(195 days)
Not Found
No
The description focuses on mechanical and sensor-based control of pressure and flow, with no mention of AI or ML terms or concepts.
Yes
The device is used to infuse volumes of IV solution, which is a therapeutic treatment.
No
The device, an infusion pump, is designed to deliver fluids to a patient, not to diagnose a medical condition. Its function involves controlling fluid flow, not analyzing data for diagnostic purposes.
No
The device description clearly outlines physical components such as a housing made of Polycarbonate, PVC tubing, ABS plastic spike, air pump, sensors, relief valve, recharger/power supply, battery pack, and carry pack. These are hardware components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to infuse volumes of fluids via intravenous or subcutaneous routes. This is a therapeutic action, delivering substances into the body.
- Device Description: The device is an infusion pump that physically delivers fluids. It uses pressure to force the fluid through tubing.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. IVDs are typically used to analyze blood, urine, tissue, etc.
The device described is a medical device used for drug delivery, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Eureka is ambulatory and intended for use in the hospital, home environment or alternate care sites for administration via intravemous cathether or central IV line or via the subcutaneous route.
The intended use of this device is for general use and the administration of intravenous antibiotics and chemotherapy drugs in solutions containers of 50mL to 100 mL. These indications and uses are the same as those of predicate devices.
Indications for Use:
Infusions
Of volumes between 50 mL to 100 ml.
Via Intravenous catheter or central IV line or subcutaneous route
In Ambulatory , Home or Hospital Setting
For General Use
Prescription Use X
Product codes (comma separated list FDA assigned to the subject device)
FRN, FPA
Device Description
The Eureka Infusion Pump and predicate devices functions with the use of restriction tubing. Pressure is exerted on a IV solution containers. When the air is pumped in to the bladder enlarges. The pressure against the IV solution container forces the IV solution to flow through the administration set.
The Eureka Infusion Pump is designed to house a pre-filled IV solution container. The housing consists of Polycarbonate material for srtength. The administration sets are a PVC tubing set and attached spike of ABS plastic.
Performance characteristics also include the ability of sensors to determine pressure being exerted on the bag and the logic control to regulate this pressure by powering on and off the air pump, and venting pressure through a relief valve.
Each Eureka Pump Model is supplied with the following optional component/accessories Pump, Recharger/Power Supply, Battery Pack, Carry Pack, Manual
The Eureka-IP and Eureka-LF Infusion Pumps are reusable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intravenous catheter or central IV line or subcutaneous route
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital, home environment or alternate care sites
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)
Non Clinical Trials to measure infusion over time
Non-clinical tests results demonstrate that the Eureka Infusion Pump has equivalent flow rate profiles and residual volume amounts. Also equivalent is the accuracy for labeled flow rates. Results show. Operating temperature is 65-90° F
+/- 12 % labeled flow rate accuracy 97-99% of volume infused 97% flow accuracy based on profile
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Summary of Safety and Effectiveness
APR 17 2006
for
Eureka Infusion Pump Models Eureka-IP & Eureka-LF
I. SMDA Information
510 K Summary Prepared 09/21/2005
1. Submitted by :
Glenn Herskowitz Universal Medical Technologies PO Box 5155 Larkspur, CA 94977-5155 (415)924-1133 Registration Number: 2951178
2. General Information
Classification Name: Infusion Pump : 880.5725 Common Name: Ambulatory Infusion Pump Proprietary Name: Eureka-IP Infusion Pump, Eureka-LF Infusion Pump
Device Classification Class II per CFR 880.5725 General Hospital and Personal Use Panel (80) ProCodes : FRN - Infusion Pump FPA - Intravenous (IV) Administration Set
- Predicate Devices to which substantial equivalence is claimed Home Pump- Block Medical K896546 SideKick - I-Flow Corporation K923875 MAXX - Medication Delivery Devices K931458
4. Device Description
The Eureka Infusion Pump and predicate devices functions with the use of restriction tubing. Pressure is exerted on a IV solution containers. When the air is pumped in to the bladder enlarges. The pressure against the IV solution container forces the IV solution to flow through the administration set.
The Eureka Infusion Pump is designed to house a pre-filled IV solution container. The housing consists of Polycarbonate material for srtength. The administration sets are a PVC tubing set and attached spike of ABS plastic.
1
Performance characteristics also include the ability of sensors to determine pressure being exerted on the bag and the logic control to regulate this pressure by powering on and off the air pump, and venting pressure through a relief valve.
Each Eureka Pump Model is supplied with the following optional component/accessories Pump, Recharger/Power Supply, Battery Pack, Carry Pack, Manual
The Eureka-IP and Eureka-LF Infusion Pumps are reusable.
Administration Set Description
The Eureka Administration set is a disposable device and intended for single patient use,. Each Eureka Administration set is individually packaged and sold in cases of 25 each.
Eureka Administration Sets are provided sterile and all fluid path components are identical or equivalent to existing predicate administration set components
Power Requirements
The Eureka Infusion Pump requires battery pack (7.2V NiMH) supplied with pump or power supply (12V 1.25A) supplied with pump in order to operate.
The unit may be operated with the power supply while charging the battery pack.
5. Intended Use
The Eureka is ambulatory and intended for use in the hospital, home environment or alternate care sites for administration via intravemous cathether or central IV line or via the subcutaneous route.
The intended use of this device is for general use and the administration of intravenous antibiotics and chemotherapy drugs in solutions containers of 50mL to 100 mL. These indications and uses are the same as those of predicate devices.
6. Biologic Specifications
Biologic testing is in conformance with ISO 10993 Part 1 for all fluid path components of the Eureka Administration Sets
7. Chemical and Drug Specifications
No Specific drugs referenced in labeling of the Eureka Pump or Eureka Administration Sets
The Eureka pumps are intended for general infusions in solution volume of 50 to 100 mL via intravenous catheter, central IV line or subcutaneous route. (This device is not intended for use with Taxol)
2
8. Comparison to Predicate Devices.
The common technical characteristics of the SideK.ick, HomePump, MAXX and Eureka Infusion Pump is that each works by utilizing flow restriction tubing and the intravenous solution is forced through such tubing by means of pressure. The main difference between these devices are that the predicate device - HomePump uses Elastomeric material to pressurize the IV infusion solution and the SideKick uses a coiled spring to exert pressure a IV solution bag.
The Eureka and Maxx exert this pressure by a bladder inflated with air.
The source of energy to power the pump in Eureka is a 7.2V Battery Pack or Power supply/recharger.
The Eureka Infusion pumps and administration sets are substantially equivalent to predicate devices.
8b1. Non Clinical Trials to measure infusion over time
Non-clinical tests results demonstrate that the Eureka Infusion Pump has equivalent flow rate profiles and residual volume amounts. Also equivalent is the accuracy for labeled flow rates. Results show. Operating temperature is 65-90° F
+/- 12 % labeled flow rate accuracy 97-99% of volume infused 97% flow accuracy based on profile
8b2. Clinical Trials
Clinical trials are not required
9. Packaging
:
The Eureka Administration Set packaging is suitable for radiation or ETO sterilization
10. Sterilization Information
The Eureka Administration sets are sterilized using Gamma Radiation
11. Conclusion
The conclusion of the Eureka Infusion Pump is that it is safe, effective and equivalent in performance to the HomePump, MAXX and Sidekick Infusion Devices.
3
Image /page/3/Picture/1 description: The image is a black and white logo. The logo consists of a circle with text around the perimeter. Inside the circle are three stylized silhouettes of birds in flight. The birds are arranged in a row, with each bird slightly overlapping the one in front of it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 17 2006
Mr. Glenn Herskowitz President Universal Medical Technologies P.O. Box 5155 Larkspur, California 94977-5155
Rc: K052817
Trade/Device Name: Eureka Infusion Pump, Models Eureka-IP, Furcka-I.F Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN, FPA Dated: March 23, 2006 Received: March 28, 2006
Dear Mr. Herskowitz:
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 ffor 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. Herskowitz
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 sct 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chiu Lin, Ph.D.
Chiu Lin. Ph.D. 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): ¥65 2817
Device Name: Eureka-IP Infusion Pump & Eureka-LF Infusion Pump
Indications for Use:
Infusions
Of volumes between 50 mL to 100 ml.
Via Intravenous catheter or central IV line or subcutaneous route
In Ambulatory , Home or Hospital Setting
For General Use
Prescription Use __ X __ (Part 21 CFR 801 Subpart D)
- .___________________________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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