The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, and infra popliteal 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 sconng 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.

AI/ML Overview

This document is a 510(k) summary for the AngioSculpt PTA Scoring Balloon Catheter (K091966). It does not contain the detailed acceptance criteria or the study results that would be needed to fill out a table of acceptance criteria and reported device performance. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting novel clinical study data against defined acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The provided document states:

No specific acceptance criteria are listed. The document focuses on demonstrating substantial equivalence to predicate devices.
No specific study is described with performance metrics. The document mentions "Design verification and validation testing demonstrated adequate device performance," but does not detail the nature, sample size, or specific results of these tests, particularly in a way that aligns with "device performance" as might be measured in a clinical study (e.g., success rates, complication rates).

The remaining sections of your request (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, how training set ground truth was established) require information that would typically be found in a detailed clinical study report or a more comprehensive premarket submission, which is not present in this 510(k) summary.

A 510(k) summary is a high-level overview intended to demonstrate substantial equivalence, not a full clinical study report.

Summary

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A final order reclassifying shortwave diathermy (SWD) intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues, a preamendments Class III device, into class II, and renaming the device "nonthermal shortwave therapy" (SWT), was published on October 13, 2015. See here: https://www.federalregister.gov/documents/2015/10/13/2015-

25923/physical-medicine-devices-reclassification-of-shortwavediathermy-for-all-other-uses-henceforth-to

While the device submitted and cleared through K091966 may serve as a valid predicate device for a new SWT device, please refer to the aforementioned final order for current regulatory requirements for this device type.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.

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

Mav 31. 2016

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

Re: K091966

AngioSculpt PTA Scoring Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PNO Dated: June 30, 2009 Received: July 1, 2009

Dear Ms. Kline:

This letter corrects our substantially equivalent letter of July 30, 2009.

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. Kimberlev 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/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): ____________________________________________________________________________________________________________________________________________________

K091966

Device Name: AngioSculpt@ Scoring Balloon Catheter

Indications for Use:

Prescription Use ਮ (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 CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)	Page 1 of 1
Division of Cardiovascular Devices510(k) Number K09 1966

5055 Branding Color Printer Com Toll Free: 1.877.264.4692 Phone: 1.510.93.7800 15.99.889.99.98.99.98.99.98.9.9.98.9

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Image /page/4/Picture/0 description: The image shows the word "AngioScore" with a registered trademark symbol. To the left of the word is a logo that appears to be the letter A inside of a square. The word "AngioScore" is written in a sans-serif font. The image is in black and white.

KO91966

JUL 8 0 2009

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 Principal Regulatory Specialist Phone: 510-933-7989 Fax: 510-933-7994

Summary Preparation Date: June 30, 2009

2. 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(K072225, K080151, K081220, and K082059)

3. Intended Use / Indications

The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, and infra popliteal arterics, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fish ulae. Not for use in the coronary or neuro-vasculature.

4. Device Description

5055 Brandial ONE (REANTHA) 84538 www.angloscore.com Toll Free: 1.877.264.4692 Phone: 1.510.933.7900 Parks 1.687.58.1987

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5. Substantial Equivalence Comparison

The AngioSculpt 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.

CONFIDENTIAL

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).