ANGIOSCULPT PTA SCORING BALLOON CATHETER

K072225 · Angioscore, Inc. · PNO · Oct 12, 2007 · Cardiovascular

Device Facts

• Record ID: K072225
• Device Name: ANGIOSCULPT PTA SCORING BALLOON CATHETER
• Applicant: Angioscore, Inc.
• Product Code: PNO · Cardiovascular
• Decision Date: Oct 12, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

AngioSculpt PTA Scoring Balloon Catheter is a two-lumen catheter featuring a distal nylon-blend balloon wrapped with a nitinol scoring element. Used by physicians in clinical settings for peripheral angioplasty. The nitinol scoring element creates focal concentrations of dilating force during inflation, minimizing balloon slippage and assisting in luminal expansion of stenotic infrapopliteal arteries. Radiopaque markers on the balloon facilitate accurate positioning under fluoroscopy. The device provides an expandable segment of known diameter and length at specific pressures. By focusing dilating force, the device aims to improve luminal expansion compared to standard non-scoring balloons.

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 via inflation. Dimensions and size configurations similar to Savvy catheter. No software or electronic components.

Indications for Use

Indicated for balloon dilatation of lesions in infrapopliteal arteries. Contraindicated for use in coronary or neurovasculature.

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

• AngioSculpt® Scoring Balloon Catheter (K050629)
• Cordis Savvy® PTA Dilatation Catheter (K971010)

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 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 [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/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 [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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# 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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K072225
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# UC7 1 2 2007

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

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

| Submitter: | AngioScore, Inc.<br>5055 Brandin Court<br>Fremont, CA 94538 |
|-----------------|----------------------------------------------------------------------------------------------------------|
| Contact Person: | Melinda Swanson<br>Director, Clinical and Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] |

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

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.

### 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.