Pulse* Spray Infusion System, Uni*Fuse Infusion System

K163356 · AngioDynamics, Inc. · QEY · May 30, 2017 · Cardiovascular

Device Facts

• Record ID: K163356
• Device Name: Pulse* Spray Infusion System, Uni*Fuse Infusion System
• Applicant: AngioDynamics, Inc.
• Product Code: QEY · Cardiovascular
• Decision Date: May 30, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pulse*Spray System, PRO Infusion Catheter, and its related components, are intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature. The Uni*Fuse Infusion System is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.

Device Story

Pulse*Spray and Uni*Fuse Infusion Systems are catheter-based devices for peripheral vascular fluid delivery. The Pulse*Spray system includes a PRO (Pressure Responsive Outlet) infusion catheter with longitudinal slits, an occluding guidewire/ball wire, syringes, Y-connector, and check valve. The Uni*Fuse system includes a catheter and occluding guidewire. The devices are used by clinicians to deliver thrombolytic agents or contrast media. The occluding wire blocks the distal end, forcing fluid through the catheter slits into the target vessel. The system is a manual, non-powered infusion tool. The modification in this submission involves changes to the catheter shaft and hub materials. The device provides a controlled delivery mechanism for therapeutic or diagnostic fluids, aiding in procedures such as thrombolysis.

Clinical Evidence

Bench testing only. Testing included catheter tensile strength, static burst pressure, flow rate, occlusion tip durability, temperature conditioning, dispersion and occlusion seal integrity, and biocompatibility per ISO 10993-1.

Technological Characteristics

Infusion catheter system; includes PRO infusion catheter with longitudinal slits, occluding guidewire/ball wire, syringes, Y-connector, and dual check valve. Materials: modified catheter shaft and hub materials. Sterilization: not specified. Connectivity: none (manual device).

Indications for Use

Indicated for administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.

Regulatory Classification

Identification

An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

Predicate Devices

• AngioDynamics Pulse*Spray and Uni*Fuse Infusion Systems (K961763)

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 30, 2017

AngioDynamics, Inc. Robin Fuller Sr. Manager, Regulatory Affairs 26 Forest Street Marlborough, MA 01752

Re: K163356

Trade/Device Name: Pulse* Spray and Uni*Fuse Infusion Systems Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: April 4, 2017 Received: May 5, 2017

Dear Robin Fuller:

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 (for the indications for use stated in the enclosure) 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 of medical devicerelated 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.

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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" (21 CFR 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,

Fernando Agnel
Fernando Aguel-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

510(k) Number (if known) K163356

Device Name Pulse* Spray Infusion System, Uni*Fuse Infusion System

#### Indications for Use (Describe)

The Pulse*Spray System, PRO Infusion Catheter, and its related components, are intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.

The Uni*Fuse Infusion System is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.

Type of Use (*Select one or both, as applicable*)

| <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------|
| <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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AngioDynamics Pulse*Spray and Uni*Fuse Infusion Systems

Traditional 510(k)

K163356

Page 1 of 4

### 510(K) SUMMARY FOR THE

### ANGIODYNAMICS, INC. PULSE*SPRAY AND UNI*FUSE INFUSION SYSTEMS

Date Prepared: 10 January 2017

A. Sponsor:

AngioDynamics, Inc.

26 Forest Street

Marlborough, MA 01752

| B. Contact: | Robin Fuller<br>Sr. Manager Regulatory Affairs |
|-------------|---------------------------------------------------------------------------------|
| | Tel: [phone] |
| | Fax: [phone] |
| | Email: <a href="mailto:[e-mail]">[e-mail]</a> |

Subject Device:

| Trade Name: | AngioDynamics Pulse*Spray and Uni*Fuse<br>Infusion Systems |
|--------------------|------------------------------------------------------------|
| Common Name: | Infusion Catheter |
| Regulation Number; | 21 CFR 870.1210 |
| Regulation Name: | Continuous Flush Catheter |

Class II

Product Code:

Classification Panel:

Regulatory Class:

Cardiovascular

KRA

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AngioDynamics Pulse*Spray and Uni*Fuse Infusion Systems

Traditional 510(k)

KJ63356

Page 2 of 4

# Predicate Device:

| Trade Name: | AngioDynamics Pulse*Spray and Uni*Fuse<br>Infusion Systems |
|-----------------------|------------------------------------------------------------|
| 510(k) Reference: | K961763 |
| Common Name: | Infusion Catheter |
| Regulation Number: | 21 CFR 870.1210 |
| Regulation Name: | Continuous Flush Catheter |
| Regulatory Class: | Class II |
| Product Code: | KRA |
| Classification Panel: | Cardiovascular |

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Traditional 510(k)

K163356

Page 3 of 4

### C. Device Description:

The Pulse*Spray Catheter is packaged in a kit configuration. The following components are sold in the Pulse*Spray Infusion Catheter Kits:

·PRO (Pressure Responsive Outlet) Infusion Catheter with longitudinal slits at the distal end. Slits are located at 90° intervals around the catheter. Radiopaque markers on the catheter shaft indicate the active infusion pattern.

· Occluding Guidewire or Occluding Ball Wire which occludes the distal end of the PRO Infusion Catheter. The Occluding Guidewires or Occluding Ball Wires have proximal markers for occlusion position verification.

·1 mL Syringe and finger flange

- •10 mL Syringe
- ·20 mL Syringe
- · Y-Connector with Tuohy-Borst adapter
- ·Dual Check Valve

The Uni*Fuse Catheters are sold in only one configuration, with an occluding guidewire.

### D. Intended Use/Indications for Use:

The Pulse*Spray System, PRO Infusion Catheter, and its related components, are intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.

The Uni*Fuse Infusion System is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature

### E. Summary of Similarities and Differences in Technology Characteristics and Performance:

The proposed device has the same design and technical characteristics as the predicate device. The purpose of this 510(k) submission is to introduce into commercial distribution a modified AngioDynamics, Inc. Pulse*Spray and Uni*Fuse Infusion catheter. The modification is a change in the catheters shaft material and hub material.

Beyond the two material changes, the proposed and predicate devices are identical in regards to design, materials, packaging and sterilization to the predicate device. There are no changes being made to any of the accessories provided within the Pulse*Spray and Uni*Fuse Infusion catheters.

### F. Performance Data:

The performance testing included non-clinical bench testing. The following tests were performed.

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Traditional 510(k)

K163356

Page 4 of 4

- CatheterTensile
- Static Burst
- Catheter Flow Rate
- Catheter Occlusion Tip Durability
- Catheter Temperature Condition
- Catheter Dispersion and Occlusion Seal
- Biocompatibility per ISO 10993-1

### G. Conclusion:

The results of the non-clinical testing and a comparison of similarities and differences demonstrate that the proposed and predicate devices are substantially equivalent.