(89 days)
Not Found
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or data-driven processes. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
This device is an adapter for withdrawing drug solutions from vials, providing needle-free access. It does not directly administer therapy or have a therapeutic effect on the patient.
No
The device is described as an adapter for withdrawing drug solution from vials, replacing traditional needles to prevent needlestick injuries. Its function is to facilitate drug transfer, not to diagnose medical conditions or analyze biological data.
No
The device description clearly indicates it is a physical, sterile plastic device with components like a septum, spike, and protector, designed for mechanical interaction with drug vials and syringes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as a tool for withdrawing drug solutions from vials for administration to a patient. This is a drug delivery/preparation function, not a diagnostic one.
- Device Description: The description reinforces its role in providing needle-free access to drug vials for withdrawal of solutions.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease. IVDs are designed to perform tests on biological samples to aid in diagnosis, monitoring, or screening.
The device is a medical device used in the preparation and administration of medication, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The SafeLine Multidose Vial Adapter is intended for multiple withdrawals of drug solution from standard size drug vial solid stoppers. The spike portion of the SafeLine Multidose Vial Adapter is inserted into the drug vial solid stopper and the drug solution is withdrawn using a blunt plastic cannula connected to a syringe. The fluid is withdrawn into the syringe through the blunt plastic cannula inserted into the injection site portion of the SafeLine Multidose Vial Adapter. The drug solution in the syringe can then be transferred to an I.V. administration set with a pre-slit septum injection site for administration of the drug solution to the patient. The SafeLine Multidose Vial Adapter replaces use of a traditional metal hypodermic needle to provide needlefree access to drug vials. Thus, eliminating the potential for accidental needlestick injury.
Product codes
Not Found
Device Description
The SafeLine™ Multidose Vial Adapter is an additional accessory device for use with McGaw's SafeLine System. It is a single sterile plastic device composed of a pre-slit rubber septum injection site, a standard drug vial spike and a plastic spike tip protector. The SafeLine Multidose Vial Adapter is designed to withdraw drug solution from the solid stopper of standard size drug vials using a blunt plastic cannula attached to a syringe. Thus providing needlefree access of drug vials. As with all of the currently marketed SafeLine devices, the new SafeLine Multidose Vial Adapter is tinted green to signify a needle free SafeLine product.
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)
Functional performance and comparison testing of the subject device and the predicate device
Microbiological challenge testing comparing the subject device and the predicate device
The conclusions drawn from the information listed above support that the new SafeLine Multidose Vial Adapter is substantially equivalent to the Baxter InterLink System Universal Vial Adapter.
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.
The currently marketed Baxter InterLink® System Universal Vial Adapter
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.
0
McGaw, Inc. 510(k) Notification
December 7, 1995
MAR - 6 1996
K 955595
ATTACHMENT 7
510(k) Summary
1
McGaw, Inc.
2525 McGaw Avenue California 92713-9791 hone: 714,660 2000 Fax: 714.660.2700
510(k) Summary
"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:
1) Submitter Information
McGaw, Inc. 2525 McGaw Avenue P.O. Box 19791 Irvine, California 92713-9791
Contact Person: John G, D'Angelo, M.S., R.Ph. Director, Regulatory Affairs Phone: (714) 660-2517 FAX: (714) 66-3293
2) Name of Device
Trade/Proprietary Name: SafeLine™ Multidose Vial Adapter Common/Usual Name: I.V. Fluid Transfer Set Classification Name: Set, Intravascular, Administration
3) Predicate Device
The currently marketed Baxter InterLink® System Universal Vial Adapter is the predicate used for the substantial equivalence claim.
4) Description of the Subject Device
The SafeLine™ Multidose Vial Adapter is an additional accessory device for use with McGaw's SafeLine System. It is a single sterile plastic device composed of a pre-slit rubber septum injection site, a standard drug vial spike and a plastic spike tip protector. The SafeLine Multidose Vial Adapter is designed to withdraw drug solution from the solid stopper of standard size drug vials using a blunt plastic cannula attached to a syringe. Thus providing needlefree access of drug vials. As with all of the currently marketed SafeLine devices, the new SafeLine Multidose Vial Adapter is tinted green to signify a needle free SafeLine product.
2
- 2525 McGaw Avenue Fax: 714 660 2700
5) Intended Use of the Subject Device
The SafeLine Multidose Vial Adapter is intended for multiple withdrawals of drug solution from standard size drug vial solid stoppers. The spike portion of the SafeLine Multidose Vial Adapter is inserted into the drug vial solid stopper and the drug solution is withdrawn using a blunt plastic cannula connected to a syringe. The fluid is withdrawn into the syringe through the blunt plastic cannula inserted into the injection site portion of the SafeLine Multidose Vial Adapter. The drug solution in the syringe can then be transferred to an I.V. administration set with a pre-slit septum injection site for administration of the drug solution to the patient. The SafeLine Multidose Vial Adapter replaces use of a traditional metal hypodermic needle to provide needlefree access to drug vials. Thus, eliminating the potential for accidental needlestick injury.
6) Technological Characteristics of the Subject Device
The subject device, the SafeLine™ Multidose Vial Adapter, is substantially equivalent to the predicate device, the Baxter InterLink® System Universal Vial Adapter. There are technological differences between the subject device and the predicate device. However, these technological differences do not raise any different questions of safety and efficacy. The substantial equivalence claim is supported by the information presented in this 510(k) submission. This information is contained in Attachments 1 through 6 and includes the following:
- · Description and intended use of the subject device and the predicate device
- · Comparison of the attributes of the subject device with the attributes of the predicate device
- · Material composition of the subject device components
- · Drawing of the subject device
- · Functional performance and comparison testing of the subject device and the predicate device
- · Microbiological challenge testing comparing the subject device and the predicate device
- · Draft labeling of the subject device and the predicate device current labeling
The conclusions drawn from the information listed above support that the new SafeLine Multidose Vial Adapter is substantially equivalent to the Baxter InterLink System Universal Vial Adapter.
7) Signature of Applicant:
McGaw, Inc. John G. D'Angelo, M.S., R.Ph. Director Regulatory Affairs
Diane Geist for J. D. Angel
Signature
Signature
12-7-95
Date