PULSE*SPRAY INJECTOR

K963574 · AngioDynamics, Inc. · FRN · Jul 18, 1997 · General Hospital

Device Facts

• Record ID: K963574
• Device Name: PULSE*SPRAY INJECTOR
• Applicant: AngioDynamics, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Jul 18, 1997
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ANGIODYNAMICS, Inc. Pulse*Spray Injector is intended for the automatic infusion of thrombolytic fluids into the peripheral vasculature through the ANGIODYNAMICS, Inc. Pulse*Spray Pulsed Infusion System.

Device Story

Pulse*Spray Injector facilitates automatic infusion of thrombolytic fluids into peripheral vasculature; used in conjunction with Pulse*Spray Pulsed Infusion System. Device automates fluid delivery process; intended for prescription use by clinicians. Benefits include controlled, automated administration of thrombolytics to treat peripheral vascular conditions.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device notification.

Technological Characteristics

Automatic infusion system for thrombolytic fluids; designed for peripheral vasculature application. Operates as part of the Pulse*Spray Pulsed Infusion System.

Indications for Use

Indicated for automatic infusion of thrombolytic fluids into peripheral vasculature.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Jeffrey R. Mannion
*Regulatory Affairs Associate
AngioDynamics, Incorporated
603 Queensbury Avenue
Queensbury, New York 12804

JUL 18 1997

Re: K963574
Trade Name: Pules*Spray Injector
Regulatory Class: II
Product Code: FRN
Dated: June 25, 1997
Received: June 27, 1997

Dear Mr. Mannion:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

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Page 2 - Mr. Mannion

On August 16, 1993 the Final Rule for Device Tracking was published in the Federal Register, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the regulation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.

This letter immediately will allow you to begin marketing your device as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in anyway represent your device or its labeling as being approved by FDA. If you desire specific advice for your device on our labeling regulation (21 CFR part 801 and additionally 809.10 for in vitro diagnostic devices), promotion, or advertising, please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) at [phone]. Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone].

Sincerely yours,

Timothy A. Ulatowski
Director
Division of Dental, Infection Control and General Hospital Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosures

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Page 1 of 1

510(k) Number (if known): K963574

Device Name: Pulse*Spray Injector

Indications For Use:

The ANGIODYNAMICS, Inc. Pulse*Spray Injector is intended for the automatic infusion of thrombolytic fluids into the peripheral vasculature through the ANGIODYNAMICS, Inc. Pulse*Spray Pulsed Infusion System.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

(Division Sign-Off) Convenience of CDRH, Office of Device Evaluation (ODE)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K963574
Prescription Use ☑ or
(Per 21 CFR 801.109)

Over-The-Counter Use ☐
(Optional Format 1-2-96)