RADIUS SNARE

K021441 · Radius Medical Technologies, Inc. · MMX · Jun 14, 2002 · Cardiovascular

Device Facts

• Record ID: K021441
• Device Name: RADIUS SNARE
• Applicant: Radius Medical Technologies, Inc.
• Product Code: MMX · Cardiovascular
• Decision Date: Jun 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Radius Snare is intended for use in the cardiovascular system and hollow viscous to retrieve and/or manipulate objects using minimally invasive surgical procedures. Manipulation procedures include retrieval and/or repositioning of intravascular foreign objects such as coils, balloons, catheters and/or guidewires within the cardiovascular system.

Device Story

Radius Snare is a minimally invasive surgical tool for retrieving or repositioning intravascular foreign objects like coils, balloons, catheters, and guidewires. Device consists of an outer sheath (catheter) and a core wire with a snare loop at the distal end. Physician operates device by sliding core wire through sheath to deploy snare. Once snare captures object, physician manipulates or retrieves it. Used in cardiovascular system and hollow viscous. Benefits include non-surgical removal or adjustment of foreign bodies.

Clinical Evidence

Bench testing only. No clinical data provided. In vitro performance testing included tensile strength, torque strength, torqueability, tip flexibility, coating adherence/integrity, and biocompatibility.

Technological Characteristics

Device comprises a stainless steel outer sheath with PTFE overjacket and a .0135" diameter stainless steel core wire with a soldered stainless steel loop. Loop sizes range from 5-35 mm; total device length is 150 cm. Sterilized via ETO to SAL 10-2. Packaged in Mylar/Tyvek pouch.

Indications for Use

Indicated for use in the cardiovascular system and hollow viscous for retrieval and/or manipulation of intravascular foreign objects (coils, balloons, catheters, guidewires) during minimally invasive surgical procedures.

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 Snare/Catheter (K972511)
• Radius PTCA Guidewire (K970466)

Submission Summary (Full Text)

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JUN 1 4 2002

K021441 Page 1 of 2

## 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.

- نسم Sponsor Name

| Submitter's Name: | Radius Medical Technologies, Inc |
|----------------------|----------------------------------|
| Address: | 63 Great Road |
| | Maynard, MA 01754 |
| Contact Person: | Maureen A. Finlayson |
| Date of Preparation: | April 29, 2002 |

- 2. Device Name

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

- 3. Identification of Predicate or Legally Marketed Device
The Radius Snare is substantially equivalent to the Microvena Amplatz Goose Neck Snare/Catheter (K972511) Radius PTCA Guidewire (K970466).

- Device Description 4.
The Radius 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 coil with a PTFE overjacket.

The stainless steel core is the same solid .0135" diameter stainless steel core wire in the FDA cleared Radius PTCA Guidewire. A stainless steel loop is soldered to

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K021441 Page 2 of 2
Page 52

the distal end of the core wire. The Radius Snare has loop sizes which range from 5 - 35 millimeters. The over-all length of the device is 150 centimeters.

The Radius Snare will be packaged in a mylar/Tyvek pouch and ETO sterilized to SAL 10-2.

- 2. Intended Use
The Radius Snare is intended for use in the cardiovascular system and hollow viscous to retrieve and/or manipulate objects using minimally invasive surgical procedures. Manipulation procedures include retrieval and/or repositioning of intravascular foreign objects such as coils, balloons, catheters and/or guidewires within the cardiovascular system.

- Comparison of Technological Characteristics 6.
The Radius Snare is substantially equivalent in material, design and function to the following predicate devices: the Microvena Amplatz Goose Neck Snare/Catheter (K972511) and the Radius PTCA Guidewire (K970466).

The Radius Snare is similar in materials, function and design to predicate Radius PTCA Guidewire (K970466). The Radius 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 Snare is the same as the Microvena Amplatz Goose Neck Snare/Catheter (K972511). Both devices are delivered via a cathether/outer sheath tube and both have a snare at the distal end. The intended use of the two devices is the same: to retrieve and/or manipulate objects in the cardiovascular system and hollow viscous.

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

- 1. Tensile Strength
- 2. Torque Strength
- 3. Torqueability
- Tip Flexibility 4,
- Coating Adherence/Integrity న్న
- 6. Biocompatability

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 4 2002

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

Re: K021441 Trade Name: Radius Snare Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II (two) Product Code: MMX Dated: May 3, 2002 Received: May 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.

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Page 2 - Ms. Maureen A. Finlayson

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 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,

N Dee N Tell
Joanne Dee Tillman, Ph.D.

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ko21441 510(k) Number (if known):

Device Name: Radius Snare

Indications For Use:

The Radius Snare is intended for use in the cardiovascular system and hollow viscous to retrieve and/or manipulate objects using minimally invasive surgical procedures. Manipulation procedures include retrieval and/or repositioning of intravascular foreign objects such as coils, balloons, catheters and/or guidewires within the cardiovascular system.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | <div> <img alt="Checkmark" src="checkmark.png"/> </div> | OR | Over-The-Counter Use | |
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Division of Cardiovascular & Respiratory Devices
510(k) Number K021441Concurrence of CDRH, Office of Device Evaluation (ODE)