(53 days)
The Manual PD-IO, and Powered PD-IO provide intraosseous access in the distal tibia of pediatric patients as an alternative to IV access during emergencies.
The Manual PD-IO consists of a proprietary pentagon shaft permanently attached to an ergonomically designed handle. The manual driver is designed to allow the user to manually insert a needle set consisting of a stylet and catheter through the cortex of the bone to a desired depth within the bone marrow to facilitate the infusion of desired fluids. After insertion of the needle set into the bone, the manual driver is detached from the needle set, leaving the stylet and catheter firmly seated in the bone. The stylet is then separated and removed from the catheter by turning the stylet hub counter clockwise leaving a standard Luer lock catheter securely seated in the bone. The catheter Luer lock permits attachment of standard syringes and IV tubing for administration of drugs and fluids (not supplied).
The Powered PD-IO consists of a reusable battery powered driver connected to a single use disposable intraosseous (IO) needle assembly. Upon activation, the drill supplies power to the needle set in order to penetrate through the cortex of the bone to a desired depth within the bone marrow. After insertion of the needle set, the power driver is detached from the needle set, leaving the stylet and catheter firmly seated in the bone. The stylet is then separated and removed from the catheter by turning the stylet hub counter clockwise leaving a standard Luer lock catheter securely seated in the bone. The catheter Luer lock permits attachment of standard syringes and IV tubing for administration of drugs and fluids (not supplied).
The provided text describes a 510(k) submission for the Manual PD-IO and Powered PD-IO intraosseous infusion systems. It seeks to extend the indication for use to include the distal tibia in pediatric patients. The submission argues for substantial equivalence to previously cleared devices (K043490 and K051992 for the same devices in proximal tibia, and K913258 for Cook, Inc.'s Disposable Intraosseous Infusion Needles which include distal tibia access).
Based on the provided text, there is no detailed study proving device performance against specific acceptance criteria in the sense of a clinical trial with quantitative results, sample sizes, expert ground truth, or adjudication methods for this specific extended indication. The submission relies on the concept of substantial equivalence to predicate devices.
Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the document. The submission is based on the premise that since there are "no changes to the design or components" of the Manual PD-IO and Powered PD-IO systems previously cleared for proximal tibia use, and similar devices (Cook, Inc. needles) already have the indication for distal tibia, their devices are "substantially equivalent." Therefore, the acceptance criteria are implicitly met by demonstrating this substantial equivalence and by the predicate devices having met their own, unstated, acceptance criteria in their original clearances.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document for the new indication. The submission asserts "no changes to the design or components." | The devices are "substantially equivalent" to predicate devices already cleared for the specified uses or similar indications. The argument is that the technology is identical and the new site (distal tibia) is similar to the already cleared site (proximal tibia) or to sites cleared for predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable/Not provided. There is no specific "test set" or clinical data presented for this 510(k) submission to evaluate the devices for the extended indication. The submission relies on substantial equivalence to existing devices.
- Data Provenance: Not applicable/Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/Not provided. No new ground truth assessment by experts for a test set is mentioned.
- Qualifications of Experts: Not applicable/Not provided.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/Not provided. There is no "test set" requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- MRMC Study: No, an MRMC study was not done. This type of study is not relevant for this kind of device and its 510(k) submission, which focuses on mechanical function and equivalence rather than interpretive accuracy by human readers (like in imaging devices).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No, a standalone performance study was not done. This is fundamentally a medical device submission, not an AI algorithm submission. The device is a tool used by a human operator, making "standalone" performance in an AI context inapplicable.
7. The type of ground truth used
- Type of Ground Truth: The concept of "ground truth" as typically applied in AI or diagnostic imaging studies (e.g., pathology, outcomes data) is not directly applicable here. The ground truth for this submission is implicitly the established safety and effectiveness of the predicate devices (Manual PD-IO and Powered PD-IO for proximal tibia, and Cook Inc. needles for distal tibia) through their various clearances and historical use. The argument is that the technology is the same, just applied to a new anatomical site with similar characteristics or to a site already covered by a predicate.
8. The sample size for the training set
- Sample Size: Not applicable/Not provided. There is no "training set" in the context of this device and submission.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable/Not provided.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).