IN-TIME RETRIEVAL DEVICE

K014109 · Boston Scientific, Target · MMX · Mar 12, 2002 · Cardiovascular

Device Facts

• Record ID: K014109
• Device Name: IN-TIME RETRIEVAL DEVICE
• Applicant: Boston Scientific, Target
• Product Code: MMX · Cardiovascular
• Decision Date: Mar 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2

Intended Use

The In-Time™ Retrieval Device is designed for use with a guiding catheter for the retrieval of intravascular foreign objects such as coils, balloons, portions of catheters and / or loop wires misplaced during interventional radiologic procedures in peripheral, neuro and cardiovasculature.

Device Story

In-Time™ Retrieval Device is a mechanical endovascular snare used to retrieve misplaced foreign objects (coils, balloons, catheter fragments, wires) during interventional procedures. Device consists of a braided catheter shaft with a radiopaque basket at the distal tip and an internal, non-removable, tapered guiding corewire. Corewire allows for rotation and 1.5 cm longitudinal movement to manipulate the basket. Catheter shaft features HYDROLENE™ hydrophilic coating to reduce friction. Operated by physicians in clinical settings (peripheral, neuro, cardiovasculature) via a guiding catheter. Fluoroscopic visualization is facilitated by a 3 cm radiopaque distal coil. Luer fitting on hub allows for accessory attachment and continuous flushing. Device benefits patients by enabling percutaneous removal of foreign bodies, potentially avoiding surgical intervention.

Clinical Evidence

Bench testing only. No clinical data provided. Verification testing included tensile strength, rotation, tip buckling, turns to failure, basket activation/closing forces, surface roughness, particulate testing, and withdrawal force from catheter. All tests met established acceptance criteria.

Technological Characteristics

Braided catheter shaft with radiopaque basket; HYDROLENE™ hydrophilic coating. Internal tapered guiding corewire (non-removable). Luer fitting for flushing/accessories. Biocompatible materials per ISO 10993-1. Dimensions: 3.0 F outer diameter, compatible with 6 F guiding catheters. Mechanical operation via manual manipulation under fluoroscopy.

Indications for Use

Indicated for retrieval of intravascular foreign objects (coils, balloons, catheter fragments, loop wires) misplaced during interventional radiologic procedures in peripheral, neuro, and cardiovasculature. For use with guiding catheters in vessels 2-4 mm diameter.

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

• Retriever -18 Endovascular Snare (K914067)

Submission Summary (Full Text)

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K014/09 (P. 1 of 3)

### IX. 510(k) Summary of Safety and Effectiveness

MAR 1 2 2002

| SUBMITTER: | Boston Scientific Target<br>47900 Bayside Parkway<br>Fremont, CA 94538 |
|------------|------------------------------------------------------------------------|
|------------|------------------------------------------------------------------------|

CONTACT PERSON: Seth A. Schulman TEL: [phone] FAX: [phone] E-MAIL: [e-mail]

DATE PREPARED: December 7, 2001

CLASSIFICATION NAME: Retrieval Device (21 CFR Section 870.1250)

COMMON NAME: Retrieval Device

PROPRIETARY NAME: In-Time™ Retrieval Device

Retriever -18 Endovascular Snare (K914067) PREDICATE DEVICE:

The In-Time™ Retrieval Device consists of a braided catheter DEVICE DESCRIPTION: shaft, with a radiopaque basket attached to the distal tip of the catheter. The inner lumen of the catheter contains a flexible, guiding corewire, which is tapered from the proximal to distal end.

> The corewire extends distally 3 cm from the basket and is not removable from the catheter. The corewire can be rotated freely as well as moved distally and proximally within the catheter approximately 1.5 cm. The 3 cm radiopaque distal coil extending from the basket facilitates fluoroscopic visualization.

A luer fitting is located on the catheter hub and is used for the attachment of accessories and to facilitate the continuous flush of solution.

The catheter shaft is coated with HYDROLENE™, a hydrophilic coating that reduces friction during manipulation in a guide catheter and in blood vessels.

The In-Time™ Retrieval Device is designed to be used with a guide catheter.

The In-Time™ Retrieval Device can be used in vessel diameters ranging from 2 mm to 4 mm.

Image /page/0/Picture/17 description: The image shows the logo for Boston Scientific Target. The words "Boston Scientific" are stacked on top of each other in a serif font. Below that, the word "TARGET" is written in a bold, sans-serif font with a line above it.

510(k) Premarket Notification In-Time™ Retrieval Device

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K014109 (P.2 of 3)

Each In-Time™ Retrieval Device is packaged with the following accessory items: catheter introducer, shaping mandrel, torquer and Rotating Hemostatic Valve (RHV). The items are sealed in a sterile pouch located within the larger pouch.

The In-Time™ Retrieval Device is designed for use with a INTENDED USE: guiding catheter for the retrieval of intravascular foreign objects such as coils, balloons, portions of catheters and / or loop wires misplaced during interventional radiologic procedures in peripheral, neuro and cardiovasculature.

All component materials of the In-Time™ Retreival Device are MATERIALS: biocompatible in accordance with ISO 10993-1.

# TECHNOLOGICAL CHARACTERISTICS COMPARISON:

| Test or Point of Comparison | In-Time™ Retrieval Device |
|-----------------------------|-------------------------------------------------------------|
| Biocompatibility | Meets acceptance criteria established by ISO 10993-1. |
| Dimensional Tests | Meets acceptance criteria established for device. |
| Friction | Meets acceptance criteria established for predicate device. |
| Foreign Body Removal | Meets acceptance criteria established for predicate device. |
| Sterilization | Meets acceptance criteria established for predicate device. |

## Verification Test Summary Table: Predicate Retriever™-18 Endovascular Snare vs In-Time™ Retrieval Device

Image /page/1/Picture/8 description: The image shows the logo for Boston Scientific Target. The words "Boston Scientific" are stacked on top of each other in a serif font. Below that is the word "TARGET" in a sans-serif font. A line separates the two sections of text.

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K014109 (P.3 of 3)

## Verification Test Summary Table: In-Time™ Retrieval Device

| Functional Test | In-Time™ Retrieval Device |
|--------------------------------|---------------------------------------------------|
| Tensile | Meets acceptance criteria established for device. |
| Rotation | Meets acceptance criteria established for device. |
| Tip Buckling | Meets acceptance criteria established for device. |
| Turns to Failure | Meets acceptance criteria established for device. |
| Basket Activation Force | Meets acceptance criteria established for device. |
| Basket Closing Force | Meets acceptance criteria established for device. |
| Surface Roughness | Meets acceptance criteria established for device. |
| Particulate Test | Meets acceptance criteria established for device. |
| Withdrawal Force from Catheter | Meets acceptance criteria established for device. |

## Conclusion:

The In-Time™ Retreival Device is substantially equivalent to the predicate Retriever™-18 Endovascular Snare with regards to safety and performance characteristics.

Boston
Scientific
TARGET

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles embedded within its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 2002

Mr. Seth A. Schulman Senior Regulatory Affairs Specialist Boston Scientific/Target 47900 Bayside Parkway Fremont, California 94538

Re: K014109

Trade/Device Name: In-Time™ Retrieval Device Regulation Number: 870.5150 Regulation Name: Percutaneous retrieval device Regulatory Class: II Product Code: MMX Dated: December 7, 2001 Received: December 14, 2001

Dear Mr. Schulman:

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.

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.

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Page 2 - Mr. Seth A. Schulman

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,

fo Mark A. Wilkerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### KO14109 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Name: In-Time™ Retrieval Device

## Indications For Use:

The In-Time™ Retrieval Device is designed for use with a guiding catheter for the retrieval of intravascular foreign objects such as coils, balloons, portions of catheters and / or loop wires misplaced during interventional radiologic procedures in peripheral, neuro and cardiovasculature.

| | | | | In-Time™ 4 and 6 strand / Guiding Catheter Selection Guide |
|--|--|--|--|------------------------------------------------------------|
|--|--|--|--|------------------------------------------------------------|

| In-Time™<br>Model | In-Time™<br>Outer Diameter | Minimum Guiding<br>Catheter Internal<br>Diameter |
|-------------------|----------------------------|--------------------------------------------------|
| 4 strand | 3.0 F | 6 F |
| 6 strand | 3.0 F | 6 F |

(Please do not write below this line - continue on another page if needed)

| Concurrence of CDRH, Office of Evaluation (ODE) | |
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| Prescription Use: | <span style="text-decoration: overline;">X</span> |
|-----------------------|---------------------------------------------------|
| (Per 21 CFR §801.109) | |

| | OR Over-The-Counter Use: <span style="text-decoration: underline;"></span> |
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| | <div style="text-align:center;"> <span style="text-decoration: overline;"></span> <p>(Division Sign-Off)</p> </div> |
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Division of General. Restorative
and Neurological Devices

| 510(k) Number | <span style="text-decoration: underline;">K014109</span> |
|---------------|----------------------------------------------------------|
|---------------|----------------------------------------------------------|

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510(k) Premarket Notification ~ In-Time™ Retrieval Device