GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL 114156, GALEO F 014 MODEL 115 487 GALEO HF 018

K982272 · Biotronik, Inc. · DQX · Jan 8, 1999 · Cardiovascular

Device Facts

• Record ID: K982272
• Device Name: GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL 114156, GALEO F 014 MODEL 115 487 GALEO HF 018
• Applicant: Biotronik, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Jan 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

Galeo guidewires are intended for use in vascular interventional procedures to facilitate the placement of catheters within the coronary arteries.

Device Story

Coronary vascular guide wires (0.014" diameter, 175 cm length) used to facilitate catheter placement in coronary arteries. Device family includes various stiffness levels (Highly Stiff to Highly Flexible) and J-tip configurations; includes extension wire for over-the-wire exchange. Distal section features silicone-based coating for lubricity; proximal section coated with PTFE. Distal 3.0 cm is manually shapeable; contains radiopaque platinum coil section for visualization. Used by physicians in clinical settings during interventional procedures. Provides mechanical support and guidance for catheter navigation through coronary vasculature.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and functional characteristics compared to legally marketed predicate devices.

Technological Characteristics

Coronary guide wire; 0.014" diameter; 175 cm length. Materials: stainless steel and platinum coils. Coatings: silicone-based (distal) and PTFE (proximal). Features: manual shapeable distal tip, radiopaque distal section, extendable design. Non-powered, mechanical device.

Indications for Use

Indicated for use in patients undergoing vascular interventional procedures requiring catheter placement within the coronary arteries.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Guidant ACS Hi-Torque guide wire (K973494)
• Medtronic Mustang guide wire (K961917)

Submission Summary (Full Text)

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# 11. 510(k) Summary

- 11.1 Submitter Information
BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035-5369 [phone] Contact: David Makanani, Vice President, Clinical and Regulatory Affairs Notification Prepared June 26, 1998

### 11.2 Device Name

| Trade Name: | Galeo HS 014 |
|----------------------|---------------------|
| | Galeo S 014 |
| | Galeo M 014 |
| | Galeo F 014 |
| | Galeo HF 014 |
| | Galeo S/J 014 |
| | Galeo M/J 014 |
| | Galeo F/J 014 |
| | Galeo ES 014 |
| | Galeo EW 014 |
| Common Name: | guide wire |
| Classification Name: | catheter guide wire |

## 11.3 Predicate Devices

The Galeo guide wire is substantially equivalent in material, design, function, and intended use to the following devices: Guidant ACS Hi-Torque guide wire

Medtronic Mustang guide wire

## 11.4 Device Description

BIOTRONIK Galeo Guide Wires are coronary vascular guide wires with a nominal diameter of 0.014"/0.36 mm and a nominal length of 175 cm. The BIOTRONIK Galeo Guide Wire Family consists of nine coronary guide wires of various flexibilities and one extension wire. Galeo has a straight configuration with five levels of stiffness: Highly Stiff (HS), Stiff (S), Medium (M), Flexible (F), and Highly Flexible (HF). There are also three stiffness variations available with a pre-formed J-tip: Floppy (F), Medium (M), and Stiff (S). Galeo ES (Extra Support) offers enhanced support during intracoronary vascular procedures.

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All Galeo Guide Wires (175 cm) are extendable to over-the-wire exchange length using the Galeo Extension Wire (EW).

The distal coil areas of the BIOTRONIK Galeo guide wires are treated with a siliconebased coating that makes the distal section of the guide wire more lubricious than the bare metal surface. The proximal wire section is coated with PTFE.

The distal 3.0 cm of the Galeo Guide Wire responds easily to manual forming or shaping. The Galeo Guide Wire offers different grades of radioopacity over its distal stainless steel and platinum coil section. The 27 cm stainless steel coil section (27 cm in length) is radiolucent; the platinum coil section (3.0 cm) is highly radioopaque.

The proximal end of the guide wire is slightly tapered and allows the attachment of the extension wire Galeo EW. The combination of Galeo EW results in an overall wire length of 325 cm.

### 11.5 Intended Use

Galeo guidewires are intended for use in vascular interventional procedures to facilitate the placement of catheters within the coronary arteries.

### 11.6 Comparison to Predicate Devices

The Galeo guide wires are functionally equivalent to market-released guide wires. In specific, the materials used and design are similar to the Guidant ACS Hi-Torque (K973494, Dec. 12, 1997) series with the exception of the coating of the distal coil region. This coating is similar between the Galeo series and the Medtronic Mustang guide wire (K961917, Nov. 20, 1996).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1999 JAN

Mr. David M. Makanani Biotronik, Inc. 6024 Jean Road 97035-5369 Lake Oswego, OR

Re: K982272 Biotronik Galeo Guide Wire Requlatory Class: II (two) Product Code: 74 DQX Dated: November 20, 1998 Received: November 23, 1998

Dear Mr. Makanani:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2 - Mr. David M. Makanani

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page Page of

510(k) Number (if known): K982272

BIOTRONIK GALEO GUIDE WIRES Device Name:

Indications For Use:

Galeo Guidewires are intended for use in vascular interventional procedures to facilitate the placement of catheters within the coronary arteries.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chaturbun Hon

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 9822 72

510(k) Number K982272

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Formal 1-2-96)