(34 days)
The Drug Access Spike is a device used to aspirate solutions/medications from a drug container (drug vial/bag). The Drug Access Spike may incorporate componentry that aid in the prevention of accidental needle sticks.
The Drug Access Spike is a plastic conduit that is a means to access drug containers. The device is center on top of the stopper of a drug container. The Drug Access Spike is pushed through the rubber stopper and locks into position. A syringe is attached to the Drug Access Spike in order to draw from the drug container. After detaching the syringe, solution/medications are dispensed into a needleless injection site. The use of a Drug Access Spike eliminates the need for a conventional needle.
On multi-dose containers, a needleless injection site is bonded to the Drug Access Spike. This allows the drug container to be accessed multiple times while maintaining a physical barrier to prevent microbial ingress.
The needleless injection port incorporated into some of the configurations of the Drug Access Spike is the NAC " Needleless Access Connector. The NAC " Needleless Access Connector was previously cleared under SE-K011193 and SE-K992268.
Here's a breakdown of the acceptance criteria and study information for the Medegen Medical Manufacturing Services Drug Access Spike, based on the provided 510(k) summary:
This device (Drug Access Spike) is a relatively simple medical accessory, and as such, the "acceptance criteria" and "study" are not presented in the same highly quantitative, performance-metric-driven way you might see for a diagnostic AI device. Instead, the submission focuses on substantial equivalence to legally marketed predicate devices, and the "proof" is demonstrating that the new device shares the same intended use and technological characteristics, and raises no new questions of safety or effectiveness.
Therefore, for aspects related to "device performance" in the context of an AI-driven system, the information is largely absent or inferred, as it's not a diagnostic or decision-support tool.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this device (a drug access spike), the acceptance criteria are not in the form of specific performance metrics like sensitivity, specificity, or AUC, as would be common for AI-based diagnostic devices. Instead, they revolve around safety, functionality, and equivalence to existing devices.
| Acceptance Criteria Category | Specific Criteria (Inferred from 510(k)) | Reported Device Performance (Summary) |
|---|---|---|
| Intended Use | Must aspirate solutions/medications from a drug container (vial/bag) and potentially aid in prevention of accidental needle sticks. | The device description and intended use statement confirm it is designed to "aspirate solutions/medications from a drug container (drug vial/bag)" and "may incorporate componentry that aid in the prevention of accidental needle sticks." This directly aligns with the broader intended use of the predicate devices. |
| Technological Characteristics | Must function as a plastic conduit pushed through a stopper, locking into position, and allowing syringe attachment and medication dispensing. The needleless injection port (if present) must function to allow multiple accesses while maintaining a physical barrier to microbial ingress. | The device is described as "a plastic conduit that is a means to access drug containers," "pushed through the rubber stopper and locks into position," and allows a "syringe to be attached... to draw from the drug container." For multi-dose configurations, it explicitly states a "needleless injection site is bonded to the Drug Access Spike... allows the drug container to be accessed multiple times while maintaining a physical barrier to prevent microbial ingress." The NAC component was previously cleared under SE-K011193 and SE-K992268, indicating its established functionality and safety. |
| Biocompatibility | Materials must meet ISO 10993 Biocompatibility Requirements for External Communicating Devices, Indirect Blood Path. | "The materials used to manufacture the Drug Access Spike meet ISO 10993 Biocompatibility Requirements for External Communicating Devices, Indirect Blood Path." This is a direct statement of compliance. |
| Safety and Effectiveness | Must raise no new questions of safety or effectiveness compared to predicate devices. | Based on the FDA's decision to clear the device, it was deemed "substantially equivalent" to legally marketed predicate devices. This implicitly means the FDA found no new questions of safety or effectiveness were raised by the device's design, materials, or intended function compared to the predicates (ICU Medical's CLAVE Vial Access Spike (K934591), ICU Medical's One Time Vial Access Spike (K934561), and Baxter Healthcare Corp's Needle*Less Drug Vial Adapter (K894177)). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This device is a physical medical accessory, not an AI model that processes data or images. Performance is demonstrated through compliance with standards (biocompatibility) and functional description/comparison to predicates, rather than a data-driven "test set."
- Data Provenance: Not applicable for an AI test set. The "provenance" here relates to the predicate devices themselves, which are legally marketed in the US.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts & Qualifications: Not applicable. The "ground truth" for this device's safety and effectiveness is established by its compliance with recognized standards (ISO 10993), functional design, and comparison to existing, cleared devices. It does not involve expert review of data/images to establish a diagnostic ground truth.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no diagnostic test set requiring adjudication in this context.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. This is not an imaging or diagnostic device that involves human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this device's approval is based on:
- Regulatory Standards Compliance: Demonstrated adherence to ISO 10993 for biocompatibility.
- Functional Equivalence: The described mechanism of action and intended use are directly comparable to those of the predicate devices.
- Predicate Device History: The predicate devices themselves have an established history of safety and effectiveness on the market.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI model with a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. This is not an AI model.
Summary of the "Study" (Rationale for Acceptance):
The "study" or basis for acceptance described in this 510(k) is a substantial equivalence demonstration. This process involves:
- Identification of Predicate Devices: Three equivalent devices (from ICU Medical and Baxter Healthcare Corp) with established 510(k) clearances were identified.
- Comparison of Intended Use: The applicant demonstrated that the Drug Access Spike shares the same intended use as the predicate devices.
- Comparison of Technological Characteristics: The applicant detailed the physical design and function of the device, showing it operates similarly to the predicates. Specific mention of the previously cleared NAC component further supports this.
- Biocompatibility Testing: The device's materials were tested to meet the ISO 10993 standard for biocompatibility, addressing a key safety aspect.
- Conclusion of No New Questions of Safety or Effectiveness: By successfully demonstrating the above, the FDA concluded that the device is substantially equivalent to the predicates and raises no new questions of safety or effectiveness.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).