In any area such as neonatal and pediatric intensive care, anesthesia, adult critical care or any other area where the pump use can be monitored or supervised by a trained healthcare professional where the precise administration of fluids including drugs, antibiotics, lipids, blood, blood products, enteral solutions, or other therapeutic solutions is required.

Delivery routes include: Intravenous, arterial, epidural, spinal, enteral, and subcutaneous.

Delivery modes include: Continuous, volume/time, mass, body weight, and bolus.

Device Description

The ABC Syringe Infusion Pump Model 4100 is software driven and microprocessor controlled electromechanical system, powered by 120VAC converted to DC (or an internal DC battery pack if AC power is not supplied), which is designed to allow the operator to program the infusion of fluid through a syringe and an administration set. The pump delivers fluid by controlling the displacement of the syringe plunger in accordance with the program entered by the operator.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ABC Syringe Infusion Pump Model 4100 are primarily demonstrated by its compliance with international standards and its performance in specific tests, showing substantial equivalence to predicate devices. The document does not provide specific numerical acceptance thresholds or detailed performance metrics for each test, but rather asserts that the device "met or exceeded" the performance of the predicates.

Acceptance Criteria Category	Reported Device Performance
Performance Testing
1. Flow delivery and accuracy (using identified syringes)	Met or exceeded the safety, effectiveness, and performance of predicate devices.
2. Occlusion testing (using identified syringes)	Met or exceeded the safety, effectiveness, and performance of predicate devices.
Software Validation	Successfully validated.
Compliance with International Standards	Compliant with: - IEC 60601-1 (General requirements for safety) - IEC 60601-1-2 (EMC requirements and tests) - IEC 60601-2-24 (Particular requirements for the safety of infusion pumps and controllers)

Study Details

Based on the provided text, the study conducted for the ABC Syringe Infusion Pump Model 4100 was primarily focused on demonstrating substantial equivalence to predicate devices through various performance tests and compliance with international standards. This is a common approach for 510(k) submissions, rather than a clinical trial in the traditional sense for AI/software devices.

Here's a breakdown of the requested information based on the available text:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify a "test set" in the context of patient data or clinical cases. The testing described appears to be bench testing or laboratory-based performance testing using "identified syringes."
- No information is provided on the number of syringes used, their provenance, or whether the data was retrospective or prospective.
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):
- This information is not applicable or provided. The "ground truth" for this type of device (an infusion pump) would be the physical measurements of flow rate, accuracy, and occlusion pressure, as defined by engineering specifications and standards, not expert clinical interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable or provided. Adjudication methods are typically used in studies involving human interpretation (e.g., image reading) to resolve discrepancies. For a mechanical/electrical device, performance is measured against objective standards.
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:
- No MRMC comparative effectiveness study was done. This type of study is relevant for AI-powered diagnostic or interpretive tools, not for an electromechanical infusion pump.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device itself is a "standalone" electromechanical system. The performance testing (flow delivery, occlusion, software validation) was inherently standalone algorithm/device performance, as it wasn't evaluating human-in-the-loop clinical use but rather the device's adherence to its operational specifications.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the performance tests would be engineering specifications, physical measurements, and compliance with the specified international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-24). For example, flow accuracy would be compared to a defined range of acceptable deviation from the programmed rate.
The sample size for the training set:
- This is not applicable as the device is not an AI/Machine Learning model that undergoes a "training phase" with a data set. The software likely went through development, verification, and validation, but not in the sense of an ML model training set.
How the ground truth for the training set was established:
- Not applicable for the same reason as above.

Summary

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K072603

Image /page/0/Picture/1 description: The image shows the logo for Elixir Corporation. The logo consists of a circular graphic on the left, followed by the word "ELIXIR" in a stylized font. To the right of "ELIXIR" is the word "CORPORATION" in a bold, sans-serif font. The overall design is clean and professional.

OCT 2 3 2008

510 (k) SUMMARY

This 510(k) summary regarding the substantial equivalence, safety and effectiveness of the ABC Syringe Infusion Pump Model 4100 is hereby submitted in compliance with the requirements of 21 CFR Part 807.92.

SUBMITTER INFORMATION

A.	Company Name:	Elixir Corporation
B.	Company Address:	3700 Namasco Drive, Suite CSuwanee, GA 30024
C.	Company Phone:	770-904-3766
	Company Fax:	770-904-3696
D.	Submitter/Contact:	William M. VondersmithDirector, QA/RA
E.	Date SummaryPrepared:	August 31, 2007

DEVICE IDENTIFICATION

A.	Device Name:	Infusion Pump
B.	Trade/Proprietary Name:	ABC Syringe Infusion Pump Model 4100
C.	Classification:	Class II
D.	Product Code:	FRN

SUBSTANTIAL EQUIVALENCE

・・・

The ABC Syringe Infusion Pump Model 4100 is substantially equivalent to the Medex (Medfusion) 3000 series (K982640 and K040899) and 2000 series (K890120, K091755, and K955231) syringe infusion pumps.

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DEVICE DESCRIPTION

The ABC Syringe Infusion Pump Model 4100 is software driven and microprocessor controlled electromechanical system, powered by 120VAC converted to DC (or an internal DC battery pack if AC

power is not supplied), which is designed to allow the operator to program the infusion of fluid through a syringe and an administration set. The pump delivers fluid by controlling the displacement of the syringe plunger in accordance with the program entered by the operator.

INTENDED USE

The ABC Syringe Infusion Pump Model 4100 intended use follows:

Delivery routes include: Intravenous, arterial, epidural, spinal, enteral, and subcutaneous.

Delivery modes include: Continuous, volume/time, mass, body weight, and bolus.

TECHNOLOGICAL CHARACTERISTICS

The ABC Syringe Infusion Pump Model 4100 and its predicates are software driven, microprocessor controlled electromechanical systems that meter fluids contained in a syringe though an administration set to the patient, with several selectable delivery routes and modes, as programmed by the operator on a membrane keyboard with an LCD display. The system is powered primarily by 120VAC converted to DC within the pump, or alternatively by an internal rechargeable DC battery pack if AC power is not supplied. The program's progress is displayed continuously during use to the operator on the LCD screen and LEDs to indicate its real-time status. Visual and audible alarms are given to the operator or attendant as the situation might demand, along with an endof- program signals. These attributes are substantially equivalent to all or some of the predicate devices.

PERFORMANCE DATA

: ・・・・

The performance data indicate that the ABC Syringe Infusion Pump Model 4100 meets the specified requirements, and therefore is substantially equivalent to the predicate devices. A comparison of the technological characteristics of the ABC Syringe Infusion Pump Model 4100 and the predicate devices was performed showing that the ABC 4100 met or exceeded the safety, effectiveness, and performance of the predicates:

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1. Flow delivery and accuracy (using identified syringes).
1. Occlusion testing (using identified syringes).
1. Software validation.
Compliance with the following international standards (same as the 4. predicates):
- . IEC 60601-1 Medical electrical equipment Part 1. General requirements for safety.
- IEC 60601-1-2 Medical electrical equipment Part 1-2. General . requirements for safety. Collateral standard: Electromagnetic compatibility - Requirements and tests.
- IEC 60601-2-24 Medical electrical equipment Part 2-24. Particular . requirements for the safety of infusion pumps and controllers.

Conclusion:

The results of the above performance testing and validation, and its compliance with the three comparable standards, demonstrated substantial equivalence to the predicate devices in technology, safety, and effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring an abstract design resembling an eagle or bird-like figure with flowing ribbons or streamers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. William M. Vondersmith Director, Quality Assurance and Regulatory Affairs Elixir Corporation 3700 Namasco Drive, Suite C Suwanee, Georgia 30024

Re: K072603

Trade/Device Name: ABC Syringe Infusion Pump, Model 4100 Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: September 19, 2008 Received: September 22, 2008

Dear Mr. Vondersmith:

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.

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Page 2 - Mr. Vondersmith

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 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). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Clus

Chiu S. Lin, Ph. D Division 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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Indications for Use

510(k) Number (if known): 4022663

Device Name: _ABC Syringe Infusion Pump Model 4100

Indications for Use:

In any area such as neonatal and pediatric intensive care, anesthesia, adult critical care or m any area where the pump use can be monitored or supervised by a trained healthcare any other wear where the precise administration of fluids including drugs, antibiotics, lipids, probosional more useral solutions, or other therapeutic solutions is required

Delivery routes include: Intravenous, arterial, epidural, spinal, enteral, and subcutaneous.

Delivery modes include: Continuous, volume/time, mass, body weight, and bolus.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cim

(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Page 1 of 1

4-1

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).