(132 days)
Provide controlled, continuous, intravenous fluid therapy for ambulatory patients.
An infusion pump used to pump fluids into a patient in a controlled manner.
The provided text does not contain detailed information about specific acceptance criteria or a comprehensive study report with quantified performance metrics for the Prepare™ Home Infusion Pump. The 510(k) summary primarily states that the device has been "functionally tested to confirm documented performance which demonstrates substantial equivalence to the predicate device."
Therefore, I cannot populate all sections of your request. However, I will extract and present the available information to the best of my ability, indicating where data is not provided in the input.
Acceptance Criteria and Study Details for Prepare™ Home Infusion Pump
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device | Confirmed documented performance. Demonstrates substantial equivalence to the predicate device (Homepump, Block Medical, Inc.) in design, material, intended use, and function. |
| Safety and Effectiveness | Deemed safe and effective for its intended use and meets all regulatory requirements to be found substantially equivalent. |
| Controlled, Continuous Intravenous Fluid Therapy | Functions to pump fluids into a patient in a controlled manner. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only mentions "functional testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The concept of "ground truth" as typically applied in AI/diagnostic studies (e.g., expert consensus on medical images) does not directly apply to the functional testing of an infusion pump, which would likely involve engineering and performance specifications.
4. Adjudication method for the test set
- Not applicable/Not specified. Functional testing of a physical device like an infusion pump would follow established engineering test protocols rather than an adjudication method for interpreting medical data.
5. 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
- Not applicable. The Prepare™ Home Infusion Pump is a physical medical device, not an AI software or diagnostic tool that would involve human readers or AI assistance in the way typically assessed by an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical pump, not an algorithm. Its performance is inherent to its mechanical and electronic functions.
7. The type of ground truth used
- Not explicitly stated in terms of "ground truth" as it would be for diagnostic accuracy. However, for an infusion pump, the "ground truth" for performance would be established by:
- Engineering specifications: Predefined flow rates, accuracy tolerances, alarm thresholds, and other functional parameters.
- Regulatory standards: Adherence to established industry and regulatory standards for infusion pump performance.
- Comparison to predicate device: The core of the 510(k) summary is the demonstration of substantial equivalence to the legally marketed predicate device (Homepump). Therefore, the predicate's known performance characteristics serve as a benchmark.
8. The sample size for the training set
- Not applicable. This device is a physical product, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for a physical device.
{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 StreetOrchard 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 ina controlled manner. |
| Intended Use: | Provide controlled, continuous, intravenous fluid therapyfor ambulatory patients. |
| Technological Characteristicsand Comparison to PredicateDevice(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 functionallytested to confirm documented performance which demon-strates substantial equivalence to the predicate device. |
| Conclusion: | The Prepare™ Home Infusion Pump is safe and effectivefor its intended use and meets all regulatory requirementsto 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
{2}------------------------------------------------
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
{3}------------------------------------------------
Page 10
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 ________________________________________________________________________________________________________________________________________________________________
§ 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).