(14 days)
Not Found
No
The device description focuses on pre-determined, fixed infusion rates and mechanical automation, with no mention of adaptive learning, data analysis for decision-making, or any terms associated with AI/ML.
Yes
The device is used for the "intermittent administration of I.V. medication," implying it's used to deliver substances that treat or prevent disease, which is the function of a therapeutic device.
No
The device is described as an "Infuser" intended for "intermittent administration of I.V. medication," which is a therapeutic function, not a diagnostic one. It automates the injection of contents from a syringe into a patient, implying drug delivery rather than disease detection or analysis.
No
The device description clearly states it is a battery-powered, portable device that automates injection and depresses the plunger of a syringe, indicating it is a hardware device with mechanical components.
Based on the provided information, the Baxa Corporation MicroFuse™ Dual Rate Infuser is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "intermittent administration of I.V. medication." This describes a device used to deliver substances into a patient's body, not to test samples from a patient's body.
- Device Description: The description clearly states it "automates the injection of the contents of a syringe into a patient." This is a drug delivery device.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or screening
The device's function is purely mechanical and related to controlled delivery of medication.
N/A
Intended Use / Indications for Use
The device is intended to be used for the intermittent administration of I.V. medication.
The Baxa Corporation MicroFuse™Dual Rate Infuser is intended to be used for the intermittent administration of I.V. medication.
This intended use is identical to the intended use for the predicate device as cleared for marketing in K933506, Baxa Dual Rate Infuser, Cleared February 25, 1994.
Product codes (comma separated list FDA assigned to the subject device)
RDN
Device Description
The Baxa Corporation MicroFuse Dual Rate Infuser, is a battery powered, portable device that automates the injection of the contents of a syringe into a patient. Each MicroFuse has two pre-determined rates that are be preset at the manufacturing facility. These preset rates can not be modified by the user or patient. The MicroFuse is used with a sterile administration set for injecting the medication into a patient. It depresses the plunger of the syringe at a controlled, pre-determined rate, delivering the dose in the syringe over an extended period of time. The MicroFuse is offered in a standard dual rate model. Some custom dual rate models with the only difference being the pre-determined infusion rates are also offered.
The MicroFuse System consists of the MicroFuse Dual Rate Infuser and a syringe and administration set. Both syringe and administration sets are sterile and disposable. Since only the accessory syringes and administration sets are in the fluid path, the MicroFuse has no patient contact materials. This also means the device is not provided sterile, nor is it sterilized in the field. The accessories have been previously cleared with the predicate device in K933506.
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
Not Found
Intended User / Care Setting
Not Found
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 MicroFuse™ has been tested to all applicable requirements of ANSI/AAMI ID26-1992. Standard for Infusion Devices. The MicroFuse met all the applicable requirements of the Standard.
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
Image /page/0/Picture/0 description: The image shows the logo for Baxa. The logo consists of a plus sign with a triangle at the bottom left of the plus sign, followed by the word "Baxa" in bold, sans-serif font. There is a horizontal line underneath the logo.
Baxa Corporation • 13760 E. Arapahoe Road • Englewood, CO 80112-3903 • 800-567-BAXA (2292) • 303-690-4804
6 1998 OCT
SAFETY AND EFFECTIVENESS SUMMARY Baxa MicroFuse™ Dual Rate Infuser
Name and address of Device Manufacturer submitting 510(k) Notification:
BAXA CORPORATION 13760 E. Arapahoe Road Englewood, Colorado 80112
Regulatory Correspondent of Device Manufacturer:
Patrick Hynes Baxa Corporation 13760 E. Arapahoe Road Englewood, Colorado 80112 Phone: (303)690-4204 FAX: (303)690-4802
Date Summary was prepared:
July 31,1998
Name of the device:
MicroFuse™ Dual Rate Infuser
Classification:
Indications for Use:
Description of the device:
Pump, infusion, Class II per 880.5725
The device is intended to be used for the intermittent administration of I.V. medication.
The Baxa Corporation MicroFuse Dual Rate Infuser, is a battery powered, portable device that automates the injection of the contents of a syringe into a patient. Each MicroFuse has two pre-determined rates that are be preset at the manufacturing facility. These preset rates can not be modified by the user or patient. The MicroFuse is used with a sterile administration set for injecting the medication into a patient. It depresses the plunger of the syringe at a controlled, pre
1
determined rate, delivering the dose in the syringe over an extended period of time. The MicroFuse is offered in a standard dual rate model. Some custom dual rate models with the only difference being the pre-determined infusion rates are also offered.
The MicroFuse System consists of the MicroFuse Dual Rate Infuser and a syringe and administration set. Both syringe and administration sets are sterile and disposable. Since only the accessory syringes and administration sets are in the fluid path, the MicroFuse has no patient contact materials. This also means the device is not provided sterile, nor is it sterilized in the field. The accessories have been previously cleared with the predicate device in K933506.
Substantial Equivalence:
The Baxa MicroFuse is substantially equivalent to:
Syringe Infuser 510(k) K933506, Cleared February 25, 1994 Baxa Corporation Englewood, CO
The MicroFuse™ has been tested to all applicable requirements of ANSI/AAMI ID26-1992. Standard for Infusion Devices. The MicroFuse met all the applicable requirements of the Standard.
Safety and Efficacy:
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 6 1898
Baxa Corporation C/O Mr. William E. McKay President Regulatory Consultants to the Medical Device Industry (RCMDI) 9712 S. Altamont Drive Sandy, Utah 84092
Re : K983321 Trade Name: MicroFuse™ Dual Rate Infuser Regulatory Class: II Product Code: RDN Dated: September 22, 1998 September 22, 1998 Received:
Dear Mr. McKay:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the qeneral 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 (Premarket Approval), 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 895. ਬ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
3
Page 2 - Mr. McKav
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page
510(k) Number (if known): Not yet assigned
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Baxa Corporation MicroFuse™Dual Rate Infuser is intended to be used for the intermittent administration of I.V. medication.
This intended use is identical to the intended use for the predicate device as cleared for marketing in K933506, Baxa Dual Rate Infuser, Cleared February 25, 1994.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office if Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) ✓
ン
OR Over-The-Counter Use
Patricia Cucenith(Optional Format 1-2-96)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
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