(405 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard electromechanical and software control, not AI/ML algorithms.
Yes
The device is described as administering "fluids including drugs, antibiotics, lipids, blood, blood products, enteral solutions, or other therapeutic solutions," making it a therapeutic device.
No
This device is an infusion pump designed to administer fluids and drugs, not to diagnose medical conditions.
No
The device description explicitly states it is an "electromechanical system" powered by AC or battery, and it controls the physical displacement of a syringe plunger. This indicates it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the administration of fluids and therapeutic solutions to a patient. This is a therapeutic function, not a diagnostic one. IVDs are used to examine specimens from the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description details a pump that controls the displacement of a syringe plunger to deliver fluid. This mechanism is consistent with drug delivery, not in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the ABC Syringe Infusion Pump Model 4100 is a medical device used for drug and fluid delivery, not an IVD.
N/A
Intended Use / Indications for Use
The ABC Syringe Infusion Pump Model 4100 intended use follows:
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.
Product codes
FRN
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.
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
neonatal and pediatric, adult
Intended User / Care Setting
monitored or supervised by a trained healthcare professional, neonatal and pediatric intensive care, anesthesia, adult critical care
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)
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:
- Flow delivery and accuracy (using identified syringes).
- Occlusion testing (using identified syringes).
- Software validation.
- Compliance with the following international standards (same as the 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K982640, K040899, K890120, K091755, K955231
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
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 C |
| Suwanee, GA 30024 | ||
| C. | Company Phone: | 770-904-3766 |
| Company Fax: | 770-904-3696 | |
| D. | Submitter/ | |
| Contact: | William M. Vondersmith | |
| Director, QA/RA | ||
| E. | Date Summary | |
| Prepared: | 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.
1
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:
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.
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:
2
-
- Flow delivery and accuracy (using identified syringes).
-
- Occlusion testing (using identified syringes).
-
- 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.
3
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.
4
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
5
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: _______________________________________________________________________________________________________________________________________________________________
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