The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, 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.

Device Description

The AngioSculpt catheter is a standard two-lumen catheter with a scoring balloon near the distal tip. The distal end of the catheter has a conventional nylon-blend balloon with a nitinol 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 ald in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.

AI/ML Overview

The provided document is a 510(k) summary for the AngioSculpt® PTA Scoring Balloon Catheter. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (K100303) rather than presenting a de novo study with specific clinical acceptance criteria for effectiveness.

Therefore, the document does not contain the acceptance criteria or a study proving the device meets those criteria for clinical effectiveness in the way typically expected for a new medical device seeking marketing authorization based on clinical performance.

Instead, the document details bench testing and animal testing to demonstrate safety and performance characteristics for substantial equivalence to a predicate device. These tests are designed to show that the new device performs as expected and does not raise new safety or effectiveness concerns compared to the predicate.

Here's a breakdown of what is in the document related to testing, formatted to address your questions where applicable, but highlighting that no clinical acceptance criteria or human clinical study results are presented:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

Disclaimer: This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing (bench and animal studies), rather than establishing clinical effectiveness against specific clinical acceptance criteria in a human study. Therefore, the requested information regarding human-in-the-loop performance, multi-reader multi-case studies, effect sizes, specific clinical ground truth, and training set details are not applicable and not found in this regulatory submission.

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) for substantial equivalence based on bench and animal testing, there are no "acceptance criteria" in the sense of clinical performance metrics for a human study. Instead, the document lists various bench tests and their purpose (e.g., to verify design outputs met design requirements, confirm proper function and durability) and describes the findings from animal testing.

Acceptance Criterion (Test Objectives)	Reported Device Performance (Summary of Results)
Bench Testing:
Balloon Rated Burst Pressure	Conducted to verify that design outputs met design requirements and to confirm proper function and durability. (Specific quantitative results not provided in this summary, but implied to meet requirements.)
Balloon Inflation and Deflation
Balloon and Scoring Element Fatigue
Bond Strength
Crossing Profile
Trackability and Pushability
Over-the-Arch Torque Strength
Catheter Body Integrity
Balloon Compliance
Surface Appearance
Secure Edges
Freedom from Interference
Scoring Element Creates Focal Force
Biocompatibility Testing:
Cytotoxicity	Non-cytotoxic
Sensitization	Non-sensitizing
Irritation	Non-irritating
Systemic Toxicity	Not systemically toxic
Hemocompatibility (PTT, Hemolysis)	Non-hemolytic
Hemocompatibility (Thrombosis in-vivo)	No thrombo-embolism observed under simulated use conditions.
Animal Testing (Acute GLP Study):
Safety & Deliverability	Successfully introduced using standard guide wires and expanded in targeted tissue. No dissection, perforation, or embolization. All devices maintained integrity with no loss of components. All procedures performed with ease, no adverse events. Clinically acceptable.
Trackability & Passability	Demonstrated as satisfactory. (Specific quantitative metrics not provided)
Device Inflation & Deflation	Demonstrated as satisfactory. (Specific quantitative metrics not provided)
Radiopacity	Demonstrated as satisfactory. (Specific quantitative metrics not provided)
Device Removal	Demonstrated as satisfactory. (Specific quantitative metrics not provided)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Bench Testing: "Test articles consisted of finished sterilized catheters." (Specific sample sizes for each test are not provided in this summary). Data provenance is from AngioScore, Inc. (Fremont, CA, USA). These are prospective tests performed as part of device development and verification.
Biocompatibility Testing: Specific sample sizes for each in vitro or in vivo test are not explicitly provided in this summary. The thrombogenicity evaluation was part of a GLP animal study.
Animal Testing: The study involved one experimental animal (a single animal). The study was acute and conducted in the femoral peripheral arteries. It was a prospective, GLP (Good Laboratory Practice) study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not Applicable. No human clinical study or test set requiring expert ground truth for diagnostic accuracy (common in AI/imaging devices) was conducted. Evaluations were based on physical measurements, biological assays, and observational findings in an animal model by study personnel.

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

Not Applicable. No human clinical study or test set requiring adjudication was conducted.

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 device is a physical medical device (balloon catheter), not an AI/imaging device that would involve human readers or AI assistance.

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

Not Applicable. This device is a physical medical device (balloon catheter), not an AI/algorithm device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For bench testing, ground truth is based on established engineering principles, material specifications, and regulatory standards.
For biocompatibility testing, ground truth is based on standard ISO 10993-1 methods and 21 CFR Part 58 GLP regulations, relying on established biological endpoints.
For animal testing, the "ground truth" (i.e., evaluation of device performance, integrity, and lack of adverse events) was established through direct observation, examination (e.g., for dissection, perforation, embolization), and assessment by the trained GLP study personnel.

8. The sample size for the training set

Not Applicable. This device is a physical medical device. There is no concept of a "training set" as would be used for an AI/machine learning model.

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

Not Applicable. As above, no training set for an AI model. For physical device development, "ground truth" is typically defined by design specifications and regulatory standards against which performance is measured.

Summary

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

May 31. 2016

AngioScore, Inc. c/o Ms. Kimberley Kline Regulatory Affairs Manager 5055 Brandin Court Fremont, CA 94538

Re: K101735

Trade/Device Name: AngioSculpt PTA Scoring Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PNO Dated: June 18, 2010 Received: June 21, 2010

Dear Ms. Kline:

This letter corrects our substantially equivalent letter of July 14, 2010.

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 or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Ms. Kline

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/Resourcesfor You/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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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): __ K 10 1 7 3 5

Device Name: AngioSculpt® PTA Scoring Balloon Catheter

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)

(Division Sign-Off)
Division of Cardiovascular Devices	Page 1 of 1
510(k) Number	K101735
5055 Brandin Court Fremont CA 94538 www.angioscore.com Toll Free: 1.877.264.4692 Phone: 1.510.933.7900 Fax: 1.510.933.7901
CONFIDENTIAL	Page 39 of 561

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K 101735

'JUL 1 4 2010

510(k) Summary for the AngioSculpt Scoring Balloon Catheter

1. Submitter's Name / Contact Person

Submitter:

AngioScore, Inc. 5055 Brandin Court Fremont, CA 94538

Contact Person:

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

Summary Preparation Date: July 13, 2010

1. General Information

Trade Name:	AngioSculpt® PTA Scoring Balloon Catheter
Common / Usual Name:	Angioplasty catheter
Classification Name:	Percutaneous catheter
Product Codes:	DQY and LIT
Predicate Devices:	AngioSculpt® Scoring Balloon Catheter(K100303)

3. Intended Use / Indications

The AngioSculpt PTA Scoring Balloon Catheter is intended for the dilatation of lesions in the iliac, femoral, illo-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

5055 Brandin Court Fremont CA 94538 www.angioscore.com Toll Free: 1.877.264.4692 Phone: 1.510.933.7901

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5. Technological Characteristics

There are no technological changes to the subject AngioSculpt catheters as compared to the 510(k) cleared AngioSculpt catheter family (K100303).

6. Summary of Bench Testing

Mechanical testing of the AngioSculpt catheter 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.

. Balloon Rated Burst Pressure
. Balloon Inflation and Deflation
Balloon and Scoring Element Fatigue
Bond Strength
Crossing Profile
. Trackability and Pushability
. Over-the-Arch Torque Strength
. Catheter Body Integrity
. Balloon Compliance
Surface Appearance
Secure Edges
. Freedom from Interference
Scoring Element Creates Focal Force
1. Summary of Biocompatibility Testing

The AngioSculpt catheter 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 - Blological evaluation of medical devices, Part 1 -Evaluation and tests within o risk management process. In addition, the product complies with the requirements identified in FDA Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices: PTCA Catheters, Atherectomy Catheters, Lasers and Introvascular Stents(1995) – Blocompatibility testing for all interventional cardiology devices.

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)
Hemocompatibility Partial Thromboplastin Time (PTT) ●
Hemocompatibility - Thrombosis (in vivo)
. Hemocompatibility - Hemolysis Direct Contact Method (NIH)

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The biocompatibility test results confirmed that the AngioSculpt catheter is non-cytotoxic, nonsensitizing, non-irritating, not systemically toxic, and non-hemolytic when evaluated under the respective test conditions. As shown in the GLP animal study, no thrombo-embolism was observed when the AngioSculpt catheter was 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. The study was conducted in the femoral peripheral arteries of one experimental animal. The catheter was evaluated on deliverability and trackability), passability, device inflation and deflation parameters, radiopacity, and device removal.

The study results demonstrated that the AngioSculpt catheter was successfully introduced using standard guide wires in combination with a 5F sheath or 6F guide catheter and expanded in the targeted tissue while demonstrating no evidence of dissection, perforation, or embolization. All 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 AngloSculpt catheter shares the same indications for use, fundamental design, scientific technology (operating principle), functional performance, and materials as the currently marketed AngioSculpt catheter. 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 AngioSculpt PTA Scoring Balloon Catheter 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 AngioSculpt PTA Scoring Balloon Catheter is therefore, substantially equivalent to the predicate AngioSculpt 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).