(143 days)
The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature.
The Attain Hybrid Guide Wire is a single use guide wire designed to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature. The guide wires consist of a core wire with springs, and coatings. Near the distal end of the device, the core wire consists of tapers to allow differing support or stiffness levels.
The provided text is a 510(k) summary for the Medtronic Attain Hybrid Guide Wires. It lacks the specific details about acceptance criteria and study data that would allow a comprehensive response to your request. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance metrics from a specific study against acceptance criteria.
However, I can extract and infer some information based on the typical content of such submissions:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not present in the provided text. The document states: "Device verification testing was performed to demonstrate the Attain Hybrid Guide Wires meet established performance criteria and to support equivalency to the referenced predicate devices. Visual, performance and compatibility testing was completed. All design and compatibility requirements were met." This indicates that performance criteria were established and met, but the specific criteria (e.g., tensile strength, kink resistance, pushability, torqueability, coating durability) and the quantitative results are not detailed.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Not specified in document, but generally stated as "All design and compatibility requirements were met." |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not present in the provided text. The document refers to "Device verification testing," but does not mention the sample size for this testing or the provenance of the data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not applicable and not present in the provided text. The device is a physical medical device (guide wire), not an AI or diagnostic imaging system that requires expert interpretation to establish ground truth for a test set. Design verification and validation for such devices typically involve engineering tests, not expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set:
This information is not applicable and not present in the provided text for the same reasons as point 3.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
This information is not applicable and not present in the provided text. This type of study is relevant for AI-powered diagnostic tools or systems where human readers interpret results. The Attain Hybrid Guide Wire is a physical medical device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable and not present in the provided text. This concept applies to AI algorithms.
7. The Type of Ground Truth Used:
For a physical device like a guide wire, "ground truth" typically refers to engineering specifications and performance standards rather than medical diagnoses or outcomes data in the way it's used for AI or diagnostic devices. The text mentions "established performance criteria" and "design and compatibility requirements," which would serve as the "ground truth" for the device's functional performance. There is also a mention of "Biocompatibility testing consistent with ISO 10993-1: 2003," which indicates a specific set of accepted standards for biological safety.
8. The Sample Size for the Training Set:
This information is not applicable and not present in the provided text. The concept of a "training set" is relevant for machine learning/AI models.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not present in the provided text for the same reasons as point 8.
In summary:
The provided document is a 510(k) summary for a physical medical device, not an AI or diagnostic imaging system. Therefore, many of the questions related to AI-specific testing methodologies (like "training set," "ground truth experts," "MRMC studies") are not applicable. The document confirms that "Device verification testing was performed to demonstrate the Attain Hybrid Guide Wires meet established performance criteria" and that "All design and compatibility requirements were met," indicating successful completion of the necessary testing, but it does not delve into the quantitative specifics of those tests or the exact acceptance criteria.
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Attain Hybrid Guide Wires K
510(K) SUMMARY
K06 32/0
MAR 1 5 2007
| Date Prepared: | October 20, 2006 |
|---|---|
| Submitter: | Medtronic, Inc.Cardiac Rhythm Disease Management7000 Central Avenue NEMinneapolis, MN 55432 |
| Contact: | Michelle NivalaRegulatory Affairs Specialist |
| Telephone: | (763) 505-7863 |
| Fax: | (763) 505-7877 |
| E-Mail: | michelle.d.nivala@medtronic.com |
| Proprietary Name: | Attain Hybrid Guide Wire |
| Common Name: | Catheter guide wire |
| Device Classification: | Class II, 21 CFR 870.1330 |
| Product Code: | DQX |
Summary of Substantial Equivalence
The intended use, design, materials and performance of the Attain Hybrid Guide Wires are substantially equivalent to the following predicate devices:
- · Guidant HI-TORQUE WHISPER Guide Wires with Hydrocoat Hydrophilic Coating (Models 6726, 6737, 6738, 4482, 4483, 4581, 4586, 4583, and 4588) - K030019 cleared January 24, 2003.
- · Medtronic Stylet Kit Models 6254, 6282 and 6293 K010906 cleared April 5, 2001
- · Medtronic GT-1 Guide Wires (Floppy, Hi-Per Flex and Light Support) K983927 cleared March 11, 1999
- · Medtronic Silk Guide Wires K903923 cleared November 21, 1990
Image /page/0/Picture/12 description: The image shows the Medtronic logo with the word "Confidential" to the right of it. The Medtronic logo consists of a stylized human figure inside of a circle. The word "Medtronic" is written in a bold, sans-serif font.
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Traditional 510(k) 510(k) Summary
Attain Hybrid Guide Wires K
Device Description
The Attain Hybrid Guide Wire is a single use guide wire designed to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature. The guide wires consist of a core wire with springs, and coatings. Near the distal end of the device, the core wire consists of tapers to allow differing support or stiffness levels.
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.
Technoloqical Characteristics
Intended use, design, materials, performance and packaging materials are substantially equivalent to the predicate devices referenced.
Summary of Testing
Device verification testing was performed to demonstrate the Attain Hybrid Guide Wires meet established performance criteria and to support equivalency to the referenced predicate devices. Visual, performance and compatibility testing was completed. All design and compatibility requirements were met.
Biocompatibility testing consistent with ISO 10993-1: 2003: "Biological Evaluation of Medical devices – Part 1: Evaluation and Testing" was also conducted.
The Attain Hybrid Guide Wire will be sterilized using a validated EtO sterilization process.
Conclusion
Medtronic considers the Attain Hybrid Guide Wires to be substantially equivalent to legally marketed predicate devices through the data and information presented. No safety or effectiveness issues were identified.
Image /page/1/Picture/14 description: The image shows the Medtronic logo with the word "Confidential" to the right of it. The Medtronic logo consists of a circular emblem with abstract figures inside, followed by the word "Medtronic" in a bold, sans-serif font. The word "Confidential" is written in a smaller, regular font, indicating the sensitive nature of the document or information associated with the logo. The logo and text are in black against a white background.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes extending from its back, representing the department's commitment to health and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle symbol. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic, Inc. c/o Ms. Michelle Nivala Regulatory Affairs Specialist 1015 Gramsie Road Shoreview, MN 55126-3082
MAR 1 5 2007
Re: K063210
Trade/Device Name: Attain Hybrid Guide Wires Models GWR419378, GWR419388 Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: March 5, 2007 Received: March 8, 2007
Dear Ms. Nivala:
We have reviewed your Section 510(k) promarket 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.
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.
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Page 2 - Ms. Michelle Nivala
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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
R. bochner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Traditional 510(k) Indications for Use Attain Hybrid Guide Wires K
INDICATIONS FOR USE
510(k) Number (if known):
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
· AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Duna R. Sochner
(Division Sign-Off) On ision of Cardiovascular Devices
510(K) Number KO G 3210
Image /page/4/Picture/17 description: The image shows the Medtronic logo with the word "Medtronic" in bold black letters. To the left of the word is a circular graphic with a figure inside. To the right of the word "Medtronic" is the word "Confidential" in a smaller, non-bold font.
§ 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.