(223 days)
Not Found
Not Found
No
The device description and intended use clearly describe a mechanical reservoir for an infusion pump, with no mention of software, algorithms, or any AI/ML related terms. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No
The device is a reservoir for infusing medicine, not a therapeutic device itself, as it does not directly treat or prevent a disease.
No
The device is used for the "infusion of medicine" and "deliver medication subcutaneously," which indicates a therapeutic function rather than a diagnostic one. It functions purely as a container for medication delivery.
No
The device description clearly states it is a physical reservoir (piston syringe) used in conjunction with an external infusion pump and infusion set, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "infusion of medicine, including insulin, from an external infusion pump." This describes a device used to deliver substances into the body, not to test samples from the body.
- Device Description: The description details a syringe-like device designed to hold and deliver liquid medication. This aligns with an infusion device, not a diagnostic test.
- 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 specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device's function is to administer medication, which is a therapeutic action, not a diagnostic one.
N/A
Intended Use / Indications for Use
The MiniMed 3.0 ml Reservoir Model 103/193 is intended for use for the infusion of medicine, including insulin, from an external infusion pump. The reservoir is not intented for use with blood or blood products.
Product codes
FRN
Device Description
The MiniMed 3.0 ml Reservoir Model 103/193 is a single use 3.0 ml piston syringe consisting of a hollow barrel, movable plunger with O-rings for sealing, and a male Luce lock fitting at the distal end of the barrel. The device is used in conjunction with an external infusion punp and infusion set to deliver medication subcutancously. The male Luer lock fitting of the reserved is connected to the female Luer fitting of an infusion set, and the reservoir is placed in an externs. Infusion pump. The 103/193 reservoir is designed for use with MiniMed infusion purpos. Models 103 and 193 differ only in end configuration and packaging. The 103 is individually packaged with a covered needly attached to the male connector, while the 193 is multi-packed with a vented cap instead of a necdle.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
MiniMed Inc. Premarket Notification - 510(k) 3.0 ml Reservoir Model 103/193
JAN 18 2000
Image /page/0/Picture/2 description: The image shows the logo for MiniMed. The logo consists of a black square with white wavy lines inside, followed by the word "MiniMed" in a bold, serif font. Above the word "MiniMed" is the text "K99/1936" in a smaller font.
Section D. 510(k) Summary
In accordance with the requirements of SMDA 1990, and 21 CFR 807.92, a 510(k) Summary follows:
Submitter: MiniMed® Inc. 12744 San Fernando Rd., Sylmar, California 91342
Contact: Jennifer Lyons, Regulatory Affairs (818) 362-5958, ext. 3111
Name of Device: MiniMcd 3.0 ml Reservoir Model 103/193
Original Device: Single Use Syringe Model 103
Description of the Device: The MiniMed 3.0 ml Reservoir Model 103/193 is a single use 3.0 ml piston syringe consisting of a hollow barrel, movable plunger with O-rings for sealing, and a male Luce lock fitting at the distal end of the barrel. The device is used in conjunction with an external infusion punp and infusion set to deliver medication subcutancously. The male Luer lock fitting of the reserved is connected to the female Luer fitting of an infusion set, and the reservoir is placed in an externs. Infusion pump. The 103/193 reservoir is designed for use with MiniMed infusion purpos. Models 103 and 193 differ only in end configuration and packaging. The 103 is individually packaged with a covered needly attached to the male connector, while the 193 is multi-packed with a vented cap instead of a necdle.
The modifications which are the subject of this premarket notification have no unloward effect on the safety and effectiveness of the device.
Intended Use of the Device: The MiniMed 3.0 ml Reservoir Model 103/193 is intended for use for the infusion of medicine, including insulin, from an external infusion pump. The reservoir is not intented for use with blood or blood products.
Comparison of the Tcchnological Features of the Modified and Original Devices: The modified device is substantially equivalent to the lawfully marketed original device. The differences between the modified and original devices are: 1) The name of the device has been changed from the Single Use Syringe Model 103 to the MiniMed 3.0 ml Reservoir Model 103/193. 2) The O-ring material has changed from a rubber compound to siliconc rubber. 3) The lubricant has changed from a silicone fluoco fluorosilicone fluid. 4) Model 193 uses bulk packaging as opposed to single packaging. 5) Model 193 has a vented cap on the distal end instead of a needle. 6) The I in. needle of the original device was changed to a 0.5 in. needle in Model 103. 7) The assembly process has been automated.
Jennifer Lyons 6/8/99
Jennifer Lyons Date
Regulatory Affairs Specialist Regulatory Affairs MiniMed Inc.
Date
®MiniMed is a Registered Trademark of MiniMed Inc.
000007
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of three curved lines that represent the wings and body of the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN | 8 2000
Ms. Jennifer Lyons Regulatory Affairs Specialist MiniMed™, Incorporated 12744 San Fernando Road Sylmar, California 91342-3728
Re : K991936 MiniMed 3.0 ml Reservoir Trade Name: Regulatory Class: II Product Code: FRN Dated: October 18, 1999 Received: October 20, 1999
Dear Ms. Lyons:
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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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
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Page 2 - Ms. Lyons
obligation you might have under sections 531 through 542 of 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 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 Amarbe 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
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
MiniMed Inc. Premarket Notification - 510(k) 3.0 ml Reservoir Model 103/193
Image /page/3/Picture/1 description: The image shows the logo for MiniMed. The logo consists of a black square with white wavy lines inside, followed by the word "MiniMed" in a serif font. There is a trademark symbol after the word "MiniMed".
INDICATIONS FOR USE
510(k) Number:
Device Name: MiniMed 3.0 ml Reservoir Model 103/193
Indications for Use: The MiniMed 3.0 ml Reservoir Model 103/193 is indicated for use Indications for Use: The Nimmived J.v in Leso. Con Resort Creat infusion pump. The rol "the midslow of or use with blood or blood or blood products.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | ✓ | or | Over-the Counter Use _____ |
|---|---|---|---|
| --------------------------------------- | -------------------------------------------------------- | ---- | ---------------------------- |
Alta Cucerule
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
R091936
510(k) Number ________________________________________________________________________________________________________________________________________________________________
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