(315 days)
The ANGIODYNAMICS, Inc. PulseSpray Injector is intended for the automatic infusion of thrombolytic fluids into the peripheral vasculature through the ANGIODYNAMICS, Inc. PulseSpray Pulsed Infusion System.
Not Found
This document is a 510(k) clearance letter for the AngioDynamics, Inc. Pulse*Spray Injector, indicating that the device has been found substantially equivalent to a pre-amendments device. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter primarily focuses on the regulatory clearance for marketing the device based on its substantial equivalence.
Therefore, I cannot provide the requested information from the provided text. The document does not describe:
- Acceptance criteria and reported device performance.
- Sample sizes, data provenance, or expert qualifications for a test set.
- Adjudication methods.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Details of a standalone algorithm performance study.
- Type of ground truth used.
- Training set sample size or how its ground truth was established.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jeffrey R. Mannion 'Requlatory Affairs Associate AngioDynamics, Incorporated 603 Queensbury Avenue Queensbury, New York 12804
JUL 1 8 1997
K963574 Re: Pules*Spray Injector Trade Name: Requlatory 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 In addition, the Food and Drug Administration (FDA) action. 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 miqht have under section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.
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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 Because the device is subject to tracking, you are tracking. 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 requlation are found in 21 CFR 821 as described in the August 16, 1993 Federal Reqister 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 leqally 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 (301) 594-4639. Other qeneral information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638#2041 or at (301) 443-6597.
Sincerely yours,
Timothy R. Whatmore
Timo hy 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. PulseSpray Injector is intended for the automatic infusion of thrombolytic fluids into the peripheral vasculature through the ANGIODYNAMICS, Inc. PulseSpray Pulsed Infusion System.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) . .
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | Patricia Cucenta |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K965574 |
| Prescription Use | ✓ (Per 21 CFR 801.109) |
| or | |
| Over-The-Counter Use |
(Optional Format 1-2-96)
§ 880.5725 Infusion pump.
(a)
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.(b)
Classification. Class II (performance standards).