The ac Wire is intended for use in peripheral vascular and heart catheterization procedures to introduce and assist in positioning diagnostic and interventional devices. The ac Wire may also function as an alignment tool by providing a reference plane of anatomical structures of interest (e.g., the aortic valve).

Device Description

The ac Wire device is a 0.035"" outside diameter, single use, disposable guidewire. The ac Wire device consists of a flexible guidewire that incorporates a low profile, radiopaque alignment element consisting of three loops with radiopaque markers that when open, form a "tulip" configuration designed to assist the physician in acquiring a reference plane under fluoroscopy.

AI/ML Overview

The MediValve acWire is a guidewire intended for use in peripheral vascular and heart catheterization procedures to introduce and assist in positioning diagnostic and interventional devices. It may also function as an alignment tool by providing a reference plane of anatomical structures of interest (e.g., the aortic valve).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary does not explicitly list quantitative acceptance criteria with numerical targets. Instead, it states that "descriptive information, laboratory bench testing, and biocompatibility testing were provided to demonstrate the device meets its design specifications, performs as intended, and is safe for its intended use." The performance is evaluated against the predicate devices for substantial equivalence.

Category	Acceptance Criteria (Implicit from Predicate Equivalence)	Reported Device Performance
Functional Testing	The guidewire should exhibit equivalent mechanical and functional performance to predicate devices (Ostial Pro Stent Positioning System and Lake Region Manufacturing Catheter Guidewire) in areas such as tip flexibility, torque strength, fracture resistance, coating integrity, particulate generation, tensile strength, repeated use durability, corrosion resistance, shelf-life, radiopacity, loop deflection, usability, stiffness, and compatibility with other interventional devices. This implies meeting industry standards or demonstrating comparable performance to the predicate devices in these specific tests. "Performs as intended" means it facilitates delivery and acts as an alignment tool.	Demonstrated safety through design verification testing for: Tip Flexibility, Torque Testing, Torque Strength, Fracture Test, Resistance to Coating Damage, Coating Adhesion, Particulate Residual, Tensile Testing, Repeated Use Test, Corrosion Test, Shelf-Life Test, Radiopacity Test, Loop Deflection Test, Usability Test, Stiffness Test, Compatibility Test, Austenite Finish Test, Ex-vivo Performance Test. The submission asserts that the "performance as evaluated in bench tests, demonstrates that the ac Wire device is as safe and effective as the predicate devices."
Biocompatibility	The guidewire materials should be biocompatible and not elicit adverse biological reactions when in contact with human tissue and blood, as per ISO 10993-1. This includes acceptable levels for cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemolysis, thrombus formation, and complement activation.	Biocompatibility testing performed in accordance with ISO 10993-1, including: Cytotoxicity Study, Maximization Sensitization, Intracutaneous Study, Systemic Toxicity Study, Pyrogen Study, Material Mediated Hemolysis, In Vivo Thromboresistance Study, SC5b-9 Complement Activation Assay, C3a Complement Activation Assay. The collective results "demonstrated that the ac Wire device is safe and is substantially equivalent to the respective predicate devices."
Substantial Equivalence	The ac Wire device should be substantially equivalent to the predicate devices (Ostial Pro Stent Positioning System (K062192) and Lake Region Manufacuring (LRM) Catheter Guidewire (K011084)) in terms of design, intended use, principles of operation, and technological characteristics, without raising new issues of safety or effectiveness. This is the overarching "acceptance criteria" for a 510(k) submission.	The submission concludes, "The design, intended use, principles of operation, and technological characteristics of the ac Wire are substantially equivalent to those of the predicate devices cited above. Substantial equivalence is based upon descriptive characteristics of the various cited predicate devices and upon the testing conducted to demonstrate that the subject device performs as intended and is substantially equivalent to the predicate devices in terms of its ability to safely perform as a cardiovascular guide wire. Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy."

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

The document describes laboratory bench testing and biocompatibility testing. It does not specify a "test set" in the context of patient data or clinical images. The testing involved physical samples of the device or its components. The document does not provide details on the specific number of units tested for each functional test (e.g., how many guidewires were used for the tensile test, or how many loops for the loop deflection test).

Data Provenance: The testing appears to be primarily laboratory-based and ex-vivo (as indicated by "Ex-vivo Performance Test" and "In Vivo Thromboresistance Study" which refers to animal studies rather than human clinical data). There is no mention of country of origin for any human data, as no human data is presented in the summary.

3. Number of Experts and their Qualifications for Ground Truth:

This information is not applicable as the summary describes bench and biocompatibility testing of a physical medical device, not an AI/software device that requires expert-established ground truth from medical images or clinical data.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as above. There is no "test set" requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI or imaging devices to compare human performance with and without AI assistance. The MediValve acWire is a physical guidewire that does not involve AI assistance for human readers.

6. Standalone (Algorithm Only) Performance:

No, a standalone performance evaluation (algorithm only without human-in-the-loop performance) was not done. This concept applies to AI algorithms and is not relevant to a physical guidewire device like the MediValve acWire.

7. Type of Ground Truth Used:

The "ground truth" for the device's performance in this context is defined by:

Engineering specifications and design requirements: Functional tests aim to verify that the device meets predetermined mechanical, physical, and performance specifications.
Biocompatibility standards (ISO 10993-1): The "ground truth" for biocompatibility is conformance to established biological safety standards as determined by specific assay results.
Predicate device characteristics: The ultimate "ground truth" for safety and effectiveness in a 510(k) submission is substantial equivalence to a legally marketed predicate device. This means the new device performs as well as, or better than, the predicate in relevant tests without raising new safety or effectiveness concerns.

8. Sample Size for the Training Set:

This information is not applicable. The MediValve acWire is a physical medical device and does not involve AI algorithms that require a "training set."

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

This information is not applicable as there is no training set for a physical guidewire device.

Summary

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K1B2545

510(k) Summary MediValve acWire

Submitter:

MediValve Ltd. Misgav Venture Accelerator Misgav Business Park 17 Tchelet Street M.P. Misgav 20174, Israel Tel: +972.72.260.7000

NOV 0 8 2013

Contact Person:	Leo BastaNorthStar Biomedical Associates93 Benefit StreetProvidence, RI, 02904Phone: 617.834.9866lbasta@northstarbiomedical.com
Date Prepared:	August 9, 2013
Trade Name:	MediValve ac Wire
Classification Name:	catheter, guide, wire
Regulation Number:	21 CFR 870.1330
Product Code:	DQX
Predicate Devices:	Ostial Pro Stent Positioning System (K062192)Lake Region Manufacuring (LRM) Catheter Guidewire(K011084)
Device Description:	The ac Wire device is a 0.035"" outside diameter, single use,disposable guidewire. The ac Wire device consists of aflexible guidewire that incorporates a low profile,radiopaque alignment element consisting of three loopswith radiopaque markers that when open, form a "tulip"configuration designed to assist the physician in acquiring areference plane under fluoroscopy.

MediValve 510(k) Response Rev. A

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Intended Use: Intended to facilitate the delivery of catheter-based . interventional devices in the cardiovascular system Indications for Use: The ac Wire is intended for use in peripheral vascular and heart catheterization procedures to introduce and assist in positioning diagnostic and interventional devices. The ac Wire may also function as an alignment tool by providing a reference plane of anatomical structures of interest (e.g., the aortic valve). Functional Testing: Descriptive information, laboratory bench testing, and biocompatibility testing were provided to demonstrate the device meets its design specifications, performs as intended, and is safe for its intended use. Specifically, safety of the ac Wire device was evaluated through design verification testing including the following: Tip Flexibility . Torque Testing . Torque Strength . Fracture Test . Resistance to Coating Damage . . Coating Adhesion Particulate Residual . � Tensile Testing o Repeated Use Test Corrosion Test .

Shelf-Life Test .
. Radiopacity Test
. Loop Deflection Test
Usability Test ●
Stiffness Test .
Compatibility Test .
Austenite Finish Test .
0 Ex-vivo Performance Test

Additionally, biocompatibility testing was performed in accordance with ISO 10993-1 and included the following tests:

. Cytotoxicity Study
. Maximization Sensitization
Intracutaneous Study .
. Systemic Toxicity Study

MediValve 510(k) Response Rev. A

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Pyrogen Study Material Mediated .
Hemolysis .
In Vivo Thromboresistance Study .
SC5b-9 Complement Activation Assay .
C3a Complement Activation Assay .

The collective results have demonstrated that the ac Wire device is safe and is substantially equivalent to the respective predicate devices with regard to safety and effectiveness. Any differences in technological characteristics between the ac Wire device and the predicate devices do not raise any new issues of safety or effectiveness.

Technological Characteristics:

Both the ac Wire and the Ostial Pro include an alignment element with alignment functionality. Both the ac Wire's and Ostial Pro's alignment element are made using the same materials. The ac Wire device is 0.035'' diameter, as is the Lake Region guidewire, while the Ostial Pro is 0.018" inches in diameter. Both the ac Wire and Lake Region devices consist of a stainless steel core and coil with a PTFE coating. Any differences in the technological characteristics between the ac Wire and its predicate devices do not raise any new issues of safety or effectiveness. The performance as evaluated in bench tests, demonstrates that the ac Wire device is as safe and effective as the predicate devices.

Summary of Substantial Equivalence:

The design, intended use, principles of operation, and technological characteristics of the ac Wire are substantially equivalent to those of the predicate devices cited above. Substantial equivalence is based upon descriptive characteristics of the various cited predicate devices and upon the testing conducted to demonstrate that the subject device performs as intended and is substantially equivalent to the predicate devices in terms of its ability to safely perform as a cardiovascular guide wire. Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Thus, the ac Wire device is substantially equivalent to the predicates devices.

MediValve 510(k) Response Rev. A

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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 consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.

Public Health Service

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

November 8, 2013

Medivalve Ltd. % Leo Basta NorthStar Biomedical Associates 93 Benefit Street Providence, RI 02904

Re: K132545

Trade/Device Name: Medivalve ac Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter, Guidewire Regulatory Class: Class II Product Code: DQX Dated: October 25, 2013 Received: October 28, 2013

Dear Mr. Basta:

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.

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Page 2 - Mr. Leo Basta

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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.fdaggov/MedicalDevices/Safety/ReportalProblem/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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

M.A. Hillerman

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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INDICATION FOR USE

510(k) Number (if known): K132545

Device Name: . Medi Valve ac Wire

Indications for Use:

X AND/OR Prescription Use: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Per 21 CFR 801 Subpart D) ...................................................................................................................................................

Over-The Counter Use: (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page I of I

M.A. Hillman

MediValve 510(k) Response Rev. A

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.