(78 days)
The pump is indicated for intravenous, subcutaneous, arterial, enteral, and epidural infusion of antibiotics, analgesics, chemotherapeutic agents and other medications or fluids requiring precisely-controlled infusion rates.
Not Found
This is a 510(k) clearance letter for an infusion pump, which is a hardware device. The questions you're asking are typically relevant to AI/ML (Artificial Intelligence/Machine Learning) powered software as a medical device (SaMD) or AI/ML components of a medical device. This document does not contain information related to AI/ML algorithms, performance studies, or acceptance criteria in the context of AI.
Therefore, I cannot answer the questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided document. The document pertains to the regulatory clearance of a physical medical device (infusion pump) based on substantial equivalence to a predicate device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 1 1999
Mr. John McInroy Manager Regulatory Affairs and Quality Assurance McKinley Medical LLLP 4080 Youngfield Street Wheat Ridge, Colorado 80033 USA
Re: K991275 Trade Name: WalkMed® 300, WalkMed® 350, WalkMed® IC, WalkMed® PCA, WalkMed® Plus Requlatory Class: II Product Code: FRN Dated: April 8, 1999 Received: April 14, 1999
Dear Mr. McInroy:
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 registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. ਸ 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. McInroy
this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq of substantial equivalence of your device to a legally marketed predicate device 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Susan Kump
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: WalkMed XXX Infusion Pump
Indications for Use:
The pump is indicated for intravenous, subcutaneous, arterial, enteral, and epidural infusion of antibiotics, analgesics, chemotherapeutic agents and other medications or fluids requiring precisely-controlled infusion rates.
here Nereau for ACC
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number -
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use __ ﺃﻧﺴﻄ or
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
McKinley Medical
§ 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).