The Alpha Infusion Pump and associated Catheters are 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 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.

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.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Alpha Infusion Pump and associated Catheters." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for proving new device efficacy through clinical trials with detailed acceptance criteria and studies as one might find for a PMA application or a de novo submission.

Therefore, the information available in this document is not a detailed clinical study report proving the device meets specific acceptance criteria in the way you've outlined for a typical clinical or AI/algorithm performance study. Instead, it focuses on demonstrating equivalence to an existing device.

Here's an analysis based on the provided text, highlighting what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document implies that the acceptance criteria are met if the revised Alpha Infusion Pump and Catheters are substantially equivalent to the currently marketed Alpha Infusion Pump and Catheters (K992551). This isn't a set of specific performance metrics with thresholds, but rather a regulatory standard.
Reported Device Performance: The primary performance characteristic mentioned that relates to functionality is "Flow Rate & Profile: 0.5 ml/hr to 10 ml/hr Continuous." The document states that both the predicate device and the revised device have this identical reported performance. There is no detailed data showing how this performance was measured for the revised device beyond the claim of equivalence.

Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Revised Device)
Pump Type	Elastomeric	Elastomeric
Intended Use	Intravenous, intra-arterial, subcutaneous, or epidural infusion of medications or fluids requiring continuous delivery at controlled infusion rates.	Intravenous, intra-arterial, subcutaneous, or epidural infusion of medications or fluids requiring continuous delivery at controlled infusion rates.
Flow Rate & Profile	0.5 ml/hr to 10 ml/hr Continuous	0.5 ml/hr to 10 ml/hr Continuous
Materials	Polycarbonate, Silicone Elastomer, Stainless Steel, Nylon Filter, PTFE Filter, Polyimide Flow Restrictor, Polyurethane Catheter	Polycarbonate, Silicone Elastomer, Stainless Steel, Versapore Filter, PTFE Filter, Polyvinyl Chloride Catheter
Safety/Alarms	N/A (not applicable/present)	N/A (not applicable/present)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable / Not provided. A 510(k) submission for an infusion pump typically involves bench testing to verify performance characteristics (like flow rate accuracy under various conditions, material compatibility, pressure resistance, etc.) rather than a clinical "test set" of patients in the way an AI diagnostic algorithm would have. The document does not describe such testing in detail, nor does it refer to patient data for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. This information pertains to studies where interpretations or diagnoses are made by experts, which is not the nature of this particular device's submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is relevant for studies involving human interpretation and ground truth establishment, which is not described here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device is an infusion pump, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device does not involve an algorithm with standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the typical sense. For an infusion pump, "ground truth" would relate to objective physical measurements (e.g., flow rate, pressure, material integrity) against engineering specifications or established standards. The document doesn't detail the experimental setup for such measurements but relies on the assertion that the revised device is "similar in design, construction, and operation" to the predicate.

8. The sample size for the training set

Not applicable. This concept belongs to machine learning or AI models, which are not relevant to this device.

9. How the ground truth for the training set was established

Not applicable. As above, this pertains to AI/ML development.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

Based on the provided 510(k) summary, the "study" demonstrating the device meets "acceptance criteria" (which in this context is primarily substantial equivalence) is a comparison to a predicate device (K992551).

The submission asserts that the revised Alpha Infusion Pump and associated Catheters are "substantially equivalent in intended use and is similar in design, construction, and operation to the currently marketed Alpha Infusion Pump and Catheters (K992551)."
The table comparing the characteristics of the predicate device and the revised device shows that for key attributes like Pump Type, Intended Use, Flow Rate & Profile, Pumping Mechanism, and many Materials, they are identical or equivalent.
The primary differences noted are the change in the filter type from "Nylon Filter" to "Versapore Filter" and the catheter material from "Polyimide Flow Restrictor / Polyurethane Catheter" to "Polyvinyl Chloride Catheter / Micro-bore Catheter" (where the flow restrictor is now part of the micro-bore catheter).
The FDA's letter states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This letter is the regulatory outcome indicating that the submission successfully "proved" (to the FDA's satisfaction for 510(k) clearance) that the device meets the criteria for substantial equivalence.

In essence, the "study" is the entirety of the 510(k) submission, providing a detailed comparison between the new device and a legally marketed predicate device, demonstrating that any differences do not raise new questions of safety or effectiveness. This type of submission relies heavily on non-clinical (bench) testing, material characterization, and engineering comparisons, rather than human clinical trial data, to establish equivalence for devices like infusion pumps.

Summary

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AUG 1 2 2002

K021964

19. 510(k) Summary

510(k) SUMMARY - Safety and Effectiveness

Alpha Infusion Pump

1. Submitters Name:
  Advanced Infusion, Inc. 6200 South McClintock #6 Tempe, AZ 85283 (480) 768-9747 (Phone) Contact: Dr. Reese Date Prepared: 8-7-02

Name of Device:

Trade Name: Alpha Infusion Pump and Catheters Common Name: Elastomeric Infusion Pump Classification Name: Pump, Infusion, Elastomeric

1. 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).
1. 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.

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

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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 DeviceK992551	Advanced Infusion Device(revised)
Pump Type	Elastomeric	Elastomeric
Intended Use	Infusion Pump for delivery ofmedication or fluidintravenous, intra-arterial,subcutaneous, or epidural	Infusion Pump for delivery ofmedication or fluidintravenous, intra-arterial,subcutaneous, or epidural
Specific Drugs, Biologics	N/A	N/A
Labeling	Similar	Similar
Components	Infusion Pump5 micron FilterHydrophobic Filter VentPressure RegulatorFlow RestrictorPU Catheter	Infusion Pump5 micron FilterHydrophobic Filter VentPressure RegulatorFlow RestrictorPVC Catheter
Pumping Mechanism	Elastomeric Membrane	Elastomeric Membrane
Admin Sets	Catheter withPolyimide Flow Restrictor	Micro-bore Catheter
Power Required	N/A	N/A
Materials	Polycarbonate	Polycarbonate

6. Comparison to Predicate

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	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

. .

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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

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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

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K021964

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

Regulation Number and Section

§ 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).