(74 days)
No
The device description and intended use clearly describe a mechanical adapter for vials, with no mention of software, data processing, or any AI/ML related terms.
No.
The device facilitates the withdrawal and transfer of medications from vials without needles but does not directly treat or diagnose a medical condition.
No
The device is described as a "Needle-Free Vial Adapter" used for the withdrawal and transfer of medications and diluents, and reconstitution of medications, without the use of needles. Its function is to facilitate the handling of medications, not to diagnose medical conditions or diseases.
No
The device description clearly describes a physical, hardware device made of polycarbonate with a luer lock fitting and a shielded spike. It is intended for physical interaction with drug vials and syringes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is focused on the administration of medications from vials, specifically for withdrawal, transfer, and reconstitution. This is a process related to drug delivery and preparation, not the diagnosis of a disease or condition.
- Device Description: The device description details a physical adapter for accessing drug vials. It doesn't mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, DNA, antibodies, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease.
The Bioject Needle-Free Vial Adapter is a medical device used in the process of administering medications, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The intended use of the Bioject Needle-Free Vial Adapter is to allow single access to 13 mm drug vials for withdrawal of medications, withdrawal and transfer of diluents, and reconstitution and withdrawal of medications, without the use of needles. The Bioject Needle-Free Vial Adapter may be used by physicians, nurses, and other practitioners who routinely administer injections, or by patients and other individuals authorized by their physicians to administer injections of prescribed medication.
Product codes
Not Found
Device Description
The Bioject Needle-Free Vial Adapter is a device which provides single access to 13 mm drug vials for withdrawal of medications, withdrawal and transfer of diluents, reconstitution and withdrawal of medications, without the use of needles. The Bioject Needle-Free Vial Adapter is a one piece, polycarbonate adapter with a standard female luer lock fitting compatible with standard luer taper syringes and a shielded spike designed to fit 13 mm outside diameter vial stopper overseals. The spike is designed to direct fluid along the drug vial walls in order to minimize foaming when used to reconstitute medications. The Bioject Needle-Free Vial Adapters are sterile, nonpyrogenic, and intended for single-use only. The adapters are individually packaged in a sterile, single-use Tyvek blister pack.
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
physicians, nurses, and other practitioners who routinely administer injections, or by patients and other individuals authorized by their physicians to administer injections of prescribed medication.
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.
0
OCT 1 5 1996
*Date
510(k) SUMMARY (21CFR Subpart 807.92)
(a) (1) Submitter Identification:
Bioject, Inc. 7620 SW Bridgeport Road Portland, OR 97224
Contact Person: Jeff Snow Regulatory Affairs & Quality Assurance
ﭘﺮ
800-683-7221 503-624-9002 (fax)
- (a)(2) Device Name: Bioject Needle-Free Vial Adapter (13 mm) Common Name: Needle-Free Fluid Transfer Device Classification Name: Accessory to a syringe, 21 CFR 880.5860
- Baxter Needle*Less™ Drug Vial Adapter (K894177) (a)(3) Predicate Devices: Abbott LifeShield™ Vial Adapter (K920737)
(a)(4) Device Description: The Bioject Needle-Free Vial Adapter is a device which provides single access to 13 mm drug vials for withdrawal of medications, withdrawal and transfer of diluents, reconstitution and withdrawal of medications, without the use of needles. The Bioject Needle-Free Vial Adapter is a one piece, polycarbonate adapter with a standard female luer lock fitting compatible with standard luer taper syringes and a shielded spike designed to fit 13 mm outside diameter vial stopper overseals. The spike is designed to direct fluid along the drug vial walls in order to minimize foaming when used to reconstitute medications. The Bioject Needle-Free Vial Adapters are sterile, nonpyrogenic, and intended for single-use only. The adapters are individually packaged in a sterile, single-use Tyvek blister pack.
(a)(5) Intended Use / Indications For Use:. The intended use of the Bioject Needle-Free Vial Adapter is to allow single access to 13 mm drug vials for withdrawal of medications, withdrawal and transfer of diluents, and reconstitution and withdrawal of medications, without the use of needles. The Bioject Needle-Free Vial Adapter may be used by physicians, nurses, and other practitioners who routinely administer injections, or by patients and other individuals authorized by their physicians to administer injections of prescribed medication.
1
(a)(6) Substantial Equivalence:, The Bioject Needle-Free Vial Adapter which is the subject of this submission is substantially equivalent to the predicate Baxter Needle*Less™ Drug Vial Adapter, K894177, and predicate Abbott LifeShield™ Vial Adapter, K920737, with respect to intended use, material, design and operational principles.
The intended use of the Bioject Needle-Free Vial Adapter is for withdrawal of medications, withdrawal and transfer of diluents, and reconstitution and withdrawal of medications, without the use of needles.
Predicate Baxter Needle*Less™ Drug Vial Adapters (K894177) and LifeShield™ Vial Adapters (K9200737) may be used to allow drug vial access for fluid (medication) transfer, and reconstitution and dilution of medications.
The Bioject Needle-Free Vial Adapter has a standard female luer lock fitting compatible with standard luer taper syringes and a shielded spike end designed to fit 13 mm outside diameter vial stopper overseals. The spike is designed to direct fluid along the drug vial walls in order to minimize foaming when used to reconstitute medications.
Both predicate vial adapters have a shielded spike end to fit the vial stopper overseals. They differ at the opposite ends which have a septum or slit reseal stopper for use with other blunt cannula devices.
Bioject Needle-Free Vial Adapters are provided sterile, nonpyrogenic, and for single-use only.
The predicate devices are provided sterile, nonpyrogenic, and for single-use only.
Product design and materials for the Bioject Needle-Free Vial Adapter demonstrate functional equivalence to the predicate devices. The device is as safe and effective as the legally marketed, predicate devices, and does not raise questions of safety and efficacy different than that of the predicate.