The AngioSculpt Scoring Balloon Catheter is intended for balloon dilatation of lesions in infrapopliteal arteries. Not for use in the coronary or neuro-vasculature.

Device Description

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

AI/ML Overview

This document is a 510(k) premarket notification for the AngioSculpt® PTA Scoring Balloon Catheter, specifically addressing a modification. The document primarily focuses on establishing substantial equivalence to previously cleared devices rather than providing detailed clinical study results or acceptance criteria in the format requested.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully extracted from the provided text. The document states that "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," but it does not detail those tests or their specific acceptance criteria.

Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and what cannot:

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

Cannot be provided. The document states that "Design verification and validation testing demonstrated adequate device performance," but it does not specify what those performance criteria were or the quantitative results of those tests. It focuses on demonstrating substantial equivalence in fundamental design, scientific technology, functional performance, and materials to a predicate device (AngioSculpt® Scoring Balloon Catheter K050629) and similar dimensions/size configurations to another predicate (Cordis Savvy® PTA Dilatation Catheter K971010).

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

Cannot be determined from the provided text. The document mentions "Design verification and validation testing" but does not provide details on sample sizes, study design (retrospective/prospective), or data provenance.

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 / Cannot be determined. This document describes a medical device submission, not a study evaluating an AI algorithm with expert ground truth.

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

Not applicable / Cannot be determined. This document describes a medical device submission, not a study involving expert adjudication of data.

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

No. This is not an AI device. The document describes a physical medical device (a scoring balloon catheter).

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

No. This is not an AI device.

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

Not applicable. The document refers to "Design verification and validation testing," which for a physical device would involve engineering tests (e.g., burst pressure, fatigue, dimensional accuracy, force profiles) rather than establishing ground truth like pathology or expert consensus for clinical disease states.

8. The sample size for the training set

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

Summary based on the provided document:

The provided document is a 510(k) submission for a modified AngioSculpt® PTA Scoring Balloon Catheter. The primary method for demonstrating the device's acceptability is through substantial equivalence to predicate devices. The document explicitly states:

"The modified AngioSculpt catheter shares the same fundamental design, scientific technology (operating principle), functional performance, and similar materials as the original AngioSculpt catheter."
"The modified AngioSculpt catheter has similar dimensions and size configurations as the Savvy 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."

However, the specific "acceptance criteria" (such as quantitative thresholds for performance metrics) and the detailed results of the "design verification and validation testing" are not included in this summary document. The document functions as a high-level notification to the FDA about a device modification and its substantial equivalence, not a detailed technical report of testing data.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles a human figure embracing a globe, representing the department's mission to protect the health of all Americans.

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. Melinda Swanson 5055 Brandlin Court Fremont, CA 94538

Re: K072225

Trade/Device Name: AngioSculpt® PTA Scoring Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: PNO Dated: September 11, 2007 Received: September 12, 2007

Dear Ms. Swanson:

This letter corrects our substantially equivalent letter of October 12, 2007.

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 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

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Page 2 - Ms. Melinda Swanson

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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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K072225

Device Name: AngioSculpt® Scoring Balloon Catheter

Indications for Use:

The AngioSculpt Scoring Balloon Catheter is intended for balloon dilatation of lesions in infrapopliteal arteries. Not for use in the coronary or neurovasculature.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRII, Office of Device Evaluation (ODE)

Blumensons

ardlovascular Devi 510(k) I

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174 of 187

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K072225
p. 1 of 1

UC7 1 2 2007

510(k) Summary for the Modified AngioSculpt Scoring Balloon Catheter

1. Submitter's Name / Contact Person

Submitter:	AngioScore, Inc.5055 Brandin CourtFremont, CA 94538
Contact Person:	Melinda SwansonDirector, Clinical and Regulatory AffairsPhone: 510-933-7910Fax: 510-933-7994

September 11, 2007 Summary Preparation Date:

2. General Information

Trade Name:	AngioSculpt® PTA Scoring Balloon Catheter
Common / Usual Name:	Angioplasty catheter
Classification Name:	Catheter, angioplasty, peripheral, transluminal (DQY and LIT)
Predicate Devices:	AngioSculpt® Scoring Balloon Catheter (K050629)
	Cordis Savvy® PTA Dilatation Catheter (K971010)

3. Intended Use / Indications

The modified AngioSculpt PTA Scoring Balloon Catheter is intended for balloon dilatation of lesions in infrapopliteal arteries. Not for use in the coronary or neuro-vasculature.

4. Device Description

5. Substantial Equivalence Comparison

There is no difference between the modified AngioSculpt catheter intended use and that of the predicate devices. The modified AngioSculpt catheter shares the same fundamental design, scientific technology (operating principle), functional performance, and similar materials as the original AngioSculpt catheter. The modified AngioSculpt catheter has similar dimensions and size configurations as the Savvy 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 modified AngioSculpt PTA Scoring Balloon Catheter is therefore, substantially equivalent to the predicate devices.

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).