(89 days)
NOT FOUND
Not Found
No
The device description and intended use clearly describe a mechanical device for accessing IV bags, with no mention of software, data processing, or any AI/ML related terms.
No
This device is an accessory for accessing I.V. bags for fluid withdrawal, not for directly treating a medical condition.
No
The device is designed for fluid withdrawal from I.V. bags for pharmaceutical uses, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical, sterile plastic device with components like a spike, septum, and spike protector, designed for physical interaction with an I.V. bag. It is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to withdraw fluid from IV bags for purposes like "I.V. pushes," flushing IV lines, or other pharmaceutical uses. This involves administering substances to a patient, not analyzing a sample from a patient to diagnose a condition.
- Device Description: The description focuses on the physical components and how it facilitates needle-free access to IV bags for fluid withdrawal.
- Lack of Diagnostic Activity: There is no mention of the device being used to test, analyze, or examine a sample (like blood, urine, tissue, etc.) to provide information about a patient's health status or diagnose a disease.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is related to drug delivery and administration, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The SafeLine I.V. Bag Access Device is intended for multiple withdrawals of fluid from the set port of standard I.V. bags. The spike portion of the SafeLine I.V. Bag Access Device is inserted into the I.V. bag set port and the fluid is withdrawn using a blunt plastic cannula connected to a syringe. The fluid is withdrawn into the syringe through the blunt plastic cannula inserted into the injection site portion of the SafeLine I.V. Bag Access Device. The fluid in the syringe can then be used for performing "I.V. pushes," to flush patient I.V. lines, or other pharmaceutical uses. The SafeLine I.V. Bag Access Device replaces the use of a traditional metal hypodermic needle to provide needlefree access to I.V. Bags. Thus, eliminating the potential for accidental needlestick injury.
Product codes
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Device Description
The SafeLine™ I.V. Bag Access Device 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 I.V. bag spike and a spike protector. The SafeLine I.V. Bag Access Device is designed to withdraw drugs from standard size I.V. bags through a blunt plastic cannula attached to a syringe. Thus providing needlefree access of IV bags. As with all of the currently marketed SafeLine devices, the new SafeLine I.V. Bag Access Device 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The substantial equivalence statement is supported by the information presented in this 510(k) submission. This information is contained in Attachments 1 through 7 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
- · Drawing of the subject device
- · Biocompatibility testing of the subject device materials
- · Functional performance testing of the subject device and comparison testing of the subject device with a standard I.V. bag spike
- · Microbiological challenge testing of the subject device
- · Draft labeling of the subject device and the predicate device current labeling
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 McGaw SafeLine Injection Site is the predicate device used for the substantial equivalence claim
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
ATTACHMENT 8
510(k) Summary
1
McGaw, Inc
California 92712-970
+McGaw
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) 660-3292
2) Name of Device
Trade/Proprietary Name: SafeLine™ I.V. Bag Access Device I.V. Fluid Transfer Set Common/ Usual Name: Set, Intravascular, Administration Classification Name:
3) Predicate Device
The currently marketed McGaw SafeLine Injection Site is the predicate device used for the substantial equivalence claim
4) Description of the Subject Device
The SafeLine™ I.V. Bag Access Device 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 I.V. bag spike and a spike protector. The SafeLine I.V. Bag Access Device is designed to withdraw drugs from standard size I.V. bags through a blunt plastic cannula attached to a syringe. Thus providing needlefree access of IV bags. As with all of the currently marketed SafeLine devices, the new SafeLine I.V. Bag Access Device is tinted green to signify a needle free SafeLine product.
2
2525 McGaw Avenue D.O. Box 1979
+McGaw
5) Intended Use of the Subject Device
The SafeLine I.V. Bag Access Device is intended for multiple withdrawals of fluid from the set port of standard I.V. bags. The spike portion of the SafeLine I.V. Bag Access Device is inserted into the I.V. bag set port and the fluid 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 I.V. Bag Access Device. The fluid in the syringe can then be used for performing "I.V. pushes," to flush patient I.V. lines, or other pharmaceutical uses. The SafeLine I.V. Bag Access Device replaces the use of a traditional metal hypodermic needle to provide needlefree access to I.V. Bags. Thus, eliminating the potential for accidental needlestick injury.
6) Technological Characteristics of the Subject Device
The subject device, the new SafeLine™ I.V. Bag Access Device, is substantially equivalent to the predicate device, the currently marketed SafeLine Injection Site. 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 statement is supported by the information presented in this 510(k) submission. This information is contained in Attachments 1 through 7 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
- · Drawing of the subject device
- · Biocompatibility testing of the subject device materials
- · Functional performance testing of the subject device and comparison testing of the subject device with a standard I.V. bag spike
- · Microbiological challenge testing of the subject 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 I.V. Bag Access Device is substantially equivalent to the currently marketed SafeLine Injection Site.
7. Signature of Applicant:
McGaw, Inc. John G. D'Angelo, M.S., R.Ph. Director Regulatory Affairs
Diane Seest for S. D. Angel
Signature
12-7-95
Date