(70 days)
No
The document describes a mechanical device for accessing IV sets and vials, with no mention of software, data processing, or AI/ML terms.
No
Explanation: The device is described as an "access pin" to allow access to IV administration sets, medication vials, blood tubes, and solution bags. Its function is to facilitate access to other medical items, not to directly treat a disease or condition. It is an accessory rather than a therapeutic device itself.
No
The device is described as an "Access Pin" that allows access to IV administration sets, medication vials, blood tubes, and solution bags. It is a modification of a "Needle Free Valve." Its function is to facilitate access and administration, not to diagnose.
No
The device description clearly states it is a physical accessory with a modified housing, protected spike, and finger grips, indicating it is a hardware device.
Based on the provided text, the SmartSite Access Pin is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes accessing IV administration sets, medication vials, blood tubes, and solution bags for the purpose of administering or transferring fluids. This is a device used in the process of patient care and treatment, not for the in vitro examination of specimens derived from the human body.
- Device Description: The description focuses on the mechanical function of accessing containers and sets without needles. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes
The SmartSite Access Pin is a medical device used for fluid transfer and access in a clinical setting, not for diagnostic testing performed outside the body.
N/A
Intended Use / 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.
Product codes
Not Found
Device Description
The SmartSite Access Pin is a stand alone accessory and is the same device as the currently marketed /VAC 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 /VAC 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.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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APR 2 | 1997
SmartSite™ Access Pin 510(k) Premarket Notification
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
- IVAC Holdings, Inc. SUBMITTER'S NAME: 1. 10221 Wateridge Circle San Diego, CA 92121-2733 (619) 458-7563 (619) 458-6223 FAX Renée L. Fluet CONTACT PERSON: Regulatory Affairs Specialist February 7, 1997 DATE PREPARED: Proprietary Name: SmartSite™ Access Pin DEVICE NAME: 2. Common Names: (1) Intravascular Administration Set (2) Transfer Set Classification Names: (1) Intravascular Administration Set (2) I.V. Fluid Transfer Set IVAC Needle Free Valve Administration Set, K960280 PREDICATE DEVICE(S): 3. ICU Medical, Inc., Piggy Lock Needle Housing, K910546. Acacia, Inc., Luer Lock Transfer Pin, K901063. DEVICE DESCRIPTION: The SmartSite Access Pin is a stand alone accessory 4. and is the same device as the currently marketed /VAC 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 /VAC 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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- INTENDED USE: The intended use for the SmartSite Access Pin is to 5. 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).
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