(39 days)
Not Found
No
The device description and intended use describe a simple mechanical reservoir for an infusion pump, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
This device is a reservoir for containing medication and is used in conjunction with a pump and infusion set to deliver medicine, but it does not directly perform a therapeutic function itself.
No
The device is a reservoir for infusing medicine, not for diagnosing conditions.
No
The device description clearly states it is a physical reservoir (piston syringe) with hardware components (barrel, plunger, O-rings, Luer lock fitting, optional cannula). It is used in conjunction with an external infusion pump and infusion set, which are also hardware devices.
Based on the provided information, the SureSet 3.0 ml Reservoir 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 for delivering substances into the body (in vivo), not for testing samples outside the body (in vitro).
- Device Description: The description details a syringe-like device designed to hold and deliver liquid medication. This aligns with an infusion device component, not a diagnostic test component.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
Therefore, the SureSet 3.0 ml Reservoir is a medical device used for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SureSet 3.0 ml Reservoir is indicated for use for the infusion of medicine, including insulin, from an external infusion pump. The reservoir is not indicated for use with blood or blood products.
Product codes (comma separated list FDA assigned to the subject device)
FRN
Device Description
The SureSet Reservoir is a single use 3.0 ml piston syringe. It consists of a hollow barrel, movable plunger with O-rings for sealing and a male Luer lock fitting at the distal end. This device is used in conjunction with an external infusion pump and infusion set (e.g. SmartSet Insulin Infusion Device cleared under K012429) to deliver medications, including insulin, subcutaneously. The male Luer lock fitting of the reservoir is connected to the female Luer fitting of an infusion set. The reservoir is placed in an external infusion pump. The SureSet Reservoir is available with a 22 gauge cannula (Model 24-103) or without a cannula (Model 24-104).
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JAN 1 7 2003
Infusion Pump Syringe
510(k) Summary (As required by 21 CFR 807.92(a))
- A. Submitter Information
Applied Diabetes Research, Inc. 1740 South IH 35E. Suite 112 Carrollton, TX 75006
| Phone Number: | 972-446-8406 |
|---|---|
| Fax Number: | 972-446-9397 |
| Contact: Rick Lynch | |
| President | |
| Date: | December 9, 2002 |
- Device Information B.
SureSet 3.0 ml Reservoir Trade/Proprietary Name:
Common name of device:
Pump, Infusion Classification Name:
-
C: MiniMed 3.0 ml Reservoir Predicate Device:
Predicate 510(k) #: -
D. Device Description:
The SureSet Reservoir is a single use 3.0 ml piston syringe. It consists of a hollow barrel, movable plunger with O-rings for sealing and a male Luer lock fitting at the distal end. This device is used in conjunction with an external infusion pump and infusion set (e.g. SmartSet Insulin Infusion Device cleared under K012429) to deliver medications, including insulin, subcutaneously. The male Luer lock fitting of the reservoir is connected to the female Luer fitting of an infusion set. The reservoir is placed in an external infusion pump. The SureSet Reservoir is available with a 22 gauge cannula (Model 24-103) or without a cannula (Model 24-104).
1
-
E. Intended Use:
The SureSet 3.0 ml Reservoir is indicated for use for the infusion of medicine, including insulin, from an external infusion pump. The reservoir is not indicated for use with blood or blood products. -
ட் Comparison of Required Technological Characteristics:
Information was submitted to demonstrate that there are no significant differences in technological characteristics between the SureSet 3.0 ml Reservoir and the cited predicate device. -
G. Summary and Conclusion of Nonclinical and Clinical Tests:
The intended use of the SureSet 3.0 ml Reservoir is identical to that of the cited predicate device. Any differences in technological characteristics were insignificant and do not raise new issues of safety or effectiveness.
Conclusion:
The SureSet 3.0 ml Reservoir is substantially equivalent to the MiniMed 3.0 ml Reservoir in indications for use and technological characteristics.
2
Image /page/2/Picture/1 description: The image is a black and white circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized graphic of what appears to be an abstract representation of a human figure or symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2003
Applied Diabetes Research, Incorporated C/O Mr. James Barley JB & Associates 28481 LaFalda Laguna Niguel, California 92677
Re: K024056
Trade/Device Name: SureSet 3.0 ml Reservoir Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: December 9, 2002 Received: December 9, 2002
Dear Mr. Barley:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Barley
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski
Timot Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1 _
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Indications for Use:
The SureSet 3.0 ml Reservoir is indicated for use for the infusion of medicine, including insulin, from an external pump. The reservoir is not intended for use with blood or blood products.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricx Cusente
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number ._______________________________________________________________________________________________________________________________________________________________
(Optional Format 3-10-98)