(112 days)
Not Found
No
The summary describes a physical guide wire and its intended use for lead placement. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on bench tests and material properties, not algorithmic performance.
No
The device is a guide wire used to aid in the placement of leads; it does not directly treat a medical condition.
No
Explanation: The device is a guide wire intended to aid in the placement of leads. Its purpose is to guide other medical devices, not to diagnose a condition or disease.
No
The device description explicitly states it is a "flexible wire of a small diameter," which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature." This describes a device used within the body for a procedural purpose (guiding another device), not for examining specimens in vitro (outside the body) to provide diagnostic information.
- Device Description: The description of a "flexible wire of a small diameter that serves as a track for directing or passing a device to a vessel, organ or cavity" aligns with an invasive medical device used for access and guidance, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVDs are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely procedural and invasive.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DOX, DQX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- Coating adhesion
- Dimensional verification
- Particulate PTFE coating adhesion test (Coating Integrity)
- Tip integrity
- Tip deflection force
- Distal tip stiffness
- Guide Wire Perforation
- Guide Wire Passage/Seal Integrity
- Silicone lubricity and durability
- Guide wire torque response
- Sterilization validation
- Shelf life evaluation
- Biocompatibility tests per ISO 10993-1:
- Cytotoxicity
- Irritation or Intracutaneous Reactivity
- Systemic Toxicity
- Hemocompatibility / Hematology
- Hemocompatibility / Thrombosis
- Pyrogen Test
- Complement Activation Assay
- Sensitization Test
The results of the above verification tests met the specified acceptance criteria and did not raise new safety or performance issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 Failure | |
| 8200 Coral Sea Street N.E. | |
| Mounds View, MN 55112 | |
| Establishment Registration Number: 218220- | |
| Contact Person: | Mia L Hunt |
| Regulatory Affairs Specialist | |
| Medtronic Cardiac Rhythm and Heart Failure | |
| Phone: 763.526.1712 | |
| Fax: 651.367.0603 | |
| Email: mia.l.hunt@medtronic.com | |
| Alternate Contact: | Rachel M Brucker |
| Senior Regulatory Affairs Specialist | |
| Medtronic Cardiac Rhythm and Heart Failure | |
| Phone: 763.526.6736 | |
| Fax: 651.367.0603 | |
| Email: 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.