem, NH 03079
Re: K032660
Trade Name: Xtrak® Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DQY Dated: August 26, 2003 Received: September 3, 2003
Dear Ms. Iampietro:
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.
2
Page 2 - Ms. Debbie Iampietro
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) 594-4646. 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,
Jhosa D. Alay for
Bram D. Zuckerman Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Xtrak Support Catheter Pre-Market Notification [510(k)]
Ver/ 3 - 4/24/96
production and and station starting the may
Applicant: XTRAK MEDICAL, INC.
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Xtrak Support Catheter
Indications For Use:
The Xtrak Support Catheter is intended to be used in conjunction with a steerable guidewire in order to access discreet regions of the vasculature.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| (Per 21 CFR 801.109) | Division of Cardiovascular Devices |
| (Optional Format 1-2-96) | 510(k) Number K032660 |
| Prescription Use |
X 10/28/03
(Per 21 CFR 801.109)