LogoFDA 510(k) Search
K Number
K113162
Device Name
SLIDEWIRETM(TRADEMARK PENDING)
Manufacturer
ACME-MONACO CORP.
Date Cleared
2012-07-20

(268 days)

Product Code
DQX
Regulation Number
870.1330
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Acme Monaco Slidewire™ (Trademark Pending) is intended for use in diagnostic or interventional procedures to assist in directing a catheter to the desired anatomical locations in the coronary or peripheral vasculature.
Device Description
The Acme Monaco Hydrophilic Guidewire, hereafter referred to as Acme Monaco Slidewire®, is composed of a Nickel Titanium (aka NiTi or Nitinol) core wire, jacketed with a durable polymer that is receptive to a coating. The polymer resin is blended with Tungsten, a radiopaque metal and affixed to the core wire via adhesive. The jacketed core wire is then coated with a hydrophilic coating. The Acme Monaco Slidewire of can be constructed to various lengths, diameters and distal configurations, is a single-use device and provided sterile for commercial distribution.
More Information

K863138, K063372

Not Found

No
The device description and performance testing focus on the physical and material properties of a guidewire, with no mention of AI or ML capabilities.

No
The device is described as assisting in directing a catheter during diagnostic or interventional procedures, which implies it is a tool for a procedure rather than actively treating a condition itself.

Yes.
The "Intended Use / Indications for Use" states that the device is "intended for use in diagnostic or interventional procedures".

No

The device description clearly outlines a physical guidewire composed of Nickel Titanium, polymer, and Tungsten, and the performance studies focus on physical and biological properties of this hardware.

Based on the provided information, the Acme Monaco Slidewire™ is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The intended use clearly states it's for "use in diagnostic or interventional procedures to assist in directing a catheter to the desired anatomical locations in the coronary or peripheral vasculature." This describes a device used within the body to facilitate a medical procedure, not a device used to examine specimens outside the body to diagnose a condition.
  • Device Description: The description details the physical components and construction of a guidewire, which is a tool used in interventional procedures.
  • Performance Studies: The performance studies focus on the physical and biological properties of the guidewire itself (tensile strength, torque, biocompatibility, etc.), not on the accuracy or reliability of a diagnostic test.
  • Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostics.

Therefore, the Acme Monaco Slidewire™ is a medical device used in vivo (within the body) for procedural assistance, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The Acme Monaco Slidewire (Trademark Pending) is intended for use in diagnostic or interventional procedures to assist in directing a catheter to the desired anatomical locations in the coronary or peripheral vasculature.

Product codes (comma separated list FDA assigned to the subject device)

DQX

Device Description

The Acme Monaco Hydrophilic Guidewire, hereafter referred to as Acme Monaco Slidewire®, is composed of a Nickel Titanium (aka NiTi or Nitinol) core wire, jacketed with a durable polymer that is receptive to a coating. The polymer resin is blended with Tungsten, a radiopaque metal and affixed to the core wire via adhesive. The jacketed core wire is then coated with a hydrophilic coating. The Acme Monaco Slidewire of can be constructed to various lengths, diameters and distal configurations, is a single-use device and provided sterile for commercial distribution.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

coronary or peripheral 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)

Performance testing has been conducted in accordance with FDA guidance document Coronary and Cerebrovascular Guidewire Guidance, January 1995, ISO 11070:1998(E), Sterile single-use intravascular catheter introducers and ISO 10993-1:2003(E), Biological evaluation of medical devices - Part 1: Evaluation and testing. The results of the following performance tests have demonstrated substantial equivalence to the predicate device:

  • Tensile Strength
  • Torque Strength
  • Torqueability
  • Tip Flexibility
  • Coating Adherence/Integrity
  • Catheter Compatibility
  • Surface Lubricity
  • Dimensional Verification
  • Resistance to corrosion

The following biocompatibility testing, performed in accordance with ISO-10993, has been performed on the Acme Monaco Slidewire®:

  • Cytotoxicity (ISO 10993-5)
  • Kligman Maximization/2 Extracts/35 animals/Concurrent (+) controls (ISO 10993-10)
  • Intracutaneous Injection/2 extracts (ISO 10993-10)
  • Acute Systematic Injection/2 extract (ISO 10993-11)
  • Rabbit Pyrogen-Material Mediated (ISO 10993-11)
  • Hemolysis Complete (Direct & Indirect) -ASTM (ISO 10993-4)
  • In Vitro Hemocompatibility (Direct) (ISO 10993-4)
  • Dog Thromboresistance/2 animals (ISO 10993-4)
  • Lee & White Clotting Time/Human Blood (Direct) (ISO-10993-4)
  • Complement Activation Assay (C3a), Direct Contact (ISO 10993-4)
  • Complement Activation Assay (SC5-b-9), Direct Contact (ISO 10993-4)

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.

K863138, K063372

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/0 description: The image shows a logo for ACME MONACO. The logo is black and white and features the word "ACME" stacked on top of the word "MONACO". The words are contained within a stylized box-like shape. There is a registered trademark symbol in the upper right corner of the logo.

K113162
p. 1 of 3

510(k) SUMMARY

This 510(k) summary is provided per the requirements of Section 807.92(c).

| Submitted by: | Acme Monaco Corporation
75 Winchell Road
New Britain, CT 06052
Phone: 860-224-1349
Fax: 860-827-9982 | JUL 20 2012 |
|----------------------|------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Benjamin Sweeney.
Manager of Device Compliance
Phone: 860-224-1349
bsweeney@acmemonaco.com | |
| Trade Name: | Acme Monaco Slidewire® | |
| Common Name: | Guidewire | |
| Classification Name: | Device – Wire, Guide, Catheter | |
| Regulation: | Catheter guide wire Per 21 CFR Part 870.1330 | |
| Product Code: | DQX | |
| Classification: | Class II | |
| Date prepared: | June 22, 2012 | |

Legally marketed device to which equivalence is claimed:

Terumo Radifocus® Guidewire M Hydrophilic Coated Guidewires, Premarket Notification K863138, and K063372.

5.1 Description of the Device:

The Acme Monaco Hydrophilic Guidewire, hereafter referred to as Acme Monaco Slidewire®, is composed of a Nickel Titanium (aka NiTi or Nitinol) core wire, jacketed with a durable polymer that is receptive to a coating. The polymer resin is blended with Tungsten, a radiopaque metal and affixed to the core wire via adhesive. The jacketed core wire is then coated with a hydrophilic coating. The Acme Monaco Slidewire of can be constructed to various lengths,

1

diameters and distal configurations, is a single-use device and provided sterile for commercial distribution.

5.2 Scientific concepts that form the basis for the device:

The Acme Monaco Slidewire® has a core wire constructed of Nickel Titanium (aka NiTi or Nitinol). The core wire is coated with a polymer jacket. A radiopaque metal is blended into the polymer resin in order to enhance visibility of the guidewire on medical imaging devices. The polymer jacket is coated with a hydrophilic coating designed to provide a low coefficient of friction when wet, thus enhancing the movement and maneuverability of the device.

5.3 Intended Use of the Device:

The Acme Monaco Slidewire® is intended for use in diagnostic or interventional procedures to assist in directing a catheter to the desired anatomical locations in the coronary or peripheral vasculature.

5.4 Comparison of technological characteristics to legally marked device:

The Acme Monaco Slidewire® is being compared for substantial equivalence against the Terumo Radifocus® Guidewire M, Premarket Notification K863138 and K063372.

The Acme Monaco Slidewire® and the predicate device both contain a Nickel Titanium core. Both products incorporate a polyurethane jacket which covers the core wire. Both the predicate device and the Acme Monaco Slidewire® contain Tungsten that is blended into the polyurethane resin in order to improve visibility on medical images. Both devices employ a hydrophilic coating over the polyurethane jacket in order to provide reduced friction between the medical devices and tissue. Both the predicate device and the Acme Monaco device retain their lubricity over multiple uses during a single procedure. Both devices provide for kink resistance and retain original conformations, even when subjected to tortuous anatomical environments.

The differences between the Acme Monaco Slidewire® and the predicate device lie in the geometric configurations of the distal end of the device, and the method of polymer jacket adherence to the core wire. These differences do not affect the intended use of the Acme Monaco Slidewire . The Acme Monaco device has been completely tested for biocompatibility in accordance with FAD General Program Memorandum #G95-1, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing", May 1, 1995.

5.5 Performance Testing

Performance testing has been conducted in accordance with FDA guidance document Coronary and Cerebrovascular Guidewire Guidance, January 1995, ISO 11070:1998(E), Sterile single-use intravascular catheter introducers and ISO 10993-1:2003(E), Biological evaluation of medical devices - Part 1: Evaluation and testing. The results of the following performance tests have demonstrated substantial equivalence to the predicate device.

2

  • Tensile Strength ●
  • Torque Strength
  • Torqueability .
  • . Tip Flexibility
  • . Coating Adherence/Integrity
  • Catheter Compatibility .
  • Surface Lubricity ●
  • Dimensional Verification .
  • Resistance to corrosion .

Biocompatibility Testing 5.6

The following biocompatibility testing, performed in accordance with ISO-10993, has been performed on the Acme Monaco Slidewire® :

  • . Cytotoxicity (ISO 10993-5)
  • Kligman Maximization/2 Extracts/35 animals/Concurrent (+) controls (ISO 10993-10) .
  • Intracutaneous Injection/2 extracts (ISO 10993-10)
  • Acute Systematic Injection/2 extract (ISO 10993-11)
  • Rabbit Pyrogen-Material Mediated (ISO 10993-11) .
  • Hemolysis Complete (Direct & Indirect) -ASTM (ISO 10993-4)
  • . In Vitro Hemocompatibility (Direct) (ISO 10993-4)
  • . Dog Thromboresistance/2 animals (ISO 10993-4)
  • Lee & White Clotting Time/Human Blood (Direct) (ISO-10993-4) .
  • Complement Activation Assay (C3a), Direct Contact (ISO 10993-4) ●
  • . Complement Activation Assay (SC5-b-9), Direct Contact (ISO 10993-4)

5.7 CONCLUSIONS

Based on the evaluation of performance and biocompatibility testing, the Acme Monaco Slidewire® is considered to be appropriate for its intended use and performs in an equivalent manner as the Terumo Radifocus Guidewire M. The materials of construction and intended use are virtually identical.

3

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUL 20 2012

Acme Monaco Corp. Mr. Benjamin Sweeney Manager, Device Compliance 75 Winchell Road New Britain, CT 06052

Re: K113162

Trade/Device Name: Acme Monaco Slidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Code: DQX Dated: July 17, 2012 Received: July 18, 2012

Dear Mr. Sweeney:

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

4

Page 2 - Mr. Benjamin Sweeney

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 device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

My Hillehen

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

5

Indications for Use

510(k) Number: K113162

Acme Monaco Slidewire™ (Trademark Pending) Device Name:

Indications for Use: The Acme Monaco Slidewire™ (Trademark Pending) is intended for use in diagnostic or interventional procedures to assist in directing a catheter to the desired anatomical locations in the coronary or peripheral vasculature.

AND/OR Over-The-Counter Use _ Prescription Use _ X

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

.g. Hillhen

Division Sign-Off) (Division Sign-Sign-Sign-Scular Devices

510(k) Number K113162