The Texan LONGhorn™ Foreign Body Retrieval Device is intended for use as a tool to retrieve and manipulate foreign bodies from distal peripheral vessels of the cardiovascular system.

Device Description

The Texan LONGhorn™ is comprised of the following:

A nitinol wire formed into a loop. The wire is secured distally to the catheter body; the proximal wire end is attached to a shaft that functions as a push-rod, and passes through a catheter. The "loop" portion of the wire has a platinum core for enhanced radiopacity.
An inner member accepting an 0.018" guidewire. The proximal end of the inner carrier extends out the side port of a Y-connector allowing for the physician to manipulate the guidewire thru the device.
An outer member. The proximal end is connected to a hemostasis Y-connector, having a side port and Tuohy-Borst connector on the central port for securing the hypotube.
the Tuohy-Borst connector allows the physician to secure the loop size once it is deployed to the desired diameter
the side port of the Y-connector allows access to the guidewire-dedicated lumen and the T-connector to allow for contrast injection and flushing
The loop is activated by moving the red capped knob and handle axially. The device should be manipulated in such a way that the loop can surround the foreign body. To capture the foreign body, the user shall slowly tighten the loop around the foreign body by retracting the red capped knob proximally while the device is held stationary in position. Once the loop is tightened around the foreign body, the handle and shaft shall be locked by rotating the hemeostasis valve connected to the proximal end of the handle clockwise. Retrieval of the foreign body is performed by slowly withdrawing the Texan LONGhorn™ TX30120060 and the foreign body as a unit into the sheath.

AI/ML Overview

The provided document is a 510(k) summary for the Texan LONGhorn™ Foreign Body Retrieval Device, seeking substantial equivalence to a predicate device. It contains information about the device description, intended use, technological characteristics, and a non-clinical performance test. However, it does not provide the detailed acceptance criteria and study results in the format requested.

Specifically, the document states:
"The Texan LONGhorn™ Foreign Body Retrieval Device has successfully passed all functional and safety testing requirements to ensure substantial equivalence to the predicate device. The testing is described below:

Tensile to verify design meets minimum tensile strength requirements at all joints, as 프 defined in product specification.
Animal Study to evaluate the safety and efficacy of a proposed device, and evaluate . operational characteristics of the device with respect to utilization of a predicate device."

This is a high-level summary and lacks the specific details required to populate the requested table and answer many of the questions.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is what can be inferred or stated as unavailable based on the provided text:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria	Reported Device Performance
Tensile Strength	"meets minimum tensile strength requirements at all joints, as defined in product specification." (Specific values and criteria not provided)
Safety and Efficacy (Animal Study)	"evaluate the safety and efficacy of a proposed device, and evaluate operational characteristics of the device with respect to utilization of a predicate device." (Specific metrics and results not provided)

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

Test set sample size: Not specified. The document mentions an "Animal Study," but the number of animals or specific foreign body retrieval instances is not provided.
Data provenance: Prospective (as it's an animal study conducted for regulatory submission). Country of origin is not specified, but the submission is to the US FDA.

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

Number of experts: Not specified.
Qualifications of experts: Not specified. Given it's an animal study for a medical device, it would likely involve veterinary professionals and/or device engineers, but no details are provided.

4. Adjudication method for the test set:

Not specified.

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, a MRMC comparative effectiveness study was not done. This device is a mechanical foreign body retrieval device, not an AI-assisted diagnostic tool.

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

No, a standalone algorithm performance study was not done. This device does not involve an algorithm.

7. The type of ground truth used:

For the tensile test, the ground truth would be the pre-defined product specifications for tensile strength.
For the animal study, the ground truth would be the observed safety outcomes (e.g., absence of perforation, embolization, or other adverse events) and successful retrieval/manipulation of foreign bodies in the animal model, observed directly by the investigators.

8. The sample size for the training set:

Not applicable. This device is a mechanical device, not an AI/machine learning algorithm that requires a training set.

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

Not applicable as there is no training set for this type of device.

Summary

{0}------------------------------------------------

510(k) Summary

Submitter:	IDev Technologies, Inc.1110 NASA Road One, Suite 311Houston, Texas 77058
Contact Person:	Mrs. Shannon HurdQuality Manager(281) 333-1998 x 224 - Phone(281) 333-4008 - Facsimile
Date Prepared:	April 12, 2005
Trade Name:	Texan LONGhorn™ Foreign Body Retrieval Device
Common Name:	Snare
Classification Name:	Catheter, Embolectomy (21 CFR 870.5150)
Product Code:	DXE
Predicate Device:	Texan™ Foreign Body Retrieval Device

Device Description:

The Texan LONGhorn™ is comprised of the following:

A nitinol wire formed into a loop. The wire is secured distally to the catheter body; the . proximal wire end is attached to a shaft that functions as a push-rod, and passes through a catheter. The "loop" portion of the wire has a platinum core for enhanced radiopacity.
An inner member accepting an 0.018" guidewire. The proximal end of the inner carrier . extends out the side port of a Y-connector allowing for the physician to manipulate the guidewire thru the device.
An outer member. The proximal end is connected to a hemostasis Y-connector, having a . side port and Tuohy-Borst connector on the central port for securing the hypotube.
- the Tuohy-Borst connector allows the physician to secure the loop size once it is u deploved to the desired diameter
- the side port of the Y-connector allows access to the guidewire-dedicated lumen and 트 the T-connector to allow for contrast injection and flushing

The loop is activated by moving the red capped knob and handle axially. The device should be manipulated in such a way that the loop can surround the foreign body. To capture the foreign body, the user shall slowly tighten the loop around the foreign body by retracting the red capped knob proximally while the device is held stationary in position. Once the loop is tightened around the foreign body, the handle and shaft shall be locked by rotating the hemeostasis valve connected to the proximal end of the handle clockwise. Retrieval of the foreign body is performed by slowly withdrawing the Texan LONGhorn™ TX30120060 and the foreign body as a unit into the sheath.

{1}------------------------------------------------

Intended Use:

The Texan LONGhorn™ is intended for use as a tool to retrieve and manipulate foreign bodies from distal peripheral vessels of the cardiovascular system.

Technological Characteristics Compared to Predicate:

I echnologies, Inc. considers the Texan LONGhorn™ TX30120060 Foreign Body 1200. Texancegres, interested, equivalent to IDev's Texan™ TX30060050 Foreign Body Retrieval Device as listed in the following:

l Indication for Use
- Loop

트

· Material
Radiopacity
· Orientation
Torque Control/Steerability
· Guidewire Compatibility
· Shaft Reinforcement
l Function
- Advancement
- Catheter Advancement
- · Loop Usage

Non-clinical Performance Testing:

The Texan LONGhorn™ Foreign Body Retrieval Device has successfully passed all functional and safety testing requirements to ensure substantial equivalence to the predicate device. The testing is described below:

Tensile to verify design meets minimum tensile strength requirements at all joints, as 프 defined in product specification.
Animal Study to evaluate the safety and efficacy of a proposed device, and evaluate . operational characteristics of the device with respect to utilization of a predicate device.

Conclusion:

IDev Technologies, Inc. considers the Texan LONGhorn™ Foreign Body Retrieval Device to be substantially equivalent to the Texan™ Foreign Body Retrieval Device based on design and technological characteristics.

· Loop Size
· Adiustabilitv
· Contract Injectability Catheter

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

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 9 2005

IVed Technologies, Inc. c/o Ms. Shannon Hurd Quality Manager 1110 Nasa Parkway, Suite 311 Houston, TX 77058

Re: K050926

Trade Name: Texan LONGhorn™ Regulation Number: 21 CFR 870.3460 Regulation Name: Embolectomy Catheter Regulatory Class: II (two) Product Code: MMX Dated: April 12, 2005 Received: April 15, 2005

Dear Ms. Hurd

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 3 10(x) pe device is substantially equivalent (for the indications felerenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the encrosure) to regally manation in the Medical Device American of to commerce prior to May 20, 1978, are excordance with the provisions of the Federal Food, Drug. devices that have been recuire in asse approval of a premarket approval application (PMA). and Cosment Act (Act) that to hot require subject to the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of gencial controls provisions of the tice, 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 If your device is classified (500 as 10,000). Existing major regulations affecting your device can may be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ourcements concerning your device in the Federal Register.

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

Page 2 – Ms. Shannon Hurd

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advised that I Dri brissaanse over device complies with other requirements of the Act that I DA has made a actornesulations administered by other Federal agencies. You must of any I coclar statutes und regalanents, including, but not limited to: registration and listing (21 Comply with an the Her s requirements)
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality byeveline (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control probegin marketing your device as described in your Section 510(k) This letter will and in yourse of substantial equivalence of your device to a legally premaince notification. The PDF imaling sitems of the 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 ffice of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Wilsoraliums o y telefone to premains on the Act may be obtained from the Other general information of the mational 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,

Dvina R. Vcliner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name:	Texan LONGhorn™ Foreign Body Retrieval Device
Indications For Use:	The Texan LONGhorn™ Foreign Body Retrieval Deviceis intended for use as a tool to retrieve and manipulateforeign bodies from distal peripheral vessels of thecardiovascular system.

Prescription Use × (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)

Page 1 of L

Duna R. Vickers

(Division Sinn-Off) Olvision City City Cardiovascular Devices

510(k) Number K050926

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).