(35 days)
Not Found
Not Found
No
The description focuses on mechanical components and fluid delivery, with no mention of AI/ML terms or functionalities.
No
The device is described as an adapter set used for administering fluids, not for treating or curing a disease or condition.
No
The device is described as an adapter set used to administer fluids, not to diagnose conditions. Its function is fluid delivery, not information gathering for diagnosis.
No
The device description explicitly states it is an "injection molded component" and describes physical parts like a "female luer-lock attachment" and a "vent cap," 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 to administer fluids to a patient's vascular system using an electronic infusion device. This is a therapeutic or delivery function, not a diagnostic one.
- Device Description: The device is described as an administration set for delivering fluids from a syringe to a patient. It's a physical component for fluid delivery, not for analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of the device being used to test, examine, or analyze biological samples (like blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body. This device operates in vivo (within the body) by delivering fluids directly to the patient.
N/A
Intended Use / Indications for Use
The Colleague® Pump Syringe Adapter Set will be used to administer fluids from a container to a patient's vascular system using an electronic infusion device.
Product codes
FPA
Device Description
The Colleague® Pump Syringe Adapter Set will be used to administer fluids from a standard syringe source container to a patient's vascular system using the Colleague® volumetric infusion pump. The only design difference between the proposed set and other Baxter IV administration sets is the container attachment mechanism which will allow the set to be directly connected to a syringe. This mechanism is an injection molded component which provides a female luer-lock attachment (syringe adapter) and a means for air inlet into the syringe (i.e., vent cap). Therefore, as air enters the syringe, fluid delivery is allowed through the Colleague® Pump Syringe Adapter Set.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
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)
Data regarding the functional performance of the proposed Colleague® Pump Syringe Adapter Set have been generated and submitted. The data indicate that the proposed set meets or exceeds all functional requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Baxter Solution Set with Microbore Tubing, Imed Vented Gemini® Syringe Set
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
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
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SEP 4 1998
510(k) SUMMARY Colleague® Pump Syringe Adapter Set
Submitted by:
Linda Coleman Manager, Regulatory Affairs Baxter Healthcare Corporation I.V. Systems Division Rte. 120 and Wilson Road Round Lake, IL 60073
Date Prepared:
August 20, 1998
Proposed Device:
Colleague® Pump Syringe Adapter Set
Predicate Devices:
Baxter Solution Set with Microbore Tubing Imed Vented Gemini® Syringe Set
Proposed Device Description:
The Colleague® Pump Syringe Adapter Set will be used to administer fluids from a standard syringe source container to a patient's vascular system using the Colleague® volumetric infusion pump. The only design difference between the proposed set and other Baxter IV administration sets is the container attachment mechanism which will allow the set to be directly connected to a syringe. This mechanism is an injection molded component which provides a female luer-lock attachment (syringe adapter) and a means for air inlet into the syringe (i.e., vent cap). Therefore, as air enters the syringe, fluid delivery is allowed through the Colleague® Pump Syringe Adapter Set.
Statement of Intended Use:
The Colleague® Pump Syringe Adapter Set will be used to administer fluids from a container to a patient's vascular system using an electronic infusion device.
Summary of Technological Characteristics of New Device to Predicate Devices
The proposed set has the same design as the currently marketed Baxter Solution Set with Microbore Tubing with the exception of the container attachment mechanism and fewer set components. The container attachment mechanism is similar to that used on the currently
1
marketed Imed Vented Gemini® Syringe Set. The solution contact materials used in the proposed device were previously tested and used in other Baxter devices for similar IV solution administration applications.
Discussion of Nonclinical Tests and Referenced Studies Reported in Published Literature
Data regarding the functional performance of the proposed Colleague® Pump Syringe Adapter Set have been generated and submitted. The data indicate that the proposed set meets or exceeds all functional requirements.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three overlapping human profiles facing to the right. The emblem is rendered in a bold, black color, contrasting with the white background.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 1998 SEP
Ms. Linda Coleman Manager, Regulatory Affairs Baxter Healthcare Corporation I.V. Systems Division Route 120 and Wilson Road Round Lake, Illinois 60073
Re: K982672 Colleague® Pump Syringe Adapter Set Trade Name: II Requlatory Class: Product Code: FPA Dated: July 30, 1998 Received: July 31, 1998
Dear Ms. Coleman:
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 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). 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 TT (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. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 - Ms. Coleman
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) 594-4692. 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
S. Sutman fr
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number: Not Available
Colleague® Pump Syringe Adapter Set Device Name:
Indication for Use:
The Colleague® Pump Syringe Adapter Set will be used to administer fluids from a container to a patient's vascular system using an electronic infusion device.
Patricia Creciente
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K982672
Prescription Use
(Per 21 CFR 801.109)