ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY

K100303 · Angioscore, Inc. · PNO · Mar 22, 2010 · Cardiovascular

Device Facts

• Record ID: K100303
• Device Name: ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY
• Applicant: Angioscore, Inc.
• Product Code: PNO · Cardiovascular
• Decision Date: Mar 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

AngioSculpt PTA Scoring Balloon Catheter is a two-lumen catheter featuring a nylon-blend balloon with an integrated nitinol scoring element. Used by physicians in clinical settings for peripheral artery angioplasty. The scoring element concentrates dilating force to minimize balloon slippage and facilitate luminal expansion of stenotic arteries. Radiopaque markers assist in positioning. Device provides controlled diameter and length expansion at specific pressures. Benefits include improved lesion dilatation and reduced slippage compared to conventional balloons. No complex software or AI components.

Clinical Evidence

Bench testing only. Design verification and validation testing demonstrated adequate device performance and confirmed substantial equivalence to predicate devices.

Technological Characteristics

Two-lumen catheter; nylon-blend balloon; nitinol scoring element; radiopaque markers for positioning. Mechanical expansion principle. No energy source, software, or connectivity.

Indications for Use

Indicated for patients requiring dilatation of lesions in iliac, femoral, ilio-femoral, popliteal, infra popliteal, and renal arteries, and treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae. Contraindicated for coronary or neuro-vasculature use.

Regulatory Classification

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.

Predicate Devices

• Cordis Aviator® PTA Dilatation Catheter (K013581)
• Cordis Savvy® PTA Dilatation Catheter (K971010)
• VascuTrak™ PTA Dilatation Catheter (K063657)
• VascuTrak™ PTA Dilatation Catheter (K082343)
• AngioSculpt® Scoring Balloon Catheter (K050629, K072225, K080151, K081220, K082059, K091966)

Submission Summary (Full Text)

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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 Kimberley Kline Regulatory Affairs Manager 5055 Brandin Court Fremont, CA 94538

Re: K100303

Trade/Device Name: AngioSculpt PTA Scoring Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: PNO Dated: February 2, 2010 Received: February 3, 2010

Dear Ms. Kline:

This letter corrects our substantially equivalent letter of March 22, 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. Kimberley 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 [phone] or [phone] 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/McdicalDevices/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 [phone] or [phone] 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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AngioScore, Inc
AngioSculpt® PTA Scoring Balloon Catheter

510(k) Premarket Notification

#### INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

): 100303

Device Name: AngioSculpt® PTA Scoring Balloon Catheter

Indications for Use:

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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Usc (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)

Duna R. Laune

(Division Sign-Off)
Division of Cardiovascular Devices

Page 1 of l

510(k) Number_K100303

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

#### 1. Submitter's Name / Contact Person

MAR 2 2 2010

Submitter:

AngioScore, Inc. 5055 Brandin Court Fremont, CA 94538

Contact Person:

Kimberley Kline Regulatory Affairs Manager Phone: [phone] Fax: [phone]

Summary Preparation Date: March 19, 2010

### 2. General Information

| Trade Name: | AngioSculpt® PTA Scoring Balloon Catheter |
|----------------------|-------------------------------------------------------------------------------------------------|
| Common / Usual Name: | Angioplasty catheter |
| Classification Name: | Catheter, angioplasty, peripheral, transluminal |
| Product Codes: | DQY and LIT |
| Predicate Devices: | Cordis Aviator® PTA Dilatation Catheter (K013581) |
| | Cordis Savvy® PTA Dilatation Catheter (K971010) |
| | VascuTrak™ PTA Dilatation Catheter (K063657) |
| | VascuTrak™ PTA Dilatation Catheter (K082343) |
| | AngioSculpt® Scoring Balloon Catheter (K050629,<br>K072225, K080151, K081220, K082059, K091966) |

#### 3. Intended Use / Indications

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.

5055 Brandin Court Fremont CA 94538 www.angioscor.com Toll Free: 1.877.264.4692 Phone: [phone]

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K100303 page 2 of 2

#### 4. 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 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.

#### 5. Substantial Equivalence Comparison

The AngioSculpt catheter intended use and that of the predicate devices, the Cordis Aviator PTA Dilatation Catheter, the Cordis Savvy PTA Dilatation Catheter, and the VascuTrak PTA Dilatation Catheter are substantially the same.

The indications for use of the subject device include the addition of renal arteries for the 510(k) cleared AngioSculpt PTA Scoring Balloon Catheter.

The AngioSculpt cathefer shares the same fundamental design, scientific technology (operating principle), functional performance, and materials as the currently marketed AngioSculpt catheter. The subject device has similar design, operating principle, and functional performance as the Cordis Aviator and Savvy Dilitation Catheters, as well as the VascuTrak Dilitation 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 inclusion of renal arteries in the indications for use does not raise new clinical risks. The anatomic and histologic features of renal arteries are substantially similar to those in the periphery, such as the infra-inguinal arteries. Both locations are similar in size and have similar fibro-fatty and calcified plaque formation.

The AngioSculpt PTA Scoring Balloon Catheter is therefore, substantially equivalent to the predicate devices.