(105 days)
The Finger Guard® is intended for use as an accessory to a pulse oximeter reusable finger sensor / probe. When the clear Guard is placed on a digit and the sensor / probe placed over the Guard, it may provide a minimum barrier protection between the digit upon which it is placed and the probe. It can be used anywhere a pulse oximeter is needed.
The device is a tubular clear sheath/sleeve. It has an opening for insertion of a digit. The sleeve is placed on the digit, and the pulse oximeter sensor/probe is placed over the sleeve/sheath.
This submission is a 510(k) premarket notification for a Class II medical device, "The Finger Guard®," an accessory to a reusable oximeter finger sensor/probe. The device is a tubular clear sheath/sleeve designed to be placed on a digit, with the pulse oximeter sensor/probe placed over the sleeve, to provide a minimum physical barrier and help prevent gross contamination of the sensor/probe.
Based on the provided information, the submission does not include a study with acceptance criteria and reported device performance in the typical sense of a clinical or performance study for diagnostic accuracy or efficacy. Instead, the entirety of the submission focuses on demonstrating substantial equivalence to an existing predicate device, the Coverox Sheath (K964821).
The assessment for substantial equivalence is based on a comparison of intended use, materials of construction, technical characteristics, and product labeling between The Finger Guard® and the predicate device. The core argument for equivalence hinges on the idea that despite a slight technical difference in placement (on the finger versus on the probe), both devices achieve the same function of acting as a physical barrier for gross contamination without impeding the pulse oximeter's reading.
Therefore, many of the specific questions regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement are not applicable in this context. The "acceptance criteria" here are essentially whether the new device can be shown to be as safe and effective as the predicate device by meeting the FDA's criteria for substantial equivalence.
Here's an attempt to answer the questions based on the available information, noting when information is absent due to the nature of the submission:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission focusing on a physical barrier accessory, traditional performance metrics like sensitivity, specificity, accuracy, or clinical outcomes are not presented. The "acceptance criteria" are implied by the comparison to the predicate device, specifically:
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Intended Use: Similar to predicate. | Both devices are accessories to reusable pulse oximeter finger sensor/probes, providing a barrier against contamination. |
| Material: Biocompatible and transparent. | New device uses clear low-density polyethylene copolymer film. Predicate uses "clear plastic." Both are transparent. The new device's material is considered safe for skin contact. |
| Technical Characteristics: Allows oximeter reading; provides physical barrier. | The Finger Guard® is a clear plastic sleeve placed directly on the finger, transparent and thin enough to allow oximeter readings. It provides a physical barrier. The predicate also does this, though placed on the sensor/probe. |
| Safety: Does not introduce new safety concerns. | The difference in placement (on finger vs. on probe) does not raise new safety issues, as the same type of material contacts the skin. |
| Effectiveness: Similar effectiveness as a barrier. | Both provide a gross contamination barrier and allow for pulsation readings. |
| Labeling: Appropriate for single use, non-sterile, disposable. | Consistent with predicate (single use, non-sterile, disposable). New device specifies latex-free, powder-free. |
2. Sample size used for the test set and the data provenance
Not applicable. There was no formal "test set" in the sense of a data set used for performance evaluation of an algorithm or diagnostic device. The evaluation was a comparison of device characteristics to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth was established by experts for a test set. The substantial equivalence argument relies on the inherent characteristics of the device and comparison to an already cleared device.
4. Adjudication method for the test set
Not applicable. No adjudication method for a test set was mentioned, as there was no test set or clinical study.
5. 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 device is a physical accessory, not an AI-powered diagnostic tool. Therefore, an MRMC study and AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical accessory, not an algorithm.
7. The type of ground truth used
Not applicable. The "ground truth," in an indirect sense, would be the established safety and effectiveness of the existing predicate device, the Coverox Sheath, which the FDA had already cleared. The substantial equivalence relies on demonstrating that The Finger Guard® is sufficiently similar to this cleared device.
8. The sample size for the training set
Not applicable. There was no training set, as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established
Not applicable. There was no training set or associated ground truth.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).