(120 days)
The intended use of this device is for the removal of 90° winged infusion sets, THE GRIPPER™, and VasTack™, having a 1-1/2" needle or shorter from implanted ports and the containment of the used needle until placed in a sharps container.
The MedCare Medical Group's HuberLoc is a device designed to assist in the removal and containment of Huber needles. The device consists of three plastic molded components; an inner slide and an outer housing, right and left halves. The HuberLoc is slid over the Huber needle, so the needle cannula is in the slot of the forks. Pressure is applied to the top of the HuberLoc to support the skin and the infusion port with your thumb. The first and middle finger of the same hand pull on the wings of the inner slide, in opposition to the thumb pressure. This action removes the Huber needle and draws it into the outer housing. The inner slide locks into place and contains the needle. The operation utilizes an easy one handed technique. This eliminates any rebound reflex. The HuberLoc is provided sterile, disposable, and for single patient use.
Here's an analysis of the provided text regarding the acceptance criteria and study for the HuberLocTM device:
Based on the provided K973497 510(k) summary, there is no explicit mention of acceptance criteria or a formal study with defined endpoints and statistical analysis to prove the device meets acceptance criteria. This submission focuses on demonstrating substantial equivalence to a predicate device, as was common for 510(k) submissions in 1998 for lower-risk devices.
Therefore, many of the requested sections below cannot be fully populated as they are not detailed in this type of regulatory submission.
Acceptance Criteria and Device Performance
There are no formal acceptance criteria or quantitative performance metrics explicitly stated in the 510(k) summary. The summary describes the device's function and claims without providing specific numerical targets for success.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Assists in the removal and containment of Huber needles. |
| Not specified | Eliminates any rebound reflex. |
| Not specified | Utilizes an easy one-handed technique. |
| Not specified | Reduces the potential of an inadvertent needle stick. |
| Not specified | Contains the removed contaminated sharps. |
Study Information (Based on available documentation)
1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document does not describe a formal test set or corresponding sample size.
- Data Provenance: Not specified. There is no mention of a study, so no data provenance is available.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There is no mention of a ground truth establishment process or experts in this 510(k) submission.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No formal test set or adjudication method is described.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This document describes a mechanical device, not an AI-assisted diagnostic tool. No MRMC study was conducted or mentioned.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a mechanical tool for needle removal and containment, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No formal ground truth was established as part of this submission. The device's functionality is described, and its "performance" is implied through its design features.
7. The sample size for the training set
- Not applicable. This is a mechanical device, not an AI/algorithm-based system requiring a training set.
8. How the ground truth for the training set was established
- Not applicable. As above, no training set was used.
Summary of Device Claims and Basis for Clearance:
The HuberLocTM device received 510(k) clearance based on demonstrating substantial equivalence to a predicate device (Doyle Extractor, K955748). The key differences highlighted are that the HuberLocTM provides containment of the removed sharps, which the predicate device does not. The claims revolve around reducing needle sticks, enabling one-handed operation, and eliminating rebound reflex.
This type of 510(k) submission focuses on comparing the new device's design, materials, and intended use to an already legally marketed device, rather than requiring extensive clinical trials or performance studies with explicit acceptance criteria. The "proof" is largely based on the engineering design and functional description, compared to an existing device with a similar purpose.
§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.
(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.