The AngioSculpt PTA.Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, lito-femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lestons of native or synthelic anteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

Device Description

The AngioSculpt PTA Scoring Balloon Catheter with HydroCross™ Coating is a standard twolumen catheter with a scoring balloon near the distal end of the catheter has a conventional nylon-blend balloon with a scoring element that wraps around the balloon. The scoring element creates focal concentrations of dilating force which minimizes balloon slippage and assists with luminal expansion of stenotic arteries. The balloon has radiopaque markers to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure. As shown below, the catheter has a segment which is coated with a hydrophilic coating (HydroCross™ Coating).

AI/ML Overview

The provided text describes a medical device, the AngioSculpt® PTA Scoring Balloon Catheter with HydroCross™ Coating, and its clearance process with the FDA. However, the document does NOT contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically expected for an AI/ML medical device submission (e.g., sensitivity, specificity, F1-score, AUC, etc., derived from clinical data).

Instead, this document is a 510(k) summary for a physical medical device (a balloon catheter) seeking substantial equivalence to already marketed devices. The "studies" described are primarily bench testing (mechanical, material properties) and biocompatibility testing, and an animal study to demonstrate safety and deliverability. These types of tests are standard for physical devices to ensure they perform as intended and are safe for use.

Therefore, many of the requested fields regarding acceptance criteria related to a device's performance in diagnosing or predicting (like sensitivity/specificity) and specific details about ground truth, expert readers, MRMC studies, or training sets for AI algorithms are not applicable to this document.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a physical medical device, the "acceptance criteria" are not reported as statistical performance metrics like sensitivity or specificity. Instead, they are defined by successful completion of various engineering and biological tests, demonstrating the device meets design requirements and safety standards. The "reported device performance" is the successful outcome of these tests.

Acceptance Criteria Category	Specific Tests Conducted	Reported Device Performance
Mechanical Performance (Bench Testing)	- Catheter Diameter and Balloon Profile	Designed to meet design outputs and requirements, confirming proper function and durability.
	- Minimum Burst Strength (RBP)
	- Balloon Compliance (Diameter vs. Pressure)
	- Balloon Inflation and Deflation Time
	- Device Fatigue
	- Bond (Tensile) Strength
	- Tip Pull Strength
	- Catheter Diameter and Balloon Profile (with Scoring Element)
	- Flexibility and Kink
	- Torque Strength
	- Pushability, Trackability and Secure Edges
	- Balloon Preparation, Deployment and Retraction
	- Freedom from Stent Interference
	- Focal Force
	- Corrosion Resistance
	- Coating Length, Thickness, Lubricity, Integrity
	- Particulate Evaluation
Biocompatibility	- Cytotoxicity (MEM Elution Test)	Non-cytotoxic, non-irritating, not systemically toxic, non-hemolytic, non-mutagenic. No thrombo-embolism observed in GLP animal study.
	- Sensitization (Guinea Pig Maximization Sensitization Test)
	- Irritation (Intracutaneous Reactivity Test)
	- Systemic Toxicity (Acute Systemic Injection Test, Material Mediated Pyrogens)
	- Hemocompatibility (Partial Thromboplastin Time, Hemolysis Direct Contact/Extract Method, Direct Contact Complement Activation Testing, Thrombosis (in vivo))
	- Genotoxicity (Reverse Bacterial Mutation, In vitro Mouse Lymphoma Assay, Rodent bone Marrow Micronucleus Assays)
Animal Study (Safety & Deliverability)	- Successful introduction with standard guidewires (6F sheath or 7F guide catheter).	Successfully introduced and expanded in target tissue; No evidence of dissection, perforation, or embolization. Maintained integrity with no loss of components. Procedures performed with ease. No adverse events. Catheters found to be clinically acceptable in peripheral (femoral) arteries.
	- Expansion in targeted tissue.
	- No evidence of dissection, perforation, or embolization.
	- Device integrity maintained with no loss of components.
	- No adverse events observed.

2. Sample Size for Test Set and Data Provenance

Bench Testing: "Test articles consisted of finished sterilized catheters." The exact number of catheters tested for each bench test is not specified in this summary.
Biocompatibility Testing: The number of biological samples or animals used for each specific biocompatibility test (e.g., L-929 Mouse Fibroblast cells for cytotoxicity, Guinea pigs for sensitization) is not specified.
Animal Study: The sample size (number of animals) for the acute GLP animal study is not explicitly stated.
Data Provenance: The document does not specify country of origin for the data; it refers to tests conducted in accordance with FDA GLP regulations (21 CFR Part 58) and ISO standards for biocompatibility. The animal study was conducted as a GLP study. Given the company is US-based (Fremont, CA), it's highly likely the testing was performed in the USA or by labs adhering to these international/US standards. All studies sound prospective as they were specifically designed to characterize this device.

3. Number of Experts and Qualifications for Ground Truth

Not Applicable: This type of information is generally relevant for studies establishing clinical ground truth (e.g., presence of a disease from imaging) for interpretive devices. For this physical device, "ground truth" is established by direct physical, chemical, and biological measurements, and observed adverse events (or lack thereof) in an animal model. The "experts" are likely laboratory technicians and veterinarians performing and assessing the animal study, certified in their respective fields, but not defined in terms of their role as "ground truth adjudicators" in a clinical sense.

4. Adjudication Method for Test Set

Not Applicable: Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among multiple human readers when establishing ground truth, typically in the context of diagnostic performance studies. This is not descriptive of the testing performed for a physical device. Outcomes of bench tests are based on objective measurements against specifications. The animal study outcomes would be assessed by the study's veterinary and pathology team.

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

No: No MRMC study was performed or described. This type of study is relevant for comparing the diagnostic performance of an AI system, with and without human assistance, against human readers. The AngioSculpt catheter is a physical interventional device, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not Applicable: There is no algorithm-only performance study because this is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

Bench Testing: The ground truth for bench tests is objective physical and chemical measurements against pre-defined engineering specifications and accepted industry standards.
Biocompatibility Testing: The ground truth is based on established biological responses (e.g., cell viability, immune response, genetic mutation) as measured by validated assays against accepted toxicity limits and ISO standards.
Animal Study: The ground truth is direct observation by trained personnel (veterinarians, histopathologists) of in-vivo events and tissue responses in an animal model, assessing for safety endpoints like dissection, perforation, embolization, and device integrity.

8. Sample Size for Training Set

Not Applicable: No "training set" in the context of machine learning was used or described. The device's design and performance are based on engineering principles, material science, and iterative testing, not on training an AI model with data.

9. How Ground Truth for Training Set Was Established

Not Applicable: As there is no training set, this question is not relevant.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The eagle is depicted with bold, curved lines, giving it a dynamic and modern appearance. The text is in a simple, sans-serif font, and the overall design is clean and professional.

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

May 31, 2016

AngioScore®, Inc. Kimberley Kline Senior Manager, Regulatory Affairs 5055 Brandin Court Fremont, CA 94538

Re: K133998

Trade/Device Name: AngioSculpt® PTA Scoring Balloon Catheter with HydroCross™ Coating Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PNO Dated: April 02, 2014 Received: April 03, 2014

Dear Ms. Kline,

This letter corrects our substantially equivalent letter of April 18, 2014.

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 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 - Kimberley Kline

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 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" (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 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,

Misti L. Malone -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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Image /page/2/Picture/0 description: The image shows the logo for AngioScore. The logo consists of a circular graphic on the left and the word "AngioScore" on the right. The circular graphic is made up of three curved shapes that are arranged in a triangular formation. The word "AngioScore" is written in a bold, sans-serif font.

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): _K133998

Device Name: AngloSculpt® PTA Scoring Balloon Catheter with HydroCross™ Coating

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use. (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)

Kenneth Kavanaugh -S

Page 1 of 1

5055 Brandin Court Fremont CA 94538 www.angioscor.com Toll Free: 1.510.933.7900 Fax: 1.510.933.7801

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510(k) Summary for the AngioSculpt Scoring Balloon Catheter with HydroCross™ Coating

1. Submitter's Name / Contact Person

AngioScore, Inc. 5055 Brandin Court Fremont, CA 94538

Contact Person:

Submitter:

Kimberley Kline Senior Manager, Regulatory Affairs Phone: 510-933-7989 Fax: 510-933-7994

Summary Preparation Date: April 16, 2014

2. General Information

Trade Name:	AngioSculpt® PTA Scoring Balloon Catheter withHydroCross™ Coating
Common / Usual Name:	Angioplasty catheter
Classification Name:	Percutaneous catheter
Product Code:	LIT
Regulation Number:	21 CFR 870.1250
Predicate Devices:	AngioSculpt® Scoring Balloon Catheter(K112182/K122685)
	VascuTrak® PTA Dilatation Catheter(K013459)

3. Intended Use / Indications

The AngioSculpt PTA Scoring Balloon Catheter is intended for the dilatation of lesions In the Illiac, femoral, ilio-femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

4. Device Description

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aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.

As shown below, the catheter has a segment which is coated with a hydrophilic coating (HydroCross™ Coating).

Image /page/4/Figure/2 description: The image shows a medical device, specifically a catheter, with a long, thin tube and a handle. The tube is labeled as a "Transition Tube with HydroCross Coating". The catheter appears to be designed for insertion into a body cavity or vessel for diagnostic or therapeutic purposes.

5. Technological Characteristics

The AngioSculpt catheters with HydroCross™ Coating incorporate substantially equivalent design, dimensional, and performance specifications when compared to the 510(k) cleared AngioSculpt catheter family (K112182/K122685) and VascuTrak® PTA Dilatation Catheters (K013459). The following minor differences are noted:

. AngioSculpt balloons (4.0/5.0/6.0mm diameter) are now available with a longer AngioSculpt balloon length (200mm). A 200mm balloon length is available in the predicate VascuTrak™ PTA Dilatation Catheter.
. The scoring element of the AngioSculpt catheters with HydroCross™ Coating incorporates. inner rings that may aid in scoring element deployment.
. Hydrophilic coating was added to the transition tube of the AngioSculpt catheters with HydroCross™ Coating to improve lubricity and deliverability.

6. Summary of Bench Testing

Mechanical testing of the AngioSculpt catheter with HydroCross™ Coating was conducted in accordance with AngioScore's Risk Analysis and all applicable FDA guidance documents and relevant standards.

The following bench tests were conducted to verify that design outputs met design requirements and to confirm proper function and durability. Test articles consisted of finished sterilized catheters.

Catheter Diameter and Balloon Profile, .
. Minimum Burst Strength (RBP)
. Balloon Compliance (Diameter vs. Pressure)
. Balloon Inflation and Deflation Time
. Device Fatigue
. Bond (Tensile) Strength
. Tip Pull Strength
. Catheter Diameter and Balloon Profile (with Scoring Element)
. Flexibility and Kink
. Torque Strength
Pushability, Trackability and Secure Edges .

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. Balloon Preparation, Deployment and Retraction
Freedom from Stent Interference
Focal Force
� Corrosion Resistance
. Coating Length
. Coating Thickness
Coating Lubricity
Coating Integrity
Particulate Evaluation

7. Summary of Biocompatibility Testing

The AngioSculpt catheter with HydroCross™ Coating is categorized as an "External communicating device in contact with circulating blood with limited exposure time". The biocompatibility of the device was assessed in accordance with ISO 10993-1:2009 - Biological evaluation of medical devices, Part 1 - Evoluation and tests within a risk management process.

The biocompatibility tests listed below, except Thrombosis (in-vivo), were conducted in accordance with the provisions of the FDA GLP regulations 21 CFR Part 58. Thrombogenicity was evaluated as part of a GLP animal study.

. Cytotoxicity - MEM Elution Test using L-929 Mouse Fibroblast cells (ISO)
Sensitization - Guinea Pig Maximization Sensitization Test
Irritation - Intracutaneous Reactivity {Irritation} Test
◆ Systemic Toxicity - Acute Systemic Injection Test (ISO)
. Systemic Toxicity - Material Mediated Pyrogens
. Hemocompatibility - Partial Thromboplastin Time (PTT)
◆ Hemocompatibility - Hemolysis Direct Contact/Extract Method (ASTM)
Hemocompatibility - Direct Contact Complement Activation Testing With C3a and SC5b
. Hemocompatibility - Thrombosis (in vivo)
. Genotoxicity - Reverse Bacterial Mutation
Genotoxicity - In vitro Mouse Lymphoma Assay-Extended Treatment
Genotoxicity - Rodent bone Marrow Micronucleus Assays

The biocompatibility test results confirm that the AngioSculpt catheter with HydroCross™ Coating, including the minor material changes, is non-cytotoxic, non-irritating, not systemically toxic, non-hemolytic , and non-mutagenic , when evaluated under the respective test conditions. As shown in the GLP animal study, no thrombo-embolism was observed when the subject catheters were evaluated under simulated use conditions.

8. Summary of Animal Testing

An acute GLP study was conducted to determine the safety and deliverability of the AngioSculpt catheter with HydroCross™ Coating.

The study results demonstrated that the AngioSculpt catheter was successfully introduced using standard guidewires in combination with a 6F sheath or 7F guide catheter and expanded in the targeted tissue while demonstrating no evidence of dissection, perforation, or embolization. All

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devices maintained integrity with no loss of components during the procedure. All treatment procedures were performed with ease and no adverse events occurred in any of the animals.

The objectives of the study were met. The catheters evaluated in the peripheral (femoral) arteries were found to be clinically acceptable.

9. Substantial Equivalence Comparison

The subject catheters share the same intended use, principles of operation, overall technical and functional capabilities, packaging and sterilization process, and similar design and materials as the predicate AngioSculpt catheters and are therefore substantially equivalent.

The subject catheters also have similar intended use and device operation, materials, design, dimensions/size configuration, guidewire platform and overall technical and functional capabilities as the BARD/YMed, Inc. VascuTraK® PTA Dilatation Catheters.

Although there are minor differences between the subject catheters and its predicate devices those differences do not raise new questions of safety or efficacy. Design verification and validation testing demonstrated adequate device performance and confirmed that no new questions of safety or effectiveness for peripheral balloon angioplasty devices were raised. The changes to the subject catheters do not affect the intended use of the device, alter the fundamental scientific technology of the device, or raise new issues of safety and effectiveness. The subject AngioSculpt PTA Scoring Balloon Catheters with HydroCross™ Coating are therefore, substantially equivalent to the predicate catheters.

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).