(237 days)
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.
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.
The manufacturer, Science Incorporated, demonstrated the performance of their Personal Infusor through studies showing its flow linearity.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Flow Linearity | Not explicitly stated, but assumed to be within clinically acceptable bounds for infusion pumps for safe and accurate drug delivery. Industry standards for elastomeric pumps often target ±5% or ±10% variation over specified temperature and viscosity ranges. | ±10% over a temperature range of 10-40° C when used with various diluents. This is explicitly stated. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text. The document refers to "our studies" and "prototype models" but does not give specific numbers for the test sets.
- Data Provenance: The studies were conducted by Science Incorporated ("In our studies"). The specific country of origin is not explicitly stated beyond Science Incorporated being located in Bloomington, MN, USA. The studies appear to be prospective as they were conducted by the manufacturer to demonstrate the performance of their new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This device is an infusion pump, and its performance is evaluated based on physical measurements of fluid flow and linearity, not on interpretation by human experts. Ground truth would be derived from calibrated measurement instruments, not expert consensus.
4. Adjudication Method for the Test Set:
Not applicable. Performance was measured objectively, not through human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
Not applicable. MRMC studies are relevant for diagnostic devices where human readers interpret medical images or data. The Personal Infusor is a drug delivery device, and its performance is assessed mechanically.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, the performance data presented is that of the device itself, functioning as a standalone unit. The description states, "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%..." This refers to the intrinsic performance of the pump.
7. The Type of Ground Truth Used:
The ground truth used would be based on objective measurements from calibrated laboratory equipment. For example, flow rate would be measured using precise mass balances or volumetric sensors over time, and temperature would be controlled and verified with calibrated thermometers. The linearity would be calculated based on these measured flow rates compared to the expected flow rates.
8. The Sample Size for the Training Set:
Not applicable. The Personal Infusor is a mechanical device, not an AI/ML algorithm that requires a training set. Its performance is based on its engineering design and manufacturing, not on learning from data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reason as point 8.
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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.
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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.
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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
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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
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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)
§ 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).