K970485 · Ivac Medical Systems · FPA · Apr 21, 1997 · General Hospital
Device Facts
Record ID
K970485
Device Name
SMARTSITE ACCESS PIN
Applicant
Ivac Medical Systems
Product Code
FPA · General Hospital
Decision Date
Apr 21, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 880.5440
Device Class
Class 2
Indications for Use
The intended use for the SmartSite Access Pin is to allow access to IV administration sets, medication vials, blood tubes, and solution bags with one convenient device without the use of needles or blunt cannulas.
Device Story
SmartSite Access Pin; needle-free accessory for IV administration sets, medication vials, blood tubes, and solution bags. Device features protected spike and finger grips; allows fluid transfer without needles or blunt cannulas. Used in clinical settings by healthcare providers to facilitate safe, needle-free access to fluid containers and IV lines. Functionally identical to predicate IVAC Needle Free Valve (K960280) with modified housing for improved handling. Benefits include elimination of needle-stick risks during fluid access and transfer.
Clinical Evidence
Bench testing only; no clinical data provided.
Technological Characteristics
Needle-free access device; modified housing with protected spike and finger grips. Materials and manufacturing methods identical to predicate K960280. Standalone mechanical device; no energy source, software, or connectivity.
Indications for Use
Indicated for clinicians requiring needle-free access to IV administration sets, medication vials, blood tubes, and solution bags.
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
IVAC Needle Free Valve Administration Set (K960280)
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K970485
APR 21 1997
SmartSite™ Access Pin
510(k) Premarket Notification
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
1. SUBMITTER'S NAME: IVAC Holdings, Inc.
10221 Wateridge Circle
San Diego, CA 92121-2733
(619) 458-7563
(619) 458-6223 FAX
CONTACT PERSON: Renée L. Fluet
Regulatory Affairs Specialist
DATE PREPARED: February 7, 1997
2. DEVICE NAME: Proprietary Name: SmartSite™ Access Pin
Common Names:
(1) Intravascular Administration Set
(2) Transfer Set
Classification Names:
(1) Intravascular Administration Set
(2) I.V. Fluid Transfer Set
3. PREDICATE DEVICE(S): IVAC Needle Free Valve Administration Set, K960280
ICU Medical, Inc., Piggy Lock Needle Housing, K910546.
Acacia, Inc., Luer Lock Transfer Pin, K901063.
4. DEVICE DESCRIPTION: The SmartSite Access Pin is a stand alone accessory and is the same device as the currently marketed IVAC Needle Free Valve (K960280) with the exception of a modified housing. The housing for the SmartSite Access Pin has been modified to accommodate the needs of an access pin by adding a protected spike and finger grips.
Functionally, the SmartSite Access Pin is the same as the currently marketed IVAC Needle Free Valve in that it allows access to IV administration sets. As an access pin device, the SmartSite Access Pin also allows access to medication vials, blood tubes, and solution bags without the use of needles or blunt cannulas.
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5. INTENDED USE:
The intended use for the SmartSite Access Pin is to allow access to IV administration sets, medication vials, blood tubes, and solution bags with one convenient device without the use of needles or blunt cannulas.
6. TECHNOLOGICAL CHARACTERISTICS:
The SmartSite Access Pin consists of components which use the same method of manufacture and use similar standard materials as the currently marketed IVAC Needle Free Valve, K960280. The primary function of the SmartSite Access Pin is also the same as the Needle Free Valve with the addition of an Access Pin application which is substantially equivalent to the ICU Medical Inc., Piggy Lock Needle Housing (K910546). In addition, the SmartSite Access Pin acts as a transfer pin and is substantially equivalent to the Acacia, Inc., Luer Lock Transfer Pin (K901063)
The SmartSite Access Pin allows easy finger grip access to IV administration sets, medication vials, blood tubes, and solution bags, without the use of needles or blunt cannulas. The technological characteristics of the device are the same as the IVAC Needle Free Valve (K960280), ICU Medical, Piggy Lock Needle Housing (K910546), and the Acacia, Inc., Luer Lock Transfer Pin (K901063) and raises no new questions of safety and effectiveness. IVAC concludes that the SmartSite Access Pin is substantially equivalent to the currently marketed IVAC Needle Free Valve (K960280), the ICU Medical Inc. Piggy Lock Needle Housing (K910546), and the Acacia Inc., Luer Lock Transfer Pin (K901063).
