SAFELINE I.V. BAG ACCESS DEVICE
K955594 · Mcgaw, Inc. · LHI · Mar 6, 1996 · General Hospital
Device Facts
| Record ID | K955594 |
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| Device Name | SAFELINE I.V. BAG ACCESS DEVICE |
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| Applicant | Mcgaw, Inc. |
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| Product Code | LHI · General Hospital |
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| Decision Date | Mar 6, 1996 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 880.5440 |
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| Device Class | Class 2 |
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Intended 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 The spike portion of the SafeLine I.V. Bag Access Device is inserted into the I.V. bag set port and the fluid is withdrawn using a blunt plastic cannula connected to a syringe. The fluid is withdrawn into the syringe through the blunt plastic cannula inserted into the injection site portion of the SafeLine I.V. Bag Access Device.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.
Device Story
SafeLine I.V. Bag Access Device is a sterile, single-use plastic accessory for needle-free access to I.V. bags. Components include a pre-slit rubber septum injection site, I.V. bag spike, and spike protector. Device is tinted green to identify as a needle-free SafeLine product. Operation involves inserting the spike into an I.V. bag port and withdrawing fluid via a blunt plastic cannula attached to a syringe. Used in clinical settings to facilitate I.V. pushes and line flushing. Eliminates need for metal hypodermic needles, reducing risk of accidental needlestick injuries to healthcare providers.
Clinical Evidence
Bench testing only. Evidence includes biocompatibility testing, functional performance testing compared to standard I.V. bag spikes, and microbiological challenge testing.
Technological Characteristics
Single-use sterile plastic device; features pre-slit rubber septum injection site and I.V. bag spike. Green tinting for identification. Mechanical fluid transfer via blunt cannula interface.
Indications for Use
Indicated for multiple fluid withdrawals from standard I.V. bags via blunt cannula and syringe for I.V. pushes, line flushing, or pharmaceutical administration; intended to replace metal hypodermic needles to prevent needlestick injuries.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- McGaw SafeLine Injection Site
Related Devices
- K955595 — SAFELINE MULTIDOSE VIAL ADAPTER · Mcgaw, Inc. · Mar 6, 1996
- K970485 — SMARTSITE ACCESS PIN · Ivac Medical Systems · Apr 21, 1997
- K120548 — HLIC NEEDLE-LESS VALVE · Health Line International Corporation · May 4, 2012
- K051930 — DRUG ACCESS SPIKE · Medegen Medical Manufacturing Services · Aug 16, 2005
- K980062 — MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE · Davis & Geck, Inc. · Mar 20, 1998
Submission Summary (Full Text)
{0}
McGaw, Inc. 510(k) Notification
December 7, 1995
K 955594
MAR - 6 1996
## ATTACHMENT 8
### 510(k) Summary
43
{1}
McGaw, Inc.
2525 McGaw Avenue
P.O. Box 19791
Irvine, California 92713-9791
Telephone: 714.660.2000
Fax: 714.660.2700
K955594
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
Common/Usual Name: I.V. Fluid Transfer Set
Classification Name: Set, Intravascular, Administration
## 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.
44
{2}
McGaw, Inc.
2525 McGaw Avenue
P.O. Box 19791
Irvine, California 92713-9791
Telephone: 714 660 2000
Fax: 714 660 2700
# 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
Signature
*Diane Geest for J. D'Angelo*
Date
12-7-95
45
