(148 days)
The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container's vascular system through the administration set's needle or catheter (which is inserted into a vein).
The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container's vascular system through the administration set's needle or catheter (which is inserted into a vein). Each set will be manufactured to unique specifications using dimensions, components and configurations specified by the customer. Standard sets will also be offered. Components used in the IV sets may be either manufactured by ICU Medical or purchased from other manufacturers. Components will be assembled into configurations specified by the customer and packaged.
The provided text is a 510(k) summary for an Intravascular Administration Set from ICU Medical Inc. It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria, particularly not in the context of an AI-powered medical device.
The questions you've asked (about sample sizes, experts, ground truth, MRMC studies, etc.) are highly relevant to the evaluation of AI/ML-based medical devices, which typically undergo rigorous performance studies to demonstrate safety and effectiveness. The document provided describes a traditional medical device (an IV administration set), which is evaluated based on its physical characteristics, materials, intended use, and equivalence to existing devices, often through bench testing, biocompatibility testing, and sterilization validation, rather than the type of performance study you're inquiring about.
Therefore, I cannot answer your specific questions based on the provided text. The document does not describe:
- A table of acceptance criteria and reported device performance related to AI/ML.
- Sample sizes for a test set or data provenance for any performance study.
- Number or qualifications of experts used to establish ground truth.
- Adjudication methods.
- Whether a MRMC comparative effectiveness study was done or effect sizes.
- Standalone (algorithm only) performance.
- The type of ground truth used (e.g., expert consensus, pathology).
- Sample size for a training set.
- How ground truth for a training set was established.
To answer these questions, you would need documentation related to the performance evaluation of an AI/ML-based medical device, which is not what this 510(k) summary for an Intravascular Administration Set details.
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ICU Medical Inc.
Intravascular Administration Set
Appendix F. 510(k) Summary of Safety and Effectiveness 14.
The following section is included as required by the Safe Medical Device Act (SMDA) of 1990.
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _ K96443 S
Applicant Information:
Date Prepared: Name: Address:
May 29, 1996 ICU Medical Inc. 951 Calle Amanecer San Clemente, CA 92673
Contact Person: Phone Number: Fax Number:
Richard Waters (714) 366-4330 (714) 366-8368
Device Information:
Trade Name: Common Name: Classification Name: Intravascular Administration Set IV Set Intravascular Administration Set
Equivalent Devices:
Medical Product Specialists I.V./Secondary Sets McGaw Intravenous Administration Sets Churchill Medical Systems IV/Extension Sets
Device Description:
The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container's vascular system through the administration set's needle or catheter (which is inserted into a vein). Each set will be manufactured to unique specifications using dimensions, components and configurations specified by the customer. Standard sets will also be offered. Components used in the IV sets may be either manufactured by ICU Medical or purchased from other manufacturers. Components will be assembled into configurations specified by the customer and packaged,
Intended Use:
The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a containers vascular system through the administration set's needle or catheler (which is Inserted into a vein).
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ICU Medical Inc.
Intravascular Administration Set
510(k) Notification Page 18 of 50
Comparison To Predicate Device:
| Characteristic Compared | ICU MEDICAL INTRAVASCULARADMINISTRATION SET | PREDICATE INTRAVASCULARADMINISTRATION SET |
|---|---|---|
| Product Labeling | Single Use, Non-pyrogenic, Sterilefluid pathway in un-opened,undamaged package.Directions for use on labeling | Single Use, Non-pyrogenic, Sterilefluid pathway In un-opened,undamaged package.Directions for use on labeling |
| Intended Use | Single use, Sterile, non-pyrogenicdevice which provides access for theadministration of fluids from acontainer to a patient's vascularsystem through the administrationset's needle or catheter (which isinserted into a vein). | Single use, Sterile, non-pyrogenicdevice which provides access for theadministration of fluids from acontainer to a patient's vascularsystem through the administrationset's needle or catheter (which isinserted into a vein). |
| Design | Tubing of various lengths and insidediameters are configured with some orall of the following: spike/dripchambers (as part of a set only),clamps, injection site(s), filters,backcheck valves and male luerfitments. Packaged in medical gradefiber-free peelable paper lidding andpouching material. | Tubing of various lengths and Insidediameters are configured with someor all of the following: spike/dripchambers, clamps, injection site(s),filters, backcheck valves and maleluer fitments, huber needle.Packaged in medical grade fiber-freepeelable paper lidding and pouchingmaterial. |
510(k), Primary Sets
§ 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.