A guide wire is a flexible wire of a small diameter that serves as a track for directing or passing a device to a vessel, organ or cavity, by threading the device over its length.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "Attain Hybrid Guide Wire." It describes the device, its intended use, and the studies performed to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information, specifically focusing on what is available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "The results of the above verification tests met the specified acceptance criteria." However, it does not provide a detailed table outlining specific numerical acceptance criteria for each test and the corresponding reported device performance values. It only lists the types of tests performed.

Test Type	Acceptance Criteria (Not Detailed in Document)	Reported Device Performance (Not Detailed in Document)
Coating adhesion	Met specified criteria	Met specified criteria
Dimensional verification	Met specified criteria	Met specified criteria
Particulate PTFE coating adhesion	Met specified criteria	Met specified criteria
Tip integrity	Met specified criteria	Met specified criteria
Tip deflection force	Met specified criteria	Met specified criteria
Distal tip stiffness	Met specified criteria	Met specified criteria
Guide Wire Perforation	Met specified criteria	Met specified criteria
Guide Wire Passage/Seal Integrity	Met specified criteria	Met specified criteria
Silicone lubricity and durability	Met specified criteria	Met specified criteria
Guide wire torque response	Met specified criteria	Met specified criteria
Sterilization validation	Met specified criteria	Met specified criteria
Shelf life evaluation	Met specified criteria	Met specified criteria
Biocompatibility tests (ISO 10993-1)	Met specified criteria	Met specified criteria
- Cytotoxicity	Met specified criteria	Met specified criteria
- Irritation or Intracutaneous Reactivity	Met specified criteria	Met specified criteria
- Systemic Toxicity	Met specified criteria	Met specified criteria
- Hemocompatibility / Hematology	Met specified criteria	Met specified criteria
- Hemocompatibility / Thrombosis	Met specified criteria	Met specified criteria
- Pyrogen Test	Met specified criteria	Met specified criteria
- Complement Activation Assay	Met specified criteria	Met specified criteria
- Sensitization Test	Met specified criteria	Met specified criteria

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample sizes used for any of the bench/performance tests or biocompatibility tests. It also does not mention any human clinical test set for this device; the testing is focused on demonstrating substantial equivalence through bench and biocompatibility testing. Therefore, there is no data provenance (e.g., country of origin, retrospective/prospective) described for a clinical test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Since the testing described is primarily bench and biocompatibility testing, there is no "ground truth" established by human experts in the context of clinical interpretation or diagnosis. The ground truth for these tests would be derived from the experimental parameters, validated methods, and material characterization.

4. Adjudication Method for the Test Set:

Not applicable, as there is no clinical test set requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document describes bench and biocompatibility testing, not a clinical study involving human readers or comparative effectiveness with or without AI assistance. This device is a guide wire, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No. This question is also not applicable. The device is a physical medical instrument, not an algorithm, and therefore does not have "algorithm only" performance.

7. Type of Ground Truth Used:

The ground truth for the studies described would be based on:

Engineering specifications and standards: For dimensional verification, coating adhesion, tip integrity, deflection force, stiffness, perforation, passage/seal integrity, lubricity, durability, and torque response. These are objective measurements against defined criteria.
Validated laboratory methods and international standards (e.g., ISO 10993-1): For biocompatibility tests. The "ground truth" here is the adherence to these standards and the established biological responses that indicate safety.
Validated sterilization and shelf-life protocols: For sterilization validation and shelf life evaluation.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set. The substantial equivalence is based on physical and biological testing against a predicate device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As established, there is no training set for this device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is simple and professional, reflecting the department's role in public health and human services.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 11, 2015

Medtronic, Inc. Mia Hunt Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, Minnesota 55112

Re: K143316

Trade/Device Name: Attain Hybrid Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX Dated: February 4, 2015 Received: February 5, 2015

Dear Mia Hunt.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

{1}------------------------------------------------

Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Hilleman

for
$D$

for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number: K143316 Device Name: Attain Hybrid Guide Wire Indications for Use: The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature.

Prescription Use _X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

{3}------------------------------------------------

510(k) Summary K143316

[As required by 21 CFR 807.92]

Date Prepared:	March 4, 2015
Submitter:	Medtronic, Inc.Medtronic Cardiac Rhythm and Heart Failure8200 Coral Sea Street N.E.Mounds View, MN 55112Establishment Registration Number: 218220-
Contact Person:	Mia L HuntRegulatory Affairs SpecialistMedtronic Cardiac Rhythm and Heart FailurePhone: 763.526.1712Fax: 651.367.0603Email: mia.l.hunt@medtronic.com
Alternate Contact:	Rachel M BruckerSenior Regulatory Affairs SpecialistMedtronic Cardiac Rhythm and Heart FailurePhone: 763.526.6736Fax: 651.367.0603Email: rachel.m.brucker@medtronic.com
General Information
Trade Name:	Attain Hybrid Guide Wire
Common Name:	Catheter Guide Wire
Regulation Number:	21 CFR 870.1330

Product Code: DQX

Classification: Class II

Classification Panel: Cardiovascular

Special Controls: Not applicable

Predicate Devices: Attain Hybrid Guide Wires K063210

{4}------------------------------------------------

Device Description

A guide wire is a flexible wire of a small diameter that serves as a track for directing or passing a device to a vessel, organ or cavity, by threading the device over its length.

Indications for Use

The Attain Hybrid Guide Wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature.

Technological Characteristics

When compared to the predicate device (K063210), the modified Attain Hybrid Guide Wires presented in this submission have the same:

Intended use/indications for use
Operating principle
Basic design features
Device functionality
Biological safety ●
Packaging materials
Sterilization and sterility assurance level
. Shelf life

The modified Attain Hybrid Guide Wires and the predicate device differ in the following:

PTFE formulation
Tip and distal segment stiffness

Substantial Equivalence and Summary of Studies:

Technological differences between the subject and predicate devices have been evaluated through bench tests to provide evidence of safe and effective use. Modified Attain Hybrid Guide Wires are substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The device design and materials have been verified through the following tests:

Bench/performance tests: ●
- o Coating adhesion
- O Dimensional verification
- Particulate PTFE coating adhesion test (Coating Integrity) O
- Tip integrity O
- Tip deflection force O
- O Distal tip stiffness
- Guide Wire Perforation O
- Guide Wire Passage/Seal Integrity O
- Silicone lubricity and durability O

{5}------------------------------------------------

o Guide wire torque response
Sterilization validation ●
Shelf life evaluation .
Biocompatibility tests per ISO 10993-1: ●
- o Cytotoxicity
- Irritation or Intracutaneous Reactivity O
- Systemic Toxicity o
- Hemocompatibility / Hematology O
- Hemocompatibility / Thrombosis O
- Pyrogen Test o
- Complement Activation Assay O
- Sensitization Test O

Conclusion:

The results of the above verification tests met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the modifications made to the Attain Hybrid Guide Wires described in this submission result in a device that is substantially equivalent to the predicate.

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.