(398 days)
The Smart-Rod™ is a single use reconstitution device intended for the transfer of a diluent contained in a prefilled syringe to a vial containing a drug product, and the return transfer of the admixture to the syringe.
The Smart-Rod™ is intended for use by physicians, nurses, and other practitioners who routinely administer injections, or patients and other individuals authorized by a physician to administer injections of prescribed medication.
The Smart-Rod™ is a single-use reconstitution device consisting of a preassembled vial socket and plunger rod. The Smart-Rod™ is designed to be used together with a pre-filled syringe. The pre-filled syringe would be legally authorized through its own clearance or customer New Drug Application and is not intended to be cleared as part of this premarket notification. The Smart-Rod™ plunger rod replaces the usual plunger rod of the pre-filled syringe and has an integral needle designed to perforate the plunger of the pre-filled syringe for fluid transfer from the syringe to the drug vial (connected using the vial socket) through the internal fluid path in the rod. Once reconstitution is complete, the device permits the transfer of the reconstituted drug product back to the syringe. The integral needle is retracted into the plunger rod by unscrewing the vial socket. The vial socket and vial are discarded, and the filled syringe containing reconstituted drug is ready for use and the drug product may be injected by means of the yet unexposed needle equipping the syringe.
The provided text describes a 510(k) summary for the Duoject Medical Systems Inc. Smart-Rod™ Reconstitution System. Here's a breakdown of the acceptance criteria and study information, based only on the provided text.
Acceptance Criteria and Device Performance
The provided document does not explicitly state specific numerical acceptance criteria or detail the performance metrics against such criteria. It broadly mentions "16 qualification tests" to demonstrate operational performance.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Not explicitly stated | "16 qualification tests were conducted to demonstrate the operational performance of the device, including attachment to vial and syringe, interaction with the vial stopper and the syringe plunger, operational performance and integrity during use." |
Study Information
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only mentions "16 qualification tests" were conducted, but does not provide the number of devices tested for each or across all tests.
- Data Provenance: Not specified. The country of origin of the data (e.g., Canada where the company is based, or another location) and whether the studies were retrospective or prospective are not mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" concept, typically related to clinical image interpretation or diagnostic accuracy studies, is not relevant to this device, which is a reconstitution system and not a diagnostic device. The performance testing described is engineering/functional in nature.
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Adjudication method for the test set:
- Not applicable. As noted above, the testing described appears to be functional/engineering performance testing, not involving human interpretation or clinical adjudication.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. The device is a "reconstitution system" and the described "Performance testing" relates to its operational functions (e.g., attachment, interaction, integrity), not diagnostic effectiveness or human reader performance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device (reconstitution system), not an algorithm or AI software. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For this type of device (fluid transfer system), "ground truth" would likely refer to objective engineering measurements or successful completion of specified functional tasks according to predetermined criteria. The document states "16 qualification tests were conducted to demonstrate the operational performance," implying objective, measurable outcomes for these tests, but does not detail the nature of these "ground truths" or their establishment.
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The sample size for the training set:
- Not applicable. As the device is a physical reconstitution system and not an AI/ML algorithm, there is no "training set" in the conventional sense of machine learning.
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How the ground truth for the training set was established:
- Not applicable, for the same reasons as point 7.
§ 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.