(197 days)
Not Found
No
The description focuses on the mechanical functions and components of a catheter, with no mention of AI or ML capabilities.
No.
The primary uses of this device are to support a guidewire, allow for guidewire exchanges, and provide a conduit for fluid delivery; these are not direct therapeutic actions but rather support other interventional procedures.
No
This device is described as a guidewire exchange and infusion device that can deliver saline solutions or diagnostic contrast agents. While it can deliver diagnostic agents, its primary function is not to diagnose, but to assist in procedures and deliver substances. Its use of diagnostic contrast agents is for delivery, not for the device itself to perform diagnosis.
No
The device description clearly outlines physical components (tubing, hub, strain relief, marker band, adhesive) and its function involves physical interaction within the peripheral vascular system (supporting guidewires, allowing exchange, infusing fluids). This is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The TransXchange Support Catheter is a physical device used within the peripheral vascular system. Its functions are mechanical: supporting guidewires, allowing guidewire exchange, and delivering fluids directly into the body.
- Lack of Sample Analysis: The description does not mention the device analyzing any biological samples or providing diagnostic information based on such analysis. The infusion of diagnostic contrast agents is for imaging purposes, not for the device itself to perform a diagnostic test on a sample.
Therefore, the TransXchange Support Catheter is a medical device used in interventional procedures, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The TransXchange Support Catheter is a guidewire exchange and infusion device designed for use in the peripheral vascular system. The catheter is intended to support a guidewire during access of vessels, allow for exchange of guidewires, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
Product codes
DQY
Device Description
The TransXchange Support Catheter is designed to perform the following functions during percutaneous intravascular procedures:
-
- Support a 0.014" guidewire during introduction of catheters with lumens of 0.035" or greater over a 0.014" guidewire. The TransXchange Support Catheter is designed to assist in the introduction of catheters with lumens of 0.035" or greater over a 0.014" guidewire. The TransXchange Support Catheter acts to fill the annular space between the smaller guidewire and larger catheter lumen.
-
- Allow for the exchange of guidewires through its lumen
-
- Infusion of fluids such as saline or diagnostic contrast agents through its lumen into the vascular system using pressures up to 150 psi
The TransXchange Support Catheter in constructed of 5 components: a single lumen high density polyethylene tubing with a tapered distal tip, a proximal female luer hub, a two piece strain relief constructed of polyolefin, a distal platinum iridium marker band, and Loctite 4304 Cyanoacrylate Adhesive.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vascular 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)
Preclinical testing was conducted to confirm the safe and effective performance of this device as well as the biocompatibility of the device.
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
MAY 25 2004
510(k) Summary
1. Sponsor's Information
Sponsor's Name and Address:
Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403
Sponsor's Phone/ Fax Number:
(707) 525-0111 (707) 591-7406
Contact Person:
Leisa Martinez Regulatory Affairs Associate Phone: (707) 541-3259 Fax: (707) 591-7406 E-mail: leisa.martinez@medtronic.com
Submitted:
April 30, 2004
2. Device Information
Name: TransXchange Support Catheter
Trade Name: N/A
Classification:
Common Name: Intravascular Catheter Classification Name: Percutaneous Catheter (21 CFR 870-1250)
3. Predicate Device Information:
| Name: | Spectranetics Support Catheter |
|---|---|
| Manufacturer: | Spectranetics |
| 510(k) Number: | K991059 |
| Clearance Date: | October 19, 1999 |
1
Device Description 4.
The TransXchange Support Catheter is designed to perform the following functions during percutaneous intravascular procedures:
-
- Support a 0.014" guidewire during introduction of catheters with lumens of 0.035" or greater over a 0.014" guidewire. The TransXchange Support Catheter is designed to assist in the introduction of catheters with lumens of 0.035" or greater over a 0.014" guidewire. The TransXchange Support Catheter acts to fill the annular space between the smaller guidewire and larger catheter lumen.
-
- Allow for the exchange of guidewires through its lumen
-
- Infusion of fluids such as saline or diagnostic contrast agents through its lumen into the vascular system using pressures up to 150 psi
The TransXchange Support Catheter in constructed of 5 components: a single lumen high density polyethylene tubing with a tapered distal tip, a proximal female luer hub, a two piece strain relief constructed of polyolefin, a distal platinum iridium marker band, and Loctite 4304 Cyanoacrylate Adhesive.
ડ. Intended Use of Device
The TransXchange Support Catheter is a guidewire exchange and infusion device designed for use in the peripheral vascular system. The catheter is intended to support a guidewire during access of vessels, allow for exchange of guidewires, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
6. Technological Characteristics:
Comparison of Technological Characteristics A.
The TransXchange Support Catheter is substantially equivalent to the currently cleared Spectranetics Support Catheter (K0991059). The subject and predicate stents are identical technology and are intended to support a guidewire during access of the vasculature, to allow for the exchange of guidewires, and to infuse saline or diagnostic contrast agent. The subject device offers a smaller catheter diameter. The subject and predicate stents are both intended to meet clinical needs. The difference between the subject and predicate devices are minor and are not relevant to the ability of the subject device to perform as intended.
B. Nonclinical testing
Preclinical testing was conducted to confirm the safe and effective performance of this device as well as the biocompatibility of the device.
2
C. Sterilization
The TransXchange Support Catheter is provided sterile. The device is not intended for reuse or resterilization.
Conclusion D.
The TransXchange Support Catheter is substantially equivalent to the currently cleared Spectranetics Support Catheter (K991059) and meets clinical needs of the physicians.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three tail feathers, representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 25 2004
Medtronic Vascular c/o Ms. Leisa Martinez 3576 Unocal Pl. Santa Rosa, CA 95403
Re: K033540
Trade/Device Name: TransXchange Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: August 8, 2003 Received: November 10, 2003
Dear Ms. Martinez:
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.
4
Page 2 - Ms. Leisa Martinez
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 Or It 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,
Dina P. Vochner
(g/ Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K033540
Device Name: TransXchange Support Catheter
Indications For Use:
The TransXchange Support Catheter is a guidewire exchange and infusion device designed for use in the peripheral vascular system. The catheter is intended to support a guidewire during access of vessels, allow for exchange of guidewires, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dima R. Vochner
(Division Sign-Off) Division of Cardiovascular Devices
510/k) Number_K033540
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