TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050

K033188 · Idev Technologies, Inc. · MMX · Nov 19, 2003 · Cardiovascular

Device Facts

• Record ID: K033188
• Device Name: TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050
• Applicant: Idev Technologies, Inc.
• Product Code: MMX · Cardiovascular
• Decision Date: Nov 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The Texan™ Foreign Body Retrieval Device is a percutaneous snare used to retrieve foreign bodies from distal peripheral vessels. The device consists of a nitinol wire loop with a platinum core and tungsten sheath for radiopacity, attached to a push-rod shaft within a two-lumen catheter. The second catheter lumen allows for guidewire insertion and contrast injection. The device is operated by a clinician who advances the catheter, deploys the loop by pushing the shaft, captures the foreign body, and tightens the loop by pulling the shaft proximally. The shaft is locked via a rotating hemostasis valve, and the device is withdrawn as a unit. This tool assists in the removal of misplaced medical devices or other foreign objects, potentially avoiding more invasive surgical interventions.

Clinical Evidence

Bench testing only. Evidence includes accelerated aging and packaging integrity studies (1-year shelf life), dimensional and tensile strength verification, biocompatibility testing, and an animal study to evaluate safety, efficacy, and operational characteristics compared to the predicate device.

Technological Characteristics

Percutaneous retrieval snare. Materials: Nitinol wire loop with platinum core and tungsten sheath; two-lumen catheter body. Features: Tuohy-Borst connector, hemostasis valve with flush port. Mechanical operation: Push-rod shaft for loop deployment/tightening; manual locking mechanism via hemostasis valve rotation. Radiopaque loop. Guidewire compatible.

Indications for Use

Indicated for the retrieval and manipulation of foreign bodies from distal peripheral vessels of the cardiovascular system.

Regulatory Classification

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.

Predicate Devices

• ev3 Amplatz "Goose-Neck" Snare

Submission Summary (Full Text)

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# NOV 1 9 2003

### 510(k) Summary

| Submitter: | IDev Technologies, Inc.<br>1110 NASA Road One, Suite 311<br>Houston, Texas 77058 | |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------|---------|
| Contact Person: | Ms. Lynne A. Davies<br>Regulatory Affairs Manager<br>[phone] x 223 - Phone<br>[phone] - Mobile<br>[phone] - Fax | K033188 |
| Date Prepared: | September 30, 2003 | |
| Trade Name: | Texan™ Foreign Body Retrieval Device | |
| Common Name: | Snare | |
| Classification Name: | Device, Percutaneous Retrieval (21 CFR 870.5150) | |
| Product Code: | MMX | |

#### Device Description:

The Texan™ 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 dedicated catheter lumen. The "loop" portion of the wire has a radiopaque feature, comprised of Nitinol wire with a platinum core and tungsten sheath
- A two-lumen catheter body. One lumen is dedicated for use by the loop wire, which is . secured to the push-rod (shaft) at the proximal end of the loop wire. The second and larger lumen is dedicated for use of a guidewire and contrast. The proximal catheter end is to be attached to a hemostasis valve with a flush port.
- The hemostasis valve has 2 ports: o
- side port having access to the guidewire-dedicated lumen for contrast injection; and す
- primary port dedicated for a guidewire, and having a Tuohy-Borst connector.

The loop is activated by pushing the shaft distal to the Touhy-Borst connector while holding the Touhy-Borst stationary. 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 pulling the shaft proximally while the device is held stationary in position. Once the loop is tightened around the foreign body the shaft shall be lockeda by rotating the homeostasis valve connected to the proximal end of the shaft clockwise. Retrieval of the foreign body is performed by slowly withdrawing the Texan™ and the foreign body as a unit into the sheath.

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#### Intended Use:

The Texan™ 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:

IDev Technologies, Inc. considers the Texan™ Foreign Body Retrieval Device as substantially equivalent to ev3's Amplatz "Goose-Neck" Snare as listed in the following:

- 이 Indication for Use
- 포 Loop
- · Material
- · Radiopacity
- · Orientation
- · Torque Control/Steerability
- · Guidewire Compatibility
- · Shaft Reinforcement
- Function
- Advancement 0
- o Catheter Advancement
- Loop Usage 0

#### Non-clinical Performance Testing:

The Texan™ 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:

- Accelerated Aging / Packaging to determine effects of time & environment on device 트 and packaging materials, to substantiate 1-year shelf life. Tests include package Seal Peel, Burst, Dye Penetration, and device functionality after aging.
- Packaging / Shipping Integrity to determine possible adverse effects of shipping & 트 transportation environments on survivability of device packaging and construction materials.
- Dimensional - to insure that the device met dimensional requirements, as defined in the product specification.
- Tensile - to verify design meets minimum tensile strength requirements at all joints, as defined in product specification.
- E Biocompatibility - to determine the potential toxicity resulting from contact of the component materials of the device with the body.
- 사 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™ Foreign Body Retrieval Device to be substantially equivalent to the ev3 Amplatz "Goose-Neck" Snare Device based on design and technological characteristics.

- · Configuration
- · Loop Size
- · Adjustability
- · Catheter

-

- · French Size
- · Contract Injectability

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a bird or abstract human figures, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 2003

IDev Technologies, Inc. c/o Ms. Lynne Davies 1110 NASA Road 1 Suite 311 Houston, TX 77058

Re: K033188

Texan™ Foreign Body Retrieval Device, Model TX30 Regulation Number: 21 CFR 870.5150 Regulation Name: Percutaneous Retrieval Device Regulatory Class: Class II (two) Product Code: MMX Dated: September 30, 2003 Received: October 1, 2003

Dear Ms. Davies:

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.

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Page 2 - Ms. Lynne Davies

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 [phone]. 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Ashley B. Boone

for
B
D
D

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

Enclosure

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#### Indications for Use Statement

Applicant: IDev Technologies, Inc.

510(k) Number (if known): K033188

Device Name: Texan™ Foreign Body Retrieval Device

Indications for Use:

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

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Concurrence of CDRH, Office of Device Evaluation (ODE) (Optional Format 3-10-98)

Anule B. Evans
(Division Sign. Of)

n of Cardlovascular Devices

510(k) Number_

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