(89 days)
No
The device description and intended use focus on a mechanical, elastomeric pump with flow control via a restrictor, and there are no mentions of AI, ML, or related concepts in the provided text.
Yes
The device is an infusion pump designed to deliver medications or fluids for treatment, which is a therapeutic purpose.
No
The device is described as an "infusion pump" intended for delivering medications or fluids, not for diagnosing medical conditions.
No
The device description explicitly states it is an "elastomeric chamber infusion pump" and describes physical components like a "flow restrictor" and delivery via a "catheter," indicating it is a hardware device.
Based on the provided information, the Alpha Infusion Pump is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Alpha Infusion Pump Function: The Alpha Infusion Pump is designed to deliver medications or fluids directly into a patient's body (intravenously, intra-arterially, subcutaneously, or epidurally). It is a drug delivery system, not a device that analyzes biological samples.
The description clearly states its purpose is for "infusion of medications or fluids requiring continuous delivery at controlled infusion rates" and that it "deliver[s] medication or fluids percutaneously to the patient via a catheter." This is the function of a therapeutic device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Alpha Infusion Pump is intended for intravenous, intra-arterial, subcutaneous, or epidural infusion of medications or fluids requiring continuous delivery at controlled infusion rates. Medications or fluids are intended to be delivered percutaneously through a catheter. The Alpha Infusion Pump is suitable for use as an ambulatory device and is intended for use in the home environment but not limited to use in the home environment.
Product codes
FPA
Device Description
The proposed device, the Alpha Infusion Pump, claims substantial equivalence in intended use and operation to the Baxter Intermate LV Elastomeric Infusion Device (K922382) and the I-Flow PainBuster Infusion System (K980558). Both are elastomeric chamber infusion pump intended to deliver medications or fluids to a patient by an intravenous, intra-arterial, subcutaneous, or epidural route. These pumps are ambulatory, external. disposable infusion pumps which deliver medication or fluids percutaneously to the patient via a catheter. They control flow rate using a flow restrictor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home environment but not limited to use in the home environment.
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)
K922382, K980558, K896422, K990101, K982256, K983454
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Statement of Indications for Use 20.
INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Alpha Infusion Pump is intended for intravenous, intra-arterial, subcutaneous, or epidural infusion of medications or fluids requiring continuous delivery at controlled infusion rates. Medications or fluids are intended to be delivered percutaneously through a catheter.
The Alpha Infusion Pump is suitable for use as an ambulatory device and is intended for use in the home environment but not limited to use in the home environment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use __ X
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR alle
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 5100k) Number Kergels
1
K 992551/
510(k) Summary 19.
510(k) SUMMARY - Safety and Effectiveness
Alpha Infusion Pump
The proposed device, the Alpha Infusion Pump, claims substantial equivalence in intended use and operation to the Baxter Intermate LV Elastomeric Infusion Device (K922382) and the I-Flow PainBuster Infusion System (K980558). Both are elastomeric chamber infusion pump intended to deliver medications or fluids to a patient by an intravenous, intra-arterial, subcutaneous, or epidural route. These pumps are ambulatory, external. disposable infusion pumps which deliver medication or fluids percutaneously to the patient via a catheter. They control flow rate using a flow restrictor.
The proposed device, the Alpha Infusion Pump, claims substantial equivalence in intended use to the Burron Ambulatory Drug Delivery System (K896422), the Sgarlato Laboratories Pain Control Infusion Pump (K990101), and the McKinley Medical OutBound Disposable Syringe Infusor (K982256). These infusion pumps differ from the Alpha Infusion Pump only in the method used to pressurize the medication or fluid contained within the pump.
The proposed device, the Alpha Infusion Pump, claims substantial equivalence in intended use to the McKinley Medical OutBound PCA Pain Management System (K982256) and the Breg Pain Care 2000 (K983454). These infusion systems provide for the delivery of a bolus of medication on patient demand through a percutaneous catheter.
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Public Health Service
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 7 1999
Mr. James Christensen Advanced Infusion, Incorporated 6200 South McClintock #6 Tempe, Arizona 85283
DEPARTMENT OF HEALTH & HUMAN SERVICES
Re: K992551 Alpha Infusion Pump Trade Name: Requlatory Class: II Product Code: FPA Dated: July 27, 1999 Received: July 30, 1999
Dear Mr. Christensen:
We have reviewed your Section 510(k) notification of intent to We have reviewed your Section 310, move have determined the market the device referenced above (for the indications for device is substantially equivacio (ces marketed in interstate use stated in the encreases, so the enactment date of the commerce prior to hay as , or to devices that have been Medical Device Amendments, or o actives of the Federal reclassified in accordance #15Act). You may, therefore, Food, Drug, and Cosmetic nee (iso, eneral controls provisions
market the device, subject to the general on of the Agt The general controls provisions of the Act of the Act. of the Act. The general conual registration, listing of Include requiremenfacturing practice, labeling, and devices, good manast misbranding and adulteration.
If your device is classified (see above) into either class II II your device is class III (Premarket Approval), it may (Special Controls) of Srabled Controls. Exisling major be subject to back addroms device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A rederal Regulations, frees === "baation assumes compliance with substantlarly equivalent acture for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic (GMP) regulacion (Dr Sood and Drug Administration (PDA) will om Inbpections, onlons. Failure to comply with the GMP vertify such abbampens. regulation may resure in regulate concerning your device in may publish farcher announcement. this response to your the reactal negion submission does not affect any
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Page 2 - Mr. Christensen
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 finding 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 oblained 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,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure