The FLEX Scoring Catheter is indicated for use with percutaneous transluminal angioplasty (PTA) catheters to facilitate dilation of stenoses in the femoral and poplited arteries and treatment of obstructive or synthetic arteriovenous dialysis fistulae.

Device Description

The FLEXTM Scoring Catheter is a sterile, single use, disposable device designed to facilitate the dilation of stenoses. The device has a working length of 120cm and is comprised of three scoring elements at the distal end. The distal end also contains an atraumatic tip and radiopaque maker band to aid in proper placement of the catheter. When the device is unsheathed the scoring elements are expanded to contact the plaque. The device scores the plaque as it is retracted. Once the desired plaque is scored the device is exchanged for a PTA balloon. The device is compatible with 0.18" guidewires.

AI/ML Overview

This document is a 510(k) Summary for the FLEX™ Scoring Catheter. It does not describe a study to prove acceptance criteria in the typical format of a clinical trial for an AI/ML medical device. Instead, it focuses on demonstrating substantial equivalence to a predicate device through bench testing, animal testing, and cadaveric studies.

Therefore, the requested information elements such as sample sizes for test sets (in the context of an AI/ML model), number of experts for ground truth, adjudication methods, MRMC studies, or training set details are not applicable in this document's context, as it's not evaluating an AI/ML algorithm.

However, I can extract the acceptance criteria (performance requirements) and the reported performance based on the information provided regarding the functional and safety testing:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Requirement (Acceptance Criteria Mentioned)	Reported Device Performance / Assessment
General Requirements for Intravascular Catheters (ISO 10555-1)	Device underwent bench testing and met these requirements.
Biocompatibility Testing (ISO 10993-1)	Device underwent testing and met these requirements. Biological evaluation followed Part 1 of ISO 10993-1.
Sterilization Validation Testing (ISO-11135-1)	Device underwent testing and met these requirements. Sterilization is via Ethylene Oxide, and validation followed ISO 11135-1.
Simulated Use Testing	Performed and demonstrated the FLEX device meets user needs and intended use.
Clinical Performance (In Vivo GLP animal testing & Cadaveric Studies)	Performed and demonstrated the FLEX device meets user needs and intended use. The conclusion states that "bench testing and pre-clinical animal studies demonstrate that none of the technical differences raise any new questions of safety and effectiveness."
Material/Design Properties	The device has the same intended use, principles of operation, and similar design features (as detailed in the technical comparison table with the predicate device).

2. Sample size used for the test set and the data provenance:

This document does not specify a "test set" in the context of an AI/ML algorithm or a clinical trial with human subjects for performance evaluation.
For bench testing: "representative samples of the device underwent bench testing." The exact number of samples is not specified.
For In Vivo GLP animal testing / Cadaveric studies: Conducted, but specific sample sizes are not provided in this summary.
Data Provenance: These are pre-clinical studies (bench, animal, cadaveric). No indication of specific country of origin, but generally, GLP (Good Laboratory Practice) studies follow international standards. These would be prospective studies (designed and conducted specifically for this submission).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as this is a device approval based on substantial equivalence, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here is adherence to engineering and biological performance standards, verified through testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable for this type of device submission.

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. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:

Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

The "ground truth" in this context is the established engineering standards, biological safety standards, and functional performance requirements. These are verified through various tests, including:
- Compliance with ISO 10555-1 (General Requirements for Intravascular Catheters), which sets performance specifications.
- Compliance with ISO 10993-1 (Biological evaluation of medical devices), focusing on biocompatibility.
- Compliance with ISO 11135-1 (Sterilization of Health Care Products).
- Verification against user needs and intended use through simulated use, animal, and cadaveric studies.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI/ML device that requires a training set.

Summary

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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 features a stylized depiction of an eagle or bird-like figure with three heads in profile, representing health, humans, and services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

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

May 25,2016

VentureMed Group Ms. Tiffini Diage, MPH Regulatory Affairs Consultant 5855 Monroe St, Suite 220 A Sylvania, OH 43560

Re: K152789

Trade/Device Name: Flex Scoring Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PNO Dated: April 21, 2016 Received: April 25, 2016

Dear Ms. Diage,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K152789

Device Name FLEX Scoring Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

Submitter:	VentureMed Group, Ltd5855 Monroe St, Suite 200Sylvania, OH 43560
Contact Person:	Tiffini DiageRegulatory Affairs ConsultantPhone: 707.799.6732E-mail: tdiage@raechelon.com
Date Prepared:	5/17/2016
Trade Name:	FLEXTM Scoring Catheter
Common Name:	Percutaneous Catheter
Classification:	Class II
Product Code:	PNO - 21 CFR 870.1250
Predicate Device(s):	The subject device is equivalent to the following devices:K113103 - SplitWire Percutaneous Transluminal Angioplasty Scoring Device
Device Description:	The FLEXTM Scoring Catheter is a sterile, single use, disposable device designed to facilitate the dilation of stenoses. The device has a working length of 120cm and is comprised of three scoring elements at the distal end. The distal end also contains an atraumatic tip and radiopaque maker band to aid in proper placement of the catheter. When the device is unsheathed the scoring elements are expanded to contact the plaque. The device scores the plaque as it is retracted. Once the desired plaque is scored the device is exchanged for a PTA balloon.The device is compatible with0.18" guidewires.
Technical Comparison Table
	FLEX TM Scoring Catheter(Subject Device)	SplitWire PercutaneousTransluminal AngioplastyScoring Device(Predicate Device)
510(k) Number	K152789	K113103
Decision Date
Manufacturer	VentureMed Group Ltd	Rex Medical
Classification	Class II	Class II
Regulation	21 CFR 870.1250	21 CFR 870.1250
Indications for Use	indicated for use with percutaneoustransluminal angioplasty (PTA)catheters to facilitate dilation ofstenoses in the femoral andpopliteal arteries and treatment ofobstructive lesions of native orsynthetic arteriovenous dialysisfistulae.	indicated for use with percutaneoustransluminal angioplasty (PTA)catheters to facilitate dilation ofstenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal,and renal arteries and treatment ofobstructive lesions of native orsynthetic arteriovenous dialysisfistulae.
Intended Use	Same	To facilitate the dilation of stenoticvessels
Overall Device Length	120cm	90cm, 180cm, 260cm
Balloon Compatibility	Not applicable – device not invessel at same time as balloon	20 – 80mm
Integrated Balloon	No	No
Visibility	Radiopaque markerband at distaltip	Radiopaque coil at distal tip, plus 2markerbands for balloon placement
Expansion Mechanism	Operator expanded	Balloon expanded
Scoring Member	3	1
Scoring Member Height	0.010"	0.014"
Scoring MemberExpanded Size	5 mm	Dependent on inflated balloondiameter
Scoring Member DepthControl	Yes	No
Deflection	Yes < 1ATM	Yes 3ATM
Scoring Member Fixedto Balloon	No	No
Sterilization	Same	Ethylene Oxide
Single Use Only	Same	Yes

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Functional andSafety Testing toDetermineSubstantialEquivalence:	To verify that the device design meets its functional andperformance requirements, representative samples of the deviceunderwent bench testing. Testing included:General Requirements for Intravascular Catheters - ISO 10555-1 Biocompatibility Testing - ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process Sterilization Validation Testing - ISO-11135-1 Sterilization of Health Care Products. Ethylene Oxide Sterilization Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices Simulated Use TestingIn Vivo GLP animal testing, cadaveric studies, and clinical evaluations were also performed and demonstrated the FLEX device meets user needs and intended use.
Conclusion:	VentureMed Group considers the FLEX™ Scoring Catheter to be substantially equivalent to the predicate device listed above.The subject device has the same intended use, principles of operation, and similar design features. Bench testing and pre-clinical animal studies demonstrate that none of the technical differences raise any new questions of safety and effectiveness.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).