(112 days)
To facilitate the placement of devices during diagnostic or interventional procedures.
NeoMetrics guidewires are constructed using stainless steel and nickel titanium alloys. Configurations include a single tip or dual tip, retracted core or fixed core, and straight or J-tipped. The guidewire is packaged in a spiral hoop fitted with a "J"-Straightener, where applicable to aid in insertion of the guidewire into the puncture needle.
This document is a 510(k) Summary for the Neometrics Spring Coil Guidewire (K143135). It demonstrates substantial equivalence to a predicate device, focusing on bench testing rather than clinical study data relevant to AI/algorithm performance. Therefore, I cannot provide a detailed answer to your request as it pertains to AI/algorithm acceptance criteria and studies.
Based on the provided document, here's what can be extracted and why the rest cannot be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Bench Test Type) | Reported Device Performance |
|---|---|
| Dimensional Verification | Met requirements |
| Tensile Strength | Met requirements |
| Tip Flexibility | Met requirements |
| Packaging Study | Met requirements |
| Kink Resistance | Met requirements |
| Fracture Resistance | Met requirements |
| Flex Resistance | Met requirements |
| Corrosion Resistance | Met requirements |
| Biocompatibility Testing | Met requirements |
| Radiopacity Testing | Met requirements |
Explanation: The document states, "To verify that device design met functional and performance requirements, representative samples of the device underwent bench testing in accordance to applicable standards and guidances." It then lists the types of performance tests conducted. While specific numerical acceptance criteria and detailed performance results are not provided in this summary, the conclusion states that "These data demonstrates that the Spring Coil Guidewire is equivalent to the predicate." implying all tests met their respective acceptance criteria.
The following questions cannot be answered from the provided document because it describes a traditional medical device (a guidewire) and its premarket notification, which relies on bench testing and substantial equivalence to a predicate, not an AI/algorithm-based device and its associated clinical/performance studies.
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) - Not applicable, as this is bench testing of physical device properties, not a study on an algorithm with a test set of data.
- 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. Ground truth for a physical guidewire is established through objective measurements and material science standards during bench testing.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set - Not applicable for bench testing.
- 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 as this is not an AI-assisted device or an imaging/diagnostic device involving human readers.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done - Not applicable as this is not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc) - For bench testing, ground truth is based on engineering specifications, material standards, and physical measurements.
- 8. The sample size for the training set - Not applicable, as there is no AI algorithm being trained.
- 9. How the ground truth for the training set was established - Not applicable, as there is no AI algorithm being trained.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 20, 2015
Neometrics, Inc. Mr. Gene Champeau CEO 2605 Fernbrook Lane, Suite J Plymouth, Minnesota 55447
Re: K143135 Trade/Device Name: Spring Coil Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: January 27, 2015 Received: January 28, 2015
Dear Mr. Champeau,
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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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,
Kenneth J. Cavanaugh -S
for
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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Indications for Use
510(k) Number (if known)
Device Name Spring Coil Guidewire
Indications for Use (Describe)
To facilitate the placement of devices during diagnostic or interventional procedures.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Submitter: | NeoMetrics, Inc.2605 Fernbrook Lane North, Suite JPlymouth, MN 55447763-559-4440763-559-7676 |
|---|---|
| Contact Person: | Eugene Champeau, CEO2605 Fernbrook Lane North, Suite JPlymouth, MN 55447 |
| Date Prepared: | January 27, 2015 |
| Device Name: | Spring Coil Guidewire |
| Device CommonName: | Catheter Guide Wire |
| Classification: | Class IIRegulation Number: 21 CFR 870.1330. |
| Product Code: | DQX |
| Predicate Device: | Company Name: Lake Region Medical.Brand Name: Cardiovascular Spring Guides510(k) number: K770977 |
| DeviceDescription: | NeoMetrics guidewires are constructed using stainless steel andnickel titanium alloys. Configurations include a single tip or dualtip, retracted core or fixed core, and straight or J-tipped. Theguidewire is packaged in a spiral hoop fitted with a "J"-Straightener, where applicable to aid in insertion of the guidewireinto the puncture needle. |
| Indication for Use: | To facilitate the placement of devices during diagnostic orinterventional procedures. |
| Principle ofOperation: | The Spring Coil Guidewire is manually inserted into a vessel andadvanced to the target region; it is a non-steerable guidewire. |
| DeviceCharacteristicsCompared to thePredicate: | The Spring Coil Guidewire has the same technologicalcharacteristics as the predicate guidewires. |
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Performance Data: To verify that device design met functional and performance requirements, representative samples of the device underwent bench testing in accordance to applicable standards and guidances.
Performance Testing:
- . Dimensional Verification
- . Tensile Strength
- Tip Flexibility .
- . Packaging Study
- Kink Resistance .
- . Fracture Resistance
- Flex Resistance ●
- Corrosion Resistance .
- Biocompatibility Testing ●
- Radiopacity Testing ●
These data demonstrates that the Spring Coil Guidewire is equivalent to the predicate.
Conclusion: NeoMetrics Inc. considers the Spring Coil Guidewire to be equivalent to the predicate device. This conclusion is based upon the fact that device has an equivalent intended use, and there are no differences that raise new types of questions of safety and effectiveness.
§ 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.