(163 days)
Not Found
No
The summary describes a physical catheter device and its performance characteristics, with no mention of AI or ML in its function, design, or testing.
Yes
The text states that the catheter is intended to assist in the controlled infusion of diagnostic or therapeutic solutions. This indicates that the device serves a therapeutic purpose.
No
The catheter's intended use is to assist in the controlled infusion of diagnostic or therapeutic solutions. While it can infuse diagnostic solutions, its primary function is delivery, not diagnosis itself.
No
The device description clearly outlines a physical, intravascular catheter with specific dimensions, materials, and features (tip, shaft, hub, radiopaque band). The performance studies focus on physical properties like strength, flexibility, flow, and pressure, which are characteristic of hardware devices. 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 "assist in the controlled infusion of diagnostic or therapeutic solutions into the peripheral or coronary vasculature." This describes a device used within the body for delivering substances, not a device used outside the body to examine specimens derived from the human body.
- Device Description: The description details an intravascular catheter, which is a device designed for insertion into blood vessels.
- Anatomical Site: The anatomical site is the "Peripheral or coronary vasculature," which are locations within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely delivery.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information about a physiological state, health, or disease. This infusion catheter does not fit that description.
N/A
Intended Use / Indications for Use
The infusion catheter is intended to assist in the controlled infusion of diagnostic or therapeutic solutions into the peripheral or coronary vasculature. The target vessel effective diameter is ≥ 2.0 mm. The catheter is placed by a physician using a guide catheter and over a guidewire that extends beyond the final position of the infusion catheter.
Product codes (comma separated list FDA assigned to the subject device)
DQO
Device Description
The TherOx® Infusion Catheter is a sterile, single-use, 4.6 French (F) intravascular catheter with a 127 cm usable length. The catheter is comprised of three sections; 1) a distal atraumatic soft tip 2) a semi-rigid but flexible shaft; and 3) a proximal luer hub for connection of solution-delivery devices. A radiopaque band at the distal tip allows fluoroscopic visualization of the catheter's location in the vessel.
The TherOx® Infusion Catheter is packaged in standard medical product packaging and sterilized with ethylene oxide. The catheter and its packaging have been qualified for a three-year shelf life under conditions of proper storage and handling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and coronary vasculature
Indicated Patient Age Range
Not intended for pediatric or neonatal use.
Intended User / Care Setting
Physician
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)
A battery of strength, flexibility, flow, and pressure tests as specified in the standards listed below was performed on both the TherOx® Infusion Catheter and the predicate Tracker® - 38 Infusion Catheter device. The tests were performed to verify Fradior - Go irfusion ce of the devices and to verify conformance to TherOx device specifications.
Test results were obtained for production samples that were sterilized twice in a validated sterilization cycle, and on samples that were sterilized twice and then thermally aged to simulate an expected shelf life. Dimensional conformance, joint strength, flexibility, pressure rating, and flow characteristics were tested on these sample groups and the test requirements were specified based on the following voluntary standard and guidance documents:
-
- FDA "Guidance on Premarket Notification (510(k)) Submission for Short-Term and Long-Term Intravascular Catheters" March 1995
-
- ISO 10555-1 " Sterile Single-Use Intravascular Catheters -- General Requirements"
-
- ISO 10555-2 " Sterile Single-Use Intravascular Catheters Angiographic Catheters"
-
- ISO 10555-3 " Sterile Single-Use Intravascular Catheters Central Venous Catheters"
In addition, the TherOx infusion catheter satisfies the biocompatibility requirements of ISO 10993-1 and is sterilized in an ethylene oxide (EtO) sterilization cycle validated per ISO 11135. The TherOx catheter packaging was designed and tested per the requirements of ISO 11607.
All functional and performance test results met their acceptance criteria and a 3-year shelf life was established for the finished product.
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
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
2006 MAR 8 510(k) SUMMARY
Date Prepared: August 19, 2005
Name and Address of Submitter: TherOx, Inc.
2400 Michelson Drive Irvine, CA 92612 Phone; (949) 757-1999 FAX: (949) 757-1989
Contact Name : Kevin Larkin, President and CEO
Trade/ Proprietary Name: TherOx® Infusion Catheter (Model No.: INCA-1)
Classification Name: Catheter, Intravascular, Diagnostic
रूर
Device Classification: Class II per 21 CFR 870.1200
SUBSTANTIAL EQUIVALENCE STATEMENT
The TherOx® Infusion Catheter, manufactured by TherOx, Inc., is substantially equivalent to the Boston Scientific/Target Therapeutics Tracker® - 38 Infusion Catheter cleared for market under 510(k) nos. K853997 and K862117. 1 Both catheters are intended to enable delivery of diagnostic and therapeutic solutions into the peripheral and coronary vasculature when infroduced percutaneously to the body through commercially available guide catheters and over commercially available quidewires. Both catheters are sterile, single lumen, end-hole catheters intended for single-use only. The substantial equivalence of the catheters is supported by physical and mechanical characteristics that are very similar and by the fact that the peripheral and coronary vessel applications for each catheter are the same.
DEVICE DESCRIPTION
The TherOx® Infusion Catheter is a sterile, single-use, 4.6 French (F) intravascular catheter with a 127 cm usable length. The catheter is comprised of three sections; 1) a distal atraumatic soft tip 2) a semi-rigid but flexible shaft; and 3) a proximal luer hub for connection of solution-delivery devices. A radiopaque band at the distal tip allows fluoroscopic visualization of the catheter's location in the vessel.
The TherOx® Infusion Catheter is packaged in standard medical product packaging and sterilized with ethylene oxide. The catheter and its packaging have been qualified for a three-year shelf life under conditions of proper storage and handling.
1 TherOx is a registered trademark of TherOx, Inc. All other trademarks referenced are the property of their respective owners.
1
INTENDED USE
The TherOx® Infusion Catheter is intended to assist in the controlled infusion of diagnostic The Therox "Thidslon Outlotor to Interal and coronary vasculature. The target vessel of therapoutie colutions into int. The catheter is placed by a physician using a guide effective diameter is = 2.0 mm.
catheter and over a guidewire that extends beyond the final position of the infusion catheter.
CONTRAINDICATIONS
- Do not place in a vessel with an effective diameter of K052637 TherOx® Infusion Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II Product Code: DQO Dated: February 22, 2006 Received: February 24, 2006
Dear Mr. Conry:
Re:
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 - Mr. Casey Conry
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a subcline with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a delectimation that your as rees by other Federal agencies. You must or any Federal statules and regulations willing, but not limited to: registration and listing (21
comply with all the Act's requirements, including, but not limited to set comply with all the Act s requirements, meres and couring practice requirements as setting CFK Part 807); labeling (21 CFR Part 800); good frankart 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (Q5) regaliation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000 product radiation control provisions (Decions be r o vice as described in your Section 510(k)
This letter will allow you to begin marketing your device to a loggios to a logg I his letter will anow you to begin hanceling your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of the p premarket notification. The PDA midning of substantial equice 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 If you desire specific advice for your done of the case note the regulation entitled, whitler, contact the Office of Compliance at (240) 270 - 126 - Fart 807.97). You may obtain "Misbranding by relefence to premarket notificances (x 1 from the Division of Small other general Information on your responsion in total free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its to be closes than Manufacturers, International and Consumer Assistance agos/cdrh/industry/support/index.html.
Sincerely yours,
Emma R. Viiner
1/) 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): Unknown
Device Name: TherOx® Infusion Catheter
Indications for Use:
The infusion catheter is intended to assist in the controlled infusion of diagnostic or therapeutic solutions into the peripheral or coronary vasculature. The target vessel effective diameter is ≥ 2.0 mm. The catheter is placed by a physician using a guide catheter and over a guidewire that extends beyond the final position of the infusion catheter.
Over-The-Counter Use Prescription Use × AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1_
una D. Vachner
(Division Sign-Off) (Division Orgin of Cardiovascular Devices
510((k) Number ك