(89 days)
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 The spike portion of the SafeLine I.V. Bag Access Device is inserted into the I.V. bag set port and the fluid is withdrawn using a blunt plastic cannula connected to a syringe. The fluid is withdrawn into the syringe through the blunt plastic cannula inserted into the injection site portion of the SafeLine I.V. Bag Access Device.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.
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.
The provided text is a 510(k) summary for a medical device (SafeLine I.V. Bag Access Device) and describes its characteristics, intended use, and comparison to a predicate device. It mentions "Functional performance testing of the subject device and comparison testing of the subject device with a standard I.V. bag spike," but it does not provide specific acceptance criteria or detailed study results.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document focuses on establishing substantial equivalence based on technological characteristics and general functional performance testing, not on providing the detailed statistical evidence you're asking for. In 1995, the level of detail provided in 510(k) summaries for performance studies was often much less comprehensive than what is expected today, especially for devices not involving complex algorithms or AI.
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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
§ 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.