(71 days)
Not Found
Not Found
No
The summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the mechanical function of fluid infusion.
No
The "Intended Use" states the device is for infusion of fluids, which is a method of delivery, not a direct therapeutic action of the device itself.
No
Explanation: The device is described as being for "controlled and selective infusion of physician-specified fluids," which indicates a therapeutic or interventional purpose rather than a diagnostic one. There is no mention of identifying or characterizing a disease or condition.
No
The device description is not found, but the intended use clearly describes a "System," "Infusion Catheter," and "related components," which are physical hardware devices used for infusing fluids. This indicates it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the infusion of fluids into the peripheral vasculature (inside the body). IVDs are used to examine specimens outside the body (in vitro).
- Device Description (Not Found): While the description is missing, the intended use clearly points to an in-vivo application.
- Anatomical Site: The anatomical site is the "peripheral vasculature," which is within the living body.
Therefore, the Pulse*Spray ® System, PRO™ Infusion Catheter, and its related components are designed for therapeutic or diagnostic procedures performed within the patient, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Pulse*Spray ® System, PRO™ Infusion Catheter, and its related components, are intended for the controlled and selective infusion of physician prescribed fluids, including thrombolytics or contrast media, into the peripheral vasculature.
Product codes
QEY, KRA
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5150 Embolectomy catheter.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of human services. To the right of the symbol is a blue square containing the acronym "FDA" in white letters. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
November 22, 2021
Angiodynamics Brian Kunst Director Of RA/QA 603 Queensbury Ave. Queensbury, New York 12804
Re: K961763
Trade/Device Name: Pulse*Spray Infusion System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEY, KRA
Dear Brian Kunst:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 17, 1996. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory.Oconnell(@FDA.HHS.gov.
Sincerely,
Gregory W - Digitally signed by Gregory W. O'connell -S O'connell -S Date: 2021.11.22
13:50:19 -05'00'
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
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 depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 17 1996
Mr. Brian Kunst Director of Regulatory Affaris/ Quality Assurance AnqioDynamics 603 Queensbury Avenue Queensbury, New York 12804
K961763 Re: Pulse* Spray® Infusion System Regulatory Class: II(two) Product Code: KRA Dated: May 3, 1996 Received: May 7, 1996
Dear Mr. Kunst:
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, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). 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 reqistration, listing of devices, good manufacturing practice, 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) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in
2
regulatory action. In addition, FDA may publish further announcements
, this regulatory action. The address, resimilation doos note:
concerning your device in the Federal Register doos not aff this concerning your device in the icacal no submission does not affect any
response to your premarket notification 531 through 542 of the Act obligation you might have under sections 531 through 542 of the Act
obligation you might have under sections Control provision obligation you might have under sections on carry
for devices under the Electronic Product Radiation Control provisions, for devices or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described This letter will allow you co begin manusemant al substantial in your 510(K) premarket notification marketed predicate device equivalence of your device to a regarly man
results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling If you desire specific advice for for for for for in for inxitre regulation (21 CFR Farc 001 and act the Office of Compliance at diagnostic devices), prease concase consions on the promotion and (301) 594-4648. AdditIonally, 101 quebers on office of Compliance at
advertising of your device, please contact the office of the (301) 594-4639. Also, please note the regulation entitled, (301) 594-4639. "AISO, premarket notification" (21 CFR 807.97).
"Misbranding by reference to premarket notification under the Act may "Misbranding by Lerener to promation on your responsibilities under the Act may Other general Information on your small Manufacturers Assistance at its
be obtained from the Division of Small Manufacturers and 113,6507 De Obcained from block one of (301) 443-6597.
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K961763/A
Page 1 of 1
510(k) Number (if known): K961763
Device Name: Pulse*Spray Infusion System
Indications For Use:
The PulseSpray ® System, PRO™ Infusion Catheter, and its related components, are intended The PulseSpray - System, FRO="" Infusion Catherer, and contrast media, into the peripheral vasculature.
Tu A. Ph
(Division Sign-Off) Division of Caronovascular, Respiratory, and Neurological Devic 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use_ Prescription Use or (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off) Division of Cardiovascul and Neurological Devio 510(k) Number