(59 days)
Not Found
No
The device description focuses on mechanical and fluidic components (elastomeric chambers, filters, pressure regulator, tubing) and does not mention any software, algorithms, or computational elements that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is intended for the infusion of medications or fluids, which means it delivers active substances for therapeutic purposes.
No
The device is described as an infusion pump intended for delivering medications or fluids, not for diagnosing conditions or diseases.
No
The device description explicitly details physical components like elastomeric chambers, a hard shell case, luer lock checkvalve, filters, a pressure regulator, and an elastomeric septum, indicating it is a hardware device with associated accessories.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Device Function: The Alpha Infusion Pump and associated Catheters are designed to deliver medications or fluids directly into the patient's body (intravenously, intra-arterially, subcutaneously, or epidurally). They are not used to analyze specimens taken from the body.
- Intended Use: The intended use clearly states "infusion of medications or fluids requiring continuous delivery." This is a therapeutic delivery function, not a diagnostic function.
Therefore, the Alpha Infusion Pump and Catheters fall under the category of devices used for drug delivery or fluid administration, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Alpha Infusion Pump and associated Catheters are intended for intravenous, intra-arterial, subcutancous, or epidural infusion of medications or fluids requiring continuous delivery at controlled infusion rates. Medications or fluids are intended to be delivered through a catheter containing a flow restriction element.
The Alpha Infusion Pump and associated Catheters are suitable for use as an ambulatory device and are intended for use in the home environment but not limited to use in the home environment.
Product codes
MEB
Device Description
The Alpha Infusion Pump is comprised of dual elastomeric chambers which hold the fluid to be infused under pressure. These chambers are contained within a hard shell case. The infusion pump also contains a luer lock checkvalve used to fill the chambers, a 5-micron fluid filter, a hydrophobic air vent filter, a pressure regulator, and an elastomeric septum for attaching infusion catheter(s) to the pump. The infusion pump is packaged as a kit in a tray containing an insertion needle used for placement of the catheter into the patient, a 60cc syringe used to fill the pump, a fabric belt used for holding the pump onto the patient, patient labels, and an Instructions For Use.
The Alpha Cath Infusion Catheters are micro-bore tubing catheters with a needle attached to one end for insertion of the catheter into the infusion pump septum. The internal diameter and length of the catheter tubing acts as the flow restrictor and determines the flow rate of the fluid through the catheter. The infusion catheters are packaged separately in Tyvek pouches and are contained in cartons along with Tegaderm adhesive dressings and an Instruction For Use.
To fill the Alpha Infusion Pump, a 60cc disposable syringe is filled with medication and connected to the female luer lock of the filling checkvalve which is located on top of the infusion pump. As each syringe of medication is emptied into the elastomeric chambers, the chambers are stretched like a balloon and fill the hard shell outer protective case of the pump. The elastomeric chambers pressurize the medication. The hard shell case restricts the maximum volume that can be filled into the pump.
When filling is complete, the elastomeric chambers force the medication contained within the infusion purno through a 5-micron fluid filter to remove any particulates, through a spring-operated pressure regulator which maintains the medication in the outflow chamber at a constant pressure, and into a delivery chamber having an elastomeric septum. A hydrophobic air vent filter allows any air in the fluid to bleed from the outflow chamber. Infusion catheters of the desired flow rate are inserted through the elastomeric septum in order to deliver medication from the outflow chamber of the infusion pump to the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intravenous, intra-arterial, subcutaneous, or epidural
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
AUG 1 2 2002
19. 510(k) Summary
510(k) SUMMARY - Safety and Effectiveness
Alpha Infusion Pump
-
- Submitters Name:
Advanced Infusion, Inc. 6200 South McClintock #6 Tempe, AZ 85283 (480) 768-9747 (Phone) Contact: Dr. Reese Date Prepared: 8-7-02
- Submitters Name:
- Name of Device:
Trade Name: Alpha Infusion Pump and Catheters Common Name: Elastomeric Infusion Pump Classification Name: Pump, Infusion, Elastomeric
-
- Predicate Device:
The proposed device, the revised Alpha Infusion Pump and associated Catheters, claims substantial cquivalence in intended use and is similar in design, construction, and operation to the currently marketed Alpha Infusion Pump and Catheters (K992551).
- Predicate Device:
-
- Description of Device:
The Alpha Infusion Pump is comprised of dual elastomeric chambers which hold the fluid to be infused under pressure. These chambers are contained within a hard shell case. The infusion pump also contains a luer lock checkvalve used to fill the chambers, a 5-micron fluid filter, a hydrophobic air vent filter, a pressure regulator, and an elastomeric septum for attaching infusion catheter(s) to the pump. The infusion pump is packaged as a kit in a tray containing an insertion needle used for placement of the catheter into the patient, a 60cc syringe used to fill the pump, a fabric belt used for holding the pump onto the patient, patient labels, and an Instructions For Use.
- Description of Device:
The Alpha Cath Infusion Catheters are micro-bore tubing catheters with a needle attached to one end for insertion of the catheter into the infusion pump septum. The internal diameter and length of the catheter tubing acts as the flow restrictor and determines the flow rate of the fluid through the catheter. The infusion catheters are packaged separately in Tyvek pouches and are contained in cartons along with Tegaderm adhesive dressings and an Instruction For Use.
To fill the Alpha Infusion Pump, a 60cc disposable syringe is filled with medication and connected to the female luer lock of the filling checkvalve which is located on top of the
1
infusion pump. As each syringe of medication is emptied into the elastomeric chambers, the chambers are stretched like a balloon and fill the hard shell outer protective case of the pump. The elastomeric chambers pressurize the medication. The hard shell case restricts the maximum volume that can be filled into the pump.
When filling is complete, the elastomeric chambers force the medication contained within the infusion purno through a 5-micron fluid filter to remove any particulates, through a spring-operated pressure regulator which maintains the medication in the outflow chamber at a constant pressure, and into a delivery chamber having an elastomeric septum. A hydrophobic air vent filter allows any air in the fluid to bleed from the outflow chamber. Infusion catheters of the desired flow rate are inserted through the elastomeric septum in order to deliver medication from the outflow chamber of the infusion pump to the patient.
5. Statement of Intended Use
The Alpha Infusion Pump and associated Catheters are intended for intravenous, intraarterial, subcutaneous, or epidural infusion of medications or fluids requiring continuous delivery at controlled infusion rates. Medications or fluids are intended to be delivered through a catheter containing a flow restriction element.
The Alpha Infusion Pump and associated Catheters are suitable for use as an ambulatory device and are intended for use in the home environment but not limited to use in the home environment.
| Characteristic | Advanced Infusion Device
K992551 | Advanced Infusion Device
(revised) |
|---------------------------|---------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Pump Type | Elastomeric | Elastomeric |
| Intended Use | Infusion Pump for delivery of
medication or fluid
intravenous, intra-arterial,
subcutaneous, or epidural | Infusion Pump for delivery of
medication or fluid
intravenous, intra-arterial,
subcutaneous, or epidural |
| Specific Drugs, Biologics | N/A | N/A |
| Labeling | Similar | Similar |
| Components | Infusion Pump
5 micron Filter
Hydrophobic Filter Vent
Pressure Regulator
Flow Restrictor
PU Catheter | Infusion Pump
5 micron Filter
Hydrophobic Filter Vent
Pressure Regulator
Flow Restrictor
PVC Catheter |
| Pumping Mechanism | Elastomeric Membrane | Elastomeric Membrane |
| Admin Sets | Catheter with
Polyimide Flow Restrictor | Micro-bore Catheter |
| Power Required | N/A | N/A |
| Materials | Polycarbonate | Polycarbonate |
6. Comparison to Predicate
2
| Silicone Elastomer | Silicone Elastomer | |
|---|---|---|
| Stainless Steel | Stainless Steel | |
| Nylon Filter | Versapore Filter | |
| PTFE Filter | PTFE Filter | |
| Polyimide Flow Restrictor | Polyvinyl Chloride Catheter | |
| Polyurethane Catheter | ||
| Flow Rate & Profile | 0.5 ml/hr to 10 ml/hr | 0.5 ml/hr to 10 ml/hr |
| Continuous | Continuous | |
| Safety/Alarms | N/A | N/A |
| Other Capabilities | N/A | N/A |
:
and the comments of the comments of the comments of
. .
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or a triple wave design.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
IG 1 2 2002
Mr. James Christensen Advanced Infusion, Incorporated 6200 South McClintock, #6 Tempe, Arizona 85283
Re: K021964
Trade/Device Name: Alpha Infusion Pump and Associated Catheters Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: June 12, 2002 Received: June 14, 2002
Dear Mr. Christensen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice
4
Page 2 – Mr. Christensen
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Statement of Indications for Use 20.
INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________ Alpha Infusion Pump and associated Catheters
Indications for Use:
The Alpha Infusion Pump and associated Catheters are intended for intravenous, intra-arterial, subcutancous, or epidural infusion of medications or fluids requiring continuous delivery at controlled infusion rates. Medications or fluids are intended to be delivered through a catheter containing a flow restriction element.
The Alpha Infusion Pump and associated Catheters are suitable for use as an ambulatory device and are 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
OR Over-The-Counter Use
Patrici Cucinata
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K021964