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. 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.

AI/ML Overview

The provided text is a 510(k) summary for the BIOTRONIK Galeo Guide Wire. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics. Therefore, many of the requested details about acceptance criteria, study design, and performance are not present in the provided document.

Here's a breakdown based on the information available:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it relies on the concept of substantial equivalence to predicate devices. The "reported device performance" is implicitly that it performs comparably or in a manner that does not raise new questions of safety or effectiveness compared to the predicate devices.

Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Material Equivalence: Materials used are comparable to predicate devices.	Materials used and design are similar to Guidant ACS Hi-Torque, with the coating similar to Medtronic Mustang.
Design Equivalence: Device design is comparable to predicate devices.	Design and various flexibilities (HS, S, M, F, HF, J-tip variations, ES) are described. Nominal diameter and length are 0.014"/0.36 mm and 175 cm.
Function Equivalence: Device functions are comparable to predicate devices.	Functionally equivalent to market-released guide wires. Distal coil treated with silicone-based coating for lubricity. Proximal wire section coated with PTFE. Distal 3.0 cm responds to manual forming. Different grades of radioopacity.
Intended Use Equivalence: Intended use is the same as predicate devices.	Intended for use in vascular interventional procedures to facilitate the placement of catheters within coronary arteries, consistent with current guidewires.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a specific "test set" or a clinical study with human subjects that would involve a sample size. The review is based on a comparison to predicate devices, material specifications, and design features.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment by experts for a test set is described in this regulatory submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set or adjudication process is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device (guide wire) submission, not an AI-enabled diagnostic device, so MRMC studies involving human readers and AI assistance are not relevant here and are not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No specific ground truth determination is mentioned as this is a substantial equivalence submission based on physical and functional comparisons.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. There is no mention of a training set or ground truth establishment for it.

In summary, the provided 510(k) summary for the BIOTRONIK Galeo Guide Wire is a regulatory document focused on demonstrating substantial equivalence to existing predicate devices based on material, design, function, and intended use. It does not describe a clinical study with detailed performance metrics, acceptance criteria, or ground truth establishment in the manner typically associated with studies for novel diagnostic or treatment algorithms.

Summary

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11. 510(k) Summary

11.1 Submitter Information
BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035-5369 (800) 547-0394 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

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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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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)

Over-The-Counter Use

(Optional Formal 1-2-96)

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
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.(b)
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.