(132 days)
Homepump
Not Found
No
The summary describes a standard infusion pump with no mention of AI/ML features or related performance metrics.
Yes
The device is described as an "infusion pump used to pump fluids into a patient in a controlled manner" and its intended use is to "provide controlled, continuous, intravenous fluid therapy for ambulatory patients." Delivering fluid therapy to a patient is a therapeutic action.
No
The device is described as an infusion pump that provides fluid therapy, which is a treatment rather than a diagnostic function.
No
The device description clearly states it is an "infusion pump," which is a hardware device used to pump fluids.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "Provide controlled, continuous, intravenous fluid therapy for ambulatory patients." This describes a device used for delivering substances into the body, not for examining specimens from the body to diagnose or monitor conditions.
- Device Description: The description states it's an "infusion pump used to pump fluids into a patient." This further reinforces its function as a delivery device, not a diagnostic one.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening
Therefore, this device falls under the category of a therapeutic or delivery device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
"Provide controlled, continuous, intravenous fluid therapy for ambulatory patients."
Product codes
MEB
Device Description
An infusion pump used to pump fluids into a patient in a controlled manner.
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 Prepare™ Home Infusion Pump has been functionally tested to confirm documented performance which demonstrates substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Homepump, Block Medical, Inc.
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
K9836634
MEDICAL INFUSION TECHNOLOGY, INC.
がなくなっています。
【
PREPARE™ HOME INFUSION PUMP
510(k) SUMMARY
| Submitter Name: | Medical Infusion Technology, Inc. |
|---|---|
| Submitter's Address: | 6576 E. Quaker Street |
| Orchard Park, NY 14127 | |
| Contact Person: | John Wynne, President |
| Phone Number: | 716-667-3318 |
| Facsimile Number: | 716-667-3319 |
| Date Prepared: | October 9, 1998 |
| Device Trade Name: | Prepare™ Home Infusion Pump |
| Device Common Name: | Elastomeric Infusion Pump |
| Classification Name: | Infusion Pump, 21 CFR 880.5725 |
| Predicate Device: | Homepump, Block Medical, Inc. |
| Device Description: | An infusion pump used to pump fluids into a patient in |
| a controlled manner. | |
| Intended Use: | Provide controlled, continuous, intravenous fluid therapy |
| for ambulatory patients. | |
| Technological Characteristics | |
| and Comparison to Predicate | |
| Device(s). | Both the Block Medical Homepump and the Prepare™ |
| Home Infusion Pump are equivalent in design, material, | |
| intended use and function. | |
| Performance Data: | The Prepare™ Home Infusion Pump has been functionally |
| tested to confirm documented performance which demon- | |
| strates substantial equivalence to the predicate device. | |
| Conclusion: | The Prepare™ Home Infusion Pump is safe and effective |
| for its intended use and meets all regulatory requirements | |
| to be found substantially equivalent to the predicate device. |
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three wavy lines that resemble a person.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 1999
Thomas L. Parker Mr. Medical Infusion Technologies, Incorporated 6576 East Quaker Street Orchard Park, New York 14127-2593
K983634 Re : Prepare Home Infusion Pump Trade Name: Requlatory Class: II Product Code: MEB February 5, 1999 Dated: February 8, 1999 Received:
Dear Mr. Parker
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 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 general controls provisions The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ಗ್ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of
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Page 2 - Mr. Parker
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 requlation (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" (21 CFR 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.fdaffgov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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SECTION 5
INDICATIONS FOR USE
PREPARE™ HOME INFUSION PUMP
"Provide controlled, continuous, intravenous fluid therapy for ambulatory patients."
(Division Sign-Off) General Hospital and General Use Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use
21 CFR 801.109
:
Petricia Cuzzortle
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________