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.

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.

AI/ML Overview

TherOx, Inc. sought 510(k) clearance for their TherOx® Infusion Catheter, indicating substantial equivalence to the Boston Scientific/Target Therapeutics Tracker® - 38 Infusion Catheter. The study performed was a non-clinical test data summary comparing the TherOx® Infusion Catheter to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Acceptance Criteria (based on predicate device and standards)	TherOx® Infusion Catheter Performance
Physical/Material
Outer Diameter	Comparable to predicate to allow intended use	4.6 F (0.060 in) overall (smaller than predicate's 5.3F/5F)
Inner Diameter	Sufficient for recommended guidewire	0.046 in overall, 0.037 in min at marker band (slightly smaller than predicate at marker band)
Usable Length	Comparable to predicate for physician manipulation	127 cm (longer than predicate's 115cm/117cm)
Materials	Biocompatible and suitable for intravascular use	High density polyethylene (HDPE) shaft, rigid HDPE luer, LDPE plasticized tip (minor differences from predicate, but compliant)
Radiopacity	Visible under fluoroscopy	Radiopaque band at distal tip allows visualization
Sterile	Sterile	Sterilized with ethylene oxide
Single-Use	Single-use only	Single-use only
Shelf Life	Established shelf life	3-year shelf life established
Functional/Performance
Strength	Meets standards (ISO 10555 series) for intravascular catheters	Test results met acceptance criteria
Flexibility	Meets standards (ISO 10555 series) for intravascular catheters	Test results met acceptance criteria
Pressure	Meets standards (ISO 10555 series) for intravascular catheters	Test results met acceptance criteria
Flow	Meets standards (ISO 10555 series) for intravascular catheters	Test results met acceptance criteria
Biocompatibility	Meets ISO 10993-1	Satisfies ISO 10993-1 requirements
Sterilization	Validated per ISO 11135	Validated per ISO 11135
Packaging	Designed and tested per ISO 11607	Designed and tested per ISO 11607
Joint Strength	Within specified requirements	Test results met acceptance criteria
Dimensional Conformance	Within specified requirements	Test results met acceptance criteria

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not explicitly state the exact sample size (number of catheters) used for each individual test. It mentions "production samples that were sterilized twice in a validated sterilization cycle" and "samples that were sterilized twice and then thermally aged to simulate an expected shelf life." This implies a sufficient number of devices were tested to validate the performance and shelf life.
Data Provenance: The data is from non-clinical bench testing conducted by TherOx, Inc. explicitly for this 510(k) submission. It is prospective in the sense that the tests were performed to demonstrate compliance of the TherOx® Infusion Catheter. The country of origin of the data is implied to be where TherOx, Inc. is located (Irvine, CA, USA) or where their testing facilities are.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This was a non-clinical bench study, not a clinical study involving human expert interpretation. Therefore, there were no experts used to establish a "ground truth" in the sense of clinical diagnosis or interpretation. The "ground truth" or acceptance criteria were derived from international standards (ISO 10555 series, ISO 10993-1, ISO 11135, ISO 11607) and internal device specifications, as well as comparison to the predicate device. The engineers and scientists conducting the tests would have been qualified in their respective fields of materials science, biomechanics, and medical device testing.

4. Adjudication method for the test set:

Not applicable. As a non-clinical bench study, there was no adjudication method involving multiple human readers or experts to determine a consensus "ground truth." Test results were compared directly to the predetermined acceptance criteria outlined in the relevant standards and internal specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not performed. This submission is for a physical medical device (an infusion catheter) and evaluates its mechanical and material properties, not an AI or imaging diagnostic tool that would involve human reader interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This is a physical medical device, not an algorithm or software. No standalone algorithm performance was evaluated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the non-clinical tests was established by predetermined engineering specifications and compliance with recognized international and national standards for intravascular catheters and medical device testing. These standards dictate acceptable ranges for physical dimensions, material properties, strength, flexibility, pressure resistance, flow rates, biocompatibility, sterilization efficacy, and packaging integrity. The predicate device's characteristics also served as a reference point.

8. The sample size for the training set:

Not applicable. This is a non-clinical bench study for a physical device, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as there was no training set for a machine learning model.

Summary

{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 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 < 2.0 mm. .
Not intended for pediatric or neonatal use. .

TECHNOLOGY COMPARISON

The TherOx® Infusion Catheter is very similar in design and performance characteristics when compared to the Tracker® - 38 Infusion Catheter predicate device. Both catheters have a soft atraumatic tip and a flexible shaft that facilitates maneuverability within the target vessel. Both catheters have a female luer hub for attachment of solution delivery devices and a radiopaque marker band at the tip to visualize catheter location under fluoroscopy. A comparison of catheter characteristics demonstrates that both catheters meet the requirements of the ISO 10555 series of standards for intravascular catheters. Both devices are substantially equivalent relative to strength, flexibility, pressure, and flow properties.

Minor differences are enumerated in Table 1, below, and are explained following the table.

Characteristic	TherOx® InfusionCatheter	Tracker® - 38 InfusionCatheter
1. Outer Diameter	4.6 F (0.060 in) overall	5.3 F (0.070 in) overall5 F (0.066 in) at tip
2. Inner Diameter	0.046 in overall0.037 in min at marker band	0.046 in overall0.040 in at marker band
3. Usable Length	127 cm	115 cm1
4. Materials	High density polyethylene(HDPE) shaftRigid HDPE luerLDPE plasticized tip	Polypropylene/Low densitypolyethylene (LDPE) shaftRigid clear thermoplastic luerLDPE plasticized tip

TABLE 1 – Summary of Catheter Differences
-------------------------------------------	--	--

1 -- 117 cm as labeled which includes strain relief length

1. The TherOx® Infusion Catheter has a smaller outer diameter that allows use with smaller quide catheters.
1. The TherOx® Infusion Catheter has a slightly smaller inner diameter at the marker band but use of the recommended size guidewire is not impeded.

{2}------------------------------------------------

510(k) SUMMARY

The TherOx® Infusion Catheter has an extra 12 cm of usable length that aids 3. the There's "infaction and manipulating the catheter outside the body and that accommodates taller patients.
1. The distal tip materials for both catheters are the same but the shaft and luer hub materials are different. Despite these minor differences, adherence to ndb matterformance attributes as specified in applicable voluntary standards has been maintained.

NON-CLINICAL TEST DATA SUMMARY

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:

1. FDA "Guidance on Premarket Notification (510(k)) Submission for Short-Term and Long-Term Intravascular Catheters" March 1995
1. ISO 10555-1 " Sterile Single-Use Intravascular Catheters -- General Requirements"
1. ISO 10555-2 " Sterile Single-Use Intravascular Catheters Angiographic Catheters"
1. 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.

{3}------------------------------------------------

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure embracing a globe, signifying the department's mission to protect the health of all Americans.

2006 MAR 8

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Therox, Inc. c/o Underwriters Laboratories, Inc. 1285 Walt Whitman Rd. Melville, NY 11747 Attn: Mr. Casey Conry

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:

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

Regulation Number and Section

§ 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).