(84 days)
Not Found
No
The description focuses on standard administration set components and a check valve, with no mention of AI or ML.
No.
The device is described as an administration set used for piggyback infusions, which is a component for delivering medication but is not itself a therapeutic device that directly treats or prevents disease.
No
The device is an administration set used for piggyback infusions, not for diagnosing medical conditions. It functions to administer fluids, not to detect or identify diseases.
No
The device description explicitly states it is an "administration set" incorporating physical components like tubing, a check valve, and a pumping cartridge. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as an "administration set" for "piggyback infusion" used with a pump. This is a device used to deliver fluids into a patient's body, which is an in vivo (within a living organism) application.
- Device Description: The description confirms it's an "administration set" with tubing and a pumping cartridge. This aligns with a device for delivering fluids, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro to provide information for diagnosis, monitoring, or screening.
Therefore, the Model D-290P Check Valve administration set is a medical device for fluid delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Model D-290P Check Valve administration set is targeted for use with those applications where a piggyback infusion is specified. The Model D-290P set is used in conjunction with a commercially available secondary infusion line inserted in the upper Y-Site and with the Invacare Model 1200 pump.
Product codes
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Device Description
The Model D-290P is an administration set that incorporates standard, off-the-shelf, h.V. set components (including a check valve), Medical Grade PVC tubing and a non-fluid path pumping cartridge.
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
Nonclinical tests were deemed not necessary to support the claim of substantial equivalence to the Block Medical and IVAC administration sets.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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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Image /page/0/Picture/0 description: The image shows the Invacare logo. The logo is in black and white and features the word "Invacare" in a bold, sans-serif font. There is a curved line above and below the word "Invacare", creating a sense of enclosure. The logo is simple and modern.
127 1997 K964384
510(k) SUMMARY
| Submitter's Name: | Invacare Infusion Systems |
|---|---|
| Address: | 13220 Evening Creek Dr. So. |
| Suite #114 | |
| San Diego, California 92128 | |
| Phone: | (619) 679-3840 |
| Contact: | Tom Kane |
| Date of Summary: | November 1, 1996 |
| Name of Device: | Model D-290P Administration Set with Check Valve |
Legally Marketed Device to Which Substantially Equivalency Is Claimed:
Block Medical, Inc. Model V021014 and IVAC Model 59093 Administration Sets with Check Valve.
Description of Device:
The Model D-290P is an administration set that incorporates standard, off-the-shelf, h.V. set components (including a check valve), Medical Grade PVC tubing and a non-fluid path pumping cartridge.
Intended Use:
The Model D-290P Check Valve administration set is targeted for use with those applications where a piggyback infusion is specified. The Model D-290P set is used in conjunction with a commercially available secondary infusion line inserted in the upper Y-Site and with the Invacare Model 1200 pump.
Technological Characteristics:
The Invacare Infusion Systems, Block Medical, Inc. and IVAC administration sets with check valves have the same general design and incorporate similar technologies. materials, and components.
The primary function of the Invacare, Block and IVAC check valve sets is to administer fluids initially from a primary container until empty and then from a secondary container to a patient's vascular system. The technological characteristics of the devices are the
INVACARE INFUSION SYSTEMS
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same and raise no new questions of safety and effectiveness. Invacare concludes that the Model D-290P is substantially equivalent to the Block Model V011014 and IVAC Model 59093 in providing primary and secondary infusion therapy that require the use of administration sets with a check valve.
Nonclinical Tests and Results
No changes in the Invacare Infusion Systems Model 1200 Infusion Pump were necessary to add the Model D-290 administration set.
Nonclinical tests were deemed not necessary to support the claim of substantial equivalence to the Block Medical and IVAC administration sets.
A certificate of compliance for USP Biological Tests has been furnished by Medex, the check valve supplier, for their check valve that is being used in the Model D-290P administration set.