(163 days)
The AMPLATZER Noodlewire Guidewire is intended for percutaneous vessel entry typically using the Seldinger technique to facilitate subsequent introduction of an intravascular device.
The AMPLATZER Noodlewire Guidewire is a guidewire comprised of a stainless steel cable and coil. The cable wire component forms the inner body of the guidewire. The outer layer of the guidewire consists of a flat wire component coated with PTFE. The cable is placed within the coil. All components are secured together forming a single quidewire.
Acceptance Criteria and Study for the AMPLATZER® Noodlewire Guidewire
The provided document describes the 510(k) submission for the AMPLATZER® Noodlewire Guidewire. This submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and a feasibility clinical trial, rather than defining specific numerical acceptance criteria for a novel performance claim that would typically be evaluated in a standalone study or MRMC study.
Therefore, the structure below will reflect the type of information available in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical acceptance criteria with corresponding device performance metrics for each criterion as might be seen for a new diagnostic device. Instead, the "acceptance criteria" are implied by the successful completion of various tests designed to show functional equivalence and safety. The "reported device performance" is a general statement about meeting these implied specifications.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functional Testing | ||
| Kink resistance | Withstand kinking forces (per ISO 11070 & FDA Guidance) | Functions according to specifications |
| Torqueability | Adequate torque transmission (per ISO 11070 & FDA Guidance) | Functions according to specifications |
| Torque strength | Withstand torsional forces (per ISO 11070 & FDA Guidance) | Functions according to specifications |
| Corrosion | Resist corrosion (per ISO 11070 & FDA Guidance) | Functions according to specifications |
| Fracture | Resist fracture (per ISO 11070 & FDA Guidance) | Functions according to specifications |
| Flexure | Demonstrate appropriate flexibility (per ISO 11070 & FDA Guidance) | Functions according to specifications |
| Tip Flexibility | Exhibit required tip flexibility (per ISO 11070 & FDA Guidance) | Functions according to specifications |
| Lubricity | Demonstrate adequate lubricity (per ISO 11070 & FDA Guidance) | Functions according to specifications |
| Pull testing | Withstand tensile forces (per ISO 11070 & FDA Guidance) | Functions according to specifications |
| Simulated Life Testing | Maintain performance under simulated in-use conditions | Documents performance under simulated, but accelerated, in-use conditions |
| Biocompatibility | Biocompatible (per ISO 10993-1) | Materials used are biocompatible |
| Clinical Performance | Safe and effective for intended use (implied by feasibility study) | Data collected as part of a feasibility clinical trial |
Conclusion from Studies: The results indicated that the AMPLATZER Noodlewire Guidewire functions according to specifications and the materials used are biocompatible. Therefore, the device is considered acceptable for human use.
2. Sample Size and Data Provenance for Test Set (Clinical Study)
- Sample Size: The document states that the AMPLATZER Noodlewire Guidewire "was used as a part of a feasibility clinical trial." It does not specify the exact sample size for this feasibility study.
- Data Provenance: The feasibility clinical trial was "conducted in the United States." This indicates a prospective study.
3. Number of Experts and Qualifications for Ground Truth
This information is not provided in the document. The clinical study mentioned is a "feasibility clinical trial," suggesting it was likely for initial safety and performance evaluation rather than establishing ground truth for a diagnostic device via expert consensus.
4. Adjudication Method for Test Set
This information is not provided as the clinical trial described is a feasibility study, not a diagnostic accuracy study requiring adjudication for ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed according to the provided text. The submission focuses on demonstrating substantial equivalence through in-vitro functional testing, biocompatibility, and a feasibility clinical trial. There is no mention of a study comparing human readers with and without AI assistance for this device.
6. Standalone (Algorithm Only) Performance Study
A standalone algorithm-only performance study was not performed. The device is a physical medical device (guidewire), not a software algorithm that would have standalone performance measured.
7. Type of Ground Truth Used (Clinical Study)
The document refers to a "feasibility clinical trial" where "Specific data to the Noodlewire Guidewire was collected." While the specific nature of this ground truth is not detailed, in a feasibility study for a guidewire, the "ground truth" would likely involve objective clinical outcomes related to device performance in-vivo, such as successful navigation, ease of use, absence of complications (e.g., vessel damage, guidewire fracture), and successful facilitation of subsequent device introduction. It is not based on expert consensus for diagnostic accuracy, pathology, or traditional outcomes data in the context of diagnostic performance.
8. Sample Size for the Training Set
This information is not applicable/not provided. The device is a physical guidewire, not an AI/ML algorithm that requires a training set. The in-vitro functional testing and biocompatibility tests are not "trained" in the same sense as an algorithm.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/not provided for the same reason as above.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows a sequence of handwritten alphanumeric characters. The sequence appears to be "K053181". The characters are written in a bold, slightly irregular style, giving them a hand-drawn appearance. The contrast between the characters and the background is high, making them easily readable.
510(k) Summary
APR 2 7 2006
| Application Date: | November 14, 2005 |
|---|---|
| Submission Type: | Traditional 510(k) |
| ApplicantManufacturingAddress: | AGA Medical Corporation682 Mendelssohn AvenueGolden Valley, Minnesota 55427 |
| Contact Person: | Patricia A. LaForteRegulatory Affairs Associate |
| EstablishmentRegistrationNumber: | 2135147 |
| DeviceClassification Name: | Wire, Guide, Catheter |
| DeviceCommon/Usual Name: | Guidewire |
| DeviceProprietary Name: | AMPLATZER® Noodlewire Guidewire |
| DeviceClassification: | Class II, Reviewed by Cardiovascular |
| DeviceProduct Code: | DQX |
| Reason for 510(k): | New Device Submission |
| EquivalenceDevice Comparison: | Lake Region Manufacturing Guidewire |
| PerformanceStandards: | Performance standards have not been promulgated todate for these devices |
{1}------------------------------------------------
Device Description
The AMPLATZER Noodlewire Guidewire is a guidewire comprised of a stainless steel cable and coil. The cable wire component forms the inner body of the guidewire. The outer layer of the guidewire consists of a flat wire component coated with PTFE. The cable is placed within the coil. All components are secured together forming a single quidewire.
Intended Use
The AMPLATZER Noodlewire Guidewire is intended for percutaneous vessel entry typically using the Seldinger technique to facilitate subsequent introduction of an intravascular device.
Technological Characteristics as Compared to Predicate Device
The AMPLATZER Noodlewire Guidewire is constructed from the same biocompatible materials, coated with polytetrafluoroethylene (PTFE), packaged / sterilized utilizing the same materials / methods, and have the same principle of use as the predicate device.
Summary of Studies:
A. Functional Testing
In-vitro testing was conducted in accordance with ISO 11070, Sterile single-use intravascular catheter introducers and FDA Coronary and Cerebrovascular Guidewire Guidance, January, 1995. The AMPLATZER Noodlewire samples were subjected to kink, torqueability, torque strength, corrosion, fracture, flexure, tip flexibility, lubricity, and pull testing.
In-vitro Simulated Life Testing to document performance of the AMPLATZER Noodlewire Guidewire under simulated, but accelerated, in-use conditions was performed.
Biocompatibility testing was completed per ISO 10993-1.
B. Clinical Studies
The AMPLATZER Noodlewire Guidewire was used as a part of a feasibility clinical trial conducted in the United States. Specific data to the Noodlewire Guidewire was collected as part of the clinical trial.
C. Conclusions Drawn from the Studies
The results of the testing indicated that the AMPLATZER Noodlewire Guidewire functions according to specifications and the materials used in the Noodlewire Guidewire are biocompatible. Therefore, the Noodlewire Guidewire is considered acceptable for human use.
{2}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
127 7 7 2006
AGA Medical Corporation c/o Ms. Patricia A. LaForte Regulatory Affairs Associate 682 Mendelssohn Avenue Golden Valley, MN 55427
K053187 Re:
AMPLATZER® Noodlewire Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guidewire Regulatory Class: II Product Code: DQX Dated: March 24, 2006 Received: March 27, 2006
Dear Ms. LaForte:
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.
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.
{3}------------------------------------------------
Page 2 – Ms. Patricia A. LaForte
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. 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 on ); pro "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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Duna R. Vichner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use Statement
510(k) Number:
Device Name: AMPLATZER® Noodlewire Guidewire
Indications for Use: The AMPLATZER Noodlewire Guidewire is intended for percutaneous vessel entry typically using the Seldinger technique to facilitate subsequent introduction of an intravascular device.
Prescription Use AND/OR × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Duna R. Lochnes
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number Kos
Page 15 of 113
§ 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.