(237 days)
Not Found
No
The description focuses on mechanical and fluid dynamics principles (elastomeric film, flow rate control, visual indicator) and performance metrics related to flow accuracy and consistency, with no mention of AI or ML terms or functionalities.
Yes
The device is described as an "infusion device" designed for the "ambulatory infusion of physician-prescribed parenteral medications," indicating it administers medication for therapeutic purposes.
No
This device is an infusion device designed for administering medications, not for diagnosing conditions. Its purpose is to deliver physician-prescribed parenteral medications, not to identify or monitor medical conditions.
No
The device description clearly outlines physical components like a substrate base, elastomeric film, rate control component, filter, and tubing set, indicating it is a hardware device for fluid delivery.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "ambulatory infusion of physician-prescribed parenteral medications." This describes a device used to administer substances into the body, not to test samples from the body.
- Device Description: The description details a "self-contained, low-profile, disposable infusion device" that delivers "fluid medicaments to a patient via an attached 36 inch tubing set that adjoins a preexisting venous access site." This clearly describes a drug delivery system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver medication, which is a therapeutic action, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Science Incorporated Personal Infusor is designed for the ambulatory infusion of physician-prescribed parenteral medications. The device is intended to be filled and prepared for administration by pharmacists, and provided to patients who have been trained in the pump's operation.
The flexibility offered by the Personal Infusor will enable physicians to choose from a variety of fluid flow rates and drug concentrations, and will provide clinicians and patients with a convenient and efficient option for administration of fluid medications to patients.
Product codes
MEB
Device Description
The Science Incorporated Personal Infusor is a self-contained, low-profile, disposable infusion device intended for the ambulatory delivery of physician-prescribed parenteral medications to patients. Its design engages three principle elements: a substrate base with molded ullage, a stored energy elastomeric film, and a preset rate control component with filter. Fluid medicaments are delivered to a patient via an attached 36 inch tubing set that adjoins a preexisting venous access site. The unit is disposable following a single use and features a novel visual flow status indicator that facilitates patient monitoring. The pump will be available in seven volume/flow rate configurations, and prototype models have demonstrated unsurpassed accuracy and consistency of fluid flow over a broad gamut of operating temperatures and with solutions of widely varying viscosities.
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
ambulatory infusion of physician-prescribed parenteral medications. The device will be filled and prepared for administration by pharmacists, and provided to eligible patients who have been trained in the pump's operation.
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 Science Incorporated Personal Infusor exhibits improved flow performance when compared to the predicate devices. In our studies, the new devices displayed linearity of ±10% over a temperature range of 10-40° C when used with various diluents.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Block Medical Inc., Homepump Eclipse™ (K896546), Baxter Healthcare Corp., Intermate® SV (K910425)
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
DEC - 4 1997
Science Incorporated Personal Infusor 510(k)
8-1
SUMMARY OF SAFETY AND EFFECTIVENESS 8.0
Submitters name:
Science Incorporated 7760 France Avenue South, Suite 1060 Bloomington, MN 55435 (612)835-1333 (612)835-1716 (fax) Contact person: Ralph E. Hogancamp, Director of Quality and Regulatory Affairs
| Device name: | Proprietary name: | To be determined |
|---|---|---|
| Common name: | Elastomeric pump | |
| Classification name: | Infusion pump | |
| Predicate devices: | Block Medical Inc., Homepump Eclipse™ (K896546) |
Baxter Healthcare Corp., Intermate® SV (K910425)
Device description:
The Science Incorporated Personal Infusor is a self-contained, low-profile, disposable infusion device intended for the ambulatory delivery of physician-prescribed parenteral medications to patients. Its design engages three principle elements: a substrate base with molded ullage, a stored energy elastomeric film, and a preset rate control component with filter. Fluid medicaments are delivered to a patient via an attached 36 inch tubing set that adjoins a preexisting venous access site. The unit is disposable following a single use and features a novel visual flow status indicator that facilitates patient monitoring. The pump will be available in seven volume/flow rate configurations, and prototype models have demonstrated unsurpassed accuracy and consistency of fluid flow over a broad gamut of operating temperatures and with solutions of widely varying viscosities.
Intended use:
The Personal Infusor is intended for the ambulatory infusion of physician-prescribed parenteral medications. The device will be filled and prepared for administration by pharmacists, and provided to eligible patients who have been trained in the pump's operation.
1
The flexibility offered by the device design will enable physicians to select from a variety of fluid flow rates and drug concentrations, and will provide clinicians and patients with a convenient and efficient option for the administration of beneficial drugs to patients.
Technological characteristics:
The Personal Infusor is technologically similar to the Baxter Intermate® SV and the Block Homepump Eclipse™. However, it offers two improvements: 1) it features a single orifice rate control component that provides superior control of flow compared to the predicate devices, and 2) it has a flow indicator that displays the states of Flowing, Blockage, and Empty.
Performance data:
The Science Incorporated Personal Infusor exhibits improved flow performance when compared to the predicate devices. In our studies, the new devices displayed linearity of ±10% over a temperature range of 10-40° C when used with various diluents.
2
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The overall design is simple and professional, reflecting the organization's role in public health and welfare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 4
Mr. Ralph E. Hogancamp Director of Quality and Regulatory Affairs Science, Incorporated Minnesota Center 7760 France Avenue South, Suite 1060 Bloomington, Minnesota 55435
K971362 Re : Personal Infusor Trade Name: Requlatory Class: II Product Code: MEB September 5, 1997 Dated: Received: September 5, 1997
Dear Mr. Hogancamp:
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. ਖ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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. Hogancamp
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) 594-4618. 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.fda.gov/cdrh/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 Radioloqical Health
. Enclosure
4
510(k) Number: K971362
Device Name: Science Incorporated Personal Infusor
Indications for Use:
The Science Incorporated Personal Infusor is designed for the ambulatory infusion of physician-prescribed parenteral medications. The device is intended to be filled and prepared for administration by pharmacists, and provided to patients who have been trained in the pump's operation.
The flexibility offered by the Personal Infusor will enable physicians to choose from a variety of fluid flow rates and drug concentrations, and will provide clinicians and patients with a convenient and efficient option for administration of fluid medications to patients.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Labrina Cocceratti
Division Sign-Off Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K971562
Prescription Use
(Per 21 CFR 801.109)
Over-The Counter Use__________________________________________________________________________________________________________________________________________________________ OR
(Optional Format 1-2-96)