RADIUS MICRO SNARE

K022201 · Radius Medical Technologies, Inc. · MMX · Feb 3, 2003 · Cardiovascular

Device Facts

• Record ID: K022201
• Device Name: RADIUS MICRO SNARE
• Applicant: Radius Medical Technologies, Inc.
• Product Code: MMX · Cardiovascular
• Decision Date: Feb 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2

Intended Use

The Radius Micro Snare is intended for use to retrieve and/or manipulate objects in the distal peripheral vessels of the cardiovascular system and hollow viscus. Manipulation procedures include retrieval and/or repositioning of intravascular foreign objects such as coils, balloons, catheters and/or guidewires within the peripheral and cardiovascular system.

Device Story

Radius Micro Snare is a catheter-based retrieval device for use in distal peripheral vessels and hollow viscus. It consists of an outer sheath tube and a core wire with a snare loop attached to the distal end. The device is operated by a physician who advances or retracts the outer sheath via a molded ABS handle to deploy or capture objects. The core wire is a .008" diameter stainless steel wire. The device is used to retrieve or reposition foreign objects such as coils, balloons, catheters, and guidewires. It is provided sterile for single use.

Clinical Evidence

Bench testing only. Performance testing included tensile strength, torque strength, tip flexibility, and biocompatibility.

Technological Characteristics

Materials: stainless steel core, polyimide tube, PTFE coating, ABS handle. Dimensions: .008" core diameter, 190 cm length, 2-7 mm loop sizes. Delivery: catheter/outer sheath system. Sterilization: ETO (SAL 10-6).

Indications for Use

Indicated for retrieval and/or manipulation of intravascular foreign objects (coils, balloons, catheters, guidewires) in distal peripheral vessels of the cardiovascular system and hollow viscus.

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

• Microvena Amplatz Goose Neck Micro Snare (K970688)
• Radius Snare (K021441)
• Radius PTCA Guidewire (K970466)

Submission Summary (Full Text)

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## FEB 0 3 2003

## 510(K) SUMMARY

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Radius Medical Technologies, Inc. is required to submit with this Premarket Notification either an "...adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Radius Medical Technologies, Inc. chooses to submit a summary of information respecting safety and effectiveness.

- 1. Sponsor Name

| Submitter's Name: | Radius Medical Technologies, Inc |
|----------------------|------------------------------------|
| Address: | 63 Great Road<br>Maynard, MA 01754 |
| Contact Person: | Maureen A. Finlayson |
| Date of Preparation: | June 28, 2002 |

- 2. Device Name

| Device Generic Name: | Snare |
|----------------------|-------------------------------------|
| Device Trade Name: | Radius Micro Snare |
| Classification Name: | Wire, Guide, Cardiovascular (74DQX) |

- Identification of Predicate or Legally Marketed Device 3.
The Radius Micro Snare is substantially equivalent to the Microvena Amplatz Goose Neck Micro Snare (K970688), the Radius Snare (K021441) and the Radius PTCA Guidewire (K970466).

- 4. Device Description
The Radius Micro Snare is composed of two primary parts: an outer sheath tube and a core wire with a snare attached to the distal end. The outer sheath acts as a catheter through which the core wire, with snare, slides.

The outer sheath is a stainless steel tube joined to a polyimide tube. The stainless steel and polyimide tubes are covered with PTFE.

The stainless steel core is a solid .008" diameter stainless steel core that is a smaller version of the solid core wire in the FDA cleared Radius PTCA Guidewire

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and the FDA cleared Radius Snare. A stainless steel loop is soldered to the distal end of the core. The Radius Micro Snare has loop sizes, which range from 2 - 7 millimeters. The over-all length of the device is 190 centimeters. A molded ABS operating handle is included on the proximal end of the Micro Snare to aid in advancing and retracting the outer sheath over the snare loop.

The Radius Micro Snare will be packaged in a Mylar/Tyvek pouch and ETO sterilized to SAL 10-6.

- న్. Intended Use
The Radius Micro Snare is intended for use to retrieve and/or manipulate objects in the distal peripheral vessels of the cardiovascular system and hollow viscus. Manipulation procedures include retrieval and/or repositioning of intravascular foreign objects such as coils, balloons, catheters and/or guidewires within the peripheral and cardiovascular system.

- 6. Comparison of Technological Characteristics
The Radius Micro Snare is substantially equivalent in material, design and function to the following predicate devices: the Microvena Amplatz Goose Neck Micro Snare (K970688), the Radius Snare (K021441), and the Radius PTCA Guidewire (K970466).

The Radius Micro Snare is similar in materials, function and design to predicate Radius PTCA Guidewire (K970466) and Radius Snare (K021441). The Radius Micro Snare uses the Radius PTCA Guidewire as its base and adds a snare onto the distal tip of the core guidewire.

The design and function of the Radius Micro Snare is the same as the Microvena Amplatz Goose Neck Micro Snare (K970668). Both are delivered via a cathether/outer sheath tube and both have a snare at the distal end. The intended use of both devices is the same: to retrieve and/or manipulate objects in the distal peripheral vessels of the cardiovascular system and hollow viscus.

- 7. Performance Testing
The following in vitro performance tests were performed on the Radius Micro Snare:

Tensile Strength Torque Strength Tip Flexibility Biocompatability

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Public Health Service

FEB 0 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Maureen A. Finlayson President Radius Medical Technologies, Inc. 63 Great Road Maynard, MA 01754

Re: K022201

> Trade/Device Name: Radius Micro Snare Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter. Regulatory Class: Class II Product Code: MMX Dated: October 14, 2002 Received: November 6, 2002

Dear Ms. Finlayson:

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

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Page 2 - Ms. Maureen A. Finlayson

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 yours,

Kaitlin Tea

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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KO2201 510(k) Number (if known):

Device Name: Radius Micro Snare

Indications For Use:

The Radius Micro Snare is intended for use to retrieve and/or manipulate objects in the distal peripheral vessels of the cardiovascular system and hollow viscus. Manipulation procedures include retrieval and/or repositioning of intravascular foreign objects such as coils, balloons, catheters and/or guidewires within the peripheral and cardiovascular system.

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

Norke Tlu

(Division Sign-Off)
Division of Cardiovascular Devices

**510(k) Number** K022201