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.

AI/ML Overview

The provided document, K113162, describes the Acme Monaco Slidewire®. This is a 510(k) summary, which means the device is seeking clearance by demonstrating substantial equivalence to a legally marketed predicate device, not necessarily proving its own clinical effectiveness through a standalone clinical study. The performance testing outlined in the document is primarily to demonstrate that the device performs equivalently to its predicate.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative or pass/fail manner for each test. Instead, it states that "The results of the following performance tests have demonstrated substantial equivalence to the predicate device." This implies that the 'acceptance criteria' for each test was to perform comparably to the predicate device.

Test Type	Reported Device Performance and Equivalence Statement
Performance Testing
Tensile Strength	"The results of the following performance tests have demonstrated substantial equivalence to the predicate device." (Implies comparable tensile strength to the predicate)
Torque Strength	"The results of the following performance tests have demonstrated substantial equivalence to the predicate device." (Implies comparable torque strength to the predicate)
Torqueability	"The results of the following performance tests have demonstrated substantial equivalence to the predicate device." (Implies comparable torqueability to the predicate)
Tip Flexibility	"The results of the following performance tests have demonstrated substantial equivalence to the predicate device." (Implies comparable tip flexibility to the predicate)
Coating Adherence/Integrity	"The results of the following performance tests have demonstrated substantial equivalence to the predicate device." (Implies comparable coating adherence/integrity to the predicate)
Catheter Compatibility	"The results of the following performance tests have demonstrated substantial equivalence to the predicate device." (Implies comparable catheter compatibility to the predicate)
Surface Lubricity	"The results of the following performance tests have demonstrated substantial equivalence to the predicate device." (Implies comparable surface lubricity to the predicate. Also, statement: "Both the predicate device and the Acme Monaco device retain their lubricity over multiple uses during a single procedure.")
Dimensional Verification	"The results of the following performance tests have demonstrated substantial equivalence to the predicate device." (Implies comparable dimensions to the predicate or adherence to specifications for equivalent performance)
Resistance to corrosion	"The results of the following performance tests have demonstrated substantial equivalence to the predicate device." (Implies comparable corrosion resistance to the predicate)
Biocompatibility Testing
Cytotoxicity (ISO 10993-5)	"The following biocompatibility testing, performed in accordance with ISO-10993, has been performed on the Acme Monaco Slidewire®." (Implies the device passed these tests as required by ISO 10993 for biocompatibility, supporting substantial equivalence.)
Kligman Maximization	"The following biocompatibility testing, performed in accordance with ISO-10993, has been performed on the Acme Monaco Slidewire®." (Implies the device passed these tests, supporting substantial equivalence.)
Intracutaneous Injection	"The following biocompatibility testing, performed in accordance with ISO-10993, has been performed on the Acme Monaco Slidewire®." (Implies the device passed these tests, supporting substantial equivalence.)
Acute Systematic Injection	"The following biocompatibility testing, performed in accordance with ISO-10993, has been performed on the Acme Monaco Slidewire®." (Implies the device passed these tests, supporting substantial equivalence.)
Rabbit Pyrogen	"The following biocompatibility testing, performed in accordance with ISO-10993, has been performed on the Acme Monaco Slidewire®." (Implies the device passed these tests, supporting substantial equivalence.)
Hemolysis Complete	"The following biocompatibility testing, performed in accordance with ISO-10993, has been performed on the Acme Monaco Slidewire®." (Implies the device passed these tests, supporting substantial equivalence.)
In Vitro Hemocompatibility	"The following biocompatibility testing, performed in accordance with ISO-10993, has been performed on the Acme Monaco Slidewire®." (Implies the device passed these tests, supporting substantial equivalence.)
Dog Thromboresistance	"The following biocompatibility testing, performed in accordance with ISO-10993, has been performed on the Acme Monaco Slidewire®." (Implies the device passed these tests, supporting substantial equivalence.)
Lee & White Clotting Time	"The following biocompatibility testing, performed in accordance with ISO-10993, has been performed on the Acme Monaco Slidewire®." (Implies the device passed these tests, supporting substantial equivalence.)
Complemenent Activation Assay (C3a)	"The following biocompatibility testing, performed in accordance with ISO-10993, has been performed on the Acme Monaco Slidewire®." (Implies the device passed these tests, supporting substantial equivalence.)
Complement Activation Assay (SC5-b-9)	"The following biocompatibility testing, performed in accordance with ISO-10993, has been performed on the Acme Monaco Slidewire®." (Implies the device passed these tests, supporting substantial equivalence.)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the sample size for individual performance or biocompatibility tests. For some biocompatibility tests, details like "2 extracts/35 animals/Concurrent (+) controls" (Kligman Maximization) and "2 extracts" (Intracutaneous Injection, Acute Systematic Injection) are mentioned. For "Dog Thromboresistance," "2 animals" are specified. These are specific to those particular tests and don't represent a general "test set" sample size for overall device evaluation.
Data Provenance: Not explicitly stated. Given it's a 510(k) for a medical device manufactured by Acme Monaco Corporation (based in New Britain, CT, USA), the testing would likely have been conducted in the US or by labs adhering to international standards (ISO). The testing is laboratory (bench) and animal-based, not human data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this document. The "test set" here refers to the physical guidewire prototypes and materials undergoing engineering and biological testing, not a dataset requiring human expert interpretation or ground truth establishment in a clinical context. The "ground truth" for these tests would be the measurement results against established specifications or comparison to the predicate device's measured performance.

4. Adjudication Method for the Test Set

This is not applicable as there is no human interpretation of data points or images requiring adjudication. The tests involve direct measurement of physical and biological properties.

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

This is not applicable. This document describes a physical medical device (guidewire), not an AI algorithm or software. Therefore, no MRMC study or AI assistance evaluation was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. This document describes a physical medical device (guidewire), not an AI algorithm or software. Therefore, no standalone algorithm performance was evaluated.

7. The Type of Ground Truth Used

For the performance tests (tensile strength, torque, lubricity, etc.), the "ground truth" is measured physical properties compared against:

Engineering specifications (implied by standardized testing)
Performance of the legally marketed predicate device (as stated for substantial equivalence)

For biocompatibility tests, the "ground truth" is the biological response observed in the in vitro and in vivo models according to ISO 10993 standards, demonstrating no unacceptable adverse biological reactions.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/machine learning device. The guidewire design is based on engineering principles and materials science.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set for an AI model.

Summary

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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 Corporation75 Winchell RoadNew Britain, CT 06052Phone: 860-224-1349Fax: 860-827-9982	JUL 20 2012
Contact Person:	Benjamin Sweeney.Manager of Device CompliancePhone: 860-224-1349bsweeney@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:

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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.

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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.

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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

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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

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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

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.