(63 days)
Not Found
No
The description focuses on mechanical and fluid dynamics principles for drug delivery and disposal, with no mention of AI or ML capabilities.
Yes
The device is described as an "ambulatory infusion" device for "physician-prescribed parenteral medications," indicating its use in delivering medical treatment.
No
This device is an infusor designed for the delivery of physician-prescribed parenteral medications, not for diagnostic purposes.
No
The device description clearly outlines physical components like a substrate base, elastomeric film, rate control component, tubing set, and septal port, indicating it is a hardware device for infusion.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Science Incorporated PDS Personal Infusor is designed for the "ambulatory infusion of physician-prescribed parenteral medications." This means it delivers medication into the patient's body, not tests samples from the patient's body.
- Intended Use: The intended use is for administering medications, not for diagnostic testing.
- Device Description: The description focuses on the mechanical aspects of delivering fluid, not on analyzing biological samples.
Therefore, this device falls under the category of a therapeutic or drug delivery device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PDS Personal Infusor with Drug Disposal Septal Port is intended for the ambulatory infusion of physician-prescribed parenteral medications. The device will be filled and prepared for administration by pharmacists, and administered by eligible patients and providers who have been trained in the pump's operation.
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.
Product codes
MEG
Device Description
The Science Incorporated PDS Personal Infusor with Drug Disposal Septal Port 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 has a septal port which allows easy removal of unused medications to allow for proper disposal of both device and medication. 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 multiple 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. It has a drug disposal septal port for proper disposal of the unused drug per normal hospital practice.
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
The device will be filled and prepared for administration by pharmacists, and administered by eligible patients and providers 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
The Science Incorporated PDS Personal Infusor with Drug Disposal Septal Port exhibits equivalent flow performance when compared to the predicate device. 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
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
3/25/99
Science Incorporated Personal Infusor with Drug Disposal Septal Port 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: | Science Incorporated Personal Infusor |
| (510 number K971362) |
Device description:
The Science Incorporated PDS Personal Infusor with Drug Disposal Septal Port 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 has a septal port which allows easy removal of unused medications to allow for proper disposal of both device and medication. 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 multiple 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. It has a drug disposal septal port for proper disposal of the unused drug per normal hospital practice.
Intended use:
The PDS Personal Infusor with Drug Disposal Septal Port is intended for the ambulatory infusion of physician-prescribed parenteral medications. The device will
1
Science Incorporated Personal Infusor with Drug Disposal Septal Port 510(k) 8-2
be filled and prepared for administration by pharmacists, and administered by eligible patients and providers who have been trained in the pump's operation.
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 PDS Personal Infusor with Drug Disposal Septal Port is technologically identical to the Science Incorporated Personal Infusor except for the addition of the drug disposal septal port.
Performance data:
The Science Incorporated PDS Personal Infusor with Drug Disposal Septal Port exhibits equivalent flow performance when compared to the predicate device. 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/1 description: The image is a black and white logo for the U.S. Department of Health and 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 caduceus symbol. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health and Human Services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 5 1999
Mr. Ralph E. Hoqancamp Director of Quality and Regulatory Affairs Science. Incorporated 7760 France Avenue South, Suite 1060 Bloomington, Minnesota 55435
Re : K990208 Personal Infusor with Drug Disposal Septal Trade Name: Port II Requlatory Class: Product Code: MEG January 20, 1999 Dated: January 21, 1999 Received:
Dear Mr. Hoqancamp
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 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਚੋ 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 regulation 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
3
Page 2 - Mr. Hoqancamp
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to beqin 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" (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,
Susan Runper
ta 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
510(k) Number:
Indications for Use:
The Science Incorporated PDS Personal Infusor with Drug Disposal Septal Port 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 device is, also, designed to allow for the removal of parenteral medication to allow for the proper disposal of both the device and the medication where disposal of both together would be contrary to normal professional health care practice.
The flexibility offered by the PDS Personal Infusor with Drug Disposal Septal Port will enable physicians to choose from a variety of fluid flow rates and drug concentrations. It will provide clinicians and patients with a convenient and efficient option for administration of fluid medications to patients, as well as allow for proper disposal of device and unused fluid medications.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricio Cucente
vision of Dental, Infection Control. and General Hospital Devic 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
Over-The Counter Use_ OR
(Optional Format 1-2-96)