Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical construction and mechanical properties of a guidewire, with no mention of AI or ML terms or functionalities.

Therapeutic

No
The device is solely intended to facilitate diagnostic or interventional procedures by aiding in the placement of other devices, not to provide therapy itself.

Diagnostic

No
The device is a guidewire used during diagnostic or interventional procedures to facilitate the placement of other devices, not to diagnose a condition itself.

SaMD (Software as a Medical Device)

No

The device description explicitly states the guidewires are constructed using stainless steel and nickel titanium alloys, indicating a physical hardware component. The performance studies also focus on physical properties like tensile strength, flexibility, and kink resistance, further confirming it is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "To facilitate the placement of devices during diagnostic or interventional procedures." This describes a tool used during a medical procedure, not a test performed on a sample (like blood, urine, or tissue) to diagnose a condition.
Device Description: The description details the physical construction of a guidewire, which is a mechanical device used to navigate within the body. This is consistent with a surgical or interventional tool, not an IVD.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.

IVDs are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This guidewire is used in vivo (within the body) to aid in the placement of other devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

To facilitate the placement of devices during diagnostic or interventional procedures.

Product codes

DQX

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K770977

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

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

1

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

2

Indications for Use

510(k) Number (if known)

K143135

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

510(k) Summary

| Submitter: | NeoMetrics, Inc.
2605 Fernbrook Lane North, Suite J
Plymouth, MN 55447
763-559-4440
763-559-7676 |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Eugene Champeau, CEO
2605 Fernbrook Lane North, Suite J
Plymouth, MN 55447 |
| Date Prepared: | January 27, 2015 |
| Device Name: | Spring Coil Guidewire |
| Device Common
Name: | Catheter Guide Wire |
| Classification: | Class II
Regulation Number: 21 CFR 870.1330. |
| Product Code: | DQX |
| Predicate Device: | Company Name: Lake Region Medical.
Brand Name: Cardiovascular Spring Guides
510(k) number: K770977 |
| Device
Description: | 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. |
| Indication for Use: | To facilitate the placement of devices during diagnostic or
interventional procedures. |
| Principle of
Operation: | The Spring Coil Guidewire is manually inserted into a vessel and
advanced to the target region; it is a non-steerable guidewire. |
| Device
Characteristics
Compared to the
Predicate: | The Spring Coil Guidewire has the same technological
characteristics as the predicate guidewires. |

4

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.