ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040

K091966 · Angioscore, Inc. · PNO · Jul 30, 2009 · Cardiovascular

Device Facts

• Record ID: K091966
• Device Name: ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040
• Applicant: Angioscore, Inc.
• Product Code: PNO · Cardiovascular
• Decision Date: Jul 30, 2009
• Decision: SESE
• Submission Type: Special
• 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, 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 Story

AngioSculpt PTA Scoring Balloon Catheter is a two-lumen percutaneous catheter featuring a nylon-blend balloon with an integrated nitinol scoring element. Used by clinicians in interventional procedures to treat stenotic arteries and dialysis fistulae. The scoring element wraps around the balloon to create focal concentrations of dilating force, minimizing balloon slippage and assisting luminal expansion. Radiopaque markers on the balloon facilitate precise positioning under imaging. Device provides controlled expansion at specific pressures to restore vessel patency. Benefits include improved procedural control and effective lesion dilatation.

Clinical Evidence

Bench testing only. 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. Percutaneous delivery. Mechanical dilatation principle.

Indications for Use

Indicated for dilatation of lesions in iliac, femoral, ilio-femoral, popliteal, and infra-popliteal 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

• AngioSculpt Scoring Balloon Catheter (K072225)
• AngioSculpt Scoring Balloon Catheter (K080151)
• AngioSculpt Scoring Balloon Catheter (K081220)
• AngioSculpt Scoring Balloon Catheter (K082059)

Submission Summary (Full Text)

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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 [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): ____________________________________________________________________________________________________________________________________________________

K091966

Device Name: AngioSculpt@ 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, 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.

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 Devices<br>510(k) Number K09 1966 | |

5055 Branding Color Printer Com Toll Free: 1.877.264.4692 Phone: [phone].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: [phone] Fax: [phone]

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<br>(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

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.

5055 Brandial ONE (REANTHA) 84538 www.angloscore.com Toll Free: 1.877.264.4692 Phone: [phone] 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